'Third wave' cognitive and behavioural therapies versus treatment as usual for depression

  • Review
  • Intervention

Authors


Abstract

Background

So-called 'third wave' cognitive and behavioural therapies represent a new generation of psychological therapies that are increasingly being used in the treatment of psychological problems. However, the effectiveness and acceptability of third-wave cognitive and behavioural therapy (CBT) approaches as treatment for acute depression remain unclear.

Objectives

1. To examine the effects of all third wave CBT approaches compared with treatment as usual/waiting list/attention placebo/psychological placebo control conditions for acute depression.

2. To examine the effects of different third wave CBT approaches (ACT, compassionate mind training, functional analytic psychotherapy, dialectical behaviour therapy, MBCT, extended behavioural activation and metacognitive therapy) compared with treatment as usual/waiting list/attention placebo/psychological placebo control conditions for acute depression.

3. To examine the effects of all third wave CBT approaches compared with different types of comparators (treatment as usual, no treatment, waiting list, attention placebo, psychological placebo) for acute depression.

Search methods

We searched the Cochrane Depression Anxiety and Neurosis Group Trials Specialised Register (CCDANCTR to 01/01/12), which includes relevant randomised controlled trials from The Cochrane Library (all years), EMBASE, (1974-), MEDLINE (1950-) and PsycINFO (1967-). We also searched CINAHL (May 2010) and PSYNDEX (June 2010) and reference lists of the included studies and relevant reviews for additional published and unpublished studies. An updated search of CCDANCTR restricted to search terms relevant to third wave CBT therapies was conducted in March 2013 (CCDANCTR to 01/02/13).

Selection criteria

Randomised controlled trials that compared third wave CBT therapies with control conditions for acute depression in adults.

Data collection and analysis

Two review authors independently identified studies, assessed trial quality and extracted data. Study authors were contacted for additional information when required. We rated the quality of evidence using GRADE methods.

Main results

Four small studies (224 participants) were included in the review. Little information was provided about the process of allocating participants to groups. None of the studies used independent outcome assessors, and evidence suggested researcher allegiance towards the active treatments. The four studies examined a diversity of third wave CBT approaches (extended behavioural activation, acceptance and commitment therapy and competitive memory training) and control conditions. None of the studies conducted follow-up assessments. The results showed a significant difference in clinical response rates in favour of third wave CBT when compared with treatment as usual (TAU) conditions (three studies, 170 participants, risk ratio (RR) 0.51, 95% confidence interval (CI) 0.27 to 0.95; very low quality). No significant difference in treatment acceptability based on dropout rates was found between third wave CBT approaches and TAU (four studies, 224 participants, RR 1.01, 95% CI 0.08 to 12.30; very low quality). Both analyses showed substantial statistical heterogeneity.

Authors' conclusions

Very low quality evidence suggests that third wave CBT approaches appear to be more effective than treatment as usual in the treatment of acute depression. The very small number of available studies and the diverse types of interventions and control comparators, together with methodological limitations, limit the ability to draw any conclusions on their effect in the short term or over a longer term. The increasing popularity of third wave CBT approaches in clinical practice underscores the importance of completing further studies of third wave CBT approaches in the treatment of acute depression, on a short- and long-term basis, to provide evidence of their effectiveness to policy-makers, clinicians and users of services.

Résumé scientifique

Comparaison des psychothérapies comportementales et cognitives de « troisième vague » aux traitements habituels de la dépression

Contexte

Les thérapies cognitives et comportementales dites « de la troisième vague » représentent une nouvelle génération des psychothérapies, de plus en plus utilisées dans le traitement de problèmes psychologiques. Leur efficacité et leur acceptabilité dans le traitement de la dépression aiguë sont cependant encore mal déterminés.

Objectifs

1. Examiner les effets de toutes les TCC de la troisième vague par rapport au traitement habituel, aux listes d’attente, aux placebos de suivi, aux placebos psychologiques pour le traitement de la dépression.

2. Examiner les effets de différentes TCC de la troisième vague (ACT, psychothérapie focalisée sur la compassion, psychothérapie analytique fonctionnelle, psychothérapie comportementale dialectique, l’activation et comportementales, MBCT, modèle étendu de la psychothérapie métacognitive) par rapport au traitement habituel, aux listes d’attente, aux placebos d’attention, aux conditions de contrôle avec placebos psychologiques dans le traitement de la dépression.

3. Examiner les effets de toutes les TCC de la troisième vague par rapport à l’aide différents types de méthodes de comparaison (traitement habituel, absence de traitement, liste d’attente, placebo d’attention, placebo psychologique) pour le traitement de la dépression.

Stratégie de recherche documentaire

Nous avons effectué des recherches dans le registre du groupe Cochrane sur la dépression, l’anxiété et la névrose (CCDANCTR, au 01/01/12), qui inclut les essais contrôlés randomisés pertinents issus de la Bibliothèque Cochrane (toutes les années), d’EMBASE (1974-), de MEDLINE (1950-) et de PsycINFO (1967-). Nous avons également effectué des recherches dans CINAHL (mai 2010) et PSYNDEX (juin 2010) et dans les références bibliographiques des études incluses et des revues pertinentes pour identifier d’autres études publiées et non publiées. Une recherche actualisée dans CCDANCTR, restreinte aux termes de recherche pertinents pour la TCC de troisième vague, a été effectuée en mars 2013 (CCDANCTR au 01/02/13).

Critères de sélection

Essais contrôlés randomisés comparant les TCC de la troisième vague avec des conditions de contrôle pour le traitement de la dépression chez l’adulte.

Recueil et analyse des données

Deux auteurs de la revue ont identifié les études, évalué la qualité des essais et extrait les données de manière indépendante. Les auteurs des études ont été contactés pour obtenir des informations supplémentaires lorsque cela était nécessaire. Nous avons évalué la qualité des données au moyen de l’échelle GRADE.

Résultats principaux

Quatre études de petite taille (224 participants) ont été inclus dans la revue. Ces études donnaient peu d’informations sur le processus d’affectation des participants aux groupes. Aucune des études n’utilisait des évaluateurs des résultats indépendants, et les preuves suggèrent une allégeance des chercheurs envers les traitements actifs. Les quatre études examinaient diverses TCC de troisième vague (activation comportementale étendue, thérapie d’acceptation et d’engagement et entraînement de la mémoire compétitive) et situations de contrôle. Aucune des études ne comprenait des évaluations de suivi. Les résultats ont montré une différence significative en termes de taux de réponse clinique en faveur des TCC de la troisième vague par rapport au traitement habituel (TH) (trois études, 170 participants, risque relatif (RR) 0,51 ; intervalle de confiance (IC) à 95 % de 0,27 à 0,95 ; très faible qualité). Aucune différence significative dans l’acceptabilité du traitement, sur la base des taux d’abandon, n’a été observée entre les TCC de la troisième vague et les traitements habituels (quatre études, 224 participants, RR 1,01, IC à 95 % de 0,08 à 12,30 ; très faible qualité). Les deux analyses ont montré une importante hétérogénéité statistique.

Conclusions des auteurs

Des preuves de très mauvaise qualité suggèrent que les TCC de la troisième vague semblent être plus efficaces que le traitement habituel dans le traitement de la dépression aiguë. Le très petit nombre d’études disponibles et les divers types d’interventions et de comparateurs de contrôle, ainsi que les limitations méthodologiques, ne permettent pas de tirer des conclusions en ce qui concerne leurs effets à court terme ou à plus long terme. La popularité croissante des TCC de la troisième vague dans la pratique clinique souligne l’importance qu’il y a à réaliser des études supplémentaires de ces approches dans le traitement de la dépression aiguë, à court aussi bien qu’à long terme, afin de fournir des preuves de leur efficacité aux décideurs, aux praticiens et aux usagers.

アブストラクト

鬱病に対する「第3世代(Third wave)」認知行動療法と通常治療法

背景

いわゆる認知行動療法の「第3世代」は心理療法の新たな世代を表し、精神的問題に対する治療への応用が増えつつある。しかし、急性うつ病に対する第3世代認知行動療法(CBT)の効果と受容性はまだはっきりしていない。

目的

1.急性うつ病に対するすべての第3世代CBTの効果を調査するため、通常治療のプラセボ(待機者リスト/attention placebo/psychological placebo)と比較すること。

2.急性うつ病に対する異なる第3世代CBT(ACT、 compassionate mind training、機能分析心理療法、dialectical behaviour therapy、MBCT、extended behavioural activation、メタ認知療法)の効果を調査するため、通常治療のプラセボ(待機者リスト/attention placebo/psychological placebo)と比較すること。

3.急性うつ病に対するすべての第3世代CBTの効果を調査するため、異なるタイプの対照群(通常治療、無治療、待機者リスト、attention placebo、psychological placebo)と比較すること。

検索戦略

Cochrane Depression Anxiety and Neurosis Group Trials Specialised Register (CCDANCTR, 01/01/12)、The Cochrane Library(all years), EMBASE (1974-), MEDLINE (1950-)and PsycINFO (1967-)から関連するランダム化比較試験を含むものを検索した。 また、CINAHL (2010年5月)と PSYNDEX (2010年6月)、その後追加発表されたあるいは未発表研究に対する掲載研究と関連レビューの参考文献リストも検索した。第3世代CBTに関連する検索語に制限して2013年5月にCCDANCTR検索を更新した(CCDANCTR 01/02/13)。

選択基準

成人急性うつ病に対する第3世代CBTとコントロール状態を比較したランダム化比較試験。

データ収集と分析

2名のレビュー著者が独立して研究を同定し、データを抽出し、試験の質を評価した。必要な場合には研究の著者に追加情報を問い合わせた。GRADE法を用いてエビデンスの質を評価した。

主な結果

本レビューには小規模研究(参加者224例)が含まれた。各群への割り付け過程についてはほとんど情報がなかった。 独立したアウトカム評価者を用いた研究はなく、エビデンスからは治療群に対する研究者の思い込みが示唆された。 4件の研究では多様な第3世代CBT (extended behavioural activation、ACT:acceptance and commitment therapy、 competitive memory training)とコントロールを対象とした。フォローアップ評価の実施された研究はなかった。通常治療(TAU)と比較すると、診療的反応率において第3世代CBTが有意に良好な結果を示した(研究3件、参加者 170例、リスク比 (RR)0.51、95% 信頼区間 (CI)0.27 - 0.95; 質は非常に低い)。脱落率による治療受容性は、第3世代CBTとTAUの間に何ら有意差は認められなかった(研究4件、参加者 224 例、 RR 1.01、95% CI 0.08 -12.30;質は非常に低い)。両解析とも強い統計学的異質性を示した。

著者の結論

急性うつ病治療に対する第3世代CBTは、通常治療よりも効果的であることが、非常に低い質のエビデンスにより示唆された。急性うつ病治療に対する第3世代CBTは、通常治療よりも効果的であることが、非常に低い質のエビデンスにより示唆された。臨床診療の場における第3世代CBTに対する認知度が増すにつれ、政策立案者や臨床医、サービス利用者にその有効性のエビデンスを提示するには、短期および長期に渡る第3世代CBTの研究をより多く完了させることが重要である。

訳注

《実施組織》厚生労働省「「統合医療」に係る情報発信等推進事業」(eJIM:http://www.ejim.ncgg.go.jp/)[2016.1.9]
《注意》この日本語訳は、臨床医、疫学研究者などによる翻訳のチェックを受けて公開していますが、訳語の間違いなどお気づきの点がございましたら、eJIM事務局までご連絡ください。なお、2013年6月からコクラン・ライブラリーのNew review, Updated reviewとも日単位で更新されています。eJIMでは最新版の日本語訳を掲載するよう努めておりますが、タイム・ラグが生じている場合もあります。ご利用に際しては、最新版(英語版)の内容をご確認ください。

Plain language summary

'Third wave' cognitive and behavioural therapies versus treatment as usual for depression

Major depression is a very common condition in which people experience a persistently low mood and loss of interest in pleasurable activities, accompanied by a range of symptoms including weight loss, insomnia, fatigue, loss of energy, inappropriate guilt, poor concentration and morbid thoughts of death. Psychological therapies are an important and popular alternative to antidepressants in the treatment of depression. Many different psychological therapy approaches have been developed over the past century, including cognitive-behavioural (CBT), behavioural, 'third wave' CBT, psychodynamic, humanistic and integrative therapies.

In this review, we focused on third wave CBT approaches, a group of psychological therapies that target the process of thoughts (rather than their content, as in CBT), helping people to become aware of their thoughts and to accept them in a non-judgemental way. The aim of the review was to find out whether third wave CBT was effective and acceptable to people in the acute phase of depression. The review included four studies, involving a total of 224 people. The studies examined three different forms of third wave CBT, consisting of extended behavioural activation (two studies), acceptance and commitment therapy (ACT) (one study) and another form of third wave CBT called competitive mind training (one study). Three of the studies compared third wave CBT approaches with treatment as usual control conditions. The fourth study compared ACT with a psychological placebo condition. The results suggested that third wave CBT approaches were effective on a short-term basis in treating depression. However, the quality of evidence was very low because of the small number of studies/participants included in the review, together with the diverse client groups, interventions and control conditions used and possible allegiance of researchers towards the active treatments, making it difficult to draw conclusions with any confidence. It is notable, too, that none of the studies looked at the long-term effect of third wave CBT approaches. Given the increasing popularity of third wave CBT approaches in clinical practice, further well-designed studies should be prioritised to establish whether third wave CBT approaches are helpful in treating people with acute depression.

Résumé simplifié

Comparaison des psychothérapies comportementales et cognitives de « troisième vague » aux traitements habituels de la dépression

La dépression est une pathologie très courante, qui se manifeste par une morosité persistante et une perte d’intérêt pour les activités agréables, accompagnée de divers symptômes tels que la perte de poids, l’insomnie, la fatigue, la perte d’énergie, un sentiment injustifié de culpabilité, un manque de concentration et des pensées morbides. Les thérapies psychologiques constituent une alternative importante et très répandue aux antidépresseurs pour le traitement de la dépression. De nombreuses approches psychothérapeutiques différentes ont été développés au cours du siècle passé, notamment les psychothérapies cognitivo-comportementales (TCC), les TCC de la « troisième vague », ou encore les psychothérapies psychodynamiques, humanistes ou intégratives.

Dans cette revue, nous nous sommes concentrés sur les TCC dites de troisième vague, un groupe des psychothérapies qui s’intéressent aux processus de pensée (plutôt qu’à leur contenu comme les TCC classiques) pour aider les sujets à prendre conscience de leurs pensées et à les accepter sans porter de jugement. L’objectif de cette revue était de déterminer si les TCC de la troisième vague étaient efficaces et acceptables pour les patients dépressifs en phase aiguë. La revue a inclus quatre études, impliquant un total de 224 patients. Ces études examinaient trois formes différentes formes de TCC de troisième vague : activation comportementale étendue (deux études), thérapie d’acceptation et d’engagement (ACT) (une étude) et une autre forme de TCC de la troisième vague appelée entraînement de la mémoire compétitive (une étude). Trois des études ont comparé des TCC de la troisième vague approches à un groupe témoin traité selon les méthodes habituelles. La quatrième étude comparait la méthode ACT à une situation psychologique constituant un placebo. Les résultats suggéraient que les TCC de la troisième vague étaient efficaces sur le court terme dans le traitement de la dépression. Cependant, la qualité des preuves était très faible en raison du petit nombre d’études et de participants inclus dans la revue, ainsi que de la diversité des groupes de clients, des interventions et des conditions de contrôle utilisées et des éventuelles allégeances des chercheurs envers les traitements actifs, de sorte qu’il est difficile de tirer des conclusions en toute confiance. Il est notable, en outre, qu’aucune des études n’a examiné l’effet à long terme des TCC de la troisième vague. Compte tenu la popularité croissante des TCC de la troisième vague dans la pratique clinique, la priorité devrait être donnée à la réalisation de nouvelles études visant à établir si cette approche est utile dans le traitement des patients atteints de dépression aiguë.

Notes de traduction

Traduit par: French Cochrane Centre 9th January, 2014
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�

平易な要約

鬱病に対する「第3世代(Third wave)」認知行動療法と通常治療法

大うつ病は、非常によくある精神疾患で、長引く抑うつ気分と楽しい活動に対する興味の喪失を経験し、体重減少、不眠、倦怠、気力喪失、不適切な罪悪感、集中力低下、自殺念慮などの幅広い症状を伴う。心理療法はうつ病治療の抗うつ剤投与に代わるものとして重要かつ一般的である。これまで、認知行動療法(CBT)、行動療法、「第3世代」CBT、精神力動療法、人間性心理学的療法、統合的心理療法など、多くの異なる心理療法が開発された。

このレビューでは、(CBTのように思考の内容ではなく)思考の過程を標的とし、評価を下される方法ではなく、自分の思考に気づき、受け入れられるように手助けをする心理療法のグループひとつの、第3世代CBTに注目した。急性うつ病の人に対し、第3世代CBTが効果的かつ受容性であるかを確認するためにレビューを実施した。レビューには研究4件、合計224例が含まれた。研究はextended behavioural activation(2件)、acceptance and commitment therapy (ACT)(1件)、また別の第3世代CBT であるcompetitive mind training(1件)という異なる3種の第3世代CBTを解析した。3件は第3世代CBTと通常治療のコントロールを比較した。 4件目の研究ではACTと心理学的プラセボを比較した。その結果、第3世代CBTは短期間のうつ病治療に対し効果的であることが示唆された。しかし、レビューに含まれた研究数と参加者数は少なく、利用者群、介入、コントロールの状況も多様で、積極治療群に対する研究者の心理的影響も示唆されたため、その結論は信頼性に乏しく、非常に質の低いエビデンスしか得られなかった。また第3世代CBTの長期的な効果をみた研究が存在しないことにも注意しなければならない。臨床診療の現場において第3世代CBTが一般的になりつつあることから、第3世代CBTが急性うつ病患者の治療に役立つかどうかを明確にするためには、さらに適切にデザインされた研究を優先的に実施すべきである。

訳注

《実施組織》厚生労働省「「統合医療」に係る情報発信等推進事業」(eJIM:http://www.ejim.ncgg.go.jp/)[2016.1.9]
《注意》この日本語訳は、臨床医、疫学研究者などによる翻訳のチェックを受けて公開していますが、訳語の間違いなどお気づきの点がございましたら、eJIM事務局までご連絡ください。なお、2013年6月からコクラン・ライブラリーのNew review, Updated reviewとも日単位で更新されています。eJIMでは最新版の日本語訳を掲載するよう努めておりますが、タイム・ラグが生じている場合もあります。ご利用に際しては、最新版(英語版)の内容をご確認ください。

Laički sažetak

"Treći val" kognitivnih i bihevioralnih terapija u odnosu na uobičajene terapije za depresiju

Veliki depresivni poremećaj je učestalo stanje gdje osobe doživljavaju kronično sniženo raspoloženje i gubitak interesa za aktivnosti u kojima su prije uživali, udruženo s nizom simptoma koji uključuju gubitak težine, nesanicu, umor, gubitak energije, neprimjerenu tugu, lošu koncentraciju i učestale misli o smrti. Psihološke terapije su važna i popularna druga mogućnost liječenja u odnosu na lijekove antidepresive za liječenje depresije. Tijekom prošlog stoljeća razvijeno je mnogo različitih terapijskih pristupa, uključujući kognitivno-bihevioralni (KBT), bihevioralni, "treći val" KBT-a, psihodinamski, humanistički i integrativni pristup.

U ovom Cochrane sustavnom pregledu cilj je bio ispitati djelotvornost trećeg vala KBT-a, grupe psiholoških terapija koje ciljaju na procese misli (radije nego na njihov sadržaj, kao u KBT-u), pri čemu se pomaže osobama da postanu svjesne svojih misli i da ih prihvate bez osuđivanja. Cilj ovog pregleda je bio otkriti je li treći val KBT-a učinkovit i prihvatljiv osobama u akutnim fazama depresije. Ovaj pregled literature je uključio četiri istraživanja, u kojima je sudjelovalo ukupno 224 ispitanika. Istraživanja su proučavala tri različita oblika trećeg vala KBT-a, koja su se sastojala od proširene bihevioralne aktivacije (engl. extended behavioural activation, BA) (dva istraživanja), terapije prihvaćanjem i predanosti (engl. acceptance and commitment therapy, ACT) (jedno istraživanje) i jednog oblika trećeg vala KBT-a koji se naziva kompetitivni trening uma (engl. competitive mind training) (jedno istraživanje). Tri od tih istraživanja uspoređivala su pristup trećeg vala KBT-a s uobičajenim načinom liječenja kao kontrolnim pristupom. Četvrto istraživanje je uspoređivalo ACT s psihološkim placebom. Rezultati pokazuju da je pristup trećeg vala KBT-a bio učinkovitiji u kratkom roku za liječenje depresije. Međutim, kvaliteta dokaza je bila jako niska zbog malog broja istraživanja i sudionika uključenih u pregled, zajedno s različitim grupama klijenata, intervencija i kontrolnih uvjeta koji su korišteni te moguće pristranosti istraživača prema aktivnim terapijama, što sve zajedno predstavlja otežavajuće faktore za donošenje pouzdanih zaključaka. Valja naglasiti i da niti jedna od studija nije mjerila dugoročne učinke trećeg vala KBT pristupa. Zbog sve veće popularnosti pristupa trećeg vala KBT-a u kliničkoj praksi, prioritet je provođenje novih, dobro osmišljenih istraživanja, koja bi trebala utvrditi je li pristup trećeg vala KBT terapija učinkovit u liječenju osoba s akutnom depresijom.

Bilješke prijevoda

Hrvatski Cochrane
Preveo: Ivan Buljan
Ovaj sažetak preveden je u okviru volonterskog projekta prevođenja Cochrane sažetaka. Uključite se u projekt i pomozite nam u prevođenju brojnih preostalih Cochrane sažetaka koji su još uvijek dostupni samo na engleskom jeziku. Kontakt: cochrane_croatia@mefst.hr

Summary of findings(Explanation)

Summary of findings for the main comparison. Third wave CBT versus TAU for depression
  1. aMethod of sequence generation/allocation concealment unclear. As with all psychological therapy trials, blinding of clinicians/participants was not achievable. The risk of bias was assessed as high for researcher allegiance and as unclear for therapist qualifications.
    bSubstantial statistical heterogeneity indicated. Diverse study settings and participants (use of student population vs older age population). Treatment length varied from a single session to 12 sessions over 3 months.
    cOnly two third wave CBT approaches included.
    dHigh proportion of participants prescribed antidepressants naturalistically.
    eOne study used a single-session intervention; therefore no dropouts from treatment. One study had 50% dropout rate in TAU group vs 8% in third wave CBT group.
    fSmall to very small sample sizes with wide confidence intervals.
    gModerate statistical heterogeneity indicated. Treatment length varied from a single session to 12 sessions over 3 months.
    hOne study limited to single-session intervention with college students reporting mild depression.

Third wave CBT versus TAU for depression
Patient or population: depression
Settings: primary, secondary and community care
Intervention: third wave CBT
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Control Third wave CBT
Clinical non-response at post-treatment Study population RR 0.51
(0.27 to 0.95)
170
(3 studies)
⊕⊝⊝⊝
very low a,b,c
 
800 per 1000 408 per 1000
(216 to 760)
Moderate
688 per 1000 351 per 1000
(186 to 654)
Treatment acceptability (dropout) at post-treatment Study population RR 1.01
(0.08 to 12.3)
224
(4 studies)
⊕⊝⊝⊝
very low a,b,d,e,f
 
206 per 1000 208 per 1000
(16 to 1000)
Moderate
42 per 1000 42 per 1000
(3 to 517)
Clinical non-remission at post-treatment Study population RR 0.77
(0.67 to 0.88)
140
(2 studies)
⊕⊝⊝⊝
very low a,c,d,f
 
953 per 1000 734 per 1000
(639 to 839)
Moderate
938 per 1000 722 per 1000
(628 to 825)
Depression levels at post-treatment Mean depression levels at post-treatment in the intervention groups were
1.12 standard deviations lower
(1.53 to 0.71 lower)
 211
(4 studies)
⊕⊝⊝⊝
very low a,d,f,g
SMD -1.12 (-1.53 to -0.71)

Anxiety levels at post-treatment—behavioural activation vs TAU

Beck Anxiety Inventory (BAI)

 Mean anxiety levels at post-treatment—behavioural activation vs tau in the intervention groups was
5.5 lower
(10.01 to 0.99 lower)
 30
(1 study)
⊕⊝⊝⊝
very low a,f,h
 

Social adjustment levels at post-treatment— behavioural activation vs TAU

Work and Social Ajustment Scale (WSAS)

 Mean social adjustment levels at post-treatment—behavioural activation vs tau in the intervention groups was
11.56 lower
(17.89 to 5.23 lower)
 38
(1 study)
⊕⊝⊝⊝
very low a,b,d,f
 
*The basis for the assumed risk (eg, 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 risk ratio 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

Major depression is characterised by persistent low mood and loss of interest in pleasurable activities, accompanied by a range of symptoms, including weight loss, insomnia, fatigue, loss of energy, inappropriate guilt, poor concentration and morbid thoughts of death (APA 2000). Somatic complaints are also a common feature of depression, and people with severe depression might develop psychotic symptoms (APA 2000). 

Depression is the third leading cause of disease burden worldwide and is expected to show a rising trend over the next 20 years (WHO 2004; WHO 2008). A recent European study has estimated the point prevalence of major depression and dysthymia (a mild long-term form of depression) at 3.9% and 1.1%, respectively (ESEMeD/MHEDEA 2004). As the largest source of non-fatal disease burden in the world, accounting for 12% of years lived with disability (Ustun 2004), depression is associated with marked personal, social and economic morbidity and loss of functioning and productivity and creates significant demands on service providers in terms of workload (NICE 2009). Depression is also associated with a significantly increased risk of mortality (Cuijpers 2002). The strength of this association, even when confounders such as physical impairment, health-related behaviours and socio-economic factors are taken into account, has been shown to be comparable with, or greater than, the strength of the association between smoking and mortality (Mykletun 2009).

Description of the intervention

Clinical guidelines recommend pharmacological and psychological interventions, alone or in combination, in the treatment of moderate to severe depression (NICE 2009). The prescribing of antidepressants has increased dramatically in many Western countries over the past 20 years, mainly with the advent of selective serotonin reuptake inhibitors and newer agents such as venlafaxine, and antidepressants continue to be the mainstay of treatment for depression in healthcare settings (Ellis 2004; NICE 2009).

Whilst antidepressants are of proven efficacy in acute depression (Cipriani 2005; Guaiana 2007; Arroll 2009; Cipriani 2009; Cipriani 2009a; Cipriani 2009b), adherence rates remain very low (Hunot 2007; van Geffen 2009), in part because of patients' concerns about side effects and possible dependency (Hunot 2007). Furthermore, surveys consistently demonstrate patients' preference for psychological therapies over antidepressants (Churchill 2000; Riedel-Heller 2005). Therefore, psychological therapies can provide an important alternative or adjunctive intervention for depressive disorders. 

A diverse range of psychological therapies is now available for the treatment of common mental disorders (Pilgrim 2002). Psychological therapies may be broadly categorised into four separate philosophical and theoretical schools, comprising psychoanalytic/dynamic (Freud 1949; Klein 1960; Jung 1963), behavioural (Watson 1924; Skinner 1953; Wolpe 1958), humanistic (Maslow 1943; Rogers 1951; May 1961) and cognitive approaches (Lazarus 1971; Beck 1979). Each of these four schools incorporates several differing and overlapping psychotherapeutic approaches. Some psychotherapeutic approaches, such as cognitive analytic therapy (Ryle 1990), explicitly integrate components from several theoretical schools. Other approaches, such as interpersonal therapy for depression (Klerman 1984), have been developed to address characteristics considered to be specific to the disorder of interest. 

Increasing interest in the role of cognition gave rise to a ‘cognitive revolution’ in the field of psychology in the 1970s (Mahoney 1978). The most influential approaches were rational emotive behaviour therapy (Ellis 1962), cognitive behaviour modification (Meichenbaum 1977) and cognitive therapy (Beck 1979). The latter developed as an approach to understanding and treating depression. However, both Beck and Ellis acknowledged the value of behaviour therapy (Rachman 1997), and during the 1980s and 1990s, the two approaches were merged to form cognitive-behavioural therapy (CBT).

CBT is generally regarded as a family of allied therapies (Mansell 2008) that draw on a common base of behavioural and cognitive models of psychological disorders and utilise a set of overlapping techniques (Roth 2008). In CBT, cognition is central to the treatment of psychological disorders, with emotions and behaviour thought to be mediated by cognitive processes. The fundamental aim of CBT is to identify unhelpful cognitions or ‘negative automatic thoughts' derived from long-standing negative beliefs/assumptions about the self, other people or the world. The CBT model proposes that by challenging their meaning and eliciting more realistic thoughts and assumptions, emotions and behaviour can be changed (Clark 1995). An extensive evidence base is available on the effectiveness of CBT, which is recommended as the first-line psychological therapy approach for depression (NICE 2009).

Although the evolution of CBT over the past three decades has tended to overshadow approaches that are more behavioural in nature, evidence supporting purely behavioural approaches has continued to emerge. The findings from Jacobson 1996, a component analysis trial of CBT, suggested that behavioural components alone might work just as well as CBT. These findings revitalised interest in purely behavioural treatments for depression and the development of a more fully realised behavioural intervention based on a contextual approach (Martell 2001).

Prompted by continuing debate in this area, a recent systematic review of 17 randomised controlled trials (RCTs) demonstrated equivalence between CBT and behavioural therapy in terms of depression recovery rates, symptom levels and participant dropout (Ekers 2008). Proponents of a new generation of behavioural therapies, the ‘third wave’ of CBT (Hayes 2004; Hofmann 2010), have suggested that rational challenging of thoughts (a principal feature of CBT interventions) is less important than was believed (Longmore 2007) and have sought new strategies by which change can be achieved (Segal 2002). Whilst differing perspectives on which approaches should be categorised as key third wave interventions continue to be put forth (Hofmann 2010), those frequently described by experts in the field as third wave include acceptance and commitment therapy (ACT) (Hayes 2004), compassionate mind training (CMT) (Gilbert 2005), functional analytic psychotherapy (FAP) (Kohlenberg 1991), metacognitive therapy (MCT) (Wells 2008), mindfulness-based cognitive therapy (MBCT) (Teasdale 1995), dialectical behaviour therapy (DBT) (Linehan 1993) and the expanded model of behavioural activation (BA) (Martell 2001) (see Types of interventions section for a detailed description of each type of therapy).    

How the intervention might work

Third wave CBT approaches conceptualise cognitions and cognitive thought processes as psychological or ’private' events (Hayes 2006; Hofmann 2008) and target the emotional response to the situation, focusing primarily on the function of cognitions, such as thought suppression (trying to suppress distressing thoughts) or experiential avoidance (trying to avoid any thoughts, feelings and memories that are causing distress) (Hofmann 2008). This contrasts with traditional CBT, which links thoughts, feelings and behaviours and targets the situation or trigger that generates the emotional response, encouraging cognitive appraisal of these triggers and focusing on changing the content of cognitions.

Third wave CBT approaches use strategies such as mindfulness exercises (eg, body scan, mindfulness of senses meditation), acceptance of unwanted thoughts and feelings and/or cognitive defusion (stepping back and seeing thoughts as just thoughts) to elicit change in the thinking process and reduce symptoms of depression. Whilst third wave CBT methods are more often delivered in an experiential rather than didactic manner (Hayes 2004), features of traditional behavioural and cognitive therapies, such as goal setting, exposure and skills acquisition (Hayes 2006), continue to play an important role in helping to reduce depressive symptoms.

Why it is important to do this review

Corrigan 2001 suggested that proponents of third wave CBT approaches were ‘getting ahead of the data'. However, over the past twelve years, an increasing number of third wave CBT trials have been conducted, and the findings have been summarised in several systematic reviews. For example, Hayes and colleagues conducted a narrative review across all conditions/disorders to provide empirical support for dialectical behaviour therapy (DBT) (a treatment used most commonly for borderline personality disorder), functional analytic psychotherapy (FAP) and acceptance and commitment therapy (ACT), but no meta-analyses were conducted (Hayes 2004). Another systematic review of mindfulness-based cognitive therapy (MBCT) focused on prevention of relapse or recurrence of major depression (Coelho 2007). Ost 2008 undertook a review and meta-analysis of third wave CBT approaches for any disorder compared with treatment as usual or any other intervention, and drew attention to the ‘less stringent’ research methodology used in third wave treatment RCTs. However, for each third wave approach, effect sizes were calculated across disorders, rather than by individual disorder. Other reviews of psychological therapies for depressive disorders have not attempted to differentiate between CBT and third wave CBT approaches (Churchill 2001; Cuijpers 2008).

Amongst CBT practitioners, much interest has been expressed in the application of third wave CBT approaches, and the updated National Institute for Health and Care Excellence treatment guidelines for depression (NICE 2009) have already recommended MBCT specifically for preventing depression in patients who have had three or more episodes of depression. Although these guidelines also recommend the use of behavioural activation (BA) for moderate to major depressive disorder, they acknowledge that the evidence for BA is currently less robust. Furthermore, the reviews upon which the recommendation for BA was based, in keeping with the approach of other recent systematic reviews, combined studies using purely behavioural therapy with those using an ‘extended’ behavioural activation approach (Churchill 2001; Cuijpers 2007; Cuijpers 2008; Ekers 2008; NICE 2009), the latter of which is increasingly regarded as a third wave CBT intervention because of its explicit focus on moving attention away from depressive 'ruminative' thoughts (Addis 2004).

Given the popularity of third wave CBT approaches and the growing body of evidence, a comprehensive review of the effectiveness and acceptability of third wave CBT interventions for depression is required to inform clinical practice and future clinical guideline development. This review serves as part of a programme of 12 reviews covering behavioural, cognitive-behavioural, psychodynamic, interpersonal, cognitive analytic and other integrative, humanistic and third wave cognitive and behavioural psychological therapies, all compared with treatment as usual or with one another.

Objectives

  1. To examine the effects of all third wave CBT approaches compared with treatment as usual/waiting list/attention placebo/psychological placebo control conditions for acute depression.

  2. To examine the effects of different third wave CBT approaches (ACT, compassionate mind training, functional analytic psychotherapy, dialectical behaviour therapy, MBCT, extended behavioural activation and metacognitive therapy) compared with treatment as usual/waiting list/attention placebo/psychological placebo control conditions for acute depression.

  3. To examine the effects of all third wave CBT approaches compared with different types of comparators (treatment as usual, no treatment, waiting list, attention placebo, psychological placebo) for acute depression.

Methods

Criteria for considering studies for this review

Types of studies

Randomised controlled trials (RCTs) were eligible for inclusion in this review. Trials employing a cross-over design were included in the review (whilst it is acknowledged that this design is rarely used in psychological therapy trials), but only data from the first active treatment phase were used. Cluster RCTs were also eligible for inclusion.

Quasi-randomised controlled trials, in which treatment assignment is decided through methods such as alternate days of the week, were not eligible for inclusion.

Types of participants

Participant characteristics

Studies of men and women aged ≥ 18 years were included. A Cochrane review on psychotherapy for depression in children and adolescents (< 18 years) has been undertaken separately and is soon to be published (Watanabe 2004). The increasing prevalence of memory decline (Ivnik 1992), cognitive impairment (Rait 2005) and multiple comorbid physical disorders/polypharmacy (Chen 2001) in individuals over 74 years of age may differentially influence the process and effect of psychological therapy interventions. Therefore, to ensure that older patients are appropriately represented in the review (Bayer 2000; McMurdo 2005) an upper age cut-off of < 75 years was used (when a study may have included individuals ≥ 75, we included it so long as the average age was < 75), and a previously published Cochrane review on psychotherapeutic treatments for older depressed people (Wilson 2008) is being updated concurrently by the review authors.

Setting

Studies could be conducted in primary care and community-based settings, or in secondary or specialist settings, and included referrals as well as volunteers. Studies involving inpatients were excluded. Studies that focused on specific populations— nurses, care givers, depressed participants at a specific workplace—were included if all participants met the criteria for depression.

Diagnosis

We included all studies that focused on acute phase treatment of clinically diagnosed depression.

  1. Studies adopting any standardised diagnostic criteria to define participants suffering from an acute phase unipolar depressive disorder were included. Accepted diagnostic criteria included Feighner criteria, Research Diagnostic Criteria and criteria of the Diagnostic and Statistical Manual of Mental Disorders, Third Edition (DSM-III) (APA 1980), DSM-III-Revised (R) (APA 1987), DSM-Fourth Edition (IV) (APA 1994), DSM-IV-Text Revision (TR) (APA 2000) and International Classification of Diseases, Tenth Edition (ICD-10) (WHO 1992). Earlier studies may have used ICD-Ninth Edition (9) (WHO 1978), but ICD-9 is not based on operationalised criteria, so studies using ICD-9 were excluded from this category.

  2. Mild, moderate and severe depressive disorders are all included in primary care (Mitchell 2009Rait 2009Roca 2009). To fully represent the broad spectrum of severity of depressive symptoms encountered by healthcare professionals in primary care, studies that used non-operationalised diagnostic criteria or a validated clinician or self-report depression symptom questionnaire, such as the Hamilton Rating Scale for Depression (Hamilton 1960) or the Beck Depression Inventory (Beck 1961), to identify depression caseness as based on a recognised threshold, were included. However, it was planned to examine the influence of including this category of studies in a sensitivity analysis.

Accepted strategies for classifying mild, moderate and severe depression on the basis of criteria used in the evidence syntheses underpinning the NICE 2009 guidelines for depression were used when possible.

Studies focusing on chronic depression or treatment resistant depression (ie, studies that list these conditions as inclusion criteria) were excluded from the review. Studies in which participants were receiving treatment to prevent relapse after a depressive episode (ie, where participants were not depressed at study entry) were also excluded. Treatments for chronic depression and treatment-resistant depression will be covered in separate Cochrane reviews.

Studies of people described as ‘at risk of suicide’ or with dysthymia or other affective disorders such as  panic disorder were included if participants met the criteria for depression as stated above, but otherwise were excluded. 

We did not include subgroup analyses of people with depression selected from people with mixed diagnoses because such studies would be susceptible to publication bias (the study authors reported such subgroup studies because the results were "interesting"). In other words, we included such studies only if the inclusion criteria for the entire study satisfied our eligibility criteria.

Comorbidity

Studies involving participants with comorbid physical or common mental disorders were eligible for inclusion as long as the comorbidity was not the focus of the study. In other words, we excluded such studies that focused on depression among individuals with Parkinson's disease or after acute myocardial infarction but accepted studies that may have included some participants with Parkinson's disease or with acute myocardial infarction.

Types of interventions

Experimental interventions

For the purposes of the current version of the review, the key criterion for categorising a CBT approach as third wave was that the intervention focused on modifying the function of thoughts rather than on modifying their content. Third wave CBT approaches eligible for inclusion were grouped into seven main categories, according to the theoretical principles set out by trial authors, as follows.

Acceptance and commitment therapy

In acceptance and commitment therapy (ACT) (Hayes 1999; Hayes 2004), therapists aim to transform the relationship between the experience of symptoms and difficult thoughts/feelings, so that symptoms no longer need to be avoided and become just uncomfortable transient psychological events (Harris 2006). In this way, symptom reduction becomes a by-product of treatment (Harris 2006). Clients are encouraged to develop psychological flexibility through six core principles: cognitive defusion (perceiving thoughts, images, emotions and memories as what they are, rather than what they appear to be); acceptance (allowing these to come and go without struggling with them); contact with the present moment (awareness of and receptiveness to the here and now); use of the observing self (accessing a transcendent sense of self); personal values (discovering what is most important to one's true self); and committed action (setting goals according to values and carrying them out responsibly) (Hayes 1999). In terms of committed action, ACT uses methods in line with traditional behaviour therapy, such as exposure, skills acquisition and goal setting.

Compassionate mind training

The key principles of compassionate mind training (CMT), also known as compassion-focused therapy (Gilbert 2005; Gilbert 2009), involve motivating individuals to care for their own well-being, to become sensitive to their own needs and distress and to extend warmth and understanding towards themselves (Gilbert 2009). By developing this style of thinking, individuals may promote the generation of prosocial behaviours that others are more likely to engage with and reward (Allen 2005). Within the therapeutic relationship, the client is encouraged to employ self-soothing actions whilst engaging in CBT techniques, compassionate meditation and imagery. 

Functional analytic psychotherapy

In functional analytic psychotherapy (FAP), therapists regard cognition as a form of covert behaviour (the activity of thinking, planning, believing and organising) (Kohlenberg 1991), with the relationship between cognition and behaviour seen as a sequence of two behaviours. Major FAP enhancements to CBT include the use of an expanded rationale for the causes and treatment of depression. Based on the premise that the closer in time and place a behaviour is to its consequences, the greater will be the effect of those consequences, the client-therapist relationship is used as an in vivo teaching opportunity to highlight processes occurring during therapy and link these with situations in day-to-day life (Kohlenberg 2002). 

Behavioural activation

The original behavioural activation (BA) approach manualised by Jacobson 1996 includes teaching relaxation skills, increasing pleasant events and providing social and problem-solving skills training; this is regarded as a traditional behavioural therapy model. More recently, the BA approach has been extended by Martell 2001 by building on the original behavioural models of depression (Lewinsohn 1974) and introducing a contextual approach to depression. The extended BA model suggests that just as avoidance maintains anxiety, avoidant coping patterns (withdrawal from situations and people) maintain depressed mood, and, therefore, avoidant coping is targeted as a primary problem. After functional analysis, in which a detailed assessment of how an individual maintains depressive behaviour is carried out, the individual is taught to formulate and accomplish behavioural goals and is encouraged to move attention away from prevailing negative thoughts towards direct, immediate experience (Hopko 2003). Traditional behavioural therapy strategies such as activity charts, relaxation training and frequent pleasant events are also used (Dobson 2001).

A second BA approach, behavioural activation treatment for depression (BATD) (Lejuez 2001), proposes that depression is maintained through the use of reinforcers such as increased social attention and escape from aversive tasks. After functional analysis, as described in the extended BA model above, access to reinforcements such as sympathy and escape from responsibility is weakened, and healthy behaviour is systematically activated through the use of goal setting and increased activities (Hopko 2003a).

Metacognitive therapy

Metacognitive therapy (MCT) for depression (Wells 2008; Wells 2009) is based on the premise that depression is maintained by problematic and difficult to control thinking patterns dominated by rumination and excessive self-focused attention on thoughts and feelings. Depression is maintained and intensified by activation of rumination and patterns of attention. MCT incorporates attention training (ATT) as a means of increasing awareness of thinking and regaining flexible control over it. The programmed practice of ATT serves to counteract depressive inertia through the provision of a set of daily exercises, which consist of actively listening and focusing attention in the context of simultaneous sounds presented at different loudness and spatial locations. MCT also focuses on reducing rumination and unhelpful coping behaviours, and modifies positive (eg, 'thinking about the causes of depression will help me prevent it') and negative (eg, 'there's nothing I can do about my thoughts') metacognitive beliefs about rumination. Although MCT is commonly regarded as a third wave CBT approach, Hofmann 2008 reports that Adrian Wells does not view it as such.

Mindfulness-based cognitive therapy (MBCT)

Mindfulness-based cognitive therapy (MBCT) has been designed as a manualised group-skills training programme intended to address vulnerability between episodes of recurrent major depression (Williams 2008). MBCT combines cognitive therapy principles with the practice of mindfulness meditation, in which close attention is paid to the present moment, whilst thoughts, feelings and body sensations are noted with an attitude of curiosity and non-judgement. This non-reactive stance creates the possibility of working more helpfully with sadness, fear and worry—emotions that are central to preventing depression. Segal 2002 and colleagues have suggested that the intensity of negative thinking and low concentration experienced by people with acute depression may make it difficult for these individuals to fully participate in MBCT. For these reasons, MBCT has not yet been evaluated as a treatment for acute depression. However, studies of MBCT will be included in this review if, in the future, they are used/modified for the treatment of acute depression.

Dialectical Behaviour Therapy (DBT)

DBT was originally developed as a treatment for chronically suicidal or self-injurious women with borderline personality disorder (Linehan 1993; Koons 2001). However, the coping skills that serve as an essential component of DBT can be conceptualised as skills that are useful for managing life, independent of diagnosis; recently, standard DBT has been modified for use with depressed older adults (Lynch 2000). Skills hypothesised to be particularly relevant in treating this population include acceptance of elements of life that cannot be changed (radical acceptance), increased awareness without judgement (mindfulness), attentional control (mindfulness), better tolerance of pain (distress tolerance), acting opposite to depressive urges (opposite action) and increased interpersonal effectiveness (Lynch 2003). Although DBT is commonly regarded as a third wave CBT approach, Hofmann 2008 noted that Marsha Linehan herself does not view it as a form of third wave CBT, but rather as a form of CBT that includes acceptance strategies.

Control comparators

In each study, descriptions of the control conditions were scrutinised to ensure that they did not comprise an active psychological therapy treatment. Control comparators were categorised as follows.

Treatment as usual (TAU) 

In this condition, participants could receive any appropriate medical care during the course of the study on a naturalistic basis, including pharmacotherapy and/or psychological therapy, as deemed necessary by the clinician. Standard care, usual care and no treatment conditions were also included in this category.

Waiting list (WL) 

A commonly used ‘treatment as usual’ consists of randomly assigning participants to active intervention groups or a control group and providing the active intervention to both groups, while delaying delivery of the intervention to the control group until after participants in the intervention group have completed treatment. As in TAU, participants in the WL condition could receive any appropriate medical care during the course of the study on a naturalistic basis.

Attention placebo (AP) 

This was defined as a control condition that is regarded as inactive by both researchers and participants in a trial.

Psychological placebo (PP) 

This was defined as a control condition in a trial that is regarded by researchers as inactive but is regarded by participants as active.

We planned to document additional naturalistic treatment(s) received by participants in both control and active comparisons for each included study.

Format of psychological therapies

The psychological therapy intervention was required to be delivered through face-to-face meetings between participant and therapist. Interventions in which face-to-face therapy was augmented by telephone or Internet-based support were included in the review. Psychological therapy approaches conducted on an individual or group basis were eligible for inclusion. The number of sessions was not limited, and we accepted psychological therapy interventions delivered in a single session.

Excluded interventions

The earlier model of behavioural activation (BA) developed and tested by Jacobson 1996 was defined primarily by the proscription of cognitive interventions (Dimidjian 2006), and does not include more contemporary procedures such as identifying and understanding the functional aspects of behaviour change (Martell 2001). For the purposes of this review, this earlier version of BA was classified as a comparator behavioural therapy intervention.

Counselling interventions traditionally draw from a wide range of psychological therapy models, including person-centred, psychodynamic and cognitive-behavioural approaches, applied integratively, according to the theoretical orientation of practitioners (Stiles 2008). Therefore, studies of counselling were usually included in the integrative therapies reviews. However, if the counselling intervention consisted of a single discrete psychological therapy approach, it was categorised as such, even if the intervention was referred to as 'counselling'. If the intervention was manualised, this informed our classification.

Psychological therapy models based on social constructionist principles (that focus on the ways in which individuals and groups participate in the construction of their perceived social reality), including couples therapy, family therapy, solution-focused therapy (de Shazer 1988), narrative therapy, personal construct therapy, neuro-linguistic programming and brief problem-solving (Watzlavick 1974), were excluded. These therapies work with patterns and dynamics of relating within and between family, social and cultural systems to create a socially constructed framework of ideas (O'Connell 2007), rather than focusing on an individual's reality. Previously published Cochrane reviews on couples therapy for depression (Barbato 2006) and family therapy for depression (Henken 2007) will be updated concurrently.

Studies of long-term, continuation or maintenance therapy interventions designed to prevent relapse of depression or to treat chronic depressive disorders were excluded from the review. Similarly, studies of interventions designed to prevent a future episode of depression were excluded.

Guided self-help, in which the practitioner provides brief face-to-face non-therapeutic support to participants who are using a self-help psychological therapy intervention, were excluded, as were bibliotherapy and writing therapies.

Psychological therapy that was provided wholly by telephone or over the Internet was not eligible for inclusion.

Studies of dual modality treatments, in which participants are randomly assigned to receive a third wave cognitive and behavioural psychotherapy intervention combined with pharmacological treatment in comparison with a treatment as usual control condition, were excluded from the current review and will be examined in a separate programme of reviews on combination treatments for depression.

Component or dismantling studies, in which the effectiveness of individual components of a third wave CBT approach is investigated, were not included. It was planned to extract data from these studies for inclusion in a separate overview of psychological therapies for depression, in which multiple treatments meta-analysis (MTM) will be used to compare the relative effectiveness of all psychotherapies, regardless of whether they have been directly compared in direct RCTs. If data were sufficient, we planned to use the MTM model proposed in Welton 2009 to allow conclusions to be drawn regarding which components, or combinations of components, are most effective in reducing depressive symptoms. See 'Unit of analysis issues' for further detail on MTM.

Types of outcome measures

Primary outcomes

1. Treatment efficacy: the number of participants who responded to treatment, as determined by changes in Beck Depression Inventory (BDI) (Beck 1961), Hamilton Rating Scale for Depression (HAM-D) (Hamilton 1960) or Montgomery-Asberg Depression Rating Scale (MADRS) (Montgomery 1979) scores, or in scores from any other validated depression scale. Many studies define response as 50% or greater reduction on BDI, HAM-D, etc., with some studies defining response by using Jacobson's Reliable Change Index; we accepted the study authors' original definition. If the original authors reported several outcomes corresponding with our definition of response, we gave preference to BDI as a self-rating scale and to HAM-D as an observer-rating scale.

2. Treatment acceptability: the number of participants who dropped out of psychological therapy for any reason.

Secondary outcomes

3. The number of participants who remitted while receiving treatment, based on the endpoint absolute status of participants, as measured by the Beck Depression Inventory (BDI) (Beck 1961), the Hamilton Rating Scale for Depression (HAM-D) (Hamilton 1960), the Montgomery-Asberg Depression Rating Scale (MADRS) (Montgomery 1979) or any other validated depression scale. Examples of definitions of remission include 10 or less on BDI, 7 or less on HAM-D or 10 or less on MADRS; we accepted the study authors' original definition. If the original authors reported several outcomes that corresponded with our definition of response, we gave preference to BDI as a self-rating scale and to HAM-D as an observer-rating scale.

4. Improvement in depression symptoms, based on a continuous outcome of group mean scores at the end of treatment using BDI, HAM-D, MADRS or any other validated depression scale.

5. Improvement in overall symptoms, as determined by using the Clinical Global Impressions scale (CGI) (Guy 1976).

6. Improvement in anxiety symptoms, as measured using a validated continuous scale, either assessor-rated, such as the Hamilton Anxiety Scale (HAM-A) (Hamilton 1959) or self-report, including the Trait subscale of the Spielberger State-Trait Anxiety Inventory (STAI-T) (Spielberger 1983) and the Beck Anxiety Inventory (BAI) (Beck 1988).

7. Adverse effects, such as completed suicides, attempted suicides and worsening of symptoms, when reported, were summarised in narrative form.  

8. Social adjustment and social functioning, including Global Assessment of Function (Luborsky 1962) scores, when reported, were summarised in narrative form.

9. Quality of life, as assessed with the use of validated measures such as Short Form (SF)-36 (Ware 1993), Health of the Nation Outcome Scales (HoNOS) (Wing 1994) and World Health Organization Quality of Life (WHOQOL) (WHOQL 1998), when reported, were summarised in narrative form.

10. Economic outcomes (eg, days of work absence/ability to return to work, number of appointments with primary care physician, number of referrals to secondary services, use of additional treatments), when reported, were summarised in narrative form.

Timing of outcome assessment

Post-treatment outcomes and outcomes at each reported follow-up point were summarised. When appropriate, and if the data allowed, outcomes were categorised as short term (up to 6 months post-treatment), medium term (7 to 12 months post-treatment) and long term (longer than 12 months).

Search methods for identification of studies

Electronic searches

The Cochrane, Depression, Anxiety and Neurosis Review Group's Specialised Register (CCDANCTR)

We searched two clinical trials registers created and maintained by the Cochrane Depression, Anxiety and Neurosis Group (CCDAN)—the CCDANCTR-Studies Register and the CCDANCTR-References Register—in June 2010, and updated searches were carried out in April 2011 and February 2012 (Register up to date as of 01/01/12), using an extensive list of search terms for a programme of reviews on all psychological therapies for depression. An updated search restricted to search terms relevant to third wave CBTs was conducted in March 2013 (Register up to date as of 01/02/13). 

References to trials for inclusion in the Group's registers are collated from routine (weekly) searches of MEDLINE, EMBASE and PsycINFO, quarterly searches of the Cochrane Central Register of Controlled Trials (CENTRAL) and additional ad hoc searches of other databases (PSYNDEX, LILACS, AMED, CINAHL). These searches employ generic terms for depression, anxiety and neuroses; together with sensitive (database specific) RCT filters. Details of CCDAN's generic search strategies can be found on the Group‘s website.

References to trials are also sourced from international trials registers via the World Health Organization’s trials portal (http://apps.who.int/trialsearch/); drug companies; and handsearching of key journals, conference proceedings and other (non-Cochrane) systematic reviews and meta-analyses.

CCDANCTR-Studies Register

The CCDANCTR-Studies Register contains more than 11,000 trials for the treatment or prevention of depression, anxiety and neurosis. Each trial has been coded using the EU-Psi coding manual (as a guide) and includes information on intervention, condition, comorbidities, age, treatment setting, etc.

The studies register was searched using the following search terms:
Condition = (depress* or dysthymi*) and Intervention = (*therap* or training).

CCDANCTR-References Register

The CCDANCTR-References Register contains bibliographic records of reports of trials coded in the CCDANCTR-Studies Register, together with several other uncoded references (total number of records > 31,500). This register was searched using a comprehensive list of terms for ‘psychotherapies’, as indicated in Appendix 1. Records already retrieved from the search of the CCDANCTR-Studies Register were de-duplicated.

The update search employed the following list of terms for third wave CBT therapies.
Title/Abstract/Keywords = depress* AND Free-Text = (mindfulness* or “third wave” or third-wave or (*therap* and (acceptance* or commitment*)) or experiential or (cognitive* and (restructur* or defusion)) or (behavio* and (activation or modification)) or (thought* and suppress*) or rumination).

CINAHL and PSYNDEX

In addition to CCDANCTR, we also searched CINAHL in May 2010 and PSYNDEX in June 2010 (see Appendix 2).

No restriction on date, language or publication status was applied to the searches.

Searching other resources

Reference lists

The references of all selected studies were searched for additional published reports and citations of unpublished studies. Relevant review papers were checked.

Personal communication

Subject experts were contacted to check that all relevant studies, published and unpublished, had been considered for inclusion.

Other websites

A website related specifically to mindfulness-based therapies (http://www.mindfulexperience.org/) was searched.

Data collection and analysis

Selection of studies

Two review authors (RC and VH) examined the abstracts of all publications obtained through the search strategy. Full articles of all studies identified by either of the review authors were then obtained and inspected by the same two review authors to identify trials meeting the following criteria.

  1. Randomised controlled trial.

  2. Participants had depression diagnosed by operationalised criteria.

  3. Any third wave CBT approach (ACT, compassionate mind training, functional analytic psychotherapy, extended behavioural activation model, metacognitive therapy, MBCT or DBT) compared with non-treatment, waiting list control or treatment as usual.

Conflicts of opinion regarding eligibility of a study were discussed with a third review author after the full paper had been retrieved and consultation with the study authors sought, if necessary, until consensus was reached. External subject or methodological experts were consulted as necessary.

Data extraction and management

Data from each study were extracted independently by two review authors. Any disagreement was discussed with an additional review author, and, when necessary, the authors of the studies were contacted for further information.

Information related to study population, sample size, interventions, comparators, potential biases in the conduct of the trial, outcomes including adverse events, follow-up and methods of statistical analysis was abstracted from the original reports into specially designed paper forms and then was entered onto a spreadsheet.

Waiting list controls

A commonly used ‘treatment as usual’ is to randomly assign participants to active intervention groups and control groups, and then provide the active intervention to both groups while delaying delivery of the intervention to the control group until after those in the intervention group have completed treatment. Thus both groups receive the active intervention but at different times. Sometimes trialists describe this as a ‘waiting list control’, or control participants are placed ‘on a waiting list’.

Data are collected at baseline, when groups are randomly assigned, and at the ‘end-of-treatment’, at which point participants in the active intervention group stop receiving the active intervention and participants on the waiting list start to receive the active intervention. Follow-up of participants may be provided at time points after the end of treatment. 

For studies such as th ese, we included data up to the time point at which the waiting list participants started to receive treatment. Follow-up data for these participants were not used. Inclusion of follow-up data could introduce bias, as the intervention was not provided as originally allocated at the point of randomisation, and participants might no longer be comparable. For instance, baseline risk for participants who received delayed treatment might have changed (eg, participants may be more depressed).  

Main comparisons
  1. Third wave CBT versus treatment as usual

Assessment of risk of bias in included studies

Risk of bias was assessed for each included study using The Cochrane Collaboration's 'Risk of bias' tool (Higgins 2008a). The following six domains were considered.

  1. Sequence generation: Was the allocation sequence adequately generated?

  2. Allocation concealment: Was allocation adequately concealed?

  3. Blinding of participants, personnel and outcome assessors for each main outcome or class of outcomes: Was knowledge of the allocated treatment adequately prevented during the study?

  4. Incomplete outcome data for each main outcome or class of outcomes: Were incomplete outcome data adequately addressed?

  5. Selective outcome reporting: Are reports of the study free of any suggestion of selective outcome reporting?

  6. Other sources of bias: Was the study apparently free of other problems that could put it at high risk of bias? Additional items to be included here are therapist qualifications, treatment fidelity and researcher allegiance/conflict of interest.

A description of what was reported to have happened in each study was provided, and a judgement on the risk of bias was made for each domain within and across studies, based on the following three categories.

  1. Low risk of bias.

  2. Unclear risk of bias.

  3. High risk of bias.

Two review authors independently assessed the risk of bias in selected studies. Any disagreement was discussed with a third review author. When necessary, study authors were contacted for further information. All risk of bias data were presented graphically and described in the text. Allocation concealment was used as a marker of trial quality for the purposes of undertaking sensitivity analyses.

Measures of treatment effect

Continuous outcomes

Where studies used the same outcome measure for comparison, data were pooled by calculating the mean difference (MD). When different measures were used to assess the same outcome, data were pooled with standardised mean difference (SMD) and 95% confidence intervals (95% CIs) calculated.

Dichotomous outcomes

These outcomes were analysed by calculating a pooled relative risk (RR) and 95% CIs for each comparison and were presented in this form for ease of interpretation.

Unit of analysis issues

Cluster-randomised trials

Cluster-randomised trials were to be included as long as proper adjustment for the intracluster correlation could be conducted according with theCochrane Handbook for Systematic Reviews of Interventions (Higgins 2008).

Cross-over trials

Trials employing a cross-over design were to be included in the review, but only data from the first active treatment phase were used.

Studies with multiple treatment groups

Multiple-arm studies (those with more than two intervention arms) can pose analytic problems in pair-wise meta-analysis. Had we found studies with two or more active treatment arms to be compared against treatment as usual, data were to be managed in this review as follows

Continuous data

Means, SDs and numbers of participants for all active treatment groups were to be pooled across treatment arms as a function of the number of participants in each arm to be compared against the control group (Law 2003; Higgins 2008; Higgins 2008b).

Dichotomous data

Data from relevant active intervention arms were to be collapsed into a single arm for comparison against the control group, or the control group was to be split equally between treatment groups.

Multiple treatment meta-analysis

One method that retains the individual identity of each intervention and allows multiple intervention comparisons to be made, without the need to lump or split intervention arms, is a multiple treatment meta-analysis (MTM) (Lu 2004; Caldwell 2005; Cipriani 2009b). MTM (also known as mixed treatment comparison or network meta-analysis) refers to ensembles of trial evidence in which direct and indirect evidence on relative treatment effects is pooled. The objective of an MTM is to combine all the available trial evidence into an internally consistent set of estimates while respecting the randomisation in the evidence. An MTM provides estimates of the effect of each intervention relative to every other, whether or not they have been directly compared in trials. One can also calculate the probability that each treatment is the most effective. We did not intend to use an MTM in this review, as we were unlikely to have sufficient data for the analysis. However, this review forms part of a series of 12 reviews that have contributed studies to an overview of reviews (Becker 2008; Higgins 2008b) in which MTM is being used as the main analytic strategy.

Dealing with missing data

Missing dichotomous data were managed through intention-to-treat (ITT) analysis, in which it was assumed that participants who dropped out after randomisation had a negative outcome. It was also planned to calculate best/worse case scenarios for the clinical response outcome, in which it would be assumed that dropouts in the active treatment group had positive outcomes and those in the control group had negative outcomes (best case scenario), and that dropouts in the active treatment group had negative outcomes and those in the control group had positive outcomes (worst case scenario), thus providing boundaries for the observed treatment effect. If a large amount of information was missing, these best/worst case scenarios were to be given greater emphasis in the presentation of results.

Missing continuous data were either analysed on an endpoint basis, including only participants with a final assessment, or analysed by using the last observation carried forward to the final assessment (LOCF), if LOCF data were reported by the trial authors. When standard deviations (SDs) were missing, attempts were made to obtain these data by contacting trial authors. When SDs were not available from trial authors, they were calculated from P values, t-values, confidence intervals or standard errors, if these were reported in the articles (Deeks 1997).

When a vast majority of actual SDs were available and only a minority of SDs were unavailable or unobtainable, it was planned to use a method for imputing SDs and calculating percentage responders; the method devised by Furukawa and colleagues (Furukawa 2005; Furukawa 2006; da Costa 2012) was used. If this method was employed, data would be interpreted with caution and the degree of observed heterogeneity would be taken into account. A sensitivity analysis would also be undertaken to examine the effect of the decision to use imputed data.

When additional figures were not available or obtainable and it was not deemed appropriate to use the Furukawa method described above, the study data were not included in the comparison of interest.

Assessment of heterogeneity

Statistical heterogeneity was formally tested using the Chi2 test, which provides evidence of variation in effect estimates beyond that of chance. Because the Chi2 test has low power to assess heterogeneity when a small number of participants or trials are included, the P value was conservatively set at 0.1. Heterogeneity was also quantified using the I2 statistic, which calculated the percentage of variability due to heterogeneity rather than to chance. We expected, a priori, that considerable clinical heterogeneity would be noted between studies, and so I2 values in the range of 50% to 90% were considered to represent substantial statistical heterogeneity and were to be explored further if sufficient studies were identified for inclusion. However, the importance of the observed I2 depended on the magnitude and direction of treatment effects and the strength of evidence for heterogeneity (Higgins 2003; Deeks 2008). Forest plots generated in RevMan 5 now provide an estimate of tau2, the between-study variance in a random-effects meta-analysis. To provide an indication of the spread of true intervention effects, we also used the tau2 estimate to determine an approximate range of intervention effects using the method outlined in Section 9.5.4 of the Cochrane Handbook for Systematic Reviews of Interventions (Deeks 2008). This was to be done only for the primary outcomes.

Assessment of reporting biases

As far as possible, the impact of reporting biases was minimised by undertaking comprehensive searches of multiple sources (including trial registries), increasing efforts to identify unpublished material and including non–English language publications.

We tried to identify outcome reporting bias in trials by recording all trial outcomes, planned and reported, and noting where outcomes were missing. When we found evidence of missing outcomes, we attempted to obtain any available data direct from the authors.

When sufficient numbers of trials allowed for a meaningful analysis, funnel plots were to be constructed to establish the potential influence of reporting biases and small-study effects.

Data synthesis

Given the potential heterogeneity of psychological therapy approaches for inclusion, together with the likelihood of differing secondary comorbid mental disorders in the population of interest, a random-effects model was used in all analyses.

Subgroup analysis and investigation of heterogeneity

Clinical heterogeneity
  1. Baseline depression severity: The severity of depression on entry into the trial was expected to have an impact on outcome. Heterogeneity analyses categorised baseline severity as mild, moderate or severe.

  2. Number of sessions: Differences in the numbers of therapy sessions received were likely, and this was expected to affect treatment outcomes. Numbers of sessions were categorised as 1 to 7 sessions, 8 to 12 sessions, 13 to 20 sessions and more than 20 sessions.

  3. Type of comparison: The type of comparator used was likely to influence the observed effectiveness of the intervention. When possible, comparators were categorised as waiting list, treatment as usual/usual care, attention placebo or psychological placebo.

  4. Strength of therapeutic alliance/perceived therapist empathy, based on validated measures such as the Barrett-Lennard Relationship Inventory (Barrett-Lennard 1986) or the Working Alliance Inventory (Horvath 1986): When reported, this information was summarised in narrative form.

In addition to the above analyses, when appropriate, small-study effects and potential publication bias were examined using funnel plots.

Sensitivity analysis

  • Fidelity to treatment: Studies that did not assess fidelity to the psychological therapy model(s) under evaluation through assessment of audiotapes or videotapes of therapy sessions were to be excluded.

  • Study quality: Allocation concealment was to be used as a marker of trial quality. Studies that did not use allocation concealment were to be excluded.

  • Trials in which missing data were imputed were to be excluded.

  • Trials that included the use of antidepressant treatment (naturalistic use; combination treatment used in both psychological therapy arms) were to be excluded.

  • Trials included in the review after post hoc decisions were made about their eligibility as third wave CBT approaches were to be excluded.

Summary of findings table

A summary of findings table was produced to present the main findings of the review; it includes a summary of the quality of evidence, the magnitude of effects of psychological therapy interventions examined and a summary of available data on main outcomes. Findings are expressed as measures of risk ratio and absolute risk for the main outcomes of clinical response and treatment acceptability, as well as for the secondary outcomes of remission and depression levels (Higgins 2011).

Results

Description of studies

Results of the search

We conducted full psychotherapy searches in June 2010, and updated searches were carried out in April 2011 and February 2012 (CCDANCTR to 01/01/12). After removing duplicates, we identified 6710 records that were relevant for the programme of reviews on all psychological therapies for depression. We excluded 6524 records on the basis of information provided in the titles and abstracts. We read the full text of 186 studies to assess their eligibility. A total of 122 studies were judged as eligible for inclusion in the programme of reviews (Figure 1).

Figure 1.

Study flow diagram.

Of those 122 studies, seven studies had third wave CBT arms. Three of these studies were not eligible for inclusion in the current review because they compared third wave CBT approaches with other psychological therapy approaches (Zettle 1984; Zettle 1989; Dimidjian 2004). These studies were assigned to a separate review on third wave CBT therapies versus other psychological therapies for depression (Hunot 2012). The remaining four studies were included in the current review (Pellowe 2006; Gawrysiak 2009; Ekers 2011; Ekkers 2011).

In March 2013 we updated the searches while restricting them to terms relevant to third wave CBTs (CCDANCTR to 01/02/2013). A total of 151 new references were identified. On the basis of the information provided in abstracts, 142 references were found not to be eligible. Three references reported on protocols for ongoing studies that appear to meet the criteria for the third wave CBT reviews (see Ongoing studies section). We read the full text of six studies to assess their eligibility for either of the two third wave CBT reviews in this series. All of the studies compared a third wave CBT with a non-active control condition. Two studies were assessed as potentially eligible for this review and are awaiting classification.

See Figure 1 for PRISMA flowchart diagram.

Included studies

Study design

The four studies all used a parallel design. Two of the studies were single centre (Pellowe 2006; Gawrysiak 2009), and two were multi-centre (Ekers 2011; Ekkers 2011).

Sample size

The overall sample size in each of the four studies ranged from 30 participants (Gawrysiak 2009) to 93 participants (Ekkers 2011).

Setting

Two studies were conducted in a non-medical university setting (Pellowe 2006; Gawrysiak 2009), one was conducted in primary care (Ekers 2011) and one was conducted in an outpatient psychiatric institute (Ekkers 2011).

Two studies were conducted in the USA (Pellowe 2006; Gawrysiak 2009), one was conducted in the Netherlands (Ekkers 2011) and one in the UK (Ekers 2011).

Participants
Gender

The proportion of female participants in the studies ranged from to 62% (Ekers 2011) to 80% (Gawrysiak 2009).

Age

Two studies included young adults based at a university (Pellowe 2006; Gawrysiak 2009), one study included adults over the age of 18 (Ekers 2011) and one study involved adults of 65 years or older, with a mean age of 72.7 years (Ekkers 2011).

Diagnosis

One study used a computerised version of the revised Clinical Interview Schedule (CIS-R) to make an assessment of depression according to ICD-10 criteria (Ekers 2011). One study used a clinically established diagnosis of major depressive disorder (MDD), which was agreed for each potential participant through discussion at team meetings (Ekkers 2011). Both of the other studies used a BDI-II score of 14 or higher (Gawrysiak 2009) or a BDI-II score of 10-29 (Pellowe 2006) to identify people with depression.

The baseline severity of depression was reported in each of the four studies, using the Geriatric Depression Scale (Ekkers 2011) and the BDI-II (Pellowe 2006; Gawrysiak 2009; Ekers 2011).

Intervention

As described previously in the Methods section, it was planned to group third wave CBT approaches into seven categories. Three categories of third wave CBT were examined in the four included studies. Two studies examined forms of extended behavioural activation (Gawrysiak 2009; Ekers 2011), one study examined acceptance and commitment therapy (ACT) (Pellowe 2006) and one study (Ekkers 2011) examined competitive memory training (COMET), a third wave approach targeting rumination and classified for the purposes of this review as 'other'. All of the studies used manuals to guide the intervention.

In two studies, participants received individual therapy (Gawrysiak 2009; Ekers 2011), and in two studies, therapy was provided in a group format of 6 to 8 participants (Ekkers 2011) and in a group format of 2 to 10 participants (Pellowe 2006).

The number of sessions ranged from one 90-minute session (Gawrysiak 2009) to 12 sessions over a 3-month period (Ekers 2011). None of the studies conducted follow-up assessments.

The therapists were mental health nurses (Ekers 2011), registered CBT therapists (Ekkers 2011), doctoral students (Gawrysiak 2009) and advanced clinical psychology graduate students (Pellowe 2006).

Comparisons

Two studies compared a third wave CBT intervention against usual care/treatment as usual, in which participants were followed up by their general practitioner (GP) or primary care mental health worker and were offered interventions deemed appropriate for their condition as per normal practice (Ekers 2011), or in which participants received pharmacotherapy, with or without psychotherapy, or a supportive and structured treatment conducted by specialist nurses (Ekkers 2011). One study used a no treatment condition (Gawrysiak 2009), and one study used a psychological placebo 'supportive therapy' condition, in which therapists facilitated an unstructured group discussion (Pellowe 2006).

Only one study, a single-session intervention, did not allow naturalistic prescribing of antidepressants (Gawrysiak 2009). In the other three studies, the number of participants prescribed antidepressants on a naturalistic basis ranged from 8% (Pellowe 2006) to 79% of the sample (Ekkers 2011).

Outcomes
Primary outcomes

Three of the studies provided clinical response figures at post-treatment. All three studies (Gawrysiak 2009; Ekers 2011; Ekkers 2011) used the Jacobson and Truax procedure to calculate reliable change. Ekers 2011 used two additional measures of response (improvement of at least 50%) and remission (score of 10 or less on the BDI-II).

Dropout rates were reported by all four studies. The intervention by Gawrysiak 2009 was a single session with no dropouts.

Secondary outcomes

Three studies used the BDI-II to measure continuous change in depression scores (Pellowe 2006; Gawrysiak 2009; Ekers 2011). Ekkers 2011 used the Quick Inventory of Depression Symptoms Self Report (QIDS-SR) and the Geriatric Depression Scale (GDS).

Other secondary outcome measures used in the four studies were the Work and Social Adjustment Scale (Ekers 2011), the Client Satisfaction Questionnaire (Pellowe 2006; Ekers 2011), the Ruminative Response Scale (Ekkers 2011), the Beck Anxiety Inventory and Multidimensional Scale of Perceived Social Support (Gawrysiak 2009) and the Acceptance and Action Questionnaire and Dysfunctional Attitude Scale (Pellowe 2006).

Excluded studies

A total of 64 studies were excluded from the whole Meta-Analysis of Psychotherapies (MAP) programme of reviews, based on the searches conducted in June 2010, along with updated searches in April 2011 and February 2012. Five of those studies included a third wave CBT arm, four of which compared third wave CBT against a treatment as usual or non-active control condition (Hopko 2003a; Bohlmeijer 2011; Reynolds 2011; Snarski 2011). These four studies were excluded because they used an inpatient population (Hopko 2003a), included people with mild to moderate cognitive impairment (Snarski 2011) or included non-depressed participants (Bohlmeijer 2011; Reynolds 2011).

In addition, three studies (Zettle 1984; Zettle 1989; Dimidjian 2004) were not included in the current review because they compared third wave CBT with another psychological therapy approach. These three studies are included in the HIRED companion third wave CBT review (Hunot 2012).

In the updated search conducted in March 2013 (CCDANCTR to 01/02/2013), four additional studies were excluded because the diagnoses did not fully meet the inclusion criteria of the review programme. The samples in each study consisted of subclinical depression (Kaviani 2012), partial remission (Korrelboom 2012), mixed population (Pinniger 2012) and chronic depression (Folke 2012).

Studies awaiting classification

Two studies are awaiting classification. The study by Azargoon 2010, written in Farsi, compares mindfulness-based therapy with a control group and is awaiting translation. The study by Armento 2012 compares single-session extended behavioural activation focused on religious behaviours with a non-active 'supportive therapy' control.

Ongoing studies

Of three ongoing studies that meet the inclusion criteria for the third wave CBT reviews, one compares a third wave CBT approach with a non-active treatment control. This study compares the effect of dialectical behaviour therapy with a waiting list control in a sample of participants with major depressive disorder and suicidal ideation (NCT01441258).

Risk of bias in included studies

Allocation

No information was provided on sequence generation across the four studies. Two of the studies conducted the allocation concealment process independent of the research team (Ekers 2011). The other two studies did not report on the methods used for allocating participants to groups.

Blinding

As it is not possible to blind participants and therapists in psychological therapy trials, the studies were all at high risk of performance bias. Each of the four studies used self-report outcome measures; therefore the risk of detection bias was assessed as high.

Incomplete outcome data

Gawrysiak 2009 examined a single-session intervention with a 0% dropout. Pellowe 2006 reported a very low dropout rate and provided reasons for dropout. These two studies were assessed as being at low risk of attrition bias. The other two studies had differential dropout rates between experimental and control conditions. One study reported a dropout rate of 50% in the TAU arm (Ekkers 2011), and neither study provided reasons for dropout; therefore both were assessed as being at high risk of attrition bias.

Selective reporting

None of the studies had published a trial protocol; therefore reporting bias across the four studies was assessed as unclear.

Other potential sources of bias

Therapist qualifications

Studies were classified as having low risk of bias only when the therapists were qualified and had received specific training in the relevant psychological therapy approach. These studies either did not meet the criteria in full or failed to describe therapist qualifications/training in sufficient detail to allow an assessment. Therefore, the risk of bias across the four studies was assessed as unclear.

Treatment fidelity

Studies were classified as being at low risk of bias when the therapy session was monitored through audiotapes or videotapes and monitoring was performed against a manual or with the use of a scale. Two of the studies included in the review monitored therapy sessions using audiotapes/independent raters together with a rating scale to assess fidelity (Pellowe 2006; Ekers 2011); they were assessed as being at low risk of bias. One study stated that a sample of sessions was observed by an independent rater but gave no further information (Ekkers 2011). The fourth study required therapists to check off a list of therapy components as they conducted the session; no independent checks were carried out (Gawrysiak 2009), and the study was deemed to be at high risk of bias.

Researcher allegiance/conflict of interest

In three of the four studies, the person responsible for manualising the experimental condition was a member of the research team (Gawrysiak 2009; Ekers 2011; Ekkers 2011). In the study by Pellowe 2006, the supportive therapy condition was designed 'as an attention control group rather than an active treatment such as CBT', thereby implying an allegiance towards the experimental condition. The overall risk of bias across the four studies was assessed as high.

Therapist allegiance/conflict of interest

In the study by Pellowe 2006, the researcher was also the primary therapist, and potential bias towards the active ACT treatment was indicated (see researcher allegiance section above). In the study by Ekers 2011, the therapists had not received primary psychotherapy training and therefore were deemed not to have allegiance to the experimental condition. The other two studies gave insufficient information to permit a decision to be made.

Other potential sources of bias

Insufficient information was provided across the four studies to allow identification of other consistent sources of bias.

See Figure 2 for graphical representation of 'Risk of bias' items. Further information on the individual studies is provided in Characteristics of included studies.

Figure 2.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Effects of interventions

See: Summary of findings for the main comparison Third wave CBT versus TAU for depression

Comparison 1. All third wave CBT approaches versus all treatment as usual control conditions

Primary outcomes
1.1 Treatment efficacy: response

Three studies provided data for clinical response rates at post-treatment (Gawrysiak 2009; Ekers 2011; Ekkers 2011), based on the Jacobson and Truax reliable change index.

A significant difference in clinical response rates favoured third wave CBT compared with TAU conditions (3 studies, 170 participants, RR 0.51, 95% CI 0.27 to 0.95). Substantial statistical heterogeneity was indicated (I2 = 63%; see Analysis 1.1).

The quality of evidence for this outcome measure was very low (see Summary of findings for the main comparison).

1.2 Treatment acceptability: dropouts for any reason

Dropout rates were obtained for all four studies (224 participants) at post-treatment. No significant difference in treatment acceptability based on dropout rates was found between third wave CBT approaches and TAU conditions (RR 1.01, 95% CI 0.08 to 12.30). Substantial statistical heterogeneity was indicated (I2 = 86%; see Analysis 1.2).

The quality of evidence for this outcome measure was very low (see Summary of findings for the main comparison).

Secondary outcomes
1.3 Remission

Two studies provided remission rates at post-treatment (Ekers 2011; Ekkers 2011). A significant difference in clinical response rates favoured third wave CBT compared with TAU (140 participants, RR 0.77, 95% CI 0.67 to 0.88; see Analysis 1.3).

The quality of evidence for this outcome measure was very low (see Summary of findings for the main comparison).

1.4 Severity of depression symptoms

All four studies provided means and SDs for depression levels based on the BDI-II (Pellowe 2006; Gawrysiak 2009; Ekers 2011) or the QIDS-SR (Ekkers 2011) at post-treatment. A significant difference in depression levels favoured third wave CBT compared with TAU conditions (211 participants, SMD -1.12, 95% CI -1.53 to -0.71) based on completers' data (Ekers 2011), full dataset (Gawrysiak 2009) and LOCF data (Pellowe 2006; Ekkers 2011). Moderate statistical heterogeneity was indicated (I2 = 44%; see Analysis 1.4).

The quality of evidence for this outcome measure was very low (see Summary of findings for the main comparison).

1.5 Improvement in overall symptoms

None of the studies reported on this outcome.

1.6 Anxiety symptoms

One study reported on this outcome at post-treatment using the Beck Anxiety Inventory (BAI) (Gawrysiak 2009). A significant difference in anxiety levels favoured third wave CBT when compared with TAU conditions (30 participants, MD -5.50, 95% CI -10.01 to -0.99).

The quality of evidence for this outcome measure was very low (see Summary of findings for the main comparison).

1.7 Adverse effects

None of the studies reported on this outcome.

1.8 Social adjustment

One study reported on this outcome at post-treatment using the Work and Social Adjustment Scale (WSAS) (Ekers 2011). A significant difference in social adjustment levels favoured third wave CBT compared with TAU conditions (38 participants, MD -11.56, 95% CI -17.89 to -5.23).

The quality of evidence for this outcome measure was very low (see Summary of findings for the main comparison).

1.9 Quality of life

None of the studies reported on this outcome.

1.10 Economic outcomes

None of the studies reported on this outcome.

Comparison 2. Individual third wave CBT approaches versus all treatment as usual control conditions

2.1 Extended BA versus TAU

Two studies compared extended BA with TAU conditions at post-treatment (Gawrysiak 2009; Ekers 2011).

Primary outcomes
2.1.1 Treatment efficacy: response

No significant difference in clinical response was found between extended BA and TAU conditions (2 studies, 77 participants, RR 0.29, 95% CI 0.05 to 1.56; see Analysis 1.1).

2.1.2 Treatment acceptability: dropouts for any reason

No significant difference in treatment acceptability based on dropout rates was found between extended BA and TAU (2 studies, 77 participants, RR 3.65, 95% CI 0.85 to 15.78; see Analysis 1.2).

2.2 ACT versus TAU

One study compared ACT with TAU conditions at post-treatment (Pellowe 2006).

Primary outcomes
2.2.1 Treatment efficacy: response

No data were available for this outcome.

2.2.2 Treatment acceptability: dropouts for any reason

No significant different in treatment acceptability based on dropout rates was found at post-treatment between ACT and TAU (54 participants, RR 3.00, 95% CI 0.13 to 70.53).

2.3 Other third wave CBT approaches versus TAU

One study compared competitive memory training (COMET) with TAU at post-treatment (Ekkers 2011).

Primary outcomes
2.3.1 Treatment efficacy: response

A significant difference in clinical response rates favoured COMET compared with TAU (93 participants, RR 0.65, 95% CI 0.52 to 0.83).

2.3.2 Treatment acceptability: dropouts for any reason

A significant difference in treatment acceptability based on dropout rates favoured COMET compared with TAU (93 participants, RR 0.15, 95% CI 0.06 to 0.41).

Test for subgroup differences
Treatment efficacy: response

The test for subgroup differences between extended BA, ACT and COMET showed no significant difference between the two approaches when compared with TAU (Chi2 = 0.88, df = 1, P = 0.35).

Treatment acceptability: dropouts for any reason

The test for subgroup differences between extended BA, ACT and COMET showed a significant difference between the three approaches when compared with TAU (Chi2 = 13.90, df = 2, P = 0.001).

Compariosn 3. All third-wave CBT approaches versus individual control conditions

3.1 All third wave CBT approaches versus TAU/usual care/no treatment

Three studies compared third wave CBT approaches against TAU/usual care/no treatment at post-treatment (Gawrysiak 2009; Ekers 2011; Ekkers 2011).

3.1.1 Treatment efficacy: response

A significant difference in clinical response rates favoured third wave CBT compared with TAU/usual care/no treatment (3 studies, 170 participants, RR 0.51, 95% CI 0.27 to 0.95). Substantial statistical heterogeneity was indicated (I2 = 63%; see Analysis 1.1).

3.1.2 Treatment acceptability: dropouts for any reason

No significant difference in treatment acceptability based on dropout rates was found between third wave CBT and TAU/usual care/no treatment (3 studies, 170 participants, RR 0.71, 95% CI 0.03 to 16.07). Substantial statistical heterogeneity was indicated (I2 = 92%; see Analysis 2.2).

3.2 All third wave CBT approaches versus psychological placebo

One study compared third wave CBT with psychological placebo at post-treatment (Pellowe 2006).

3.2.1 Treatment efficacy: response

The study by Pellowe 2006 did not report on this outcome.

3.2.2 Treatment acceptability: dropouts for any reason

No significant difference in treatment acceptability based on dropout rates was found between third wave CBT and psychological placebo (54 participants, RR 3.00, 95% CI 0.13 to 70.53).

Test for subgroup differences
Treatment efficacy: response

Only one subgroup was included in this outcome; therefore a test for subgroup differences could not be conducted.

Treatment acceptability: dropouts for any reason

The test for subgroup differences between TAU/usual care/no treatment and psychological placebo showed no significant difference between the two control conditions compared with third wave CBT.

Subgroup and sensitivity analyses

It was not possible to conduct subgroup or sensitivity analyses because of the small number of studies included in the review.

Summary of findings tables

The results of our analyses expressed in relative and absolute terms, together with ratings of the quality of evidence, are given in Summary of findings for the main comparison.

Reporting bias

It was not possible to analyse reporting bias because of the small number of studies included in the review.

Discussion

Summary of main results

This review aimed to assess the efficacy and acceptability of third wave CBT based on three planned comparisons: all third wave CBT approaches compared with all treatment as usual control conditions, individual third wave CBT approaches compared with all TAU control conditions, and all third wave CBT approaches compared with individual TAU control conditions (TAU/usual care/no treatment, waiting list, attention placebo and psychological placebo).

Four small studies (224 participants) were included in the review. Little information was provided about the process of allocating participants to groups, and no studies used independent outcome assessors. Evidence suggested researcher allegiance towards the active treatments. Results showed evidence of a difference in favour of third wave CBT compared with TAU for efficacy at post-treatment (RR of clinical response 0.51, 95% CI 0.27 to 0.95) based on 3 studies involving a total of 170 participants. No evidence indicated a difference between third wave CBT and TAU control conditions for acceptability at post-treatment based on all 4 studies, involving 224 participants (RR 1.01, 95% CI 0.08 to 12.30). Substantial statistical heterogeneity was indicated in both primary analyses. Analysis of secondary outcomes revealed an effect in favour of third wave CBT approaches compared with TAU conditions for remission (2 studies, 140 participants, RR 0.77, 95% CI 0.67 to 0.88) and for depression levels (4 studies, 211 participants, SMD -1.12, 95% CI -1.53 to -0.71) at post-treatment. None of the studies conducted follow-up assessments.

Overall completeness and applicability of evidence

Although every possible effort was made to identify relevant trials, the number of studies currently included in this review is very small. Given the increasing interest in and application of third wave CBT approaches over the past ten years, the possibility that some studies have been missed, either unpublished or in grey literature, cannot be discounted.

When recruiting participants, none of the studies used diagnostic inclusion criteria in a standardised clinical interview to identify potential participants with depression. Whilst it is unclear to what extent many of the participants included in the review met full DSM criteria for major depressive disorder, it could be argued that recruitment of participants based on depression rating scales would be representative of those presenting with depression symptoms in primary care. Nevertheless, it is acknowledged the two trials that used depression rating scales both recruited psychology student samples, and as such could be considered as analogue studies.

Most mindfulness-based third wave CBT therapies, including FAP, CMT, MBCT, DBT and metacognitive therapy, were not represented at all in the current version of the review. The lack of MBCT studies to date is likely to be explained by the use of this approach as a relapse prevention intervention for people in remission, hence it is beyond the scope of this review. Similarly, the lack of DBT and metacognitive therapy studies may be due to their predominant use in populations with mental health disorders other than depression. A recent search of clinicaltrials.gov conducted by our review team, using the search term 'mindfulness', retrieved more than 300 registered ongoing trials; however, very few of these trials appear to target populations with acute depression.

None of the studies included all of the primary and secondary outcomes of interest in this review, and in particular, none reported on quality of life, adverse effects or economic outcomes. Furthermore, whilst Beck 2012 comments that an essential feature of the efficacy of a psychological therapy approach is its durability over an extended time, no follow-up assessments were conducted in the four studies included in the review; therefore evidence for the sustained effect of third wave CBT is currently not available.

Quality of the evidence

The quality of evidence for each of our main outcomes was very low (see Summary of findings for the main comparison). The most common reasons for downgrading across all outcomes were imprecision, indirectness of evidence, inconsistency and risk of bias. All analyses included no more than four studies, three of which had small sample sizes, resulting in wide confidence intervals and lack of statistical power to asses the effects of third wave CBT approaches. The psychological therapies examined in the four studies were limited to three third wave CBT approaches, thus offering a restricted version of the main review question in terms of intervention. Moderate to substantial statistical heterogeneity was observed in all analyses and remained unexplained because of the small number of studies included in the review.

Each of the four studies included in this review described its assignment procedure as 'randomised'; however, none of the studies provided a full account of the sequence generation and allocation concealment methods used. The complete lack of information on these procedures as followed in two studies introduces considerable uncertainty as to whether bias may have been introduced during the allocation process, leading to the decision to assess these risk of bias domains as unclear across studies.

Testing of therapists' fidelity to treatment manuals through systematic or random checking of videotapes/audiotapes against standardised checklists by independent clinicians is a key methodological requirement of psychological therapy studies to provide certainty that any observed treatment effect can be attributed to specific components and characteristics of the model. Two studies were thorough in their consideration of fidelity and applied appropriate criteria (Pellowe 2006; Ekers 2011). The study by Ekkers 2011 used several appropriate methods in measuring fidelity but lacked information on the method used in observing sessions and on how many sessions were assessed. The study by Gawrysiak 2009 relied upon the therapists' own assessment of their treatment fidelity performed by ticking boxes on a form—a method that exposed the study to performance bias. Overall, the extent to which bias was minimised in the delivery of therapy approaches across studies was assessed as unclear.

Another common source of bias in psychological therapy trials involves researcher allegiance, whereby trialists responsible for developing the manuals/protocols under evaluation might be considered to have a vested interest in their superior efficacy over other approaches. Each of the studies included in the review were exposed to this form of bias, as authors were involved in development of the therapy (Ekkers 2011), had developed a variation of an already established treatment (Gawrysiak 2009; Ekers 2011) or expressly favoured the active therapy against a psychological placebo approach (Pellowe 2006). Overall, therefore, the potential for researcher allegiance towards the third wave CBT approaches under evaluation is considered high across the four studies.

Therapist qualifications and experience are regarded as a further potential source of bias in psychological therapy studies, as the risk of unqualified or inadequately trained therapists delivering the intervention without appropriate skill and accuracy is considered high. The therapists used in the four included studies consisted of a diverse group of clinicians in terms of background qualifications, and information provided on their level of experience was inadequate; hence an overall assessment of unclear risk of bias was made.

It is clear that the four studies included in the review were diverse in terms of participant age (ranging from a student to an older population), level of depression severity at baseline, type and duration of third wave CBT under examination and the control comparators used. Therefore, it is not surprising that substantial statistical heterogeneity was observed when the study data were combined. It was not possible to determine causes of heterogeneity among the results because of the small number of studies identified for inclusion. Nevertheless, it was considered worthwhile to combine the data in this first version of the review on the basis that a random-effects meta-analysis was used, with due caution recommended in interpreting the results.

Potential biases in the review process

Whilst two of the review authors specialise in CBT (TAF is a diplomate of the Academy of Cognitive Therapy, and VH provides CBT in independent practice), no therapists specialising in other psychological therapy approaches were included in the review team; therefore the possibility of a bias towards CBT cannot be excluded.

Whilst developing the third wave cognitive and behavioural therapies review, we have aimed to be transparent about our management of the third wave therapy classification. We have held regular team meetings to ensure 100% consensus regarding the categorisation of approaches, and when uncertainties continued because of lack of information provided in the articles, we have made contact with the authors to request a fuller description. We acknowledge that considerable debate is likely regarding which CBT approaches should be regarded as 'third wave' in theoretical principle. In the current version of the review, we classified competitive memory training, a newly developed third wave approach, within the 'Other' category to ensure that we adhered fully to our a priori classifications. In future versions of the review, it may be necessary to reconsider our management of the categories based on further development of psychological therapy models and approaches. It is possible too that as the evidence base grows, scope will be increased to allow management of the approaches in separate reviews.

Perhaps the most contentious decision in this review was to categorise the extended version of BA as a third wave CBT approach. We note that this decision contrasted with the approach of previous reviews, in which extended BA was regarded as a form of BT. Whilst acknowledging the common components, we decided that the addition of behavioural strategies for targeting rumination, including 'an emphasis on the function of ruminative thinking and on moving attention away from the content of ruminative thoughts towards direct, immediate experience' (Dimidjian 2004) in extended BA set it apart from earlier BA approaches and placed it more in line with third wave approaches.

One study included in the current review (Pellowe 2006) used a control comparator described as a 'supportive therapy'. Initially this study was allocated to the third wave CBT versus other psychological therapies review as an active humanistic therapy. However after careful discussion by the review team, it was decided that when supportive therapy interventions were regarded as an active treatment by participants but as a control treatment by study investigators, they would be re-categorised as a 'psychological placebo' for inclusion in the TAU reviews of the MAP programme. Hence, Pellowe 2006 was included in the current review. In future versions of the review, the inclusion of psychological placebo conditions will be examined as a potential source of heterogeneity.

Agreements and disagreements with other studies or reviews

Two previous systematic reviews of third wave CBT approaches have limited their remit to participants in remission from depression who have attended an MBCT course (Coelho 2007) or have not conducted meta-analyses (Hayes 2004).

The systematic review and meta-analysis by Ost 2008 included 29 studies that examined five different third wave behavioural therapies (ACT, DBT and FAP, as covered in the current review, together with the cognitive-behavioural analysis sytem of psychotherapy and integrative behavioural couples therapy) against control conditions and active treatments for a wide range of disorders, including borderline personality disorder, eating disorders, epilepsy and smoking, as well as depression. Effect sizes were calculated for ACT and for DBT compared with waiting list and treatment as usual in a set of separate meta-analyses across all disorders (Ost 2008), thus precluding the possibility of making any meaningful comparisons with the current review.

Two systematic reviews have examined the efficacy of behavioural activation treatments (Cuijpers 2008; Ekers 2008), but neither attempted to differentiate between the extended BA model developed by Martell 2001 and the 'pure' BT approach originally evaluated in the seminal trial by Jacobson 1996; therefore these findings are not comparable with those of the current review.

A recently published systematic review and network analysis examined the efficacy of seven psychological therapies for individuals with depression (Barth 2013); however, third wave CBT interventions were not managed in a separate category, therefore no comparable findings were reported. It is notable, too, that the authors included Internet-delivered therapies and those delivered face to face, together with studies of participants whose primary disorder was a medical condition, resulting in a more heterogeneous set of populations and interventions than those included in the current review.

Authors' conclusions

Implications for practice

Mindfulness-based third wave cognitive and behavioural approaches are becoming an increasingly common feature of clinical practice, as treatments and as relapse prevention interventions, for a wide range of common mental disorders. However, whilst the findings from this review appear to suggest that third wave CBT approaches are more effective than TAU conditions in treating the acute symptoms of depression, the very low quality of the evidence base limits the ability to draw conclusions on their efficacy, either as individual approaches or as a collective approach.

Implications for research

Given the popularity of third wave CBT approaches in clinical practice, this review draws attention to the need for further studies of third wave CBT approaches to fully assess their efficacy, effectiveness and acceptability as treatment for people with acute depression. It is notable that a recently published study indicates that those with residual symptoms may also benefit, irrespective of the number of previous depression episodes (Geschwind 2012), and highlights the importance of conducting trials involving participants with acute depression symptoms. The findings from an ongoing trial of dialectical behaviour therapy compared with waiting list in a population with depression and suicidal ideation (NCT01441258) will be assessed for eligibility in a future update of the review.

In addition to ensuring the use of standard methodological features such as allocation concealment and blinding of outcome assessors, future studies of third wave CBT approaches should pay close attention to key quality indicators for psychological therapy trials, including treatment fidelity, therapist qualifications/experience and researcher/therapist allegiance.

Measurement of under-investigated outcomes such as acceptability (using validated scales), adverse effects, quality of life and cost-effectiveness should be prioritised. It is also important that future studies should include longer-term follow-up to establish to what extent third wave CBT approaches have durability in the treatment of depression.

Acknowledgements

Our grateful thanks to Professor Willem Kuyken, University of Exeter, for his guidance on the assessment/categorisation of psychological therapy manuals and protocols.

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 review 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. Third wave CBT versus TAU
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Clinical response at post-treatment3170Risk Ratio (M-H, Random, 95% CI)0.51 [0.27, 0.95]
1.1 Behavioural activation vs TAU277Risk Ratio (M-H, Random, 95% CI)0.29 [0.05, 1.56]
1.2 Others (COMET) vs TAU193Risk Ratio (M-H, Random, 95% CI)0.65 [0.52, 0.83]
2 Treatment acceptability (dropout) at post-treatment4224Risk Ratio (M-H, Random, 95% CI)1.01 [0.08, 12.30]
2.1 Behavioural activation vs TAU277Risk Ratio (M-H, Random, 95% CI)3.65 [0.85, 15.78]
2.2 ACT vs TAU154Risk Ratio (M-H, Random, 95% CI)3.0 [0.13, 70.53]
2.3 Others (COMET) vs TAU193Risk Ratio (M-H, Random, 95% CI)0.15 [0.06, 0.41]
3 Clinical remission at post-treatment2140Risk Ratio (M-H, Random, 95% CI)0.77 [0.67, 0.88]
3.1 Behavioural activation vs TAU147Risk Ratio (M-H, Random, 95% CI)0.70 [0.48, 1.00]
3.2 Others (COMET) vs TAU193Risk Ratio (M-H, Random, 95% CI)0.78 [0.67, 0.90]
4 Depression levels at post-treatment4211Std. Mean Difference (IV, Random, 95% CI)-1.12 [-1.53, -0.71]
4.1 Behavioural activation vs TAU268Std. Mean Difference (IV, Random, 95% CI)-1.36 [-1.90, -0.82]
4.2 ACT vs TAU152Std. Mean Difference (IV, Random, 95% CI)-0.60 [-1.16, -0.04]
4.3 Others (COMET) vs TAU191Std. Mean Difference (IV, Random, 95% CI)-1.27 [-1.73, -0.82]
5 Anxiety levels at post-treatment1 Mean Difference (IV, Random, 95% CI)Totals not selected
5.1 Behavioural activation vs TAU1 Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]
6 Social adjustment levels at post-treatment1 Mean Difference (IV, Random, 95% CI)Totals not selected
6.1 Behavioural activation vs TAU1 Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]
Analysis 1.1.

Comparison 1 Third wave CBT versus TAU, Outcome 1 Clinical response at post-treatment.

Analysis 1.2.

Comparison 1 Third wave CBT versus TAU, Outcome 2 Treatment acceptability (dropout) at post-treatment.

Analysis 1.3.

Comparison 1 Third wave CBT versus TAU, Outcome 3 Clinical remission at post-treatment.

Analysis 1.4.

Comparison 1 Third wave CBT versus TAU, Outcome 4 Depression levels at post-treatment.

Analysis 1.5.

Comparison 1 Third wave CBT versus TAU, Outcome 5 Anxiety levels at post-treatment.

Analysis 1.6.

Comparison 1 Third wave CBT versus TAU, Outcome 6 Social adjustment levels at post-treatment.

Comparison 2. Third wave CBT vs types of control condition
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Clinical response at post-treatment3 Risk Ratio (M-H, Random, 95% CI)Subtotals only
1.1 Third wave CBT vs TAU/usual care/no treatment3170Risk Ratio (M-H, Random, 95% CI)0.51 [0.27, 0.95]
2 Treatment acceptability (dropout) at post-treatment4224Risk Ratio (M-H, Random, 95% CI)1.01 [0.08, 12.30]
2.1 Third wave CBT vs TAU/usual care/no treatment3170Risk Ratio (M-H, Random, 95% CI)0.71 [0.03, 16.07]
2.2 Third wave CBT vs psychological placebo154Risk Ratio (M-H, Random, 95% CI)3.0 [0.13, 70.53]
Analysis 2.1.

Comparison 2 Third wave CBT vs types of control condition, Outcome 1 Clinical response at post-treatment.

Analysis 2.2.

Comparison 2 Third wave CBT vs types of control condition, Outcome 2 Treatment acceptability (dropout) at post-treatment.

Appendices

Appendix 1. CCDANCTR-References Register search (psychotherapies for depression)

1Title/Abstract=therap* or psychotherap*
2Keywords=psychotherapy
3Free-Text=acceptance* or commitment* or “activity scheduling” or adlerian or art or aversion or behvio* or brief or “client cent*” or cognitive* or color or colour or compassion-focused or “compassion* focus*” or compassionate or conjoint or conversion or conversational or couples or dance or dialectic* or diffusion or distraction or eclectic or (emotion and focus*) or emotion-focus* or existential or experiential or exposure or expressive or family or focus-oriented or “focus oriented” or freudian or gestalt or “group” or humanistic or implosive or insight or integrative or interpersonal or jungian or kleinian or logo or marital or metacognitive or meta-cognitive or milieu or morita or multimodal or multi-modal or music or narrative or nondirective or non-directive or “non directive” or nonspecific or non-specific or “non specific” or “object relations” or “personal construct” or “person cent*” or person-cent* or persuasion or play or ((pleasant or pleasing) and event*) or primal or problem-focused or “problem focused” or problem-solving or “problem solving” or process-experiential or “process experiential” or psychodynamic or “rational emotive” or reality or “reciprocal inhibition” or relationship* or reminiscence or restructuring or rogerian or schema* or self-control* or “self control*” or “short term” or short-term or sex or “social effectiveness” or “social skill*” or socio-environment* or “socio environment*” or “solution focused” or solution-focused or “stress management” or supportive or time-limited or “time limited” or “third wave” or transference or transtheoretical or validation
4Free-Text=(abreaction or “acting out” or “age regression” or ((assertive* or autogenic or mind or sensitivity) and train*) or autosuggestion or “balint group” or ((behavior* or behaviour*) and (activation or therap* or treatment or contracting or modification)) or biofeedback or catharsis or cognitive* or “mind training” or counsel* or “contingency management” or countertransference or “covert sensitization” or “eye movement desensiti*” or “crisis intervention” or “dream analysis” or “emotional freedom” or “free association” or “functional analys*” or griefwork or “guided imagery” or hypno* or imagery or meditation* or “mental healing” or mindfulness* or psychoanaly* or psychodrama or psychoeducat* or “psycho* support*” or psychotherap* or relaxation or “role play*” or “self analysis” or “self esteem” or “sensitivity training” or “support* group*” or therapist or “therapeutic technique*” or “transactional analysis”)
5 ((1 or 2) and 3) or 4
6Title/Abstract=(depress* or dysthymi*)
7 5 and 6
8Tagged to CCDANCTR-Study=Empty
9 7 and 8

Appendix 2. CINAHL and PSYNDEX search strategies

Psychotherapies for depression (n1114) 2010-05-19 (310 duplicates - CCDAN Registers)

EBSCO CINAHL (Cumulative Index to Nursing and Allied Health Literature) was searched as follows:
1. (MH "Clinical Trials+")
2. TI (clinic* N1 trial*) or AB (clinic* N1 trial*)
3. TI ((singl* or doubl* or trebl* or tripl*) and (blind* or dummy or mask)) or AB ((singl* or doubl* or trebl* or tripl*) and (blind* or dummy or mask))
4. TI ( randomi?ed or randomly) or AB (randomi?ed or randomly)
5. AB (random* N3 allocat*) or AB (random* N3 assign*)
6. (MH "Random Assignment")
7. PT clinical trial
8. (MH "Placebos")
9. TI placebo* or AB placebo*
10. AB (control N3 trial*) or AB (control N3 study) or AB (control N3 studies)
11. S1 or S2 or S3 or S4 or S5 or S6 or S7 or S8 or S9 or S10
12. (MM "Depression+")
13. (MM "Psychotherapy+")
14. (MH "Psychotherapy+")
15. (MM "Psychological Processes and Principles+")
16. (MM "Behavior and Behavior Mechanisms+")
17. (acceptance* or commitment* or “activity scheduling” or adlerian or art or aversion or brief or “client cent*” or cognitive or color or colour or “compassion focused” or compassionate or conjoint or conversion or conversational or couples or dance or dialectic* or diffusion or eclectic or (emotion* W1 focus*) or existential or experiential or exposure or expressive or family or (focus W1 oriented) or gestalt or group or humanistic or implosive or insight or integrative or interpersonal or marital or metacognitive or milieu or morita or multimodal or “multi-modal” or music or narrative or nondirective or “non-directive” or “non directive” or nonspecific or “non-specific” or “non specific” or “object relations” or “personal construct” or “person cent*” or persuasion or play or “pleasant event*” or primal or “problem-focused” or “problem focused” or “problem-solving” or “problem solving” or “process-experiential” or “process experiential” or psychodynamic or “rational emotive” or reality or “reciprocal inhibition” or relationship* or reminiscence or restructuring or schema* or “self-control*” or “self contol*” or “short term” or “short-term” or sex or “social effectiveness” or “social skill*” or socioenvironmental or “solution focused” or “stress management” or supportive or “time-limited” or “time limited” or transference or transtheoretical or validation)
18.(S13 or S14 or S15 or S16) and S17
19. behavio#r W3 modification*
20. behavio#r W3 contract*
21. behavio#r W3 treat*
22. behavio#r W3 therap*
23. (sensitivity W3 train*)
24. (mind W3 train*)
25. (autogenic W3 train*)
26. (assertive* W3 train*)
27. (autosuggestion or “balint group” or biofeedback or catharsis or cognitive or “mind training” or counsel* or “contingency management” or countertransference or “covert sensitization” or “eye movement desensiti*” or “crisis intervention” or distraction or “dream analysis” or “emotional freedom” or “free association” or freudian or “functional analys*” or griefwork or “guided imagery” or hypno* or imagery or jungian or kleinian or meditation* or “mental healing” or mindfulness* or psychoanaly* or psychodrama or psychoeducat* or “psycho* support*” or psychotherap* or relaxation or rogerian or “role play*” or “self analysis” or “self esteem” or “sensitivity training” or “support* group*” or therapist or “therapeutic technique*” or third-wave or “third wave” or “transactional analysis”)
28.S13 or S18 or S19 or S20 or S21 or S22 or S23 or S24 or S25 or S26 or S27
29. S11 and S12 and S28

OVID PSYNDEX Search Strategy (11 June 2010 726 records NOT de-duplicated)
1. Clinical Trials.sh.
2. Treatment Effectiveness Evaluation.sh.
3. Mental Health Program Evaluation.sh.
4. randomi#ed.mp.
5. randomly.mp.
6. randomized.ep.
7. pla#ebo$.mp.
8. trial$.ti,ab.
9. ((singl$ or doubl$ or trebl$ or tripl$) adj3 (blind$ or mask$ or dummy)).mp.
10. clinical study.ep.
11. experimental study.md.
12. multicenter study.md.
13. (zugewiesen and kontrollgruppe$).ab.
14. randomisiert$.ab,ti.
15. ((zufa?ll$ or randomi$) and (experiment$ or evalu$ or effe?t$) and treat$).mp.
16. (doppelblind$ or doppel-blind$).ti,ab.
17. or/1-16
18. major depression/ or anaclitic depression/ or dysthymic disorder/ or endogenous depression/ or postpartum depression/ or reactive depression/ or recurrent depression/ or treatment resistant depression/
19. atypical depression/
20. or/18-19
21. exp Psychotherapy/
(psychotherapy/ or adlerian psychotherapy/ or analytical psychotherapy/ or autogenic training/ or behavior therapy/ or brief psychotherapy/ or client centered therapy/ or cognitive behavior therapy/ or conversion therapy/ or eclectic psychotherapy/ or emotion focused therapy/ or existential therapy/ or experiential psychotherapy/ or expressive psychotherapy/ or eye movement desensitization therapy/ or feminist therapy/ or geriatric psychotherapy/ or gestalt therapy/ or group psychotherapy/ or guided imagery/ or humanistic psychotherapy/ or hypnotherapy/ or individual psychotherapy/ or insight therapy/ or integrative psychotherapy/ or interpersonal psychotherapy/ or logotherapy/ or narrative therapy/ or persuasion therapy/ or primal therapy/ or psychoanalysis/ or psychodrama/ or psychodynamic psychotherapy/ or psychotherapeutic counseling/ or rational emotive behavior therapy/ or reality therapy/ or relationship therapy/ or solution focused therapy/ or supportive psychotherapy/ or transactional analysis/)
22. exp Behavior Therapy/
(behavior therapy/ or aversion therapy/ or conversion therapy/ or dialectical behavior therapy/ or exposure therapy/ or implosive therapy/ or reciprocal inhibition therapy/ or response cost/ or systematic desensitization therapy/)
23. exp Cognitive Behavior Therapy/
(cognitive behavior therapy/ or acceptance and commitment therapy/)
24. exp Cognitive Techniques
(cognitive techniques/ or cognitive restructuring/ or cognitive therapy/ or self instructional training/)
25. Schema/
26. Group Psychotherapy/
(group psychotherapy/ or encounter group therapy/ or therapeutic community/)
27. Milieu Therapy/
28. Family Therapy/ or Couples Therapy/ or Cotherapy/ or Conjoint Therapy/ or Sex Therapy/
29. Educational Therapy/ or Psychoeducation/
30. exp Psychotherapeutic processes/
(psychotherapeutic processes/ or contertransference/ or insight (psychotherapeutic process) or negative therapeutic reaction/ or psychotherapeutic breakthrough/ or psychotherapeutic resistance// or psychotherapeutic transference/ or therapeutic alliance/)
31. exp Psychotherapeutic techniques/
(psychotherapeutic techniques/ or animal assisted therapy/ or autogenic training/ or cotherapy/ or dream analysis/ or guided imagery/ or mirroring/ morita therapy/ or motivational interviewing/ or mutual storytelling technique/ or paradoxical techniques/ or psychodrama/)
32. exp Psychoanalysis/
(psychoanalysis or alderian psychotherapy/ or dream analysis/ or self analysis/)
33 Covert Sensitization/
34. Behavior Contracting/
35. exp Biofeedback/
(biofeedback/ or biofeedback training/ or neurofeedback/)
36. Assertiveness Training/ or Behavior Modification/ or Sensitivity Training/
37. Social Skills Training/
38. exp Counseling/
39. exp Contingency Management/
(contingency management/ or token economy programs/)
40. Functional Analysis/
41. exp Problem Solving/
(problem solving/ or anagram problem solving/ or cognitive hypothesis testing/ or group problem solving/ or heuristics/)
42. exp Relaxation Therapy/
(relaxation therapy/ or progressive relaxation therapy/)
43. Meditation/ or Mindfulness/
44. Stress Management/
45. Self Control/
46. Existential Therapy/
47. Gestalt Therapy/
48. exp Jungian Psychology/
(Jungian Psychology/ or Collective Unconscious)
49. Free Association/
50. Object Relations/
51. Multimodal Treatment Approach/
52. Acting Out/
53. exp Hypnotherapy/
(hypnotherapy/ or age regression/)
54. exp Hypnosis/
(hypnosis/ or age regression (hypnotic) or autohypnosis)
55. exp Creative Arts Therapy/
(creative arts therapy/ or art therapy/ or dance therapy/ or music therapy/ or poetry therapy/ or recreation therapy/)
56. Catharsis/
57. Crisis Intervention/
58. Play Therapy/
59. (third wave or mind train* or person cent* or person* construct*).mp.
60. (person cent* or person* construct*).mp.
61. (activity scheduling or behavioral activation or pleasant event*).mp.
62. ((therap* or psychotherap*) adj1 (abreaction or analytic* or color or colour or compassion or diffusion or distraction or emotion* or interpersonal or inter-personal* or insight oriented or focus* or functional anal* or metacognitive or nondirective or non directive or problem focus* or process experiential or reciprocal inhibition or reminiscence or socioenvironmental or socio environmental or supportive or transference or transtheoretical)).mp.
63. (freudian or jungian or klenian or rogerian).mp.
64. griefwork.mp.
65. mental healing.mp.
66. or/21-65
67. (17 and 20 and 66)

Contributions of authors

Rachel Churchill conceived, designed, secured funding for and is managing this programme of linked reviews. She worked on all aspects of development of this project, including building and managing the review team, developing the protocol, devising a search strategy, compiling data extraction forms and compiling the overall dataset. Dr Churchill is responsible for writing and preparing this review. Along with Dr Vivien Hunot, she conducted the original review on which this programme is based. She is the guarantor of the individual reviews in this programme of work.

Theresa HM Moore is managing the organisation of data for the 12 linked reviews of psychotherapies for depression, including search results, tracking of papers and management of references for the project. She has developed the data collection forms, designed the database and spreadsheets for data collection and has contributed to writing of sections of the protocols and commented on the text.

Philippa Davies contributed to design of the review and development of the protocol.

Deborah Caldwell provided methodological and statistical advice for each of 12 linked protocols assessing the effects of different psychotherapies for depression. She contributed to the design of the data extraction form, drafted some sections of the protocols and commented on the protocol manuscripts. She designed the plan to perform a multiple treatment meta-analysis for the overview of reviews.

Glyn Lewis provided a clinical perspective on 12 linked psychotherapies for depression protocols.

Vivien Hunot provided theoretical and clinical expertise for designing this programme of linked reviews, drawing from her training and clinical practice as a psychotherapeutic counsellor and a cognitive-behavioural therapist in NHS primary care settings. She worked on protocol development, developed a search strategy and compiled data extraction forms and wrote the protocol for each review. Along with Dr Rachel Churchill, she conducted the original review on which this programme is based.

Hannah Jones read and commented on the protocols.

Toshi A Furukawa provided theoretical and clinical expertise for this programme of linked reviews. He is a diplomate of the Academy of Cognitive Therapy (Philadelphia). He commented on the protocol manuscripts, helped revise the data extraction and summary forms, extracted data and contacted the original authors of relevant studies.

Kiyomi Shinohara and Hissei Imai extracted the data, contributed to the development of the revised data extraction and summary form and managed and organised the data extraction and summary process.

Declarations of interest

None known.

Sources of support

Internal sources

  • University of Bristol, UK.

External sources

  • Department of Health, UK.

    NIHR Programme Grant

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Ekers 2011

Methods

Design: RCT, parallel design, multi-centre

Study duration: 3 months

Follow-up: none

Participants

Sample size: 47 individuals eligible and agreed to participate    

Recruitment: referred by GPs (n = 26) or mental health workers (n = 21) in participating general practices

Inclusion criteriadiagnostic classification criteria:  ICD-10 diagnosis made using computerised version of CISR

Inclusion criteriarating scales: none

Included disorders: depression

Gender: 62% of sample women

Mean age: 44.7 years (range 24 to 63 years)

Country/Ethnicity: conducted in UK: no information on ethnicity

Pharmacotherapy during the study: naturalistic prescribing of antidepressants to 68% of participants (65% in BA arm and 71% in UC arm)

Interventions

Behavioural activation (BA)

Intervention:  BA consisted of a structured programme of increasing contact with potentially antidepressant environmental reinforcers through scheduling and reducing the frequency of negatively reinforced avoidance behaviours. Specific techniques incorporated in the 12-session protocol were self-monitoring, identifying 'depressed behaviours', developing alternative goal-orientated behaviours and scheduling. In addition, the role of avoidance and rumination was addressed through functional analysis, and alternative responses developed. Participants received twelve 1-hour individual face-to-face sessions over a 3-month period

Therapists:  BA was provided by two qualified mental health nurses with no previous formal psychotherapeutic training or experience. Both had worked in a range of services in inpatient and community settings with 3 and 6 years' experience since qualification. Therapists received 5 days of training in BA and 1 hour of clinical supervision fortnightly from the PI

Usual care (UC)

Participants were followed up by their GP or primary care mental health worker and were offered interventions deemed appropriate for their condition as per normal practice

Outcomes

BDI-II

Work and Social Adjustment Scale (WSAS)

Client Satisfaction Questionnaire (CSQ-8)

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot described
Allocation concealment (selection bias)Unclear riskParticipants randomly assigned to two arms through an allocation concealment process independent of the study team (page 67, col 1, para 2)—no further information provided
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible to blind participants and personnel in a psychological therapy trial
Blinding of outcome assessment (detection bias)
All outcomes
High riskAll outcomes self-report—not possible to blind participants in a psychological therapy trial
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskAppropriate statistical methods used to take account of missing data; however, differential dropout rates between the two arms (16% in BA arm vs 5% in UC arm) and no reasons for dropout provided
Selective reporting (reporting bias)Unclear riskNo study protocol available—insufficient information for an assessment
Researcher allegiance and other conflicts of interest (financial or other)High risk12-Session protocol followed for sessions (treatment manual available from author—page 67, col 1, para 5) based on two behavioural approaches developed in previous research (Martell 2001 and Hopko 2003a)
Therapist allegiance and other conflicts of interest (financial or other)Low riskNo previous training in psychotherapy for therapists
Therapist qualificationsHigh riskNo previous therapy training for therapists; relatively recently qualified, employed at the base level of registered psychiatric nurses (page 71, col 1, para 5) with only 5 days of training in BA
Treatment fidelityLow riskAll treatment sessions audiotaped and 20% randomly selected by a research assistant masked to session content. Recordings assessed by independent accredited CBT therapists with extensive experience in both CBT and BA (page 67, col 2, para 3). All sessions classed 1 as an example of BA and 0 when other therapy modes were prominent (page 69, col 1, para 2)
Other biasUnclear riskInsufficient information provided

Ekkers 2011

Methods

Design: RCT, parallel design, single centre

Study duration: 7 weeks

Follow-up: none

Participants

Sample size: 93 individuals eligible and agreed to participate    

Recruitment: referred by therapists working in four older age outpatient departments of psychiatric institute

Inclusion criteriadiagnostic classification criteria: clinically established diagnosis of MDD based on DSM-IV-TR criteria, obtained through multidisciplinary team meeting between psychiatrist, clinical psychologist and nurse

Inclusion criteriarating scales: 11 or more on Geriatric Depression Scale

Included disorders: major depressive disorder

Gender: 67% of sample women

Mean age: 72.7 years

Country/Ethnicity: conducted in Netherlands: no information on ethnicity

Pharmacotherapy during the study: naturalistic prescribing of antidepressants to 79% of participants (75% in COMET arm and 83% in treatment as usual arm)

Interventions

Competitive Memory Training (COMET)

Intervention:  COMET for depressive rumination targets underlying cognitive processes instead of the content of dysfunctional cognitions. Its aim is not to change the negative emotions and thoughts themselves but rather the amount of involvement the individual has with these thoughts and emotions. Using counter themes of being indifferent or adopting an attitude of acceptance, clients are trained to become more emotionally salient. COMET conducted in groups of 6 to 8 participants in 7 manualised sessions of 90 minutes each. Participants also received ongoing treatment as usual (see description below)

Therapists:  all sessions administered by two trained therapists. At least one of the therapists was a registered cognitive-behavioural therapist. All therapists trained and supervised by the first two authors. Training consisted of 8 hours' training in the theory and practice of the COMET protocol. All therapists met once a month for 1 hour with the first author to discuss progress/deal with treatment issues

Treatment as usual (TAU)

Consisted mainly of pharmacotherapy prescribed by a psychiatrist, with or without psychotherapy conducted by a psychologist, or supportive and structured treatment conducted by nurses who specialised in psychosocial and psychiatric care

Outcomes

Quick Inventory of Depressive Symptomatology–Self Report (QIDS-SR)

Geriatric Depression Scale (GDS)

Ruminative Response Scale (RRS)

Rumination on Sadness Scale (RSS)

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskTherapists at each of the four locations received 38 closed envelopes containing an equal number of allocations to both conditions (page 591, col 1, para 1). No information on how envelopes were selected
Allocation concealment (selection bias)Low riskPreparation of envelopes and randomisation procedures carried out by independent assistants with no involvement at all of the researchers (page 591, col 1, para 1)
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible to blind participants and personnel in a psychological therapy trial
Blinding of outcome assessment (detection bias)
All outcomes
High riskOutcomes all self-report—not possible to blind participants in a psychological therapy trial
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskAppropriate statistical methods used to take account of missing data; however, very high dropout rate of 50% in TAU arm, incomplete figures provided on reasons for dropout and authors report that some people in TAU arm were disappointed not to be randomly assigned into the COMET group (page 592, col 1, para 1)
Selective reporting (reporting bias)Unclear riskNo study protocol available—insufficient information for an assessment
Researcher allegiance and other conflicts of interest (financial or other)High riskSecond author developed the COMET intervention (page 589, col 1, para 2)
Therapist allegiance and other conflicts of interest (financial or other)Unclear riskGroup sessions of COMET administered by two trained therapists; at least one of the therapists was a registered cognitive-behavioural therapist (page 590, col 1, para 4); however, authors do not state in which approach remaining therapists had been trained
Therapist qualificationsUnclear riskNo information provided on therapist qualifications or experience, except that some were registered cognitive-behavioural therapists. Eight hours' training in theory and practice of COMET provided (page 590, col 1, para 4)
Treatment fidelityUnclear riskSample of the COMET sessions observed by an independent rater, who assessed deliverance of the manualised steps for each session by ticking a list of treatment elements and elements not included in the manual (page 591, col 1, para 1). 90% of elements of the protocol delivered (page 592, col 2, para 3). However, no information provided on method used for observing sessions, number of sessions assessed or status of raters
Other biasUnclear riskInsufficient information provided

Gawrysiak 2009

Methods

Design: RCT, parallel design, single centre

Study duration: 2 weeks

Follow-up: none

Participants

Sample size: 30 individuals eligible and agreed to participate    

Recruitment: volunteer psychology students based at a public university

Inclusion criteriadiagnostic classification criteria: none

Inclusion criteriarating scales: score of 14 or higher on BDI-II

Included disorders: depression

Gender: 80% of sample women

Mean age: 18.4 years (SD 0.81)

Country/Ethnicity: conducted in USA: 70% Caucasian, 13% African American, 7% Latino, 7% Asian American, 3% other

Pharmacotherapy during the study: participants required not to be receiving pharmacological treatment

Interventions

Behavioural Activation Treatment for Depression (BATD)

Intervention:  based on premise that increased activity and resulting experience of environmental reinforcement are sufficient for reduction of depressive symptoms/corresponding increase in positive thoughts and feelings. Emphasis on engaging in value-based activities that elicit a sense of pleasure and accomplishment. Treatment protocol for current study represented major modification to original BATD intervention in that it was reduced to a single session. Treatment consisted of a single individual 90-minute face-to-face session

Therapists:  Two male doctoral students in clinical psychology who were trained in BATD administered the intervention. No other information provided on training, qualifications, experience and supervision

No treatment control

Control group participants completed questionnaires, were provided with a brief explanation of the study and were told to engage in their lives as usual

Outcomes

BDI-II

Environmental Reward Observation Scale (EROS)

Beck Anxiety Inventory (BAI)

Multidimensional Scale of Perceived Social Support (MSPSS)

NotesPotential participants were offered credit for taking part in the study
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot described
Allocation concealment (selection bias)Unclear riskNot described
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible to blind participants and personnel in a psychological therapy trial
Blinding of outcome assessment (detection bias)
All outcomes
High riskAll outcomes self-report—not possible to blind participants in a psychological therapy trial
Incomplete outcome data (attrition bias)
All outcomes
Low risk0% attrition in both BATD and control conditions at 2-week follow-up (page 471, col 2, para 3)
Selective reporting (reporting bias)Unclear riskNo study protocol available—insufficient information for an assessment
Researcher allegiance and other conflicts of interest (financial or other)High riskLast author, DR Hopko, developed BATD and this modified version of BATD and is the contact author for the study 
Therapist allegiance and other conflicts of interest (financial or other)Unclear riskNo information provided on therapists' previous training or preferred psychological therapy approach
Therapist qualificationsUnclear riskTherapists were non-qualified doctoral students in clinical psychology (page 471, col 1, para 5). No information provided on their level of experience. No information provided on training in BATD and supervision
Treatment fidelityHigh riskTreatment fidelity measured by therapists' checking off/initialing a list of therapy components in treatment protocol (page 471, col 1, para 3). No audiotaping/videotaping, no independent assessments; therefore no evidence that treatment was delivered as specified
Other biasUnclear riskInsufficient information provided

Pellowe 2006

Methods

Design: RCT, parallel design, single centre

Study duration: 4 weeks

Follow-up: none

Participants

Sample size: 54 individuals eligible and agreed to participate    

Recruitment: volunteer psychology students

Inclusion criteriadiagnostic classification criteria: none

Inclusion criteriarating scales: score of 10 to 29 on BDI-II

Included disorders: mild to moderate depression

Gender: 70% of sample women

Mean age: 20.4 years (SD 4.73)

Country/Ethnicity: conducted in USA: 92% of participants Caucasian, 6% Hispanic and 3% African American

Pharmacotherapy during the study: naturalistic prescribing allowed—4 participants in ACT group and no participants in supportive therapy group taking medication for a psychological condition

Interventions

Acceptance and commitment therapy (ACT)

Intervention:  Session 1 focused on a discussion of value-directed living and typical means of coping with private events associated with depression. Session 2 covered ineffective use of control strategies and introduction to cognitive defusing. Session 3 introduced the concept of mindfulness. Session 4 reviewed core concepts of ACT and discussed how to maintain valued life direction

Therapists:  groups led by 1 or 2 advanced clinical psychology graduate students trained in the respective therapy protocols. Author facilitated most sessions

Supportive group therapy (SGT)

Intervention: SGT was intended to provide a clinically relevant comparison treatment for ACT but was regarded as a placebo control condition, consisting of relatively unstructured group discussion prompted by facilitators, with avoidance of CBT and ACT techniques

Therapists: groups led by one or two advanced clinical psychology graduate students trained in the respective therapy protocols. Author facilitated most sessions

Outcomes

Acceptance and Action Questionnaire (ACT)

BDI-II

Dysfunctional Attitude Scale (DAS)

Final Session Questionnaire (satisfaction scale)

NotesSGT categorised as psychological placebo as participants are likely to have believed that they were receiving an active treatment, although the author regarded it as a placebo control
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot described
Allocation concealment (selection bias)Unclear riskNot described
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible to blind participants and personnel in a psychological therapy trial
Blinding of outcome assessment (detection bias)
All outcomes
High riskAll outcomes self-report—not possible to blind participants in a psychological therapy trial
Incomplete outcome data (attrition bias)
All outcomes
Low riskDropout very low in both groups (2 in ACT group) and reasons for dropout provided (page 43, para 2). Appropriate statistical methods used to take account of missing data
Selective reporting (reporting bias)Unclear riskNo study protocol available—insufficient information for an assessment
Researcher allegiance and other conflicts of interest (financial or other)High riskResearcher states that 'the current study ulitized an attention control group rather than an active treatment such as CBT' (page 34, para 1), indicating an allegiance towards ACT
Therapist allegiance and other conflicts of interest (financial or other)High riskResearcher facilitated most sessions in both treatment conditions (page 41, para 1)
Therapist qualificationsUnclear riskTwo advanced clinical psychology graduate students trained in respective therapy protocols. No information provided on level of experience (page 41, para 1)
Treatment fidelityLow riskAll sessions videotaped and random selection of 15 tapes reviewed by a trained independent judge, who was familiar with manuals but blind to condition (page 41, para 1). Judge used checklist for 8 ACT sessions reviewed—all exercises included (page 41, para 2)
Other biasUnclear riskInsufficient information provided

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Bohlmeijer 2011A defined depression scale cut-off not applied by researchers
Dimidjian 2004Comparator condition of active treatment
Folke 2012Not an acute depression population—participants with chronic depression (mean of 351 days' consecutive sick leave)
Hopko 2003aInpatient population
Kaviani 2012Not an acute depression population—participants with subclinical depression
Korrelboom 2012Participants already in treatment for depression; high proportion of sample in partial remission
Pinniger 2012Mixed population with self-reported stress, anxiety and/or depression; no defined depression scale cut-off
Reynolds 2011Participants' mean depression score in the normal range
Snarski 2011Inpatient participants who had mild to moderate cognitive impairment
Zettle 1984Comparator condition of active treatment
Zettle 1989Comparator condition of active treatment

Characteristics of studies awaiting assessment [ordered by study ID]

Armento 2012

MethodsRandomised controlled trial
ParticipantsMild to moderately depressed undergraduate students
Interventions
  • Religious action in behavioural activation (PRA-BA): individualised one-session intervention of 60 minutes, followed by 2-week activation interval

  • No treatment 'support' condition: individualised one-session intervention of 60 minutes, providing a supportive environment, followed by 2-week interval of life as usual

Outcomes

BDI-II

Environmental Reward Observation Scale

State-Trait Anxiety Inventory

BAI

Quality of Life Inventory

Religious Background and Behaviour Scale

Spiritual Well-being Scale

Ways of Religious Coping Scale

NotesTrial used the same one-session extended BA protocol as Gawrysiak 2009, revised to focus on religious behaviours

Azargoon 2010

MethodsRandomised controlled trial
ParticipantsDepressed students
InterventionsMindfulness training versus no treatment control. Mindfulness training consisting of 8 weekly two-hour sessions
OutcomesDAS Inventory and ATQ Questionnaire
NotesPaper written in Farsi—translation required

Characteristics of ongoing studies [ordered by study ID]

NCT01441258

Trial name or titleAdaptation of Dialectical Behavior Therapy Skills-Groups for Individuals With Suicidal Ideation and Depression
MethodsRandomised controlled trial
ParticipantsAdult participants with MDD who also report current suicidal ideation
Interventions
  • Dialectical behaviour therapy skills (DBT-S): weekly group DBT-S (1.5-hour sessions) in groups of 8 participants, for 18 weeks

  • Waiting list: participants to be seen by their standard treaters for 18 weeks as usual and given the opportunity to participate in a DBT skills group after 18-week wait period has ended

OutcomesPrimary outcome: Beck Scale for Suicidal Ideation
Starting dateOctober 2011
Contact informationKate A Hails: khails@partners.org
NotesEstimated completion date—May 2013

Ancillary