Bricker 2014a.
Study characteristics | ||
Methods |
Study design: RCT Location: USA Setting: community Recruitment: uninsured callers to the South Carolina State Quitline Study dates: 2012‐13 |
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Participants | N = 121 Specialist population?: uninsured Definition of smoker used: ≥ 10 cpd for at least the past 12 months Participant characteristics: 69% female; average age: 39 years; 73% white; 55% high school education or less; nicotine dependence: 71% HSI score ≥ 4; 39% positive depression screen |
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Interventions |
Comparator: standard CBT‐based counselling intervention offered through the South Carolina State Quitline Mode of delivery: telephone Intensity: 5 calls (1 x 30 min, 4 x 15 min) Pharmacotherapy: 2 weeks of nicotine patch or gum (participant’s choice) Type of therapist/provider: bachelor's‐ or master's‐level providers with ≥ 3 years of general counselling experience and > 100 h of training BCTs: 1.2 Problem solving, 1.4 Action planning, 3.1 Social support (unspecified), 11.1: Pharmacological support, 12.4 Distraction Intervention: ACT programme
Mode of delivery: telephone Intensity: 5 calls (1 x 30 min, 4 x 15 min) Pharmacotherapy: 2 weeks of nicotine patch or gum (participant’s choice) Type of therapist/provider: bachelor's‐ or master's‐level providers with ≥ 3 years of general counselling experience and > 100 h of training BCTs: 1.4 Action planning, 3.1 Social support (unspecified), 11.1: Pharmacological support |
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Outcomes |
Definition of abstinence: 30‐day point prevalence Longest follow‐up: 6 months Biochemical verification: none Other relevant outcomes reported: none |
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Notes |
Relevant comparisons: ACT (telephone) + NRT vs CBT (quitline) + NRT Funding source: National Institute on Drug Abuse (R21DA030646) Author conflicts of interest: “In 2011 Dr. Heffner served as a consultant for Pfizer.” |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised by automated algorithm |
Allocation concealment (selection bias) | Low risk | Quote: “Randomized study arm assignments were computer generated and concealed from participants after eligibility was determined and consent for participation was obtained. Neither research staff nor participants had access to upcoming randomized study arm assignments” |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Abstinence self‐reported but no face‐to‐face contact so no difference in intensity; differential report unlikely |
Incomplete outcome data (attrition bias) All outcomes | Low risk | At 6‐month follow‐up 27.1% (16/59) were lost to follow‐up in the intervention group and 38.7% (24/62) in the control group |
Selective reporting (reporting bias) | Low risk | Prespecified outcomes reported |