Bloom 2020.
Study characteristics | ||
Methods |
Study design: RCT Location: USA Setting: community Recruitment: paper and electronic advertisements Study dates: not reported |
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Participants | N = 69 Specialist population?: women motivated to quit smoking and concerned about post‐cessation weight gain Definition of smoker used: ≥ 5 combustible cpd for at least the past year Participant characteristics: 100% female; average age: 50 years; 74% white; 42% SES; average cpd: 16; nicotine dependence: average FTND 4.8 |
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Interventions | All participants received CBT, including preparation for quit date, reinforcement, and support for quitting, discussion of past and ongoing quit experiences, initiation of self‐monitoring, identification of triggers and high‐risk situations, development of coping strategies for triggers, obtaining social support, instruction in how to use nicotine patches, and relapse prevention. Recommendations for how to minimise weight gain were brief, de‐emphasised, and consistent with standard CBT (e.g. take a walk to cope with craving instead of smoking, eat low‐calorie snacks) Comparator CBT + smoking health education. Diet and exercise were mentioned as strategies for health promotion and prevention of disease but no specific recommendations for how to change diet or increase physical activity Mode of delivery: face‐to‐face (individual and group), telephone Intensity: 9 sessions (1 x 60 min, 8 x 90 min) and 1 phone call (20 min) over 9 weeks Pharmacotherapy: 8 weeks of nicotine patches from quit date, adjusted to individual cpd Type of therapist/provider: each session was co‐led by 2 trained group leaders, including a physician, doctoral‐level psychologists, and clinical psychology doctoral students BCTs: 1.2 Problem solving; 2.3 Self‐monitoring of behaviour; 3.1 Social support; 5.1 Information about health consequences; 11.1 Pharmacological support Intervention CBT + distress tolerance for weight concern. Based on ACT and included: psychoeducation about the relationship between smoking and weight; distress tolerance skills; discussion of weight concern as a barrier to successful initiation of abstinence; and values‐oriented living skills targeting reduction of emotional eating after quitting Mode of delivery: face‐to‐face (individual and group), telephone Intensity: 9 sessions (1 x 60 min, 8 x 90 min) and 1 phone call (20 min) over 9 weeks Pharmacotherapy: 8 weeks of nicotine patches from quit date, adjusted to individual cpd Type of therapist/provider: each session was co‐led by 2 trained group leaders, including a physician, doctoral‐level psychologists, and clinical psychology doctoral students BCTs: 1.2 Problem solving; 2.3 Self‐monitoring of behaviour; 3.1 Social support; 5.1 Information about health consequences; 5.5 Anticipated regret; 11.1 Pharmacological support |
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Outcomes |
Definition of abstinence: 7‐day point prevalence Longest follow‐up: 6 months Biochemical verification: CO ≤ 6 ppm Other relevant outcomes reported: negative affect |
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Notes |
Relevant comparisons: distress tolerance for weight concern + CBT + NRT vs health education + CBT + NRT Funding source: National Institute on Drug Abuse (grant number K23DA035288) Author conflicts of interest: “RAB has equity ownership in Health behaviour Solutions, Inc., which is developing products for tobacco cessation that are not related to this study. The terms of this arrangement have been reviewed and approved by the University of Texas at Austin in accordance with its policy on objectivity in research. The other authors have no interests to declare.” |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Stated randomised but method not specified |
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 21.2% (7/33) were lost to follow‐up in the intervention group and 22.2% (8/36) in the control group |
Selective reporting (reporting bias) | Unclear risk | No protocol available |