Rohsenow 2014.
Methods | Study design: RCT Location: USA Setting: state‐funded inner‐city residential substance abuse treatment programme with state‐wide catchment Recruitment: residents of the abstinence‐oriented programme were told the study would provide informational sessions about smoking without requiring cessation, and asked if they would like to take part. |
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Participants | Defining eligibility criteria?: alcohol‐dependent smokers Participant characteristics: 165 adult smokers meeting current alcohol dependence criteria, randomised to intervention (80) and control (85); 32.4% female; mean age 33.8; cpd 21.2 Motivation to quit?: not selected on motivation |
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Interventions | 1. Control: brief advice used AHRQ‐recommended methods. At the Initial session (15 mins), therapists assessed smoking rate and interest in quitting, directly advised participants to stop smoking now during substance use treatment for their health, and given advice about useful methods. 43 participants were randomised to receive booster sessions (5 to 15 mins each), 7 and 30 days after the initial session. The remaining 42 participants did not receive boosters. 2. Intervention: used motivational therapist style with assessment feedback, based on motivational interviewing. Initial session (45 mins) involved discussing pros and cons of smoking, interpreting health risks, costs of smoking, smoking rate, relationship of smoking to ongoing alcohol use, and barriers to change, with corrective information. 40 participants were randomised to booster sessions (5 to 15 mins each), 7 and 30 days after the initial session. The remaining 40 participants did not receive boosters. All participants informed of free access to smoking cessation pamphlets, smoking cessation skills groups, hard candy, and free access to NRT (transdermal nicotine or nicotine gum) if medically eligible and willing to cease smoking while using it. Provider: counsellors Intensity: single 45‐minute initial session, with two 5‐ to 15‐minute booster sessions (in booster group only) Was MI fidelity monitored?: "Treatment session audiotapes (24% of initial sessions, 19% of booster sessions) were reviewed in weekly group supervision with Dr. Rohsenow and a treatment coordinator, and rated for MI style and adherence to the manual (see 2.4.4), with immediate feedback to therapists to prevent drift. Treatment sessions were rated by the treatment coordinator (primary rater) or the first author on 1 (not at all) to 5 (extensively) scales for five motivational style measures (arguing, demonstrating empathy, reflective listening, supporting self‐efficacy, emphasizing personal responsibility for change), and supervisors endorsed adequacy of six MI adherence items (discuss ambivalence (pros and cons, goal discrepancies), discuss feedback about smoking effects, explore barriers to change, provide summaries, discuss various goals, discuss methods)." |
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Outcomes | Definition of cessation used: 7‐day point prevalence Length of longest follow‐up: 12 months Validation: exhaled CO ≤ 10 ppm Was mental health and/or well‐being measured at follow‐up?: no Was quality of life measured at follow‐up?: no |
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Funding source | A grant from the National Institute of Alcohol Abuse and Alcoholism (1 RO1 AA11318) and two Senior Research Career Scientist Awards from the United States Department of Veterans Affairs | |
Author conflicts of interest | Not reported | |
Notes | The study was made up of 4 trial arms: MI with and without booster sessions and brief advice with and without booster sessions. For the purpose of MI versus other smoking cessation support analyses, we combined these into 2 groups: 1. MI and 2. brief advice. However, we also compared the two MI groups in our intensity analysis. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | QUOTE: "Randomization to MI or BA and to booster sessions versus no boosters within each gender occurred in the first week of the program using a random numbers table". |
Allocation concealment (selection bias) | Unclear risk | QUOTE: "Assignment was placed in a sealed envelope opened just before the first treatment session." Did not state whether envelopes were opaque. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Abstinence was validated by exhaled carbon monoxide. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 27/80 (34%) in the MI intervention group and 25/85 (29%) in the BA control group were lost to 12‐month follow‐up. Therefore, dropout rate was similar between arms. |