Gifford 2003.
Study characteristics | ||
Methods |
Study design: RCT Location: USA Setting: community Recruitment: through newspaper and radio advertisements and flyers Study dates: not reported |
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Participants | N = 102 Specialist population?: no Definition of smoker used: self‐identified nicotine dependence, ≥ 10 cpd for the last 12 months Participant characteristics: 59% female; average age: 43 years; 77% white; 4% some high school or less; average cpd: 21; nicotine dependence: average FTND 5.4 |
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Interventions |
Comparator: nicotine replacement therapy Mode of delivery: face‐to‐face Intensity: 1‐h session plus weekly return visits to receive new patches for following week Pharmacotherapy: 7 weeks of nicotine patches (22 mg/d for 4 weeks, followed by patches of 11 mg/d for 3 weeks) Type of therapist/provider: psychiatrist with extensive training in the medical management of smoking cessation, including NRT, or psychiatry resident under supervision of psychiatrist BCTs: 4.1 Instruction on how to perform behaviour, 11.1 Pharmacological support Intervention: ACT Mode of delivery: face‐to‐face (individual and group), telephone call if missed face‐to‐face individual session Intensity: 7 individual sessions and 7 group sessions over 7 weeks (duration of sessions not reported) Pharmacotherapy: none Type of therapist/provider: ACT therapist BCTs: 1.1 Goal setting (behaviour), 1.2 Problem solving, 1.9: Commitment, 7.3 Reduce prompts and cues, 8.7 Graded tasks, 12.6 Body changes |
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Outcomes |
Definition of abstinence: 7‐day point prevalence Longest follow‐up: 12 months Biochemical verification: CO < 11 ppm Other relevant outcomes reported: negative affect |
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Notes |
Relevant comparisons: ACT vs NRT Funding source: National Institutes of Health, National Cancer Institute (CA84813) Author conflicts of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “If participants were accepted into the study, they were randomly assigned to treatment condition using a random numbers generator” |
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 12‐month follow‐up 38.3% (18/47) were lost to follow‐up in the intervention group and 23.6% (13/55) in the control group |
Selective reporting (reporting bias) | Unclear risk | No protocol available |