Brown 2013.
Study characteristics | ||
Methods |
Study design: RCT Location: USA Setting: unclear, recruitment from community Recruitment: newspaper and radio advertisements targeting smokers who had “previous difficulty quitting for even short periods of time” Study dates: not reported |
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Participants | N = 49 Specialist population?: smokers with a history of early lapse (< 72 h post‐quit) Definition of smoker used: ≥ 15 cpd for at least the past 3 years Participant characteristics: 49% female; average age: 48 years; 90% white; 33% high school education or less; average cpd: 22; nicotine dependence: average FTND 6.3; 29% one or more depressive episodes |
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Interventions |
Comparator: standard treatment covering self‐monitoring, identifying triggers, developing self‐management strategies for coping with triggers, and relapse prevention skills Mode of delivery: face‐to‐face (group), telephone Intensity: 6 face‐to‐face group sessions (x 90 min) and 1 phone call (20 min) over 6 weeks Pharmacotherapy: 8 weeks of nicotine patches from quit date (4 weeks x 21 mg, 2 x 14 mg, 2 x 7 mg) Type of therapist/provider: doctoral‐level psychologists or trainees (trained by senior investigators) BCTs: 1.2 Problem solving, 2.3 Self‐monitoring of behaviour, 8.2 Behaviour substitution; 11.1 Pharmacological support Intervention: distress tolerance treatment. This included exercises aimed at increasing participants’ tolerance of distress while maintaining a focus on the valued life goals associated with quitting smoking Mode of delivery: face‐to‐face (individual and group) Intensity: 6 individual sessions (x 50 min) and 9 group sessions (x 2 h) over 8 weeks Pharmacotherapy: 8 weeks of nicotine patches from quit date (4 weeks x 21 mg, 2 x 14 mg, 2 x 7 mg) Type of therapist/provider: doctoral‐level psychologists or trainees (trained by senior investigators) BCTs: 7.3 Reduce prompts/cues: 'nicotine fading', 11.1 pharmacological support |
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Outcomes |
Definition of abstinence: 7‐day point prevalence Longest follow‐up: 6 months Biochemical verification: CO ≤ 5 ppm and cotinine ≤ 10 ng/mL Other relevant outcomes reported: negative affect |
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Notes |
Relevant comparisons: distress tolerance training + NRT vs standard treatment + NRT Funding source: National Institute on Drug Abuse (DA017332) Author conflicts of interest: “None declared” |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method not reported |
Allocation concealment (selection bias) | Unclear risk | Concealment not reported |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Abstinence biochemically verified |
Incomplete outcome data (attrition bias) All outcomes | Low risk | At 6‐month follow‐up 7.4% (2/27) were lost to follow‐up in the intervention group and 4.8% (1/21) in the control group |
Selective reporting (reporting bias) | Unclear risk | No protocol available |