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

Bloom 2020.

Study characteristics
Methods Study design: RCT
Location: USA
Setting: community
Recruitment: paper and electronic advertisements
Study dates: not reported
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
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
Outcomes Definition of abstinence: 7‐day point prevalence
Longest follow‐up: 6 months
Biochemical verification: CO ≤ 6 ppm
Other relevant outcomes reported: negative affect
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.”
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