Bock 2019.
Study characteristics | ||
Methods |
Study design: RCT Location: USA Setting: community Recruitment: advertisements on local radio stations and websites, flyers and brochures at physician’s offices and stores Study dates: not reported |
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Participants | N = 227 Specialist population?: no Definition of smoker used: ≥ 5 cpd Participant characteristics: 56% female; average age: 46 years; 86% white; 28% high school education or less; average cpd: 17; nicotine dependence: average FTND 4.9 |
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Interventions | All participants were provided with an 8‐week group CBT programme for smoking cessation, including planning for a targeted quit day (week 4), handling smoking triggers, coping with cravings, and managing withdrawal. Comparator Group CBT + wellness classes Mode of delivery: face‐to‐face (group) Intensity: 8 CBT sessions (x 1 h) and 16 wellness classes (x 1 h) over 8 weeks Pharmacotherapy: none provided, but participants were permitted to use NRT or other smoking cessation medications in conjunction with the programme Type of therapist/provider
BCTs: 1.1 Goal setting (behaviour), 1.2 Problem solving, 3.1 Social support, 12.6 Body changes Intervention Group CBT + Iyengar yoga Mode of delivery: face‐to‐face (group) Intensity: 8 CBT sessions (x 1 h) and 16 yoga classes (x 1 h) over 8 weeks Pharmacotherapy: none provided, but participants were permitted to use NRT or other smoking cessation medications in conjunction with the programme Type of therapist/provider
BCTs: 1.1 Goal setting (behaviour), 1.2 Problem solving; 3.1 Social support (unspecified) |
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Outcomes |
Definition of abstinence: continuous (based on 7‐day point prevalence at end of treatment and follow‐up) Longest follow‐up: 6 months Biochemical verification: CO < 10 ppm or salivary cotinine < 15 mg/mL Other relevant outcomes reported: none |
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Notes |
Relevant comparisons: Iyengar yoga + CBT vs wellness classes + CBT Funding source: National Institutes of Health, National Center for Complementary and Integrative Health (R01 AT006948) Author conflicts of interest: “The authors have no competing financial interests to declare.” |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote [protocol]: “The randomization scheme generated by the study statistician uses a permuted block randomization procedure, with small, random sized blocks. Randomization is stratified based on gender and level of nicotine dependence.” |
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 6.2% (7/113) were lost to follow‐up in the intervention group and 4.4% (5/114) in the control group |
Selective reporting (reporting bias) | Low risk | Prespecified outcomes reported |