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

Gifford 2003.

Study characteristics
Methods Study design: RCT
Location: USA
Setting: community
Recruitment: through newspaper and radio advertisements and flyers
Study dates: not reported
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
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
Outcomes Definition of abstinence: 7‐day point prevalence
Longest follow‐up: 12 months
Biochemical verification: CO < 11 ppm
Other relevant outcomes reported: negative affect
Notes Relevant comparisons: ACT vs NRT
Funding source: National Institutes of Health, National Cancer Institute (CA84813)
Author conflicts of interest: not reported
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