Media-delivered cognitive behavioural therapy and behavioural therapy (self-help) for anxiety disorders in adults

  • Review
  • Intervention

Authors


Abstract

Background

Anxiety disorders are the most common mental health problems. They are chronic and unremitting. Effective treatments are available, but access to services is limited. Media-delivered behavioural and cognitive behavioural interventions (self-help) aim to deliver treatment with less input from professionals compared with traditional therapies.

Objectives

To assess the effects of media-delivered behavioural and cognitive behavioural therapies for anxiety disorders in adults.

Search methods

Published and unpublished studies were considered without restriction by language or date. The Cochrane Depression, Anxiety and Neurosis Review Group's Specialized Register (CCDANCTR) was searched all years to 1 January 2013. The CCDANCTR includes relevant randomised controlled trials from the following bibliographic databases: The Cochrane Library (all years), EMBASE (1974 to date), MEDLINE (1950 to date) and PsycINFO (1967 to date). Complementary searches were carried out on Ovid MEDLINE (1950 to 23 February 2013) and PsycINFO (1987 to February, Week 2, 2013), together with International trial registries (the trials portal of the World Health Organization (ICTRP) and ClinicalTrials.gov). Reference lists from previous meta-analyses and reports of randomised controlled trials were checked, and authors were contacted for unpublished data.

Selection criteria

Randomised controlled trials of media-delivered behavioural or cognitive behavioural therapy in adults with anxiety disorders (other than post-traumatic stress disorder) compared with no intervention (including attention/relaxation controls) or compared with face-to-face therapy.

Data collection and analysis

Both review authors independently screened titles and abstracts. Study characteristics and outcomes were extracted in duplicate. Outcomes were combined using random-effects models, and tests for heterogeneity and for small study bias were conducted. We examined subgroup differences by type of disorder, type of intervention provided, type of media, and recruitment methods used.

Main results

One hundred and one studies with 8403 participants were included; 92 studies were included in the quantitative synthesis. These trials compared several types of media-delivered interventions (with varying levels of support) with no treatment and with face-to-face interventions. Inconsistency and risk of bias reduced our confidence in the overall results. For the primary outcome of symptoms of anxiety, moderate-quality evidence showed medium effects compared with no intervention (standardised mean difference (SMD) 0.67, 95% confidence interval (CI) 0.55 to 0.80; 72 studies, 4537 participants), and low-quality evidence of small effects favoured face-to-face therapy (SMD -0.23, 95% CI -0.36 to -0.09; 24 studies, 1360 participants). The intervention was associated with greater response than was seen with no treatment (risk ratio (RR) 2.34, 95% CI 1.81 to 3.03; 21 studies, 1547 participants) and was not significantly inferior to face-to-face therapy in these studies (RR 0.78, 95 % CI 0.56 to 1.09; 10 studies, 575 participants), but the latter comparison included versions of therapies that were not as comprehensive as those provided in routine clinical practice. Evidence suggested benefit for secondary outcome measures (depression, mental-health related disability, quality of life and dropout), but this evidence was of low to moderate quality. Evidence regarding harm was lacking.

Authors' conclusions

Self-help may be useful for people who are not able or are not willing to use other services for people with anxiety disorders; for people who can access it, face-to-face cognitive behavioural therapy is probably clinically superior. Economic analyses were beyond the scope of this review.

Important heterogeneity was noted across trials. Recent interventions for specific problems that incorporate clinician support may be more effective than transdiagnostic interventions (i.e. interventions for multiple disorders) provided with no guidance, but these issues are confounded in the available trials.

Although many small trials have been conducted, the generalisability of their findings is limited. Most interventions tested are not available to consumers. Self-help has been recommended as the first step in the treatment of some anxiety disorders, but the short-term and long-term effectiveness of media-delivered interventions has not been established. Large, pragmatic trials are needed to evaluate and to maximise the benefits of self-help interventions.

Résumé scientifique

La thérapie cognitivo-comportementale et la thérapie comportementale par media (auto-assistées) pour les troubles anxieux chez les adultes

Contexte

Les troubles anxieux sont les problèmes de santé mentale les plus courants. Ils sont chroniques et incessants. Des traitements efficaces sont disponibles, mais l'accès aux services est limité. La thérapie cognitivo-comportementale et la thérapie comportementale par media (auto-assistées) visent à administrer le traitement avec moins de participation des professionnels par rapport aux traitements conventionnels.

Objectifs

Évaluer les effets des thérapies cognitivo-comportementale et comportementale par media (auto-assistées) pour les troubles anxieux chez les adultes.

Stratégie de recherche documentaire

Les études publiées et non publiées ont été prises en compte sans restriction de langue ou de date. Le Cochrane Depression, Anxiety and Neurosis Review Group's Specialized Register(CCDANCTR) a fait l'objet de recherches dans toutes les années jusqu' au 1er janvier 2013. Le CCDANCTR comprend des essais contrôlés randomisés pertinents issus des bases de données bibliographiques suivantes: La Bibliothèque Cochrane (toutes les années), EMBASE (de 1974 à la date indiquée), MEDLINE (de 1950 à la date indiquée) et PsycINFO (1967 à la date indiquée). Des recherches complémentaires ont été effectuées dans Ovid MEDLINE (de 1950 jusqu' au 23 février 2013) et PsycINFO (de 1987 à février, la semaine 2, 2013), ainsi que dans les registres d'essais internationaux(portail des essais de l'Organisation Mondiale de la Santé (ICTRP) and ClinicalTrials.gov).. Les listes de références bibliographiques des méta-analyses précédentes et les rapports d'essais contrôlés randomisés ont été examinés, et les auteurs ont été contactés pour obtenir des données non publiées.

Critères de sélection

Les essais contrôlés randomisés de thérapie comportementale ou cognitivo-comportementale par media chez les adultes atteints de troubles anxieux (autres que le trouble de stress post-traumatique) par rapport à l'absence d'intervention (y compris les contrôles en attention/relaxation) ou par rapport à un traitement en face à face.

Recueil et analyse des données

Les deux auteurs de la revue ont indépendamment passé au crible les titres et résumés. Les caractéristiques des études et les résultats ont fait l'objet d'une double extraction. Les résultats ont été combinés en utilisant des modèles à effets aléatoires, et des tests d'hétérogénéité et de biais pour études de petite taille ont été réalisés. Nous avons examiné les différences en sous-groupes par type de trouble, par type d'intervention fournie, par type de média, et par méthode de recrutement utilisée.

Résultats principaux

Cent et une études totalisant 8403 participants ont été inclues; 92 études ont été incluses dans la synthèse quantitative. Ces essais comparaient différents types d'interventions par media (avec différents niveaux de soutien) avec l'absence de traitement et avec des interventions en face à face. L'hétérogénéité et le risque de biais réduisent notre confiance dans les résultats globaux. Pour le critère de jugement principal relatif aux symptômes d'anxiété, des preuves de qualité modérée ont montré des effets moyens par rapport à l'absence d'intervention (différence moyenne standardisée (DMS) 0,67, intervalle de confiance (IC) à 95% 0,55 à 0,80; 72 études, 4537 participants), et des preuves de médiocre qualité de petits effets en faveur de la thérapie en face à face (DMS -0,23, IC à 95% -0,36 à -0,09; 24 études, 1360 participants). L'intervention était associée à une réponse plus grande que celle observée avec l'absence de traitement (risque relatif (RR) 2,34, IC à 95% 1,81 à 3,03; 21 études, 1547 participants) et n'était pas significativement inférieure à un traitement en face à face dans ces études (RR 0,78, IC à 95% 0,56 à 1,09; 10 études, a participants), mais cette dernière comparaison incluait des versions de traitements qui n'étaient pas aussi exhaustives que celles dispensées dans la pratique clinique courante. Des preuves suggéraient un bénéfice pour les critères de jugement secondaires (dépression, incapacités liées à la santé mentale, qualité de vie et sortie d'étude), mais ces preuves étaient de qualité faible à modérée. Les preuves concernant les effets délétères étaient absentes.

Conclusions des auteurs

L'auto-assistance peut être utile pour les personnes qui ne sont pas en mesure ou ne sont pas disposées à utiliser d'autres services destinés aux patients atteints de troubles anxieux; pour les personnes qui peuvent y avoir accès la thérapie cognitivo-comportementale en face à face, est probablement cliniquement supérieure. Les analyses économiques n'étaient pas dans le champ de cette revue.

Une importante hétérogénéité entre les essais a été observée. De récentes interventions pour des problèmes spécifiques qui incorporent une aide de cliniciens sont peut être plus efficaces que les interventions "transdiagnostiques" ( comme par exemple les interventions pour plusieurs troubles ) fournies sans recommandations, mais ces questions sont irrésolues dans les essais disponibles.

Bien que de nombreux essais de petite taille ont été réalisés, la possibilité de généraliser leurs résultats est limitée. La plupart des interventions testées ne sont pas disponibles pour les consommateurs. L'auto-assistance a été recommandée comme la première étape dans le traitement de certains troubles anxieux, mais l'efficacité à court terme et à long terme des interventions par média n'a pas été établie. De grands essais pragmatiques sont nécessaires pour évaluer et optimiser les bénéfices des interventions d'auto-assistance.

Plain language summary

Self-help for anxiety disorders

Anxiety disorders are common. They interfere with normal living, and they tend not to go away without treatment. Effective treatments are available, including cognitive behavioural therapy. These are known to work when delivered in person, but many people cannot access face-to-face treatment. This review examined 101 clinical trials of self-help and statistically analysed 92 of them. In these trials, 8403 people received self-help or were assigned to a control condition. 

Overall, self-help with some support from a professional appears to be more effective than no treatment. Only half of the people who used self-help were better at the end of treatment, but self-help may still be considered effective because people with anxiety do not tend to get better without treatment. Self-help may be less effective than normal face-to-face therapy. Some results were difficult to interpret because the effects of treatments varied and the risk of overestimating the results was serious because of limitations in the study methods. We conclude that self-help is probably better than no treatment, but many people with an anxiety disorder would get better results from treatment provided by a skilled psychologist. Furthermore, most of the self-help materials used in these studies are intended for research and are not available to the public, so the results reported here may not apply to commercially available products.

Résumé simplifié

Auto-assistance pour le traitement des troubles anxieux

Les troubles anxieux sont courants. Ils interfèrent avec les activités normales, et ils ont tendance à ne pas disparaître sans traitement. Des traitements efficaces sont disponibles, notamment la thérapie cognitivo-comportementale. Ces traitements sont connus pour fonctionner lorsqu' ils sont administrés en direct, mais de nombreuses personnes ne peuvent pas avoir accès au traitement en face à face. Cette revue a examiné 101 essais cliniques d'auto-assistance et a analysé statistiquement 92 d'entre eux. Dans ces essais, 8403 personnes ont reçu l'auto-assistance ou ont été assignés à un groupe de contrôle. 

Globalement, l'auto-assistance accompagnée d'une certaine forme d'aide par un professionnel apparaît plus efficace que l'absence de traitement. Seule la moitié des personnes ayant utilisé l'auto-assistance étaient mieux à la fin du traitement, mais l'auto-assistance peut encore être considérée comme efficace, car les personnes souffrant d'anxiété ont tendance à ne pas être améliorées sans traitement. L'auto-assistance pourrait être moins efficace que le traitement normal en face à face. Certains résultats étaient difficiles à interpréter car les effets des traitements étaient variables et le risque de surestimation des résultats était sérieux en raison de limitations dans les méthodes d'étude. Nous avons conclu que l'auto-assistance est probablement meilleure que l'absence de traitement, mais de nombreuses personnes souffrant d'un trouble anxieux auraient de meilleurs résultats avec un traitement fourni par un psychologue qualifié. En outre, la plupart des documents d'auto-assistance utilisés dans ces études sont conçus pour la recherche et ne sont pas disponibles pour le public, de sorte que les résultats rapportés ici peuvent ne pas s'appliquer aux produits disponibles dans le commerce.

Notes de traduction

Traduit par: French Cochrane Centre 15th December, 2013
Traduction financée par: Financeurs pour le Canada : Instituts de Recherche en Sant� du Canada, Minist�re de la Sant� et des Services Sociaux du Qu�bec, Fonds de recherche du Qu�bec-Sant� et Institut National d'Excellence en Sant� et en Services Sociaux; pour la France : Minist�re en charge de la Sant�

Laički sažetak

Samopomoć za anksiozne poremećaje

Anksiozni poremećaji česta su pojava. Sprječavaju normalno svakodnevno funkcioniranje osobe, a najčešće ne nestaju bez liječenja. Dostupne su učinkovite metode liječenja za anksioznost, uključujući kognitivno-bihevioralnu terapiju. Poznato je da te metode djeluju kada ih pruža direktno terapeut, no velikome broju ljudi nije dostupna takva terapija licem u lice. Ovaj je Cochrane sustavni pregled uključio je 101 klinički pokus o samopomoći za anksioznost i statistički obradio njih 92. U tim je istraživanjima sudjelovalo 8403 ispitanika u skupini koja je ispitivala učinkovitost samopomoći ili u kontrolnoj skupini.

Analizirani dokazi pokazuju da se samopomoć uz neki oblik profesionalne podrške čini učinkovitijom nego nikakvo liječenje. Samo je polovica ljudi koja je koristila samopomoć bila bolje na kraju liječenja, ali se samopomoć svejedno smatra učinkovitom s obzirom da se ljudi s anksioznošću ne oporavljaju bez liječenja. Samopomoć može biti manje učinkovita nego terapija licem u lice. Neke je rezultate bilo teško protumačiti jer su se učinci liječenja razlikovali i postojao je ozbiljan rizik od precjenjivanja rezultata zbog ograničenja u metodama istraživanja. Autori zaključuju da je samopomoć vjerojatno bolja nego nedostatak liječenja uopće, ali da bi ljudi s anksioznim poremećajem imali bolje rezultate liječenja ako bi im terapiju pružio stručni psiholog. Nadalje, većina materijala samopomoći korištena u ovome istraživanju namijenjena je istraživanjima i nije otvorena javnosti pa ovdje navedeni rezultati možda neće biti primjenjivi na komercijalno dostupne proizvode.

Bilješke prijevoda

Hrvatski Cochrane ogranak.
Prevela: Marija Franka Marušić

Summary of findings(Explanation)

Summary of findings for the main comparison. 
  1. 1Downgraded for inconsistency.

    2Downgraded for risk of bias.

Media-delivered interventions compared with no intervention for anxiety disorders

Patient or population: adults with anxiety

Settings: recruited from referrals and advertising

Intervention: media-delivered cognitive behavioural therapy or behavioural therapy

Comparison: wait-list, no intervention, treatment as usual

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No. of participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
No interventionMedia-delivered intervention
Anxiety (any measure), self-rated at post-treatment Across studies, the typical scores in intervention conditions were, on average, 0.67 standard deviations better (with a 95% CI ranging from 0.55 to 0.78 standard deviations) than scores in the control conditions 

4537

(72 studies)

⊕⊕⊕⊝
moderate 1
This is a medium effect
Response (specific), self-rated at post-treatment 180 per 1000 421 per 1000 RR 2.34 (1.81 to 3.03)

1547

(21 studies)

⊕⊕⊝⊝
low 1,2
The probability of clinical improvement doubled, but most people did not improve
Depression, self-rated at post-treatment Across studies, the typical scores in intervention conditions were, on average, 0.47 standard deviations better (with a 95% CI ranging from 0.36 to 0.58 standard deviations) than scores in the control conditions 

3682

(50 studies)

⊕⊕⊕⊝
moderate 1
This is a medium effect
Quality of life, self-rated at post-treatment Across studies, the typical scores in intervention conditions were, on average, 0.36 standard deviations better (with a 95% CI ranging from 0.22 to 0.49 standard deviations) than scores in the control conditions 

1344

(18 studies)

⊕⊕⊝⊝
low 1,2
This is a medium effect
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio.
GRADE Working Group grades of evidence:
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Summary of findings 2

Summary of findings 2. 
  1. 1Downgraded for inconsistency.

    2Downgraded for risk of bias.

    3Downgraded for indirectness.

Media-delivered interventions compared with face-to-face intervention for anxiety disorders

Patient or population: adults with anxiety

Settings: recruited from referrals and advertising

Intervention: media-delivered cognitive behavioural therapy or behavioural therapy

Comparison: face-to-face interventions

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No. of participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Face-to-face interventionMedia-delivered intervention
Anxiety (any measure), self-rated at post-treatment 

SMD -0.23 (-0.36 to -0.09)

Across studies, the typical scores in intervention conditions were, on average, 0.23 standard deviations worse (with a 95% CI ranging from 0.09 to 0.36 standard deviations) than scores in the control conditions

 1360 (24)⊕⊕⊝⊝
low 2,3
This is a small effect in favour of face-to-face intervention
Response (specific), self-rated at post-treatment 537 per 1000 419 per 1000 RR 0.78 (0.56 to 1.09) 575 (10)⊕⊝⊝⊝
very low1,2,3
The difference was not statistically significant
Depression, self-rated at post-treatment Across studies, the typical scores in intervention conditions were, on average, 0.01 standard deviations worse (with a 95% CI ranging from -0.21 to 0.22 standard deviations) than scores in the control conditions 906 (13)⊕⊝⊝⊝
very low 1,2,3
The difference was not statistically significant
Quality of life, self-rated at post-treatment Across studies, the typical scores in intervention conditions were, on average, 0.08 standard deviations better (with a 95% CI ranging from -0.23 to 0.38 standard deviations) than scores in the control conditions 282 (4)⊕⊝⊝⊝
very low 1,2,3
The difference was not statistically significant
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio.
GRADE Working Group grades of evidence:
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Background

Description of the condition

Anxiety disorders include generalised anxiety disorder (GAD), obsessive compulsive disorder (OCD), panic disorder (with or without agoraphobia), social phobia (social anxiety disorder) and specific phobias (APA 1994). They are characterised by excessive fears and worries that are difficult to control. Avoidance of feared situations or stimuli (including thoughts) is a cardinal behavioural feature of most anxiety disorders. 

Anxiety disorders are the most common class of mental disorders. They are seen across cultures (Demyttenaere 2004) and will be experienced by about 18% of adults every year and by about 32% of people during their lifetimes (Kessler 2005a; Kessler 2005b). Half of all anxiety disorders begin by the age of 11 years (Kessler 2005a; Kessler 2005b), and most are chronic and unremitting (Bruce 2005). Anxiety reduces quality of life (Cramer 2005; Rapaport 2005; Saarni 2007) and contributes to disability (Bloom 2011), causing severe occupational impairment and lost productivity (Greenberg 1999, Ormel 1994). Despite their severity and prevalence, few people with anxiety disorders ever obtain professional treatment, and fewer obtain specialty care (Wittchen 2002).

Description of the intervention

Cognitive behavioural therapy (CBT) and behavioural therapy (BT) are well-established and effective treatments in the short and medium term (Mitte 2005a; Mitte 2005b; Butler 2006). They are the most researched therapies for anxiety, and they are recommended by the National Institute for Health and Care Excellence (NICE) as front-line treatments for both adults and young people (Kendall 2011; NCCMH 2006; Pilling 2013). Despite its effectiveness, face-to-face therapy is expensive and difficult to access.

To increase access to care and to reduce burden on therapists, computer programmes, books and other types of media have been developed to deliver CBT and BT. Self-help has been defined as "(a) a therapeutic intervention administered through text-audiotape, videotape or computer text, or through group meetings or individual exercises such as ‘therapeutic writing’, and (b) designed to be conducted predominantly independently of professional contact" (Bower 2001). Guided self-help usually involves minimal contact that is primarily "of supportive or facilitative nature, and is meant to support the patient in working through the standardised psychological treatment" (Cuijpers 2010); it is commonly prescribed in primary and secondary care (Clark 2009). An overwhelming majority of behavioural and cognitive therapists use self-help materials, most often in addition to traditional therapy (Keeley 2002).

How the intervention might work

Behavioural therapy has proved effective in the treatment of people with anxiety. Exposure therapy puts participants in direct and prolonged contact with feared situations (Marks 1971). Exposure in vivo (Emmelkamp 1975) aims to evoke fearful responses and to help participants develop coping strategies that will generalise to everyday circumstances (Foa 1986). Some reviews suggest that progressive muscle relaxation (Jacobson 1938) and controlled breathing are efficacious (Conrad 2007). Little evidence of long-term benefit has been found when relaxation is used alone; muscle relaxation is sometimes used as an attentional control in the evaluation of treatments for anxiety. Applied relaxation teaches users to use relaxation techniques as coping mechanisms during exposure therapy, and it may provide some other benefits (Öst 1987; Öst 1988).

Cognitive behavioural therapy often includes (1) behavioural experiments, which aim to test one’s fears rather than habituate to a stimulus (Bennett-Levy 2004), and (2) cognitive restructuring, which teaches people to recognise negative thoughts as they occur and to challenge unrealistic thoughts (Wells 1997). Treatment for anxiety may include other specific techniques, including exposure with ritual prevention for OCD (Steketee 1982), attention training for social anxiety (Rapee 2009) and meta-cognitive training for GAD (Wells 2006). CBT may also include many non-specific components that are common to effective forms of psychotherapy (e.g. goal setting, psychoeducation).

Why it is important to do this review

Media-delivered interventions are intended to be inexpensive and easily accessible. Many literature reviews (Bessell 2002; Bower 2001; Glasgow 1978; Kaltenthaler 2002; Newman 2003; Richards 2003b; Riordan 1989; Schrank 1981; Stevens 1982; Mataix-Cols 2006; Przeworski 2006; Pull 2006; van Boeijen 2005b) and meta-analyses (Andrews 2010; Bower 2001; Cuijpers 2009; Cuijpers 2010; den Boer 2004; Gould 1993b; Griffiths 2006; Griffiths 2010b; Haug 2012; Hirai 2006; Kaltenthaler 2008; Lewis 2012; Marrs 1995; Menchola 2007; Norton 2007; Reger 2009; Scogin 1990; Spek 2007) have suggested that media-delivered CBT may be effective in treating psychological problems, including anxiety, alone or in conjunction with other interventions.

Differences in inclusion criteria and methodological inconsistencies contribute to different conclusions across these reviews. An analysis of interventions for GAD found a large overall effect (g = 0.80, 95% CI 0.29 to 1.30) but significant heterogeneity (Mitte 2005a), similar to a recent review (Haug 2012), which reported a large effect across disorders (g = 0.78, 95% CI 0.67 to 0.90). However, another review (Bower 2001) reports a much smaller effect of self-help manuals (d = 0.41; 95% CI 0.09 to 0.72), similar to an earlier review of bibliotherapy for many conditions (Marrs 1995). Several reviews reference the Cochrane Handbook for Systematic Reviews of Interventions, but one summed items on the risk of bias tool and failed to follow Cochrane methods for assessing each item (Andrews 2010). Despite the title, one recent review was not systematic (Wade 2010). A recent meta-analysis (Lewis 2012) missed many studies that should have been included and suggested that media-delivered interventions have large effects. The most recent analysis used single coding and included no assessment of bias (Haug 2012). Research in this area is advancing quickly, with many studies reported each year, and a rigorous and up-to-date review is needed to estimate the effects of media-delivered interventions provided with or without professional support.

Objectives

To assess the effects of media-delivered behavioural and cognitive behavioural therapies for anxiety disorders in adults.

Methods

Criteria for considering studies for this review

Types of studies

Randomised controlled trials and cluster-randomised trials with a parallel-group design, in which intervention and control groups were enrolled concurrently.

Types of participants

Adults (older than 18 years) with an anxiety disorder (as measured through diagnostic interview or questionnaire) other than post-traumatic stress disorder (PTSD) or acute stress disorder were included.

We included studies of health anxiety because it shares the cardinal features of anxiety disorders, and it is included in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), as “illness anxiety disorder”.  

We excluded PTSD and acute stress disorder, which differ from other anxiety disorders. They may involve physical injury, difficulty separating past from present events and feelings of guilt. Reactions to severe stress are treated separately in the Tenth Revision of the International Classification of Diseases (ICD-10) and in DSM-V.

Studies of people experiencing worries or stress as the result of upcoming events (e.g. medical procedures) were excluded unless participants demonstrated symptoms of an underlying anxiety disorder (e.g. phobic avoidance of dental examinations). Other fears were excluded (e.g. "test anxiety", "fear of public speaking") unless participants met criteria for an anxiety disorder (e.g. specific phobia, social anxiety).

Studies including participants with other problems (e.g. depression) were eligible if participants with anxiety (including those with co-morbid problems) could be separated from other participants (i.e. those whose problems do not include anxiety), or if most of the population had an anxiety disorder. In the absence of diagnostic interviews, studies were included when average scores on validated measures of anxiety were indicative of caseness.

No restrictions by setting were applied.

Types of interventions

Experimential intervention

Interventions must have delivered CBT or BT using printed materials, audio recordings, video recordings, or computers (including Internet), or via some combination of media. It must have been possible to use them as stand-alone interventions (i.e. without a therapist), but we included studies with researcher or therapist contact and support. Computer programmes that could be used without the aid of a therapist were included whilst virtual reality systems, which use technology to facilitate therapist-delivered interventions, were excluded. Interventions that encouraged users to enlist the help of a spouse or a friend were included.

We included studies of media-delivered interventions alone and studies of media-delivered interventions as adjuncts to treatment as usual or another intervention.

Comparator

We compared media-delivered interventions with no intervention and with face-to-face behavioural or cognitive behavioural interventions. Only intervention arms in which the difference was a media-delivered intervention were compared. Thus, '10 hours of therapy' versus '10 hours of therapy plus booklet-delivered CBT' was eligible; '10 hours of therapy' versus '5 hours of therapy plus booklet-delivered CBT' was not eligible. If data had been available, we also would have compared media-delivered interventions with medication, psychoeducation and other forms of media-delivered interventions.

If it had been possible to analyse the effects of media-delivered interventions with and without adjunct medication, we would have treated these separately; most trials included participants with and without concurrent medication, so it was not possible to separate “standalone” and “adjunct” treatments. Instead, we report the number of participants in each trial who are taking medication.

Types of outcome measures

Clinician- and self-rated measures were analysed separately because service users and clinicians may have different views about a person's improvement, and because these outcomes may be at risk of bias for different reasons.

Primary outcomes

1. Symptoms of anxiety:

a) Continuous symptom measures (e.g. Agoraphobic Cognitions Questionnaire (Chambless 1984), Beck Anxiety Inventory (Beck 1988), Liebowitz Social Anxiety Scale (Liebowitz 1987));

b) Response (e.g. Clinical Global Impression (Zaider 2003));

c) Recovery (e.g. no longer met criteria for diagnosis).

Secondary outcomes

2. Behavioural test (level of hierarchy achieved).

3. Behavioural test (subjective units of distress).

4. Depression.

5. Mental-health related disability.

6. Quality of life.

7. Dropout.

Timing of outcome assessment

Outcome measures were grouped by length of follow-up. We analysed outcomes at post-treatment, at follow-up less than six months after randomisation and at follow-up longer than six months after randomisation. For outcomes measured at multiple time points in a single period, we included the longest time point after randomisation.

Search methods for identification of studies

Published and unpublished studies were considered without language restriction, although all searches were conducted in English and all contacts with authors were initiated in English. No date restrictions were applied.

Electronic searches

Searches were conducted using the following databases (Appendix 1).

  • The Cochrane Depression, Anxiety and Neurosis Review Group's Specialized Register (CCDANCTR-Studies and CCDANCTR-References) (all years to 1 January 2013). This search was conducted at the editorial base by the Group's Trials Search Co-ordinator (TSC).

  • The Cochrane Central Register of Controlled Trials (CENTRAL) (all years to 2 April 2012) restricted to records submitted from the CCDANCTR-References Register (SR-DEPRESSN). Original search was conducted by the author team.

  • Ovid MEDLINE (all years to 23 February 2013).

  • Ovid PsycINFO (all years to February, Week 2, 2013).

International trial registries were also searched via the World Health Organization's trials portal (ICTRP) and ClinicalTrials.gov to identify unpublished or ongoing studies (all years to 1 Januray 2013).

Searching other resources

References from previous meta-analyses and from articles retrieved during the search were examined for additional studies, and authors of included studies were contacted for unpublished data.

Data collection and analysis

Selection of studies

Two review authors independently screened titles and abstracts to determine which were eligible for inclusion. We were not blind to study authors, institutions, journal of publication or results. Disagreements regarding eligibility were resolved by seeking additional information and through discussion.

Data extraction and management

Data regarding methodology and outcomes were extracted independently in Excel by EM-W and a second rater.

We included the following information from each study:

  • Year;

  • Location (country, urban/rural);

  • Method of recruitment;

  • Diagnosis (DSM category, method of assessment);

  • Inclusion criteria;

  • Risk of bias (see later).

Participants:

  • Socio-demographics (e.g. age, sex);

  • Co-morbidities.

For each intervention and comparison group of interest:

  • Type of intervention;

  • Type of media;

  • Duration;

  • Contact with participants.

For each outcome of interest:

  • Time points (collected and reported);

  • Loss to follow-up.

Main comparisons
  1. Media-delivered intervention versus no treatment.

  2. Media-delivered intervention versus face-to-face intervention.

  3. Media-delivered intervention versus psychoeducation.

  4. Media-delivered intervention versus medication.

Assessment of risk of bias in included studies

EM-W and a second rater (JJ, RC or AH) coded each included study using the Cochrane Collaboration's tool for assessing risk of bias (Higgins 2011). We judged whether each study was at low, high or unclear risk of bias in relation to sequence generation; allocation concealment; blinding of personnel; blinding of outcome assessors; incomplete outcome data; selective outcome reporting; and other sources of bias. Disagreements were resolved through discussion and by seeking further information.

Measures of treatment effect

Studies often report outcomes using multiple definitions and outcome measures. We gave preference to data that involved the least manipulation by authors or inference by review authors, that is, we extracted raw values at endpoint (e.g. means, standard deviations) rather than calculated effect sizes (e.g. Cohen’s d).

Unit of analysis issues

Cluster-randomised trials

For each cluster-randomised trial, we would have determined whether or not its data incorporated sufficient controls for clustering (e.g. robust standard errors, hierarchical linear models). If the data did not have proper controls, then we would have attempted to obtain an appropriate estimate of the data’s intra-cluster correlation coefficient (ICC). If we could not find an estimate in the report of the trial, then we would have requested an estimate from the trial report authors. If the authors could not provide an estimate, then we would have obtained one from a similar study and conducted a sensitivity analysis to determine whether the results were robust when different values were imputed. We would have used the ICC estimate to control the trial’s data for clustering (Higgins 2011).

Cross-over trials

For cross-over trials, we extracted and analysed data from the first period only.

Studies with multiple treatment groups

For factorial studies, we included all comparisons. In other studies with multiple eligible intervention groups (e.g. interventions with or without a specific component), all eligible intervention groups were combined to estimate an average treatment effect compared with the control.

Dealing with missing data

Missing data, and methods for imputing such data, may affect the magnitude and direction of effects. For all analyses, we attempted to include all randomly assigned study participants. When analyses were reported for completers and controlled for the effects of missing cases (e.g. using mixed effects), we extracted the latter. If data were missing for some cases, or if reasons for dropout were not reported, we contacted study authors to request missing data and further information about dropouts. We conducted a sensitivity analysis that excluded studies at high risk of bias (see Sensitivity analysis).

Assessment of heterogeneity

Differences among included studies are discussed in terms of their participants, interventions, outcomes and methods. For each meta-analysis, we also visually inspected forest plots to see whether the confidence intervals of individual studies had poor overlap (a rough indication of statistical heterogeneity); conducted a Chi2 test; and calculated the I2 statistic (Higgins 2011). We considered meta-analyses to have heterogeneity when the P value for Chi2 was less than 0.10 and I2 was greater than 25%.

Assessment of reporting biases

For each meta-analysis that included 10 or more studies, we drew a funnel plot and looked for asymmetry to assess the possibility of small study or reporting bias. We also compared effects using random-effects and fixed-effect models (see Sensitivity analysis), and we identified unpublished studies through correspondence and trial registration databases.

Data synthesis

In studies of transdiagnostic interventions (i.e. interventions for multiple anxiety disorders) that reported outcomes separately for participants with specific diagnoses (e.g. panic disorder, social anxiety), symptoms of anxiety were extracted for each diagnostic group where possible.

We used Review Manager (RevMan) Version 5.1 (Review Manager 2011) to conduct all meta-analyses. Risk ratios (RRs) and 95% confidence intervals (CIs) were calculated for dichotomous outcomes and were combined with the use of Mantel-Haenszel methods. Standardised mean differences (SMDs) and 95% CIs were calculated for continuous measures and were combined by using inverse variance methods. Random-effects models were used because studies included different interventions and populations. When studies reported more than one measure of a particular outcome (e.g. symptoms of social anxiety measured using two scales), we averaged the results in Comprehensive Meta-Analysis Version 2 software (Borenstein 2005) before entering them into RevMan (e.g. Imdad 2010); the specific measures included in each analysis for each study are listed in the Characteristics of included studies.  For all analyses, the area to the right of the 'line of no effect' (SMD > 0, RR > 1) indicates a favourable outcome for media-delivered interventions.

Subgroup analysis and investigation of heterogeneity

For the primary outcome, we conducted the following subgroup analyses to explore possible differences across the disorders and interventions included in this review. Because many factors co-varied (e.g. several research groups contributed multiple studies in which the intervention and the population were very similar), these were considered hypothesis generating rather than hypothesis testing.

  1. Types of controls.

    1. Wait-list, attention controls, treatment as usual, adjunct to a treatment versus other treatment alone.

    2. Group psychotherapy, individual psychotherapy.

  2. Types of disorders: GAD, health anxiety, mixed populations, OCD, panic disorder, social anxiety, specific phobias.

  3. Types of interventions: CBT, exposure/desensitisation, relaxation.

  4. Types of media: book, computer/Internet, other.

  5. Types of recruitment: advertising only, referral only, other.

In future updates, we plan to investigate the level of therapist contact as a subgroup analysis.

Sensitivity analysis

We conducted the following sensitivity analyses to determine whether findings were robust to methodological decisions made throughout the review process.

  1. We repeated the analyses using fixed-effect models.

  2. To investigate the influence of bias, we repeated the primary meta-analysis by excluding studies at high risk of bias as the result of incomplete outcome data, which we considered the most important source of bias in the available data.

Results

Description of studies

Results of the search

The searches retrieved 1456 (CCDANCTR) and 1323 (Medline and PsycINFO) citations (Figure 1). After duplicates were removed electronically, two review authors screened 2801 abstracts.

Figure 1.

Study flow diagram.

Included studies

One hundred and one studies reported in 159 papers were included. Eighteen studies included multiple eligible comparisons, which we treated separately, and 21 studies included multiple eligible intervention groups, which we combined for analysis.

Included studies randomly assigned 8403 participants (mean 83, median 60); the largest included 274 participants with anxiety, depression or mixed anxiety and depression (Proudfoot 2004a). Across studies, approximately 4277 participants received media-delivered intervention, 2850 received no intervention, 916 received face-to-face intervention and 383 were assigned to a group not included in this review.

Ten included studies were not included in the quantitative synthesis because they reported no outcome data that could be analysed (Barrera 1977; Botella 2009; Holdsworth 1996; Koszycki 2011; Salaberria 1995; Tyrer 1988) or compared only two eligible interventions (Fraser 2001; Matthews 2011; Titov 2010b; Tortella-Feliu 2011). Thus, characteristics are described for 101 studies, and 91 are included in a meta-analysis.

Design

All studies randomly assigned individuals (Characteristics of included studies). One study randomly assigned general practices, then randomly assigned participants within practices (van Boeijen 2005a).

Setting

Studies were reported between 1973 and 2012; more were reported in 2011 than in any previous year. Most were conducted in four countries: UK (26), Australia (21), USA (17) and Sweden (20).

Participants

Studies included participants who were predominantly female (67% mean of means), white (94%) and in their 30s (37 years), who had more than a high school education (13 years). Most had long-standing disorders (14 years), and many participants were taking an antidepressant or some other psychiatric medication (35%).

Interventions targeted panic (19 panic disorder, 3 panic disorder with agoraphobia, 3 panic attacks), social anxiety (19 unspecified, 2 specific subtype, 2 general subtype), specific phobias (11 spider, 2 snake, 1 flying, 1 heights), GAD (10), OCD (5), health anxiety (2), several diagnoses (11) or unspecified symptoms of anxiety (14). Some studies included participants with symptoms of anxiety or depression (9); these were included because a minority of participants had depression only, and further details are included in the Characteristics of included studies (Fletcher 2005; Grime 2004; Holdsworth 1996; Maunder 2009; Mead 2005; Proudfoot 2004a; Seekles 2011; Tyrer 1988; Zetterqvist 2003). Most studies assessed participants through a clinical interview (61 face-to-face interviews, 28 telephone interviews) or relied on a previous diagnosis (2), although some used questionnaires (10).

Participants were recruited through advertising (56), referral (24), mixed advertising and referral (15), college classes (Lewis 1978; Muller 2011; Shoenberger 2008), prison (Maunder 2009) or workplace (Grime 2004); the recruitment strategy was unclear in one study (Tolin 2011). Exclusion rates varied with method of recruitment and ranged from 0% to 99% (mean 48%). Studies reported that participants were excluded for suicidality (66), depression (54), drug or alcohol misuse (53) or physical health problems (33). Studies also explicitly excluded participants who had received psychotherapy previously (20) or were receiving it currently (64). Most studies (66) restricted the amount or type of medication that participants could be taking or asked participants to remain on a stable dose throughout the study.

Interventions

Of the included studies, 81 compared a media-delivered intervention with no treatment (including wait-list and attention controls). Additionally, 29 compared a media-delivered intervention with a face-to-face intervention. Four compared a media-delivered intervention only with another form of media-delivered intervention; studies including more than one type of media-delivered intervention and those comparing multiple forms of media-delivered intervention only were idiosyncratic in design and objectives, thus a systematic synthesis was not possible. No studies that included a medication group reported outcomes that could be synthesised (Koszycki 2011; Tyrer 1988). Some studies provided information about anxiety or relaxation instructions to control for non-specific intervention factors (Al-Kubaisy 1992; Carlbring 2003; Furmark 2009b; Gilroy 2000; Greist 2002; Marks 2004; Schneider 2005); we treated these as attention controls rather than as active comparisons because the comparisons were described with the use of terms like “relaxation placebo” (Gilroy 2000) and “self-relaxation as a placebo” (Marks 2004).

In most studies, interventions were developed by the authors (89). Exposure and behavioural experiments were the most common components (84). Most studies provided a version of cognitive behavioural therapy (70); others tested exposure alone (19), desensitisation alone (2), muscle relaxation (6), applied relaxation (3) or “self-examination therapy”, which the author described as a type of CBT but which appears similar to problem solving (Bowman 1997). Interventions were designed to take up to 12 weeks to complete (mean 57 days to post-treatment assessment), but some consisted of a single session (Heading 2001; Matthews 2011), and others did not specify how long the interventions should take to complete, with some lasting up to six months before assessment (Carlbring 2003; Wright 1997a).

Almost as many studies examined the use of books and booklets (39) as studied Internet-delivered interventions (43). Most Internet-delivered interventions did not exceed the capabilities of printed materials, that is, they provided static content on a Website or in a PDF. Some studies tested computer-delivered interventions (11), mixed media (8) or a computerised telephone system (Greist 2002), and some of these were interactive. Interventions in 13 studies (including 10 of the computerised interventions) had to be used in a general practice office, a clinic, or a workplace. 

Therapist contact

In most studies, participants had some contact with providers during treatment, and this is an important source of heterogeneity across studies (82). Contact occurred face-to-face (35), by e-mail (22), by e-mail and phone (11), by e-mail and short message service (SMS) (1), by Internet forum only (1) or by telephone (12). When providers had contact with participants, this ranged from 10 minutes to about 6 hours. When studies with no contact and studies in which some contact was common to both groups were excluded (Kenardy 2003; Salaberria 1995), about eight (mean of means) contacts during treatment (six median of means) lasted about 103 (standard deviation (SD) 92) minutes (median 81). A few studies included automated reminders (e-mail or SMS), which we recorded separately.

Excluded studies

We immediately excluded studies that were not randomised controlled trials, treatments for post-traumatic stress, treatments for stress associated with medical procedures and other interventions that were not relevant to this review. In other studies, participants did not have anxiety disorders (64); these included studies of hoarding, perfectionism, public speaking, specific fears, stress, test anxiety and trichotillomania (currently listed as an impulse control disorder). Additionally, we excluded studies in which participants were younger than 18 years of age (21), interventions were not stand-alone (27) or no eligible comparison was available (18). In others, the intervention was not BT or CBT, including a book about snakes (2) and interventions that were educational only (2), attentional retraining alone (2) or designed for group leaders (1; Characteristics of excluded studies). We also excluded a relapse prevention study (Wright 1997) that followed another study in this review (Febbraro 1997a). Ninety studies were identified through correspondence and the checking of reference lists and were excluded.

Two studies appeared likely to be eligible but were discontinued early because of poor recruitment; neither reported any results (Hetherton 2004; Jones 2002b).

Ongoing studies

We identified 11 studies that appear to be ongoing (Characteristics of ongoing studies).

Studies awaiting classification

We identified 15 studies that appear to be completed but not yet reported (Characteristics of studies awaiting classification).

Risk of bias in included studies

Because of the nature of the intervention, it was impossible to blind participants, so all studies were at high risk of bias. Other sources of bias are described later (see also Figure 2).

Figure 2.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Allocation

Sequence generation

All included studies were described as randomised controlled trials: 57 specified the method of sequence generation and were at low risk of bias, but the method of randomisation was not described in 34. Ten studies had high risk of bias because randomisation appeared to be inadequate or undermined.

Allocation concealment

Allocation concealment was adequate in most studies reporting the method of randomisation, and 54 studies were at low risk of bias; risk of bias was unclear in 31 and high in 16.

Blinding

Providers

In nine studies, participants had no contact with researchers or clinicians, or providers were blind. Providers were not blind in 89 studies, which were at high risk of bias, and provider blinding was unclear in three studies.

Assessors

Most studies either did not report assessor-rated outcomes or used blind assessors, thus 85 were at low risk of bias. Blinding of assessors was at high risk of bias in 13 studies and unclear in three. Of the studies that used assessor ratings (46), most (30) reported that assessors were blind.

Incomplete outcome data

For response and recovery (dichotomous) data, we assumed that dropouts in both groups did not improve.

For continuous outcomes, 60 studies reported no dropout or analysed outcomes in a manner that mitigated the effect of missing cases and measures. Methods of analysis were at high risk of bias in 38 studies. It was unclear how three studies handled missing data.

Selective reporting

Most of the studies in the review included multiple outcome measures. Only 20 studies appeared to be free of selective outcome reporting, and 40 clearly omitted measured outcomes and were at high risk of bias. Risk of selective outcome reporting was unclear in 41 studies that reported all outcomes mentioned in the text but did not reference a protocol.

Other potential sources of bias

In addition to the sources of bias already discussed, 11 studies were at risk of bias for other reasons, which are described in the Characteristics of included studies.

Effects of interventions

See: Summary of findings for the main comparison; Summary of findings 2

Comparison 1: Media-delivered interventions versus no intervention

Primary Outcomes
1.1 Symptoms of anxiety
1.1.a Continuous symptom measures
Any measure of anxiety (mean effect of all measures of anxiety in each study)

At post-treatment, 72 studies, including 4537 participants, reported any self-rated measure of anxiety (Figure 3). A medium effect was noted (SMD 0.67, 95% CI 0.55 to 0.78), although heterogeneity was substantial (Chi² = 227.97, degrees of freedom (df) = 75, P < 0.00001, I² = 67%). Only 13 studies, including 684 participants, reported controlled follow-up within six months; a slightly smaller overall effect was reported (SMD 0.49, 95% CI 0.24 to 0.75) with substantial heterogeneity (Chi² = 32.96, df = 14, P = 0.003, I² = 58%). Long-term follow-up (> 6 months) was reported in five studies, including 287 participants; the overall effect was not significant (SMD 0.18, 95% CI -0.15 to 0.52), though heterogeneity approached significance (Chi² = 6.60, df = 4, P = 0.16, I² = 39%).

Figure 3.

1 Self-help compared with no treatment.

1.3 Anxiety (any measure), self-rated at post-treatment (by disorder).

Specific and general symptoms of anxiety

Effects described previously (any measure of anxiety) include the average of all measures of anxiety for each study, which are listed in the Characteristics of included studies. Most studies in the main analysis measured symptoms of a particular disorder (e.g. Leibowitz Social Anxiety Scale), but to ensure that the results were not influenced by the inclusion of broader measures (e.g. Beck Anxiety Inventory), we also analysed specific and general measures separately.

At post-treatment, 55 studies including 3192 participants reported a self-rated measure of a specific anxiety disorder. A medium to large effect was noted (SMD 0.68, 95% CI 0.57 to 0.80), though heterogeneity was moderate (Chi² = 128.49, df = 58, P < 0.00001, I² = 55%). Only 10 studies including 439 participants reported controlled follow-up within six months, and a slightly smaller overall effect was found (SMD 0.61, 95% CI 0.27 to 0.94) with substantial heterogeneity (Chi² = 31.13, df = 11, P = 0.0004, I² = 65%). Long-term follow-up was reported in two studies including 194 participants; the overall effect was not significant (SMD 0.20, 95% CI -0.22 to 0.62), although heterogeneity approached significance (Chi² = 5.90, df = 4, P = 0.21, I² = 32%). The pattern of results in subgroup analyses was unchanged.

Additionally, 13 studies including 629 participants reported a clinician-rated measure of a specific anxiety disorder. There was a large effect (SMD 1.04, 95% CI 0.50 to 1.58), though heterogeneity was considerable (Chi² = 124.76, df = 14, P < 0.00001, I² = 89%). Only five studies including 98 participants reported controlled follow-up within six months, and a larger overall effect was described (SMD 1.12, 95% CI 0.70 to 1.53). No studies reported long-term follow-up. At post-treatment, studies reporting a clinician-rated measure were consistent with all self-rated measures (SMD 0.70, 95% CI 0.46 to 0.95); larger effects on clinician-rated measures may be explained by bias.

At post-treatment, 48 studies including 3101 participants reported a self-rated measure of general symptoms. There was a medium effect (SMD 0.58, 95% CI 0.43 to 0.73), though heterogeneity was considerable (Chi² = 176.38, df = 47, P < 0.00001, I² = 73%). Only nine studies including 569 participants reported controlled follow-up within six months, and a small effect was described (SMD 0.22, 95% CI 0.06 to 0.39) with no important heterogeneity (Chi² = 7.46, df = 8, P = 0.49, I² = 0%). Long-term follow-up was reported in two studies including 194 participants; the overall effect was not significant (SMD -0.07, 95% CI -0.63 to 0.49), but the studies were inconsistent (Chi² = 3.19, df = 1, P = 0.07, I² = 69%). 

1.1.b Response

At post-treatment, 21 studies including 1547 participants reported response to treatment according to study criteria (Figure 4). Overall, intervention participants were twice as likely to respond (RR 2.34, 95% CI 1.81 to 3.03), although heterogeneity was moderate (Chi² = 40.30, df = 20, P = 0.005, I² = 50%). Only two studies including 128 participants reported controlled follow-up within six months, and the effect was maintained (RR 2.12, 95% CI 1.18 to 3.79) with no heterogeneity (Chi² = 0.35, df = 1, P = 0.55, I² = 0%). No studies reported long-term follow-up. Several studies reported exceptional effect sizes, but only 18% of all participants in the comparison groups were classified as responders at the end of treatment; in absolute terms, media-delivered interventions were associated with a 31% (95% CI 0.22 to 0.40) increase in response (number needed to treat for an additional beneficial outcome (NNTB = 3)).

Figure 4.

1 Self-help compared with no treatment.

1.26 Response at post-treatment (by disorder).

1.1.c Recovery

Only nine studies with 605 participants reported the number of participants no longer meeting criteria for diagnosis at the end of treatment. Overall, media-delivered interventions were associated with a fivefold increase in recovery (RR 5.36, 95% CI 1.62 to 17.68), but heterogeneity was considerable (Chi² = 74.23, df = 8, P < 0.00001, I² = 89%). Only one study reported more than 20% recovery in the comparison group, which could be explained by participants seeking treatment outside the study (Baillie 2002); in the other studies, only 6% of participants in the comparison groups recovered, and media-delivered interventions were associated with a 45% (95% CI 0.26 to 0.65) increase in recovery (NNTB = 2).

Secondary outcomes
1.2 Behavioural test (level achieved)

Some studies of animal or situational phobias also reported behavioural measures. At post-treatment, seven studies including 250 participants reported the level completed in a behavioural assessment; a large overall effect was described (SMD 1.11, 95% CI 0.36 to 1.87), but heterogeneity was considerable (Chi² = 37.20, df = 6, P < 0.00001, I² = 84%). When one study (Hassan 1992) that reported an implausible effect was excluded (SMD 8.17), a medium to large effect was still described (SMD 0.76, 95% CI 0.32 to 1.21). At follow-up, one study including 30 participants reported a large difference (SMD 1.23, 95% CI 0.47 to 1.99). No studies reported long-term follow-up.

1.3 Behavioural test (symptoms)

At post-treatment, five studies including 191 participants reported symptom ratings, and the overall effect was not significant (SMD 0.59, 95% CI -0.33 to 1.51), but heterogeneity was considerable (Chi² = 30.48, df = 4, P < 0.00001, I² = 87%). At follow-up, one study including 30 participants reported no significant difference (SMD 0.60, 95% CI -0.11 to 1.31). No studies reported long-term follow-up.

1.4 Depression

At post-treatment, 50 studies including 3682 participants reported a self-rated measure of depression. A medium effect was described (SMD 0.47, 95% CI 0.36 to 0.58), although heterogeneity was substantial (Chi² = 120.40, df = 50, P < 0.00001, I² = 58%). Only seven studies including 526 participants reported controlled follow-up within six months, and the combined effect was small (SMD 0.28, 95% CI 0.05 to 0.52), but heterogeneity was substantial (Chi² = 9.89, df = 6, P = 0.13, I² = 39%). When the largest study in the review, which targeted both anxiety and depression (Proudfoot 2004a), was excluded, the effect at follow-up was not significant (SMD 0.20, 95% CI -0.04 to 0.43), and the results were not significantly heterogeneous (Chi² = 6.00, df = 5, P = 0.31, I² = 17%). Long-term follow-up was reported in two studies including 194 participants; the overall effect was not significant (SMD -0.25, 95% CI -0.58 to 0.08), and heterogeneity was not significant (Chi² = 1.11, df = 1, P = 0.29, I² = 10%).

1.5 Mental-health related disability

At post-treatment, 20 studies including 1629 participants reported a self-rated measure of disability. A medium effect was found (SMD 0.48, 95% CI 0.33 to 0.63), although heterogeneity was substantial (Chi² = 37.21, df = 19, P = 0.007, I² = 49%). Only seven studies including 513 participants reported controlled follow-up within six months, and no significant effect was found (SMD 0.21, 95% CI -0.15 to 0.57), but heterogeneity was substantial (Chi² = 22.09, df = 6, P = 0.001, I² = 73%). Long-term follow-up was reported in three studies including 147 participants; the overall effect was not significant (SMD -0.14, 95% CI -0.33 to 0.60), and heterogeneity was not significant (Chi² = 3.50, df = 2, P = 0.17, I² = 43%).

1.6 Quality of life

At post-treatment, 18 studies including 1344 participants reported a self-rated measure of quality of life. A medium effect was found (SMD 0.36, 95% CI 0.22 to 0.49), although heterogeneity was moderate (Chi² = 24.58, df = 17, P = 0.10, I² = 31%). Only three studies including 211 participants reported controlled follow-up within six months, and the combined effect was not significant (SMD 0.08, 95% CI -0.19 to 0.35) with no heterogeneity (Chi² = 0.95, df = 2, P = 0.62, I² = 0%). One study reported no effect at long-term follow-up (SMD -0.06, 95% CI -0.48 to 0.36).

1.7 Dropout

Of those receiving media-delivered interventions and no-intervention, 855 (20%) and 463 (16%) did not complete the study. A small difference favoured no treatment (RR 0.96, 95% CI 0.94 to 0.99), and heterogeneity was moderate (Chi² = 129.33, df = 77, P = 0.0002, I² = 40%).

Comparison 2: Media-delivered interventions versus face-to-face interventions

Primary Outcomes
2.1 Symptoms of anxiety
2.1.a Continuous symptom measures
Any measure of anxiety (mean effect of all measures of anxiety in each study)

At post-treatment, 24 studies, including 1360 participants, reported any self-rated measure of anxiety (Figure 5). A small effect favoured face-to-face intervention (SMD -0.23, 95% CI -0.36 to -0.09), and moderate heterogeneity approached significance (Chi² = 31.46, df = 23, P = 0.11, I² = 27%). Only 11 studies including 677 participants reported controlled follow-up within six months, and a slightly smaller effect favoured face-to-face intervention (SMD -0.14, 95% CI -0.30 to -0.01) with no heterogeneity (Chi² = 6.50, df = 10, P = 0.77, I² = 0%). Long-term follow-up (> 6 months) was reported in eight studies including 423 participants; the overall difference was not significant (SMD -0.16, 95% CI -0.50 to 0.18), although heterogeneity was substantial (Chi² = 18.09, df = 7, P = 0.01, I² = 61%) and was attributable to one study that reported a large effect favouring face-to-face intervention (Ost 1991); in that study, values for participants in the media-delivered intervention group were consistent with those of other studies, and the face-to-face intervention appeared to be very effective.

Figure 5.

2 Self-help compared with face-to-face therapy.

2.3 Anxiety (any measure), self-rated at post-treatment (by disorder).

Specific and general symptoms of anxiety

At post-treatment, 23 studies including 1255 participants reported a self-rated measure of a specific anxiety disorder. A small effect favoured face-to-face intervention (SMD -0.23, 95% CI -0.37 to -0.10), and moderate heterogeneity approached significance (Chi² = 30.57, df = 22, P = 0.11, I² = 28%). Only 10 studies including 573 participants reported controlled follow-up within six months, and the overall difference was not significant (SMD -0.15, 95% CI -0.31 to -0.02) with no heterogeneity (Chi² = 8.61, df = 9, P = 0.47, I² = 0%). Long-term follow-up (> 6 months) was reported in eight studies including 423 participants; the overall difference was not significant (SMD -0.20, 95% CI -0.54 to 0.14), although heterogeneity was substantial (Chi² = 18.08, df = 7, P = 0.01, I² = 61%) and was attributable to one study that reported a large effect favouring face-to-face intervention (Ost 1991). The pattern of results in subgroup analyses was unchanged.

Additionally, six studies including 418 participants reported a clinician-rated measure of a specific anxiety disorder. The difference was not significant (SMD -0.13, 95% CI -0.33 to 0.06), and no heterogeneity was noted (Chi² = 3.97, df = 5, P = 0.55, I² = 0%). Only three studies including 185 participants reported controlled follow-up within six months, and the effect was similar to the effect at post-treatment (SMD -0.19, 95% CI -0.69 to 0.30). Only one study including 98 participants reported long-term follow-up, and the effect was similar to the effect at post-treatment (SMD -0.13, 95% CI -0.53 to 0.28).

At post-treatment, 11 studies including 627 participants reported a self-rated measure of general symptoms. No significant difference between groups was noted (SMD -0.08, 95% CI -0.36 to 0.20), although heterogeneity was substantial (Chi² = 30.19, df = 10, P = 0.0008, I² = 67%). Only five studies including 308 participants reported controlled follow-up within 6 months, and no significant difference (SMD 0.10, 95% CI -0.30 to 0.09) and no important heterogeneity were described (Chi² = 1.24, df = 4, P = 0.87, I² = 0%). Long-term follow-up was reported in four studies including 241 participants; no significant difference was noted (SMD 0.04, 95% CI -0.22 to 0.30), and no heterogeneity was reported (Chi² = 1.34, df = 3, P = 0.72, I² = 0%). 

2.1.b Response

At post-treatment, 10 studies including 575 participants reported response to treatment (Figure 6). Overall effects were not significant (RR 0.78, 95% CI 0.56 to 1.09), but heterogeneity was substantial (Chi² = 32.38, df = 9, P = 0.0002, I² = 72%). The absolute difference also was not significant (RD -0.15, 95% CI -0.35 to 0.04), but the absolute rate of response was only 47% overall. Only four studies including 224 participants reported controlled follow-up within six months, and although no significant difference was found (RR 0.99, 95% CI 0.73 to 1.35), heterogeneity was substantial (Chi² = 7.97, df = 3, P = 0.05, I² = 62%). Three studies including 116 participants reported long-term follow-up and no significant difference (RR 0.58, 95% CI 0.20 to 1.64), but heterogeneity was considerable (Chi² = 8.68, df = 2, P = 0.01, I² = 77%).

Figure 6.

Forest plot of comparison: 2 Media-delivered intervention compared with face-to-face therapy, outcome. 2.21 Response (specific), self-rated at post-treatment (by disorder).

2.1.c Recovery

Only six studies including 587 participants reported the number of participants no longer meeting criteria for diagnosis at the end of treatment. No significant difference in recovery was found (RR 1.05, 95% CI 0.88 to 1.24), and no heterogeneity was noted (Chi² = 2.65, df = 5, P = 0.75, I² = 0%). Only three studies including 354 participants reported controlled follow-up within six months; no significant difference was found (RR 1.04, 95% CI 0.70 to 1.56), but heterogeneity was substantial (Chi² = 4.02, df = 2, P = 0.13, I² = 50%). Only two studies including 147 participants reported long-term follow-up; no significant difference was found (RR 0.90, 95% CI 0.64 to 1.25), but the studies were inconsistent (Chi² = 3.60, df = 1, P = 0.06, I² = 72%).

Secondary outcomes
2.2 Behavioural test (level achieved)

Six studies included behavioural tests. At post-treatment, five studies including 211 participants reported the level completed; a small to medium effect was found (SMD -0.44, 95% CI -0.76 to -0.13), and no important heterogeneity was noted (Chi² = 4.75, df = 4, P = 0.31, I² = 16%). Two studies including 60 participants reported the level competed at follow-up; no significant difference was noted (SMD -0.02, 95% CI -0.74 to 0.71), but the studies were inconsistent (Chi² = 2.02, df = 1, P = 0.16, I² = 50%). Two studies including 122 participants reported the level completed at long-term follow-up; no significant difference was found (SMD -0.1, 95% CI -0.97 to 0.76), but the studies were not consistent (Chi² = 3.83, df = 1, P = 0.05, I² = 74%).

2.3 Behavioural test (symptoms)

At post-treatment, five studies including 209 participants reported self-rated symptoms, the overall difference was not significant (SMD -0.57, 95% CI -1.35 to 0.21) and considerable heterogeneity was noted (Chi² = 26.16, df = 4, P < 0.0001, I² = 85%). One study including 30 participants reported symptoms at follow-up, and no significant difference was noted (SMD -0.09, 95% CI -0.79 to 0.60). Three studies including 162 participants reported symptoms at long-term follow-up, and no significant difference was found (SMD -0.46, 95% CI -1.19 to 0.27), but heterogeneity was considerable (Chi² = 8.93, df = 2, P = 0.01, I² = 78%).

2.4 Depression

At post-treatment, 13 studies including 906 participants reported a self-rated measure of depression. No overall difference was found (SMD -0.01, 95% CI -0.22 to 0.21), lthough heterogeneity was substantial (Chi² = 28.27, df = 12, P = 0.005, I² = 58%). Only five studies including 403 participants reported controlled follow-up within six months, and the combined effect was not significant (SMD 0.09, 95% CI -0.19 to 0.36), but heterogeneity was moderate (Chi² = 7.11, df = 4, P = 0.13, I² = 44%). Long-term follow-up was reported in five studies including 339 participants; the overall effect was not significant (SMD 0.08, 95% CI -0.14 to 0.30), and no important heterogeneity was noted (Chi² = 4.08, df = 4, P = 0.40, I² = 2%).

2.5 Mental-health related disability

At post-treatment, 10 studies including 670 participants reported a self-rated measure of disability. No significant difference was found (SMD -0.07, 95% CI -0.33 to 0.20), although heterogeneity was substantial (Chi² = 25.58, df = 9, P = 0.002, I² = 65%). Only five studies including 337 participants reported controlled follow-up within six months, and the combined effect was not significant (SMD -0.10, 95% CI -0.39 to 0.19), but heterogeneity was moderate (Chi² = 6.80, df = 4, P = 0.15, I² = 41%). Long-term follow-up was reported in three studies including 242 participants; the overall effect was not significant (SMD -0.21, 95% CI -0.47 to 0.04), and no heterogeneity was noted (Chi² = 0.11, df = 2, P = 0.95, I² = 0%).

2.6 Quality of life

At post-treatment, four studies including 282 participants reported a self-rated measure of disability. No significant difference was found (SMD 0.08, 95% CI -0.23 to 0.38), although heterogeneity was moderate (Chi² = 4.82, df = 3, P = 0.19, I² = 38%). Only two studies including 143 participants reported controlled follow-up within six months, and the combined effect favoured media-delivered intervention (SMD 0.40, 95% CI -0.07 to 0.73) with no heterogeneity noted (Chi² = 0.64, df = 1, P = 0.43, I² = 0%). One study reported no difference at long-term follow-up (SMD -0.15, 95% CI -0.41 to 0.70).

2.7 Dropout

Of those receiving media-delivered interventions and face-to-face interventions, 855 (20%) and 166 (18%) did not complete the studies. This difference was not significant (RR 1.08, 95% CI 0.90 to 1.30), and no heterogeneity was noted (Chi² = 25.77, df = 26, P = 0.48, I² = 0%).

Comparison 3: Media-delivered interventions versus psychoeducation

No outcomes could be analysed.

Comparison 4: Media-delivered interventions versus medication

No outcomes could be analysed.

Subgroup analyses

Comparison 1: Media-delivered interventions versus no intervention

We examined the impact of methodological differences.

Types of controls

The specific control condition appeared related to relative effects (Chi² = 21.84, df = 3, P = 0.0001, I² = 86%). Specifically, interventions had similar effects compared with wait-list and attention controls (Chi² = 3.99, df = 2, P = 0.14, I² = 50%), but the overall effect was small when participants were recruited from clinical settings and interventions were compared with treatment as usual (SMD 0.21, 95% CI 0.02 to 0.40). Without studies of treatment as usual, the overall effect was not importantly different from the primary result (SMD 0.72, 95% CI 0.61 to 0.84), and heterogeneity remained substantial (Chi² = 183.67, df = 68, P < 0.00001, I² = 63%).

Types of disorders

Effects were significantly different across types of disorders (Chi² = 17.04, df = 6, P = 0.009, I² = 65%). Studies of mixed disorders reported the smallest combined effect (SMD 0.36, 95% CI 0.19 to 0.52). After these were excluded, subgroups were no longer heterogeneous (Chi² = 3.96, df = 5, P = 0.56, I² = 0%); the overall effect remained medium to large (SMD 0.77, 95% CI 0.64 to 0.91), and heterogeneity remained substantial (Chi² = 157.63, df = 57, P < 0.00001, I² = 64%).

Types of interventions

Effects were not significantly different across types of interventions (Chi² = 1.88, df = 3, P = 0.60, I² = 0%), although the effect for relaxation was not significant. A medium effect for media-delivered CBT was found (SMD 0.62, 95% CI 0.51 to 0.73), along with substantial heterogeneity (Chi² = 127.24, df = 55, P < 0.00001, I² = 57%).

Types of media

Effects were significantly different across types of media (Chi² = 7.70, df = 3, P = 0.05, I² = 61%) and were largest for Internet-delivered interventions (SMD 0.79, 95% CI 0.62 to 0.96), although heterogeneity within this group was substantial (Chi² = 132.37, df = 35, P < 0.00001, I² = 74%).

Types of recruitment

Studies that advertised through mass media (including the Internet) reported larger effects than studies recruiting only through clinical referrals (Chi² = 14.98, df = 2, P = 0.0006, I² = 87%), although heterogeneity remained substantial among studies that used advertising (Chi² = 168.47, df = 54, P < 0.00001, I² = 68%).

Comparison 2: Media-delivered interventions versus face-to-face interventions
Types of disorders

Effects were not significantly different across types of disorders (Chi² = 6.22, df = 4, P = 0.18, I² = 35.7%), although studies of specific phobias reported the largest difference between media-delivered and face-to-face interventions (SMD -0.39, 95% CI -0.73 to -0.06), and studies of social anxiety reported the smallest (SMD 0.02, 95% CI -0.18 to 0.22).

Types of interventions

Disorders varied with types of therapy, and the difference between media-delivered exposure and face-to-face exposure might be larger than the difference between different deliveries of CBT (Chi² = 2.36, df = 1, P = 0.12, I² = 57.6%), but no between-group heterogeneity was noted after one study was removed from the exposure group (Ost 1991). Effects did not vary between individual and group CBT.

Types of media

Effects were not significantly different across types of media (Chi² = 5.07, df = 3, P = 0.17, I² = 40.9%).

Types of recruitment

Consistent with the first comparison, studies recruiting through advertisements found smaller differences than studies recruiting only through clinical referrals (Chi² = 2.94, df = 1, P = 0.09, I² = 66.0%), that is, recruiting participants through advertising was associated with more favourable outcomes for media-delivered therapy.

Discussion

Summary of main results

This review suggests that media-delivered interventions may be superior to no intervention for people with anxiety; there were positive effects on symptoms of anxiety and depression, response and recovery from illness, disability, and quality of life. Face-to-face interventions may be superior to media-delivered interventions; there were differences favouring face-to-face treatment for symptoms of anxiety, but no significant differences in response and recovery from illness, disability and quality of life. Statistical heterogeneity suggests that effects probably vary across participants and interventions. Effects may be maintained after cessation of treatment, but few studies included follow-up after six months.

Overall, interventions for specific disorders may be superior to interventions for any anxiety disorder. However, one recent transdiagnostic study reported effects that were consistent with the effects of interventions for specific disorders (Titov 2010a). The largest effects were reported in studies of Internet-based CBT, which may be a superior medium for delivering interventions; however, many of these studies offered only documents for download and printing (PDFs) or access to non-interactive Websites. More recent trials follow current models for treatment, so changes in intervention components and content may correlate with changes in disorders studied and technologies used, thus confounding these effects.

Overall completeness and applicability of evidence

In general, studies were conducted in high-income, English-speaking countries among white, female, middle-aged participants; these results may not generalise to other settings or participants. Trials had high exclusion rates, for example, one study excluded 100 of 333 applications for high scores on a measure of depression, or for risk of suicide (Titov 2008a). Despite the large numbers of studies and participants in this review, the combined results of efficacy studies cannot demonstrate effectiveness in the general population, and few controlled comparisons suggest that benefits may be maintained after cessation of treatment.

For people seeking treatment, the magnitude of these effects should be interpreted with caution. For example, standardised effects appear similar to effective pharmacotherapies (Kapczinski 2003; Schneier 2001), but there was virtually no response among wait-list and no-treatment controls. It is also true that wait-list participants who receive many face-to-face psychotherapies do not respond, but within-group changes in these studies were not comparable with evidence-based face-to-face interventions in which most participants respond or recover (e.g. Clark 2006).

Differences between media-delivered interventions and face-to-face interventions were small, but some studies (particularly the older ones) provided face-to-face interventions designed to control for specific effects of media-delivered interventions rather than face-to-face interventions as they would be provided in usual services. Established interventions may be more effective than these diminished controls. For example, one study demonstrated that a single session of therapist-guided exposure was greatly superior to media-delivered intervention for people with specific phobias (Ost 1991). 

On the other hand, these interventions increase the number of people receiving help. Anxiety disorders are very common, most people with anxiety never receive treatment and these disorders are naturally chronic and unremitting. For people who would not receive another intervention, NNTBs of 2 and 3 may be valid estimates of treatment efficacy.

Among trials that included some contact with participants, the amount of therapist input varied greatly. Interventions in these studies may not be representative of the interventions that users can access outside of clinical trials or outside of particular services that are designed to offer guided self-help.

Quality of the evidence

This review includes large numbers of studies and participants. Most trials reported the primary outcome, self-rated symptoms of anxiety, and the evidence was of moderate quality compared with no treatment (Summary of findings for the main comparison) but of low quality compared with face-to-face intervention (Summary of findings 2).

Overall, methods of randomisation and allocation concealment appear unlikely to influence overall effects. However, participants and providers were not blind, and assessors were blind in only 64% of studies using clinician ratings. Compared with self-ratings, clinician ratings suggest a greater effect compared with no treatment and a smaller difference compared with face-to-face therapy. Studies reporting self-ratings and clinician ratings have reported effects on self-ratings that were consistent with the average effect for all studies. Additionally, the post-treatment effect for recovery (SMD 0.75, 95% CI 0.61 to 0.90) was slightly larger than the effect for symptoms of anxiety. Few studies referenced a protocol and reported all outcomes, thus the results of this review may be overestimated because of selective outcome reporting, which could explain the relatively larger effects on clinician-rated outcomes and recovery. Compared with no intervention and compared with face-to-face intervention, 10 of 82 studies and 5 of 29 studies did not report a measure of anxiety that could be included in the main analysis. Incomplete outcome data may also lead to overestimation of continuous outcomes; however, for dichotomous outcomes, we assumed that dropouts did not respond, thus the response and recovery outcomes are unlikely to be overestimated due to missing data. Anxiety disorders tend to be chronic and naturally unremitting, so the assumption that dropouts did not improve may represent the true outcome for most missing cases. Subgroup analyses should be interpreted with caution, as some variables may correlate with risk of bias, for example, average effects of exposure alone may be overestimated compared with the effects of CBT. 

Safety data were inadequately reported. Whilst a few studies mentioned adverse events in intervention or control groups, a systematic synthesis was not possible. It is unclear whether adverse events were not reported because they do not occur, or if they were not reported because they were not monitored; most trials excluded participants at greatest risk. Similarly, measures of participant satisfaction, the need for alternative interventions and costs were reported so selectively and incompletely that a formal synthesis would be inappropriate.

Statistical heterogeneity was substantial in most analyses (i.e. I2 > 50%). We attempted to explain this heterogeneity through prespecified analyses, but inconsistency remained within subgroups. Many of the individual studies were not significantly different from zero, but most reported positive effects compared with no intervention.

The quality of most outcomes was low according to GRADE criteria (GRADE 2004), although the quality of response and recovery data was moderate. Outcomes were downgraded for risk of selective outcome reporting. Continuous data were downgraded due to risk of bias, especially for incomplete outcome data.

Potential biases in the review process

This review included a comprehensive search for published and unpublished data. We obtained some unpublished data for 25 studies: Seven completely unpublished studies were included, we obtained an additional report of seven published papers (e.g. a thesis) and authors provided unpublished outcomes for nine studies reported only in published papers. To examine the effects of small study bias, the main analysis was repeated for each comparison using a fixed-effect model. The magnitude and the precision of the effects were essentially unchanged compared with no treatment (SMD 0.64, 95% CI 0.58 to 0.70) and compared with face-to-face therapy (SMD, -0.21, 95% CI -0.32 to -0.10). Funnel plots appeared symmetrical; however, these tests for small study bias were unlikely to identify bias in a review with a large number of small studies, each of which received similar weight in the analysis. The Characteristics of studies awaiting classification include several trials that may be complete, and the Characteristics of excluded studies include two trials that were discontinued.

Several trials included participants with anxiety or depression. Two did not report symptoms of anxiety (Holdsworth 1996; Tyrer 1988), and one excluded participants with depression from the analysis because so few people with depression were recruited (Maunder 2009). Six others contributed to the primary analysis (Fletcher 2005; Grime 2004; Mead 2005; Proudfoot 2004a; Seekles 2011; Zetterqvist 2003). Excluding these studies did not importantly change the overall effect (SMD 0.70, 95% CI 0.58 to 0.82; Chi² = 210.97, df = 69, P < 0.00001, I² = 67%); furthermore, these studies were not included in an analysis restricted to symptoms of a specific anxiety disorder, which was also consistent with the primary analysis.

Agreements and disagreements with other studies or reviews

Many recent reviews have focused on Internet- and computer-delivered interventions, and this review has a wider scope. After accounting for differences in inclusion criteria, this review still includes more trials than previous syntheses of self-help for anxiety. As a result, few trials appear in both this review and most other meta-analyses, but overlap is difficult to characterise for other reasons. For example, one review aimed to include studies with less than an hour of contact (Lewis 2012); by contacting the authors, we discovered that many included studies did not meet this criterion. In addition to studies of PTSD, one review (Haug 2012) included a study that was not randomised (the wait-list taken from another trial in Tillfors 2008), one study that the author described as quasi-randomised (Lucock 2008) and one study that combined self-help with another intervention (i.e. Andersson 2006 compared self-help with in vivo exposure vs waiting list). One meta-analysis refers to studies that report outcome data but do not appear in the quantitative summary (Spek 2007). Another meta-analysis omitted many studies that we included, and it included studies that met neither our inclusion criteria nor its stated criteria (Hirai 2006).

Effects on symptoms of anxiety were somewhat smaller than those reported in recent reviews (Andrews 2010; Cuijpers 2010; Griffiths 2010b; Haug 2012; Lewis 2012; Reger 2009), and we report effects for secondary outcomes that have not been widely analysed. Furthermore, this review includes more information about the characteristics of included studies than was provided in previous reviews. This review also includes a comprehensive assessment of risk of bias, which identifies some important limitations in the results that have not been fully considered elsewhere.

Authors' conclusions

Implications for practice

We found evidence of efficacy compared with no intervention, and media-delivered interventions could be useful for people who are not seeking other services, but only a small number of people respond and recover when using media-delivered interventions alone. For people seeking services, face-to-face interventions appear to be superior to media-delivered interventions, leading to higher rates of recovery in practice.

This review identifies a lack of evidence about safety. No reports suggest that media-delivered interventions are unsafe, although trials have been limited to people who do not have severe depression, substance misuse or other risk factors. Confidence in the results of this review are also mitigated by risk of bias and differences among the included studies.

Many of the included studies provided therapist input averaging just over an hour. Contact during the intervention for research and treatment purposes could be related to compliance and efficacy.

Studies used a variety of delivery formats, and users may prefer different media. Although effects for Internet-delivered interventions were larger than effects for other media, books with similar content could be equally effective.

This evidence is consistent with recent guidance indicating that people seeking treatment for social anxiety disorder in England and Wales should be offered individual cognitive therapy first; those who decline individual therapy should be offered supported self-help (Pilling 2013). Current recommendations for the treatment of generalised anxiety disorder suggest a stepped-care approach (Kendall 2011), which is not consistent with clinical results in this review, but health economic modelling based on these clinical results might inform an update of these guidelines.

Implications for research

Many studies have demonstrated the efficacy of particular interventions in particular populations; however, some of these interventions are not available outside a few academic groups. Most studies were conducted by the intervention developers. Further research is needed to examine publicly available interventions (e.g. self-help books) and interventions that could be widely rolled-out. Some of the included studies have also been examined in uncontrolled longitudinal studies (Hilvert-Bruce 2012; Mewton 2012; Sunderland 2012), but large effectiveness trials are needed to demonstrate that such interventions work for large populations.

The benefits that can be achieved using media-delivered interventions may be limited; however, improved treatment manuals, increased interactivity and other innovations might lead to better outcomes than those observed here. 

In many trials, study dropout rate was high, and some participants completing assessments did not complete treatment. Large studies could investigate mediators and moderators of compliance by monitoring how participants use Websites and which core components they receive, for example, a case series preceding an ongoing trial includes details about the interventions offered and actual uptake by participants (Stott 2013). Many trials in this review share limitations that have been documented in reports of complex interventions (Grant 2013), and future research would be more useful if similar data about implementation and uptake of interventions were reported consistently across trials (Mayo-Wilson 2007).

Most people do not respond to media-delivered interventions, but it is unclear why response and recovery rates are so low. Identifying the differences between responders and non-responders could help improve treatment effectiveness and could help clinicians determine how to allocate people with anxiety to different services in a stepped-care framework.

Few studies have compared media-delivered CBT with CBT as it is normally delivered. Future studies of face-to-face therapies might use media-delivered CBT as a control condition (rather than no treatment). In addition, future studies might examine media-delivered interventions to prime people before they begin face-to-face therapy, to support face-to-face therapy or to help maintain gains from face-to-face therapy to examine the effects of media-delivered interventions at various stages in a stepped-care pathway.

Finally, this review includes a large number of studies and multiple co-variates, in addition to the main outcomes. Although the subgroup analyses already described are informative, a multivariate meta-regression might be a useful way to explore the importance of potential mediators and moderators, including contact with professionals.

Acknowledgements

Many authors of included and excluded studies answered questions and provided information about methods, study characteristics and outcomes; we are very grateful for their help in conducting this review.

We gratefully acknowledge support from the Centre for Evidence-Based Intervention (Department of Social Policy and Intervention; University of Oxford). EM-W also thanks the Centre for Outcomes Research and Effectiveness (Research Department of Clinical, Educational & Health Psychology; University College London) and the National Collaborating Centre for Mental Health (NCCMH). We thank Rachel Churchill, the Cochrane Methods Groups and anonymous reviewers for their helpful suggestions.

CRG Funding Acknowledgement:
The National Institute for Health Research (NIHR) is the largest single funder of the Cochrane Depression, Anxiety and Neurosis Group. 

Disclaimer:
The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NIHR, the NHS or the Department of Health.

Data and analyses

Download statistical data

Comparison 1. Media-delivered interventions compared to no intervention
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Anxiety (any measure), self-rated at post-treatment764537Std. Mean Difference (Random, 95% CI)0.67 [0.55, 0.78]
2 Anxiety (any measure), self-rated at post-treatment (type of control)764537Std. Mean Difference (Random, 95% CI)0.67 [0.55, 0.78]
2.1 Adjunct193Std. Mean Difference (Random, 95% CI)0.33 [-0.08, 0.75]
2.2 Attention controls 221028Std. Mean Difference (Random, 95% CI)0.65 [0.48, 0.82]
2.3 Treatment as Usual7745Std. Mean Difference (Random, 95% CI)0.21 [0.02, 0.40]
2.4 Wait-List462671Std. Mean Difference (Random, 95% CI)0.77 [0.61, 0.92]
3 Anxiety (any measure), self-rated at post-treatment (by disorder)764537Std. Mean Difference (Random, 95% CI)0.67 [0.55, 0.78]
3.1 GAD10649Std. Mean Difference (Random, 95% CI)0.95 [0.44, 1.45]
3.2 Health2120Std. Mean Difference (Random, 95% CI)1.01 [0.24, 1.78]
3.3 Mixed181376Std. Mean Difference (Random, 95% CI)0.36 [0.19, 0.52]
3.4 OCD2220Std. Mean Difference (Random, 95% CI)0.68 [0.41, 0.95]
3.5 Panic21797Std. Mean Difference (Random, 95% CI)0.62 [0.45, 0.79]
3.6 Social151152Std. Mean Difference (Random, 95% CI)0.73 [0.59, 0.87]
3.7 Specific8223Std. Mean Difference (Random, 95% CI)0.99 [0.50, 1.48]
4 Anxiety (any measure), self-rated at post-treatment (by media)764537Std. Mean Difference (Random, 95% CI)0.67 [0.55, 0.78]
4.1 Book271046Std. Mean Difference (Random, 95% CI)0.48 [0.30, 0.65]
4.2 Computer8458Std. Mean Difference (Random, 95% CI)0.69 [0.31, 1.07]
4.3 Internet362522Std. Mean Difference (Random, 95% CI)0.79 [0.62, 0.96]
4.4 Other5511Std. Mean Difference (Random, 95% CI)0.51 [0.32, 0.71]
5 Anxiety (any measure), self-rated at post-treatment (by therapy)764537Std. Mean Difference (Random, 95% CI)0.67 [0.55, 0.78]
5.1 CBT563550Std. Mean Difference (Random, 95% CI)0.62 [0.51, 0.73]
5.2 Exposure/ Desensitization13448Std. Mean Difference (Random, 95% CI)0.79 [0.49, 1.09]
5.3 Relaxation6504Std. Mean Difference (Random, 95% CI)0.84 [-0.06, 1.73]
5.4 Self-examination135Std. Mean Difference (Random, 95% CI)0.92 [0.22, 1.62]
6 Anxiety (any measure), self-rated at post-treatment (by setting)754506Std. Mean Difference (Random, 95% CI)0.67 [0.55, 0.78]
6.1 Advertising553438Std. Mean Difference (Random, 95% CI)0.77 [0.63, 0.90]
6.2 Referral Only16884Std. Mean Difference (Random, 95% CI)0.32 [0.14, 0.51]
6.3 Other4184Std. Mean Difference (Random, 95% CI)0.46 [0.10, 0.82]
7 Anxiety (any measure), self-rated at post-treatment (sensitivity analysis for bias)764537Std. Mean Difference (Random, 95% CI)0.67 [0.55, 0.78]
7.1 High or Unclear Risk for Incomplete Outcome Data301481Std. Mean Difference (Random, 95% CI)0.68 [0.46, 0.90]
7.2 Low Risk for Incomplete Outcome Data463056Std. Mean Difference (Random, 95% CI)0.66 [0.53, 0.79]
8 Specific symptoms, self-rated at post-treatment593192Std. Mean Difference (Random, 95% CI)0.68 [0.57, 0.80]
9 Specific symptoms, self-rated at post-treatment (type of control)593192Std. Mean Difference (Random, 95% CI)0.68 [0.57, 0.80]
9.1 Adjunct193Std. Mean Difference (Random, 95% CI)0.31 [-0.10, 0.73]
9.2 Attention controls 19873Std. Mean Difference (Random, 95% CI)0.68 [0.47, 0.89]
9.3 Treatment as Usual2118Std. Mean Difference (Random, 95% CI)0.02 [-0.35, 0.40]
9.4 Wait-List372108Std. Mean Difference (Random, 95% CI)0.74 [0.60, 0.88]
10 Specific symptoms, self-rated at post-treatment (by disorder)583201Std. Mean Difference (Random, 95% CI)0.69 [0.57, 0.80]
10.1 GAD8514Std. Mean Difference (Random, 95% CI)0.68 [0.29, 1.07]
10.2 Health2120Std. Mean Difference (Random, 95% CI)0.85 [-0.50, 2.21]
10.3 Mixed4231Std. Mean Difference (Random, 95% CI)0.21 [-0.15, 0.57]
10.4 OCD2220Std. Mean Difference (Random, 95% CI)0.68 [0.41, 0.95]
10.5 Panic20740Std. Mean Difference (Random, 95% CI)0.61 [0.43, 0.79]
10.6 Social151153Std. Mean Difference (Random, 95% CI)0.76 [0.63, 0.89]
10.7 Specific8223Std. Mean Difference (Random, 95% CI)0.99 [0.50, 1.48]
11 Specific symptoms, self-rated at post-treatment (by media)593192Std. Mean Difference (Random, 95% CI)0.68 [0.57, 0.80]
11.1 Book19691Std. Mean Difference (Random, 95% CI)0.53 [0.32, 0.74]
11.2 Computer7261Std. Mean Difference (Random, 95% CI)0.79 [0.29, 1.28]
11.3 Internet291829Std. Mean Difference (Random, 95% CI)0.77 [0.61, 0.92]
11.4 Other4411Std. Mean Difference (Random, 95% CI)0.60 [0.39, 0.82]
12 Specific symptoms, self-rated at post-treatment (by therapy)593192Std. Mean Difference (Random, 95% CI)0.68 [0.57, 0.80]
12.1 CBT442662Std. Mean Difference (Random, 95% CI)0.67 [0.54, 0.80]
12.2 Exposure/ Desensitization13440Std. Mean Difference (Random, 95% CI)0.77 [0.46, 1.08]
12.3 Muscle relaxation290Std. Mean Difference (Random, 95% CI)0.66 [0.22, 1.09]
13 Specific symptoms, self-rated at post-treatment (by setting)593192Std. Mean Difference (Random, 95% CI)0.68 [0.57, 0.80]
13.1 Advertising482749Std. Mean Difference (Random, 95% CI)0.74 [0.62, 0.86]
13.2 Referral Only9350Std. Mean Difference (Random, 95% CI)0.38 [0.09, 0.67]
13.3 Other293Std. Mean Difference (Random, 95% CI)0.53 [-0.25, 1.31]
14 Specific symptoms, self-rated at post-treatment (sensitivity analysis for bias)593192Std. Mean Difference (Random, 95% CI)0.68 [0.57, 0.80]
14.1 High or Unclear Risk for Incomplete Outcome Data23949Std. Mean Difference (Random, 95% CI)0.60 [0.44, 0.76]
14.2 Low Risk for Incomplete Outcome Data362243Std. Mean Difference (Random, 95% CI)0.73 [0.57, 0.88]
15 Specific symptoms, self-rated at post-treatment (studies also reporting clinician rated)593192Std. Mean Difference (Random, 95% CI)0.68 [0.57, 0.80]
15.1 Not reporting clinician rated472674Std. Mean Difference (Random, 95% CI)0.68 [0.55, 0.81]
15.2 Also reporting clinician rated12518Std. Mean Difference (Random, 95% CI)0.70 [0.46, 0.95]
16 Specific symptoms, clinician-rated at post-treatment15629Std. Mean Difference (Random, 95% CI)1.04 [0.50, 1.58]
17 Specific symptoms, clinician-rated at post-treatment15629Std. Mean Difference (Random, 95% CI)1.04 [0.50, 1.58]
17.1 Not reporting self-rated3112Std. Mean Difference (Random, 95% CI)1.39 [0.97, 1.80]
17.2 Also reporting self-rated12517Std. Mean Difference (Random, 95% CI)0.97 [0.32, 1.61]
18 General symptoms, self-rated at post-treatment483101Std. Mean Difference (Random, 95% CI)0.58 [0.43, 0.73]
19 Behavioural Test (level), clinician-rated at post-treatment7250Std. Mean Difference (Random, 95% CI)1.11 [0.36, 1.87]
20 Behavioural Test (symptoms), self-rated at post-treatment5196Std. Mean Difference (Random, 95% CI)0.59 [-0.33, 1.51]
21 Response (specific), self-rated at post-treatment211547Risk Ratio (M-H, Random, 95% CI)2.34 [1.81, 3.03]
22 Response (specific), self-rated at post-treatment (type of control)211547Risk Ratio (M-H, Random, 95% CI)2.34 [1.81, 3.03]
22.1 Adjunct195Risk Ratio (M-H, Random, 95% CI)1.43 [0.91, 2.25]
22.2 Attention controls 7526Risk Ratio (M-H, Random, 95% CI)1.85 [1.39, 2.45]
22.3 Treatment as Usual1120Risk Ratio (M-H, Random, 95% CI)1.33 [0.49, 3.61]
22.4 Wait-List12806Risk Ratio (M-H, Random, 95% CI)3.18 [2.16, 4.68]
23 Response (specific), self-rated at post-treatment (by disorder)211751Risk Ratio (M-H, Random, 95% CI)2.42 [1.88, 3.12]
23.1 GAD4342Risk Ratio (M-H, Random, 95% CI)4.60 [2.75, 7.68]
23.2 Mixed2161Risk Ratio (M-H, Random, 95% CI)2.00 [1.23, 3.24]
23.3 OCD1149Risk Ratio (M-H, Random, 95% CI)2.36 [1.16, 4.82]
23.4 Panic9384Risk Ratio (M-H, Random, 95% CI)1.73 [1.29, 2.30]
23.5 Social4695Risk Ratio (M-H, Random, 95% CI)2.85 [1.59, 5.11]
23.6 Specific120Risk Ratio (M-H, Random, 95% CI)17.50 [1.16, 263.03]
24 Response (specific), self-rated at post-treatment (by media)211751Risk Ratio (M-H, Random, 95% CI)2.42 [1.88, 3.12]
24.1 Book7250Risk Ratio (M-H, Random, 95% CI)1.85 [1.36, 2.52]
24.2 Computer2115Risk Ratio (M-H, Random, 95% CI)3.75 [0.25, 56.38]
24.3 Internet8882Risk Ratio (M-H, Random, 95% CI)3.76 [2.84, 4.97]
24.4 Other4504Risk Ratio (M-H, Random, 95% CI)1.79 [1.08, 2.99]
25 Response (specific), self-rated at post-treatment (by therapy)211547Risk Ratio (M-H, Random, 95% CI)2.34 [1.81, 3.03]
25.1 Applied relaxation00Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]
25.2 CBT191378Risk Ratio (M-H, Random, 95% CI)2.30 [1.76, 3.01]
25.3 Exposure/ Desensitization2169Risk Ratio (M-H, Random, 95% CI)4.36 [0.63, 29.98]
25.4 Muscle relaxation00Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]
25.5 Self-examination00Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]
26 Response (specific), self-rated at post-treatment (by setting)211547Risk Ratio (M-H, Random, 95% CI)2.34 [1.81, 3.03]
26.1 Advertising191386Risk Ratio (M-H, Random, 95% CI)2.43 [1.82, 3.25]
26.2 Referral Only2161Risk Ratio (M-H, Random, 95% CI)2.00 [1.23, 3.24]
26.3 Other00Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]
27 Response (specific), clinician-rated at post-treatment11922Risk Ratio (M-H, Random, 95% CI)4.90 [3.12, 7.68]
28 Response (general), self-rated at post-treatment8622Risk Ratio (M-H, Random, 95% CI)2.11 [1.13, 3.93]
29 Recovery, clinician-rated at post-treatment9605Risk Difference (M-H, Random, 95% CI)0.40 [0.20, 0.60]
30 Depression, self-rated at post-treatment513682Std. Mean Difference (Random, 95% CI)0.47 [0.36, 0.58]
31 Depression, clinician-rated at post-treatment150Std. Mean Difference (Random, 95% CI)0.06 [-0.49, 0.60]
32 Depression improvement, self-rated at post-treatment5224Risk Ratio (M-H, Random, 95% CI)2.64 [1.36, 5.14]
33 Disability, self-rated at post-treatment201629Std. Mean Difference (Random, 95% CI)0.48 [0.33, 0.63]
34 Disability, clinician-rated at post-treatment5293Std. Mean Difference (Random, 95% CI)0.56 [-0.01, 1.14]
35 Quality of Life, self-rated at post-treatment181344Std. Mean Difference (Random, 95% CI)0.36 [0.22, 0.49]
36 Dropout at post-treatment786059Risk Ratio (M-H, Random, 95% CI)0.96 [0.94, 0.99]
37 Anxiety (any measure), self-rated at follow-up15684Std. Mean Difference (Random, 95% CI)0.49 [0.24, 0.75]
38 Specific symptoms, self-rated at follow-up12439Std. Mean Difference (Random, 95% CI)0.61 [0.27, 0.94]
39 Specific symptoms, clinician-rated at follow-up598Std. Mean Difference (Random, 95% CI)1.12 [0.70, 1.53]
40 General symptoms, self-rated at follow-up9569Std. Mean Difference (Random, 95% CI)0.22 [0.06, 0.39]
41 Behavioural Test (level), clinician-rated at follow-up130Std. Mean Difference (Random, 95% CI)1.23 [0.47, 1.99]
42 Behavioural Test (symptoms), self-rated at follow-up130Std. Mean Difference (Random, 95% CI)0.60 [-0.11, 1.31]
43 Response (specific), self-rated at follow-up2128Risk Ratio (M-H, Random, 95% CI)2.12 [1.18, 3.79]
44 Response (specific), clinician-rated at follow-up123Risk Ratio (M-H, Random, 95% CI)3.93 [0.21, 73.71]
45 Response (general), self-rated at follow-up195Risk Ratio (M-H, Random, 95% CI)0.97 [0.51, 1.84]
46 Recovery, clinician-rated at follow-up1117Risk Ratio (M-H, Random, 95% CI)0.91 [0.64, 1.28]
47 Depression, self-rated at follow-up7526Std. Mean Difference (Random, 95% CI)0.28 [0.05, 0.52]
48 Depression, clinician-rated at follow-up150Std. Mean Difference (Random, 95% CI)0.32 [-0.23, 0.87]
49 Disability, self-rated at follow-up7513Std. Mean Difference (Random, 95% CI)0.21 [-0.15, 0.57]
50 Disability, clinician-rated at follow-up3108Std. Mean Difference (Random, 95% CI)0.53 [0.14, 0.93]
51 Quality of Life, self-rated at follow-up3211Std. Mean Difference (Random, 95% CI)0.08 [-0.19, 0.35]
52 Anxiety (any measure), self-rated at >6m5287Std. Mean Difference (Random, 95% CI)0.18 [-0.15, 0.52]
53 Specific symptoms, self-rated at >6m5287Std. Mean Difference (Random, 95% CI)0.20 [-0.11, 0.51]
54 General symptoms, self-rated at >6m2194Std. Mean Difference (Random, 95% CI)-0.07 [-0.63, 0.49]
55 Response (specific), self-rated at >6m2148Risk Ratio (Random, 95% CI)1.51 [0.67, 3.36]
56 Depression, self-rated at >6m2194Std. Mean Difference (Random, 95% CI)-0.25 [-0.58, 0.08]
57 Disability, self-rated at >6m3147Std. Mean Difference (Random, 95% CI)0.14 [-0.33, 0.60]
58 Quality of Life, self-rated at >6m1115Std. Mean Difference (Random, 95% CI)-0.06 [-0.48, 0.36]
Analysis 1.1.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 1 Anxiety (any measure), self-rated at post-treatment.

Analysis 1.2.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 2 Anxiety (any measure), self-rated at post-treatment (type of control).

Analysis 1.3.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 3 Anxiety (any measure), self-rated at post-treatment (by disorder).

Analysis 1.4.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 4 Anxiety (any measure), self-rated at post-treatment (by media).

Analysis 1.5.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 5 Anxiety (any measure), self-rated at post-treatment (by therapy).

Analysis 1.6.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 6 Anxiety (any measure), self-rated at post-treatment (by setting).

Analysis 1.7.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 7 Anxiety (any measure), self-rated at post-treatment (sensitivity analysis for bias).

Analysis 1.8.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 8 Specific symptoms, self-rated at post-treatment.

Analysis 1.9.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 9 Specific symptoms, self-rated at post-treatment (type of control).

Analysis 1.10.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 10 Specific symptoms, self-rated at post-treatment (by disorder).

Analysis 1.11.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 11 Specific symptoms, self-rated at post-treatment (by media).

Analysis 1.12.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 12 Specific symptoms, self-rated at post-treatment (by therapy).

Analysis 1.13.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 13 Specific symptoms, self-rated at post-treatment (by setting).

Analysis 1.14.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 14 Specific symptoms, self-rated at post-treatment (sensitivity analysis for bias).

Analysis 1.15.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 15 Specific symptoms, self-rated at post-treatment (studies also reporting clinician rated).

Analysis 1.16.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 16 Specific symptoms, clinician-rated at post-treatment.

Analysis 1.17.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 17 Specific symptoms, clinician-rated at post-treatment.

Analysis 1.18.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 18 General symptoms, self-rated at post-treatment.

Analysis 1.19.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 19 Behavioural Test (level), clinician-rated at post-treatment.

Analysis 1.20.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 20 Behavioural Test (symptoms), self-rated at post-treatment.

Analysis 1.21.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 21 Response (specific), self-rated at post-treatment.

Analysis 1.22.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 22 Response (specific), self-rated at post-treatment (type of control).

Analysis 1.23.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 23 Response (specific), self-rated at post-treatment (by disorder).

Analysis 1.24.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 24 Response (specific), self-rated at post-treatment (by media).

Analysis 1.25.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 25 Response (specific), self-rated at post-treatment (by therapy).

Analysis 1.26.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 26 Response (specific), self-rated at post-treatment (by setting).

Analysis 1.27.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 27 Response (specific), clinician-rated at post-treatment.

Analysis 1.28.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 28 Response (general), self-rated at post-treatment.

Analysis 1.29.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 29 Recovery, clinician-rated at post-treatment.

Analysis 1.30.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 30 Depression, self-rated at post-treatment.

Analysis 1.31.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 31 Depression, clinician-rated at post-treatment.

Analysis 1.32.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 32 Depression improvement, self-rated at post-treatment.

Analysis 1.33.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 33 Disability, self-rated at post-treatment.

Analysis 1.34.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 34 Disability, clinician-rated at post-treatment.

Analysis 1.35.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 35 Quality of Life, self-rated at post-treatment.

Analysis 1.36.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 36 Dropout at post-treatment.

Analysis 1.37.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 37 Anxiety (any measure), self-rated at follow-up.

Analysis 1.38.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 38 Specific symptoms, self-rated at follow-up.

Analysis 1.39.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 39 Specific symptoms, clinician-rated at follow-up.

Analysis 1.40.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 40 General symptoms, self-rated at follow-up.

Analysis 1.41.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 41 Behavioural Test (level), clinician-rated at follow-up.

Analysis 1.42.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 42 Behavioural Test (symptoms), self-rated at follow-up.

Analysis 1.43.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 43 Response (specific), self-rated at follow-up.

Analysis 1.44.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 44 Response (specific), clinician-rated at follow-up.

Analysis 1.45.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 45 Response (general), self-rated at follow-up.

Analysis 1.46.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 46 Recovery, clinician-rated at follow-up.

Analysis 1.47.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 47 Depression, self-rated at follow-up.

Analysis 1.48.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 48 Depression, clinician-rated at follow-up.

Analysis 1.49.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 49 Disability, self-rated at follow-up.

Analysis 1.50.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 50 Disability, clinician-rated at follow-up.

Analysis 1.51.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 51 Quality of Life, self-rated at follow-up.

Analysis 1.52.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 52 Anxiety (any measure), self-rated at >6m.

Analysis 1.53.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 53 Specific symptoms, self-rated at >6m.

Analysis 1.54.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 54 General symptoms, self-rated at >6m.

Analysis 1.55.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 55 Response (specific), self-rated at >6m.

Analysis 1.56.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 56 Depression, self-rated at >6m.

Analysis 1.57.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 57 Disability, self-rated at >6m.

Analysis 1.58.

Comparison 1 Media-delivered interventions compared to no intervention, Outcome 58 Quality of Life, self-rated at >6m.

Comparison 2. Media-delivered interventions compared to face-to-face interventions
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Anxiety (any measure), self-rated at post-treatment241360Std. Mean Difference (Random, 95% CI)-0.23 [-0.36, -0.09]
2 Anxiety (any measure), self-rated at post-treatment (group versus individual)241360Std. Mean Difference (Random, 95% CI)-0.23 [-0.36, -0.09]
2.1 Group CBT5477Std. Mean Difference (Random, 95% CI)-0.18 [-0.44, 0.09]
2.2 Individual CBT9549Std. Mean Difference (Random, 95% CI)-0.17 [-0.34, 0.00]
2.3 Individual Exposure10334Std. Mean Difference (Random, 95% CI)-0.39 [-0.65, -0.13]
3 Anxiety (any measure), self-rated at post-treatment (by disorder)241360Std. Mean Difference (Random, 95% CI)-0.23 [-0.36, -0.09]
3.1 Mixed2165Std. Mean Difference (Random, 95% CI)-0.25 [-0.56, 0.05]
3.2 OCD2147Std. Mean Difference (Random, 95% CI)-0.26 [-0.59, 0.06]
3.3 Panic8430Std. Mean Difference (Random, 95% CI)-0.27 [-0.51, -0.03]
3.4 Social4373Std. Mean Difference (Random, 95% CI)0.02 [-0.18, 0.22]
3.5 Specific8245Std. Mean Difference (Random, 95% CI)-0.39 [-0.73, -0.06]
4 Anxiety (any measure), self-rated at post-treatment (by media)241360Std. Mean Difference (Random, 95% CI)-0.23 [-0.36, -0.09]
4.1 Book10535Std. Mean Difference (Random, 95% CI)-0.34 [-0.60, -0.08]
4.2 Computer4136Std. Mean Difference (Random, 95% CI)-0.38 [-0.71, -0.04]
4.3 Internet7519Std. Mean Difference (Random, 95% CI)-0.05 [-0.22, 0.12]
4.4 Other3170Std. Mean Difference (Random, 95% CI)-0.23 [-0.53, 0.07]
5 Anxiety (any measure), self-rated at post-treatment (by therapy)241360Std. Mean Difference (Random, 95% CI)-0.23 [-0.36, -0.09]
5.1 CBT13916Std. Mean Difference (Random, 95% CI)-0.16 [-0.31, -.00]
5.2 Exposure/ Desensitization10419Std. Mean Difference (Random, 95% CI)-0.37 [-0.62, -0.13]
5.3 Muscle relaxation125Std. Mean Difference (Random, 95% CI)-0.14 [-0.92, 0.65]
6 Anxiety (any measure), self-rated at post-treatment (by setting)241360Std. Mean Difference (Random, 95% CI)-0.23 [-0.36, -0.09]
6.1 Advertising17916Std. Mean Difference (Random, 95% CI)-0.15 [-0.32, 0.02]
6.2 Referral Only7444Std. Mean Difference (Random, 95% CI)-0.37 [-0.56, -0.18]
7 Anxiety (any measure), self-rated at post-treatment (sensitivity analysis for bias)24 Std. Mean Difference (Random, 95% CI)-0.23 [-0.36, -0.09]
7.1 High or Unclear Risk for Incomplete Outcome Data11 Std. Mean Difference (Random, 95% CI)-0.28 [-0.44, -0.13]
7.2 Low Risk for Incomplete Outcome Data13 Std. Mean Difference (Random, 95% CI)-0.18 [-0.40, 0.04]
8 Specific symptoms, self-rated at post-treatment231255Std. Mean Difference (Random, 95% CI)-0.23 [-0.37, -0.10]
9 Specific symptoms, self-rated at post-treatment (group versus individual)23 Std. Mean Difference (Random, 95% CI)-0.23 [-0.37, -0.10]
9.1 Group CBT4 Std. Mean Difference (Random, 95% CI)-0.17 [-0.52, 0.19]
9.2 Individual CBT9 Std. Mean Difference (Random, 95% CI)-0.18 [-0.35, -0.02]
9.3 Individual Exposure10 Std. Mean Difference (Random, 95% CI)-0.40 [-0.65, -0.14]
10 Specific symptoms, self-rated at post-treatment (by disorder)231255Std. Mean Difference (Random, 95% CI)-0.23 [-0.37, -0.10]
10.1 Mixed2165Std. Mean Difference (Random, 95% CI)-0.24 [-0.54, 0.07]
10.2 OCD2145Std. Mean Difference (Random, 95% CI)-0.29 [-0.62, 0.03]
10.3 Panic7327Std. Mean Difference (Random, 95% CI)-0.30 [-0.56, -0.04]
10.4 Social4373Std. Mean Difference (Random, 95% CI)0.03 [-0.18, 0.23]
10.5 Specific8245Std. Mean Difference (Random, 95% CI)-0.40 [-0.74, -0.06]
11 Specific symptoms, self-rated at post-treatment (by media)221275Std. Mean Difference (Random, 95% CI)-0.26 [-0.39, -0.12]
11.1 Book10553Std. Mean Difference (Random, 95% CI)-0.42 [-0.65, -0.20]
11.2 Computer4136Std. Mean Difference (Random, 95% CI)-0.38 [-0.71, -0.04]
11.3 Internet6416Std. Mean Difference (Random, 95% CI)0.01 [-0.18, 0.20]
11.4 Other3170Std. Mean Difference (Random, 95% CI)-0.23 [-0.54, 0.07]
12 Specific symptoms, self-rated at post-treatment (by therapy)231255Std. Mean Difference (Random, 95% CI)-0.23 [-0.37, -0.10]
12.1 CBT12811Std. Mean Difference (Random, 95% CI)-0.16 [-0.33, 0.01]
12.2 Exposure/ Desensitization10419Std. Mean Difference (Random, 95% CI)-0.38 [-0.62, -0.14]
12.3 Muscle relaxation125Std. Mean Difference (Random, 95% CI)-0.14 [-0.92, 0.65]
13 Specific symptoms, self-rated at post-treatment (by setting)231255Std. Mean Difference (Random, 95% CI)-0.23 [-0.37, -0.10]
13.1 Advertising17917Std. Mean Difference (Random, 95% CI)-0.16 [-0.32, 0.00]
13.2 Referral Only6338Std. Mean Difference (Random, 95% CI)-0.42 [-0.64, -0.21]
14 Specific symptoms, self-rated at post-treatment (sensitivity analysis for bias)231255Std. Mean Difference (Random, 95% CI)-0.23 [-0.37, -0.10]
14.1 High or Unclear Risk for Incomplete Outcome Data10523Std. Mean Difference (Random, 95% CI)-0.29 [-0.47, -0.12]
14.2 Low Risk for Incomplete Outcome Data13732Std. Mean Difference (Random, 95% CI)-0.20 [-0.41, 0.02]
15 Specific symptoms, clinician-rated at post-treatment6418Std. Mean Difference (Random, 95% CI)-0.13 [-0.33, 0.06]
16 General symptoms, self-rated at post-treatment11627Std. Mean Difference (Random, 95% CI)-0.08 [-0.36, 0.20]
17 Behavioural Test (level), clinician-rated at post-treatment5211Std. Mean Difference (Random, 95% CI)-0.44 [-0.76, -0.13]
18 Behavioural Test (symptoms), self-rated at post-treatment5209Std. Mean Difference (Random, 95% CI)-0.57 [-1.35, 0.21]
19 Response (specific), self-rated at post-treatment10575Risk Ratio (M-H, Random, 95% CI)0.78 [0.56, 1.09]
20 Response (specific), self-rated at post-treatment (group versus individual)10575Risk Ratio (M-H, Random, 95% CI)0.78 [0.56, 1.09]
20.1 Group CBT1126Risk Ratio (M-H, Random, 95% CI)1.61 [1.07, 2.44]
20.2 Individual CBT7382Risk Ratio (M-H, Random, 95% CI)0.73 [0.53, 1.01]
20.3 Individual Exposure267Risk Ratio (M-H, Random, 95% CI)0.39 [0.02, 7.29]
21 Response (specific), self-rated at post-treatment (by disorder)10575Risk Ratio (M-H, Random, 95% CI)0.78 [0.56, 1.09]
21.1 OCD3217Risk Ratio (M-H, Random, 95% CI)0.59 [0.40, 0.87]
21.2 Panic4165Risk Ratio (M-H, Random, 95% CI)0.82 [0.55, 1.23]
21.3 Social1126Risk Ratio (M-H, Random, 95% CI)1.61 [1.07, 2.44]
21.4 Specific267Risk Ratio (M-H, Random, 95% CI)0.39 [0.02, 7.29]
22 Response (specific), self-rated at post-treatment (by media)10575Risk Ratio (M-H, Random, 95% CI)0.78 [0.56, 1.09]
22.1 Book6224Risk Ratio (M-H, Random, 95% CI)0.58 [0.30, 1.10]
22.2 Computer133Risk Ratio (M-H, Random, 95% CI)1.06 [0.74, 1.52]
22.3 Internet2175Risk Ratio (M-H, Random, 95% CI)1.17 [0.61, 2.25]
22.4 Other1143Risk Ratio (M-H, Random, 95% CI)0.61 [0.39, 0.95]
23 Response (specific), self-rated at post-treatment (by therapy)10575Risk Ratio (M-H, Random, 95% CI)0.78 [0.56, 1.09]
23.1 CBT7365Risk Ratio (M-H, Random, 95% CI)0.87 [0.60, 1.26]
23.2 Exposure/ Desensitization3210Risk Ratio (M-H, Random, 95% CI)0.54 [0.22, 1.34]
24 Response (specific), self-rated at post-treatment (by setting)10575Risk Ratio (M-H, Random, 95% CI)0.78 [0.56, 1.09]
24.1 Advertising7430Risk Ratio (M-H, Random, 95% CI)0.90 [0.64, 1.27]
24.2 Referral Only3145Risk Ratio (M-H, Random, 95% CI)0.48 [0.30, 0.76]
25 Response (specific), clinician-rated at post-treatment9663Risk Ratio (M-H, Random, 95% CI)0.49 [0.31, 0.77]
26 Response (general), self-rated at post-treatment1 Risk Ratio (M-H, Random, 95% CI)Totals not selected
27 Recovery, clinician-rated at post-treatment6587Risk Ratio (M-H, Random, 95% CI)1.05 [0.88, 1.24]
28 Depression, self-rated at post-treatment13906Std. Mean Difference (Random, 95% CI)-0.01 [-0.22, 0.21]
29 Depression, clinician-rated at post-treatment1 Std. Mean Difference (Random, 95% CI)Totals not selected
30 Depression improvement, self-rated at post-treatment273Risk Ratio (M-H, Random, 95% CI)1.21 [0.74, 1.97]
31 Disability, self-rated at post-treatment10670Std. Mean Difference (Random, 95% CI)-0.07 [-0.33, 0.20]
32 Disability, clinician-rated at post-treatment3200Std. Mean Difference (Random, 95% CI)0.24 [-0.04, 0.52]
33 Quality of Life, self-rated at post-treatment4282Std. Mean Difference (Random, 95% CI)0.08 [-0.23, 0.38]
34 Dropout at post-treatment281852Risk Ratio (M-H, Random, 95% CI)0.99 [0.95, 1.03]
35 Anxiety (any measure), self-rated at follow-up11677Std. Mean Difference (Random, 95% CI)-0.14 [-0.30, 0.01]
36 Specific symptoms, self-rated at follow-up10573Std. Mean Difference (Random, 95% CI)-0.15 [-0.31, 0.02]
37 Specific symptoms, clinician-rated at follow-up3185Std. Mean Difference (Random, 95% CI)-0.19 [-0.69, 0.30]
38 General symptoms, self-rated at follow-up5308Std. Mean Difference (Random, 95% CI)-0.10 [-0.30, 0.09]
39 Behavioural Test (level), clinician-rated at follow-up260Std. Mean Difference (Random, 95% CI)-0.02 [-0.74, 0.71]
40 Behavioural Test (symptoms), self-rated at follow-up1 Std. Mean Difference (Random, 95% CI)Totals not selected
41 Response (specific), self-rated at follow-up4224Risk Ratio (M-H, Random, 95% CI)0.99 [0.73, 1.35]
42 Response (specific), clinician-rated at follow-up3280Risk Ratio (M-H, Random, 95% CI)1.10 [0.83, 1.45]
43 Recovery, clinician-rated at follow-up3354Risk Ratio (M-H, Random, 95% CI)1.04 [0.70, 1.56]
44 Depression, self-rated at follow-up5403Std. Mean Difference (Random, 95% CI)0.09 [-0.19, 0.36]
45 Depression, clinician-rated at follow-up1 Std. Mean Difference (Random, 95% CI)Totals not selected
46 Depression improvement, self-rated at follow-up1 Risk Ratio (M-H, Random, 95% CI)Totals not selected
47 Disability, self-rated at follow-up5337Std. Mean Difference (Random, 95% CI)-0.10 [-0.39, 0.19]
48 Disability, clinician-rated at follow-up2145Std. Mean Difference (Random, 95% CI)0.18 [-0.30, 0.65]
49 Quality of Life, self-rated at follow-up2143Std. Mean Difference (Random, 95% CI)0.40 [0.07, 0.73]
50 Anxiety (any measure), self-rated at >6m8423Std. Mean Difference (Random, 95% CI)-0.16 [-0.50, 0.18]
51 Specific symptoms, self-rated at >6m8423Std. Mean Difference (Random, 95% CI)-0.20 [-0.54, 0.14]
52 Specific symptoms, clinician-rated at >6m1 Std. Mean Difference (Random, 95% CI)Totals not selected
53 General symptoms, self-rated at >6m4241Std. Mean Difference (Random, 95% CI)0.04 [-0.22, 0.30]
54 Behavioural Test (level), clinician-rated at >6m2122Std. Mean Difference (Random, 95% CI)-0.11 [-0.97, 0.76]
55 Behavioural Test (symptoms), self-rated at >6m3162Std. Mean Difference (Random, 95% CI)-0.46 [-1.19, 0.27]
56 Response (specific), self-rated at >6m3116Risk Ratio (M-H, Random, 95% CI)0.58 [0.20, 1.64]
57 Response (specific), clinician-rated at >6m282Risk Ratio (M-H, Random, 95% CI)0.54 [0.16, 1.80]
58 Response (general), self-rated at >6m1 Risk Ratio (M-H, Random, 95% CI)Totals not selected
59 Recovery, clinician-rated at >6m2147Risk Ratio (M-H, Random, 95% CI)0.90 [0.64, 1.25]
60 Depression, self-rated at >6m5339Std. Mean Difference (Random, 95% CI)0.08 [-0.14, 0.30]
61 Depression improvement, self-rated at >6m1 Risk Ratio (M-H, Random, 95% CI)Totals not selected
62 Disability, self-rated at >6m3242Std. Mean Difference (Random, 95% CI)-0.21 [-0.47, 0.04]
63 Quality of Life, self-rated at >6m1 Std. Mean Difference (Random, 95% CI)Totals not selected
Analysis 2.1.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 1 Anxiety (any measure), self-rated at post-treatment.

Analysis 2.2.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 2 Anxiety (any measure), self-rated at post-treatment (group versus individual).

Analysis 2.3.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 3 Anxiety (any measure), self-rated at post-treatment (by disorder).

Analysis 2.4.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 4 Anxiety (any measure), self-rated at post-treatment (by media).

Analysis 2.5.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 5 Anxiety (any measure), self-rated at post-treatment (by therapy).

Analysis 2.6.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 6 Anxiety (any measure), self-rated at post-treatment (by setting).

Analysis 2.7.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 7 Anxiety (any measure), self-rated at post-treatment (sensitivity analysis for bias).

Analysis 2.8.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 8 Specific symptoms, self-rated at post-treatment.

Analysis 2.9.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 9 Specific symptoms, self-rated at post-treatment (group versus individual).

Analysis 2.10.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 10 Specific symptoms, self-rated at post-treatment (by disorder).

Analysis 2.11.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 11 Specific symptoms, self-rated at post-treatment (by media).

Analysis 2.12.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 12 Specific symptoms, self-rated at post-treatment (by therapy).

Analysis 2.13.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 13 Specific symptoms, self-rated at post-treatment (by setting).

Analysis 2.14.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 14 Specific symptoms, self-rated at post-treatment (sensitivity analysis for bias).

Analysis 2.15.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 15 Specific symptoms, clinician-rated at post-treatment.

Analysis 2.16.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 16 General symptoms, self-rated at post-treatment.

Analysis 2.17.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 17 Behavioural Test (level), clinician-rated at post-treatment.

Analysis 2.18.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 18 Behavioural Test (symptoms), self-rated at post-treatment.

Analysis 2.19.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 19 Response (specific), self-rated at post-treatment.

Analysis 2.20.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 20 Response (specific), self-rated at post-treatment (group versus individual).

Analysis 2.21.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 21 Response (specific), self-rated at post-treatment (by disorder).

Analysis 2.22.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 22 Response (specific), self-rated at post-treatment (by media).

Analysis 2.23.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 23 Response (specific), self-rated at post-treatment (by therapy).

Analysis 2.24.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 24 Response (specific), self-rated at post-treatment (by setting).

Analysis 2.25.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 25 Response (specific), clinician-rated at post-treatment.

Analysis 2.26.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 26 Response (general), self-rated at post-treatment.

Analysis 2.27.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 27 Recovery, clinician-rated at post-treatment.

Analysis 2.28.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 28 Depression, self-rated at post-treatment.

Analysis 2.29.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 29 Depression, clinician-rated at post-treatment.

Analysis 2.30.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 30 Depression improvement, self-rated at post-treatment.

Analysis 2.31.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 31 Disability, self-rated at post-treatment.

Analysis 2.32.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 32 Disability, clinician-rated at post-treatment.

Analysis 2.33.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 33 Quality of Life, self-rated at post-treatment.

Analysis 2.34.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 34 Dropout at post-treatment.

Analysis 2.35.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 35 Anxiety (any measure), self-rated at follow-up.

Analysis 2.36.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 36 Specific symptoms, self-rated at follow-up.

Analysis 2.37.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 37 Specific symptoms, clinician-rated at follow-up.

Analysis 2.38.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 38 General symptoms, self-rated at follow-up.

Analysis 2.39.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 39 Behavioural Test (level), clinician-rated at follow-up.

Analysis 2.40.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 40 Behavioural Test (symptoms), self-rated at follow-up.

Analysis 2.41.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 41 Response (specific), self-rated at follow-up.

Analysis 2.42.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 42 Response (specific), clinician-rated at follow-up.

Analysis 2.43.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 43 Recovery, clinician-rated at follow-up.

Analysis 2.44.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 44 Depression, self-rated at follow-up.

Analysis 2.45.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 45 Depression, clinician-rated at follow-up.

Analysis 2.46.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 46 Depression improvement, self-rated at follow-up.

Analysis 2.47.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 47 Disability, self-rated at follow-up.

Analysis 2.48.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 48 Disability, clinician-rated at follow-up.

Analysis 2.49.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 49 Quality of Life, self-rated at follow-up.

Analysis 2.50.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 50 Anxiety (any measure), self-rated at >6m.

Analysis 2.51.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 51 Specific symptoms, self-rated at >6m.

Analysis 2.52.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 52 Specific symptoms, clinician-rated at >6m.

Analysis 2.53.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 53 General symptoms, self-rated at >6m.

Analysis 2.54.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 54 Behavioural Test (level), clinician-rated at >6m.

Analysis 2.55.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 55 Behavioural Test (symptoms), self-rated at >6m.

Analysis 2.56.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 56 Response (specific), self-rated at >6m.

Analysis 2.57.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 57 Response (specific), clinician-rated at >6m.

Analysis 2.58.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 58 Response (general), self-rated at >6m.

Analysis 2.59.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 59 Recovery, clinician-rated at >6m.

Analysis 2.60.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 60 Depression, self-rated at >6m.

Analysis 2.61.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 61 Depression improvement, self-rated at >6m.

Analysis 2.62.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 62 Disability, self-rated at >6m.

Analysis 2.63.

Comparison 2 Media-delivered interventions compared to face-to-face interventions, Outcome 63 Quality of Life, self-rated at >6m.

Appendices

Appendix 1. Search strategies

1. The Cochrane Depression, Anxiety and Neurosis Review Group's Specialised Register (CCDANCTR)
The Cochrane Depression, Anxiety and Neurosis Group (CCDAN) maintains two clinical trials registers at its editorial base in Bristol, UK: a references register and a studies-based register. The CCDANCTR References Register contains more than 31,900 reports of randomised controlled trials in depression, anxiety and neurosis. Approximately 65% of these references have been tagged to individual, coded trials. The coded trials are held in the CCDANCTR Studies Register, and records are linked between the two registers through the use of unique Study ID tags. Coding of trials is based on the EU-Psi coding manual. Please contact the CCDAN Trials Search Co-ordinator for further details.

Reports of trials for inclusion in the Group's registers are collated from routine (weekly), generic searches of MEDLINE (1950-), EMBASE (1974-) and PsycINFO (1967-) and from quarterly searches of the Cochrane Central Register of Controlled Trials (CENTRAL) and review-specific searches of additional databases. Reports of trials are also sourced from international trials registers c/o the World Health Organisation’s trials portal (ICTRP), ClinicalTrials.gov, drug companies and handsearching of key journals, conference proceedings and other (non-Cochrane) systematic reviews and meta-analyses.

Details of CCDAN's generic search strategies can be found on the Group's Website.

Both Registers (CCDANCTR Studies and CCDANCTR References) were searched by CCDAN's Trials Serach Co-ordinator (TSC) (all years to 1 January 2013) using the following free-text terms:

CONDITION = (anxiety or compulsi* or fear* or GAD or hypochondria* or obsess* or OCD or panic or *phobi* or "public speaking" or shy or shyness or "social avoidance")
+
INTERVENTION = (*psychotherap* or *cognitive* or *behavio* or bibliotherap* or *CBT* or acceptance* or assertive* or attribution or reattribution or re-attribution or (brief* and *therap*) or commitment* or desensiti* or expos* or *feedback* or "group therapy" or guided or imag* or implosive or “problem solving” or problem-solving or "solution focused" or solution-focused or schema or “contingency management” or “functional analys*” or mindfulness* or “mind training” or psychoeducat* or “rational emotive” or rational-emotive or REBT or relax* or “role play*” or (self* and (*administer* or *direct* or *examin* or *help)))
+
MODE OF DELIVERY = (audio* or bibliotherap* or book* or "chat room*" or computer* or CD-ROM or distance* or DVD or homework or information or instruct* or "instant messaging" or iCBT or Internet* or web* or WWW or phone or mobile or e-mail* or email* or leaflet* or material* or manual or manuals or multi-media or multimedia or online* or on-line or pamphlet or pamphlets or program or programme or remote or tele* or tape or taped or video* or virtual* or workbook*)

An additional search of the  CCDANCTR-Studies Register was conducted using a  set of controlled vocabulary terms for Condition + Intervention (only) to ensure no studies had been missed:
CONDITION = (anxiety or compulsi* or fear* or GAD or hypochondria* or obsess* or OCD or panic or *phobi* or “psychological stress” or "public speaking" or shy or shyness or "social avoidance")
+ INTERVENTION = (*self* or internet or computer or format or setting)
The searches of the Studies Register were limited to adult studies.

2. The Cochrane Central Register of Controlled Trials (CENTRAL)restricted to records submitted from the CCDANCTR References Register (SR-DEPRESSN)
Authors carried out their own, independent search of the CCDANCTR c/o CENTRAL (all years to 2 April 2012) using the following free-text terms:
#1. anxiety or anxious or agoraphobi* or phobi* or “panic disorder” or asthenia or obsess* or compuls*
#2. (audiotherapy or bibliotherapy or book* or CD* or computer* or cyber* or DVD or internet* or “interactive voice response” or interapy or inter-therapy or intertherapy or multimedia or multi-media or online or on-line or pamphlet or pamphlets or pc* or pcs or self administered or self desensiti* or self directed or self exposure or self help or tape or taped or video* or web* or www) or (“beating the blues" or “blues begone” or btstep* or bt step* or caccbt or CALM or CAVE or ccbt or “coping with panic” or fearfighter or “fear fighter” or ffeducation or “ff education” or “glasgow steps” or internetff or internet ff or “living with fear” or “living life to the full” or “managing anxiety” or moodgym or “mood gym” or netcope or net cope or nettff or nett ff or ocfighter or oc fighter or “overcoming anxiety” or “overcoming obsessive” or “overcoming panic” or “overcoming shyness” or “panic control” or “panic online” or “panic surfing” or positivestep or “positive step” or standaloneff or standalone ff or “stop obsessing” or stresspac or “talk to me”):ti,ab,kw
#3. SR-DEPRESSN

3. Ovid MEDLINE and PsycINFO (cross-search)
Additional searches were conducted on Ovid MEDLINE (23 February 2013) and PsycINFO (February, Week 2, 2013) simultaneously, using the following terms:

1. exp Agoraphobia/
2. exp Hypochondriasis/
3. exp Obsessive-compulsive disorder/
4. exp Panic disorder/
5. exp Phobic disorders/
6. (fear$ adj3 (air travel or animal$ or blood$ or buses or ((closed or public) adj2 space$) or crowd$ or dark$ or dental$ or dentist$ or dog$1 or dying or flight$ or fly or flying or height$ or hypochondriacal or injection$ or injur$ or lightening or movement$ or needle$ or negative evaluation or panic$ or performance or plane$ or snake$ or social or space$ or spider$ or sweat& or thunder$ or train$ or travel$ or tremble$ or water)).ti,ab.
7. (acrophob$ or agoraphob$ or agrophobi$ or ((anxiety$ or phobi$) adj2 neuros$) or anxiety disorders or claustrophob$ or Compul$ or emetophob$ or GAD or ((generalised or generalized or health) adj2 anxiety) or hypochondri$ or ((interpersonal or inter personal or social or speak$) adj3 (anxiety$ or avoid$ or fear$)) or kinesiophob$ or (specific adj2 (phobi$ or fear$)) or Obsess$ or OCD or (panic adj3 (attack$ or disorder$ or fear or symptoms)) or SAD or shyness).ti,ab.
8. anxiety.ti.
9. stress.ti.
10. anxiety.ti,ab.
11. 9 and 10
12. 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 11
13. exp bibliotherapy/
14. (audiotherapy or bibliotherapy or biblio therap$ or book$ or CD$ or computer$ or cyber$ or DVD or internet$ or interactive voice response or interapy or inter-therapy or intertherapy or multimedia or multi media or online or on-line or pamphlet or pamphlets or pc$ or pcs or (self adj (administered or desensiti$ or directed or exposure or help)) or tape or taped or video$ or web$ or www).ti,ab.
15. 13 or 14
16. (CBT or (cognitive adj2 behav$) or ((cognitive or behav$) adj3 (therap$ or intervention$ or program$ or restructur$)) or CT or desensiti$ or exposure or flooding or implosion or MCBT or mindfulness$ or metacognitive or mymct or modelling or relax$).ti,ab.
17. 15 and 16
18. (blues begone or caccbt or CALM or CAVE or ccbt or c cbt or (coping adj2 panic) or ffeducation or ff education or glasgow steps or internetff or internet ff or (living adj2 fear) or (living life adj3 full) or managing anxiety or moodgym or mood gym or netcope or net cope or nettff or nett ff or ocfighter or oc fighter or overcoming anxiety or overcoming obsessive or overcoming panic or overcoming shyness or (panic adj2 control) or (panic adj2 online) or (panic adj2 surfing) or positivestep or positive step or ((shyness or wellbeing) adj4 (program or programme)) or standaloneff or standalone ff or stop obsessing or stresspac or talk to me).ti,ab.
19. (bibliotherapy or self-help or interapy or (internet-based adj2 (intervention$ or management or self-help or treatment$ or therapy or therapies or program$))).ti.
20. 17 or 18 or 19
21. 12 and 20
22. ((beating adj2 blues) or btstep$ or bt step$ or fearfighter or fear fighter).ti,ab.
23. 21 or 22
24. exp clinical trial/
25. random$.af.
26. ((clinical$ adj2 control$) or cross over or crossover or dummy or experiment$ or factorial or mask$ or ((single$ or doubl$ or trebl$ or tripl$) adj2 blind) or (singleblind$ or doubleblind$ or trebleblind$ or tripleblind$) or placebo$ or trial or ((wait list or waitlist or waiting list or no treatment) adj (condition or control or group))).ti,ab.
27. 24 or 25 or 26
28. limit 27 to animal
29. limit 27 to animal studies
30. 28 or 29
31. limit 30 to humans
32. 30 not 31
33. 27 not 32
34. 23 and 33
35. remove duplicates from 34

Contributions of authors

Both review authors contributed to designing the project and to writing the protocol. EM-W conducted the searches and screened citations for eligibility with PM or with G.J. Melendez-Torres. EM-W extracted data (with Robyn Cox (RC), Jean Junior (JJ), Andreas Hein Willius (AH) or Kayleigh Kew (KK)), conducted the analyses and wrote a first draft of the results. Both review authors contributed to the interpretation and discussion.

Declarations of interest

None.

Sources of support

Internal sources

  • Centre for Evidence-Based Intervention (Department of Social Policy and Intervention), University of Oxford, UK.

  • Centre for Outcomes Research and Effectiveness (Research Department of Clinical, Educational & Health Psychology), University College London, UK.

External sources

  • No sources of support supplied

Differences between protocol and review

In addition to the CCDAN Controlled Trials Register, we searched MEDLINE and PsycINFO. In both cases, we used terms to identify media-delivered interventions for anxiety. Methods for assessing risk of bias were updated to follow current guidelines. We included measures of disability that were not specified in the protocol. We were unable to assess the use of other services, satisfaction, adverse events or cost.

The prespecified primary outcome, "Specific symptoms of anxiety", had to be refined because studies used several relevant measures. First, we analysed the average effects of all measures for each study. For studies of a single disorder, we also analysed specific measures of that disorder (e.g. LSAS) apart from general measures of anxiety (e.g. BAI). For studies including behavioural tests, which are commonly used to evaluate phobic avoidance, we analysed the level in the hierarchy achieved and subjective distress.

We added a Summary of findings table.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Abramowitz 2009

Methods

Location: Rochester (MN), USA

Recruitment: Advertising and referral

Exclusion rate: 25%

Randomised (N): 21 (11 intervention; 10 comparison)

Participants

Disorder: Social Anxiety (Unspecified); MINI (DSM-IV)

Duration (years): Unknown

Age (years): 43.4

Sex (female): 76.19%

Race (white): 57.14%

Medication (using at baseline): 57.14%

Education (years):  Unknown

 

EXCLUSIONS

Depression: Yes

Psychotherapy:  Previous psychotherapy restricted

Medication: "Individuals on psychotropic medication were instructed to remain on their current dose and were included as long as they had been at the same dosage for 3 months or more."

Drug/Alcohol: "individuals were excluded if they reported substance abuse/dependence in last 6 months"

Physical: N/A

Interventions

Comparison group(s): Wait-List

 

Intervention name: Shyness and Social Anxiety Workbook (Antony and Swinson, 2000)

Days of treatment: 48

Author wrote: No 

Type of media: Book / Booklet

Type of therapy: CBT

Location used: Anywhere

Type of contact: Face-to-face & Phone

Automated contact: N=0

Provider contact: N=7 (180 min)

Contact description: “At weeks 1, 2, 3, 6, and 8, a brief (<30 min) meeting with the therapist was held to review the chapters...No exposure or cognitive therapy took place; all CBT techniques were performed by the patient on his or her own. Questions for how to implement these techniques could be addressed...On weeks when no therapist contact was scheduled, a maximum 15-min telephone call was scheduled."   "Individuals who inquired about the study were screened by telephone. If they appeared to meet entry criteria, they were invited to undergo a diagnostic interview…"

Intervention description: “Patients were provided with a copy of the SSAW free of charge. The 11 chapters in the workbook were divided into 5 sections to be read over the 8 weeks of therapy as shown in Table 1.”  "CBT-based self-help resource that includes instruction in how to implement cognitive restructuring and situational exposure..."

Compliance: "on the adherence question pertaining to completion of non-exposure therapy assignments in the SSAW was 6.38 (SD=0.80; range 5–7), suggesting relatively good self-reported adherence. On the question assessing adherence to exposure assignments, the mean score was 5.85 (SD= 1.32; range 2–7), also suggesting fairly good...."  Adherence associated with better outcomes at follow-up though not at post-test.

Outcomes

Specific Symptoms: Brief Social Phobia Scale; Clinical Global Impression (CGI): Severity; Social Interaction Anxiety Scale (SIAS)

General Symptoms: State-Trait Anxiety Inventory (STAI): Trait

Depression: Beck Depression Inventory (BDI)

Notes

Funding: Mayo Clinic and Mayo Foundation. Grant awarded to Elizabeth Moore.

Unpublished data: Abramowitz provided details about the generation of the allocation sequence, recruitment methods, and duration of contact for assessment.  Unable to provide further outcome data or data about participants.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Method:  Computer/Online

“Participants were randomly assigned to 1 of 2 conditions"  "We used a random number generator on a computer" (personal communication)

Allocation concealment (selection bias)Low risk“the allocation was not administered by a third party. The study coordinator simply generated the assignment on a computer.”  (personal communication)
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

“...meeting with the therapist was held to review the chapters assigned for that particular week. The same therapist (ELM) worked with each patient and used a manual (available from the authors) to guide each meeting."

Blinding of outcome assessment (detection bias)
All outcomes
Low risk

Assessor-rated outcomes: Yes 

Assessor blind: Yes

“Two independent evaluators (IEs) administered all posttest and follow-up assessments. IEs were trained in the administration of the BSPS and CGI-S and completely blind to treatment condition and assessment time.”

Incomplete outcome data (attrition bias)
All outcomes
Low risk

Not analysed at post-treatment

Intervention: N=0 (0%)

Comparison: N=0 (0%)

Method of analysis: No Dropout

There were 3 dropouts at follow-up, but this occurred after the WL group received treatment and the results are not included in this review.

Selective reporting (reporting bias)Unclear riskNo trial registration number given.
Other biasLow riskN/A

Al-Kubaisy 1992

Methods

Location: London, England

Recruitment: Referral

Exclusion rate: 36.13%

Randomised (N): 99 (34 intervention; 31 comparison)

Participants

Disorder: Mixed (AG, SAD, SP); Clinical Interview (ICD-10)

Duration (years): 18

Age (years): 35

Sex (female): 65.66%

Race (white): 11.25%

Medication (using at baseline): 11.25%

Education (years):  12.02

 

EXCLUSIONS

Depression: Yes

Psychotherapy:  Previous psychotherapy restricted

Medication: "If medication exceeds more than the daily equivalent of 5mg of diazepam, 100mg imipramine, or 10mg propranolol, taken only at night, for at least 4 months"

Drug/Alcohol: "no more than 2 units of alcohol a day from at least 3 weeks before entering the trial"

Physical: "no severe organic disease"

Interventions

Comparison group(s): Applied relaxation (self-help)

Comparison description: "patients were asked to carry out 90 minutes daily of r while lying or sitting comfortably and listening to one or more of three half-hour audiotapes of progressive muscle relaxation instructions (Jacobsen's) which were supplied....play the tapes of their choice intermittently to a total of 90 minutes daily and to record homework daily in a diary"

 

Intervention name: Living With Fear (Marks, 1980)

Days of treatment: 64

Author wrote: Yes

Type of media: Book / Booklet

Type of therapy: Exposure

Location used: Anywhere

Type of contact: Face-to-face

Automated contact: N=0

Provider contact: N=6 (360 min)

Contact description: "saw the clinician six times for an hour each time (at weeks 0, 1, 2, 3, 4, 6). In these six sessions the clinician helped the patient set relevant self-guided homework (e or r) to be carried out over weeks 0-8 for at least 90 minutes daily and be recorded in a daily diary. The clinician and patient reviewed problems and the homework diary together at each session except the first...Ee patients had a further 1.5 hours of clinician contact per session doing clinician-accompanied live exposure (E) (6 × 1.5 hours =9 hours in all)."

Intervention description: were asked to read the self-help chapter from Living With Fear (Marks, 1980) and to follow its guidelines. From the avoidance profile worked out at initial assessment the patient and clinician together planned the (e) (self- exposure) program together. Patients were asked to complete 90 minutes of e daily to their most phobic stimuli that they could tolerate without escape (crowds, shops, zoo, etc.), and to record completed exposure homework tasks in a daily diary."

Compliance: In the intervention group, participants reported 58 hours of homework out of 83 prescribed (72%).  In the relaxation group, participants reported 62 of 84 hours (70%).  Daily diary.  Participants were not asked if they read the manual. Patient's compliance with homework was rated by the therapists based on a semi-structured interview.

Outcomes

Specific Symptoms: Fear Questionnaire (FQ)

General Symptoms: Fear Questionnaire (FQ): Anxiety Depression

Depression: Beck Depression Inventory (BDI); Hamilton Depression Rating Scale, clinician-rated (HAM-D)

Disability: Work and Social Adjustment Scale (WSAS)

Notes

Funding: Republic of Iraq grant awarded to TA-K, ORS grant, University of London PhD.

Unpublished data: Located thesis.  Unable to contact first author. 

Two eligible intervention groups differed only in amount of contact.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High risk

Method:  Unclear

“Randomization was stratified according to 3 phobic types-agoraphobia, social phobia, or specific phobia" Dropouts were replaced (See Incomplete Outcome Data).

Allocation concealment (selection bias)High risk“At the end assessment the blind assessor made further assessment appointment for week 8, and handed the clinician a sealed envelope about the patient's treatment condition.  Therapy then began (week 0) in the assigned treatment mode.” Dropouts were replaced (See Incomplete Outcome Data).
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

“Patients in all three conditions saw the clinician six times for an hour each time…"  "The clinician helped the patient set relevant self-guided homework..."

Blinding of outcome assessment (detection bias)
All outcomes
Low risk

Included assessor-rated outcomes (blind)

“...measures were self-rated (S) and rated by an assessor (A)- psychiatrists, psychologists and nurse therapists-kept blind to the treatment condition…”

Incomplete outcome data (attrition bias)
All outcomes
High risk

Not analysed at post-treatment

Intervention: N=12 (35.29%)

Comparison: N=6 (19.35%)

Method of analysis: Per protocol

“The number of any patient who dropped out was returned to the pool of random numbers and reassigned to a fresh patient.”  Int: 12/34 (4 treatment dropouts remained in the study, 4 refused, 4 dropouts).  Con: 6/31 (2  refused, 4 dropouts).

Selective reporting (reporting bias)Low riskNo trial registration number given, but data extracted from thesis likely complete.  At 2-year follow-up "Only self-rated measures were analysed because assessor-rated measures were unavailable for patients who did not attend follow-up and so could be biased."
Other biasHigh riskDropouts were replaced (See Incomplete Outcome Data).

Al-Kubaisy 1992 (AG)

MethodsAs above.
Participants 
Interventions 
Outcomes 
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment (selection bias)Low risk 
Blinding of participants and personnel (performance bias)
All outcomes
High risk 
Blinding of outcome assessment (detection bias)
All outcomes
Low risk 
Incomplete outcome data (attrition bias)
All outcomes
High risk 
Selective reporting (reporting bias)Low risk 
Other biasLow risk 

Al-Kubaisy 1992 (SAD)

MethodsAs above.
Participants 
Interventions 
Outcomes 
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment (selection bias)Low risk 
Blinding of participants and personnel (performance bias)
All outcomes
High risk 
Blinding of outcome assessment (detection bias)
All outcomes
Low risk 
Incomplete outcome data (attrition bias)
All outcomes
High risk 
Selective reporting (reporting bias)Low risk 
Other biasLow risk 

Al-Kubaisy 1992 (SP)

MethodsAs above.
Participants 
Interventions 
Outcomes 
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment (selection bias)Low risk 
Blinding of participants and personnel (performance bias)
All outcomes
High risk 
Blinding of outcome assessment (detection bias)
All outcomes
Low risk 
Incomplete outcome data (attrition bias)
All outcomes
High risk 
Selective reporting (reporting bias)Low risk 
Other biasLow risk 

Andersson 2009a

Methods

Location: Stockholm, Sweden

Recruitment: Advertising/ Internet

Exclusion rate: 71.7%

Randomised (N): 30 (15 intervention; 15 comparison)

Participants

Disorder: Specific Phobia; SCID (DSM-IV R)

Duration (years): Unknown

Age (years): 25.6

Sex (female): 84.8%

Race (white): Unknown

Medication (using at baseline): Unknown

Education (years):  14.22

 

EXCLUSIONS

Depression: Yes

Psychotherapy:  No restrictions reported

Medication: N/A

Drug/Alcohol: N/A

Physical: N/A

Interventions

Comparison group(s): Individual Exposure

Comparison description: “one-session treatment was delivered in two sessions, with a first brief orientation session and then the 3-hr exposure session, following Ost’s (1997) guidelines...cognitions are challenged during the exposures...and four jars with spiders of increasing size were prepared...participants were given the video after the completion of the exposure. They were also given a maintenance program and instructed to confront spiders...”

 

Intervention name: Not named

Days of treatment: 28

Author wrote: Yes 

Type of media: Internet

Type of therapy: Exposure

Location used: Anywhere

Type of contact: Email

Automated contact: N=0

Provider contact: N=4 (25min)

Contact description: “Participants were contacted if they failed to send in homework assignment reports." "When the homework was reported the following week, the participant had to complete a brief set of questions in order to be allowed to proceed to the next module."  "contact with the therapist was 25 min in total per client"

Intervention description: “five text modules, which were presented on web pages and as downloadable PDF files...each participant had a therapist who was responsible for the whole treatment. E-mails were used in the contact, and the whole process was password-protected. In addition, a videotape illustrating exposure instruction was sent by post to the participants. Included psychoeducation, detailed exposure instructions, avoided situations and cognitions, exposure in real life, maintenance programme.”

Compliance: “on average the participants’ own estimate of how much time they had devoted to the treatment was 2.4 hr. per week (total time: 12 hr.).” "participant had to complete a brief set of questions in order to be allowed to proceed to the next module" "participants were contacted if they failed to send in homework assignment reports"

Outcomes

Specific Symptoms: Fear Survey Schedule

General Symptoms: Beck Anxiety Inventory (BAI)

Response: Behavioural Approach Test: Completed

Depression: Beck Depression Inventory (BDI)

Notes Funding: Swedish Research Council
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

Method:  Unclear

“randomised by an independent person”

Allocation concealment (selection bias)Unclear riskSee “Sequence Generation”
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

“each participant had a therapist who was responsible for the whole treatment. E-mails were used in the contact…”

Blinding of outcome assessment (detection bias)
All outcomes
High risk

Included assessor-rated outcomes (NOT blind)

Clinically significant improvement was derived from the BAT.

Incomplete outcome data (attrition bias)
All outcomes
Low risk

Not analysed at post-treatment

Intervention: N=2 (13.33%)

Comparison: N=1 (6.67%)

 

Method of analysis: Available Case

because of computer problems (N=1) or lack of time (N=2). At follow-up, "one participant dropped out from the Internet treatment condition and two from the live-exposure treatment either because of lack of time or relocation."  Percentages for the BAT indicate 7 missing.

Selective reporting (reporting bias)High risk

No trial registration number given.

The stated primary outcome (BAT) is not reported in full.  Mean scores for each group appear in a line graph with no error bars.

Other biasLow riskN/A

Andersson 2012a

Methods

Location: Stockholm, Sweden

Recruitment: Advertising/ Internet

Exclusion rate: 52.36%

Randomised (N): 101 (50 intervention; 51 comparison)

Participants

Disorder: OCD; SCID (DSM-IV R)

Duration (years): 18

Age (years): 34.01

Sex (female): 66.34%

Race (white): 22.77%

Medication (using at baseline): 22.77%

Education (years):  13.89

 

EXCLUSIONS

Depression: No

Psychotherapy:  Current and previous therapy restricted

Medication: "Concurrent use of psychotropic medication was permitted, if it had been stable for at least 2 months prior to inclusion, and if the participant agreed to maintain a constant dosage throughout the study."

Drug/Alcohol: "Current alcohol or drug abuse."

Physical: "Physical illness that could interfere with ICBT."

Interventions

Comparison group(s): Attention/Monitoring

Comparison description: “…online non-directive supportive therapy, which consisted of access to an e-mail function integrated in the treatment platform…no active treatment components such as self-help texts or worksheets. Each week, the therapist contacted the participant through the treatment platform to enquire how the week had progressed and to encourage the participant to discuss current distressing life events…”

 

Intervention name: Not named (Andersson et al. 2011)

Days of treatment: 70

Author wrote: Yes 

Type of media: Internet

Type of therapy: CBT

Location used: Anywhere

Type of contact: Email & Phone

Automated contact: N=0

Provider contact: N=52 (129min)

Contact description: “provide feedback on homework assignments, grant consecutive access to the modules, and to support the participants in doing ERP…support or clarification…if they had not logged on to the treatment platform for 7 days.”  “for the ICBT group was 129 min (SD=67.26) and the total number of messages sent from the therapist was 35 (SD=13.95)"  17 min/16 messages control.  "... 17 telephone calls to the ICBT group reminding them to report ERP progression on the treatment platform. For the control condition, the therapists made 41 telephone calls..."

Intervention description: “text material (about 100 pages) and worksheets divided into 10 modules…accessible as an mp3 file (about 5 h of total listening)… read the same texts relating to general psychoeducation and rationale for the treatment, but tailored examples of obsessions and compulsions…Modules 1–4 consisted of psychoeducation, cognitive restructuring of meta-cognitions, and of establishing an individual ERP hierarchy…Modules 5–10 focused on doing daily in vivo ERP...”

Compliance: “The average number of completed modules in the ICBT group was 7.28…Six participants in the ICBT group were considered as non-completers, as they did not begin ERP.”

Outcomes

Specific Symptoms: Clinical Global Impression (CGI): Improvement

Response: Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)

Depression: Montgomery and Asberg Depression Rating Scale (MADRS)

Disability: Global Assessment of Functioning Scale (GAF)

Notes Funding: Swedish Research Council and the Swedish Society of Medicine.  “support was provided through the regional agreement on medical training and clinical research (ALF) between Stockholm County Council and Karolinska Institutet.”
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Method:  Computer/Online

“Participants were randomized (www.random.org) with a 1:1 ratio”

Allocation concealment (selection bias)Low risk“by an independent person who was not involved in the study.”
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

“This group used the same therapists as the ICBT group but this contact did not include any CBT interventions.”

Blinding of outcome assessment (detection bias)
All outcomes
Low risk

Included assessor-rated outcomes (blind)

“Blinding was broken for five participants in the ICBT group and for one participant in the control condition during the post-treatment interview assessments.”

Incomplete outcome data (attrition bias)
All outcomes
Low risk

Not analysed at post-treatment

Intervention: N=2 (4%)

Comparison: N=0 (0%)

 

Method of analysis: Available Case

“One participant in the ICBT group was lost to the post-treatment telephone interview assessment, and two participants did not complete the internet self- rating questionnaires...There was no loss of data for the control group at baseline or post-treatment.”

Selective reporting (reporting bias)High risk

Trial registration number: NCT01347099

Dimensional Obsessive Compulsive Scale and EuroQoL not reported.  CGI and GAF were not registered.  Dichotomous CGI results not reported.

Other biasLow riskN/A

Andersson 2012b

Methods

Location: Sweden

Recruitment: Advertising/ Internet

Exclusion rate: 44.1%

Randomised (N): 204 (102 intervention; 102 comparison)

Participants

Disorder: Social Anxiety (Unspecified); SCID (DSM-IV)

Duration (years): Unknown

Age (years): 38.3

Sex (female): 60.20%

Race (white): Unknown

Medication (using at baseline): 13.73%

Education (years): 12.96

EXCLUSIONS

Depression: Yes

Psychotherapy: Current restricted; no previous restrictions reported

Medication: "if on prescribed medication for anxiety/ depression, dosage had to be constant for 3 months before the treatment onset and kept constant throughout the study"

Drug/Alcohol: "not admitting another serious or dominant disorder (e.g. psychosis, substance misuse) that could be expected to influence the outcome of the study"

Physical: N/A

Interventions

Comparison group(s): Wait-list

Intervention name: Social Fobi-Effektiv Hjalp med Kognitiv Beteendeterapi [Social Phobia - Effective Help with CBT]

Days of treatment: 56

Author wrote: Yes

Type of media: Internet

Type of therapy: CBT

Location used: Anywhere

Type of contact: Email

Automated contact: N=9

Provider contact: N=9 (135 min)

Contact description: “Feedback was given each week by the therapists. Text messages were used to remind participants to log in or to complete weekly reports on the LSAS-SR.” “The treatment group had access to an Internet therapist during the 9 week treatment period. E-mail correspondence occurred weekly (Sundays) and generally concerned the results of homework assignments as described in the self-help manual.…On average, Internet therapists spent 15 min per week for each participant reading messages and providing feedback via the online contact handling system.”

Intervention description: "186 pages divided into nine chapters (modules) adapted for use via the Word Wide Web…introductory module describing SAD and…CBT… a cognitive model for SAD…cognitive restructuring... exposure and attention shifting exercises…social skills and relapse prevention…complete one module every week...Each module consisted of information, exercises (home-work assignments) and ended with a short quiz..." "both groups had access to separate moderated online discussion forums."

Compliance: "46/102 (45%) failed to complete all nine modules...activity in the online discussion forums varied in line with previous investigations, which means that a majority made few comments and postings in addition to the postings linked to the ‘‘topic of the week’’, some were more active with discussions, and some mainly read were passive."

Outcomes

Specific Symptoms: Liebowitz Social Anxiety Scale (LSAS); Social Phobia Scale (SPS); Social Interaction Anxiety Scale (SIAS); Social Phobia Screening Questionnaire (SPSQ)

Response: Clinical Global Impression (CGI); Liebowitz Social Anxiety Scale (LSAS)

Depression: Montgomery and Asberg Depression Rating Scale (MADRS)

Quality of Life: Quality of Life Inventory (QOLI)

Notes Funding: Swedish Research Council
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Method: Computer/Online

"Randomization was performed by an independent third-party using an online true random-number service (www.random.org)."

Allocation concealment (selection bias)Low riskSee "Sequence Generation."
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

"Feedback was given each week by the therapists"

Blinding of outcome assessment (detection bias)
All outcomes
Low risk

Included assessor-rated outcomes (blind)

"independent"

Incomplete outcome data (attrition bias)
All outcomes
Low risk

Not analysed at post-treatment

Intervention: N= 8 (7.84%)

Comparison: N= 2 (1.96%)

Method of analysis: LOCF

"the last previous LSAS-SR score was used to replace missing data."

Selective reporting (reporting bias)Low risk

Trial registration number: UMIN000001383

All outcomes reported.

Other biasLow riskN/A

Andersson 2012c

Methods

Location: Sweden

Recruitment: Advertising/ Internet

Exclusion rate: 54.49%

Randomised (N): 54 (27 intervention; 27 comparison)

Participants

Disorder: GAD; SCID (DSM-IV)

Duration (years): 20.05

Age (years): 42

Sex (female): 75.93%

Race (white): Unknown

Medication (using at baseline): Unknown

Education (years): Unknown

EXCLUSIONS

Depression: Yes

Psychotherapy: Current restricted; no previous restrictions reported

Medication: "(e) if taking prescribed medication for anxiety or depression, the duration had to be at least 12 weeks, and the participant had to be on a stable dosage for at least 6 weeks (and such participants were instructed not to change medication and/or dosage during the trial)"

Drug/Alcohol: N/A

Physical: N/A

Interventions

Comparison group(s): Wait-list

Intervention name: Not named (as in Paxling 2011)

Days of treatment: 56

Author wrote: Yes

Type of media: Internet

Type of therapy: CBT

Location used: Anywhere

Type of contact: Internet forum

Automated contact: N=9

Provider contact: N=9 (90 min)

Contact description: “Except for the weekly online treatment contact and diagnostic procedures, no other contact took place between the therapists and participants…5 therapists provided the treatment for this group. Two were licensed psychologists…3 were psychology students…four supervision sessions were given of approximately 90 min each. Feedback from the therapist was provided…In addition, occasional reminders were sent. The mean therapist time devoted to each client during the overall treatment period was 92 min (SD = 61).”

Intervention description: "text-based treatment modules delivered on a weekly basis for 8 weeks… Introduction to GAD and the treatment…applied relaxation…applied relaxation, and worry time…cognitive restructuring…applied relaxation, cognitive distancing, and problem solving…exposure…interpersonal problem solving…sleep management…Relapse prevention and maintenance of progress.”

Compliance: "Mean 5.1 (SD=2.5) modules completed."

Outcomes

Specific Symptoms: Generalized Anxiety Disorder Questionnaire–IV; Penn State Worry Questionnaire (PSQW);

General Symptoms: Beck Anxiety Inventory (BAI); State-Trait Anxiety Inventory (STAI)

Response: Generalized Anxiety Disorder Questionnaire–IV; Penn State Worry Questionnaire (PSWQ)

Depression: Beck Depression Inventory (BDI); Montgomery and Asberg Depression Rating Scale (MADRS)

Quality of Life: Quality of Life Inventory (QOLI)

Recovery: No longer met criteria for diagnosis

Response: Generalized Anxiety Disorder Questionnaire–IV; Penn State Worry Questionnaire (PSQW); Clinical Global Impression (CGI)

Notes Funding: Swedish Council for Working and Life Research
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Method: Computer/Online

"unrestricted randomization"

Allocation concealment (selection bias)Unclear riskN/A
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

"Feedback from the therapist was provided…"

Blinding of outcome assessment (detection bias)
All outcomes
Low risk

Included assessor-rated outcomes (blind)

"participants were asked not to reveal whether they had received treatment."

Incomplete outcome data (attrition bias)
All outcomes
Low risk

Not analysed at post-treatment

Intervention: N= 0 (0%)

Comparison: N= 0 (0%)

Method of analysis: mixed effects

"Mixed effect models are able to accommodate missing data and integrate time-varying factors."

Selective reporting (reporting bias)Unclear riskNo trial registration number given.
Other biasLow riskN/A

Andrews 2011a

Methods

Location: Sydney, Australia

Recruitment: Referral

Exclusion rate: 50.67%

Randomised (N): 37 (23 intervention; 14 comparison)

Participants

Disorder: Social Anxiety (Unspecified); Clinical Interview (DSM-IV)

Duration (years): Unknown

Age (years): 31.9

Sex (female): 40.5%

Race (white): Unknown

Medication (using at baseline): Unknown

Education (years):  Unknown

 

EXCLUSIONS

Depression: No

Psychotherapy:  Current restricted, no previous restrictions reported

Medication: "Change in medications during last 1 month or intended change during study duration."

Drug/Alcohol: "Current substance abuse/dependence"

Physical: N/A

Interventions

Comparison group(s): Individual CBT

Comparison description: "Each group had a maximum of seven participants (not all of whom were research participants) who met weekly for seven weeks for 4 h under the guidance of the same clinician (M.D.). The content of the programme followed the programme outlined in a standard text. All participants were given a copy of the programme to use in the sessions and to revise between sessions." (Andrews G, Creamer M, Crino R, Hunt C, Lampe L, Page A (2003). The treatment of anxiety disorders.)

 

Intervention name: Shyness Program (http://www.climateclinic.tv)

Days of treatment: 56

Author wrote: Yes 

Type of media: Internet

Type of therapy: CBT

Location used: Anywhere

Type of contact: Email & Phone

Automated contact: N=11

Provider contact: N=7 (duration unknown)

Contact description: “automatic emails and fortnightly short message service (SMS)...Participants were telephoned or emailed each week by the clinician.”

Intervention description: “six online lessons; a summary/homework assignment for each lesson; comments by participants on a forum moderated by the clinician (M.D.)…provided education about the symptoms and treatment…how to develop an exposure hierarchy…cognitive restructuring…relapse prevention. Participants were encouraged to complete the first four lessons within the first two weeks, in order to provide more opportunity to practise the graded exposure, cognitive skills and other coping techniques.”

Compliance: 6 withdrew before treatment began.  1 terminated at lesson 3, 1 at lesson 4, 1 at lesson 6.

Outcomes

Specific Symptoms: Social Interaction Anxiety Scale (SIAS)

Disability: WHO Disability Assessment Schedule (WHODAS-II)

Notes

Funding: None acknowledged

Unpublished data: Personal correspondence.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Method:  Computer/Online

“by NT via a true randomization process (www.random.org)”

Allocation concealment (selection bias)Low risk“by NT via a true randomization process (www.random.org)”
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

“Participants were telephoned or emailed each week by the clinician.”

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo assessor-rated outcomes
Incomplete outcome data (attrition bias)
All outcomes
High risk

Not analysed at post-treatment

Intervention: N=6 (26.09%)

Comparison: N=0 (0%)

 

Method of analysis: LOCF

The pre-treatment scores of the 10 participants who did not complete the post-treatment questionnaires were replicated as their post-treatment scores but only those who started lesson 1 were "eligible for analysis.”

Selective reporting (reporting bias)High risk

Trial registration number: ACTRN12609000212257

PHQ-9, Kessler-10 and Sheehan Disability Scale all stated in protocol and omitted from write-up

Other biasLow riskN/A

Baillie 2002

Methods

Location: Sydney, Australia

Recruitment: Advertising/ Internet

Exclusion rate: 77.06%

Randomised (N): 117 (51 intervention; 66 comparison)

Participants

Disorder: Panic Attacks; CIDI (DSM-IV)

Duration (years): 8.13

Age (years): 37.93

Sex (female): 76.07%

Race (white): 59.83%

Medication (using at baseline): 59.83%

Education (years):  13.38

 

EXCLUSIONS

Depression: No

Psychotherapy:  No restrictions reported

Medication: N/A

Drug/Alcohol: N/A

Physical: N/A

Interventions

Comparison group(s): Treatment-as-usual

 

Intervention name: Booklet based on Rapee, Craske and Barlow (1996) and "Panic Surfing"

Days of treatment: 137

Author wrote: Yes 

Type of media: Book / Booklet

Type of therapy: CBT

Location used: Anywhere

Type of contact: Phone

Automated contact: N=0

Provider contact: N=1 (duration unknown)

Contact description: People who did not complete assessments were reminded by post after two weeks, sent a second copy of the questionnaire after 4 weeks, and telephoned after 6 weeks.

Intervention description: Stepped-up care, moving up if panic attacks continued or MIA score 1.67 or greater.  First: "posted a psychoeducational booklet."  Second: a manual that "focuses on catastrophic misinterpretations of physical sensations...daily diary and described a five-week program of activities to challenge catastrophic thought, carry out exposure to situations and sensations related to panic, and develop a plan of relapse prevention."

Compliance: There was not evidence that treatment group, overall (est.=0.29, SE=0.27, Z=1.10) nor the self-help manual specifically (est.=0.04, SE=0.31, Z=0.13) influencing the frequency that participants used exposure.

Outcomes Recovery: Clinically Significant Improvement (Composite)
Notes

Funding: National Health and Medical Research Council Public Health Postgraduate Research Scholarship.  Macquire University Postgraduate Research Fund.  Division of Scientific Affairs of the Australian Psychological Society.

Unpublished data: Baillie provided unpublished thesis and information about the trial design. 

Requiring written consent introduced a delay between assessment and posting the booklet of 18.5 (14.6) days.  Data about duration of illness appear unreliable.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Method:  Computer/Online

“A list of random assignments was constructed at the outset of the trial and participants were assigned in the order that their consent forms were received by post." (personal communication)

Allocation concealment (selection bias)High riskSee “Sequence Generation”
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

“All telephone interviews were conducted by the first author…”

Blinding of outcome assessment (detection bias)
All outcomes
High risk

Included assessor-rated outcomes (NOT blind)

“Participants were not blind to their allocation and all telephone assessments [were] conducted by the first author who was not blind to group allocation." "At baseline and at 6 weeks, 4.5 months (20 weeks), and 9 months (40 weeks) participants completed a telephone interview and a self report questionnaire sent by post."

Incomplete outcome data (attrition bias)
All outcomes
Low risk

Not analysed at post-treatment

Intervention: N=0 (0%)

Comparison: N=2 (3.03%)

 

Method of analysis: Available Case

Of 468 assessment points (117 participants x 4 collections), there were 437 valid responses.  For Panic Disorder Severity Scale, group means were substituted for missing cases.  Further details are not reported by group.

Selective reporting (reporting bias)High risk

No trial registration number given.

Raw data are not reported and regressions based on 9 month outcomes cannot be incorporated in meta-analysis.  The authors interpret the data to indicate no effect.  Missing measures include the Depression, Anxiety, Stress Scales (DASS), Mobility Inventory for Agoraphobia (MIA), and panic diary.

Other biasLow riskN/A

Baker 1973

Methods

Location: Cambridge (Mass), USA

Recruitment: Advertising/ Internet

Exclusion rate: Unknown

Randomised (N): 30 (9 intervention; 9 comparison)

Participants

Disorder: Specific Phobia; Unclear

Duration (years): Unknown

Age (years): 32

Sex (female): 70%

Race (white): Unknown

Medication (using at baseline): Unknown

Education (years):  Unknown

 

EXCLUSIONS

Depression: No

Psychotherapy:  No restrictions reported

Medication: N/A

Drug/Alcohol: N/A

Physical: N/A

Interventions

Comparison group(s): Individual Exposure

Comparison description: “standard systematic desensitization with a therapist (cf. Wolpe and Lazarus, 1966)...Following one session for hierarchy construction, three or four sessions were used for relaxation training; S was also encouraged to practice relaxation at home...median of eight desensitization sessions (range 5-10); each session included a median of 14 image presentations, each lasting about 30 set with 45 set rest between trials...continued until S completed his hierarchy.”

 

Intervention name: Based on Behavior Therapy Techniques: A Guide to the Treatment of Neurosis (Wolpe, J & A. A Lazarus; 1996)

Days of treatment: 49

Author wrote: Yes 

Type of media: Audio

Type of therapy: Desensitization

Location used: Clinic/ Surgery

Type of contact: Face-to-face

Automated contact: N=0

Provider contact: N=6 (90 min)

Contact description: “seen by this therapist for only one full session, to construct a hierarchy. Thereafter, S came to an office to conduct, on his own, a tape recorded relaxation or desensitization session...every second session S would speak with his therapist for about 5 min to discuss progress or problems.”

Intervention description: “came to an office to conduct, on his own, a tape recorded relaxation or desensitization session, using a taped version of the self-directed desensitization record…” "...three or four relaxation sessions were followed by median of 7 desensitization sessions (range 5-14)."

Compliance: The number of sessions intended was not reported.  The totals reported are the sessions actually attended.

Outcomes Specific Symptoms: Acrophobia Questionnaire: Anxiety
Notes

Funding: Foundations' Fund for Research

Unpublished data: Provided information about assignment of participants.  Unable to provide further information about the results. 

It is unclear how previous reviewers calculated effect sizes for this study.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High risk

Method:  Unclear

“Wait-list group excluded: 'Ss who would be unable to schedule sessions throughout the following 2 months (but were available later) were arbitrarily placed on the WL. All other Ss were blocked by sex and randomly assigned to one of three conditions..."  WL group excluded as clearly not random (12 participants not included).

Allocation concealment (selection bias)High riskAfter the initial interview and the polygraph session, S was scheduled to begin treatment or was placed on the Waiting List.
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Provider contact: Yes

Provider blind: No

“assigned randomly to one of the authors, but was seen by this therapist for only one full session”

Blinding of outcome assessment (detection bias)
All outcomes
High risk

Included assessor-rated outcomes (NOT blind)

“this session was conducted by an E who was blind to S’s treatment condition. Since S’s treatment condition would become apparent to E during the interview, E first administered the objective tests, then gave S a self-report questionnaire to complete, and then conducted the interview.”

Incomplete outcome data (attrition bias)
All outcomes
Low risk

Not analysed at post-treatment

Intervention: N=0 (0%)

Comparison: N=2 (22.22%)

Method of analysis: Available Case

9 were assigned to face-to-face therapy.  1 transferred to the wait-list and 1 dropped out after 3 relaxation and 2 desensitization sessions.  After post-treatment assessment, 3 WL participants were assigned to each treatment group and 6 undertook treatment at home and were not followed.

Selective reporting (reporting bias)High risk

No trial registration number given.

Summary statistics are not reported and statistical tests are reported selectively.  Authors report that changes on the Leary and MMPI were not significant.  Data insufficient to analyse Slide-Series Discomfort Rating.

Other biasHigh riskMay not be a RCT, and it is not indexed as such in electronic databases.

Barrera 1977

Methods

Location: Eugene (Oregon), USA

Recruitment: Advertising/ Internet

Exclusion rate: Unknown

Randomised (N): 24 (16 intervention; 8 comparison)

Participants

Disorder: Specific Phobia; Questionnaire & BAT

Duration (years): 25.6

Age (years): 31.6

Sex (female): 100%

Race (white): Unknown

Medication (using at baseline): Unknown

Education (years):  Unknown

 

EXCLUSIONS

Depression: No

Psychotherapy:  No restrictions reported

Medication: N/A

Drug/Alcohol: N/A

Physical: N/A

Interventions

Comparison group(s): Attention/Monitoring

Comparison description: “self-administered placebo with self-reward contracting”

 

Intervention name: Rosen, G. M. (1974).   A manual for self-administering systematic desensitization in your home. University of Oregon.

Days of treatment: 56

Author wrote: Yes 

Type of media: Book / Booklet

Type of therapy: Desensitization

Location used: Anywhere

Type of contact: Face-to-face

Automated contact: N=0

Provider contact: Unknown

Contact description: The self-reward contingency contracting supplement received by subjects in SSDCC and PCC was explained during an individual session that followed pretesting.

Intervention description: 1) self-administered desensitization 2) "self-administered desensitization with self-reward contracting" "adapted from Rosen et al. (1976)."

Compliance: “While working on their programs, subjects had no contact with project staff, although they were to mail in weekly progress reports as previously described.”  "As in earlier studies, 50% of SSD subjects (n = 4) finished treatment, whereas not one of the subjects in SSDCC progressed beyond the relaxation training phase of the program."

Outcomes

Specific Symptoms: Liebowitz Social Anxiety Scale, self-rated (LSAS-SR)

Response: Liebowitz Social Anxiety Scale, self-rated (LSAS-SR); Social Interaction Anxiety Scale (SIAS); Social Phobia Scale (SPS)

Depression: Beck Depression Inventory (BDI)

Notes

Funding: None acknowledged

Unpublished data: Programme duration not reported - assumed it was delivered as in Rosen 1976.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

Method:  Unclear

“Subjects were assigned on a random basis...”

Allocation concealment (selection bias)Unclear riskSee “Sequence Generation”
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

“The self-reward contingency contracting supplement received by subjects in SSDCC and PCC was explained during an individual session that followed pretesting.”

Blinding of outcome assessment (detection bias)
All outcomes
Low risk

No assessor-rated outcomes included.

“Assessment instruments included a standard behavioral avoidance test, fear thermometer (FT) ratings, a snake attitude questionnaire, the snake item from Geer's Fear Survey Schedule (FSS), discomfort ratings while viewing snake and neutral slides, and a general fear-change rating.”

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk

Not analysed at post-treatment

Intervention: Unknown

Comparison: Unknown

 

Method of analysis: Unclear

Selective reporting (reporting bias)High risk

No trial registration number given.

Outcome data cannot be analysed.  "Assessments occurred at pre- assessment, postassessment, and 1-month follow- up periods." "between-groups differences on posttest or follow-up scores were not revealed"

Other biasLow riskN/A

Bell 2012

Methods

Location: Christchurch, New Zealand

Recruitment: Referral

Exclusion rate: 92.73%

Randomised (N): 83 (40 intervention; 43 comparison)

Participants

Disorder: Mixed (GAD, PD, SAD); SCID (DSM-IV)

Duration (years): 18.01

Age (years): 35.31

Sex (female): 67.47%

Race (white): Unknown

Medication (using at baseline): 59.03

Education (years): 12

EXCLUSIONS

Depression: No

Psychotherapy: Current restricted; no previous restrictions reported

Medication: "started on, or changed the dose of, an antidepressant in the previous 6 weeks."

Drug/Alcohol: "current diagnosis of substance dependence"

Physical: "significant or disabling cardiac, respiratory or neurological condition (which would make participation in the trial medically unwise)"

Interventions

Comparison group(s): Wait-list

Intervention name: Based on Andrews et al. 2003 (The Treatment of Anxiety Disorders: Clinician Guides and Patient Manuals)

Days of treatment: 89

Author wrote: Yes

Type of media: Internet

Type of therapy: CBT

Location used: Anywhere

Type of contact: Phone

Automated contact: N=0

Provider contact: N=6 (30 min)

Contact description: "The research assistant telephoned participants in the CCBT condition every 2 weeks over the treatment phase of the study (i.e. the first 12 weeks)...the WLC group were also contacted by the research assistant every 2 weeks over the same timeframe. The content of the telephone call followed a predetermined structure for both groups and was of about 5 minutes’ duration. It involved checking if participants were having any technical problems with the programme and encouraged them to complete the sessions."

Intervention description:“(GAD: four lessons; panic disorder: six lessons; social phobia: six lessons). Part of the content of each lesson was presented in the form of an illustrated story…provided education…gave instructions about developing an exposure hierarchy and practising graded exposure, demonstrated principles of cognitive restructuring and concluded with information about relapse prevention.”

Compliance: "Of the 40 patients randomised to CCBT, 14 (35%) did not complete the treat- ment (as defined above) (GAD = 2/7, 29%; social phobia = 5/17, 29%; panic disorder = 7/16, 44%)...In order to allow comparison with other CCBT studies using the same programme in different settings and with different design, the absolute completion rates of the CCBT (i.e. all sessions completed) were 4/7 (57%) patients with GAD, 9/17 (53%) patients with social phobia, and 5/16 (31%) patients with panic disorder."

Outcomes

Specific Symptoms: Global severity

General Symptoms: Beck Anxiety Inventory (BAI); Fear of Negative Evaluation (FNE); Fear Questionnaire (FQ); Generalised Anxiety Disorder Assessment Inventory (GADI); Liebowitz Social Anxiety Scale (LSAS)

Depression: Beck Depression Inventory (BDI)

Disability: Work and Social Adjustment Scale

Notes Funding: Canterbury District Health Board, Canterbury Medical Research Foundation, New Zealand Lottery Grants Board
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Method: Computer/Online

"randomised to either CCBT or the WLC, using a strati- fied block design for the primary diagnosis (GAD, panic disorder or social phobia). The stratified randomisation list was generated by a statistician (CF) who was not involved in implementation of the study. " "Participants were randomised in a 1:1 ratio to the computerised programme and WLC."

Allocation concealment (selection bias)Low risk"The allocation list and envelopes containing the allocations were held by the CRU coordinator (who was not involved directly in implementa- tion of the study) to ensure that the clinicians and the research assistant involved in assessment and enrolment were not biased in the enrolment process"
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

"All participants in the trial (both those randomised to CCBT and those to WLC) were contacted by the research assistant at two-weekly intervals across the treatment phase of the study (six times over the 12 weeks)."

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo assessor-rated outcomes
Incomplete outcome data (attrition bias)
All outcomes
Low risk

Not analysed at post-treatment

Intervention: N= 0 (0%)

Comparison: N= 0 (0%)

Method of analysis: mixed effects

"All data analysis was carried out according to a pre-established statistical analysis plan. Analyses of participants’ self-rated questionnaire scores were undertaken using mixed model repeated measures (MMRM) controlling for baseline scores and testing for the between-group factors of group (CCBT, WLC) and primary diagnosis (GAD, panic disorder, social phobia)."

Selective reporting (reporting bias)Unclear riskTrial registration is incomplete and does not list measures used: ACTRN12606000349549; URB/06/05/039
Other biasLow riskN/A

Berger 2009

Methods

Location: Bern, Switzerland

Recruitment: Advertising/ Internet

Exclusion rate: 70.45%

Randomised (N): 52 (31 intervention; 21 comparison)

Participants

Disorder: Social Anxiety (Unspecified); SCID (DSM-IV)

Duration (years): 10.05

Age (years): 28.9

Sex (female): 55.8%

Race (white): 1.92%

Medication (using at baseline): 1.92%

Education (years):  13.77

 

EXCLUSIONS

Depression: No

Psychotherapy:  Current restricted, no previous restrictions reported

Medication: N/A

Drug/Alcohol: N/A

Physical: N/A

Interventions

Comparison group(s): Wait-List

 

Intervention name: Based on CBT (Clark and Wells 1995; Stangier, Heidenreich and Peitz 2003).

Days of treatment: 70

Author wrote: Yes 

Type of media: Internet

Type of therapy: CBT

Location used: Anywhere

Type of contact: Email

Automated contact: N=0

Provider contact: N=10.9 (duration unknown)

Contact description: “therapists have their own Internet-based platform where they have an overview of all their patients and an easy and quick access to the Web-based environment of each patient.”  "therapists were instructed to write a short motivating message to the clients once a week"  Author estimates 120 minutes for SCID (personal communication), and  "The average number of emails written by the participants was 6.01....The average number of emails written by the therapists was 10.9..."

Intervention description: “based on the established cognitive–behavioral approach by Clark and Wells (1995; Stangier, Heidenreich, & Peitz, 2003)...participants are able to freely navigate through the Web pages and repeat exercises...57 Web sites that are divided into five sessions.” "module for establishing regular text-based contact with a therapist, a continuous monitoring and feedback system of patients’ responses, as well as collaborative online group elements"

Compliance: 1 participant did not write to the therapist and completed only 15% of the guide, 2 completed 40% and 50% of the guide but not post-treatment (no reason, lack of time).  Those who completed post-treatment completed 85% of the self-help guide (16 completed 5 sessions, 6 completed 4 sessions, 5 completed 3 sessions, one completed only the first session).

Outcomes

Specific Symptoms: Liebowitz Social Anxiety Scale, self-rated (LSAS-SR)

Response: Liebowitz Social Anxiety Scale, self-rated (LSAS-SR); Social Interaction Anxiety Scale (SIAS); Social Phobia Scale (SPS)

Depression: Beck Depression Inventory (BDI)

Notes

Funding: Swiss National Science Foundation (SNF 100011-112345)

Unpublished data: Berger provided demographic details, contact with participants, and details about randomisation and allocation concealment.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Method:  Computer/Online

“According to a computer-generated randomization scheme, 31 of the 52 subjects included in the randomization were assigned to the treatment group and 21 to the control group.”

Allocation concealment (selection bias)Unclear riskSee “Sequence Generation”
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

“When patients log into the program for the first time, they are redirected to the contact module, where a therapist has introduced her- or himself and informed the patients that they may contact her/him whenever they want to.”

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo assessor-rated outcomes
Incomplete outcome data (attrition bias)
All outcomes
Low risk

Not analysed at post-treatment

Intervention: N=0 (0%)

Comparison: N=0 (0%)

 

Method of analysis: LOCF

“All statistical analyses used intent-to-treat principles in which pretreatment data were carried forward for noncompleters to replace missing values. However, there were few drop-outs in our study, with 90% of the participants completing the questionnaires at postassessment.”

Selective reporting (reporting bias)High risk

Trial registration number: ISRCTN62304985

The trial registration lists the State-Trait Anxiety Inventory (STAI), but this is not reported.

Other biasLow riskThe registered age range was 18-35 but the report includes participants 18-45.

Bergstrom 2010

Methods

Location: Stockholm, Sweden

Recruitment: Referral

Exclusion rate: 71.46%

Randomised (N): 113 (53 intervention; 60 comparison)

Participants

Disorder: Panic disorder; MINI (DSM-IV)

Duration (years): 6.68

Age (years): 34.22

Sex (female): 61.4%

Race (white): 45.04%

Medication (using at baseline): 45.04%

Education (years):  Unknown

 

EXCLUSIONS

Depression: Yes

Psychotherapy:  Current restricted, no previous restrictions reported

Medication: "If taking prescribed drugs for panic disorder, having had a constant dosage for 2 months prior to commencing treatment in the study"

Drug/Alcohol: N/A

Physical: N/A

Interventions

Comparison group(s): Group CBT

Comparison description: The group treatment was led by two clinical psychologists who presented the self-help programme mentioned above during weekly 2-hour sessions, with the support of printed handouts of the modules given to the patients.  "the 54 group patients were distributed over 10 different groups whose sessions were 2 hours each and led by 2 therapists, and that the actual average number of weekly group sessions attended in the group treatment was 8.1 (SD = 2.1)"

 

Intervention name: Not named

Days of treatment: 70

Author wrote: Yes 

Type of media: Internet

Type of therapy: CBT

Location used: Anywhere

Type of contact: Email

Automated contact: N=0

Provider contact: N=11.3 (35 min)

Contact description: “Each module ended with a number of questions to be answered by the patient through interactive forms (e.g. homework assignments). After reviewing these answers, the psychologist gave access to the next module and provided feedback. At any moment the patient could post a message if he or she needed further help."  "The total number of e-mails sent by the therapists during treatment was 555 (mean per patient: 11.3, SD = 4.3). The total average therapist time spent per patient in the Internet treatment was 35.4 minutes (SD = 19.0)."

Intervention description: “...psychoeducation (module 1), cognitive restructuring (modules 2 and 3), interoceptive exposure (modules 4 and 5), exposure in-vivo (for agoraphobic situations; modules 6 to 9), and relapse prevention (module 10)...The patient also had the opportunity to participate in an online discussion forum with other patients in treatment during the same time period. However, this was not mandatory."

Compliance: The average number of weekly modules completed in the Internet treatment was 6.7 (SD = 2.5).

Outcomes

Specific Symptoms: Panic Disorder Severity Scale (PDSS)

General Symptoms: Anxiety Sensitivity Index (ASI)

Response: Clinical Global Impression (CGI): Improvement; Panic Disorder Severity Scale (PDSS)

Recovery: No longer met criteria for diagnosis

Depression: Montgomery and Asberg Depression Rating Scale (MADRS)

Disability: Sheehan Disability Scale (SDS)

Notes

Funding: Stockholm County Council

Unpublished data: Table 3 appears to contain an error - means and SEs are not reported for each group.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Method:  Unclear

“The participants were divided into two groups, Internet or group treatment, by an independent random-number procedure…”

Allocation concealment (selection bias)Low risk“...each patient was assigned to either treatment by the opening of sealed numbered envelopes.”
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

“Each module ended with a number of questions to be answered by the patient through interactive forms (e.g. homework assignments). After reviewing these answers, the psychologist gave access to the next module and provided feedback.”

Blinding of outcome assessment (detection bias)
All outcomes
Low risk

Included assessor-rated outcomes (blind)

“The psychiatrists performing the clinical interviews at post-treatment and follow-up were blind to treatment condition.”

Incomplete outcome data (attrition bias)
All outcomes
High risk

Not analysed at post-treatment

Intervention: N=9 (16.98%)

Comparison: N=11 (18.33%)

 

Method of analysis: Available Case

“Nine participants dropped out after randomisation but before commencing treatment. Various reasons were given for not starting treatment, but all pertained to different life circumstances of the individual participants and not to randomisation status. These initial dropouts were excluded from the statistical analyses.”  "A number of patients did not return for the clinical interview...a Mixed effects models approach was used in the statistical analysis to adjust for these missing values."

Selective reporting (reporting bias)Unclear risk

Trial registration number: NCT00845260

The study was registered after it had been completed.  All registered outcomes are reported, but the CGI is reported and not registered.

Other biasLow riskN/A

Bickel 2007

Methods

Location: Ohio, USA

Recruitment: Advertising/ Internet

Exclusion rate: 85.03%

Randomised (N): 22 (11 intervention; 11 comparison)

Participants

Disorder: Panic disorder; ADIS (DSM-IV)

Duration (years): Unknown

Age (years): 42

Sex (female): 73.73%

Race (white): 68.18%

Medication (using at baseline): 68.18%

Education (years):  Unknown

 

EXCLUSIONS

Depression: No

Psychotherapy:  Current and previous therapy restricted

Medication: "Patients who were currently taking medication for the treatment of panic disorder on a regular basis had to be willing to keep their dosage constant through the 6-week evaluation period."  No "Initiation or reinitiation of tricyclic antidepressants, SSRIs, or MAO inhibitors during the past 6 months." nor "Initiation or reinitiation of benzodiazepines in the past 30 days."

Drug/Alcohol: N/A

Physical: "Lifetime history of severe medical disorders that could complicate panic disorder including cardiovascular, respiratory or renal disorders, stroke, epilepsy or hypertension."

Interventions

Comparison group(s): Wait-List

Comparison description: Participants in both groups completed twice-weekly monitoring forms.

 

Intervention name: CALM (Bickel)

Days of treatment: 42

Author wrote: Yes 

Type of media: Computer

Type of therapy: Exposure

Location used: Clinic/ Surgery

Type of contact: Face-to-face

Automated contact: N=0

Provider contact: N=10 (duration unknown)

Contact description: “The treatment was administered twice weekly at scheduled appointments. At each appointment, a trained undergraduate administrator asked the participant to complete a symptom monitoring form for the intervening period between sessions. These forms were used to alert the experimenter to any drastic changes in symptoms."

Intervention description: 10 sessions, twice weekly for 5 weeks.  "includes video, audio, and text.  Approximately two thirds of the treatment is comprised of audio accompanied by text. The rest of the treatment is video-based with supplementary text. The computer program is moderately interactive. In addition to the above, participants respond to onscreen quiz questions during the psychoeducational portion of treatment. Correct responses are required for the patient to proceed..."

Compliance: “The quality of homework completed was rated either 'fair' or 'good for all clients across sessions with little variability between or within groups.  Compliance ratings were completed by K.W.B.”

Outcomes

Specific Symptoms: Agoraphobic Cognitions Questionnaire (ACQ)

General Symptoms: Anxiety Sensitivity Index (ASI); Beck Anxiety Inventory (BAI)

Depression: Beck Depression Inventory (BDI)

Notes

Funding: Society for the Science of Clinical Psychology and the Coca Cola Foundation

Unpublished data: Bickel provided dissertation but was unable to provide further details about the study.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

Method:  Unclear

"Twenty-two participants (see power analysis below) were matched on severity of panic and agoraphobic symptoms and randomly assigned to one of two treatment conditions: treatment via CALM or a delayed treatment control condition, in a matched- pairs design."  "Participants who qualified for the treatment study after the Time 1 interview were matched with another participant and were randomly assigned to receive immediate treatment or wait 5-weeks to begin a delayed treatment."

Allocation concealment (selection bias)Low risk"The initial assessment, as well as the post-treatment assessment, included the administration of the Anxiety Disorders Interview Schedule for the DSM-IV (ADIS-IV), conducted by a trained administrator who was blind to treatment condition."  "All substantive interactions with clients were conducted by trained research assistants (assessments) or advanced undergraduate students (subsequent appointments) in order to reduce interactions with the therapist from the computer intervention (KWB)."
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

“At each appointment, a trained undergraduate administrator asked the participant to complete a symptom monitoring form for the intervening period between sessions.” 

"By administering the treatment at regular appointments, we were able to monitor completion of the treatment."

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo assessor-rated outcomes are reported, but the paper reports, "The initial assessment, as well as the post-treatment assessment.. conducted by a trained administrator who was blind to treatment condition." "Time 2 assessment was conducted subsequently by a trained interviewer who was blind to treatment condition"
Incomplete outcome data (attrition bias)
All outcomes
High risk

Not analysed at post-treatment

Intervention: N=3 (27.27%)

Comparison: N=6 (54.55%)

 

Method of analysis: Available Case

At the end of the study, there were only 5 complete matched-pairs.  "we proceeded under the assumption that attrition was different between the two groups... For this review, data were extracted for all completers.  The author's main analyses include only complete matched-pairs.  The pattern of results was essentially the same, but the effects were smaller for the author's analysis.  (Those remaining in the comparison group were the most distressed.)  "at the time of recruitment, our clinic was in a transition phase and therapist-administered treatment was not available. Subsequent to the initiation of the study, therapists became available..."

Selective reporting (reporting bias)High risk

No trial registration number given.

Mobility Inventory for Agoraphobia (MI) and Fear Questionnaire (FQ) not reported, except as graphs.  Safety Maneuver Questionnaire measured but not reported as authors found it problematic and in need of further study.  Baseline values for the ACQ and the BSQ (Table 2) are either incorrect or transformed through a process that is not described.

Other biasLow riskN/A

Botella 2009

Methods

Location: Castelló, Spain

Recruitment: Advertising and referral

Exclusion rate: Unknown

Randomised (N): 52 (30 intervention; 22 comparison)

Participants

Disorder: Social Anxiety (Specific); ADIS (DSM-IV)

Duration (years): Unknown

Age (years): 24.4

Sex (female): Unknown

Race (white): Unknown

Medication (using at baseline): Unknown

Education (years):  13.85

 

EXCLUSIONS

Depression: Yes

Psychotherapy: Current restricted, no previous restrictions reported

Medication: N/A

Drug/Alcohol: "Exclusion criteria were current alcohol or drug dependence"

Physical: N/A

Interventions

Comparison group(s): Individual CBT

Comparison description: “The therapist followed exactly the same steps as ‘Talk to me’: education, cognitive therapy, and exposure. The main difference was that instead of being a computer- based self-applied treatment delivered over the Internet, treatment was provided by an experienced therapist.”  "two sessions every week until they finished the treatment, receiving face-to-face therapy for no longer than two months"

 

Intervention name: Talk to Me

Days of treatment: 61

Author wrote: Yes 

Type of media: Internet

Type of therapy: CBT

Location used: Anywhere

Type of contact: None

Automated contact: N=0

Provider contact: N=0 (0 min)

Contact description: “These participants could contact the psychologist by e-mail or telephone when they had any doubt or problem.”

Intervention description: “six scenarios which consist of real videotaped audiences...the system asks some questions to make sure that the patient has understood the content...rationale for cognitive restructuring, highlighting the role of negative thoughts...Each scenario offered by the program has several variables (e.g., number of people) in order to build an exposure hierarchy.”  "if they had no Internet access they could self-apply the program at the university."

Compliance: N/A

OutcomesNone
Notes Funding: Ministerio de Educacion y Ciiencia, Spain, PROYECTOS CONSOLIDER-C (SEJ2006-14301/PSIC), by Programa de Acciones Integradas con Sudafrica (HS2006-0001), and by Universitat Jaume I - Fundacio Caixa Castello (P1 1A2005-06)
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

Method:  Unclear

“All participants who wanted to take part in the study were randomly allocated to one of the two experimental conditions.”

Allocation concealment (selection bias)Unclear riskN/A
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

“These participants could contact the psychologist by e-mail or telephone when they had any doubt or problem.  Another group received face-to-face therapy.”

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo assessor-rated outcomes
Incomplete outcome data (attrition bias)
All outcomes
High risk

Not analysed at post-treatment

Intervention: Unknown

Comparison: Unknown

 

Method of analysis: Unclear

No information given on dropout at any stage of the trial, only that there were more participants in the self-administered condition because it usually had a higher attrition rate.

Selective reporting (reporting bias)High risk

No trial registration number given.

Data could not be extracted.  The paper reports only significant correlations.

Other biasUnclear riskMethods are poorly reported and the conduct of the study cannot be fully assessed.

Botella 2010

Methods

Location: Castelló, Spain

Recruitment: Advertising and referral

Exclusion rate: 27.84%

Randomised (N): 127 (62 intervention; 29, 36 comparisons)

Participants

Disorder: Social Anxiety (Unspecified); ADIS (DSM-IV)

Duration (years): Unknown

Age (years): 24.4

Sex (female): 79.22%

Race (white): Unknown

Medication (using at baseline): Unknown

Education (years):  14.82

 

EXCLUSIONS

Depression: Yes

Psychotherapy: Current restricted, no previous restrictions reported

Medication: N/A

Drug/Alcohol: "not be diagnosed for substance abuse or dependence"

Physical: N/A

Interventions

Comparison group(s): Wait-List, Individual CBT

Comparison description: For two months, "Participants in the live therapy condition received therapy once or twice a week, depending on their availability. Treatment included individual sessions lasting 45 to 60 minutes. This treatment featured the same components as Talk to Me: education, cognitive therapy, and exposure." "wait-list control group were assessed when they asked for help and 1 month afterwards when they had the chance to be treated"

 

Intervention name: Talk to Me

Days of treatment: 61

Author wrote: Yes 

Type of media: Internet

Type of therapy: CBT

Location used: Anywhere

Type of contact: None

Automated contact: N=0

Provider contact: N=0 (0 min)

Contact description: “Participants in the self- administered condition did not have any contact with the psychologist during the treatment, although they could e-mail or telephone her if they had any problem with the system.”

Intervention description: “information about the nature and physiological characteristics of anxiety, fear, and phobias. The cognitive restructuring component teaches users to identify and challenge negative thoughts…the program organizes a hierarchy of public speaking scenarios that were created during the initial assessment…When their level of fear has diminished 2 or more points, Talk to Me presents them with a new situation.”

Compliance: N/A

Outcomes

Specific Symptoms: Brief Fear of Negative Evaluation (BFNE)

Behaviour Test (Level): Impromptu Speech Task: Performance

Behaviour Test (Symptoms): Impromptu Speech Task: Anxiety; Impromptu Speech Task: Anxiety, assessor rated

Recovery: No longer met criteria for diagnosis

Depression: Beck Depression Inventory (BDI)

Disability: Maladjustment Scale (MS)

Notes Funding: Ministerio de Educacion y Ciiencia, Spain, PROYECTOS CONSOLIDER-C (SEJ2006-14301/PSIC), by Programa de Acciones Integradas con Sudafrica (HS2006-0001), and by Universitat Jaume I - Fundacio Caixa Castello (P1 1A2005-06)
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

Method:  Unclear

“One hundred twenty-seven participants were randomly assigned to one of the following experimental conditions”

Allocation concealment (selection bias)Unclear riskN/A
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

Participants in the self- administered condition did not have any contact with the psychologist during the treatment, although they could e-mail or telephone her if they had any problem with the system.  Another group received face-to-face therapy.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear risk

Included assessor-rated outcomes (blinding unclear)

The participant reports his or her level of fear during the task, and the therapist also assesses it on a scale of 0, no fear at all, to 10, severe fear).  "The therapist assesses the global severity of the participant on a 6-point scale…"

Incomplete outcome data (attrition bias)
All outcomes
High risk

Not analysed at post-treatment

Intervention: N=0 (0%)

Comparison (wait-list): N=0 (0%)

Comparison (individual CBT): N=0 (0%)

 

Method of analysis: LOCF

“We have postbaseline data of 35 of the 50 dropouts...We used the last rating as a postbaseline for those participants...In the 15 cases where the postbaseline data were unavailable because they dropped out right after randomization, baseline data were carried forward...”  "...obligations like university exams and having not enough time to dedicate to the treatment. Some participants also dropped out because they had doubts about the efficacy of the program, and some because they felt better after a few sessions." Global Impression may be an Available Case analysis.

Selective reporting (reporting bias)High risk

No trial registration number given.

Dichotomous data not reported for the control group.  Data for the "Maladjustment Scale (MS): Work" and "Maladjustment Scale (MS): Social" appear to be incorrect - the values are identical.

Other biasUnclear riskMethods are poorly reported and the conduct of the study cannot be fully assessed.

Bowler 2012

Methods

Location: East Anglia, England

Recruitment: Advertising/ Internet

Exclusion rate: Unknown

Randomised (N): 71 (24 intervention; 22 comparison; 25 other)

Participants

Disorder: Social Anxiety (unspecified); Questionnaire only

Duration (years): Unknown

Age (years): 21.91

Sex (female): 64.29%

Race (white): Unknown

Medication (using at baseline): Unknown

Education (years): Unknown

EXCLUSIONS

Depression: No

Psychotherapy: Current or previous restricted

Medication: N/A

Drug/Alcohol: N/A

Physical: N/A

Interventions

Comparison group(s): Wait-list

Intervention name: E-couch

Days of treatment: 14

Author wrote: No

Type of media: Internet

Type of therapy: CBT

Location used: Anywhere

Type of contact: Face-to-face

Automated contact: N=0

Provider contact: N=4

Contact description: "A researcher ensured participant attendance and general compliance with the module."

Intervention description: “…accessed the e-couch social anxiety program online over four sessions in the laboratory. A researcher ensured participant attendance and general compliance with the module…psychoeducational subsection, which contained information on the nature of social anxiety…’exposure practice,’ ‘modifying your thinking,’ ‘attention practice,’ and ‘social skills training.’…During the course, participants completed two pieces of homework concerning exposure practice and social skills practice, respectively.”

Compliance: "A researcher ensured participant attendance and general compliance with the module."

Outcomes

Specific Symptoms: Fear of Negative Evaluation (FNE); Social Phobia Inventory (SPIN)

General Symptoms: State Trait Anxiety Intentory (STAI) - Trait

Depression: Beck Depression Inventory (BDI)

Notes Funding: Wellcome Trust Grant 083475
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk"Randomization was subject to the restriction that group sizes were approximately equal."
Allocation concealment (selection bias)Unclear risk"Randomization was subject to the restriction that group sizes were approximately equal."
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

"A researcher ensured participant attendance and general compliance with the module."

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo assessor-rated outcomes
Incomplete outcome data (attrition bias)
All outcomes
High risk

Not analysed at post-treatment

Intervention: N= 3 (12.5%)

Comparison: N= 2 (9.1%)

Method of analysis: Per protocol

"A complete-case analysis approach, where only participants with all data points complete are included, was the primary approach used to analyze the data due to the small number of cases who dropped out (see Figure 1) and because it was reasonable to assume that the data were missing at random (Little & Rubin, 1987). In addition, for the symptom outcomes we also report intent-to-treat (ITT) analyses, and the pattern of results was unaltered." "Two participants (one in the cCBT group and one in the control group) were excluded from the analysis because they did not follow instructions correctly."

Selective reporting (reporting bias)Unclear riskNo trial registration number given.
Other biasLow riskN/A

Bowman 1997

Methods

Location: Birmingham, AL, USA

Recruitment: Advertising/ Internet

Exclusion rate: 38.71%

Randomised (N): 38 (19 intervention; 19 comparison)

Participants

Disorder: Generalised Anxiety Disorder; ADIS (DSM-III R)

Duration (years): Unknown

Age (years): 42.91

Sex (female): 73.68%

Race (white): Unknown

Medication (using at baseline): Unknown

Education (years):  Unknown

 

EXCLUSIONS

Depression: No

Psychotherapy:  Current restricted, no previous restrictions reported

Medication: "not receiving pharmacotherapy unless stabilized on medication that one had taken for at least 2 months"

Drug/Alcohol: N/A

Physical: N/A

Interventions

Comparison group(s): Wait-List

 

Intervention name: Self-Examination Therapy

Days of treatment: 28

Author wrote: Yes 

Type of media: Book / Booklet

Type of therapy: SET

Location used: Anywhere

Type of contact: Phone

Automated contact: N=0

Provider contact: N=4 (20min)

Contact description: “Daniel Bowman called participants once each week to make sure that no one needed to be referred to a mental health professional for evidencing psychosis, suicidal risk, homicidal risk, or mania…During the calls, he also offered to clarify any questions about SET, but no therapy was provided. Calls were restricted to approximately 5 min.”

Intervention description: “The booklet contained 28 identical worksheets. We encouraged participants to use a worksheet each day.  On the worksheets, participants recorded what mattered to them. They also recorded any problems they were having. Then they compared what was bothering them with what mattered. If what was bothering them did not relate to what mattered, they crossed it out and left the problem alone...”

Compliance: “To be included in this study, participants receiving SET were required to complete at least seven worksheets in the SET booklet. All participants who received SET reported meeting the inclusion criterion.”  "Before treatment, participants averaged answering 2.54 out of 7...After completing treatment, participants averaged answering 5.16 out of 7 questions correctly..."

Outcomes

General Symptoms:

Hamilton Anxiety Rating Scale, clinician-rated (HAM-A)

Notes

Funding: None acknowledged

Unpublished data: Authors confirmed that an equal number of participants were assigned to each group.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

Method:  Unclear

“randomly assigned to either the SET or the delayed-treatment group.”

Allocation concealment (selection bias)Unclear risk"Immediately after the screening, one of three trained clinicians used the HARS-R to assess participants who met the inclusion criteria. The clinicians were unaware of the treatment condition to which each participant was assigned. After the HARS-R interview, participants completed the SCL-90-R, STAI, and SET quiz and were randomly assigned..."
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

“Daniel Bowman called participants once each week"

Blinding of outcome assessment (detection bias)
All outcomes
Low risk

Included assessor-rated outcomes (blind)

“Each participant spent 4 weeks in a treatment condition and then was reassessed on the HARS-R by a clinician who was unaware of the participant's treatment condition.”

Incomplete outcome data (attrition bias)
All outcomes
Low risk

Not analysed at post-treatment

Intervention: N=2 (10.53%)

Comparison: N=1 (5.26%)

 

Method of analysis: Available Case

“Two participants from the SET group and 1 from the delayed-treatment group did not return for the second assessment. One participant moved, 1 did not return our calls, and 1 was excluded from the study because she decided to start psychotherapy.”

Selective reporting (reporting bias)Unclear riskNo trial registration number given.
Other biasLow riskN/A

Carlbring 2001

Methods

Location: Uppsala, Sweden

Recruitment: Advertising/ Internet

Exclusion rate: 91.8%

Randomised (N): 41 (21 intervention; 20 comparison)

Participants

Disorder: Panic disorder; ADIS (DSM-IV)

Duration (years): Unknown

Age (years): 34

Sex (female): 70.73%

Race (white): 64%

Medication (using at baseline): 64%

Education (years):  Unknown

 

EXCLUSIONS

Depression: Yes

Psychotherapy:  Current restricted, no previous restrictions reported

Medication: "if on prescribed drugs for panic disorder, (a) the dosage had to be constant for 3 months before the start of the treatment, and (b) the patient had to agree to keep the dosage constant throughout the study"

Drug/Alcohol: N/A

Physical: "no epilepsy, kidney problems, strokes, organic brain syndrome, emphysema, heart disorders, or chronic high blood pressure."

Interventions

Comparison group(s): Wait-List

Comparison description: Study homepage included general information abut CBT.

 

Intervention name: An End to Panic: Breakthrough Techniques for Overcoming Panic Disorder (Zuercher-White, 1998).  20% was Mastery of Your Anxiety and Panic II (Barlow and Craske, 1994), Overcoming Panic: A Complete Nine-Week Home-based Treatment Program for Panic Disorder

Days of treatment: 70

Author wrote: Yes 

Type of media: Internet

Type of therapy: CBT

Location used: Anywhere

Type of contact: Email

Automated contact: N=0

Provider contact: N=7.5 (90min)

Contact description: “The mean total time spent on each participant was approximately 90 minutes, including assessment, administration, and responding to the e-mails. The number of reciprocal contacts (receive and send) ranged from 6 to 15 (M = 7.5, SD = 1.2)."  "Each module ended with five to eight questions...Individual feedback was given within 24 hours...an assessment was made to judge whether the participant was ready to continue; if so, the password to the next module was sent."

Intervention description: .”..six modules...psychoeducation...Clark's cognitive model (Clark, 1986)...breathing retraining...reveal catastrophic interpretations of physical symptoms and then to produce alternative interpretations... interoceptive exposure... exposure in vivo... assertiveness skills and how to deal with setbacks.”

Compliance: All participants, except the dropouts, managed to complete all modules.  Extensions permitted for business trips and illness.

Outcomes

Specific Symptoms: Agoraphobic Cognitions Questionnaire (ACQ)

General Symptoms: Beck Anxiety Inventory (BAI)

Depression: Beck Depression Inventory (BDI); Montgomery and Asberg Depression Rating Scale (MADRS)

Quality of Life: Quality of Life Inventory (QOLI)

Notes

Funding: Swedish Foundation for Health Care Sciences and Allergy Research, the Boëthius Foundation, the Swedish Council for Research in the Humanities and Social Sciences, and the Swedish Medical Council

Unpublished data: Carlbring provided details about randomisation, demographic measures, and number assigned to each group.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Method:  Mechanical

“Participants were divided into two groups by the drawing of lots. These were drawn for the two treatment groupings pairwise for participants who had completed their baseline measurements. In other words, as soon as two participants had completed their baseline measurements, one was allocated to the treatment group and the other to the waiting-list group.”

Allocation concealment (selection bias)Low riskSee “Sequence Generation”
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

“Individual feedback was given within 24 hours... an assessment was made to judge whether the participant was ready to continue”

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo assessor-rated outcomes
Incomplete outcome data (attrition bias)
All outcomes
Low risk

Not analysed at post-treatment

Intervention: N=0 (0%)

Comparison: N=0 (0%)

 

Method of analysis: LOCF

“In the treatment group, lack of time was given as the main reason for discontinuing (n = 3). One patient dropped out because of a newly discovered cancer. The person who left the waiting-list group gave no reason.  "In the statistical analysis, preassessment data for applicants who were allocated to one of the two study groupings but who did not complete the treatment were brought forward and used as postassessment data. This was done on the basis of an intention-to-treat evaluation of the results, which is a more conservative approach compared to only including completers of treatment."

Selective reporting (reporting bias)Unclear riskNo trial registration number given.
Other biasLow riskN/A

Carlbring 2003

Methods

Location: Uppsala, Sweden

Recruitment: Advertising/ Internet

Exclusion rate: 63.33%

Randomised (N): 22 (11 intervention; 11 comparison)

Participants

Disorder: Panic disorder; SCID (DSM-IV)

Duration (years): 10.4

Age (years): 37.95

Sex (female): 68.18%

Race (white): 99.9%

Medication (using at baseline): 99.9%

Education (years):  Unknown

 

EXCLUSIONS

Depression: Yes

Psychotherapy:  Current restricted, no previous restrictions reported

Medication: "if on prescribed drugs for PD, (a) the dosage had to be constant for 3 months before the start of the treatment, and (b) the patient had to agree to keep the dosage constant throughout the study"

Drug/Alcohol: N/A

Physical: "no epilepsy, kidney problems, strokes, organic brain syndrome, emphysema, heart disorders, or chronic high blood pressure."

Interventions

Comparison group(s): Applied relaxation (self-help)

Comparison description: In the AR group Ost’s applied relaxation book( Ost, 1997) was adapted for self-help use via the WWW. A compact disc (CD) with three relaxation instructions was also sent to the participants. The treatment was divided into 9 modules: (1) psychoeducation, (2) rational, (3) progressive muscle relaxation: long version, (4) progressive muscle relaxation: short version, (5) conditioned relaxation, (6) differential relaxation, (7) quick relaxation, (8) applied relaxation, and (9) relapse prevention.

 

Intervention name: An End to Panic: Breakthrough Techniques for Overcoming Panic Disorder (Zuercher-White, 1998).  20% was Mastery of Your Anxiety and Panic II (Barlow and Craske, 1994), Overcoming Panic: A Complete Nine-Week Home-based Treatment Program for Panic Disorder

Days of treatment: 183

Author wrote: Yes 

Type of media: Internet

Type of therapy: CBT

Location used: Anywhere

Type of contact: Email & SMS

Automated contact: N=0

Provider contact: N=7 (30min)

Contact description: An e-mail message to inquire how work with the current module was progressing was sent out once...  "Participants had to answer the questions at the end of each module before they received the password to the next module. The mean total time spent by the therapist on each participant was approximately 30 min, including administration, and responding to the e-mails. Most answers were fully standardized. Often only the participants name was altered in the greeting phrase of the e-mails."

Intervention description: The main treatment component in the CBT group was a self-help manual that was adapted for use via the WWW, and to be suitable for Swedish conditions. It consisted of 197 pages of text and exercises divided into 6 modules: psychoeducation, breathing retraining, cognitive restructuring, interoceptive exposure, exposure in vivo, relapse prevention and assertiveness training (for details see Carlbring et al., 2001).

Compliance: The intervention group completed 56.1% (17.1) of modules, the control group completed 56.6% (30.0).

Outcomes

Specific Symptoms: Agoraphobic Cognitions Questionnaire (ACQ)

General Symptoms: Beck Anxiety Inventory (BAI)

Response: Panic Free

Depression: Beck Depression Inventory (BDI)

Quality of Life: Quality of Life Inventory (QOLI)

Notes

Funding: Swedish Foundation for Health Care Sciences and Allergy Research, the Boëthius Foundation, the Swedish Council for Research in the Humanities and Social Sciences, and the Söderström-Köniska Foundation

Unpublished data: Carlbring provided details about randomisation and demographic measures. 

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Method:  Computer/Online

Participants were divided into two groups by a true random number service (http://www.random.org).

Allocation concealment (selection bias)Low riskWe thank Per Forslin and Carola Strandlund for the SCI interviews.  "When it had been decided on what people to include all participants were randomized by a third party" (personal communication).
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

Standardized feedback was given within 7 days of the participants sending their answers via e-mail. On the basis of these e-mails, an assessment was made of whether the participant was ready to continue, if so, the password to the next module was sent.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo assessor-rated outcomes.
Incomplete outcome data (attrition bias)
All outcomes
Low risk

Not analysed at post-treatment

Intervention: N=0 (0%)

Comparison: N=0 (0%)

 

Method of analysis: LOCF

After randomization, five people dropped out during the course of the study. There were three dropouts from the CBT group and two from the AR group. Lack of time was given as the main reason for discontinuing.  In the statistical analysis, preassessment data for applicants who were allocated to one of the two study groupings but who did not complete the treatment were brought forward and used as postassessment data (n=5).

Selective reporting (reporting bias)Unclear riskNo trial registration number given.
Other biasLow riskN/A

Carlbring 2005

Methods

Location: Uppsala, Sweden

Recruitment: Advertising/ Internet

Exclusion rate: 88.52%

Randomised (N): 49 (25 intervention; 24 comparison)

Participants

Disorder: Panic disorder; SCID (DSM-IV)

Duration (years): 9

Age (years): 34.98

Sex (female): 71.43%

Race (white): 51%

Medication (using at baseline): 51%

Education (years): Unknown

 

EXCLUSIONS

Depression: Yes

Psychotherapy:  Current restricted, no previous restrictions reported

Medication: "if on prescribed drugs for PD: (a) the dosage had to be constant for 3 months before the start of the treatment and (b) the patient had to agree to keep the dosage constant throughout the study"

Drug/Alcohol: N/A

Physical: "to rule out general medical conditions the participant must have had a previous contact with a physician, psychologist, or other health professional as a consequence of panic attacks; no epilepsy, kidney problems, strokes, organic brain syndrome, emphysema, or heart disorders."

Interventions

Comparison group(s): Individual CBT

Comparison description: Participants in the live therapy condition received 10 weekly individual sessions lasting 45–60 min. Between each session the participant was expected to do homework, which included reading a module handout identical to the text in the IT condition. Furthermore, each session was tape recorded and the participant was instructed to listen to it after the sessions to consolidate learning (Clark,1989).

 

Intervention name: (Similar to Carlbring 2001.)

Days of treatment: 70

Author wrote: Yes 

Type of media: Internet

Type of therapy: CBT

Location used: Anywhere

Type of contact: Email

Automated contact: N=0

Provider contact: N=15.4 (150min)

Contact description: “All contact was exclusively via e-mail.  The participants were encouraged to come up with questions or reflections during treatment, and they were free to send an unlimited number of e- mails. The total number of reciprocal contacts (receive and send) ranged from 4 to 31 (M=15:4; SD=5.5). As the e-mail response to the participants often were very similar much text could be recycled.  The mean total time spent on each participant was approximately 150 min, including administration, and responding to the e-mails."

Intervention description: The treatment was manualized and divided into 10 modules: (1–2) psychoeducation and socialization, (3) breathing retraining and hyperventilation test, (4–5) cognitive restructuring, (6–7) interoceptive exposure, (8–9) exposure in vivo, and finally (10) relapse prevention and assertiveness training. Each module consisted of approximately 25 pages, and was in large part similar to the previously tested self-help material by Carlbring et al. (2001).

Compliance: The intervention and control groups completed 7.4 (2.2) and 9.0 (2.7) modules (See Table 1).  28% intervention group finished all modules; 88% of comparison completed all sessions.  Sessions completed did not correlate to change on any measure.  "each module ended with an interactive multiple-choice quiz that the participants needed to get 100% correct in order to proceed"

Outcomes

Specific Symptoms: Agoraphobic Cognitions Questionnaire (ACQ)

General Symptoms: Beck Anxiety Inventory (BAI)

Response: Agoraphobic Cognitions Questionnaire (ACQ); Body Sensations Questionnaire (BSQ); Mobility Inventory for Agoraphobia (MIA)

Recovery: No longer met criteria for diagnosis

Depression: Beck Depression Inventory (BDI); Montgomery and Asberg Depression Rating Scale (MADRS)

Quality of Life: Quality of Life Inventory (QOLI)

Notes

Funding: Swedish Foundation for Health Care Sciences and Allergy Research, the Boëthius Foundation, the Swedish Council for Research in the Humanities and Social Sciences, and the Soderstrom Konigska Foundation.

Unpublished data: Carlbring provided details about randomisation and demographic measures. 

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Method:  Computer/Online

"Participants were divided into two groups, live therapy (LIVE) or Internet-based (IT) by a true random-number-service (http://www.random.org)."

Allocation concealment (selection bias)Low riskWe thank Anders Wiberg for conducting nine SCID-interviews and Katharina Johansson for the CBT-supervision.  "When it had been decided on what people to include all participants were randomized by a third party" (personal communication).
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

"On the basis of these e-mails, a subjective assessment was made by the therapist of whether the participant was ready to continue…"

Blinding of outcome assessment (detection bias)
All outcomes
Low risk

Included assessor-rated outcomes (blind)

"To determine the clinical significance of the treatment a clinical reinterview (SCID) was administered by an independent psychologist blind for treatment condition. This was done 1 month after the treatment ended, and at a 1-year follow-up. To ensure the reliability of the diagnosis made, 10% of the tapes was randomly selected and reassessed by an independent psychiatrist with extensive SCID training."

Incomplete outcome data (attrition bias)
All outcomes
Low risk

Not analysed at post-treatment

Intervention: N=0 (0%)

Comparison: N=0 (0%)

 

Method of analysis: LOCF

"Lack of time was given as the main reason for discontinuing.  However, in accordance with the intention to treat paradigm (e.g., Nich & Carroll, 2002; Newell, 1992) post-treatment data were collected from all dropouts. Six participants did not return their follow-up questionnaires, and their post-treatment scores were carried forward to the follow-up assessment point.  Hence, all 49 participants that were randomized to one of the two conditions are included in the statistical analysis."

Selective reporting (reporting bias)Unclear riskNo trial registration number given.
Other biasLow riskN/A

Carlbring 2006a

Methods

Location: Uppsala, Sweden

Recruitment: Advertising/ Internet

Exclusion rate: 83.24%

Randomised (N): 60 (30 intervention; 30 comparison)

Participants

Disorder: Panic disorder; SCID (DSM-IV)

Duration (years): Unknown

Age (years): 36.7

Sex (female): 60%

Race (white): 54%

Medication (using at baseline): 54%

Education (years):  13.09

 

EXCLUSIONS

Depression: Yes

Psychotherapy:  Current restricted, no previous restrictions reported

Medication: "If the participant was taking prescribed drugs for panic disorder, a) the dosage had to be constant for 3 months before starting treatment, and b) the participant had to agree to keep the dosage constant throughout the study"

Drug/Alcohol: N/A

Physical: "To rule out general medical conditions, the participant must have consulted a physician, psychologist, or other health professional"

Interventions

Comparison group(s): Wait-List

 

Intervention name: Similar to Carlbring 2001.

Days of treatment: 70

Author wrote: Yes 

Type of media: Internet

Type of therapy: CBT

Location used: Anywhere

Type of contact: Email & Phone

Automated contact: N=0

Provider contact: N=23.5 (238min)

Contact description: “The total number of reciprocal contacts (received and sent) ranged from seven to 29 (mean=13.5, SD=4.4)...The mean time spent on each participant per week was approximately 12 minutes, including administration and responding to e-mail.  Weekly telephone calls were...timed and lasted an average of 11.8 minutes per week (range=9.6–15.6).”  "In addition to the written material, all participants received one telephone call per week by the same therapist, each lasting, on average, 17.8 min (SD=4.2). The median total telephone time was 188 min." Data about contact from 2006 and 2011 paper are contradictory.

Intervention description: received either the full book at the start of the treatment or one module per week during the 10 weeks  "modules 1–2, psychoeducation and socialization; module 3, breathing retraining and hyperventilation test; modules 4–5, cognitive restructuring; modules 6–7, interoceptive exposure; modules 8–9, exposure in vivo; and finally, module 10, relapse prevention and assertive- ness training. Each module consisted of approximately 25 pages of written text...converted into interactive web pages..."

Compliance: “The questions were included to promote learning and to enable the research supervisors to assess whether the participants had understood the material and completed their homework.”  "Of 30 participants, 24 (80%) finished all of the modules within the intended 10-week time limit. Hence, the average number of modules completed in this study was nine (mean=8.9, SD=2.6)."

Outcomes

Specific Symptoms: Agoraphobic Cognitions Questionnaire (ACQ)

General Symptoms: Beck Anxiety Inventory (BAI)

Recovery: No longer met criteria for diagnosis

Depression: Beck Depression Inventory (BDI); Montgomery and Asberg Depression Rating Scale (MADRS)

Quality of Life: Quality of Life Inventory (QOLI)

Notes

Funding: Swedish Foundation for Health Care Sciences and Allergy Research, the Boëthius Foundation, Swedish Research Council and the Soderstrom Konigska Foundation

Unpublished data: Carlbring provided details about randomisation and demographic measures.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Method:  Computer/Online

“The participants were divided into two groups, treatment or a waiting list, by a true random-number service.” (www.random.org)

Allocation concealment (selection bias)Low risk“The authors thank Tommy Maurin and Josefin Nilsson for conducting the blind clinical telephone interviews.”  "When it had been decided on what people to include all participants were randomized by a third party" (personal communication).
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

“Weekly telephone calls were made by the therapists to each participant. The purpose was to provide positive feedback and answer questions about the modules.”

Blinding of outcome assessment (detection bias)
All outcomes
Low risk

Included assessor-rated outcomes (blind)

“The clinical significance of the treatment was assessed in two ways: one with a statistical method, the other with clinical judgment in a reinterview administered by an independent psychologist who was blind to treatment condition.”

Incomplete outcome data (attrition bias)
All outcomes
Low risk

Not analysed at post-treatment

Intervention: N=0 (0%)

Comparison: N=0 (0%)

 

Method of analysis: LOCF

“posttreatment data were also collected from the participant who dropped out. Two participants in the treatment condition and one on the waiting list did not return their posttreatment questionnaires. Therefore, their pretreatment scores were carried forward to the posttreatment assessment point. Hence, all 60 participants who were randomly assigned to one of the two conditions were included in the statistical analysis.”

Selective reporting (reporting bias)Unclear risk

No trial registration number given.

Anxiety diary reported in other papers but does not appear here.

Other biasUnclear riskN/A

Carlbring 2007

Methods

Location: Uppsala, Sweden

Recruitment: Advertising/ Internet

Exclusion rate: 75.31%

Randomised (N): 60 (30 intervention; 30 comparison)

Participants

Disorder: Social Anxiety (Unspecified); SCID (DSM-IV R)

Duration (years): Unknown

Age (years): 32.65

Sex (female): 61.67%

Race (white): Unknown

Medication (using at baseline): Unknown

Education (years):  13.75

 

EXCLUSIONS

Depression: Yes

Psychotherapy:  Current and previous therapy restricted

Medication: "if taking prescribed drugs for anxiety or depression, the dosage had to be constant for 3 months before the start of the treatment, and the participants had to agree to keep the dosage constant throughout the study"

Drug/Alcohol: "... or substance misuse."

Physical: N/A

Interventions

Comparison group(s): Wait-List

 

Intervention name: Social Phobia-Effective Treatment with Cognitive-Behavioural Therapy (Furmark et al. 2006)

Days of treatment: 63

Author wrote: Yes 

Type of media: Internet

Type of therapy: CBT

Location used: Anywhere

Type of contact: Email & Phone

Automated contact: N=0

Provider contact: N=19 (198min)

Contact description: One weekly telephone call was made by the therapists to each participant in the treatment group.  "Feedback on homework assignments was usually given within 24h after participants had sent their answers by email."  "The mean total time per week spent on each participant was approximately 22 min, including telephone calls, administration, and reading and responding to emails. Hence, the total human contact time per participant including screening was over 2.5 h."

Intervention description: “based on established cognitive–behavioural methods as described in self-help books (e.g. Rapee, 1998; Antony & Swinson, 2000). The text, consisting of 186 pages, was taken from an existing manual (Furmark et al, 2006), divided into nine modules...included information, exercises and an interactive quiz, and ended with three to eight essay questions. Participants were asked to explain in their own words the most important sections of the module they had just completed, provide thought records...”

Compliance: “The questions were intended to promote learning and to enable the online therapists to assess whether the participants had assimilated the material. For each module participants were required to post at least one message in an online discussion group about a predetermined topic.”  "A total of 27 of the 29 people in the treatment group completed all nine modules within the intended 9-week time frame. Lack of time was provided as the explanation for terminating treatment prematurely."

Outcomes

Specific Symptoms: Liebowitz Social Anxiety Scale, self-rated (LSAS-SR): Avoidance

General Symptoms: Beck Anxiety Inventory (BAI)

Depression: Montgomery and Asberg Depression Rating Scale (MADRS)

Quality of Life: Quality of Life Inventory (QOLI)

Notes

Funding: Swedish Research Council and the Soderstrom Konigska Foundation

Unpublished data: Carlbring provided details about randomisation, demographic measures, recruitment, and contact with participants.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Method:  Computer/Online

“divided into two groups (treatment or waiting-list control) by an online true random-number service…”

Allocation concealment (selection bias)Low risk"independent of the investigators and therapists.  This service is run by the Department of Computer Science at the University of Dublin..."  "When it had been decided on what people to include all participants were randomized by a third party" (personal communication).
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

“One weekly telephone call was made by the therapists to each participant in the treatment group. The purpose was to provide positive feedback and to answer any questions the participant might have regarding the modules.”

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo assessor-rated outcomes.
Incomplete outcome data (attrition bias)
All outcomes
Low risk

Not analysed at post-treatment

Intervention: N=2 (6.67%)

Comparison: N=2 (6.67%)

Method of analysis: Available Case

“Prior to completing baseline measures, one control participant was excluded for lack of access to a computer.  One participant in each condition was excluded because they started another treatment, and they do not appear in the analyses.  One treatment-completer did not provide post-treatment measures.”  "A total of 27 of the 29 people in the treatment group completed all nine modules within the intended 9-week time frame. Lack of time was provided as the explanation for terminating treatment prematurely. One of them did not send in post-treatment measures, which explains why intention-to-treat analysis was used."

Selective reporting (reporting bias)Unclear riskNo trial registration number given.
Other biasUnclear riskN/A

Carlbring 2011

Methods

Location: Umeå, Sweden

Recruitment: Advertising/ Internet

Exclusion rate: 60.58%

Randomised (N): 54 (27 intervention; 27 comparison)

Participants

Disorder: Mixed (any anxiety disorder); SCID (DSM-IV)

Duration (years): Unknown

Age (years): 38.8

Sex (female): 75.93%

Race (white): 25.93%

Medication (using at baseline): 25.93%

Education (years):  13.43

 

EXCLUSIONS

Depression: Yes

Psychotherapy:  Current restricted, no previous restrictions reported

Medication: " taking no current medication for psycho-logical problems or, if on medication, have an unchanged dosage during the last three months."

Drug/Alcohol: N/A

Physical: N/A

Interventions

Comparison group(s): Attention/Monitoring

Comparison description: “invited to join a new confidential online support group specifically targeting anxiety problems. Each participant was asked to make at least one posting a week about a predetermined topic...presented by a therapist every eighth day, and participants were encouraged to comment on one another’s postings. The mean number of postings per participant, per topic were M=1.23 (SD=0.42) and total therapist time for writing and monitoring the online discussion area was approximately 1 h a week.”

 

Intervention name: Not named

Days of treatment: 70

Author wrote: Yes 

Type of media: Internet

Type of therapy: CBT

Location used: Anywhere

Type of contact: Email

Automated contact: N=0

Provider contact: N=10 (150min)

Contact description: “Eight clinical psychology M.Sc. students...responsible for 7-10 participants...All contact with the participants, once they had been interviewed and included in the study, was via e-mail. "If the therapist had not heard from the participant after a week, a reminder was sent by e-mail."  "Individual feedback was usually given within 24 h...an assessment was made to judge whether the participant was ready to continue...total time per week spent on each participant in this study was approximately 15 min, including administration as well as reading and responding to e-mails."

Intervention description: “combination of previous Internet-based programs...All of these were, in turn, based on established CBT methods. From a total of 16 different modules, each participant was prescribed 6 to 10 modules to work with during the 10 week treatment period. First (intro) and last (relapse prevention) modules fixed.  Others included cognitive restructuring (2), SAD (2), GAD (3), PD (2), AG, behavioural activation (2), applied relaxation, and sleep."  "modules were available for download in PDF format."

Compliance: “On average, participants were prescribed M=8.86 (SD=1.20, range 6-10) modules, and typically completed M=7.96 modules (SD=2.37, range 2-10 ) during the ten weeks of treatment. Fifty nine per cent of the participants finished all prescribed modules within the 10 week time limit.”

Outcomes

General Symptoms: Beck Anxiety Inventory (BAI)

Response: Clinical Global Impression (CGI): Improvement

Depression: Montgomery and Asberg Depression Rating Scale (MADRS)

Quality of Life: Quality of Life Inventory (QOLI)

Notes Funding: Swedish Council for Working Life and Social Research
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Method:  Computer/Online

“by an online true random-number service…”

Allocation concealment (selection bias)Low risk"...independent of the investigators and therapists."
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

"on the basis of these emails an assessment was made to judge whether the participant was ready to continue. If not, participant received instructions on what needed to be completed to be able to get to the next step..."

Blinding of outcome assessment (detection bias)
All outcomes
Low risk

Included assessor-rated outcomes (blind)

"after a telephone interview by a blind assessor who had no earlier contact with the participants and no knowledge of to which group they had been randomly allocated."

Incomplete outcome data (attrition bias)
All outcomes
Low risk

Not analysed at post-treatment

Intervention: N=0 (0%)

Comparison: N=0 (0%)

 

Method of analysis: LOCF

"Since the missing data at post-treatment was only in the treatment group, repeated ANOVAs with conservative imputation according to the last observation-carried-forward method in case of missing data was used in the analysis of the immediate results."

Selective reporting (reporting bias)Unclear riskNo trial registration number given.
Other biasLow riskN/A

Chung 2008

Methods

Location: Seoul, South Korea

Recruitment: Referral

Exclusion rate: Unknown

Randomised (N): 45 (27 intervention; 15 comparison)

Participants

Disorder: Social Anxiety (Unspecified); ADIS (DSM-IV)

Duration (years): Unknown

Age (years): 26.36

Sex (female): 39.5%

Race (white): Unknown

Medication (using at baseline): Unknown

Education (years): 15.03 

 

EXCLUSIONS

Depression: No

Psychotherapy: No restrictions reported

Medication: N/A

Drug/Alcohol: N/A

Physical: N/A

Interventions

Comparison group(s): Wait-List

 

Intervention name: Too much shyness: A cognitive therapy for social phobia (Kwon, Cho, and Lee, 1998)

Days of treatment: 42

Author wrote: Yes

Type of media: Book / Booklet

Type of therapy: CBT

Location used: Home/ Anywhere

Type of contact: Email

Automated contact: N= 0

Provider contact: N=6 (duration unknown)

 

Contact description: Group 1: “did their homework weekly, which was based on the contents of the book, and received feedback about their homework via e-mail from the first author…Moreover, the BT 1 group could con- tact the therapist via e-mail whenever they had a question about the homework.”  Group 2: “just read the book for about 6 weeks without any feed- backs and were then debriefed with a semi- structured interview, in order to determine if they had correctly understood the content of the book at the end of the BT.”

Intervention description: “information about social phobia…how to monitor social anxiety and record events in the Social Anxiety Record Form… identifying cognitive biases (e.g., catastrophic thinking) and changing dysfunctional beliefs…identify one’s underlying core beliefs and modify them… exposure techniques.”

Compliance: "did their homework weekly, which was based on the contents of the book, and received feedback about their homework via e-mail from the first author."

Outcomes

Specific Symptoms: Social Interaction Anxiety Scale (SIAS); Social Phobia Scale (SPS)

Response: Social Interaction Anxiety Scale (SIAS)

Notes Funding: Korea Science and Engineering Foundation funded by the Korean government (Ministry of Education, Science, & Technology) (No. R01-2008-000-11782-0)
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

Method:  Unclear

"participants were randomly assigned"

Allocation concealment (selection bias)Unclear riskSee "Sequence Generation."
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Provider contact: Yes

Provider blind: No 

"received feedback about their homework via e-mail from the first author"

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo assessor-rated outcomes.
Incomplete outcome data (attrition bias)
All outcomes
High risk

Not analysed at post-treatment

Intervention: N=3 (11.11%)

Comparison: N=4 (26.67%)

 

Method of analysis: Available Case

"the remaining 7 participants (two in BT 1, one in BT 2, and four in WL) dropped out"

Selective reporting (reporting bias)Unclear riskNo trial registration number given.
Other biasLow riskN/A

Donnan 1990

Methods

Location: Northumberland, England

Recruitment: Referral

Exclusion rate: Unknown

Randomised (N): 103 (51 intervention; 52 comparison)

Participants

Disorder: Mixed (not specified); Unclear

Duration (years): Unknown

Age (years): 41.49

Sex (female): 74.26%

Race (white): 58.25%

Medication (using at baseline): 58.25%

Education (years):  Unknown

 

EXCLUSIONS

Depression: No

Psychotherapy:  No restrictions reported

Medication: N/A

Drug/Alcohol: N/A

Physical: N/A

Interventions

Comparison group(s): Treatment-as-usual

 

Intervention name: Not named

Days of treatment: 42

Author wrote: Yes 

Type of media: Book / Booklet

Type of therapy: Relaxation

Location used: Anywhere

Type of contact: None

Automated contact: N=0

Provider contact: Unknown

Contact description: No information was collected about the frequency of consultation. The initial questionnaire was followed by postal questionnaires at six weeks and three months.

Intervention description: printed illustrated booklet (27 pages, approximately 4000 words)  Psychoeducation, "...stopping anxiety developing...ways in which anxiety can be coped with better, including understanding the problem, dealing with the causes of the anxiety where possible, using relaxation, coping with worry, planning better coping, having realistic expectations, letting other people help, and dealing with panic."  Relaxation tape.

Compliance: N/A

OutcomesNone
Notes Funding: None acknowledged
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

Method:  Unclear

“The self-help package was evaluated using a randomized controlled trial...Forty general practitioners in Northumberland agreed to recruit up to six patients each, randomly selecting three for the intervention group and three for the control group.”

Allocation concealment (selection bias)High risk"Each patient received an envelope at the end of the consultation with their general practitioner, which at random contained either the self-help materials and a questionnaire or the questionnaire alone. The envelopes were similar but those containing the self-help material were heavier."
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

"Each patient received an envelope at the end of the consultation with their general practitioner, which at random contained either the self-help materials and a questionnaire or the questionnaire alone. The envelopes were similar but those containing the self-help material were heavier."

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo assessor-rated outcomes.
Incomplete outcome data (attrition bias)
All outcomes
High risk

Not analysed at post-treatment

Intervention: N=18 (35.29%)

Comparison: N=9 (17.31%)

 

Method of analysis: Available Case

“Patients who dropped out of the intervention group had lower baseline scores than those who dropped out of the control group but there were no statistically significant differences. The characteristics of patients prior to loss to follow up at each time period were also examined and no statistically significant differences were found between the intervention and control groups.”

Selective reporting (reporting bias)High risk

No trial registration number given.

No data could be extracted for analysis.

Other biasHigh riskThe study is very poorly described.

Febbraro 1997a

Methods

Location: Virginia, West Virginia and Pennsylvania, USA

Recruitment: Advertising/ Internet

Exclusion rate: Unknown

Randomised (N): 98 (50 intervention; 48 comparison)

Participants

Disorder: Panic disorder; ADIS (DSM-IV)

Duration (years): 6.94

Age (years): 44.4

Sex (female): 74.6%

Race (white): 65.1%

Medication (using at baseline): 65.1%

Education (years):  14.1

 

EXCLUSIONS

Depression: No

Psychotherapy:  No restrictions reported

Medication: "Participants taking medication for anxiety or depression were allowed to participate provided they had been stabilised on the medication and dosage for at least four weeks and continued to experience full-blown or limited symptom attacks…"

Drug/Alcohol: "In addition, participants who were alcohol or substance dependent or had any type of psychotic disorder were also excluded from data analyses."

Physical: "seizure disorder, kidney disease, stroke…emphysema or heart problems."

Interventions

Comparison group(s): Wait-list, Monitoring alone

 

Intervention name: Coping with Panic: A Drug-Free Approach to Dealing with Anxiety Attacks (G Clum; 1990)

Days of treatment: 70

Author wrote: Yes 

Type of media: Book / Booklet

Type of therapy: CBT

Location used: Anywhere

Type of contact: None

Automated contact: N=0

Provider contact: N=0 (0 min)

Contact description: All participants had been exposed to assessment and feedback as part of an earlier study.  The amount of contact listed here is unique to this part of the study and thus underestimates contact with this research team over the course of several years.  "There was no contact with researchers at pretreatment assessment unless the pretreatment measures were not received by the experimenter within 7 days of their mailing. In this case, participants were contacted by telephone to ascertain if they had received the measures."

Intervention description: 1) Self-help alone, 2) Self-help & monitoring.  Included "(a) educating individuals about the etiology and nature of panic disorder; (b) teaching individuals a variety of cognitive and behavioral strategies that include relaxation, cognitive restructuring, breathing retraining, and exposure...Advice on implementing coping strategies is provided and homework assignments are incorporated to encourage active practice of these techniques."

Compliance: Treatment knowledge was defined as being able to successfully answer at least 7 of 10 questions about principles discussed in the book.  All participants were able to answer at least 70% of questions about the booklet correctly.

Outcomes

Specific Symptoms: Panic Attack Cognitions Questionnaire (PACQ)

General Symptoms: State-Trait Anxiety Inventory (STAI): State

Response: Panic Free

Depression: Beck Depression Inventory (BDI)

Notes

Funding: None acknowledged

Unpublished data: Author provided details about study methods.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

Method:  Unclear

“Stratified assignment was utilized in order to ensure as much as possible that an equal number of participants from each condition in Phase 1 (i.e., assessment only, assessment with face-to-face feedback, assessment with mailed feedback, and wait-list) were assigned to each condition in the present study.”  "the best way to describe the method I used to assign participants to groups was to try and match groups as closely as possible" (personal communication)

Allocation concealment (selection bias)High riskSee “Sequence Generation”
Blinding of participants and personnel (performance bias)
All outcomes
Low risk

Provider contact: No

Provider blind: N/A 

Contact appears to be for assessment only and by post.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo assessor-rated outcomes.
Incomplete outcome data (attrition bias)
All outcomes
High risk

Not analysed at post-treatment

Intervention: N=18 (36%)

Comparison: N=17 (35.42%)

 

Method of analysis: Per protocol

98 assigned; 63 completers (17 booklet; 15 booklet plus monitoring; 13 monitoring; 18 wait list).  31 dropouts (11 No longer interested, 5 Project taking too long, 2 Moved, 13 Unknown).  "Four additional participants were removed from the study for various reasons as well (e.g., beginning or changing medications during treatment [n = 2], beginning therapy during treatment [n = 1], or experiencing heart problems [n = 1])."  "In addition, participants who were alcohol or substance dependent or had any type of psychotic disorder were also excluded from data analyses."

Selective reporting (reporting bias)Low risk

No trial registration number given.

Thesis likely includes all outcomes.

Other biasLow riskN/A

Febbraro 1997b

MethodsAs above.
Participants 
Interventions 
Outcomes 
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Allocation concealment (selection bias)High risk 
Blinding of participants and personnel (performance bias)
All outcomes
Low risk 
Blinding of outcome assessment (detection bias)
All outcomes
Low risk 
Incomplete outcome data (attrition bias)
All outcomes
High risk 
Selective reporting (reporting bias)Low risk 
Other biasLow risk 

Febbraro 2005

Methods

Location: Iowa, USA

Recruitment: Advertising/ Internet

Exclusion rate: 46.07%

Randomised (N): 48 (32 intervention; 16 comparison)

Participants

Disorder: Panic Attacks; ADIS (DSM-IV)

Duration (years): 8.66

Age (years): 47.1

Sex (female): 73.3%

Race (white): 53.33%

Medication (using at baseline): 53.33%

Education (years):  14.6

 

EXCLUSIONS

Depression: No

Psychotherapy:  Current restricted, no previous restrictions reported

Medication: "Participants taking medications to cope with panic symptoms and/or other psycho- logical problems needed to be stabilized on a particular dosage per their self-report for four weeks prior to beginning this study."

Drug/Alcohol: N/A

Physical: N/A

Interventions

Comparison group(s): Attention/Monitoring

Comparison description: Phone contact alone: like the intervention group, participants in the control group received phone calls at weeks 2, 4, 6 and 8.

 

Intervention name: Coping with Panic: A Drug-Free Approach to Dealing with Anxiety Attacks (G Clum; 1990)

Days of treatment: 56

Author wrote: No 

Type of media: Book / Booklet

Type of therapy: CBT

Location used: Anywhere

Type of contact: Phone

Automated contact: N=0

Provider contact: N=2 (30min)

Contact description: “approximately one hour of phone contact with the principal investigator during the pre-treatment assessment session….”  Contact averaged; in one group "in addition to utilizing the book, participants were contacted via telephone at weeks 2, 4, 6, and 8...contact did not ever involve discussing how to implement coping strategies... If participants ever asked for such information, they would be referred to the book...The phone contact lasted no more than 15 minutes, as it was meant to be brief..."

Intervention description: Two groups.  Both received book "(1) educating individuals about the etiology and nature of panic attacks and panic disorder; (2) teaching individuals a variety of cognitive and behavioral strategies that include relaxation, cognitive restructuring, breathing retraining, and exposure to panic-related situations; and (3) advising individuals on how to implement the above cognitive and behavioral strategies."  One group received phone calls.

Compliance: In one group "To monitor compliance, participants were asked how they were doing in reading the book, whether they had any questions about what they had read, and whether they were using any of the coping strategies suggested."

Outcomes

Specific Symptoms: Panic Attack Cognitions Questionnaire (PACQ)

Response: Panic Free

Notes

Funding: None acknowledged

Unpublished data: Febbraro provided details of randomisation process, number assigned to each group, and number of dropouts per group.  Did not provide data for one person excluded from analyses for protocol violations. 

Assumed equal allocation of 48 participants.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Method:  Mechanical

“participants meeting study inclusion criteria were randomly assigned to one of the following conditions...”  "choosing group assignments out of a hat" (personal communication)

Allocation concealment (selection bias)Low riskSee Sequence Generation.  "briefly screened over the telephone by the principal investigator to determine eligibility... moved into the pre-treatment phase of the study."
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

“to monitor their compliance in reading the book, provide some support, and answer any questions about the study”

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo assessor-rated outcomes.
Incomplete outcome data (attrition bias)
All outcomes
High risk

Not analysed at post-treatment

Intervention: N=14 (43.75%)

Comparison: N=2 (12.5%)

Method of analysis: Per protocol

Of these 48 participants, 30 completed the study, and 18 dropped out for various reasons...  "If participants began some other form of psychological treatment during the study, they were allowed to continue in the study, but their data was removed from the final analyses. There was only one participant who began therapy during the course of the study."  Author reports "Given that only one participant began therapy during the study thus resulting in their exclusion from the analyses, it is not possible to conduct some of the additional analyses you suggest" (personal communication).

Selective reporting (reporting bias)Unclear riskNo trial registration number given.
Other biasLow riskN/A

Fletcher 2005

Methods

Location: Manchester, England

Recruitment: Referral

Exclusion rate: 91.71%

Randomised (N): 30 (15 intervention; 15 comparison)

Participants

Disorder: Mixed (Mean HADS Anxiety score over the minimal clinical cutoff of 8 (average >10) ); No diagnostic interview (questionnaire only)

Duration (years): Unknown

Age (years): 38.6

Sex (female): 76.67%

Race (white): Unknown

Medication (using at baseline): Unknown

Education (years):  12.27

 

EXCLUSIONS

Depression: Yes

Psychotherapy:  No restrictions reported

Medication: "Use of antidepressant medication was not an exclusion criterion, but data gathered about patient use of antidepressants was incomplete, mainly due to patient recall issues."

Drug/Alcohol: "not primary diagnosis of substance misuse"

Physical: N/A

Interventions

Comparison group(s): Wait-List

 

Intervention name: Kennedy and Lovell (2002).  A Handy Guide to Managing Depression and Anxiety: what should I do?

Days of treatment: 84

Author wrote: Yes 

Type of media: Book / Booklet

Type of therapy: CBT

Location used: Anywhere

Type of contact: None

Automated contact: N=0

Provider contact: N=0 (0 min)

Contact description: Continued to receive treatment by a GP, but no support using the booklet.

Intervention description: Pocket sized.  "...general advice about lifestyle, professional help and treatments available for anxiety and depression. Part two uses cognitive behavioural techniques...helps the reader to recognize thoughts, physical symptoms and behaviour and also to identify problems and set goals. The second part also teaches self-help interventions such as behavioural activation, relaxation, problem solving, exposure and cognitive therapy."

Compliance: “Process/satisfaction data were collected from the experimental group. There was a high level of satisfaction with the self-help, with all parts of the book being rated as useful or highly useful by over 50% of the patients (except for ‘evaluating your progress’ for which several patients gave feedback that 12 weeks was too soon to evaluate progress)."

Outcomes

General Symptoms: Hospital Anxiety and Depression Scale (HADS): Anxiety

Depression: Hospital Anxiety and Depression Scale (HADS): Depression

Notes

Funding: None acknowledged.  Authors wrote the booklet but do not derive income from it.

Unpublished data: Fletcher (now Archer) provided SPSS file with anonymous data, but was unable to locate mid-point data.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Method:  Mechanical

“The 30 patients were randomly allocated to one of two groups, self-help intervention (n=15) or waiting list control (n=15). Randomization was conducted using sealed plain opaque envelopes inside 15 of which was a slip of paper stating 'control group', whilst the other 15 contained a slip stating 'experimental group'. All the envelopes were equal in terms of size, design and weight.”

Allocation concealment (selection bias)Low risk“The 30 envelopes were then mixed up and given to the administrator of the Primary Care Mental Health Team, who randomly slotted an envelope into each of the 30 consecutively numbered study packs. The packs were then allocated by the principal investigator.”
Blinding of participants and personnel (performance bias)
All outcomes
Low risk

Provider contact: No

Provider blind: N/A 

“The patients were given a brief description of the book and advised to read it at their own pace.”

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo assessor-rated outcomes.
Incomplete outcome data (attrition bias)
All outcomes
Low risk

Not analysed at post-treatment

Intervention: N=0 (0%)

Comparison: N=0 (0%)

 

Method of analysis: LOCF

'"The main analysis used an independent samples t-test to detect significant differences between the intervention group and the control group on week 12 scores using intention-to-treat analysis, with missing data replaced by last observation carried forward (LOCF). Therefore, data collected at weeks 0 or 6 were used in the analyses when data at week 12 were not available."  "The two significant differences found between completers and those lost-to-follow-up were (1) age, which was higher in the latter group (t=3.62; df, 28; p = .001), and (2) CORE total score, which was also higher (t=2.74; df, 28, p = .011)."

Selective reporting (reporting bias)Unclear riskNo trial registration number given.
Other biasUnclear riskN/A

Fraser 2001

Methods

Location: Tasmania, Australia

Recruitment: Advertising/ Internet

Exclusion rate: 41.18%

Randomised (N): 30 (15 intervention; 15 comparison)

Participants

Disorder: Specific Phobia; CIDI (DSM-III R)

Duration (years): Unknown

Age (years): 32.55

Sex (female): 93.33%

Race (white): 0%

Medication (using at baseline): 0%

Education (years):  Unknown

 

EXCLUSIONS

Depression: Yes

Psychotherapy:  Current and previous therapy restricted

Medication: "not taking psychotropic medication"

Drug/Alcohol: "alcohol or illicit drug abuse problem"

Physical: N/A

Interventions

Comparison group(s): Self-help (Exposure)

Comparison description: 3 sessions of the same programme.

 

Intervention name: CAVE (Smith 1997)

Days of treatment: 21

Author wrote: Yes 

Type of media: Computer

Type of therapy: Exposure

Location used: Clinic/ Surgery

Type of contact: Face-to-face

Automated contact: N=0

Provider contact: N=6 (30min)

Contact description: “The therapist stayed with the participant for the first five minutes of the treatment to answer any questions. No self-exposure homework instructions were given by the therapist, the program or by handout.”

Intervention description: 6 sessions received twice weekly.  "...assist an animated screen figure to overcome his/her fear of spiders...There are four levels on the program, which model exposure to a spider picture, a plastic spider, a dead spider and a live spider, in a household setting. An on-screen 'anxiety thermometer' models the screen figure’s initial anxiety on approach of spider stimuli, and habituation with the accumulation of approach behaviours."

Compliance: “Process measures analysed were: (a) the time spent with a spider stimulus visible, on each level; (b) the number of enactments of vicarious touching of the spider at each level; and (c) the score rate per 5-minute epoch as a summary measure of overall vicarious exposure activity." "Mann-Whitney U tests showed no significant differences between the groups’ final session on any variable."  Homework activities 6-session versus 3-session: PT=2.3 (1.3) vs. 2.2 (1.9), FU=2.7 (1.5) vs. 2.3 (1.8).

Outcomes

Specific Symptoms: Fear Questionnaire (FQ): Global Phobia

Behaviour Test (Level): Behavioural Approach Test: Level

Behaviour Test (Symptoms): Behavioural Approach Test: Subjective Units of Distress

Disability: Work and Adjustment Rating Scale (WARS)

Notes Funding: None acknowledged
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High risk

Method:  Unclear

“The participant was randomly allocated to one of the two treatment conditions…"  See Allocation Concealment.

Allocation concealment (selection bias)High risk“Participants who did not complete the treatment program were replaced by new participants allocated to the same treatment group.”
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

“The therapist stayed with the participant for the first five minutes of the treatment to answer any questions. No self-exposure homework instructions were given by the therapist, the program or by handout.”

Blinding of outcome assessment (detection bias)
All outcomes
High risk

Included assessor-rated outcomes (NOT blind)

“A replication study with blind assessment and a control group is warranted.”

Incomplete outcome data (attrition bias)
All outcomes
High risk

Not analysed at post-treatment

Intervention: N=3 (20%)

Comparison (other): N=4 (26.67%)

 

Method of analysis: Per protocol

“Seven participants (three-session group n=4; six-session group n=3) did not complete the full treatment program, reportedly due to: work commitments (n=1); travel commitments (n=3); the participant’s opinion that they were cured (n=1); and because they felt the program was not helpful (n=1).”

Selective reporting (reporting bias)Unclear risk

No trial registration number given.

“Assessments were repeated immediately following the final treatment session (posttreatment) and four weeks after treatment (follow-up). These comprised BAT, SUDS, SPQ, FQ Main, FQ Global, PT Problem, PT Total, WARS Total, and HWQ.”

Other biasLow risk“Participants who did not complete the treatment program were replaced by new participants allocated to the same treatment group"

Furmark 2009a

Methods

Location: Uppsala, Sweden

Recruitment: Advertising/ Internet

Exclusion rate: 59.48%

Randomised (N): 120 (80 intervention; 40 comparison)

Participants

Disorder: Social Anxiety (Unspecified); SCID (DSM-IV)

Duration (years): Unknown

Age (years): 36.13

Sex (female): 67.5%

Race (white): 6.67%

Medication (using at baseline): 6.67%

Education (years):  Unknown

 

EXCLUSIONS

Depression: Yes

Psychotherapy: Current restricted, no previous restrictions reported

Medication: "if prescribed drugs for anxiety or depression, the dosage had to be constant for 3 months before the treatment onset and kept constant throughout the study"

Drug/Alcohol: "substance misuse"

Physical: N/A

Interventions

Comparison group(s): Wait-List

Comparison description: “The waiting-list control (WLC) group controlled for time and repeated assessments during the initial 9-week period. Participants had no contact with each other or with the study team during their waiting period except for conditional reminders by email or SMS to complete the weekly assessment of the LSAS-SR.”

 

Intervention name: Social Fobi-Effektiv Hjalp med Kognitiv Beteendeterapi [Social Phobia - Effective Help with CBT]

Days of treatment: 63

Author wrote: Yes 

Type of media: Mixed

Type of therapy: CBT

Location used: Anywhere

Type of contact: Email

Automated contact: N=Unknown

Provider contact: N=4.5 (67.5min)

Contact description: “in all groups, some participants received neutral reminders, sent by email or SMS, to complete the LSAS-SR  ICBT:”  "15min per week giving email feedback to each participant"

Intervention description: 1) The "pure" bibliotherapy (Bib) arm (40/80 intervention) received the manual by post.  2) 186 pages divided into nine modules for use over the internet. "Modules were also sent by post on a weekly basis..."  Psychoeducation, cognitive restructuring, exposure, attention training, social skills, relapse prevention.  "had access to an online discussion forum...Discussions were surveyed but the study personnel did not take part in them."

Compliance: “each module…ended with a short quiz to check adherence” "in cases of missing data, brief, neutral reminder was sent 24h later by email, and if necessary followed by another reminder as autogenerated short text message"  For Furmark 2009a and 2009b: completed modules 1 (100%), 2 (95%), 3 (92.5%), 4 (85%), 5 (80%), 6 (77.5%), 7 (72.5%), 8 (70%), 9 (62.5%).

Outcomes

Specific Symptoms: Liebowitz Social Anxiety Scale, self-rated (LSAS-SR)

General Symptoms: Beck Anxiety Inventory (BAI)

Response: Liebowitz Social Anxiety Scale, self-rated (LSAS-SR); Social Interaction Anxiety Scale (SIAS); Social Phobia Scale (SPS); Social Phobia Screening Questionnaire (SPSQ)

Depression: Montgomery and Asberg Depression Rating Scale (MADRS)

Quality of Life: Quality of Life Inventory (QOLI)

Notes

Funding: Swedish Research Council.  "The manual was released as a self-help book for the Swedish market after completion of the study."  T.F., A.H., E.S., P.Ca. and G.A. receive royalties for authoring the self-help book

 

Trial 1: Combined ICBT and Bib groups to form the intervention group.  Averaged outcomes and treatment characteristics, including number and duration of contact.  5-year follow-up includes data only for the treatment group.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Method:  Computer/Online

“Randomisation was performed by an independent third party using an online true random-number service (www.random.org).”

Allocation concealment (selection bias)Low riskSee “Sequence Generation”
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

"...giving email feedback to each participant. There were 13 internet therapists in the study, of whom 6 were licensed clinical psychologists and 7 were clinical psychology students in their last semester of the 5-year master’s degree programme. The students had clinical supervision during the trial. Participants were randomly allocated to their therapist."

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo assessor-rated outcomes.
Incomplete outcome data (attrition bias)
All outcomes
Low risk

Not analysed at post-treatment

Intervention: N=0 (0%)

Comparison: N=0 (0%)

 

Method of analysis: LOCF

“one each from the pure bibliotherapy and waiting-list groups, withdrew immediately after randomisation because of personal reasons and one additional participant (ICBT group) did not provide post-treatment data. The waiting-list control group received delayed treatment after 9 weeks (see below) but 3 individuals withdrew...” "missing data were replaced by the last obtained score (pre- or post-treatment), i.e. last observation carried forward." "all participants were asked to complete post-treatment and follow-up assessments, regardless of how many treatment modules they had completed."

Selective reporting (reporting bias)Low risk

Trial registration number: NCT01145690

All outcomes reported.

Other biasLow riskN/A

Furmark 2009b

Methods

Location: Uppsala, Sweden

Recruitment: Advertising/ Internet

Exclusion rate: 59.48%

Randomised (N): 115 (86 intervention; 29 comparison)

Participants

Disorder: Social Anxiety (Unspecified); SCID (DSM-IV)

Duration (years): Unknown

Age (years): 34.7

Sex (female): 67.83%

Race (white): 13.91%

Medication (using at baseline): 13.91%

Education (years):  Unknown

 

EXCLUSIONS

Depression: Yes

Psychotherapy: Current restricted, no previous restrictions reported

Medication: "if prescribed drugs for anxiety or depression, the dosage had to be constant for 3 months before the treatment onset and kept constant throughout the study"

Drug/Alcohol: "substance misuse"

Physical: N/A

Interventions

Comparison group(s): Applied relaxation (self-help)

Comparison description: “Participants in the internet-delivered applied relaxation (IAR) group followed an applied relaxation manual, which had been adapted for self-help use via the internet and evaluated (e.g. for panic disorder)...The structure of the manual was the same as in the ICBT and Bib groups, i.e. the text was divided into nine modules containing information and exercises, and participants completed one module per week.”  "had access to an internet therapist during the 9-week treatment period."

 

Intervention name: Social Fobi-Effektiv Hjalp med Kognitiv Beteendeterapi [Social Phobia - Effective Help with CBT]

Days of treatment: 63

Author wrote: Yes 

Type of media: Mixed

Type of therapy: CBT

Location used: Anywhere

Type of contact: Email

Automated contact: N=Unknown

Provider contact: N=3 (45min)

Contact description: “in all groups, some participants received neutral reminders, sent by email or SMS, to complete the LSAS-SR.” One third "had no contact with the study team except for the usual online assessments before, immediately after, and 1 year after treatment"  One third "had access to an internet therapist during the 9-week treatment period."  "Email correspondence occurred weekly...instruction on what needed to be completed to proceed to the next module...therapists spent approximately 15 min per week..."

Intervention description: 1 AND 2) Two bibliotherapy groups received the manual by post.  57/86 had online discussion group.  "had access to an online discussion forum...Discussions were surveyed but the study personnel did not take part in them.  3) The other arm received 186 pages divided into nine modules for use over the internet." "Modules were also sent by post on a weekly basis..."  Psychoeducation, cognitive restructuring, exposure, attention training, social skills, relapse prevention.

Compliance: “each module…ended with a short quiz to check adherence” "in cases of missing data, brief, neutral reminder was sent 24h later by email, and if necessary followed by another reminder as autogenerated short text message"  For Furmark 2009a and 2009b: completed modules 1 (100%), 2 (95%), 3 (92.5%), 4 (85%), 5 (80%), 6 (77.5%), 7 (72.5%), 8 (70%), 9 (62.5%).

Outcomes

Specific Symptoms: Liebowitz Social Anxiety Scale, self-rated (LSAS-SR)

General Symptoms: Beck Anxiety Inventory (BAI)

Response: Liebowitz Social Anxiety Scale, self-rated (LSAS-SR); Social Interaction Anxiety Scale (SIAS); Social Phobia Scale (SPS); Social Phobia Screening Questionnaire (SPSQ)

Depression: Montgomery and Asberg Depression Rating Scale (MADRS)

Quality of Life: Quality of Life Inventory (QOLI)

Notes

Funding: Swedish Research Council.  "The manual was released as a self-help book for the Swedish market after completion of the study."  T.F., A.H., E.S., P.Ca. and G.A. receive royalties for authoring the self-help book

 

Trial 2: Combined ICBT, Bib, BibDG groups to form the intervention group.  Averaged outcomes and treatment characteristics, including number and duration of contact.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Method:  Computer/Online

“Randomisation was performed by an independent third party using an online true random-number service (www.random.org).”

Allocation concealment (selection bias)Low riskSee “Sequence Generation”
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

"...giving email feedback to each participant. There were 13 internet therapists in the study, of whom 6 were licensed clinical psychologists and 7 were clinical psychology students in their last semester of the 5-year master’s degree programme. The students had clinical supervision during the trial. Participants were randomly allocated to their therapist."

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo assessor-rated outcomes.
Incomplete outcome data (attrition bias)
All outcomes
Low risk

Not analysed at post-treatment

Intervention: N=0 (0%)

Comparison: N=0 (0%)

 

Method of analysis: LOCF

0 lost to post-treatment; 14 intervention 2 control lost to follow-up.  Applies to Furmark 2009a and 2009b: "Ten participants (4.3%) withdrew from the study after the first (n = 6) or second (n = 4) treatment week, the main reasons being lack of time or motivation and personal problems..." "For all randomised participants, missing data were replaced by the last obtained score (pre- or post-treatment), i.e. last observation carried forward." "In accordance with the intention-to-treat principle, all participants were asked to complete post-treatment and follow-up assessments, regardless of how many treatment modules they had completed."

Selective reporting (reporting bias)Low risk

Trial registration number: NCT01145690

All outcomes reported.

Other biasLow riskN/A

Ghosh 1984

Methods

Location: London, England

Recruitment: Referral

Exclusion rate: 42.11%

Randomised (N): 88 (59 intervention; 29 comparison)

Participants

Disorder: Mixed (AG, SAD, SP); Clinical Interview (ICD-9)

Duration (years): 11

Age (years): 36

Sex (female): 74.65%

Race (white): 0%

Medication (using at baseline): 0%

Education (years):  Unknown

 

EXCLUSIONS

Depression: Yes

Psychotherapy: Current restricted, no previous restrictions reported

Medication: If patients were on drugs they were asked to gradually come off them before being included in the trial."

Drug/Alcohol: N/A

Physical: "uncontrolled hypertension, cardiac or severe respiratory conditions"

Interventions

Comparison group(s): Individual Exposure

Comparison description: “Therapist-instructed patients had the same treatment approach and worked only in discussion with a therapist (AG)."

 

Intervention name: Living With Fear (Marks, 1980)

Days of treatment: 70

Author wrote: Yes 

Type of media: Mixed

Type of therapy: Exposure

Location used: Other

Type of contact: Face-to-face

Automated contact: N=0

Provider contact: N=6 (67min)

Contact description: 40 minutes, 4.2 hours and 3.2 hours. "book-instructed patients were only seen three times during the treatment phase and thrice during the follow-up period; computer- and therapist-instructed patients were seen at weekly intervals during the treatment phase and thrice during follow up..." "Participants could contact the psychiatrist at any time, though none did so. All patients were treated individually."  All received an explanation of avoidance, exposure, and homework, and they were told to enlist relatives and friends to help.

Intervention description: 2 groups combined: (i) "given a copy of the book ‘Living with Fear’ (Marks 1978), which explains step by step how patients can help themselves by slowly coming off sedatives and alcohol and devising a detailed programme of graded exposure..."  (ii)  "3-10 treatment sessions of 40-60 minutes..."  "computer was programmed to "discus' exposure tasks from a hierarchical list of patients' phobic situations. At the end of the ‘interview' it printed out an ‘exposure homework' diary..."

Compliance: Homework diaries.  Diary data are recorded and analysed.

Outcomes

Specific Symptoms: Fear Questionnaire (FQ): Agoraphobia

General Symptoms: Fear Questionnaire (FQ): Anxiety Depression; Fear Questionnaire (FQ): Anxiety Depression, assessor rated

Disability: Work and Adjustment Rating Scale (WARS)

Notes

Funding: Medical Research Council Project Grant

Unpublished data: Marks identified Ghosh 1984 as a preliminary report of the participants in the 1987 and 1988 papers.  Unable to provide further information.  The 1988 paper says the therapist group was added 3 months into the study. 

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High risk

Method:  Unclear

“Patients were randomly assigned to one of three self-exposure treatment groups"  "imbalance in numbers arose because (a) originally the study had been planned to compare only computer and book-instructed self-exposure, and the therapist-instructed group was added 3 months into the trial"

Allocation concealment (selection bias)High riskSee “Sequence Generation”
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

“book-instructed patients were only seen three times during the treatment phase and thrice during the follow-up period; computer- and therapist-instructed patients were seen at weekly intervals during the treatment phase and thrice during follow up...”

Blinding of outcome assessment (detection bias)
All outcomes
Low risk

Included assessor-rated outcomes (blind)

“Patients were assessed before and after treatment and at 3 and 6 months follow-up by an experienced behavioural psychotherapist, who was blind to the treatment condition.”

Incomplete outcome data (attrition bias)
All outcomes
High risk

Not analysed at post-treatment

Intervention: N=7 (11.86%)

Comparison: N=10 (34.48%)

 

Method of analysis: Unclear

Dropouts occurred "before completing an adequate trial of treatment." "Seventy-five patients completed treatment, but included 4 who had not been randomized and so these were omitted from the analysis. Of the 71 patients who completed the randomized trial, all except one in the computer-instructed group completed six months' follow-up."

Selective reporting (reporting bias)High risk

No trial registration number given.

“Most statistical tests are not reported for the whole sample.  The only results are for the subgroup with AG.”

Other biasHigh riskNumbers randomised and analysed differ among reports.  A 1987 report is presented as a stand-alone trial, but the author confirms it reports data for a subgroup of the earlier trial.  One group was added 3 months into the study.  Dropout figures assume equal allocation, but allocation may not have been equivalent.

Gilroy 2000

Methods

Location: Tasmania, Australia

Recruitment: Advertising/ Internet

Exclusion rate: 13.46%

Randomised (N): 45 (15 intervention; 15, 15 comparisons)

Participants

Disorder: Specific Phobia; CIDI (DSM-III R)

Duration (years): Unknown

Age (years): 33.11

Sex (female): 100%

Race (white): Unknown

Medication (using at baseline): Unknown

Education (years): Unknown

 

EXCLUSIONS

Depression: Yes

Psychotherapy: Current and previous therapy restricted

Medication: N/A

Drug/Alcohol: N/A

Physical: N/A

Interventions

Comparison group(s): Muscle relaxation (self-help), Individual exposure

Comparison description: 1) "An audiotape of progressive muscle relaxation...The long and short versions of Jacobson's complete deep muscle relaxation were repeated twice to fill the 45-minute..." 2) "five pictorial representations of spiders and then moving onto a sequence of steps of increasing fearfulness similar to those in the BAT. Throughout treatment, progression to a higher step was based on three successful attempts at the previous step, a SUDS rating of below 20...." 

 

Intervention name: CAVE (Smith 1997)

Days of treatment: 42

Author wrote: Yes 

Type of media: Computer

Type of therapy: Exposure

Location used: Clinic/ Surgery

Type of contact: Face-to-face

Automated contact: N=0

Provider contact: N=3 (15min)

Contact description: Pretreatment assessment comprised two sessions. The first session involved obtaining written consent, demographic details, and completion of the CIDI... "Each participant then received three 45-minute treatment sessions..."  "In the initial session the therapist stayed with the participant for approximately 5 minutes to ensure the participant was comfortable using the pro- gram. The therapist then left the participant to work through the program."

Intervention description: The program instructed participants in vicarious exposure for spider phobia. Participants used a point-and- click method with the computer mouse to guide a person" (a screen figure) through a house. The participant could direct the screen figure into scenarios depicting a spider picture, a plastic spider, a dead spider, and a live spider in various rooms." 3 x 45-min sessions every two weeks.

Compliance: Measured exposure homework at 33 months.

Outcomes

Specific Symptoms: Fear Questionnaire (FQ): Global Phobia

Behaviour Test (Level): Behavioural Approach Test: Level

Behaviour Test (Symptoms): Behavioural Approach Test: Symptom Rating

Disability: Work and Adjustment Rating Scale (WARS)

Notes

Funding: None acknowledged

Unpublished data: Gilroy described the method of randomisation, demographic details and estimated contact with participants, including time required for consent and assessment (email, 19 May 2009). 

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High risk

Method:  Computer/Online

The first 45 participants were randomly assigned to one of the three treatment conditions.  See Allocation Concealment.

Allocation concealment (selection bias)High risk"Five participants (4 from relaxation condition, 1 from live exposure condition) did not complete treatment due to time constraints (3), moving interstate (1), and having already undergone prior relaxation treatment (1). These participants were replaced with new participants who were allocated to the same treatment groups as those who had not completed treatment."
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

The assessor, a master's student in psychology (LG), delivered both the assessment and treatment sessions.

Blinding of outcome assessment (detection bias)
All outcomes
High risk

Included assessor-rated outcomes (NOT blind)

The assessor, a master's student in psychology (LG), delivered both the assessment and treatment sessions.

Incomplete outcome data (attrition bias)
All outcomes
High risk

Not analysed at post-treatment

Intervention: N=1 (6.67%)

Comparison (muscle relaxation): N=0 (0%)

Comparison (individual exposure): N=2 (13.33%)

 

Method of analysis: Per protocol

Dropouts replaced. 14 intervention, 13 face-to-face and 15 relaxation subjects completed questionnaires at 147 week follow-up.  13 intervention 11 face-to-face and 8 relaxation subjects completed the BAT at 147 week follow-up.

Selective reporting (reporting bias)High risk

No trial registration number given.

BAT results for the relaxation group at 33 months are missing, but other outcomes appear to be reported clearly and completely.

Other biasHigh riskDropouts were replaced, thus violating the randomisation.

Gould 1993a

Methods

Location: Virginia, USA

Recruitment: Advertising/ Internet

Exclusion rate: 69.16%

Randomised (N): 33 (12 intervention; 12, 9 comparison)

Participants

Disorder: Panic disorder w/ AG; ADIS (DSM-III R)

Duration (years): Unknown

Age (years): 35.7

Sex (female): 64.52%

Race (white): 18.18%

Medication (using at baseline): 18.18%

Education (years):  14.26

 

EXCLUSIONS

Depression: No

Psychotherapy: Current restricted, no previous restrictions reported

Medication: Subjects taking medication for anxiety or depression were allowed to participate if they had been stabilized on the medication for at least four weeks and continued to have panic symptoms (n = 6)."

Drug/Alcohol: N/A

Physical: "having been diagnosed by a physician as having seizure disorder, kidney disease, stroke...emphysema, heart attack, or chronic hypertension."

Interventions

Comparison group(s): Wait-list, Inidivudal CBT

Comparison description: 1) "WL subjects were told that they would have to wait 7 weeks for their treatment to begin."  "Subjects who did not mail in their weekly data were reminded to do so by telephone."  2) Individual therapy "plans were derived primarily from material in Coping with Panic."  "Subjects met with a therapist twice per week for 4 weeks for a total of eight 1-hour individual therapy sessions targeting their panic attacks. There were four graduate-level therapists in this study."

 

Intervention name: Coping with Panic: A Drug-Free Approach to Dealing with Anxiety Attacks (G Clum; 1990)

Days of treatment: 28

Author wrote: Yes 

Type of media: Book / Booklet

Type of therapy: CBT

Location used: Anywhere

Type of contact: Phone

Automated contact: N=0

Provider contact: N=2 (30min)

Contact description: Total experimenter contact time for subjects in the WL and BT groups was for assessment purposes only and was 2.5 and 3.0 hours, respectively; ITGIC subjects required 10.5 hours. "  In all groups, subjects who did not complete weekly measures were reminded by phone.  "contacted at weeks 2 and 4 by the experimenter to assess their progress in reading the book. Each phone call lasted approximately 10 minutes, during which the experimenter followed a written protocol and did not answer questions..."

Intervention description: 2-week monitoring and assessment (common to all groups, beginning in week 5 for the wait-list).  "...the etiology and nature of panic disorder; (2) teaching them a variety of cognitive and behavioral strategies that include relaxation, cognitive restructuring, breathing retraining, and exposure; and (3) advising them on how to implement these strategies."

Compliance: Experimenters questioned subjects about specific material covered in the book to ascertain if subjects were reading the book and to determine their level of comprehension. A score of 70% on this assessment was considered evidence that the subject was reading the book.

Outcomes

Specific Symptoms: Mobility Inventory for Agoraphobia (MIA)

General Symptoms: Anxiety Sensitivity Index (ASI)

Response: Panic Free

Depression: Beck Depression Inventory (BDI)

Notes

Funding: None acknowledged

Unpublished data: Author provided information about the conduct of the study. 

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High risk

Method:  Unclear

The paper explains: "Subjects were matched on level of avoidance and then randomly assigned to one of the three experimental conditions."  The author explains: "individuals who agreed to be in the study and were eligible were alternately assigned to groups" (personal communication).

Allocation concealment (selection bias)High riskSee “Sequence Generation”
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

"Experimenters questioned subjects about specific material covered in the book to ascertain if subjects were reading the book"

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo assessor-rated outcomes.
Incomplete outcome data (attrition bias)
All outcomes
Low risk

Not analysed at post-treatment

Intervention: N=1 (8.33%)

Comparison (wait-list): N=1 (8.33%)

Comparison (individual CBT): N=0 (0%)

 

Method of analysis: Per protocol

Only 2 subjects dropped out: 1 from the WL group and 1 from the BT group. The subject from the WL group reported that she had to move to a different state to seek employment and could no longer continue in the study. The subject from the BT condition completed all the dependent measures of the study, but was not included in the analyses because she had failed to read the book.

Selective reporting (reporting bias)High risk

No trial registration number given.

Limited symptom panic attacks not reported.

Other biasLow riskN/A

Gould 1995

Methods

Location: Virginia, USA

Recruitment: Advertising/ Internet

Exclusion rate: 76.56%

Randomised (N): 33 (17 intervention; 16 comparison)

Participants

Disorder: Panic disorder; ADIS (DSM-III R)

Duration (years): 10.3

Age (years): 36.2

Sex (female): 84%

Race (white): 44%

Medication (using at baseline): 44%

Education (years):  13.8

 

EXCLUSIONS

Depression: No

Psychotherapy:  Current restricted, no previous restrictions reported

Medication: "Subjects taking medication for anxiety or depression were allowed to participate if they had been stabilized on the medication for at least 4 weeks and continued to have panic symptoms, and if they recorded their medication usage throughout the study (n

Drug/Alcohol: "chronic use of alcohol, drug dependence or abuse.."

Physical: "any of the following conditions: seizure disorder, kidney disease, stroke...emphysema, myocardial infarction, or chronic hypertension."

Interventions

Comparison group(s): Wait-List

 

Intervention name: Coping with Panic: A Drug-Free Approach to Dealing with Anxiety Attacks (G Clum; 1990)

Days of treatment: 28

Author wrote: Yes 

Type of media: Book / Booklet

Type of therapy: CBT

Location used: Anywhere

Type of contact: Phone

Automated contact: N=0

Provider contact: N=2 (30min)

Contact description: Subjects who failed to mail in their weekly data were reminded to do so by telephone contact from one of the study's personnel.  "The total time spent with researchers/therapists for each group of subjects was 2.5 hours for the WL group and 3.0 hours for the SH group, including the initial diagnostic evaluation."   "SH subjects were told that their progress in reading the book would be assessed at mid- and posttreatment by telephone."

Intervention description: 2-week monitoring and assessment (common to all groups, beginning in week 5 for the wait-list).  "...the etiology and nature of panic disorder; (2) teaching them a variety of cognitive and behavioral strategies that include relaxation, cognitive restructuring, breathing retraining, and exposure, and (3) advising them on how to implement these strategies."  "videotape was a 15-minute role-played therapy session"  "an audiotape that taught the progressive muscle relaxation"

Compliance: "SH subjects were instructed to complete and mail in the same four weekly measures as WL subjects. In addition, they were instructed to fill out a weekly Practice Record..."  "Subjects also kept a weekly log of the amount of time they spent practicing specific coping techniques, including self-exposure. This self-monitoring procedure was not included as a dependent measure but rather was included as an inducement to practice coping strategies."

Outcomes

Specific Symptoms: Mobility Inventory for Agoraphobia (MIA)

Response: Panic Free

Notes

Funding: None acknowledged

Unpublished data: Author provided information about the conduct of the study. 

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High risk

Method:  Unclear

At the end of the baseline period, all subjects were matched on their pretreatment level of avoidance score and randomly assigned to either the SH or WL groups.   The author explains: "subjects were alternately placed in the two groups" (personal communication)

Allocation concealment (selection bias)High riskSee “Sequence Generation”
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

"SH subjects were told that their progress in reading the book would be assessed at mid- and posttreatment by telephone."

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo assessor-rated outcomes.
Incomplete outcome data (attrition bias)
All outcomes
High risk

Not analysed at post-treatment

Intervention: N=5 (29.41%)

Comparison: N=3 (18.75%)

 

Method of analysis: Per protocol

“...the baseline period, 3 subjects decided not to be in the study...prior to their learning their treatment assignment.”  "Among the WL dropouts, 1 subject reported not having the time to keep records and the other gave no reason for termination. Among SH subjects, 1 decided he needed to see a psychiatrist and wanted medication for his problems, 1 terminated for no discernible reason and did not return our telephone calls, and 1 never read the book."

Selective reporting (reporting bias)Unclear risk

No trial registration number given.

A similar study by the same authors (Gould 1993) included the BDI.

Other biasLow riskN/A

Granado 2007

Methods

Location: Sao Paulo, Brazil

Recruitment: Advertising/ Internet

Exclusion rate: 84.38%

Randomised (N): 25 (13 intervention; 12 comparison)

Participants

Disorder: Specific Phobia; SCID (DSM-IV)

Duration (years): 23

Age (years): 31.3

Sex (female): Unknown

Race (white): Unknown

Medication (using at baseline): Unknown

Education (years):  Unknown

 

EXCLUSIONS

Depression: No

Psychotherapy:  No restrictions reported

Medication: N/A

Drug/Alcohol: N/A

Physical: N/A

Interventions

Comparison group(s): Attention/Monitoring

Comparison description: Placebo

 

Intervention name: SLAT: Spiderless Arachnophobia Therapy

Days of treatment: 28

Author wrote: Yes 

Type of media: Internet

Type of therapy: Exposure

Location used: Anywhere

Type of contact: Face-to-face

Automated contact: N=0

Provider contact: N=4 (duration unknown)

Contact description: To assess progress during the treatment, placebo and treatment subjects underwent the BAT (including the SUDS) each week.

Intervention description: "patients attend a computer presentation of images that, while not being spiders, have a subset of the characteristics of spiders"  "patient was instructed to run the presentation twice a day at home

preferably during moments in which she/he was not tired or under stress."  "To assess progress during the treatment, placebo and treatment subjects underwent the BAT (including the SUDS) each week."

Compliance: Prior to each presentation run, the patient was given one question to answer at the end of the run.  Every week these data were checked out in order to verify the rate of cooperation of patients and to encourage noncooperative patients, if any. In all subjects, the cooperation was satisfactory and no statistics were deemed necessary to measure the rate of cooperation.

Outcomes

Specific Symptoms: Fear of Spider Questionnaire (FSQ)

Behaviour Test (Level): Behavioural Approach Test: Level

Behaviour Test (Symptoms):

Behavioural Approach Test: Subjective Units of Distress

Notes Funding: supported by a CNPq Fellowship 154342/2006-8 and, previously, by a FAPESP Fellowship 03/08804-0
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

Method:  Unclear

“randomly divided into two groups”

Allocation concealment (selection bias)Unclear risk“randomly divided into two groups”
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

“To assess progress during the treatment, placebo and treatment subjects underwent the BAT (including the SUDS) each week.”

Blinding of outcome assessment (detection bias)
All outcomes
High risk

Included assessor-rated outcomes (NOT blind)

“To assess progress during the treatment, placebo and treatment subjects underwent the BAT (including the SUDS) each week.”

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo dropout.
Selective reporting (reporting bias)Unclear riskNo trial registration number given.
Other biasLow riskN/A

Greist 2002

Methods

Location: Salt Lake City, UT; Wheat Ridge, CO; Gainesville, FL; Houston, TX; Toronto, ON; Raleigh, NC; Worcester, MS; Atlanta, GA, USA/Canada

Recruitment: Advertising and referral

Exclusion rate: Unknown

Randomised (N): 218 (74 intervention; 75, 69 comparisons)

Participants

Disorder: OCD; SCID (DSM-IV)

Duration (years): 22

Age (years): 39

Sex (female): 42%

Race (white): 49%

Medication (using at baseline): 49%

Education (years):  14.63

 

EXCLUSIONS

Depression: Yes

Psychotherapy:  No restrictions reported

Medication: "51% had not taken an SRI for at least 2 weeks prior to prescreening...  The remainder were taking an SRI at or above an adequate minimum stable dose…The study did not allow dose adjustments or other prescription psychotropics."

Drug/Alcohol: "in the past 6 months, alcohol or substance abuse"

Physical: "unstable medical conditions"

Interventions

Comparison group(s): Relaxation, Individual Exposure

Comparison description: 1) "asked to perform progressive relaxation exercises for at least an hour daily and to keep daily relaxation diaries…" 2) 11 weekly, 1-hour (or longer) sessions.

 

Intervention name: BT STEPS

Days of treatment: 70

Author wrote: Yes 

Type of media: Computerised Phone

Type of therapy: Exposure

Location used: Anywhere

Type of contact: Face-to-face

Automated contact: N=12

Provider contact: N=3 (45min)

Contact description: All participants met with a clinician for 15 minutes at the end of weeks 2, 6, and 10 after starting treatment to assess improvement, safety, and appropriateness of continued participation.  "Patients get feedback on their progress via the calls and reports mailed to them weekly".

Intervention description: 9-step, computer-driven IVR [interactive voice response] system that allows patients with OCD to telephone from home and progress through a self-paced workbook."  Education and assessment, daily self-exposure, relapse prevention.

Compliance: The mean length of telephone calls to BT STEPS was 8.6 minutes…YBOCS improvement correlated significantly with more calls (mean ± SD = 22.5  ± 71.6...  "The number of self-exposure homework sessions completed by patients in the BT STEPS groups (mean ± SD = 9.9 ±  35.2) correlated significantly with mean YBOCS improvement…"  "61% of calls were made between 5:00 p.m. and 9:00 a.m. or on weekends."

Outcomes

Specific Symptoms: Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)

Response: Clinical Global Impression (CGI): Improvement; Patient Global Impression (PGI): Improvement

Depression: Hamilton Depression Rating Scale, self-rated (HAM-D S)

Disability: Work and Social Adjustment Scale (WSAS)

Notes

Funding: Cathryn Clary was employed by Pfizer.  Isaac Marks and Lee Baer received royalties from BT STEPS, owned by Healthcare Technology Systems.  Greist, Kobak, Wenzel, Hirsch and Mantle were employed by HTS.

 

Follow-up paper notes that severity moderates response.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

Method:  Unclear

“After screening, subjects were randomly assigned…”

Allocation concealment (selection bias)Unclear risk“After screening, subjects were randomly assigned…”
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

In addition to contact in the face-to-face therapy group, "All participants met with a clinician for 15 minutes at the end of weeks 2, 6, and 10…."

Blinding of outcome assessment (detection bias)
All outcomes
Low risk

Included assessor-rated outcomes (blind)

"Ratings were determined by an interviewing clinician (not the therapist) using paper-and pencil scales (CGI) and by the patient using paper-and-pencil (TRT-X, PSQ) or telephone interactive voice response (IVR) scales* (YBOCS, PGI, WSAS HAM-D).   A subsample of 90 patients was also rated on the clinician-administered YBOCS at baseline and end-point by a rater blind to treatment condition."

Incomplete outcome data (attrition bias)
All outcomes
High risk

Not analysed at post-treatment

Intervention: N=19 (25.68%)

Comparison (relaxation): N=9 (12%)

Comparison (exposure): N=14 (20.29%)

 

Method of analysis: Per protocol

Subjects whose total YBOCS scores fell by 25% or more during assessment (placebo responders, N=16) or who did not complete assessment tasks (N=5), violated the protocol (N=12), or withdrew (N=2) were excluded. "176 had at least 1 evaluable post-week 0 visit and were included in the end-point intent-to-treat analyses..."  "the last available postrandomization rating was input to endpoint for subjects who stopped prematurely."

Selective reporting (reporting bias)High risk

No trial registration number given.

"A subsample of 90 patients was also rated on the clinician-administered YBOCS…"   Data for goals completed not reported.  Expectation (TRT-X) and satisfaction (PSQ) not reported (but available from author on request).

Other biasHigh riskA run-in undermined the randomisation; 24% of the intervention group were excluded from further analyses: "One hundred eighty-three reached week 0 after 2 weeks' assessment (baseline visit: 57 in the BT STEPS group, 59 in the clinician guided behavior therapy group, and 67 in the relaxation group)."

Grime 2004

Methods

Location: London, England

Recruitment: Workplace

Exclusion rate: 64.85%

Randomised (N): 48 (24 intervention; 24 comparison)

Participants

Disorder: Mixed (Mean HADS Anxiety score in the moderate range (i.e. mean >11) ); No diagnostic interview (questionnaire only)

Duration (years): Unknown

Age (years): 39

Sex (female): 58.33%

Race (white): 20.83%

Medication (using at baseline): 20.83%

Education (years):  Unknown

 

EXCLUSIONS

Depression: No

Psychotherapy:  No restrictions reported

Medication: "All participants continued whatever care they were otherwise receiving (conventional care), details of which were recorded"

Drug/Alcohol: N/A

Physical: N/A

Interventions

Comparison group(s): Treatment-as-usual

Comparison description: 21% received the intervention outside the trial.

 

Intervention name: Beating the Blues (Ultrasis; http://www. ultrasis.com)

Days of treatment: 56

Author wrote: Yes 

Type of media: Computer

Type of therapy: CBT

Location used: Workplace

Type of contact: Face-to-face

Automated contact: N=0

Provider contact: N=8 (125min)

Contact description: Author estimates that the first interaction was 30-45 minutes and subsequent visits were 5-10 minutes (as in Proudfoot, and as estimated for other clinic-based studies).  When participants failed to attend, the researcher contacted them by phone.  "A weekly progress report of distress self-ratings and suicidal ideation is generated for the user and for the supervising clinician. "

Intervention description: “‘Beating The Blues’ is an interactive computerized CBT programme. Its cognitive components explore automatic thoughts, thinking errors and distraction, challenging unhelpful thinking, core beliefs and attributional style...activity scheduling, task breakdown, problem solving, sleep management, relaxation training and biofeedback, planning and prioritizing and graded exposure. Cognitive and behavioural exercises are prescribed at the end of each module, and debriefed at the start of the next."

Compliance: “Of those randomized to ‘Beating The Blues’, 16 completed all eight sessions of the programme, one completed six sessions, two completed four sessions, one completed three sessions and four completed two sessions. Reasons for not completing the programme included attrition, inability to commit the necessary time, and a desire not to continue.”

Outcomes

General Symptoms: Hospital Anxiety and Depression Scale (HADS): Anxiety

Depression: Hospital Anxiety and Depression Scale (HADS): Depression

Notes

Funding: None acknowledged

Unpublished data: Grime provided unpublished manuscript, demographics, qualitative feedback.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Method:  Computer/Online

Eligible participants giving written, informed consent, were randomized according to a sequence generated by a random number table

Allocation concealment (selection bias)Low riskRandomisation codes in sealed envelopes were opened sequentially, after collection  of  baseline  demographic, absence  and psychological data.
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

Participants were seen at the start and end of each session.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo assessor-rated outcomes.
Incomplete outcome data (attrition bias)
All outcomes
High risk

Not analysed at post-treatment

Intervention: N=8 (33.33%)

Comparison: N=1 (4.167%)

 

Method of analysis: Available Case

Analysis was performed on an intention to treat basis...  "Of the eight who did not complete the programme, four completed follow up questionnaires and four were lost to follow up. One participant completed all eight sessions of ‘Beating The Blues’, but none of the follow up questionnaires."  Four control participants were excluded from absenteeism analyses as they were absent for (i) unemployment and (ii) maternity leave.

Selective reporting (reporting bias)Low risk

No trial registration number given.

Author provided unpublished dissertation.

Other biasLow riskN/A

Hassan 1992

Methods

Location: Leeds, England

Recruitment: Advertising/ Internet

Exclusion rate: 5%

Randomised (N): 42 (11 intervention; 9, 22 comparison)

Participants

Disorder: Specific Phobia; Clinical Interview (DSM-III R)

Duration (years): 20.34

Age (years): 28.74

Sex (female): 78.95%

Race (white): Unknown

Medication (using at baseline): Unknown

Education (years): Unknown

 

EXCLUSIONS

Depression: No

Psychotherapy: No restrictions reported

Medication: N/A

Drug/Alcohol: N/A

Physical: N/A

Interventions

Comparison group(s): Wait-list, Individual exposure

Comparison description: (i) Exposure with modelling and live spiders.  When all photos were viewed with little or no fear, live spiders were introduced.  Concluded when participants could perform target behaviours with clear ease and confidence.  Tarantulas used.  (N=10.5). (ii) Exposure plus relaxation (N=10.5).  (iii) Wait-list (N=10).  [First two groups combined for analysis.] (Intervention strategies similar, method of delivery varied.)

 

Intervention name: Computer-Based Symbolic Modelling

Days of treatment: 18

Author wrote: Yes 

Type of media: Computer

Type of therapy: Exposure

Location used: Clinic/ Surgery

Type of contact: Face-to-face

Automated contact: N=0

Provider contact: N=5 (20min)

Contact description: Therapist was present in the treatment room, but no help was offered or requested by clients. 20 minute session followed completion of computer modelling; researcher had live spiders in boxes and explained the BAT verbally without demonstration.

Intervention description: Computerised exposure.  Information, relaxation.  Video and photographs of a woman approaching spiders (like BAT). Rate controlled by participants.  Twice weekly 40-min sessions.  Anxiety Rating Scale displayed when "Stop" pressed, and subjects saw relaxation instructions or listened to classical music.  Session terminated if stopped twice for an item.  Resumed where previous session ended.  Debriefing preceded post-treatment assessment.

Compliance: Intervention participants completed 5 sessions on average, duration of 3.34 hours.  By comparison, graded exposure and live modeling (combined for analysis) lasted 4.78 and 4.45 sessions and involved 3.19 and 2.97 hours of therapist contact.

Outcomes

Specific Symptoms: Spider Phobia Questionnaire (SPQ)

Behaviour Test (Level): Behavioural Approach Test: Level

Response: Behavioural Approach Test: Completed; Spider Phobia Questionnaire (SPQ)

Notes

Funding: None acknowledged

Unpublished data: Contacted Leeds, which provided the dissertation, but unable to contact the author directly. 

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

Method:  Unclear

Using a matched-group design technique, clients were first stratified into groups on four on the basis  of their BAT scores.  This was done by ranking all clients in terms of their BAT scores in ascending order, the first group of four in the list were taken...then randomly assigned to the four conditions of the study.

Allocation concealment (selection bias)High riskSee “Sequence Generation”
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

Participants were seen at the start and end of each session.

Blinding of outcome assessment (detection bias)
All outcomes
High risk

Included assessor-rated outcomes (NOT blind)

Participants were seen at the start and end of each session.

Incomplete outcome data (attrition bias)
All outcomes
Low risk

Not analysed at post-treatment

Intervention: N=1 (9.09%)

Comparison (wait-list): N=1 (11.11%)

Comparison (individual exposure): N=2 (9.09%)

 

Method of analysis: Available Case

Three clients who attended assessment but did not attend any further sessions were not included in the analyses.  One client withdrew who thought her condition was "beyond treatment.”  Estimated number of participants assuming equivalent group sizes.

Selective reporting (reporting bias)Low risk

No trial registration number given.

The composite score is not reported, but other measures appear to be reported completely and clearly.  Data extracted from thesis likely complete.

Other biasLow riskN/A

Hazen 1996

Methods

Location: Winnipeg, Canada

Recruitment: Referral

Exclusion rate: 9.4%

Randomised (N): 117 (32 intervention; 28, 28 comparison)

Participants

Disorder: Panic disorder; SCID (DSM III)

Duration (years): 8.6

Age (years): 37.12

Sex (female): 72.6%

Race (white): 46.99%

Medication (using at baseline): 46.99%

Education (years):  11.36

 

EXCLUSIONS

Depression: Yes

Psychotherapy:  Current restricted, no previous restrictions reported

Medication: "current pharmacological treatment for panic disorder, with the exception of low doses of benzodiazepines (equivalent of 20 mg diazepam or less) or stable doses of antidepressants (i.e., prescribed for at least 6 months and stable dose for at least 3 mont

Drug/Alcohol: "substance abuse"

Physical: "physician agreement regarding participation. Exclusion criteria included: (1) presence of organic disease which might be related to panic disorder or interfere with participation in the study"

Interventions

Comparison group(s): Wait-list, Group CBT

Comparison description: 1) Wait-list.  2) "thirteen 1.5 hour sessions were conducted over a fourteen-week period.  Sessions were structured around the content of the self-help manual, and included discussion of reading and practice homework assignments."

 

Intervention name: Coping with Panic: A Drug-Free Approach to Dealing with Anxiety Attacks (G Clum; 1990)

Days of treatment: 98

Author wrote: No 

Type of media: Book / Booklet

Type of therapy: CBT

Location used: Anywhere

Type of contact: None

Automated contact: N=0

Provider contact: N=0 (0 min)

Contact description: “Potential participants were initially assessed with a 30-minute structured telephone interview. Respondents who appeared to meet the inclusion criteria were then interviewed in person by a clinician experienced in assessing anxiety disorders.”

Intervention description: “The content of the treatment program included psycho-educational information about anxiety, and cognitive-behavioral treatment strategies, including relaxed breathing, progressive muscle relaxation, cognitive restructuring, and graduated exposure to feared situations. Subjects assigned to the self-help manual condition were instructed to complete one section of the self-help manual weekly for 14 weeks.”

Compliance: N/A

Outcomes

Specific Symptoms: Fear Questionnaire (FQ): Agoraphobia

General Symptoms: Anxiety Sensitivity Index (ASI)

Response: Clinical Global Impression (CGI): Improvement

Notes

Funding: Manitoba Health Research Council

Unpublished data: Walker provided slides from presentations showing number randomised to each group.  Described randomisation process and demographics. 

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Method:  Mechanical

“..we would recruit a block of participants – say eight or ten – then that block would be assigned to one of the four conditions…we would have four slips of paper with the four conditions, and blindly pull one from a hat…We would then recruit for the next block.  When that block was ready, we would pull a strip randomly (for the remaining three conditions) and assign to that condition.”

Allocation concealment (selection bias)Low risk“If we were screening a lot of people at once, we would also try to match up the groups a bit in terms of gender and severity (before they were randomized).”
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

Comparison group received face-to-face treatment.

Blinding of outcome assessment (detection bias)
All outcomes
Low risk

Included assessor-rated outcomes (blind)

“Subjects also attended a post-treatment evaluation interview, during which several rating scales, including the Clinical Global Improvement scale, were administered by the first author, who served as the independent assessor for the treatment study. Over the course of the study, the assessor remained blind to subjects’ treatment group status in order to ensure that unbiased ratings were made."

Incomplete outcome data (attrition bias)
All outcomes
High risk

Not analysed at post-treatment

Intervention: N=5 (15.63%)

Comparison (wait-list): N=1 (3.57%)

Comparison (group CBT): N=2 (7.14%)

 

Method of analysis: Available Case

Unpublished presentation clarifies that 11 participants were assigned and not analysed.

Selective reporting (reporting bias)High risk

No trial registration number given.

Unable to extract Frequency of PAs, BDI.

Other biasLow riskN/A

Heading 2001

Methods

Location: Tasmania, Australia

Recruitment: Advertising/ Internet

Exclusion rate: 22.4%

Randomised (N): 45 (15 intervention; 16, 14 comparison)

Participants

Disorder: Specific Phobia; CIDI (DSM-IV)

Duration (years): Unknown

Age (years): 34.9

Sex (female): 95%

Race (white): 0%

Medication (using at baseline): 0%

Education (years):  Unknown

 

EXCLUSIONS

Depression: Yes

Psychotherapy:  No restrictions reported

Medication: "not taking psychotropic medication"

Drug/Alcohol: "substance-abuse problem"

Physical: N/A

Interventions

Comparison group(s): Wait-list, Individual exposure

Comparison description: 1) Wait list, 2) "The treatment rationale focused on habituation/extinction of the anxiety response (Gilroy et al., 2000)...No relaxation exercises, modelling, or behavioural experiments aimed at disconfirming specific beliefs were used in the exposure sessions. No exposure homework instructions were given to the participant."

 

Intervention name: CAVE (Smith 1997)

Days of treatment: 1

Author wrote: Yes 

Type of media: Computer

Type of therapy: Exposure

Location used: Clinic/ Surgery

Type of contact: Face-to-face

Automated contact: N=0

Provider contact: N=1 (20min)

Contact description: The therapist stayed with the participant for the first 5 minutes of the treatment, to answer any questions. The program was reset by the therapist every 45 minutes to total 3 hours.

Intervention description: Participants are asked to assist an animated screen figure to overcome his/her fear of spiders, using a computer mouse to direct the figure through different exposure scenarios. An on-screen “anxiety thermometer” models habituation with the accumulation of approach behaviours, while a score displays the figure’s progress towards a target score of 2000."

Compliance: There were no significant differences in scores on the HWQ for self-directed homework between the LGE, CAVE, and waiting-list groups at both post-treatment and follow-up assessment. Overall, participants reported few self-initiated homework activities: mean for LGE 2.8 (SD 1.2), CAVE 2.0 (SD .8), and waiting list 2.0 (SD 1.8).

Outcomes

Specific Symptoms: Fear Questionnaire (FQ): Global Phobia

Behaviour Test (Level): Behavioural Approach Test: Level

Behaviour Test (Symptoms): Behavioural Approach Test: Subjective Units of Distress

Disability: Work and Social Adjustment Scale (WSAS)

Notes

Funding: None acknowledged

Unpublished data:

Heading, Kirkby and Gilroy contacted.  Gilroy described the baseline measures and estimated contact with participants.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

Method:  Unclear

The participant was randomised to one of the three conditions, with the treatment session 1 week after the pre-treatment assessment.

Allocation concealment (selection bias)Unclear riskSee “Sequence Generation”
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

The therapist stayed with the participant for the first 5 minutes of the treatment.

Blinding of outcome assessment (detection bias)
All outcomes
High risk

Included assessor-rated outcomes (NOT blind)

"The researcher accompanied the participant during all steps to advise of the next step, to record SUDS, and to score steps. Participants were debriefed following the BAT. BATs are considered highly sensitive measures of treatment change (de Beurs, Lange, Van Dyck, Blonk, & Pieter, 1991)."

Incomplete outcome data (attrition bias)
All outcomes
Low risk

Not analysed at post-treatment

Intervention: N=3 (20%)

Comparison (wait-list): N=1 (6.25%)

Comparison (individual exposure): N=1 (7.14%)

 

Method of analysis: Available Case

Five participants with- drew from the study (CAVE = 2, waiting list = 3) due to time commitments, before receiving treatment.  "One participant (LGE) withdrew following the post-treatment assessment."

Selective reporting (reporting bias)Unclear riskNo trial registration number given.
Other biasLow riskN/A

Hedman 2011a

Methods

Location: Stockholm, Sweden

Recruitment: Advertising and referral

Exclusion rate: 30.77%

Randomised (N): 81 (40 intervention; 41 comparison)

Participants

Disorder: Health Anxiety; MINI (DSM-IV)

Duration (years): 20.99

Age (years): 39.05

Sex (female): 74.07%

Race (white): 38.27%

Medication (using at baseline): 38.27%

Education (years):  Unknown

 

EXCLUSIONS

Depression: Yes

Psychotherapy:  Current and previous therapy restricted

Medication: "constant dosage 2 months prior to treatment if on prescribed medication for anxiety or depression and agree to keep dosage constant throughout the study"

Drug/Alcohol: "not currently fulfilling the diagnostic criteria for substance misuse according to the MINI"

Physical: "no serious somatic disease as assessed by a physician based on a review of medical records and the anamnesis from the diagnostic assessment interview"

Interventions

Comparison group(s): Attention/Monitoring

Comparison description: “The control condition consisted of an online discussion forum where participants could send messages anonymously to each over a period of 12 weeks…the rationale for employing this control condition design was to ensure a basic control for attention and the possible anxiety-alleviating effect of sharing one’s distress with others. Participants were encouraged to discuss their health anxiety and helpful ways of coping with it, and to provide support to others...”

 

Intervention name: Not named

Days of treatment: 84

Author wrote: Yes

Type of media: Internet

Type of therapy: CBT

Location used: Anywhere

Type of contact: Email

Automated contact: N=0

Provider contact: N=12 (108min)

Contact description: Estimated 1 weekly contact based on the following: "The role of the therapist was mainly to provide feedback regarding all homework and to grant access to the succeeding treatment modules; however, the participant could contact the therapist at any time and expect a reply within 24h.  In addition, therapists encouraged inactive participants to continue the treatment work.  The participant and therapist had no face-to-face or telephone contact during the treatment.  On average therapists spent 9min (s.d. = 5.6) weekly per participant."

Intervention description: “118 pages, divided into 12 modules” with homework exercise...emphasising the role of avoidance and safety behaviours, internal focus and interpretations of bodily sensations as signs of serious illness as maintaining factors of hypochondriasis.  In addition, the treatment included mindfulness training as a means of acquiring skills to help participants expose themselves...” "an online discussion forum that enabled anonymous contact with other participants receiving internet- based CBT."

Compliance: “The average number of completed modules in internet-based CBT was 9.1 (s.d. = 3.3). Six participants completed fewer than six modules and were considered non-completers...The most common reason reported for not completing treatment was lack of time. In the control group, the average number of postings was 16.1 (s.d. = 19.3). Thirty-nine of 41 participants in the control group posted at least one message.”

Outcomes

Specific Symptoms: Illness Attitude Scale (IAS)

General Symptoms: Anxiety Sensitivity Index (ASI); Beck Anxiety Inventory (BAI)

Response: Clinical Global Impression (CGI): Improvement

Recovery: No longer met criteria for diagnosis

Depression: Montgomery and Asberg Depression Rating Scale (MADRS)

Disability: Global Assessment of Functioning Scale (GAF)

Quality of Life:

Quality of Life Inventory (QOLI)

Notes Funding: Karolinska Institutet
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Method:  Computer/Online

“The randomisation procedure was managed by an external person not involved in the study. A true random number service (www.random.org) was used to ensure complete randomness.”

Allocation concealment (selection bias)Low risk“The random sequence was generated after inclusion of participants to ensure that assignment of intervention was concealed from the assessing psychologists and researchers involved in the study.”
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

“The role of the therapist was mainly to provide feedback regarding all homework and to grant access to the succeeding treatment modules…”

Blinding of outcome assessment (detection bias)
All outcomes
Low risk

Included assessor-rated outcomes (blind)

“The clinical psychologists performing the assessments were masked to treatment status and when summoned to clinician assessment all participants were instructed not to mention which intervention they had received.” "In two instances masking was broken...no significant association between assessors’ guess and actual treatment allocation (P50.58–0.052)."

Incomplete outcome data (attrition bias)
All outcomes
Low risk

Not analysed at post-treatment

Intervention: N=0 (0%)

Comparison: N=0 (0%)

 

Method of analysis:

No Dropout

Selective reporting (reporting bias)Low risk

Trial registration number: NCT00828152

All outcomes reported.

Other biasLow riskN/A

Hedman 2011b

Methods

Location: Stockholm, Sweden

Recruitment: Advertising and referral

Exclusion rate: 45.22%

Randomised (N): 126 (64 intervention; 62 comparison)

Participants

Disorder: Social Anxiety (Unspecified); SCID (DSM-IV)

Duration (years): 20.96

Age (years): 35.35

Sex (female): 35.71%

Race (white): 24.6%

Medication (using at baseline): 24.6%

Education (years):  Unknown

 

EXCLUSIONS

Depression: Yes

Psychotherapy:  Current and previous therapy restricted

Medication: "have constant dosage two months prior to treatment of any prescribed medication for anxiety or depression and agree to keep dosage constant throughout the study"

Drug/Alcohol: "not currently meet the diagnostic criteria for substance abuse"

Physical: N/A

Interventions

Comparison group(s): Group CBT

Comparison description: Heimberg RG, Becker RE (2002) Cognitive-behavioral group therapy for social phobia. Basic mechanisms and clinical strategies. New York: Guilford Press. "an initial individual session followed by 14 group sessions over 15 weeks. The individual session prepared the participant to begin group treatment sessions and included a rationale for group treatment. Each group session was 2.5 hours long, including a 15 minute break. Groups were lead by two therapists and had six to seven participants."

 

Intervention name: Not named

Days of treatment: 105

Author wrote: Yes 

Type of media: Internet

Type of therapy: CBT

Location used: Anywhere

Type of contact: Email

Automated contact: N=0

Provider contact: N=17.4 (82.5min)

Contact description: “...mainly to provide feedback regarding home work and to grant access to the treatment modules...could contact the therapist at any time and expect a reply within 24 hours during week days...no face-to-face or telephone contact ...instruction to the internet therapists was to have the ambition to restrict time spent on each patient to less than 10 minutes per week.”  "spent 5.5 minutes (SD = 3.6) weekly per patient. The corresponding amount of time in CBGT was 50 minutes (2.5 h sessions with two therapists and 6 patients)....ICBT therapists sent 17.4 messages..."

Intervention description: “stresses the importance of avoidance and safety behaviors as well as misinterpretations of social events and internal focus as maintaining factors of SAD...15 text modules, each covering a specific theme (e.g., exposure or cognitive restructuring) completed with a homework component”

Compliance: “The average number of completed modules in ICBT was 9.33 (SD=4.95) of 15. Fifty- one participants in ICBT (80%) completed at least 5 modules and 19 (29.7%) completed all...”  Comparison: "all reviewed sessions were judged to have been conducted in accordance with the treatment manual."  "9.40 (SD=4.87) out of a possible total of 15. Fifty participants in CBGT (81%) attended at least five sessions and 17 (27%) attended all..."

Outcomes

Specific Symptoms: Liebowitz Social Anxiety Scale, self-rated (LSAS-SR)

General Symptoms: Anxiety Sensitivity Index (ASI); Beck Anxiety Inventory (BAI)

Response: Clinical Global Impression (CGI): Improvement; Liebowitz Social Anxiety Scale, self-rated (LSAS-SR)

Recovery: No longer met criteria for diagnosis

Depression: Montgomery and Asberg Depression Rating Scale (MADRS)

Disability: Global Assessment of Functioning Scale (GAF)

Quality of Life: Quality of Life Inventory (QOLI)

Notes Funding: Stockholm County Council (Nils Lindefors) and the Bror Gadelius Fund (Erik Hedman)
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Method: Computer/Online

“A true random number service (http://www.random.org) was used to ensure randomization.”

Allocation concealment (selection bias)Low risk"The randomization procedure involved two external persons not involved in the study; one provided randomization data and the other monitored that no manipulation of treatment allocation was performed by the research group...The random sequence was generated after inclusion of participants to ensure that assignment of intervention was concealed from assessing psychiatrists and researchers of the study."
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Provider contact: Yes

Provider blind: No

“most messages to patients are very brief entailing the core feed-back that the homework was successfully completed and the next treatment module is accessible”

Blinding of outcome assessment (detection bias)
All outcomes
Low risk

Included assessor-rated outcomes (blind)

"...participants were instructed not to mention which treatment they had received during the post- treatment and follow-up interviews. After completing the interviews, the assessing psychiatrists guessed allocation..." "On two occasions participants accidentally mentioned their treatment allocation status to the assessor, and in other two occasions it was deemed necessary to break the blinding because of the need to assess increased depressive symptoms during treatment."

Incomplete outcome data (attrition bias)
All outcomes
Low risk

Not analysed at post-treatment

Intervention: N=1 (1.57%)

Comparison: N=0 (0%)

 

Method of analysis: Available Case

“On the CGI-I scale, missing values were replaced with 'no change'. As a complement, the social anxiety measures were also analyzed based on the sample of completers only."  At post-treatment, 1 intervention and 0 controls failed to provide self-report data, 5 and 10 failed to complete clinician assessment.  At follow-up, 4 intervention and 3 controls failed to provide self-report data, 10 and 11 failed to complete clinician assessment.

Selective reporting (reporting bias)High risk

Trial registration number: NCT00564967

The protocol lists three measures (WQ, TIC-P, SSP) that are not reported.  "During treatment, the LSAS-SR and the suicide ideation item of MADRS-S were administered on a weekly basis."

Other biasLow riskN/A

Hellström 1995

Methods

Location: Uppsala, Sweden

Recruitment: Advertising and referral

Exclusion rate: 0%

Randomised (N): 52 (42 intervention; 10 comparison)

Participants

Disorder: Specific Phobia; ADIS (DSM-III R)

Duration (years): 19.7

Age (years): 26.7

Sex (female): 100%

Race (white): Unknown

Medication (using at baseline): Unknown

Education (years):  Unknown

 

EXCLUSIONS

Depression: No

Psychotherapy:  No restrictions reported

Medication: N/A

Drug/Alcohol: N/A

Physical: "no disease of the heart or lungs"

Interventions

Comparison group(s): Individual Exposure

Comparison description: Based on the description given by Ost (1989a), this method includes a combination of gradual exposure and modelling. The treatment is described in detail in Ost et al. (1991).  The previous trial included 126.2 (30.5) minutes contact.  Included modeling and live spiders.  Sessions videotaped and replayed to patients. (Intervention strategies similar, method of delivery varied.)

 

Intervention name: 1) Living with Fear (Marks, translated) or 2) Not named (also used in Ost 1991)

Days of treatment: 14

Author wrote: Yes 

Type of media: Book / Booklet

Type of therapy: Exposure

Location used: Other

Type of contact: Phone

Automated contact: N=0

Provider contact: N=1 (duration unknown)

Contact description: Averaged clinic visits across groups.  Unspecified phone contact (all groups) between treatment and 1-year assessment.  "The program involved 7 time periods during 6 months with specific forms that the patients should fill in and send to the therapist at certain intervals. Upon receiving the form the therapist either phoned the patient or wrote a letter to her in order to provide feedback."

Intervention description: Group 1 "instructed to follow a 30 page manual specifically written for spider phobics used in an earlier study (0st et al., 1991)...based on the one-session therapist-directed exposure..." Group 2 "general manual (Marks, 1978) consists of 23 pages beginning with questions for the patient and a description of the exposure procedure.  Both groups were split into those who used the book at (a) home or (b) clinic.  For clinic groups, spiders were provided.

Compliance: N/A

Outcomes

Specific Symptoms: Fear Survey Schedule

General Symptoms: Beck Anxiety Inventory (BAI); State-Trait Anxiety Inventory (STAI)

Response: Behavioural Approach Test: Completed

Depression: Beck Depression Inventory (BDI)

Notes

Funding: Swedish Medical Research Council

Unpublished data: Contacted Hellstrom and Ost.  The lead author did not respond.  Ost provided data for another study.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

Method:  Unclear

'"After the pre-treatment assessment, the patients were randomly assigned to 5 different treatment groups"

Allocation concealment (selection bias)Unclear riskSee “Sequence Generation”
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

“Half the intervention group interacted with researcher/clinician (not blind) throughout the trial.  Therapists treated participants in each group.”

Blinding of outcome assessment (detection bias)
All outcomes
High risk

Included assessor-rated outcomes (NOT blind)

The therapists who conducted the treatments were the authors of this paper.  "The patient's degree of phobic severity was rated by the clinician"

Incomplete outcome data (attrition bias)
All outcomes
Low risk

Not analysed at post-treatment

Intervention: N=4 (9.52%)

Comparison: N=0 (0%)

 

Method of analysis: Imputed

“Four patients in the manual groups at the clinic (3 in S-C and 1 in G-C) stopped treatment prior to the post-treatment assessment, but since this was in effect comparable to patients in the two manual at home groups who performed less than two 2-hour sessions prior to the post-treatment assessment, it was not counted as attrition. For ethical reasons, we offered these four patients therapist-directed one session treatments and therefore their results are included in the follow-up data, but as estimates based on the post-treatment data."

Selective reporting (reporting bias)High risk

No trial registration number given.

Behavioural test, self-rated anxiety, and clinician-rated anxiety are presented as graphs, and significance tests are reported.  However, there is not enough information to include these outcomes in meta-analysis.  Variance not reported for physiological measures.

Other biasLow riskN/A

Holdsworth 1996

Methods

Location: Northumberland, England

Recruitment: Referral

Exclusion rate: Unknown

Randomised (N): 106 (53 intervention; 53 comparison)

Participants

Disorder: Mixed (Mean scores on the GHQ-12 were above accepted threshold for caseness, and anxiety scores were higher than depression scores ); Other

Duration (years): Unknown

Age (years): Unknown

Sex (female): Unknown

Race (white): Unknown

Medication (using at baseline): Unknown

Education (years):  Unknown

 

EXCLUSIONS

Depression: No

Psychotherapy:  No restrictions reported

Medication: N/A

Drug/Alcohol: N/A

Physical: N/A

Interventions

Comparison group(s): Treatment-as-usual

 

Intervention name: Managing Anxiety and Depression: A Self-help Guide (Holdsworth and Paxton, 1999)

Days of treatment: 30

Author wrote: Yes 

Type of media: Book / Booklet

Type of therapy: CBT

Location used: Anywhere

Type of contact: Face-to-face

Automated contact: N=0

Provider contact: N=0 (0 min)

Contact description: “no contact by participants with researchers.”

Intervention description: “a 42 page manual containing a range of treatment techniques for anxiety, depression and related complaints. The material is arranged and presented within the theoretical framework of the Three-Systems-Model (Lang, 1968; Rachman, 1978; Hugdahl, 1981). This model analyses psychological functioning in terms of thought, feeling and behaviour...selection of exercises designed to change what they have identified as most troubling them.”

Compliance: Asked about use of the booklet at 3 months.

OutcomesNone included.
Notes

Funding: The Mental Health Foundation, The Design and Communications Department of Northumberland Mental Health NHS Trust.

Unpublished data: Paxton had no information.  Holdsworth provided details of randomisation, but was unable to provide details about baseline or outcomes.   The Mental Health Foundation was contacted: "I have received a response from our Head of Research. Unfortunately, they have both said that they do not recognise this report.  It was suggested that this could be a report the Foundation supported but it wasn’t catalogued, which is very unusual, as all of our publications are recorded with The British Library and can be located using their ISBN number."

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Method:  Unclear

"a randomised controlled trial in the primary care setting."  "Equivalent levels of stress were controlled for at the outset in the experimental and control groups using the Social Readjustment Rating Scale." It is not clear how this was done, but the author indicates that a random assignment list was administered using numbered sealed envelopes that were indistinguishable on weight and handling (personal communication).

Allocation concealment (selection bias)Low risk"recruits were handed a sealed envelope which contained either a questionnaire and SAE only or these items together with a copy of Managing Anxiety and Depression: A Self-Help Guide. The general practitioner did not know what each envelope contained."  It is not clear how these could have been indistinguishable, but the author indicates that they were (personal communication).
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

GPs recruited and treated patients.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo assessor-rated outcomes.
Incomplete outcome data (attrition bias)
All outcomes
High risk

Not analysed at post-treatment

Intervention: N=23 (43.39%)

Comparison: N=21 (39.62%)

 

Method of analysis: Per protocol

“At the outset of the trial, 106 patients were recruited by 40 general practitioners. At the close of the trial, 62 patients had successfully completed all questionnaires: 32 in the control group and 30 in the intervention group."  Only participants who completed the first questionnaire were sent questionnaires at 1 and 3 months.

Selective reporting (reporting bias)High risk

No trial registration number given.

It was not possible to extract most outcome measures because means are reported without measures of variance and only significant p values are reported.

Other biasUnclear riskIt is unclear how many participants were assigned to each group; we assumed equal allocation.

Houghton 2008

Methods

Location: Internet, USA

Recruitment: Advertising/ Internet

Exclusion rate: 77.98%

Randomised (N): 231 (116 intervention; 115 comparison)

Participants

Disorder: Generalised Anxiety Disorder; Unclear

Duration (years): Unknown

Age (years): 44

Sex (female): 100%

Race (white): Unknown

Medication (using at baseline): Unknown

Education (years):  15.24

 

EXCLUSIONS

Depression: No

Psychotherapy:  No restrictions reported

Medication: N/A

Drug/Alcohol: N/A

Physical: "currently in good health as acknowledged by their primary care physician"

Interventions

Comparison group(s): Wait-List

 

Intervention name: Mindfulness-Based Stress Reduction Program (J Kabat-Zinn)

Days of treatment: 56

Author wrote: No

Type of media: Internet

Type of therapy: Muscle Relaxation

Location used: Anywhere

Type of contact: None

Automated contact: N=0

Provider contact: N=0 (0 min)

Contact description: None reported.

Intervention description: breathing exercises, mindfulness meditation, and yoga stretching

Compliance: N/A

Outcomes General Symptoms: State-Trait Anxiety Inventory (STAI)
Notes Funding: None acknowledged
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

Method: Unclear

"The participants were then randomized to either the treatment or the wait list control group."

Allocation concealment (selection bias)Unclear risk"Participants were notified as to which group they were randomized to after they completed the pretests."
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskUnclear if there was contact with researchers or clinicians.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo assessor-rated outcomes.
Incomplete outcome data (attrition bias)
All outcomes
High risk

Not analysed at post-treatment

Intervention: N=66 (%)

Comparison: N=65 (%)

 

Method of analysis: Unclear

"At the end of eight weeks all 116 participants in the experimental group were sent the post-tests and 84 returned the tests. The data was randomly selected for analysis from the participants who completed the post-tests (n = 50 experimental group, n = 50 wait list control group, (See Figure 1). Also at the completion all 57 wait list control participants who returned the post-tests were given access to the MBSR information."

Selective reporting (reporting bias)Unclear riskNo trial registration number given.
Other biasLow riskN/A

Johnston 2011

Methods

Location: Sydney, Australia

Recruitment: Advertising/ Internet

Exclusion rate: 48.22%

Randomised (N): 139 (93 intervention; 46 comparison)

Participants

Disorder: Mixed (GAD, PD, SAD); MINI (DSM-IV)

Duration (years): Unknown

Age (years): 41.62

Sex (female): 58.8%

Race (white): 29%

Medication (using at baseline): 29%

Education (years):  13.91

 

EXCLUSIONS

Depression: Yes

Psychotherapy:  Current restricted, no previous restrictions reported

Medication: "if taking medication (people taking benzodiazepines were excluded), had been taking the same dose for at least 1 month and did not intend to change that dose during the course of the program"

Drug/Alcohol: "not using illicit drugs or consuming more than three standard drinks a day"

Physical: N/A

Interventions

Comparison group(s): Wait-List

Comparison description: Wait list.

 

Intervention name: Anxiety Program (enhanced)

Days of treatment: 70

Author wrote: Yes 

Type of media: Internet

Type of therapy: CBT

Location used: Anywhere

Type of contact: Email & Phone

Automated contact: N=20.01

Provider contact: N=16.4 (69.39min)

Contact description: weekly telephone or email/asynchronous messaging contact with the Clinician or Coach, and regular automated reminder and notification emails  Coach/Clinician: 7.56/7.54 phone calls, 8.88/8.83 mutual written contacts, 19.37/20.43 automated contacts, 69.09/69.59 minutes.

Intervention description: 1) Clinician-assisted, 2) Coach-assisted.  "Eight online lessons; a summary/homework assignment for each lesson…access to additional written resources that included guidelines about managing low mood, improving sleep, and answers to frequently asked questions…also provided with access to de-identified vignettes written by participants in previous iCBT programs covering topics relevant to each of the eight lessons.”

Compliance: 4% withdrew before the programme began or did not start.  72% completed all lessons.

Outcomes

General Symptoms: Depression Anxiety Stress Scales - 21 Item (DASS-21)

Depression: Patient Health Questionnaire (PHQ-9)

Disability: Sheehan Disability Scale (SDS)

Notes

Funding: National Health and Medical Research Council of Australia: Dora Lush Priority PhD scholarship, the New South Wales Institute of Psychiatry, and the Australian Rotary Health Research Fund

 

Request disaggregated data by disorder and data for each intervention.  Did not use disorder-specific measures reported only for the total sample.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Method:  Computer/Online

“randomized via a true randomization process (www.random.org)”

Allocation concealment (selection bias)Low risk"generated by an independent person, to either CL, CO or Control groups. The allocation sequence preceded pre-treatment diagnostic interviews and was concealed from LJ and JS"
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

“weekly telephone or email/asynchronous messaging contact with the Clinician or Coach, and regular automated reminder and notification emails”

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo assessor-rated outcomes
Incomplete outcome data (attrition bias)
All outcomes
Low risk

Not analysed at post-treatment

Intervention: N=4 (4.30%)

Comparison: N=4 (8.70%)

 

Method of analysis: LOCF

"Thirty-two of 43 (74%) CO and 35/46 CL (76%) group participants completed all eight lessons within the 10-week program; intention-to-treat (ITT) design and missing data was addressed by carrying forward the first available data (baseline-observation carried-forward; BOCF"

Selective reporting (reporting bias)High risk

Trial registration number: ACTRN12610000242022

NEO-5 and Agoraphobia Cognitions Questionnaire not reported.  Treatment groups collapsed for analyses.  Outcomes not reported for specific diagnoses.

Other biasLow riskN/A

Jones 2002a

Methods

Location: Manchester, England

Recruitment: Referral

Exclusion rate: Unknown

Randomised (N): 40 (20 intervention; 20 comparison)

Participants

Disorder: Health Anxiety; Other

Duration (years): Unknown

Age (years): 50.3

Sex (female): Unknown

Race (white): Unknown

Medication (using at baseline): Unknown

Education (years):  Unknown

 

EXCLUSIONS

Depression: No

Psychotherapy:  No restrictions reported

Medication: N/A

Drug/Alcohol: N/A

Physical: "Half of the patients involved were also suffering from a medically diagnosed, physically-based problem"

Interventions

Comparison group(s): Treatment-as-usual

 

Intervention name: Understanding Health Anxiety: A Self-help Guide for Suffers and their Families (Kuchemann, C & D Sanders; 1999)

Days of treatment: 28

Author wrote: No 

Type of media: Book / Booklet

Type of therapy: CBT

Location used: Anywhere

Type of contact: Face-to-face

Automated contact: N=0

Provider contact: N=4 (180min)

Contact description: Assessment and weekly sessions 1-hour (personal communication).  45 min intervention and 15 min feedback.

Intervention description: “…consistent with the cognitive-behavioural model of health anxiety. The aim of the booklet is to educate the reader on how heath worries come about, what keeps them going and to provide guidelines on what can be done."

Compliance: After four weeks, the intervention group "confirmed that they had read the self-help booklet and completed the exercises."

Outcomes

Specific Symptoms: Health Anxiety Questionnaire (HAQ)

General Symptoms: State-Trait Anxiety Inventory (STAI)

Notes

Funding: None acknowledged

Unpublished data: Jones was contacted and provided information about the conduct of the study.  She was unable to describe the randomisation process (see the Risk of Bias table).

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

Method: Unclear

They were then randomly allocated to two groups Asked about the number assigned to each group, Jones replied "I think it was 50-75", but 40 participants are described in the paper.

Allocation concealment (selection bias)Unclear risk“At the first interview all participants were given information about the study, then asked to complete the questionnaires assessing their health anxiety."  Author reports "The participants were assigned to each group as they were referred to me they were assigned a number and assigned to each group by numbers." (personal communication.)  "The participants were randomly assigned to each group as they were referred and before I had looked at the referral." (personal communication.)
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

Weekly sessions 1-hour (personal communication)

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo assessor-rated outcomes.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk

Not analysed at post-treatment

Intervention: N=2 (10%)

Comparison: N=1 (5%)

 

Method of analysis: Unclear

Statistical tests indicate that 37 people are included in each of the post-treatment analyses.  Details for dropouts are not reported; assumed groups were initially equal in size.

Selective reporting (reporting bias)Unclear riskNo trial registration number given.
Other biasHigh riskDescription of randomisation and allocation very poor.  Number assigned unclear; we assumed participants were allocated evenly to groups.

Kenardy 2003

Methods

Location: Fife, SCO and Brisbane, AU, UK/Australia

Recruitment: Advertising and referral

Exclusion rate: 55.71%

Randomised (N): 186 (50 intervention; 45 comparison)

Participants

Disorder: Panic disorder; SCID (DSM-IV)

Duration (years): 5.95

Age (years): 36.8

Sex (female): 75.5%

Race (white): 30.35%

Medication (using at baseline): 30.35%

Education (years):  11.9

 

EXCLUSIONS

Depression: Yes

Psychotherapy:  Current restricted, no previous restrictions reported

Medication: "All patients taking medication at the time of entry must have been on a stable dose for 3 months and must have been willing and able to remain on a stable regime for 3 months during the course of treatment."

Drug/Alcohol: "no evidence of alcohol or drug dependence"

Physical: "...no evidence of cardiovascular disease, asthma, epilepsy, or pregnancy or intention to become pregnant during the course of the study."

Interventions

Comparison group(s): SH + Individual CBT versus CBT alone

Comparison description: Six 1-hr sessions.  "The manuals provided specific detail of content to be covered within each session, including session agendas, information to be presented, homework exercises, and specific therapeutic procedures (e.g., interoceptive exposure, relapse prevention). The CBT approach was based on panic control treatment (Barlow, Cerney, & Klosko, 1989) that incorporated the cognitive and behavioral theories of panic (e.g., Barlow et al., 1989; Clark, 1986)..."

 

Intervention name: Based on Panic Control Treatment (Barlow, Cerney and Klosko 1989)

Days of treatment: 42

Author wrote: Yes 

Type of media: Computer

Type of therapy: CBT

Location used: Anywhere

Type of contact: Face-to-face

Automated contact: N=0

Provider contact: N=5.9 (354 min, common to both groups)

Contact description: 90 min assessment (personal communication). "On average, patients completed 5.9 therapy sessions in CBT6-CA and 5.9 sessions in CBT6. In the CBT6-CA condition, patients continued to carry the palmtop computer for the remaining 6 weeks, after which it was returned."

Intervention description: Participants in both group received the same face-to-face therapy.  Intervention group also "The palmtop computer used in the CBT6-CA was the Hewlett Packard 200LX, which weighs about 300g...programmed to signal the participant five times daily...to prompt the practice of the therapy components. The computer program included a self-statement module, a breathing control module, and a new exposure module incorporating both situational exposure and interoceptive exposure."

Compliance: On average, participants in each group completed 5.9 therapy sessions.  "Adherence data was complex but overall we achieved 96.8% adherence to treatment protocol. Scotland had 98.5% and Australia had 95.1%." (personal communication)

Outcomes

Specific Symptoms: Agoraphobic Cognitions Questionnaire (ACQ)

General Symptoms: State-Trait Anxiety Inventory (STAI): Trait

Response: Panic Free

Depression: Beck Depression Inventory (BDI)

Quality of Life: Medical Outcomes Study Short Form (SF-36)

Notes

Funding: National Health Service and Medical Research Council, Australia, and from the Chief Scientist's office, Scottish Executive, Scotland

Unpublished data: Kenardy provided details about recruitment, demographics, randomisation, allocation concealment, numbers of participants in analyses, contact with participants.  He also provided data for the BDI and the SF-36.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High risk

Method:  Unclear

"Patients who dropped out were replaced."  "Additional cases were randomly assigned in the next “cohort” to make up the shortfall, we had four cohorts which recruited and randomised about 20 each but this number varied depending on the dropouts.  In the last cohort we just went with what we had." (Personal communication)

Allocation concealment (selection bias)High risk"Patients who dropped out were replaced."  Administered by a third party (research assistant).  "Additional cases were randomly assigned in the next “cohort” to make up the shortfall, we had four cohorts which recruited and randomised about 20 each but this number varied depending on the dropouts.  In the last cohort we just went with what we had." (personal communication)
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

“each therapist treating approximately equal proportions of patients in each of the three treatment conditions.”

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo assessor-rated outcomes.
Incomplete outcome data (attrition bias)
All outcomes
High risk

Not analysed at post-treatment

Intervention: N=15 (30%)

Comparison: N=11 (24.44%)

 

Method of analysis: Per protocol

12% did not complete at least three sessions of treatment or provide "adequate data."  "and were defined as dropouts.  An additional 13 participants were lost to follow-up, leaving 93 participants with 9-month follow-up analysis."  "An intent-to-treat analysis was also conducted in which all cases with available pretreatment data were carried forward...The intent-to-treat analysis was limited to 3-months posttreatment because it was judged that extrapolation of pretreatment data to the 6-month follow-up was untenable."

Selective reporting (reporting bias)Low risk

No trial registration number given.

BDI and SF-36 are not reported in the paper, but received from the author.

Other biasHigh risk“Patients who failed to receive at least three sessions of their respective course of treatment or who failed to provide adequate pretreatment and endpoint data were defined as dropouts. Patients who dropped out were replaced.”

Kiely 2002

Methods

Location: Herefordshire, England

Recruitment: Referral

Exclusion rate: 0%

Randomised (N): 60 (20 intervention; 20, 20 comparison)

Participants

Disorder: Generalised Anxiety Disorder; ADIS (DSM-III R)

Duration (years): 7.6

Age (years): 41.1

Sex (female): 54.35%

Race (white): Unknown

Medication (using at baseline): Unknown

Education (years):  Unknown

 

EXCLUSIONS

Depression: No

Psychotherapy:  Current and previous therapy restricted

Medication: N/A

Drug/Alcohol: "alcohol or substance misuse"

Physical: N/A

Interventions

Comparison group(s): Wait-list, Psychoeducation

Comparison description: 1) Wait-list.  2) "The IOP comprised two booklets of 27 pages total length containing general information, about the causes and consequences of anxiety, including the common symptoms of anxiety, Lazarus and Folkman’s (l984) model of stress and Cannon’s (l929) Fight-Flight survival mechanism."

 

Intervention name: Not named

Days of treatment: 91

Author wrote: Yes 

Type of media: Book / Booklet

Type of therapy: CBT

Location used: Anywhere

Type of contact: Face-to-face

Automated contact: N=0

Provider contact: N=1 (10 min)

Contact description: The total assessment interview took up to 120 minutes. "Those in the treatment group were introduced to the intervention through a 10 minute presentation following assessment."

Intervention description: “two booklets of 27 pages total length...common symptoms...plus six others, totalling 106 pages and an audio cassette detailing relaxation exercises.”  "detect internal and external anxiety cues and to learn to apply new coping strategies...self-monitoring of thoughts, feelings and behaviours (Durham and Turvey, l987), cognitive change (Beck and Emery, 1985)..."

Compliance: Author asked about use of material and strategies implemented in addition to amount read and frequency of reading.  Measures of advice implemented are compared between groups.

Outcomes

Specific Symptoms: Penn State Worry Questionnaire (PSWQ)

General Symptoms: Beck Anxiety Inventory (BAI); Hospital Anxiety and Depression Scale (HADS): Anxiety

Depression: Hospital Anxiety and Depression Scale (HADS): Depression

Notes

Funding: "part of my post in an NHS psychology service" (personal communication)

Unpublished data:

Kiely provided unpublished papers with study details, demographics, outcome data.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Method:  Other

“with reference to a prepared list of 60 spaces, numbered 1-60 consecutively, each number being allocated in advance to one of the 3 conditions via a random number table.”

Allocation concealment (selection bias)Low risk“The assessor only referred to the randomised list once a patient was allocated to the next available space on the main list –hence they were unaware of the relevant condition in advance of allocation.”
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

“Those receiving the IOP or FP were introduced to the respective programmes by the assessor using a scripted presentation lasting up to 10 minutes.”

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo assessor-rated outcomes.
Incomplete outcome data (attrition bias)
All outcomes
High risk

Not analysed at post-treatment

Intervention: N=4 (20%)

Comparison (wait-list): N=6 (30%)

Comparison (psychoeducation): N=4 (20%)

Method of analysis: Available Case

“independent Clinical Psychologist...blind to treatment condition and patient’s scores...read the initial assessments on each patient, including the ADIS-R interview and their biographical self-completion questionnaire. They then assigned a diagnosis, primary and secondary, to each patient. If the independent assessor decided a patient did not meet the criteria for the study, the patient’s results were excluded from the subsequent analysis.  12 were excluded on this basis.  2 failed to attend follow-up.  Participants with complete pre- and post-treatment data were included in the analyses.”

Selective reporting (reporting bias)Unclear riskNo trial registration number given.
Other biasUnclear risk“12 patients included (and randomised) were then excluded from analyses because didn't have primary diagnosis of GAD - and unclear how many in each group.”

Kiropoulos 2008

Methods

Location: Victoria, Australia

Recruitment: Advertising/ Internet

Exclusion rate: 89.24%

Randomised (N): 86 (46 intervention; 40 comparison)

Participants

Disorder: Panic disorder; ADIS (DSM-IV)

Duration (years): Unknown

Age (years): 38.96

Sex (female): 72.09%

Race (white): 48.24%

Medication (using at baseline): 48.24%

Education (years):  12.53

 

EXCLUSIONS

Depression: Yes

Psychotherapy:  Current restricted, no previous restrictions reported

Medication: "Those participants who were taking medication for anxiety or depression were accepted if they had been stabilised on their medication for at least 12 weeks but continued to experience panic symptoms and met a diagnosis of PD."

Drug/Alcohol: "alcohol or drug dependency"

Physical: "heart condition…chronic hypertension"

Interventions

Comparison group(s): Individual CBT

Comparison description: “Participants attended one hour weekly treatment sessions with their allocated psychologist…given a copy of the manual ‘Mastery of Your Anxiety and Panic – Third Edition’  (Barlow & Craske, 2000)…focuses on teaching participants a variety of cognitive and behavioral strategies that include controlled breathing, cognitive restructuring, and interoceptive and situational exposure …weekly reading and were instructed to work through this manual with the assistance of the treating psychologist.”

 

Intervention name: Panic Online (Klein and Richards)

Days of treatment: 84

Author wrote: Yes 

Type of media: Internet

Type of therapy: CBT

Location used: Anywhere

Type of contact: Email & Phone

Automated contact: N=0

Provider contact: N=18.6 (352min)

Contact description: See Table 4.  Participants received 10.64 emails and sent 18.24.  Therapists made .36 phone calls per participant.  Author estimated assessment lasted 60 to 90 min (personal communication). “All psychologists interacted with their participant via email, which allowed the psychologist to provide individualized support and feedback to the participant, according to the participants’ individual needs…maintained a log of the time they spent…”

Intervention description: “introductory module, four learning modules, and a relapse prevention module… instructions for controlled breathing, cognitive restructuring, and interoceptive and situational exposure...participants had access to the stress and benzodiazepine reduction modules…did not vary according to participant input. Participants were instructed to read one specified module per week and to practice the described activities in this module.”

Compliance: “Participants in the face-to-face CBT treatment group completed a mean 10.96 sessions of the 12-week treatment program. Unfortunately, no data is available about how many modules the PO participants completed.”  "Therapists treating participants in the face-to-face CBT rated their participants as having higher compliance to treatment and having greater understanding of the treatment material given to them compared to the PO participants."

Outcomes

Specific Symptoms: Agoraphobic Cognitions Questionnaire (ACQ)

General Symptoms: Anxiety Sensitivity Index (ASI); Depression, Anxiety, Stress Scales (DASS): Anxiety

Response: Panic Free

Recovery: High End-State Functioning

Depression: Depression, Anxiety, Stress Scales (DASS): Depression

Quality of Life: WHO Quality of Life - BREF

Notes

Funding: National Health and Medical Research Council.  Panic Online developed by Jeffrey Richards with funds from the Australian Rotary Health Research Fund.

Unpublished data: Kiropoulos confirmed contact, duration of follow-up, was aware of the allocation sequence.  Further baseline measures not recorded, unable to reconcile discrepancy between education in text (p. 1275) and Table 1.  

Unable to provide weekly panic attacks or to recall assignment of 22 missing cases.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Method:  Other

“After all pre-assessment questionnaires were completed by the participants, they were randomly allocated using a random numbers table to either the PO or face-to-face CBT treatment  condition.”

Allocation concealment (selection bias)Low riskAll assessors were blind to treatment allocation of eligible participants into the study.   "I had access and knowledge of the sequence table only. The manager of the project (me) allocated participants into the groups based on the random numbers table."
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

“All psychologists interacted with their participant via email”

Blinding of outcome assessment (detection bias)
All outcomes
High risk

Included assessor-rated outcomes (NOT blind)

“Additionally the ADIS-IV was also conducted during a face-to-face interview by the assessor.  Clinicians providing treatment to participants also completed the TAQ at post-assessment for each participant they were allocated.”

Incomplete outcome data (attrition bias)
All outcomes
Low risk

Not analysed at post-treatment

Intervention: N=0 (0%)

Comparison: N=0 (0%)

 

Method of analysis: LOCF

“Data analysis involved intention-to-treat analyses. Participants who had missing post-assessment questionnaire(s) (n=22) or who discontinued treatment (n = 7) were treated as 'intention to treat’ (ITT). That is, participants’ pre-assessment scores were carried forward and used in post treatment.  5 intervention and 2 controls discontinued treatment.  22 had missing post-assessment questionnaires.”

Selective reporting (reporting bias)Unclear riskNo trial registration number given.
Other biasUnclear riskN/A

Klein 2001

Methods

Location: Melbourne or Victoria, Australia

Recruitment: Advertising/ Internet

Exclusion rate: Unknown

Randomised (N): 23 (11 intervention; 12 comparison)

Participants

Disorder: Panic disorder; ADIS (DSM-IV)

Duration (years): Unknown

Age (years): 40.82

Sex (female): 86.36%

Race (white): 40.91%

Medication (using at baseline): 40.91%

Education (years):  11.7

 

EXCLUSIONS

Depression: No

Psychotherapy:  Current restricted, no previous restrictions reported

Medication: "Nine participants (41%) reported the use of anxiety medication but subsequently all reported no alteration in their dosage levels throughout the 3 weeks."

Drug/Alcohol: Measured by the Prime MD

Physical: "absence of any significant physical health problems"

Interventions

Comparison group(s): Wait-List

Comparison description: Self-monitoring only

 

Intervention name: Panic Online (Klein and Richards)

Days of treatment: 21

Author wrote: Yes 

Type of media: Internet

Type of therapy: CBT

Location used: Anywhere

Type of contact: Phone

Automated contact: N=0

Provider contact: Unknown

Contact description: Provided assistance loading programme.  Random telephone checks conducted to ensure compliance.  Average length of calls was 5 minutes and is included in the time reported for assessment.  Assessment took 2.5 to 3 hours (personal communication) and the lower estimate was extracted.

Intervention description: 2 x 45-min sessions: "nature, effects and causes of panic, and the second on useful and non-useful ways of managing panic. Negative self- statements were discussed as were errors in thinking. Brief techniques on how to overcome these cognitive errors were explained...considerable use of colour, animated illustrations, hyperlinks between sections of the text, and self- assessment quizzes with immediate feedback."

Compliance: None reported, though the study indicates that information about progress was obtained from participants.

Outcomes

Specific Symptoms: Body Vigilance Scale (BVS)

General Symptoms: Anxiety Sensitivity Index (ASI)

Notes

Funding: None acknowledged

Unpublished data: Klein provided unpublished outcome data and details of contact with participants.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

Method:  Unclear

“Participants were randomly assigned…”

Allocation concealment (selection bias)Unclear riskSee “Sequence Generation”
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

“Random telephone checks conducted to ensure compliance” (personal communication)

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo assessor-rated outcomes.
Incomplete outcome data (attrition bias)
All outcomes
Low risk

Not analysed at post-treatment

Intervention: N=1 (9.09%)

Comparison: N=0 (0%)

 

Method of analysis: Available Case

“One participant failed to complete the study and subsequently her data were excluded.”

Selective reporting (reporting bias)Low risk

No trial registration number given.

Full outcome data were provided by the author.

Other biasLow riskN/A

Klein 2006

Methods

Location: Australia

Recruitment: Advertising/ Internet

Exclusion rate: 57.69%

Randomised (N): 55 (37 intervention; 18 comparison)

Participants

Disorder: Panic disorder; ADIS (DSM-IV)

Duration (years): Unknown

Age (years): Unknown

Sex (female): 80%

Race (white): 52.73%

Medication (using at baseline): 52.73%

Education (years):  12.5

 

EXCLUSIONS

Depression: No

Psychotherapy:  Current restricted, no previous restrictions reported

Medication: "Those participants who were taking medication for anxiety or depression were accepted if they had been stabilised on their medication for at least 4 weeks but continued to experience panic symptoms and met a diagnosis of PD."

Drug/Alcohol: "alcohol or drug dependency"

Physical: "stroke...heart condition...or chronic hypertension"

Interventions

Comparison group(s): Attention/Monitoring

Comparison description: participated in the same telephone and online assessments as those in the PO and MAN conditions...contacted the IC participants each week and inquired about their current panic status. She provided minimal support (e.g., empathic listening) and asked participants whether they had been doing their daily monitoring and advised them to re-read the information on an internet-based informational program...

 

Intervention name: Panic Online (Klein and Richards)

Days of treatment: 54

Author wrote: Yes 

Type of media: Mixed

Type of therapy: CBT

Location used: Anywhere

Type of contact: Email & Phone

Automated contact: N=0

Provider contact: N=12.45 (292.85min)

Contact description: Internet: "Therapist interaction occurred via email, enabling the therapist to provide individualised support and feedback to the participant, according to their requests and needs."  Mean 16.39 emails sent.  Book: "informed that a therapist would telephone them at home once weekly to assist them and monitor their progress...The therapist was required to keep a log of amount of time spent..."  Mean 7.73 calls.

Intervention description: Two groups combined 1) "6-week structured program comprised of an introductory module, four learning modules, and a relapse prevention module...controlled breathing, cognitive restructuring, and interoceptive and situational exposure."  "did not vary according to participant input."  2)  "MAP-3 (Barlow & Craske, 2000) free of charge...cognitive and behavioural strategies that include controlled breathing, cognitive restructuring, and interoceptive and situational exposure as in PO."

Compliance: Participants reported using the program mostly from home and rarely at their workplaces."

Outcomes

Specific Symptoms: Agoraphobic Cognitions Questionnaire (ACQ)

General Symptoms: Anxiety Sensitivity Profile (ASP); Depression, Anxiety, Stress Scales (DASS): Anxiety

Recovery: High End-State Functioning

Depression: Depression, Anxiety, Stress Scales (DASS): Depression

Notes Funding: Australian Rotary Health Research Fund
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High risk

Method:  Other

After assessment, all participants were randomly assigned sequentially (i.e., ABC, ABC) using a block design to internet-based treatment, treatment with a self-help manual with limited therapist assistance, or an internet-based information control (IC) condition.

Allocation concealment (selection bias)Low riskThe assessors were blind to which treatment the participant would be assigned to until after the pre-assessment was completed.
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Included contact with researcher/clinician (not blind)

 

...enabling the therapist to provide individualised support and feedback to the participant, according to their requests and needs

Blinding of outcome assessment (detection bias)
All outcomes
Low risk

Included assessor-rated outcomes (blind)

“The clinician who conducted the post- and follow-up assessments did not provide the treatment.”

Incomplete outcome data (attrition bias)
All outcomes
Low risk

Not analysed at post-treatment

Intervention: N=0 (0%)

Comparison: N=0 (0%)

 

Method of analysis: LOCF

Data analysis involved intention-to-treat analyses. That is, for those participants who discontinued their involvement during treatment (n= 9), their pre-assessment scores were carried forward and used in both the post-treatment (PO, MAN, and IC) and follow-up assessments (PO and MAN).

Selective reporting (reporting bias)Unclear riskNo trial registration number given.
Other biasLow riskN/A

Koszycki 2011

Methods

Location: Canada

Recruitment: Advertising and referral

Exclusion rate: 13.1%

Randomised (N): 251 (126 intervention; 125 comparison)

Participants

Disorder: Panic disorder; SCID (DSM-IV)

Duration (years): 9.83

Age (years): 36.15

Sex (female): 40.3%

Race (white): 0%

Medication (using at baseline): 0%

Education (years):  Unknown

 

EXCLUSIONS

Depression: Yes

Psychotherapy:  Current and previous therapy restricted

Medication: "use of any psychotropics within 14 days of the baseline visit (6 weeks for fluoxetine)"

 

Drug/Alcohol: Other primary comorbid disorder like generalized anxiety disorder, social phobia, somatization disorder and specific phobia. Other psychiatric disorders; electroconvulsive therapy in the past 6 months; if on Oxazepam, a  maximum daily dose of 15 mg, 60 mg

Physical: "a history of psychosurgery; significant medical conditions; abnormal laboratory findings; a hypersensitivity to serotonergic agents; a history of non-response to sertraline; lactose intolerance"

Interventions

Comparison group(s): Sertraline only, Placebo Only

 

Intervention name: Not named

Days of treatment: 84

Author wrote: Yes 

Type of media: Audio

Type of therapy: CBT

Location used: Anywhere

Type of contact: Face-to-face

Automated contact: N=0

Provider contact: N=8 (duration unknown)

Contact description: Tapes were distributed weekly during acute treatment by a research coordinator and a standard format was adopted for instructions to be given to patients. Compliance was assessed at each visit by asking patients how much time they spent listening to the tape, whether they attempted the suggested homework and whether they recorded their homework in the workbook. Patients who entered the 12-week extension phase were given the CBT package to use at their own discretion and no particular instructions were given.

Intervention description: SCBT+ Sertraline and SCBT +Placebo  "SCBT consisted of 12 audiotapes and a workbook that contained monitoring forms for homework. The tapes and workbook were developed for this study by psychologists with expertise in CBT. psychoeducation about anxiety and the cognitive model of PD, breathing retraining and relaxation skills, cognitive restructuring that addressed misappraisal of panic symptoms, interoceptive and situational exposure, and relapse prevention."

Compliance: "Compliance was assessed at each visit by asking patients how much time they spent listening to the tape, whether they a