Hall 2002.
Methods | Study design: Randomized controlled trial Country: USA Recruitment: Community volunteers. Exclusion criteria included current MDD Group size: 3 ‐ 11 |
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Participants | 220 smokers of ≥ 10 cpd 40% ‐ 47% women, av. age 37 ‐ 43, av. cpd 20 ‐ 23; 33% had history of MDD Therapists: Masters‐level counsellors | |
Interventions | 3 x 2 factorial design with pharmacotherapies: bupropion, nortriptyline, or placebo 1. Medical Management (MM) control: physician advice, S‐H, 10 ‐ 20 mins 1st visit, 5 mins at 2, 6, 11 wks) 2. Psychological Intervention (PI) as MM plus 5 x 90‐min group sessions at 4, 5, 5, 7, 11 wks) | |
Outcomes | Prolonged abstinence at 1 yr (47 wks post‐quit date). PPA also reported Validation: CO ≤ 10 ppm, urine cotinine ≤ 60 ng/mL | |
Notes | Comparison 1.3, group versus physician advice No significant interaction between pharmacotherapy and behaviour therapy, so pharmacotherapy arms collapsed in analysis | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomized, method not specified, "double blind" |
Allocation concealment (selection bias) | Unclear risk | No details given |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Biochemical validation of abstinence |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 19% lost to follow‐up at 1 yr, no difference by group, included in ITT analysis |