Patten 2002.
Methods | Study design: Cluster‐randomized controlled trial Country: USA Recruitment: Volunteers attending Alcoholics Anonymous Group size: approx 8 |
|
Participants | 48 smokers with history of alcohol dependence but 3 m of drug and alcohol abstinence; 47% women, av. age 42, av. cpd 28 Therapists: different clinical psychologist and doctoral student pair for each condition | |
Interventions | 1. Behavioural counselling, 12 x 2‐hr weekly, TQD wk 8. Includes nicotine fading, skills training, homework, discussion 2. As 1 + Cognitive Behavioural Mood Management skills training. Same length | |
Outcomes | Abstinence at 12 m, sustained at 1, 3 m. Validation: CO < 10 ppm (PPA rates and informant or CO‐validated rates also reported) | |
Notes | No non‐group control. Comparison 2.3, effect of additional mood management component | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method not described; cluster‐randomized to small groups based on order of recruitment |
Allocation concealment (selection bias) | Unclear risk | Unclear |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Biochemical validation of abstinence |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 73% BC and 84% CBT completed 12‐m follow‐up. All participants included in ITT analysis |