Bailey 2013.
Methods | Country: USA Setting: 10 continuation high schools, San Francisco Bay Area Study design: RCT |
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Participants | Participants: 143 smokers (I = 72, C = 71). 38% female Age: mean = 16.9 years, SD = 0.80 Criteria for inclusion: 14‐18 years old, attended a participating school, smoked ≥ 10 cpd, expressed interest in quitting smoking. Excluded if currently receiving treatment for major depression, panic disorder, social anxiety or agoraphobia; taking antidepressants, antipsychotics, benzodiazepines or theophylline; current heavy alcohol or substance abuse; diagnosed heart problems or high blood pressure; current use of nicotine replacement therapy; allergy to adhesive tape; currently pregnant or planning on becoming pregnant. Follow‐up method: self‐report through questionnaire Inducements to enter study: gift cards, values not reported No differences in baseline participant characteristics between trial arms Pre‐test smoking status assessment: cpd mean = 13.9, SD = 5.53, dependence measured with mFTQ mean = 17.5, SD = 4.5 Post‐test smoking status assessment: self‐reported biochemically validated abstinence |
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Interventions | Intervention: extended treatment of 24 weeks of group‐based CBT and skills training, concurrent with 9 weeks of nicotine patch therapy. Extended treatment focuses on relapse prevention skills and effective coping plans. Theoretical basis for intervention: CBT (for the non‐pharmacological component of the intervention) Control: 10 weeks of group‐based CBT and skills training, concurrent with 9 weeks of nicotine patch therapy |
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Outcomes | Measurement: 7‐day PPA Relevant follow‐up periods: 10 weeks and 26 weeks Verification: expired‐air CO < 10 ppm, using a Bedfont Smokerlyzer Loss to follow‐up: at 26 weeks both intervention and control groups lost 18% of participants Adverse events: specific details not given |
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Notes | New for 2017 update | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Computer generated randomisation to extended treatment was conducted by the study statistician" |
Allocation concealment (selection bias) | Low risk | "Intervention staff and participants remained blind to treatment group assignments until the end of open label treatment" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Behavioural intervention makes blinding difficult, and intervention group received extended treatment in comparison to the control |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Biochemically validated outcome |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up was 18% in both intervention and control groups, sufficiently low and similar to be judged low risk of attrition bias. |