Intervention Review

You have free access to this content

Smoking cessation interventions for smokers with current or past depression

  1. Regina M van der Meer1,*,
  2. Marc C Willemsen2,3,
  3. Filip Smit4,5,
  4. Pim Cuijpers6

Editorial Group: Cochrane Tobacco Addiction Group

Published Online: 21 AUG 2013

Assessed as up-to-date: 1 APR 2013

DOI: 10.1002/14651858.CD006102.pub2


How to Cite

van der Meer RM, Willemsen MC, Smit F, Cuijpers P. Smoking cessation interventions for smokers with current or past depression. Cochrane Database of Systematic Reviews 2013, Issue 8. Art. No.: CD006102. DOI: 10.1002/14651858.CD006102.pub2.

Author Information

  1. 1

    STIVORO, Dutch Expert Centre on Tobacco Control, The Hague, Netherlands

  2. 2

    STIVORO - Dutch Expert Centre on Tobacco Control, The Hague, Netherlands

  3. 3

    Maastricht University, CAPHRI, Maastricht, Netherlands

  4. 4

    VU University Medical Centre, Trimbos Institute (Netherlands Institute of Mental Health and Addiction), Utrecht, Netherlands

  5. 5

    VU University Medical Centre, Department of Epidemiology and Biostatistics, Amsterdam, Netherlands

  6. 6

    VU University, Department of Clinical Psychology, Amsterdam, Netherlands

*Regina M van der Meer, STIVORO, Dutch Expert Centre on Tobacco Control, The Hague, Netherlands. rvandermeer@stivoro.nl.

Publication History

  1. Publication Status: New
  2. Published Online: 21 AUG 2013

SEARCH

 
Characteristics of included studies [ordered by study ID]
Batra 2010

MethodsStudy design: RCT, subgroup current depression (pre-stated stratification)

Setting: Germany, community, university hospital outpatient clinic

Recruitment: Press release, email campaign and flyers


Participants41 adult smokers (1: N = 23; 2: N = 18) with a depressive profile according to BDI and ISE, mean age 48.3, 57.1% F, mean FTCD 4.0, mean CPD 19.9, mean BDI 13.3, mean ISE-N 39.3;

Exclusion criteria included presence of an acute major depressive episode, alcohol use disorder, lifetime diagnosis of a psychotic disorder, use of neuroleptics


Interventions1. Modified smoking cessation: Additional pharmacobehavioural treatment (reinforcing positive/pleasurable activities, emotion regulation and cognitive restructuring of dysfunctional thoughts) and primary recommendations for bupropion: 150mg/day for the first 7 days and 300 mg/day for 8-9 weeks (Secondary recommendations for participants with high nicotine addiction were 24-h nicotine patch, 52.5 mg for 4 wks, 35 mg for 2-4 wks, and 17.5 mg for 2-4 wks + nicotine gum 4mg ad libitum up to 16/day for 8-12 wks. Secondary recommendations for low nicotine addiction participants were 16 h nicotine patch 24.9 mg for 4 weeks, 16.6 mg for 2-4 weeks, and 8.3 mg for 2-4 weeks + nicotine gum 4mg ad libitum up to 16/day)

2. Standard pharmacobehavioural treatment: Participants with high nicotine addiction: Recommendations for participants with high nicotine addiction were 24-h nicotine patch, 52.5 mg for 4 wks, 35 mg for 2-4 wks, and 17.5 mg for 2-4 wks. Recommendations for other participants were 16-h nicotine patch 24.9 mg for 4 weeks, 16.6 mg for 2-4 weeks, and 8.3 mg for 2-4 weeks. Or nicotine gum, 4mg ad libitum up to 16/day for 8-12 wks;

Both arms: Pharmacobehavioural treatment consisted of psychological treatment components (self-monitoring of smoking behavior, decisional balance, coping with high-risk situations, behavioral alternatives to smoking, social support/behavioral contracting, progressive muscle relaxation, relapse prevention and coping with lapses/relapses), 6 wks, 2-hour group sessions.

Pharmacotherapy was strongly recommended but not required


OutcomesAbstinence at 6 and 12 m follow-up (7-day PP and CA since end of treatment)

Validation: CO: values > 9 ppm (12-m follow-up, one randomly selected participant in each group who reported being abstinent)

Unpublished abstinence outcome data


Notes10% used recommended pharmacotherapy at final session in experimental group and 53.3% in control group. Analysis: comparison 1 (psychosocial mood management), but not in meta-analysis because of different advices for pharmacotherapy in both arms


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskCluster-randomisation, using random numbers generated by a spreadsheet program

Allocation concealment (selection bias)Low risk"The order was constantly regenerated randomly right before the participants were contacted and could not be predicted in advance by researchers or therapists."

Blinding (performance bias and detection bias)
All outcomes
High riskNo description of blinding in the article. However, it is not possible to blind the participants for a psychosocial intervention

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskITT. The response rates for all at risk participants response rates were 66.3% for the control group and 75.5% for the experimental group at 12-m follow-up

Blondal 1999

MethodsStudy design: RCT, subgroup current depression (post hoc)

Setting: Iceland, smokers' cessation clinic

Recruitment: Advertisement in mass media


Participants32 adult smokers (1: N = 16; 2: N = 16) with depressive symptoms according to BDI ≥ 10, mean age 42.1, 65.6% F, mean FTCD 6.5 , mean CPD 25, mean BDI 15.8

Exclusion criteria included currently and in the preceding 2 years treated with an antidepressant, current abuse of alcohol


Interventions1. Fluoxetine (antidepressant) (10 mg/d 16 d before quitting, 20 mg/d 10 d before quitting, continuing for up at least 3 m)

2. Placebo (schedule as fluoxetine)

Both arms: Nicotine inhaler (6-12 units pd after quitting up to 6 m) plus supportive group treatment (five 1-hr sessions: 1 d before quitting and 1, 8, 15 and 22 d after quitting)


OutcomesAbstinence at 6 and 12 m follow-up (CA since quitting date)

Validation: CO values ≥ 10

Unpublished abstinence outcome data


NotesAnalysis: fluoxetine comparison 4


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated randomisation code pill boxes

Allocation concealment (selection bias)Low riskA laboratory technician delivered the lowest numbered box

Blinding (performance bias and detection bias)
All outcomes
Low riskPlacebo controlled study

Incomplete outcome data (attrition bias)
All outcomes
Low riskITT. The response rates for all of the study participants were 100% for the control group and 100% for the experimental group at 12-m follow-up

Brown 2001

MethodsStudy design: RCT, past depression

Setting: USA, community

Recruitment: Newspaper, radio, television advertisements and flyers


Participants179 cigarette smokers (1: N = 86; 2: N = 93) with past major depressive disorder (MDD) according to DSM-III-R (SCID-NP), mean age 45.1, 59.8% F, mean FTCD 6.8, mean CPD 27.3, mean BDI 7.8, 54.7% had recurrent past major depression

Exclusion criteria included DSM-III-R diagnosis of current MDD, dysthymia, or other Axis I disorder; DSM-III-R diagnosis of psychoactive substance abuse or dependence within the past 6 m (other than nicotine); current use of psychotropic medication; current weekly psychotherapy; and intent to use pharmacological aid to smoking


Interventions1. Group sessions of standard cognitive behavioural smoking cessation treatment plus CBT for depression and patient manual. Standard smoking cessation skills (same as control group) and cognitive behavioural coping skills for depression, including daily mood ratings, pleasant event scheduling, cognitive restructuring and assertiveness training. Eight 2-hr sessions over 6 weeks.

2. Group sessions of standard cognitive behavioural smoking cessation treatment and patient manual. Comprehensive program including self-monitoring, self-management, nicotine fading, relapse prevention and social support enhancement. Eight 2-hr sessions over 6 wks

Non-pharmacological treatment.


OutcomesAbstinence at 6 and 12-m follow-up (7-day PP and CA: confirmed abstinence at post-treatment, 1, 6 and 12 m)

Validation: CO ≤ 10 ppm and saliva cotinine ≤ 46 ng/ml (In 6.5% of the cases abstinence was verified through interviews with significant others)

Published abstinence outcome data


NotesAnalysis: psychosocial mood management comparison 2


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskAllocation sequence was generated by the urn randomisation technique

Allocation concealment (selection bias)Unclear riskNot described

Blinding (performance bias and detection bias)
All outcomes
High riskNo description of blinding in the article. However, it is not possible to blind the participants for a psychosocial intervention

Incomplete outcome data (attrition bias)
All outcomes
Low riskITT. Response rate was 92.2% at 12-m follow-up

Brown 2007

MethodsStudy design: RCT, 2 x 2 factorial design, subgroup current depression (pre-stated stratification) and subgroup past depression (post hoc)

Setting: USA, community, hospital

Recruitment: Newspaper, radio and television advertisements


Participants45 adult smokers (1: N = 12; 2: N = 8; 3: N = 13; 4: N =12) with current depressive symptoms (CES-D > 16).

No information regarding mean age, % F, mean FTCD, mean CPD, mean CES-D

108 adult smokers (1: N = 36; 2: N = 26; 3: N = 28; 4: N = 18) with history of MDD according to SCID-NP

No information regarding mean age, % F, mean FTCD, mean CPD, mean CES-D

All study participants: mean age 44.3, 48% F, mean FTCD 6.4, mean CPD 24.6, mean CES-D 6.1

Exclusion criteria were current Axis I disorder according to DSM-IV (including current MDD); DSM-IV diagnosis of past year psychoactive substance abuse or dependence (other than nicotine); current use of psychotropic medication or medication that may interact adversely with bupropion; current weekly (or more frequent) psychotherapy


Interventions1: Standard cognitive behavioural smoking cessation treatment combined with cognitive behavioural treatment (12 90-min. group sessions over 12 weeks) for depression plus bupropion (150 mg/day for first 3 days, followed by 300 mg/day for a total of 12 wks)

2: Standard cognitive behavioural smoking cessation treatment combined with cognitive-behavioral treatment for depression (12 90-min. group sessions over 12 wks) plus placebo (150 mg/day for first 3 days, followed by 300 mg/day for a total of 12 wks)

3: Standard cognitive-behavioral smoking cessation treatment (12 90-min. group sessions over 12 wks) plus bupropion (150 mg/day for first 3 days, followed by 300 mg/day for a total of 12 wks)

4: Standard cognitive-behavioral smoking cessation treatment (12 90-min. group sessions over 12 wks) plus placebo (150 mg/day for first 3 days, followed by 300 mg/day for a total of 12 wks)


OutcomesAbstinence at 6 and 12 m follow-up (7-day PP and CA: Confirmed abstinence at post-treatment, 2, 6, 12 m)

Validation: CO ≤ 10 ppm and saliva cotinine ≤ 15 ng/ml (In 8.2% of the cases abstinence was verified through interviews with significant others)

Unpublished abstinence outcome data


NotesAnalysis: 2 x 2 design: the bupropion and the placebo arms were collapsed in the psychosocial mood management analysis (comparisons 1 and 2)

The standard and the standard / mood arms were collapsed in the bupropion analysis (comparisons 3 and 6)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskAllocation sequence was generated by the urn randomisation technique

Allocation concealment (selection bias)Unclear riskNo description of the allocation concealment in the article

Blinding (performance bias and detection bias)
All outcomes
Unclear riskParticipants and study staff were blind to medication condition. However, it is not possible to blind the participants for a psychosocial intervention

Incomplete outcome data (attrition bias)
All outcomes
Low riskITT. Response rate was 81.3% at all follow-ups. The odds of completing follow-ups were not significantly related to treatment condition

Carmody 2008

MethodsStudy design: RCT, subgroup current depression (post hoc) and subgroup past depression (post hoc)

Setting: USA, medical centre

Recruitment: Flyers, press releases and postings


Participants126 adult smokers (1: N = 65; 2: N = 61) with current depressive symptoms (BDI ≥ 10), mean age 47.1, 42.1% F, mean FTCD 5.2, mean CPD 20.6, mean BDI 18.0.

102 adult smokers (1: N = 47; 2: N = 55) with a history of depression according to a single item question 'presence or absence of such a history', mean age 48.1, 33.3% F, mean FTCD 5.5, mean CPD 21.7, mean BDI 14.2

Exclusion criteria included a contraindication to nicotine replacement


Interventions1. Hypnosis: (two 60-min face-to-face sessions and three 20 min follow-up phone calls). Goal: Master hypnosis skills and to use these skills to increase motivation and self-efficacy for resisting temptations to smoke. Hypnotic suggestions encouraged relaxation, commitment to quitting, self-image as a nonsmoker, ability to resist the urge to smoke, mood management, and development of healthy lifestyle

2. Standard behavioral counselling (two 60-min face-to-face sessions and three 20 min follow-up phone calls).

Both arms: nicotine patches (2 months; 21 or 14 mg)


OutcomesAbstinence at 6 and 12-m follow-up (7-day PP)

Validation: saliva cotinine ≥ 15 ng/ml (In a few of the cases abstinence was verified through interviews with significant others)

Unpublished abstinence outcome data


NotesAnalysis: psychosocial mood management comparison 1 and 2


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskThe randomisation allocation list was computer generated

Allocation concealment (selection bias)Low risk"The randomisation key was kept under lock and key by the study coordinator and the sealed envelopes were not given out until a subject was enrolled."

Blinding (performance bias and detection bias)
All outcomes
High riskNo placebo control group and the research assistants conducting the follow-up assessments were also not blind to the treatment condition

Incomplete outcome data (attrition bias)
All outcomes
Low riskITT. Response rates were 86.4% for control group and 88.7% for experimental group at 12-m follow-up

Catley 2003

MethodsStudy design: RCT, subgroup current depression (post hoc)

Setting: USA, hospital

Recruitment: Smoking cessation clinic, other hospital clinics, lobby of clinic building


Participants177 African American adult smokers (1: N = 86; 2: N = 91) with depressive symptoms according to the Medical Outcomes Survey Short Depression Screen (SDS).

All study participants: mean age 43, 60% F, mean FTCD 5, mean CPD 19.8, mean SDS 0.16.

Exclusion criteria included any other forms of tobacco in previous 30 days, contraindications for using nicotine replacement therapy and self reported alcohol or drug dependency.


Interventions1. Culturally sensitive self-help materials (tailored guide and video)

2. Standard self-help quitting materials (guide and video)

Both arms: Two phone calls (wk 1 and 3) for encouraging use of intervention materials and setting a quit day, plus nicotine patch (8 wks: 4 wks 21 mg/day, 2 wks 14mg/day and 2 wks 7 mg/day)


OutcomesAbstinence at 6 m follow-up (7-day PP)

Validation: CO < 10 ppm


NotesSDS is an 8 item self-report measure developed to screen for depressive disorders. (Cut-off point of 0.06 to indicate the likelihood of a current depressive disorder)

Unpublished abstinence outcome data

Analysis: psychosocial comparison, not in meta-analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskAllocation sequence was computer-generated with block size set at 20

Allocation concealment (selection bias)Unclear riskNo information

Blinding (performance bias and detection bias)
All outcomes
High riskIt is not possible to blind the participants for a psychosocial intervention

Incomplete outcome data (attrition bias)
All outcomes
High riskITT. Response rates were 62.8% for the experimental group and 59.3% for the control group at 6-m follow-up

Catley 2005

MethodsStudy design: RCT, subgroup current depression (post hoc)

Setting: USA, community healthcare centre

Recruitment: Clinic media and community outreach


Participants161 adult African American smokers (1: N = 78; 2: N = 83) with current depressive symptoms (CES-D >16), mean age 41.5, 80% F, mean FTCD 4.8, mean CPD 18.5, mean CES-D 23.3.

Exclusion criteria included currently use of psychoactive medication or illicit drugs, being treated for depression, or drugs in the past 6 m.


Interventions1. Bupropion (7 wk: 150 mg/d for 3 days; 2 x 150 mg/d)

2. Placebo (same schedule as bupropion)

Both arms: Eight individual and telephonic brief counselling sessions (Baseline, QD, 3d, 7d, 3wk, 5wk, 6wk, 7wk) and a smoking cessation guide


OutcomesAbstinence at 6-m follow-up (7-day PP and CA: no cigarettes since QD)

Validation: CO ≤ 10 ppm

Unpublished abstinence outcome data


NotesAnalysis: bupropion comparison 3


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated randomisation codes in blocks of 50

Allocation concealment (selection bias)Low risk"The pharmaceutical company packaged the treatment and shipped the blinded drug to the investigator"

Blinding (performance bias and detection bias)
All outcomes
Unclear riskInvestigators and participants were blinded to treatment. However it is not possible to blind for the psychosocial part of the intervention

Incomplete outcome data (attrition bias)
All outcomes
Low riskITT. Response rates were 84.3% for control group and 84.6% for experimental group at 6-m follow-up

Cinciripini 2010

MethodsStudy design: RCT, subgroup current depression (post hoc) and subgroup lifetime past depression (pre-stated stratification)

Setting: USA

Recruitment: Newspaper ads, television ads, and physician referrals


Participants60 pregnant smokers (1: N = 33; 2: N = 27) with current major depression according to SCID, mean age 24.2, 100% F, mean FTCD 3.3, mean CPD 7.9

194 pregnant smokers (1: N = 95; 2: N = 99) with lifetime past depression according to SCID, mean age 24.9, 100% F, mean FTCD 3.2, mean CPD 9.3

Exclusion criteria included currently participating in psychotherapy, unstable medical conditions, or demonstrated psychological instability


Interventions1. Depression focused treatment for smoking cessation (cognitive behavioral analysis system of psychotherapy; CBASP). (10 individual counselling sessions, on average 1 session of 60 min per wk)

2. Time and contact health education control focused on health and wellness (HW) (10 individual counselling sessions, on average 1 session of 60 min per wk)

Both conditions included standard behavioral and motivational smoking cessation counselling (15 min per session for both groups) in addition to the varied treatment component (45 min per session)


OutcomesAbstinence at 6 m follow-up after ending treatment (7-day PP and CA: no smoking from EOT)

Validation: No

Unpublished abstinence outcome data


NotesThe amount of time between end of treatment and delivery varied across participants. Analysis: psychosocial mood management comparison 1 and 2


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskAdaptive randomisation

Allocation concealment (selection bias)Unclear riskNo information

Blinding (performance bias and detection bias)
All outcomes
High riskIt is not possible to blind the participants and therapists for a psychosocial intervention

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskITT. Unclear response rates

Covey 1999

MethodsStudy design: RCT, subgroup past depression (post hoc)

Setting: USA, university

Recruitment: Notices posted at university and advertisements in newspaper


Participants36 adult smokers (1: N = 14; 2: N = 22) with past major depression according to the Schedule for Affective Disorders-Lifetime version.

All study participants: mean age 37, 64% F, mean CPD 32.

Exclusion criteria for all study participants were serious medical illness, a current psychiatric disorder including major depression, drugs or alcohol abuse or dependence, and a history of a psychotic illness.

A history of major depression was not an exclusion criteria.


Interventions1. Naltrexone (long-acting opiate antagonist) (daily for four wks: 25 mg for 3 d prior to QD, 50 mg on QD, if well tolerated increased to 75 mg)

2. Placebo (daily for four wks)

Both arms: Weekly individual behavioural counselling sessions (six times?)


OutcomesAbstinence at 6 m follow-up after ending treatment (7-day PP)

Validation: not at 6 m

Published abstinence outcome data


NotesAnalysis: other pharmacotherapy comparison, not in meta-analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo information

Allocation concealment (selection bias)Unclear riskNo information

Blinding (performance bias and detection bias)
All outcomes
Unclear riskPlacebo controlled study; double blind trial, but no explanation in the article

Incomplete outcome data (attrition bias)
All outcomes
High riskNot a complete ITT

Covey 2002

MethodsStudy design: RCT, past depression

Setting: USA, Clinic site

Recruitment: Newspaper and other print advertisements


Participants134 adult smokers (1: N = 68 ; 2: N = 66) with history of major depression according to DSM-III-R for at least one episode of major depression, which must have remitted more than 6 months before the start of the study (SCID).

Mean age 44.5, 63.5% F, mean FTCD 6.5, mean CPD 28.2, mean BDI 8.0, mean CES-D 14.9.

Exclusion criteria were serious medical illness; use of a psychotropic medication, major depression, alcohol or drug dependence, panic disorder, posttraumatic stress disorder, anorexia nervosa, or bulimia nervosa within the past 6 months; lifetime diagnosis of bipolar disorder, antisocial or schizotypal personality disorder, severe borderline personality disorder, obsessive-compulsive disorder, or psychosis including schizophrenia


Interventions1. Sertraline (selective serotonin reuptake inhibitor) (11.3 weeks in total: 1 wk placebo washout, 3 wks medication build up before the QD, 6 wks 200 mg/d, 9 d taper period)

2. Placebo (same schedule as sertraline)

Both arms: Intensive individual cessation counselling during 9 clinic visits, 45 min per session, incorporated standard smoking cessation techniques and was augmented by a supportive approach designed to help the smoker recognise, express, and manage negative affects related to the effort to quit


OutcomesAbstinence at 6 m follow-up (7-day PP)

Validation: serum cotinine < 25 ng/ml

Published abstinence outcome data


NotesAnalysis: sertraline comparison 11, not in meta-analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk'Medications were provided in prepared bottles that were numbered according to the randomisation schedule and dispensed at each visit'

Allocation concealment (selection bias)Low riskAll study staff were blinded to treatment assignment

Blinding (performance bias and detection bias)
All outcomes
Unclear riskParticipants were blind for medication and all study staff were blinded to treatment assignment

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskITT. Unclear response rates

Duffy 2006

MethodsStudy design: RCT, subgroup current depression (post hoc)

Setting: USA, hospital

Recruitment: Waiting room of the clinic


Participants64 Adult patients (1: N = 35; 2: N = 29) with head and neck cancer who smoked in the past 6 months and have probable depression according to Geriatric Depression Scale-Short Form ≥ 4

All study participants: mean age 57, 16% F, Probable depression 69%, Smoker past 6 months 74%

Subgroup participants: No information

Exclusion criteria included distant metastatic disease and/or were terminal; had unstable psychiatric/mental conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, severe major depression (Hamilton Depression Rating Scale scores > 20) or dementia


InterventionsMultifaceted intervention for smoking, depression and alcohol

All participants received 45-min nursing baseline assessment for smoking and depression followed by brief counselling related to these disorders

1. Tailored smoking and depression intervention: CBT workbook plus 9 to 11 sessions of CBT telephone counselling plus pharmacologic management (NRT and/or bupropion and antidepressants)

2. Enhanced usual care for smoking and depression: A handout for resources (referral)


OutcomesAbstinence at 6m follow-up (PP, CA, PA unclear; "Quitters: those who were not currently smoking at 6 m of follow-up")

Validation: No

Published abstinence outcome data


NotesAnalysis: psychosocial mood management comparison 1, not in meta-analysis because of pharmacotherapy and mood management in the experimental condition


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo information

Allocation concealment (selection bias)Unclear riskNo information

Blinding (performance bias and detection bias)
All outcomes
Unclear riskNo information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskITT. Unclear response rates for subgroup current depression

Hall 1994

MethodsStudy design: RCT, subgroup past depression (post hoc)

Setting: USA, clinic

Recruitment: Announcements about the program or referrals


Participants46 adult smokers (1: N = 29 ; 2: N = 17) with a past history of major depression according to DSM-III (DIS)

All study participants: mean age 40.6, 52% F, mean FTCD 6.4, mean CPD 24.9, 31% history of MDD

Subgroup history of MDD: mean BDI 6.3

Exclusion criteria included alcohol or drug problems within the past 6 m; current treatment for a psychiatric problem; or hospitalisation during the past year because of psychiatric illness


Interventions1. Cognitive-behavioural intervention, content same as standard treatment (see 2) plus mood management (teaching and practicing cognitive-behavioural skills: increasing pleasant activities and social contacts, identifying and modifying maladaptive thoughts, relaxation training), 10 2-hour group sessions over 8 wks

2. Standard treatment, content included information about the health consequences of smoking, prescription and monitoring of nicotine gum and development personal plan for abstinence from smoking, 5 group sessions over 8 wks

Both arms: Nicotine gum (2 mg: 8 wks as needed, from 9 - 12 wks taper to 0 pieces p/d, 4 - 6 m use in high risk situations)


OutcomesAbstinence at 6 and 12 m (7-day PP and CA: Abstinence at all assessments)

Validation: CO ≤ 10 ppm (6 and 12 m) and urine cotinines ≤ 60 ng/ml (12 m)

Published abstinence outcome data


NotesDIS: Diagnostic Interview Schedule

Analysis: psychosocial mood management comparison 2


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo information

Allocation concealment (selection bias)Unclear riskNo information

Blinding (performance bias and detection bias)
All outcomes
High riskNo information of blinding in the article. However, it is not possible to blind the participants for a psychosocial intervention

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskITT. No information regarding response rates for subgroup past depression

Hall 1996

MethodsStudy design: RCT, 2 x 2 design, subgroup past depression (pre-stated stratification)

Setting: USA, university

Recruitment: Media, flyers and word of mouth


Participants44 adult smokers with a past history of major depression according to DSM-III (DIS).

All study participants: mean age 39.7 , 52% F, mean FTCD 6.4, mean CPD 23.8, 22% history of MDD, mean BDI 6.7

Exclusion criteria included current alcohol or drug problems, current mental health treatment, or use of psychoactive drugs, current MDD (within the past 3 m)


Interventions1. Mood Management (MM) intervention, content focuses on developing skills for managing affective distress associated with quitting smoking and relapse, monitoring mood, thoughts, social factors, increasing pleasant activities, decreasing negative thoughts, relaxation training plus nicotine gum 2 mg

2. Health Education (HE) intervention, content included health related information, development personalized plan to quit smoking and weekly modification of that plan, personal motivations for quitting, sources of social support, proper use of nicotine gum, successes and difficulties in maintaining nonsmoking plus nicotine gum 2 mg

3. MM intervention (see 1) plus placebo gum

4. HE intervention (see 2) plus placebo gum

Both psychological interventions were provided in a 10 session group format over an 8-wk period. The group quit date was during the 3rd session. Nicotine gum was first provided during that session (first 3 wks: one piece of gum/hour for at least 12 hr/day; additional 5 wks: gum used as needed; wk 8-11: taper use; after week 11: gum for emergency urges; participants were abstinent at the end of 6 m)


OutcomesAbstinence at 6 and 12 months after ending treatment (7-day PP and CA: abstinence at wk 8, 12, 26, 52)

Validation: CO ≤ 10 ppm (6 m) and urine cotinines ≤ 60 ng/ml (12 m)

Published abstinence outcome data


NotesAnalysis: 2 x 2 design: the gum and the placebo arms were collapsed in psychosocial mood management comparison 2. The HE and the MM arms were collapsed in the NRT analysis comparison 13


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo information

Allocation concealment (selection bias)Unclear riskNo information

Blinding (performance bias and detection bias)
All outcomes
Unclear riskParticipants: Blinding for medication but not for psychosocial intervention. Study staff: no info

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskITT. No information regarding response rates for subgroup past depression

Hall 1998

MethodsStudy design: RCT, 2 x 2 design, subgroup past depression (pre-stated stratification)

Setting: USA, university

Recruitment: Public service and newspaper announcements


Participants65 adult smokers (1: N = 17; 2: N = 17; 3: N = 15; 4: N = 16) with a history of major depression according to DSM-III (DIS) (50 smokers with recurrent episodes), mean age 41.1, 42% F, mean FTCD 5.5, mean CPD 21.8, mean BDI 12.1

Exclusion criteria were current MDD (within 3 m), use of prescribed psychotropic drugs, use of alcohol or other non nicotine drugs, use of monoamine oxidase inhibitor within the last 2 wks


Interventions1. CB (Cognitive Behavioural) treatment plus nortriptyline

2. CB treatment plus placebo 2

3. HE (Health Education) intervention plus nortriptyline

4. HE intervention plus placebo

Nortriptyline (antidepressant) was dispensed from wk 1 through wk 12: 25 mg/d for 3 d, 50 mg/d for 4 d, increased to 75 mg/d if therapeutic level had not been reached in wk 2, if necessary increased to 100 mg/d in wk 4, tapered during wk 13.

CB treatment: Sessions focused on mood management skills to manage dysphoria and maintain non smoking, including methods for increasing pleasant activities and positive social contacts, decrease relapse-related thoughts and rational-emotive techniques. (10, 2-hour group sessions for 8 wks)

HE intervention: Provided health related information and facilitated discussion, development of a plan to quit smoking and weekly modification of that plan. (5, 90-min group sessions for 8 wks)

Psychological treatment occurred from wk 4 through wk 12, smoking quit date was in wk 5


OutcomesAbstinence at 6 and 12 months after ending treatment (7-day PP)

Validation: CO ≤ 10 ppm and urine cotinines ≤ 341 nmol/L

Published abstinence outcome data


NotesAnalysis: 2 x 2 design: The nortriptyline and the placebo arms were collapsed in the psychosocial mood management comparison 2. The CB and the HE arms were collapsed in the nortriptyline comparison 8, not in meta-analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputerised randomisation program

Allocation concealment (selection bias)Unclear riskNo information

Blinding (performance bias and detection bias)
All outcomes
Unclear riskParticipants: Blinding for medication but not for psychosocial intervention. Study staff: No info

Incomplete outcome data (attrition bias)
All outcomes
Low riskITT. Response rates were 82.4% for experimental 1, 82.4% for experimental 2, 86.7% for experimental 3 and 81.3% for the control group at 12 m follow-up

Hall 2002

MethodsStudy design: RCT, 2 x 3 design, subgroup past depression (pre-stated stratification)

Setting: USA, university

Recruitment: Advertising, public service announcements and flyers


Participants73 adult smokers (1: N = 14; 2: N = 11; 3: N = 12; 4: N = 12; 5: N = 12; 6: N = 12) with history of major depression according to Structured Clinical Interview for DSM-IV

All study participants: mean age 39.4 , 44% F, mean FTCD 4.8

Exclusion criteria included use of a monoamine oxidase inhibitor within 2 wks, bipolar disease, current major depression, treatment for alcohol or drug use within 6 m, psychiatric hospitalisation within 1 yr, use of psychiatric medication, suicidal or psychotic symptoms, and current NRT use


Interventions1. Placebo plus medical management intervention

2. Placebo plus psychological intervention

3. Nortriptyline plus medical management intervention

4. Nortriptyline plus psychological intervention

5. Bupropion plus medical management intervention

6. Bupropion plus psychological intervention

Medical Management intervention: advice to stop smoking, antidepressant medication, adverse effects monitoring, and educational materials. During wk 1 the physician reviewed the treatment rationale and prescription instructions, discussed behavioral factors and established a quit date during wk 5. During wk 2, 6, 11 participants were queried about cessation progress (wk 1: 10-20 min. visit; wk 2, 6, 11: 5 min visits)

Psychological Intervention: Medical Management intervention plus additional 5 group 90 min. sessions (wk 4: 1 session; wk 5: 2 sessions; wk 7: 1 session; wk 11: 1 session): included health related information for mood management, smoking cessation and discussion of cessation, development and weekly modification of a quit smoking plan.

Bupropion:150 mg/d for 3 d; from day 4 until wk 12: 300 mg/d; decreased to 150 mg/d for 3d, then discontinued.

Nortriptyline: was dispensed from wk 1 through wk 12: 25 mg/d for 3 d, 50 mg/d for 4 d, increased to 75 mg/d if therapeutic level had not been reached in wk 2, if necessary increased to 100 mg/d in wk 4, tapered during wk 1


OutcomesAbstinence at 52 wks after baseline measurement (7-day PP)

Validation: CO ≤ 10 ppm and urine cotinines ≤ 60 ng/mL

Published abstinence outcome data


NotesAnalysis: antidepressants comparison 4. Only information available which compared nortriptyline versus bupropion: the medical management intervention and the psychological intervention arms were collapsed in the analysis (intervention 3 and 4 versus intervention 5 and 6). Not included in the meta-analysis, because of no placebo control group


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo information

Allocation concealment (selection bias)Unclear riskNo information

Blinding (performance bias and detection bias)
All outcomes
Unclear riskParticipants: Blinding for medication but not for psychosocial intervention. Study staff: ? No explanation about double blind

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskITT. No information regarding response rates for subgroup past depression

Hall 2006

MethodsStudy design: RCT, current depression

Setting: USA, mental health outpatient

Recruitment: Provider referral, invitation letters and flyers


Participants322 adult smokers (1: N = 163; 2: N = 159) with current unipolar depression according to the Primary Care Evaluation of Mental Disorders, mean age 41.9, 70% F, mean FTCD 4.0, mean CPD 15.6, mean BDI 21.0, 83.3% current MDD, 54.7% recurrent MDD, and the desire to quit smoking was not a prerequisite for participation

Exclusion criteria included history of bipolar disorder, presence of a condition that contraindicated use of the pharmacological treatments


Interventions1. Staged care intervention: Stage 1: Computerised motivational feedback (Four 15 min treatment sessions at baseline, month 3, 6, and 12); Stage 2: Cessation treatment program for participants who reached contemplation stage on basis of stage 1 (N = 53), including psychological counselling, nicotine patches and if necessary use of bupropion (Six 30 min session for 8 wks)

2. Brief contact and referral consisted of providing participants at the first visit a folder containing a list of referrals to smoking cessation programs and a stop-smoking guide


OutcomesAbstinence at 6, 12 and 18 m (7-day PP)

Validation: CO ≤ 10 ppm

Published abstinence outcome data


NotesAnalysis: Other comparison, not in meta-analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskThe randomisation allocation list was computer generated by statistical staff

Allocation concealment (selection bias)Unclear riskNo information

Blinding (performance bias and detection bias)
All outcomes
High riskInterviewers who did the assessments were not informed of participant experimental condition. However, it is not possible to blind the participants for a psychosocial intervention

Incomplete outcome data (attrition bias)
All outcomes
Low riskITT. Response rates were 74.8% for experimental group and 69.2% for control group at 18m follow-up

Hall 2009

MethodsStudy design: Open RCT, subgroup with past depression (pre-stated stratification)

Setting: USA, smoking treatment research clinic

Recruitment: Advertising, public service announcements and flyers


Participants113 adult smokers of 50 years and older (1: N = 28; 2: N = 29; 3: N = 27; 4: N = 29) with a history of major depression according to the Computerized Diagnostic Interview Schedule for DSM-IV (CDIS).

All study participants: mean age 56.7, 40% F, mean FTCD 4.8, mean CPD 20.5

Exclusion criteria included life-time bipolar disorder, current major depressive disorder, current use of any psychiatric medication, treatment for drug or alcohol use within 6 m, psychiatric hospitalisation within 1 yr


Interventions1. Extended CBT and Extended NRT (E-combined). Standard treatment combined with extended CBT and extended NRT (NRT was reinforced by counsellor).

2. Extended CBT (E-CBT): Standard treatment + 11 individual CBT treatment sessions after the 5 group sessions from wk 10 to 52. CBT included motivation, mood management, weight control, social support and withdrawal/dependence. Sessions lasted 20-40 min.

3. Extended NRT (E-NRT): Standard treatment + NRT till wk 52

4. Standard treatment (ST): 12 wks of sustained release bupropion (150 mg/d first; from wk 2 300 mg/d) and 10 wks of 2 mg and 4 mg nicotine gum, and received 5 group counselling sessions (wk 1, 3 (2 sessions), 5 and 8) from a counsellor and a self-help manual. No further treatment after wk 12


OutcomesAbstinence at 24 wks, 52 wks, 64 wks and 104 wks after randomisation (7-day PP).

Validation: CO ≤ 10 ppm and anatabine/anabasine levels of ≤ 2 mg/ml

Unpublished abstinence outcome data


NotesAnalysis: arm 2 was compared with arm 4 in the psychosocial mood management comparison 2, not in meta-analysis. Arm 3 was compared with arm 4 in the NRT comparison, not in meta-analysis because of no placebo control


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskThe randomisation allocation list was computer generated by statistical staff

Allocation concealment (selection bias)Low riskAssignment of individual participants by subject number was transmitted electronically to clinical staff

Blinding (performance bias and detection bias)
All outcomes
High riskParticipants: no blinding for psychosocial intervention or medication. Study staff: no info

Incomplete outcome data (attrition bias)
All outcomes
Low riskITT. Response rates were 89.3% for condition 1, 79.3% for condition 2, 81.5% for condition 3 and 96.6% for condition 4 at 12-m follow-up

Hayes 2010

MethodsStudy design: RCT, subgroup current depression (post hoc)

Setting: USA, home healthcare nursing services

Recruitment: Referred by nurses


Participants179 medically ill smokers (1: N = 87; 2: N = 92 ) with current depressive symptoms (CES-D ≥ 16), mean age 55.2, 52% F, mean FTCD 6.6, mean CPD 17.7, mean CES-D 28.3.

133 medically ill smokers (1: N = 60; 2: N = 73) with current depressive symptoms (CES-D >20), mean age 54.7, 51% F, mean FTCD 6.7, mean CPD 27.5, mean CES-D 31.9.

Participants did not have to want to quit smoking to be in the study

Exclusion criteria included currently using NRT or treatment for smoking


InterventionsMotivational enhancement: Brief counselling tailored to the patient's readiness to quit delivered using motivational interviewing along with provision of CO feedback (delivered over 3 home visits (20-30 min per session) by a nurse plus an additional phone call (5 min))

Standard care: Brief counselling based on clinical practice guidelines such as the 5As (during a single home visit by a nurse (5-15 min)

Both treatments were integrated into a regular medical visit, such that patients were not being seen exclusively for smoking cessation. At first visit all patients received a self-help quit smoking manual tailored for older and medically ill smokers


OutcomesAbstinence at 6 m and 12 m (7-day PP and CA: no smoking since the previous assessment (2, 6 and 12 m follow-up))

Validation: CO < 10 ppm

Unpublished abstinence outcome data


NotesCES-D > 20 suggests high levels of depressed mood among medical population. In the analyses we will use CES ≥ 16 smokers

Analysis: psychosocial comparison, not in meta-analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskUrn randomisation was used

Allocation concealment (selection bias)Unclear riskNo information

Blinding (performance bias and detection bias)
All outcomes
High riskParticipants: Blinding for psychosocial intervention is not possible. Study staff: No explanation

Incomplete outcome data (attrition bias)
All outcomes
Low riskITT. Response rates for all study participants were 80.4% at 6 m and 70.5% at 12 m

Hayford 1999

MethodsStudy design: RCT, subgroup with past depression (post hoc)

Setting: USA, clinical, university

Recruitment: Advertisements and press releases


Participants114 adult smokers (1: N = 35; 2: N = 26; 3: N = 22; 4: N = 31) with past depression according to structured clinical interview for DSM-III. Subgroup non-alcoholic smokers: (N = 95) mean age 43.5, 66% F, mean FTQ 7.5, mean CPD 27.6, mean BDI 5.8. Subgroup recovering alcoholic smokers: (N = 19) mean age 42.2, 63% F, mean FTQ 8.3, mean CPD 32.3, mean BDI 5.5.

Exclusion criteria included an unstable medical or psychiatric illness including a current major depressive episode, history of alcohol or non-nicotine substance dependence within the past year, prior use of bupropion, and current use of psychotropic medications


Interventions1. Bupropion (7 wks: 50mg twice daily)

2. Bupropion (7 wks: 150 mg every morning and placebo every evening)

3. Bupropion (7 wks: 150 mg/d 3d; then 150 mg twice daily)

4. Placebo (7 wks: twice daily)

All arms: Psychosocial treatment, a physician's advice to stop smoking and self-help material at baseline, target quit date one wk after beginning medication, weekly brief counselling for 7 wks (10-15 min per session). Telephoned 3 days after QD and after 4, 5, 7, 8, 9, 10 and 11 m


OutcomesAbstinence at 12 m (7-day PP)

Validation: CO ≤ 10 ppm

Published abstinence outcome data


NotesIn the review comparison arm 3 vs arm 4

Analysis: bupropion comparison 6


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo information

Allocation concealment (selection bias)Unclear riskNo information

Blinding (performance bias and detection bias)
All outcomes
Unclear riskParticipants: Blinding for medication but not for psychosocial intervention. Study staff: ? No explanation about meaning double blind

Incomplete outcome data (attrition bias)
All outcomes
High riskITT. Response rates for all study participants were 65% for condition 1, 64% for condition 2, 71% for condition 3 and 57% for condition 4 at 12 m follow-up

Kahler 2008

MethodsStudy design: RCT, subgroup past depression (post hoc)

Setting: USA, University

Recruitment: Postings on community bulletin boards, newspaper and radio advertisements


Participants79 Heavy drinking and smoking adults (1:N = 37; 2: N = 42) with past major depression according to the SCID, mean age 41.6, 48% F, mean FTCD 4.9, mean CPD 20.2, mean CES-D 10.5.

Exclusion criteria included full DSM-IV criteria for alcohol dependence in the past 12 m, current (past month) affective disorder.


Interventions1. Standard individual smoking cessation treatment incorporating a brief alcohol intervention (3 wks with 4 sessions: wk 1 session 1 (70 min), QD in week 2 session 2 (40 min ), session 3 and 4 (20 min)

2. Standard smoking cessation treatment (3 wks with 4 sessions: same schedule as experimental)

Both arms: NRT - nicotine patch (8 weeks: 21 mg for 4 wks, followed by 14 mg for 2 wks, and then 7 mg for 2 wks)

No depression component in both arms


OutcomesAbstinence at 6 m follow-up after QD (7-day PP)

Validation: CO ≤ 10 ppm and cotinine ≤ 15 ng/ml

Unpublished abstinence outcome data


NotesAnalysis: psychosocial comparison, not in meta-analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskAllocation sequence was generated by the computer-based urn randomisation technique

Allocation concealment (selection bias)Low riskData for randomisation were sent by research assistants to the lead researcher, who conducted the computer based randomisation and informed the treatment provider

Blinding (performance bias and detection bias)
All outcomes
High riskIt is not possible to blind the participants for a psychosocial intervention

Incomplete outcome data (attrition bias)
All outcomes
Low riskITT. Response rates for all study participants were 91.5% for the experimental group and 90.8% for the control group at 6-m follow-up

Killen 2000

MethodsStudy design: RCT, subgroup current depression (post hoc) and subgroup past depression (post hoc)

Setting: USA

Recruitment: Local newspapers


Participants33 adult smokers (1: N = 11; 2: N = 12; 3: N = 10) with current depressive symptoms (CES-D ≥ 16), mean age 44.0, 39%F, mean FTQ 15.3, mean CPD 26.3, mean CES-D 22.3

44 adult smokers (1: N = 19; 2: N = 9; 3: N = 16) with past major depression according to SCID, mean age 44.2, 52% F, mean modified FTQ 14.5, mean CPD 22.9, mean CES-D 11.5

Exclusion criteria included active treatment for or reported current depression or substance abuse, taking antidepressants, psychotropics


Interventions1. Paroxetine (antidepressant) (20 mg/d) (9 wks)

2. Paroxetine (40 mg/d) (9 wks)

3. Placebo (9 wks)

All arms: Nicotine patch for 8 wks (21 mg during wks 1-6, 14 mg in wk 7, 7 mg in wk 8), print-based self-help treatment manual and two 15-min brief behavioral counselling interventions (wk 1 and 4)


OutcomesAbstinence at 6 m (7-day PP)

Validation: CO < 9 ppm and saliva cotinine < 20 ng/ml

Unpublished abstinence outcome data


NotesAnalysis: arm 1 versus arm 3 and arm 2 versus arm 3, both in paroxetine comparisons 5 and 9. Not in meta-analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo information

Allocation concealment (selection bias)Unclear riskNo information

Blinding (performance bias and detection bias)
All outcomes
Unclear riskDouble blind: Participants were blinded for medication, study staff = no info

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskITT. No information regarding response rates

Killen 2008

MethodsStudy design: RCT, subgroup current depression (post hoc) and subgroup past depression (post hoc)

Open-label treatment phase followed by extended treatment phase. Randomization conducted prior to entry open-label treatment phase

Setting: USA, community smoking cessation clinic

Recruitment: Advertisements in local newspapers, radio, community website, notices


Participants27 adult smokers (1: N = 15; 2: N = 12) with current depressive symptoms (CES-D ≥ 16), mean age 41.5, 33%F, mean FTQ 16.3, mean CPD 19.9, mean CES-D 22.7

31 adult smokers (1: N = 19; 2: N = 12) with past depression according to structured clinical interview for DSM-IV, mean age 45.1, 32% F, mean FTQ 17.4 , mean CPD 21.1, mean CES-D 10.3

Exclusion criteria included bipolar disorder, schizophrenia, receiving active treatment for or reporting current depression or substance abuse, medication use that could interact with bupropion


InterventionsOpen label (8 wks): all participants received bupropion (9 wks: 150 mg for 3d; then 300 mg/d), nicotine patch (8 wks: 21 mg for four wks, 14 mg for 2 wks, 7 mg for 2 wks), CBT individually (baseline, quit week, and wks 1, 2, 4 and 6 for 30 min per session) followed by extended treatment (12 wks):

1. Extended CBT (4 30-min sessions in wk 8, 12, 16 and 20) plus voicemail monitoring and telephone counselling

2. Telephone-based general support (4 5-min calls in wk 8, 12, 16 and 20)


OutcomesAbstinence at 12 m (7-day PP)

Validation: CO ≤ 10 ppm

Unpublished abstinence outcome data


NotesAnalysis: psychosocial comparison, not in meta-analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo information

Allocation concealment (selection bias)Unclear riskNo information

Blinding (performance bias and detection bias)
All outcomes
High riskThe research team and participants were blinded to extended treatment assignment to the end of the open-label phase. Furthermore, participants: No blinding for psychosocial intervention or medication. Study staff?

Incomplete outcome data (attrition bias)
All outcomes
Low riskITT. Response rates for all study participants were 90% for experimental group and 89% for control group at 12-m follow-up

Kinnunen 2008

MethodsStudy design: RCT, subgroup current depression (post hoc)

Setting: USA, community

Recruitment: Newspaper advertisements and press releases


Participants196 adult smokers (1: N = 126; 2: N = 70) with current depression according to CES-D ≥ 16, mean age 38.5, 56% F, mean FTCD 5.9, mean CPD 23.5, mean CES-D 24.6.

Exclusion criteria included current use of psychiatric medications.


Interventions1. Nicotine gum (2 or 4 mg) (recommendation for 9-15 pieces of gum/day for 2 m, after that weaning from the gum

2. Placebo

Both arms: Brief individual counselling (1 visit before QD; 9 visits after QD; 1, 7, 14, 30, 60, 90, 180, 270, 365 days; 10 min per session) and a booklet


OutcomesAbstinence at 12 m (CA, relapsed: ≥ 7 consecutive days of smoking or smoking on ≥ 3 consecutive weekends)

Validation: CO < 8 ppm

Published abstinence outcome data


NotesAnalysis: NRT comparison, not in meta-analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo information

Allocation concealment (selection bias)Unclear riskNo information

Blinding (performance bias and detection bias)
All outcomes
Unclear riskParticipants: Blinding for medication but not for psychosocial intervention. Study staff: ? No explanation about meaning double blind

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskITT. No information regarding response rates

Kodl 2008

MethodsStudy design: RCT, subgroup current depression (post hoc)

Setting: USA, 3 substance abuse treatment sites

Recruitment: Study protocol was described to all new patients


Participants191 adult alcohol dependent smokers (1: N = 103; 2: N = 88) with current depression according to BDI-II ≥ 14, mean age 39.2, 37% F, mean BDI-II 22.7


Interventions1. Concurrent smoking cessation treatment, individual behavioural (1 hour face-to-face counselling session; QD; 3 follow-up sessions) and NRT (recommendation 21 mg for 6 wks, 14 mg for 2 wk and 7 mg for 2 wks; participants who smoked more than 20 cigarettes were offered a combination of nicotine patches and nicotine gum).

2. Control: Delayed smoking cessation treatment (same as experimental only 6 m after study enrolment)

Both arms: Intensive alcohol dependence treatment followed by longer period of less intensive treatment

Exclusion criteria included severe psychiatric disorder


OutcomesAbstinence at 12 and 18 months after baseline (7-day PP)

Validation: CO

Unpublished abstinence outcome data


NotesAnalysis: Other comparison, not in meta-analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskA computer-generated random sequence

Allocation concealment (selection bias)Low riskThe study co-ordinator obtained the treatment assignment from an independent office holding the master list

Blinding (performance bias and detection bias)
All outcomes
High riskData collectors were blind to treatment assignment. It is not possible to blind for concurrent or delayed intervention

Incomplete outcome data (attrition bias)
All outcomes
Low riskITT, Response rates for all study participants were 72% at 12m and 80% at 18m, no differences between treatment groups

Levine 2003

MethodsStudy design: RCT, subgroup current depression (post hoc) and subgroup past depression (post hoc)

Setting: USA, community

Recruitment: Newspaper advertisements, flyers, and public service announcements


Participants64 adult smoking women (1: N = 20; 2: N = 25; 3: N = 19) with current depressive symptoms (BDI ≥ 10), motivated to quit, concerned about gaining weight, mean age 44.3, mean FTCD 5.4, mean CPD 22.3, mean BDI 15.4

115 adult smoking women (1: N = 40; 2: N = 43; 3: N = 32) with a lifetime history major depression according to the Inventory to Diagnose Depression-Lifetime Version, motivated to quit, concerned about gaining weight, mean age 45.1, mean FTCD 5.4, mean CPD 22.1, mean BDI 9.6, 34.8% BDI ≥ 10

Exclusion criteria included being hospitalised for treatment of any psychiatric problem during the last year, current, untreated depression, treated for serious medical conditions.

Women stable on medications over the previous year were eligible for treatment


InterventionsAll participants received a group based standard cognitive behavioural smoking cessation treatment. In addition women were randomly assigned to one of three adjunctive treatments to address the issue of weight gain:

1. CBT designed to promote acceptance of a modest weight gain

2. Behavioural weight control to prevent post-cessation weight gain (weight control)

3. Standard counselling alone in which weight gain was not explicitly addressed

Each treatment condition consisted of 10 90-min sessions in 7 wks

No pharmacotherapy


OutcomesAbstinence at 6 and 12 m post-quit (7-day PP and CA: no relapse since quit day)

Validated: CO ≤ 8 ppm

Unpublished abstinence outcome data


NotesAnalysis: psychosocial comparison, not in meta-analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputerised randomisation program

Allocation concealment (selection bias)Low risk"Participants did not learn of their treatment condition until the first treatment session."

Blinding (performance bias and detection bias)
All outcomes
Unclear riskParticipants: Blinding for psychosocial intervention is not possible. Study staff: ? No explanation

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskITT. No information regarding response rates

Levine 2010

MethodsStudy design: RCT, 2 x 2 design, subgroup current depression (post hoc)

Setting: USA, community

Recruitment: posters, advertisements, and mailings


Participants53 adult smoking women (1: N = 12; 2: N = 12; 3: N = 17; 4: N = 12) with current depressive symptoms (BDI ≥ 10), motivated to quit, concerned about gaining weight, mean age 43, mean FTCD 6.1, mean CPD 23.2, mean BDI 14.6

Exclusion criteria included current major depression, drug or alcohol dependence within the past year, use of medications contraindicated with bupropion


InterventionsAll participants received counselling involved 12, 90-minute group sessions delivered over 3 m. The CBT and standard interventions differed only in the additional content related to weight concerns.

1. CBT designed to promote acceptance of a modest weight gain plus bupropion (6 m: 150 mg/d 2d; then 150 mg twice daily)

2. CBT designed to promote acceptance of a modest weight gain plus placebo (same schedule as bupropion)

3. Standard counselling alone in which weight gain was not explicitly addressed plus bupropion (6 m: 150 mg/d 2d; then 150 mg twice daily)

4. Standard counselling alone in which weight gain was not explicitly addressed plus placebo (same schedule as bupropion)


OutcomesAbstinence at 6 and 12 m post-quit (7-day PP and PA: 7-day PP at each point prior and including the current assessment point)

Validated: CO ≤ 8 ppm and saliva cotinine < 15 μg/L

Unpublished abstinence outcome data


NotesAnalysis: 2 x 2 design: the CBT and the standard counselling arms were collapsed in the bupropion comparison 3. The bupropion and placebo arms were collapsed in the psychosocial comparison, not in meta-analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputerised randomisation program

Allocation concealment (selection bias)Unclear riskNo information

Blinding (performance bias and detection bias)
All outcomes
Unclear riskParticipants: Blinding for medication but not for psychosocial intervention. Study staff: no info

Incomplete outcome data (attrition bias)
All outcomes
High riskITT. Response rates for all study participants were 53.8% for experimental 1, 42.5% for experimental 2, 51.7% for experimental 3 and 41.8% for the control group at 12 m follow-up

MacPherson 2010

MethodsStudy design: RCT, current depression

Setting: USA, university and community

Recruitment: Radio, web-based, and newspaper advertisements


Participants68 adult smokers (1: N = 35; 2: N = 33) with mildly elevated depressive symptoms (BDI-II ≥ 10), mean age 43.8 , 49% F, mean FTCD 5.9, mean CPD 18.1, mean BDI-II 10.6.

Exclusion criteria included a current Axis I disorder (including MDD) assessed by the SCID-NP, current use of psychotropic medication, current participation in psychotherapy, physical concerns contraindicating use of nicotine patch


Interventions1. Behavioural Activation Treatment for Smoking (BATS) (eight 1 hr wkly group sessions: 30 min ST and 30 m BATS), content included treatment rationale on structuring a variety of reinforcing activities to promote a more rewarding non smoking lifestyle, planning and monitoring of activities, identifying values and life goals plus nicotine patch (8 wks: 21 mg for four wks, 14 mg for 2 wks, 7 mg for 2 wks)

2. Standard Treatment (ST) (eight 1 hr wkly group sessions), content included self-monitoring, identifying effective cessation strategies from prior quit attempts, relaxation, coping with triggers, identifying social support, making lifestyle changes, relapse prevention and homework plus nicotine patch (8 wks: 21 mg for four wks, 14 mg for 2 wks, 7 mg for 2 wks)

For both treatments: 8 sessions of group based treatment, Quit data session 4


OutcomesAbstinence at 6 m after quit date (7-day PP and CA: did not smoke since quit date)

Validated: CO ≤ 10 ppm and saliva cotinines ≤ 15 ng/ml

Published abstinence outcome data


Notes26 dropout before start interventions.

Analysis: psychosocial mood management comparison 1


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo information

Allocation concealment (selection bias)Unclear riskNo information

Blinding (performance bias and detection bias)
All outcomes
High riskParticipants: Blinding for psychosocial intervention is not possible. Study staff: Assessments were conducted by research assistants blinded to treatment condition

Incomplete outcome data (attrition bias)
All outcomes
High riskITT. Response rates were 42.9% for experimental and 36.4% for the control group at 6 m follow-up

McAlister 2004

MethodsStudy design: RCT, subgroup current depression (post hoc)

Setting: USA, community and quit line

Recruitment: Mass media promotion


Participants375 adult smokers (1: N = 209; 2: N = 166) with depression according to a single self-report question: "Have you felt sad or blue every day for the last two weeks?", mean age 41.0 , 74.9% F, mean CPD 24.5

The only exclusion criteria was not making a quit attempt within 2 wks


Interventions1. Three self-help booklets (standard advice) plus eligible for telephone counselling, tailored counselling based on recognised guidelines, stages of change, principles of social cognitive theory and motivational interviewing techniques (5 sessions: 1 immediately after enrolment; 2nd 2d before QD, 3rd 1d after QD, 4th 5-7 d after QD, 12-14d after QD)

2. Three self-help booklets (same as experimental)


OutcomesAbstinence at 12 m after presumed QD (PA: maintained cessation: abstinent at the time of call and no more than five single-day slips)

Validation: No

Unpublished abstinence outcome data


NotesAnalysis: psychosocial comparison 12


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskUse of randomisation programme

Allocation concealment (selection bias)Unclear riskNo information

Blinding (performance bias and detection bias)
All outcomes
High riskParticipants: Blinding for psychosocial intervention is not possible. Study staff: No info

Incomplete outcome data (attrition bias)
All outcomes
High riskITT. Response rates for all study participants were 49.9% for the experimental group and 44.1% for the control group at 12 m follow-up

McFall 2010

MethodsStudy design: RCT, subgroup current depression (pre-stated stratification) and subgroup past depression (post hoc)

Setting: Outpatients PTSD clinics at 10 veterans affairs medical centres

Recruitment: Via specialized outpatient PTSD programs


Participants398 veteran smokers(1: N = 205; 2: N = 193) with Post-traumatic Stress Disorder (PTSD) and current major depression according to SCID, mean age 53.3, 7.8%F, mean FTCD 5.9, mean CPD 22.0, 78.6% anti-depressant use

255 veteran smokers (1: N = 121; 2: N = 134) with PTSD with past major depression according to SCID, mean age 54.9, 7.1% F, mean FTCD 5.5, mean CPD 22.0, 75.3% antidepressant use

Exclusion criteria included current psychotic, bipolar, or substance dependence disorder other than nicotine, severe psychiatric symptoms, psychosocial instability, or cognitive impairment


Interventions1. Integrated Care (IC): Smoking cessation treatment integrated within mental care for PTSD delivered by mental health clinicians. IC delivered 5 weekly 30 min core individual tobacco cessation sessions focusing on tobacco use education, behavioral skills for quitting smoking, setting a QD (following session 5), and relapse prevention. Core sessions were followed by 3 follow-ups. Pharmacotherapy (NRT, bupropion, NRT, and varenicline) was described if desired by the participants

2. Referral to smoking cessation clinics (SCC) for usual care. Prescribed medications for quitting. Participating SCCs reported a typical treatment course of 4 to 16 (median, 7) treatment sessions


OutcomesAbstinence at 12 and 18 m follow-up (7-day PP, 12 m PA: Abstinence between 6 and 18 m non-abstinence: seven consecutive days of smoking or smoking for at least once a week for two consecutive weeks)

Validation: CO ≤ 8 ppm and urine cotinine < 100 ng/mL

Unpublished abstinence outcome data


NotesAnalysis: Other comparison, not in meta-analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskA telephone randomisation method

Allocation concealment (selection bias)Low riskA telephone randomisation method

Blinding (performance bias and detection bias)
All outcomes
High risk"Neither site investigators nor patients were blinded with respect to treatment assignment"

Incomplete outcome data (attrition bias)
All outcomes
Low riskITT. Response rates for all study participants were 82.4% for the experimental group and 83.2% for the control group at 18 m follow-up

Muñoz 1997

MethodsStudy design: RCT, subgroup current depression (pre-stated stratification) and subgroup past depression (pre-stated stratification)

Setting: community

Recruitment: television, radio, newspaper, bulletin board announcements, health fairs, community events


Participants53 Spanish speaking Latino smokers (1: N = 28; 2: N = 25) with current MDE according to modified DIS.

53 Spanish speaking Latino smokers (1: N = 26; 2: N = 27) with lifetime past MDE (but not current MDE) according to modified DIS.

All study participants: mean age 35.3, 38.2% F, mean CPD 14.1, mean CES-D 21.3.

Exclusion criteria: none.


Interventions1. Immediate arm: received quit smoking guide (Guía) and the mood management intervention materials (audio cassette including relaxation exercise; booklet for noting number of cigarettes smoked, pleasant activities and mood; self-monitoring chart) by mail.

2. Delayed arm: received quit smoking guide (Guía) by mail and after the 3 m follow-up interview the mood management materials by mail.


OutcomesAbstinence at 6 m after randomisation (7-day PP)

Validation: no

Published abstinence outcome data


NotesAnalysis: psychosocial mood management comparison 1 & 2.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo information

Allocation concealment (selection bias)Unclear riskNo information

Blinding (performance bias and detection bias)
All outcomes
Unclear riskIt is not possible to blind participants for a psychosocial intervention

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskITT

Muñoz 2006a

MethodsStudy 3 in the article

Study design: RCT, subgroup current depression (pre stated stratification) & subgroup past depression (pre stated stratification)

Setting: International, online 11 countries

Recruitment: Press releases and standard links search engines


Participants32 adult English speaking smokers (1: N = 19; 2: N = 13) with current major depressive episodes according to the MDE screener, planning to quit within the next month, mean age 37.9, 69% F, mean FTCD 6.3, mean CPD 21.2, mean CES-D 33.1.

53 adult English speaking smokers (1: N = 25; 2: N = 28) with past major depressive episodes according to the MDE screener, planning to quit within the next month, mean age 36.6, 72% F, mean FTCD 5.1, mean CPD 19.5, mean CES-D 16.3.


Interventions1. Guía + ITEMs + MM: Same as condition 2 plus an 8 lesson mood management course (MM), including self monitoring screens to record cigarettes smoked, mood and anxiety levels, pleasant activities, helpful and harmful thoughts, and contact with helpful people; and relaxation instructions.

2. Guía + ITEMs: The Guía is a self-help smoking cessation web site, covering reasons to stop smoking, prepare to quit, relapse, refuse cigarettes from friends and family, information on nicotine replacement and bupropion, and a self monitoring tool used to track daily consumption of cigarettes. Additional advices for smoking cessation was individually tailored based on responses to the baseline questionnaires. Participants with high levels of nicotine addiction were encouraged to use nicotine replacement therapies. Individually Timed Educational Messages (ITEMs) were emailed (7, 3, 1 day before QD and 1, 3, 7, 14 and 21 days after QD) to all participants for increasing likelihood to log on to the site . The messages included encouraging comments and links to relevant sections of the site.


OutcomesAbstinence at 6 and 12 m (7-day PP)

Validation: No

Unpublished abstinence outcome data


NotesUsage of pharmacological aids?

Analysis: psychosocial mood management comparison 1 & 2


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskAllocation sequence by an automated algorithm programmed into the website

Allocation concealment (selection bias)Low riskCentral allocation (web-based)

Blinding (performance bias and detection bias)
All outcomes
High riskIt is not possible to blind participants for a psychosocial intervention

Incomplete outcome data (attrition bias)
All outcomes
High riskITT. Response rates for all study participants were 34.4% for condition 1 and 31.9% for condition 2 at 12-m follow-up

Muñoz 2006b

MethodsStudy 4 in the article

Study design: RCT, subgroup current depression (pre-stated stratification) and subgroup past depression (pre-stated stratification)

Setting: International, online 11 countries

Recruitment: Press releases and standard links search engines


Participants48 adult Spanish speaking smokers (1: N = 20; 2: N = 28) with current major depressive episodes according to the MDE screener, planning to quit within the next month, mean age 34.0, 44% F, mean FTCD 6.3, mean CPD 23.0, mean CES-D 31.9

52 adult Spanish speaking smokers (1: N = 25; 2: N = 27) with past major depressive episodes according to the MDE screener, planning to quit within the next month, mean age 36.2, 52% F, mean FTCD 5.5, mean CPD 24.0, mean CES-D 11.6


Interventions1. Guía + ITEMs + MM: Same as control group plus an 8 lesson mood management course (MM), including self monitoring screens to record cigarettes smoked, mood and anxiety levels, pleasant activities, helpful and harmful thoughts, and contact with helpful people; and relaxation instructions.

2. Guía + ITEMs: The Guía is a self-help smoking cessation website, covering reasons to stop smoking, prepare to quit, relapse, refuse cigarettes from friends and family, information on nicotine replacement and bupropion, and a self monitoring tool used to track daily consumption of cigarettes. Additional advices for smoking cessation was individually tailored based on responses to the baseline questionnaires. Participants with high levels of nicotine addiction were encouraged to use nicotine replacement therapies. Individually Timed Educational Messages (ITEMs) were emailed (7, 3, 1 day before QD and 1, 3, 7, 14 and 21 days after QD) to all participants for increasing likelihood to log on to the site . The messages included encouraging comments and links to relevant sections of the site.


OutcomesAbstinence at 6 and 12 m (7-day PP)

Validation: None

Unpublished abstinence outcome data


NotesUsage of pharmacological aids?

Analysis: psychosocial mood management comparison 1 and 2


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskAllocation sequence by an automated algorithm programmed into the website

Allocation concealment (selection bias)Low riskCentral allocation (web-based)

Blinding (performance bias and detection bias)
All outcomes
High riskIt is not possible to blind participants for a psychosocial intervention

Incomplete outcome data (attrition bias)
All outcomes
High riskITT. Response rates for all study participants were 60.6% for condition 1 and 62.3% for condition 2 at 12-m follow-up

Muñoz 2009

MethodsStudy design: RCT, subgroup current depression (pre-stated stratification) and subgroup past depression (pre-stated stratification)

Setting: International, online from 68 countries

Recruitment: Google adwords campaigns, search engines, links other websites, media stories, or word of mouth


Participants129 adult smokers (1: N = 31; 2: N = 33; 3: N = 33; 4: N = 32) with current major depressive episodes according to the MDE screener, planning to quit within the next month, mean age 35.3, 42% F, mean FTCD 5.7, mean CPD 19.9, mean CES-D 34.2

174 adult smokers (1: N = 44; 2: N = 42; 3: N = 44; 4: N = 44) with past major depressive episodes according to the MDE screener, planning to quit within the next month, mean age 35.8, 55% F, mean FTCD 5.6, mean CPD 20.4, mean CES-D 17.6


Interventions1. Guía + ITEMs: The Guía plus 'Individually Timed Educational Messages (ITEMs), that is, automated E-mails with links to sections of the Guía keyed to quit date.

2. Guía + ITEMs + MM: The Guía, ITEMs, plus an 8 lesson cognitive-behavioural mood management course.

3. Guía + ITEMs + MM + VG: The Guía, ITEMs, mood management intervention, and a 'virtual group' (an asynchronous bulletin board for mutual support and suggestions).

4. Guía alone: The online static 'Guía', a cigarette counter, and an online journal to record experiences while quitting. The Guía covered reasons to quit, cessation strategies, relapse prevention and management, pharmacological aids, and how to help a smoker quit.


OutcomesAbstinence at 6 and 12 m after QD (7-day PP and PA: defined as "no" response to "During the past [period since last assessment], have you smoked at least part of a cigarette every day for 7 consecutive days?" and "During [period since last assessment], have you smoked part of a cigarette at least once a week for 2 consecutive weeks?"

Validation: No

Unpublished abstinence outcome data


NotesUsage of pharmacological aids?

Analysis: arm 1 was compared with arm 2 in the psychosocial mood management comparisons 1 and 2. Arm 2 was compared with arm 3 in the psychosocial comparison, not in meta-analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskAllocation sequence by an automated algorithm programmed into the website

Allocation concealment (selection bias)Low riskCentral allocation (web-based)

Blinding (performance bias and detection bias)
All outcomes
High riskIt is not possible to blind the participants for a psychosocial intervention. However research assistants were blind to assigned condition

Incomplete outcome data (attrition bias)
All outcomes
Low riskITT. Response rates for all study participants were 68.9% for condition 1, 68.9% for condition 2, 68.1% for condition 3, and 70.9% for condition 4 at 12-m follow-up

Patten 1998

MethodsStudy design: RCT, past depression

Setting: USA, community

Recruitment: Announcements and flyers directed to AA groups


Participants29 adult smoking abstinent alcoholics (1: N = 13; 2: N = 16) with a history of major depression according to DIS-III-R, mean age 41.8, 52% F, mean FTCD 6.9, mean CPD 30.2, mean BDI 12.2, mean HRSD 9.3

Exclusion criteria included current episode of major depression (within the last 3 m), lifetime history of schizophrenia or other major thought disorder, or current use of antidepressant or other psychotropic medications


Interventions1. Behavioural counselling (BC) plus cognitive behavioural mood management (CBT). Content same as control intervention plus mood management training to minimize negative affect during smoking reduction and abstinence: pleasant activities, relaxation, communication and assertiveness skills

2. BC, included behavioural smoking intervention, group support to aid in quitting and smoking reduction

Both interventions: 12 2-hour weekly group sessions. QD in wk 8


OutcomesAbstinence at 12 m follow-up (24 hours- PP and CA: abstinence at post-treatment and 1, 3, 12 m follow-up)

Validation: CO ≤ 10 parts per million or informant report

Published abstinence outcome data


NotesAnalysis: psychosocial mood management comparison 2


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo information

Allocation concealment (selection bias)Unclear riskNo information

Blinding (performance bias and detection bias)
All outcomes
High riskNot possible for psychosocial treatment

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskITT. No information regarding response rates

Piper 2009

MethodsStudy design: RCT, subgroup lifetime depression (post hoc) and subgroup past-year depression (post hoc)

Setting: USA, community

Recruitment: TV, radio, newspaper advertisements, community flyers and earned media


Participants259 adult smokers with a lifetime major depression according to Composite International Diagnostic Interview (CIDI) (1: N = 46; 2: N = 38; 3: N = 42; 4: N = 47; 5: N = 53; 6: N =33), mean age 45.1, 71% F, mean FTCD 5.6, mean CPD 21.2

71 adult smokers with past-year major depression according to CIDI (1: N = 12; 2: N = 10; 3: N = 12; 4: N = 8; 5: N = 17; 6: N = 12), mean age 43.1, 66% F, mean FTCD 5.5, mean CPD 21.0.

Exclusion criteria included current use of any medications contraindicated for use with any of the study pharmacotherapies (f.e. monoamine oxidase inhibitors), any history of psychosis, bipolar disorder


Interventions1. Nicotine patch (24 hr patch; 21, 14, and 7 mg; titrated down during 8 wks post-quit)

2. Nicotine lozenge (2 or 4 mg based on dependence level for 12 wks)

3. Nicotine patch plus lozenge

4. Bupropion (150 mg 2/d for 9 wks total)

5. Bupropion plus lozenge

6. Placebo

All arms: Six 10-20 min individual counselling sessions (baseline; QD; 1, 2, 4, 8 wks after QD), including provided intratreatment social support and training in problem solving and coping skills


OutcomesAbstinence at 6m after quitting (7-day PP)

Validation: CO < 10 ppm

Unpublished abstinence outcome data


NotesData from the lifetime depression was used for analysis and included in the past depression analysis. Some of the participants with lifetime depression may experience current depressive symptoms.

Analysis: arm 4 vs arm 6 in bupropion comparison 6. Arm 1 versus arm 6, arm 2 versus arm 6, arm 3 versus 6, all three were included in the NTR comparison 13


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer randomisation program

Allocation concealment (selection bias)Low riskAllocation sequence was generated by computer-generated random numbers

Blinding (performance bias and detection bias)
All outcomes
Unclear riskParticipants were blinded for medication; Staff were blinded to whether the medication was active or placebo; Only database administrator and study scientist had knowledge of treatment condition and neither interacted with participants or front-line staff on regular basis

Incomplete outcome data (attrition bias)
All outcomes
Low riskITT. For all of the study participants the response rates were very high

Rabius 2007a

MethodsStudy design: RCT, current depression (post hoc)

Setting: USA, community and quit line

Recruitment: Participants recruited from callers seeking information about assistance


Participants5046 adult smokers (1: N = 607 ;2: N = 117; 3: N = 379; 4: N = 366; 5: N = 343; 6: N = 350; 7: N = 2884) (information author) with depression according to a single self report question: "Have you felt sad or blue every day for the last two weeks?", mean age 44.3, 73.3% F, mean CPD 24.9

Inclusion criteria: daily smoking, interest in making a quit attempt within 2 wks. Psychiatric disorders and psychotropic medication were no exclusion criteria


Interventions1. Telephonic counselling, 5 sessions (50 min) (10-14 d before QD, 2-3 d before QD, 1-2 d after QD, 6-9 d after QD, 13-16 d after QD)

2. Telephonic counselling, 7 sessions (80 min)(10-14 d before QD, 2-3 d before QD, 1-2 d after QD, 6-9 d after QD, 13-16 d after QD) , including 2 booster sessions (10 min per booster, wk 4 and 8 after QD)

3. Telephonic counselling, 3 sessions (105 min) (2-3 d before QD, 1-2 d after QD, 6-9 d after QD)

4. Telephonic counselling, 5 sessions (135 min) (2-3 d before QD, 1-2 d after QD, 6-9 d after QD), including 2 booster sessions (10 min per booster, wk 4 and 8 after QD)

5. Telephonic counselling, 5 sessions (210 min) (10-14 d before QD, 2-3 d before QD, 1-2 d after QD, 6-9 d after QD, 13-16 d after QD)

6. Telephonic counselling, 7 sessions (240 min)(10-14 d before QD, 2-3 d before QD, 1-2 d after QD, 6-9 d after QD, 13-16 d after QD), including 2 booster sessions (10 min per booster, wk 4 and 8 after QD)

7. Mailed self-help booklets


OutcomesAbstinence at 6-m follow-up (30-day PP)

Validation: none

Unpublished abstinence outcome data

Unpublished abstinence outcome data


NotesAnalysis: psychosocial comparison 12. Arm 1 till 6 were collapsed in the analysis and compared with condition 7


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomisation by a computer-generated random number sequence

Allocation concealment (selection bias)Unclear riskNo information

Blinding (performance bias and detection bias)
All outcomes
High riskParticipants: Blinding for psychosocial intervention is not possible. Study staff: no info

Incomplete outcome data (attrition bias)
All outcomes
High riskITT. The response rates were above or near 50% in the different groups

Rabius 2007b

MethodsStudy design: RCT, current depression (post hoc)

Setting: USA, community and quit line

Recruitment: [no information]


Participants1051 adult smokers (1: N = 294; 2: N = 256; 3: N = 249; 4: N = 252) with depression according to a single self report question: "Have you felt sad or blue every day for the last two weeks?", mean age 43.8, 73.2% F, mean CPD 23.8

Exclusion criteria included (no information)


Interventions1. Telephone counselling enhanced with cognitive therapy for depression and training for proactive enrolment of social support (5 sessions)

2. Telephone counselling enhanced with cognitive therapy for depression and training for proactive enrolment of social support (5 sessions) plus 2 relapse prevention boosters (4 & 8 wks after completion of counselling)

3. Standard telephonic counselling (3 sessions)

4. Standard telephonic counselling (3 sessions) plus 2 relapse prevention boosters (4 and 8 wks after completion of counselling)


OutcomesAbstinence at 7m after randomisation (30-day PP)

Validation: none

Unpublished abstinence outcome data


NotesAnalysis: psychosocial mood management comparison 1 (arm 1 versus arm 3 and arm 2 versus arm 4). psychosocial comparison (arm 4 versus arm 3 and arm 2 versus 1), not in meta-analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskno information

Allocation concealment (selection bias)Unclear riskno information

Blinding (performance bias and detection bias)
All outcomes
High riskParticipants: Blinding for psychosocial intervention is not possible. Study staff: No info

Incomplete outcome data (attrition bias)
All outcomes
High riskITT. Response rates were 39.8% for condition 1, 39.8% for condition 2, 36.2% for condition 3 and 40.9% for condition 4 at 7 m follow-up

Rabius 2008

MethodsStudy design: RCT, current depression (post hoc)

Setting: USA, community

Recruitment: Via a link on the American Cancer Society website for smokers who wanted help in quitting via the internet


Participants1961 adult smokers (1: N = 314; 2: N = 354; 3: N = 296; 4: N = 351; 5: N = 333; 6: N = 313) with depression according to a single self report question: "Whether or not they felt sad or blue every day for the past 2 weeks" mean age 44.3, 73.3% F, mean CPD 24.9

No exclusion criteria


Interventions1. Interactive site 1, tailored interactive site

2. Interactive site 2, tailored interactive site

3. Interactive site 3, tailored interactive site

4. Interactive site 4, tailored interactive site

5. Interactive site 5, tailored interactive site

6. Control site, targeted, minimally interactive ACS site with text, photographs, and graphics providing stage-based quitting advice and peer modelling


OutcomesAbstinence at 13m after randomisation (30-day PP)

Validation: none

Published abstinence outcome data


NotesAnalysis: psychosocial comparison (arms 1 till 5 were collapsed versus arm 6), not in meta-analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer randomisation programme

Allocation concealment (selection bias)Low riskCentral allocation (web-based)

Blinding (performance bias and detection bias)
All outcomes
High riskParticipants: Blinding for psychosocial intervention is not possible. Study staff: no info

Incomplete outcome data (attrition bias)
All outcomes
High riskITT. Response rates were 37.3% for condition 1, 33.3% for condition 2, 32.4% for condition 3, 35.9% for condition 4, 28.8% for condition 5 and 37.4% for condition 6 at 13m follow-up

Saules 2004

MethodsStudy design: RCT, subgroup current depression (post-hoc) & subgroup past depression (pre stated stratification)

Setting: USA, community and university

Recruitment: Flyers, notices, advertisements in local newspapers and radio stations


Participants22 adult smokers with current depressive symptoms (BDI ≥ 10), mean age ?, 58% F, mean FTCD ?, mean CPD 24.8 and mean BDI 14.9

30 adult smokers with a history of major depression according to the Structured Clinical Interview for DSM-IV (SCID), mean age ?, 67% F, mean FTCD ?, mean CPD 25.4 and mean BDI 9.7

All study participants: mean age 39.8 and mean FTCD 5.9

Exclusion criteria included acute psychiatric crisis, psychiatric disorder within the past 6 months, currently taking psychiatric medications


Interventions1. Fluoxetine 20 mg (antidepressant) (14 wks: 4 wks before QD and 10 wks after)

2. Fluoxetine 40 mg (14 wks: 4 wks before QD and 10 wks after)

3. Placebo (14 wks)

All arms: In addition all participants received group cognitive behavioural therapy (6 sessions: before QD wk 1, 2; wk 3; wk 4, 5, 6 after QD) and nicotine patch (10 wks: 6 wks on 15mg; 2 wks on 10mg; 2 wks on 5mg)


OutcomesAbstinence at 12 m (7-day PP)

Validation: CO < 10 ppm

Unpublished abstinence outcome data


NotesAnalysis: arm 1 versus arm 3 and arm 2 versus arm 3, both in fluoxetine comparisons 4 and 7


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"A computer program generated random group assignments."

Allocation concealment (selection bias)Low risk"The statistician who assigned participants to treatment conditions did not interact with them at all. She simply informed project."

Blinding (performance bias and detection bias)
All outcomes
Unclear riskParticipants: Blinding for medication but not for psychosocial intervention. Study staff: no info

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskITT. No information regarding response rates

Schnoll 2010

MethodsStudy design: RCT, subgroup current depression (pre-stated stratification)

Setting: USA, clinical

Recruitment: After screening smoking status in electronic medical record the participants were first screened for interest by phone and then in person


Participants55 smokers (1: N = 28; 2: N = 27) with cancer and depressive symptoms (CES-D ≥ 16), mean age 51.7, 64% F, mean FTCD 3.2, mean CPD 17.6

Exclusion criteria included current drug or alcohol dependence, current Axis I psychiatric conditions (f.e. example major depression), using an MAO inhibiter


Interventions1. Bupropion for 9 wks (start 2 wks before QD, 150 mg 1/d for 1wk, 150 mg 2/d after 1 wk)

2. Placebo for 9 wks (same schedule as bupropion)

Both arms: 5 counselling sessions focused on behavioral strategies for preparing to quit smoking and avoiding relapse prevention (individual wk1, wk 3 (QD), wk 5; phone: wk 7 and wk 9) and 8 wks of transdermal nicotine (participants smoking < cig/day: 4 wks of 14 mg patches followed by 4 wks of 7mg; participants smoking ≥ 10 cig/day: 2 wks of 21 mg patches followed by 2 wks of 14 mg patches and 4 wks of 7 mg patches


OutcomesAbstinence at 6m post-QD (7-day PP)

Validation: CO ≤ 10

Published abstinence outcome data


NotesAnalysis: bupropion comparison 3


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"Computerized randomisation table integrated into data management system."

Allocation concealment (selection bias)Low risk"Only the study statistician and the pharmacist who maintained the study drug supply were aware of the allocation."

Blinding (performance bias and detection bias)
All outcomes
Unclear riskParticipants: Blinding for medication but not for psychosocial intervention. Study staff: the same

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskITT. Response rates were 67.9% for the experimental group and 63.0% for the control group

Smith 2003

MethodsStudy design: RCT, subgroup past depression (post hoc)

Setting: USA, clinical and community

Recruitment: Media advertisements


Participants163 adult smokers with a history of depression according to the mood disorders section of the structured clinical interview for DSM-IV (1: N = 43; 2: N = 44; 3: N = 51; 4: N = 25), mean age 42.9, 71% F, mean FTQ 7.7, mean CPD 26.9, mean BDI 5.4

Exclusion criteria included serious medical or psychiatric conditions (e.g. current depression), use of exclusionary medications (e.g. antidepressants), psychoactive substance use in the prior week, or substance abuse in the prior year


Interventions1. Bupropion (9 wks starting 1 wk prior QD: 150 mg/d for 3 d, 2 x 150 mg/d until wk 9) plus nicotine patch (8 wks after QD: 21 mg for 5 wks, 14 mg for 1 wk, 7 mg for 1 wk)

2. Placebo tablet plus nicotine patch (8 wks after QD: 21 mg for 5 wks, 14 mg for 1 wk, 7 mg for 1 wk)

3. Bupropion (9 wks starting 1 wk prior QD: 150 mg/d for 3 d, 2 x 150 mg/d until wk 9) plus placebo patch

4. Placebo tablet plus placebo patch

All arms: Brief individual cessation counselling was provided during 9 weekly clinic visits (15 min or less per session) and one supportive telephone call from the counsellor 3 days after QD and 8 follow-up counselling telephone calls (month 3, 4, 5, 7-11) (less than 10 min per call)


OutcomesAbstinence at 12 m post-cessation (7-day PP)

Validation: CO ≤ 10 pp

Published abstinence outcome data


NotesAnalysis: arm 1 versus arm 2 and arm 3 versus arm 4, both in bupropion comparisons 6. Arm 1 versus arm 3 and arm 2 versus 4, both in NRT comparison 13


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskAllocation sequence was generated by computer-generated random numbers

Allocation concealment (selection bias)Low riskAllocation sequence was generated by computer-generated random numbers

Blinding (performance bias and detection bias)
All outcomes
Unclear riskParticipants and research staff were blinded for medication, but this was not possible for the brief individual counselling

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskITT. Response rate for all of the study participants was 80.2%

Spring 2007

MethodsStudy design: RCT, subgroup past depression (pre-stated stratification)

Setting: USA, clinic and community

Recruitment: Newspaper and radio advertisements


Participants109 adult smokers with history of major depression (1: N = 58; 2: N = 51) according to Structured Clinical Interview for DSM-IV, mean age 42.8, 33% F, mean FTCD 6.4, mean CPD 22.9, mean BDI 10.8.

Exclusion criteria included currently depressed (BDI > 15 or Ham-D score > 14 or MDD episode within past 6 m), any current episode of Axis I disorder (other than nicotine dependence), use of psychotropic medication within past month


Interventions1. Fluoxetine (12 wks: 20 mg for 4d, 30 mg for 3d, 40 mg for 3d, 50 mg for 5d, and 60 mg until 12 wks) plus cognitive behavioural smoking cessation group treatment (9 sessions in 12 wks: 3 before QD and 6 after)

2. Placebo plus cognitive behavioural smoking cessation group treatment (see time schedule condition1)


OutcomesAbstinence at 6m after QD (PA: CA from a grace period ending 2 wks after QD)

Validation: CO ≤ 10 ppm or cotinine ≥ 20 ng/ml

Published abstinence outcome data


NotesAnalysis: fluoxetine comparison 7


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk

Allocation concealment (selection bias)Low risk

Incomplete outcome data (attrition bias)
All outcomes
High risk

Swan 2010

MethodsStudy design: RCT, subgroup lifetime depression (post hoc)

Setting: USA, community

Recruitment: Health plan magazine advertisements, employee mailings, physician referrals, Free and clear quit for life program


Participants661 adult smokers (1: N = 226; 2: N = 236; 3: N = 199) with probable lifetime depression according to a self report item "have you ever experienced in your lifetime a period of two weeks or more when you felt down, depressed or hopeless or had little interest or pleasure in doing things", mean age 48.1, 75% F, mean FTCD 5.0, mean CPD 19.6

Exclusion criteria included self-report of poor health, current treatment for or self-report of bipolar disorder, high-frequency alcohol use over the past 6 m, drugs use, use of bupropion or NRT


Interventions1. Web-based counselling (access to the online programme, which contained standardised content and interactive tools: quit plan, educational content in an online library, quit calendar, cost calculator, progress tracker, a tool to email to friends and family for support, and active discussion forums)

2. Proactive telephone-based counselling (received up to 5 calls from a counsellor: practical expert support to help participants develop problem-solving and coping skills, secure social support, and design a plan for quitting

3. Web and proactive telephone based counselling: received access to both programs described above

All arms: Varenicline (12 wks supply, staring 1 wk prior to QD), 5-10 min orientation call, printed quit guides, and access to a toll free inbound support line for ad hoc calls


OutcomesAbstinence at 6 m (7-day PP and 30-day PP)

Validation: None

Unpublished abstinence outcome data


NotesAt 3 m follow-up 64% of all study participants were not taking varenicline.

Data from the lifetime depression was used for analysis and included in the past depression analysis. Some of the participants with lifetime depression may experience current depressive symptoms.

Analysis: arm 3 versus arm 1, arm 3 versus arm 2, both were included in the psychosocial comparison


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"Group assignment was randomly allocated using an automated algorithm built into the study database."

Allocation concealment (selection bias)Low risk"Group assignment was randomly allocated using an automated algorithm built into the study database."

Blinding (performance bias and detection bias)
All outcomes
High risk"Participants and study staff were not blinded to treatment assignment."

Incomplete outcome data (attrition bias)
All outcomes
Low riskITT. Response rates for all study participants were 74.2% at 6 m follow-up. No differences in participation among the three arms

Thorndike 2008

MethodsStudy design: RCT, current depression (post hoc) twice

Setting: USA, hospital and at home

Recruitment: No information


ParticipantsAdult smokers (1: N = 44; 2: N = 52) with acute cardiovascular disease and with mild depressive symptoms (BDI ≥ 10), mean age , %F, mean FTCD, mean CPD.

53 adult smokers (1: N = 21; 2: N = 32) with acute cardiovascular disease and with moderate to severe depressive symptoms (BDI ≥ 16), mean age 55, 45% F, mean FTCD 5.7, mean CPD 25.

Exclusion criteria included heavy alcohol use, illegal drug use, contraindication to bupropion, major depression.


Interventions1. Bupropion (12 wks: 150 mg/d for 3 days followed by 150mg/2d)

2. Placebo (same schedule as bupropion)

Both arms: Multicomponent cognitive behavioural smoking cessation and relapse prevention counselling program. Counselling (30-45 min) began during hospitalisation and continued by telephone 5 times after discharge (2 d and 1, 3, 8, and 12 wks) (10 min per call), supplemented by self-help material.


OutcomesAbstinence at 12 m after discharge (7-day PP and CA: 7-day abstinence at 2, 4, 12 wks and 12 m)

Validation: CO < 8 ppm (2 wks follow-up) saliva cotinine > 20 ng/ml (12 wks and 12-m follow-up)

Unpublished abstinence outcome data


NotesIn patients with medical illness a score of 16 or higher indicates moderate to severe depressive symptoms. In analysis we use BDI ≥ 10.

Analysis: bupropion comparison 3.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskAllocation sequence was generated by computer-generated random numbers

Allocation concealment (selection bias)Low riskAllocation sequence was generated by computer-generated random numbers

Blinding (performance bias and detection bias)
All outcomes
Unclear risk"Subjects and study personnel, except the statistician and pharmacist, were blind to treatment assignment."

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskITT. Response rate was 66% for participants with BDI ≥ 16

Van der Meer 2010

MethodsStudy design: RCT, subgroup current depression (post hoc) and past depression

Setting: The Netherlands, community and quit line

Recruitment: Media announcements, advertisements and articles in newspapers, banners, flyers and letters


Participants237 adult smokers with current depressive symptoms (CES-D ≥ 16) (1: N = 118; 2: N = 119), mean age 44.5, 75% F, mean CPD 21.5, mean FNTD 5.3, mean CES-D 24.9.

485 adult smokers with past major depression (1: N = 243; 2: N = 242) according to CIDI, mean age 43.8, 77% F, mean CPD 21.6, mean FNTD 5.1, mean CES-D 16.6, 53% recurrent past major depression.

Exclusion criteria included current use of antidepressant medication, current major depression, a DSM-IV diagnosis of alcohol dependence or alcohol abuse in the last month, currently receiving or on the waiting-list for treatment of psychological problems, alcohol problems or drug problems


Interventions1. Experimental: Mood management intervention was an integration of condition 2 with a mood management component. This component consisted of a self-help mood management manual, two more preparatory proactive telephone counselling sessions and supplementary homework assignments and advice. The self-help manual includes modules on behavioural activation, cognitive restructuring and social skills training. One 30-min intake session (10 days) and two 15-min sessions (7 and 2 days) before QD and seven 15-min sessions afterwards (3, 7, 14, 21, 35, 56 and 91 days).

2. Proactive telephone counselling consisted of strengthening stop-smoking skills, namely social support, increasing self-efficacy, self-rewarding and relapse prevention. One 30-min intake session before QD and seven 12-min sessions afterwards (3, 7, 14, 21, 35, 56 and 91 days)

Both arms were advised to use pharmacological aids for cessation if they smoked > 10 CPD


OutcomesAbstinence at 6 and 12 m after the baseline (7-day PP and PA: not having smoked from month 2 - 6 after baseline and from month 2 - 12 after baseline)

Validation: saliva cotinine (sample)

Published and unpublished abstinence outcome data


Notes50.0% of the participants used no pharmacotherapy, 38.2% used nicotine replacement therapy, 8.9% used bupropion or nortriptyline and 3.0% used nicotine replacement therapy combined with bupropion or nortriptyline.

Analysis: psychosocial mood management comparison 1 and 2


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskAllocation sequence was generated by computer-generated random numbers

Allocation concealment (selection bias)Low riskBy using sealed and coded randomisation envelopes, the research assistant was blinded

Blinding (performance bias and detection bias)
All outcomes
High riskBy using sealed and coded randomisation envelopes, the research assistant was blinded. It is not possible to blind participants and counsellors for a psychosocial intervention

Incomplete outcome data (attrition bias)
All outcomes
Low riskITT. Response rates were 77.0% for the experimental group and 76.4% for the control group at 12-m follow-up

Vickers 2009

MethodsStudy design: RCT, current depression

Setting: USA, clinical and community

Recruitment: News releases and advertisements in local print and electronic media


Participants60 female adult smokers (1: N = 30; 2: N = 30) with current depression according to CES-D ≥ 16, mean age 41.4, mean CPD 20.8, mean FNTD 5.1, mean CES-D 16.6, mean FTCD 6.0, mean CES-D 31.1, 55% current pharmacotherapy, 30% current psychotherapy

Exclusion criteria included current alcohol dependence, current non nicotine drug dependence, use of bupropion or nortriptyline within the past 30 d, all other antidepressant medications were acceptable if the participant had been on a steady dose for past 3 m


Interventions1. Experimental: Individually delivered exercise counselling (10 wkly, 30 min sessions). Exercise improves mood

2. Control: Individually health education contact (10 wkly, 30 min sessions), including information on a variety of heath topics other than smoking

Both arms received nicotine patch therapy (21 mg/d from QD through wk 10) and behavioral counselling for smoking cessation (10 min at each visit)


OutcomesAbstinence at 24 wks (7-day PP)

Validation: CO < 8 ppm and urine cotinine

Published abstinence outcome data


NotesPilot study. Analysis: psychosocial mood management comparison 1


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskAllocation sequence was generated by computer-generated random numbers

Allocation concealment (selection bias)Low riskBy using sealed and coded randomisation envelopes, the research assistant was blinded

Blinding (performance bias and detection bias)
All outcomes
High riskIt is not possible to blind participants and counsellors for a psychosocial intervention

Incomplete outcome data (attrition bias)
All outcomes
High riskITT. Response rates were 53.3% for the experimental group and 50% for the control group at 24-wks follow-up

Walsh 2008

MethodsStudy design: RCT, subgroup current depression (post hoc)

Setting: USA, clinical laboratory

Recruitment: Advertisement, word of mouth and physician referrals


Participants14 adult smokers (1: N = 8; 2: N = 6) with depressive symptoms (BDI ≥ 10).

All study participants: mean age 43.6, 49% F, mean CPD 21.0, mean FTCD 5.9, mean BDI 5.0.

Exclusion criteria included no current or past major medical or psychiatric disorders within the past year from participating, no use of psychotropic medications in the previous year.


Interventions1. Naltrexone (opioid antagonist) (3d before QD 25 mg/d; 8 wks 50 mg/d)

2. Placebo

Both arms: Nicotine patches (1 m: 21 mg/d for first 2 wks; 14 mg/d wk 3; 7 mg/d wk 4) and individual behavioral counselling (6 sessions: 1 hr/session per wk)


OutcomesAbstinence at 24 wks follow-up after quit date (PA: not smoking even one puff at any point in the trial, allowing for a one wk grace period after the QD)

Validation: CO ≤ 10 ppm

Unpublished abstinence outcome data


NotesAnalysis: other pharmacotherapy comparison, not in meta-analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskAllocation sequence was generated by computer-generated random number list

Allocation concealment (selection bias)Low riskA separate coder generated the allocation sequence and did not interact with subjects

Blinding (performance bias and detection bias)
All outcomes
Unclear riskParticipants and study staff were blinded for the medication

Incomplete outcome data (attrition bias)
All outcomes
Low riskITT, response rates for all study participants at 24 wks follow-up: 78.2%, no difference between treatment groups

Weinberger 2010

MethodsStudy design: RCT, subgroup past depression (post hoc)

Setting: USA, clinical

Recruitment: Flyers, newspaper, television and radio advertisements


Participants26 smokers (1: N = 15; 2: N = 11) with history of depression according to SCID, mean age 49.0, 54% F, mean CPD 21.1, mean FTCD 6.3, mean BDI 4.9

Exclusion criteria included current major depression, evidence of alcohol or other drug abuse or dependence in the previous 6 m, and antidepressant medication


Interventions1. Selegiline hydrochloride (antidepressant) (9 wks: 5 mg/d for the first 7 days, followed by 2 x 5mg/d from day 8 till wk 8, 1 x 5 mg/d in wk 9). Day 15 was TQD

2. Placebo (same schedule as selegiline)

Both arms: 10 brief (< 10 min) manualised smoking cessation individual counselling appointments


OutcomesAbstinence at 6-m follow-up (7-day PP)

Validation: CO < 10 ppm and plasma cotinine level < 15 ng/ml

Unpublished abstinence outcome data


NotesAnalysis: selegiline comparison, not in meta-analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskSequence generation is unclear

Allocation concealment (selection bias)Low riskThe randomisation was assigned by the pharmacist and the blinding was broken after the last follow-up was completed

Blinding (performance bias and detection bias)
All outcomes
Unclear riskParticipants and research staff were blinded for the medication, but this was not possible for the brief psychosocial intervention

Incomplete outcome data (attrition bias)
All outcomes
High riskITT. Response rates for all study participants at 26 wks follow-up: 51%

Wewers 2009

MethodsStudy design: RCT, subgroup current depression (post hoc)

Setting: USA, health clinic, community

Recruitment: Invitation of the selected county clinics to participate in the study


Participants153 smoking Ohio Appalachian women (1: N = 77; 2: N = 76) with depressive symptoms (CES-D ≥ 16), mean age 36, mean CPD 19.2, mean FTCD 4.7, mean CES-D 28.6


Interventions1. A nurse-managed, lay-led protocol that incorporated nicotine patch (21 mg/d for 8 wks) and behavioural counselling, including health effects, self-monitoring, relapse prevention etc. (12 wks: 8 face-to-face 30-40 min visits, QD in wk 3)

2. Personalised letter from clinic physician, who advised them to quit smoking and requested to schedule a clinic appointment to discuss cessation and a self-help educational pamphlet


OutcomesAbstinence at 6 and 12 m post randomisation (7-day PP and PA)

Validation: saliva cotinine ≤ 14 ng/mL

Unpublished abstinence outcome data


NotesAnalysis: Other comparison, not in meta-analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskAllocation sequence was generated by computer-generated random number list

Allocation concealment (selection bias)Low riskAllocation sequence was generated by computer-generated random number list

Blinding (performance bias and detection bias)
All outcomes
High riskIt is not possible to blind participants and counsellors for a psychosocial intervention

Incomplete outcome data (attrition bias)
All outcomes
Low riskITT. Response rates for all study participants were 77.6% for the experimental group and 85.2% for the control group at 12-m follow-up

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Aycicegi-Dinn 2011Depression is not an inclusion criteria and not a variable for subgroup analysis

Bernard 2012Not a randomised controlled trial

Blalock 2008Short follow-up (3 months)

Blalock 2011Not a randomised controlled trial

Borrelli 1996Short follow-up (10 weeks)

Brewer 2011Depression is not an inclusion criterion and not a variable for subgroup analysis and short follow-up (4 months)

Caponnetto 2011Short follow-up (24 weeks)

Castro 2011Not a randomised controlled trial and short follow-up (4 weeks)

Chengappa 2001Not a randomised controlled trial and short follow-up (3 months)

Cinciripini 2000Short follow-up (1 month post-partum)

Cinciripini 2003Depression is not an inclusion criterion and not a variable for subgroup analysis

Cornelius 1999Not a smoking cessation intervention

Cox 2004Not a smoking cessation intervention, but a relapse prevention intervention (inclusion criteria are abstinent smokers)

Csonka 2008Not a randomised controlled trial and short follow-up (2 months)

Ebbert 2009Not a randomised controlled trial

El-Mohandes 2011Short follow-up

Evins 2008Short follow-up

Frederick 1997Short follow-up (8 weeks)

Glassman 1988Outcome data for depression subpopulation not available

Glassman 1993Outcome data for depression subpopulation not available

Grassi 2011Depression is not an inclusion criterion and it is not a randomised controlled trial

Kapson 2010Short follow-up (3 months)

Kinnunen 1996Short follow-up (3 months)

Knekt 2010Not a smoking cessation trial

Krishnan-Sarin 2003Short follow-up (3-4 wks after treatment)

Lerman 2004Outcome data for depression subpopulation not available

McClure 2011Short follow-up and not a smoking cessation intervention (smoking cessation is not the primary aim of the intervention)

Morris 2011Not a smoking cessation intervention (smoking reduction intervention)

Niaura 2002Depression is not an inclusion criterion and not a variable for subgroup analysis

O'Neil 2011Not a smoking cessation intervention (smoking cessation is not the primary aim of the intervention)

Oncken 2007No subgroup outcome data available for this study

Parsons 2009Depression is not an inclusion criterion and not a variable for subgroup analysis

Patten 2002Outcome data for depression subpopulation not available

Reitzel 2010Not a smoking cessation intervention, but a relapse prevention intervention (inclusion criteria are abstinent smokers)

Rennard 2012Depression is not an inclusion criterion and not a variable for subgroup analysis

Schleicher 2012Not a smoking cessation intervention (participants could choose between a smoking reduction intervention or a smoking cessation intervention)

Sonne 2010No subgroup outcome data available for this study

Stapleton 2008Short follow-up (4 weeks after quit date)

Thorndike 2006Depression is not an inclusion criterion and not a variable for subgroup analysis and short follow-up (1 month)

Thorsteinsson 2001Short follow-up

Trockel 2008No smoking cessation intervention

Vázquez 1999Not a randomised controlled trial

Williams 2010Depression is not an inclusion criterion and not a variable for subgroup analysis and short follow-up

Yun 2012Not a randomised controlled trial

Ziedonis 1997Short follow-up (3 months)

 
Characteristics of studies awaiting assessment [ordered by study ID]
Bock 2012

MethodsStudy design: RCT, pilot. Subgroup current depression (post hoc)

Setting: USA, clinical?

Recruitment: Advertisements in local newspapers and websites, posting flyers, placing brochures at commercial locations and physician's offices, and television coverage

ParticipantsSmoking women with depressive symptoms according to CES-D 10 ≥ 11.

Exclusion criteria included currently in treatment for psychiatric illness or using illegal substances

Interventions1. Experimental: Yoga: Each class consists of 5 min breathing exercises and seated meditation, followed by 45 min of dynamically linked asanas. Classes conclude with 10 min of closing postures and final seated meditation (8 wks: twice weekly 1-hr)

2. Control: Wellness program: Videos regarding a variety of health topics followed by a discussion and distribution of written material relevant to the video topic (8 wks: weekly)

Both arms: Group-based cognitive behavioural therapy smoking cessation intervention (8 wks: weekly 1-hour session, scheduled at the same night as the Yoga or Wellness session)

Participants are allowed to use pharmacotherapy for smoking cessation

OutcomesAbstinence at 6-m follow-up (7-day PP)

Validation: CO < 10 ppm and saliva cotinine 15 mg/ml

NotesAsked authors if they are willing to share the abstinence outcome subgroup data (CES-D 10 ≥ 11)

Borrelli 2002

MethodsStudy design: RCT, subgroup current depression (post hoc)

Setting: USA, at home

Recruitment: Asthma Care Coordinator

ParticipantsSmoking caregivers who have children with asthma and who have depressive symptoms according to CES-D ≥ 16

Interventions1. Experimental: Motivational enhancement treatment based on the precaution adoption model (1.25 hour)

2. Control: Motivational enhancement treatment based on the behavioral action model (1.25 hour)

Both interventions were nurse delivered smoking cessation interventions embedded in an in-home asthma education program. Both arms receive an additional 15-min follow-up phone call from their nurse to provide support for smoking cessation or motivate quit attempts

Nicotine patches were provided to smokers who reported readiness to quit within 30 days

OutcomesAbstinence at 12-m follow-up (7-day PP)

Validation: CO < 10 ppm

NotesAsked authors if they are willing to share the abstinence outcome subgroup data (CES-D ≥ 16)

Campayo 2008

MethodsStudy design: RCT, current depression

Setting: Spain, 29 primary care health centres

Recruitment: By doctors working in the primary care centres

Participants180 smokers with depression according to MINI psychiatric interview.

Exclusion criteria included score of ≥ 60 on the Zung self-rating depression scale, active psychosis and/or treatment with antipsychotic drugs, alcohol or drug abuse

Interventions1. Experimental: Topiramate as pharmacotherapy for smoking cessation (100-200 mg/day) (8 wks treatment)

2. Control: NRT (nicotine patches: 21 mg/day first and second fortnight, 14 mg/day third fortnight, and 7 mg/day fourth and last fortnight) (8 wks treatment)

Both arms: Group cognitive behavioural therapy (16 sessions of 90 min/per session: -1, QD + 1, 1, 2, 3, 4, 6, 8, 10, 13 wks and 4, 5, 6, 8, 10, 12 m). Free use of nicotine gums or lozenges for 8 wks

OutcomesAbstinence at 6, 8, 10 and 12 m follow-up (CA: As of the visit at 30 days, participants affirm that they were abstinent at the month before)

Validation: CO < 10 ppm and saliva cotinine < 5 ng/ml

NotesAsked author if the 'outcome' paper has been published

Carmody 2012

MethodsStudy design: RCT, subgroup current depression (post hoc)

Setting: USA

Recruitment: Drug and Alcohol Treatment programs

Participants? alcohol-dependent smokers with depressive symptoms according to BDI ≥ 10

Exclusion criteria included unstable psychiatric disorder

Interventions1. Experimental: Intensive smoking cessation intervention: 16 sessions of cognitive behavioral therapy for smoking cessation, including mood management , 4 m of nicotine patches, and 6 m of nicotine lozenges or gum. The mood management component was implemented during session 6 through 16 and included cognitive restructuring and behavioural activation

2. Control: Usual care: Referral to the medical centre's smoking cessation clinic

OutcomesAbstinence at 6 m follow-up (7-day PP)

Validation: CO < 10 ppm

NotesAsked authors if they are willing to share the abstinence outcome subgroup data (BDI ≥ 10)

Cox 2012

MethodsStudy design: RCT, current depression (post hoc)

Setting: USA, clinic and community

Recruitment:

Participants? smokers with depressive symptoms according to CES-D 10 ≥ 10

Exclusion criteria included use of psychoactive medication

Interventions1. Experimental: Bupropion (150 mg once daily for 3 days and then 150 mg twice daily) (7 weeks)

2. Control: Placebo (7 weeks)

Both arms received up to six sessions of individual health education counselling (15-20 min per session)

OutcomesAbstinence at 6-m follow-up (7-day PP)

Validation: Salivary cotinine

NotesAsked authors if they are willing to share the abstinence outcome subgroup data (CES-D 10 ≥ 10)

Strong 2012

MethodsStudy design: RCT, past depression

Participants53 smokers with recurrent major depression

Exclusion criteria included current depression

Interventions1. Experimental: proactive phone counselling intervention for smoking cessation that integrated cognitive behavioral mood management (8 sessions)

2. Control:standard proactive phone counselling intervention for smoking cessation (8 sessions)

Outcomes

NotesThis pilot showed increased biochemically verified point prevalence abstinence 6 months after quitting (OR=2.64, 95%CI=0.93-7.45)

See also: http://clinicaltrials.gov/show/NCT00500877

Asked authors if they are willing to share the abstinence outcome data with us.

Vidrine 2009

MethodsStudy design: RCT subgroup current depression (post hoc)

Setting: USA

Recruitment: Local print media

Participants158 smokers with depressive symptoms according to CES-D ≥ 16

Exclusion criteria included use of psychotropic medication use

Interventions1. Experimental: Mindfulness intervention that integrated mindfulness based stress reduction with a cognitive behavioural relapse prevention based intervention (8-weekly group therapy sessions)

2. Control: Standard of care treatment

OutcomesAbstinence at 6 m

Validation: Yes

NotesAsked authors if the 'outcome' paper has been published

West 2011

MethodsStudy design: RCT, subgroup current depression (post hoc)

Setting: Poland, clinical

Recruitment:?

Participants? smokers with depressive symptoms according to BDI ≥ 10

Exclusion criteria included diagnosis of current psychiatric disorder

Interventions1. Experimental: Cytisine (25 days: six 1.5 mg per day (day 1 through 3); five tablets per day (days 4 through 12); four tablets (days 13 through 16); three tablets (days17 through 20); two tablets (days 21 through 25). Quit date: 5th day

2. Control: Placebo (25 days)

Both arms received the same minimal amount of counselling

OutcomesAbstinence at 6-m and12-m follow-up (sustained and 7-day PP)

Sustained: smoked fewer than 5 cigarettes in each of the previous 6 months

Validation: CO < 10 ppm

NotesAsked authors if they are willing to share the abstinence outcome subgroup data (BDI ≥ 10)

 
Characteristics of ongoing studies [ordered by study ID]
Anthenelli 2013

Trial name or titleVarenicline for smokers with past and current major depression

MethodsStudy design: RCT, current depression and past depression

Setting: International 38 centres in USA and Europe

Recruitment:

Participants525 Smokers with past and current major depression

Exclusion criteria:

InterventionsExperimental: varenicline

Control:

OutcomesAbstinence at 52 weeks follow-up (continuous abstinence rate from week 9 - 52)

Validation

Starting date

Contact information

NotesSee reference for preliminary results

Brown 2011

Trial name or titleSequential use of fluoxetine for smokers with elevated depressive symptoms

MethodsStudy design: RCT, current depression

Setting: USA, clinical

Recruitment:

Participants216 smokers with elevated depressive symptoms according to CES-D ≥ 6

Exclusion criteria included major depressive disorder

Interventions1. Experimental: Sequential antidepressant pharmacotherapy with fluoxetine 20 mg 1/d for 16 wks (start 8 wks prior to and extended throughout smoking cessation treatment and NRT) plus same as control.

2. Experimental: Concurrent antidepressant pharmacotherapy with fluoxetine 20 mg plus same as control

3. Control: Brief standard behavioral smoking cessation treatment with NRT (transdermal nicotine patch)

OutcomesAbstinence at 12-m follow-up (PP)

Validation: ?

Starting date

Contact information

NotesFindings indicated that experimental group 1 resulted in significantly higher point prevalence abstinence than experimental group 2 at 12 m follow-up (31.2% versus 22.7%; OR = 1.65)

The 'outcome' paper has not been published yet

Dickson-Spillmann 2012

Trial name or titleGroup hypnotherapy versus group relaxation for smoking cessation: an RCT study protocol

MethodsStudy design: RCT, current depression (post hoc)

Setting: Switzerland, community

Recruitment: Online and print advertisements

Participants? smokers with depressive symptoms according to BDI V

Interventions1. Experimental: Hypnosis (1 group session, 40 min)

2. Control: Relaxation (1 group session, 40 min)

Both arms received first 40 min of mental preparation based on motivational interviewing

OutcomesAbstinence at 6 m post-intervention (30-day PP)

Validation: Salivary cotinine

Starting date

Contact information

NotesThe 'outcome' paper has not been published yet

Johnson 2012

Trial name or titlePanic-Smoking Program

MethodsStudy design: RCT, current depression (post hoc)

Setting: USA

Recruitment: Newspaper, radio, and internet participation

Participants? Adult smokers with major depression

Interventions1. Experimental: Smoking based behavioural intervention focused on emotional vulnerability (4 sessions)

2. Control: Standard pharmacological and psychosocial care

OutcomesAbstinence: unknown

Validation: unknown

Starting date

Contact information

NotesResults are expected autumn 2014

 
Comparison 1. Psychosocial mood management versus control for smokers with current depression. Abstinence at six months or greater follow-up

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Psychosocial mood management versus control for smokers with current depression111844Risk Ratio (M-H, Fixed, 95% CI)1.47 [1.13, 1.92]

 2 Psychosocial mood management versus control for smokers with current depression (without Carmody 2008 and Vickers 2009)91658Risk Ratio (M-H, Fixed, 95% CI)1.42 [1.07, 1.88]

 3 Length of follow-up111844Risk Ratio (M-H, Fixed, 95% CI)1.47 [1.13, 1.92]

    3.1 abstinence 6m follow-up
51292Risk Ratio (M-H, Fixed, 95% CI)1.45 [0.99, 2.11]

    3.2 abstinence 12m follow-up
6552Risk Ratio (M-H, Fixed, 95% CI)1.50 [1.03, 2.18]

 4 Current depression measurement111844Risk Ratio (M-H, Fixed, 95% CI)1.47 [1.13, 1.92]

    4.1 current major depression
5257Risk Ratio (M-H, Fixed, 95% CI)1.71 [0.90, 3.26]

    4.2 multi item depressive symptoms
5536Risk Ratio (M-H, Fixed, 95% CI)1.56 [1.03, 2.36]

    4.3 one item depressive symptoms
11051Risk Ratio (M-H, Fixed, 95% CI)1.31 [0.86, 1.98]

 5 Depression group in study111844Risk Ratio (M-H, Fixed, 95% CI)1.47 [1.13, 1.92]

    5.1 depression inclusion criteria
2128Risk Ratio (M-H, Fixed, 95% CI)2.26 [0.34, 15.08]

    5.2 depression subgroup pre stated
5242Risk Ratio (M-H, Fixed, 95% CI)1.18 [0.64, 2.20]

    5.3 depression subgroup posthoc
41474Risk Ratio (M-H, Fixed, 95% CI)1.52 [1.13, 2.06]

 6 Published or unpublished data111844Risk Ratio (M-H, Fixed, 95% CI)1.47 [1.13, 1.92]

    6.1 published data
3181Risk Ratio (M-H, Fixed, 95% CI)2.25 [0.68, 7.46]

    6.2 unpublished data
81663Risk Ratio (M-H, Fixed, 95% CI)1.43 [1.09, 1.88]

 7 Antidepressants use participants exclusion criteria111844Risk Ratio (M-H, Fixed, 95% CI)1.47 [1.13, 1.92]

    7.1 antidepressants use is an exclusion criteria
3350Risk Ratio (M-H, Fixed, 95% CI)1.42 [0.88, 2.29]

    7.2 antidepressants use is not an exclusion criteria
81494Risk Ratio (M-H, Fixed, 95% CI)1.49 [1.08, 2.05]

 8 Format intervention111844Risk Ratio (M-H, Fixed, 95% CI)1.47 [1.13, 1.92]

    8.1 group
145Risk Ratio (M-H, Fixed, 95% CI)0.42 [0.09, 1.85]

    8.2 group plus self help
168Risk Ratio (M-H, Fixed, 95% CI)4.72 [0.24, 94.85]

    8.3 individual
2120Risk Ratio (M-H, Fixed, 95% CI)2.0 [0.54, 7.36]

    8.4 individual plus telephone
1126Risk Ratio (M-H, Fixed, 95% CI)2.19 [0.90, 5.33]

    8.5 telephone
11051Risk Ratio (M-H, Fixed, 95% CI)1.31 [0.86, 1.98]

    8.6 telephone plus self help
1237Risk Ratio (M-H, Fixed, 95% CI)1.62 [0.96, 2.76]

    8.7 self help
4197Risk Ratio (M-H, Fixed, 95% CI)1.56 [0.77, 3.18]

 9 Level of behavioural support111844Risk Ratio (M-H, Fixed, 95% CI)1.47 [1.13, 1.92]

    9.1 multi session behavioural support
71647Risk Ratio (M-H, Fixed, 95% CI)1.46 [1.09, 1.94]

    9.2 no behavioural support
4197Risk Ratio (M-H, Fixed, 95% CI)1.56 [0.77, 3.18]

 10 Additional pharmacotherapy91562Risk Ratio (M-H, Fixed, 95% CI)1.52 [1.11, 2.09]

    10.1 pharmacotherapy
3254Risk Ratio (M-H, Fixed, 95% CI)2.20 [0.98, 4.94]

    10.2 no pharmacotherapy
61308Risk Ratio (M-H, Fixed, 95% CI)1.41 [1.00, 2.00]

 
Comparison 2. Psychosocial mood management versus control for smokers with past depression. Abstinence at six months or greater follow-up

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Psychosocial mood management versus control for smokers with past depression131496Risk Ratio (M-H, Fixed, 95% CI)1.41 [1.13, 1.77]

 2 Psychosocial mood management versus control for smokers with past depression (without Carmody 2008)121394Risk Ratio (M-H, Fixed, 95% CI)1.38 [1.09, 1.74]

 3 Length of follow-up131496Risk Ratio (M-H, Fixed, 95% CI)1.41 [1.13, 1.77]

    3.1 abstinence 6m follow-up
2247Risk Ratio (M-H, Fixed, 95% CI)2.29 [1.13, 4.64]

    3.2 abstinence 12m follow-up
111249Risk Ratio (M-H, Fixed, 95% CI)1.32 [1.04, 1.68]

 4 Past depression measurement131496Risk Ratio (M-H, Fixed, 95% CI)1.41 [1.13, 1.77]

    4.1 past major depression
121394Risk Ratio (M-H, Fixed, 95% CI)1.38 [1.09, 1.74]

    4.2 single item depressive symptoms
1102Risk Ratio (M-H, Fixed, 95% CI)2.01 [0.86, 4.68]

 5 Depression group in study131496Risk Ratio (M-H, Fixed, 95% CI)1.41 [1.13, 1.77]

    5.1 depression inclusion criteria
3693Risk Ratio (M-H, Fixed, 95% CI)1.45 [1.04, 2.02]

    5.2 depression subgroup pre stated
7547Risk Ratio (M-H, Fixed, 95% CI)1.33 [0.91, 1.93]

    5.3 depression subgroup post hoc
3256Risk Ratio (M-H, Fixed, 95% CI)1.49 [0.86, 2.60]

 6 Published or unpublished data131496Risk Ratio (M-H, Fixed, 95% CI)1.41 [1.13, 1.77]

    6.1 published data
7901Risk Ratio (M-H, Fixed, 95% CI)1.61 [1.21, 2.14]

    6.2 unpublished data
6595Risk Ratio (M-H, Fixed, 95% CI)1.12 [0.76, 1.63]

 7 Antidepressants use participants exclusion criteria131496Risk Ratio (M-H, Fixed, 95% CI)1.41 [1.13, 1.77]

    7.1 antidepressants use is an exclusion criteria
6910Risk Ratio (M-H, Fixed, 95% CI)1.39 [1.04, 1.86]

    7.2 antidepressants use is not an exclusion criteria
7586Risk Ratio (M-H, Fixed, 95% CI)1.45 [1.01, 2.09]

 8 Format intervention131496Risk Ratio (M-H, Fixed, 95% CI)1.41 [1.13, 1.77]

    8.1 group
5292Risk Ratio (M-H, Fixed, 95% CI)1.44 [0.87, 2.36]

    8.2 group plus self help
1179Risk Ratio (M-H, Fixed, 95% CI)0.70 [0.32, 1.52]

    8.3 individual
1194Risk Ratio (M-H, Fixed, 95% CI)1.56 [0.67, 3.65]

    8.4 individual plus telephone
1102Risk Ratio (M-H, Fixed, 95% CI)2.01 [0.86, 4.68]

    8.5 telephone plus self help
1485Risk Ratio (M-H, Fixed, 95% CI)1.70 [1.16, 2.49]

    8.6 self help
4244Risk Ratio (M-H, Fixed, 95% CI)1.16 [0.70, 1.93]

 9 Level of behavioural support131496Risk Ratio (M-H, Fixed, 95% CI)1.41 [1.13, 1.77]

    9.1 multi session behavioural support
91252Risk Ratio (M-H, Fixed, 95% CI)1.48 [1.15, 1.91]

    9.2 no behavioural support
4244Risk Ratio (M-H, Fixed, 95% CI)1.16 [0.70, 1.93]

 10 Additional pharmacotherapy9794Risk Ratio (M-H, Fixed, 95% CI)1.30 [0.95, 1.79]

    10.1 pharmacotherapy
2148Risk Ratio (M-H, Fixed, 95% CI)1.99 [1.01, 3.92]

    10.2 no pharmacotherapy
7646Risk Ratio (M-H, Fixed, 95% CI)1.14 [0.80, 1.65]

 
Comparison 3. Bupropion versus placebo for current depression. Abstinence at six months or greater follow-up

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Bupropion versus placebo5410Risk Ratio (M-H, Fixed, 95% CI)1.37 [0.83, 2.27]

    1.1 Bupropion alone versus placebo
4355Risk Ratio (M-H, Fixed, 95% CI)1.32 [0.78, 2.24]

    1.2 Bupropion and NRT versus placebo and NRT
155Risk Ratio (M-H, Fixed, 95% CI)1.93 [0.38, 9.68]

 
Comparison 4. Fluoxetine versus placebo for current depression. Abstinence at six months or greater follow-up

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Fluoxetine versus placebo264Risk Ratio (M-H, Fixed, 95% CI)1.02 [0.14, 7.32]

 
Comparison 5. Paroxetine versus placebo for current depression. Abstinence at six months or greater follow-up

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Paroxetine versus placebo143Risk Ratio (M-H, Fixed, 95% CI)1.09 [0.34, 3.51]

 
Comparison 6. Bupropion versus placebo for past depression. Abstinence at six months or greater follow-up

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Bupropion versus placebo4404Risk Ratio (M-H, Fixed, 95% CI)2.04 [1.31, 3.18]

    1.1 Bupropion alone versus placebo
4317Risk Ratio (M-H, Fixed, 95% CI)1.57 [0.96, 2.58]

    1.2 Bupropion and NRT versus placebo and NRT
187Risk Ratio (M-H, Fixed, 95% CI)5.46 [1.71, 17.40]

 
Comparison 7. Fluoxetine versus placebo for past depression. Abstinence at six months or greater follow-up

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Fluoxetine versus placebo2147Risk Ratio (M-H, Fixed, 95% CI)1.18 [0.47, 2.93]

 
Comparison 8. Nortriptyline versus placebo for past depression. Abstinence at six months or greater follow-up

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Nortriptyline versus placebo165Risk Ratio (M-H, Fixed, 95% CI)1.03 [0.41, 2.61]

 
Comparison 9. Paroxetine versus placebo for past depression. Abstinence at six months or greater follow-up

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Paroxetine versus placebo160Risk Ratio (M-H, Fixed, 95% CI)2.03 [0.86, 4.74]

 
Comparison 10. Selegiline versus placebo for past depression. Abstinence at six months or greater follow-up

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Selegiline versus placebo126Risk Ratio (M-H, Fixed, 95% CI)3.75 [0.20, 71.12]

 
Comparison 11. Sertraline versus placebo for past depression. Abstinence at six months or greater follow-up

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Sertraline versus placebo1134Risk Ratio (M-H, Fixed, 95% CI)0.71 [0.30, 1.64]

 
Comparison 12. Psychosocial intervention for current depression. Abstinence at six months or greater follow-up

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Telephone counselling versus self help25421Risk Ratio (M-H, Fixed, 95% CI)1.17 [0.98, 1.39]

 
Comparison 13. NRT versus placebo for past depression. Abstinence at six months or greater follow-up

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 NRT versus placebo3432Risk Ratio (M-H, Fixed, 95% CI)1.17 [0.85, 1.60]

 
Summary of findings for the main comparison. Psychosocial mood management versus control for smokers with current depression. Abstinence at six months or longer follow-up

Psychosocial mood management versus control for smokers with current depression. Abstinence at 6 m or longer follow-up

Patient or population: smokers with current depression1
Intervention: Psychosocial mood management

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

ControlPsychosocial mood management

Smoking cessation
Biochemical validation (minority) and self report
Follow-up: 6 - 12 months
88 per 10002130 per 1000
(100 to 170)
RR 1.47
(1.13 to 1.92)
1844
(11 studies)
⊕⊕⊝⊝
low3,4

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1 Smokers with past depression evaluated separately see Summary of findings table 3; Summary of findings table 4.
2 Baseline control risk calculated as average across included studies.
3 The Risk of Bias has been downgraded as most of the studies included under this outcome contained unclear or high risks, especially where blinding or incomplete outcome data were concerned.
4 Total number of events fewer than 300.
 
Summary of findings 2. Bupropion versus control for smokers with current depression. Abstinence at six months or longer follow-up

Bupropion vs control for smokers with current depression. Abstinence at 6 m or longer follow-up

Patient or population: smokers with current depression
Intervention: Bupropion

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

ControlBupropion

Bupropion versus placebo
All biochemically validated
Follow-up: 6 - 12 months
112 per 10001153 per 1000
(93 to 253)
RR 1.37
(0.83 to 2.27)
410
(5 studies)
⊕⊕⊝⊝
low2,3,4

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1 Baseline risk calculated as average across all control groups.
2 The Risk of Bias has been downgraded as all of the studies included under this outcome contained some unclear risks.
3 There were no differences across two subgroups for Bupropion use (1) without additional NRT; 2) with NRT across both control and intervention). Taking NRT did not change the overall effect.
4 Number of events is fewer than 300, and the confidence intervals encompass both negative and positive outcomes.
 
Summary of findings 3. Psychosocial mood management versus control for smokers with past depression. Abstinence at six months or longer follow-up

Psychosocial mood management versus control for smokers with past depression. Abstinence at 6 months or longer follow-up.

Patient or population: patients with smokers with past depression
Intervention: Psychosocial mood management

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

ControlPsychosocial mood management

Smoking cessation
Biochemical validation (majority) and self report
Follow-up: 6-12 months
142 per 10001201 per 1000
(161 to 252)
RR 1.41
(1.13 to 1.77)
1496
(13 studies1)
⊕⊕⊝⊝
low2,3

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1 Baseline control risk calculated as average across included studies.
2 The Risk of Bias has been downgraded as most of the studies included under this outcome contained unclear or high risks, especially where allocation concealment, blinding or incomplete data were concerned.
3 Total number of events fewer than 300.
 
Summary of findings 4. Bupropion versus control for smokers with past depression. Abstinence at six months or longer follow-up

Bupropion for smokers with past depression

Patient or population: patients with smokers with past depression
Intervention: Bupropion

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

ControlBupropion

Bupropion versus placebo
Biochemical validation (majority) and self report
Follow-up: 6-12 months
123 per 10001251 per 1000
(161 to 391)
RR 2.04
(1.31 to 3.18)2
404
(4 studies)
⊕⊕⊝⊝
low3,4

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1 Baseline control risk calculated as average across included studies.
2 There were no differences across two subgroups for Bupropion use (1) without additional NRT; 2) with NRT across both control and intervention). Taking NRT did not change the overall effect.
3 The risk of bias has been downgraded as all the studies included under this outcome contained unclear or high risks, mainly where blinding or incomplete outcome data were concerned.
4 Total number of events fewer than 300.