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. 2022 Apr 14;2022(4):CD013696. doi: 10.1002/14651858.CD013696.pub2

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 
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
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
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
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”
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