Brown 2001.
Methods | Study design: Randomized controlled trial Country: USA Recruitment: Community volunteers Group size: not stated |
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Participants | 179 smokers with history of MDD; 60% women, av. age 45, av. cpd 27 Therapists: 2 for each group, clinical psychologists | |
Interventions | 1. Standard group therapy. 8 x 2 hrs over 6 wks, TQD session 5. Including nicotine fading, RP, homework 2. As 1. + CBT for depression. Same schedule + coping skills to control depressive symptoms | |
Outcomes | Sustained abstinence at 12 m (confirmed at post‐Rx, 1 m, 6 m). (PPA was main trial outcome) Validation: CO ≤ 10 ppm + saliva cotinine ≤ 46 ng/ml (abstinence was only verified by significant others in 6.5% of cases) | |
Notes | No non‐group control. Comparison 2.2.1 ‐ testing effect of depression/mood management programme. Direction of effect opposite for sustained and PPA | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomized, stratified on gender, current depressive symptoms, FTQ, using urn method |
Allocation concealment (selection bias) | Low risk | No details given, but use of urn technique makes it likely that enrolment occurred before allocation known |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Biochemical validation of abstinence |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 8% lost to follow‐up at 12 m, included in ITT analysis |