1. Effectiveness of residential versus outpatient therapy for smoking cessation: The START randomized clinical trial.
- Author
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Dickreuter, Jonas Levin, Schmoor, Claudia, Jähne, Andreas, Bengel, Jürgen, Pschichholz, Barbara, Lorz, Christina, Schulz, Christina, Vozelj, Jana, and Leifert, Jens Albert
- Subjects
SMOKING cessation ,SELF-evaluation ,MILIEU therapy ,RESEARCH funding ,OUTPATIENT medical care ,STATISTICAL sampling ,CLINICAL trials ,SMOKING ,GROUP psychotherapy ,TREATMENT effectiveness ,RANDOMIZED controlled trials ,DESCRIPTIVE statistics ,ADVERTISING ,ODDS ratio ,REHABILITATION centers ,COMPARATIVE studies ,CONFIDENCE intervals ,TOBACCO products ,GROUP process ,DRUG abstinence ,BEHAVIOR therapy - Abstract
Background and Aims: Tobacco smoking represents a major cause for preventable death and morbidity. Results from non‐randomized studies suggest that smoking cessation therapy in a residential setting might be a new viable way to facilitate smoking abstinence. We aimed to test the effects of residential multicomponent group therapy for smoking cessation compared with outpatient group therapy. Design: Prospective parallel‐group open‐label randomized superiority trial, with assessments at baseline, 6 and 12 months. Setting: Recruitment throughout Germany via media advertisements. Participants: Adult smokers (≥10 cigarettes/day) randomly assigned to residential (n = 157) or outpatient (n = 158) therapy. 51.8% female; mean age 53.2 years; mean years of smoking 34.4. Intervention and Comparator: Residential 9‐day smoking cessation group therapy comprising six daily therapy sessions and supportive interventions for cessation and daily structure embedded in the routines of a somatic rehabilitation center, compared with weekly outpatient smoking cessation group therapy (3–7 weeks) provided in routine care courses close to the participants' places of residence, both including at least 9 h of behavioral therapy. Measurements Co‐primary outcomes were self‐reported continuous 6‐ and 12‐month abstinence (hierarchically ordered). Primary analyses were conducted in the therapy‐uptake population including participants who started therapy with sensitivity analyses in the intention‐to‐treat population of all randomized participants. Findings Intervention uptake rates were 87.3% (n = 137) in the residential and 60.1% (n = 95) in the outpatient group. In the therapy‐uptake population, abstinence rates were 46.7% in the residential versus 26.3% in the outpatient group at 6 months (odds ratio [OR] = 2.46, 95% confidence interval [CI] = 1.39–4.33, P = 0.0019) and 39.4% versus 24.2% at 12 months (OR = 2.04, 95% CI = 1.14–3.64, P = 0.017). Biochemically validated abstinence rates at 12 months were 33.1% in the residential versus 17.4% in the outpatient group (OR = 2.35, 95% CI = 1.22–4.51, P = 0.011). In the intention‐to‐treat population, self‐reported and biochemically validated abstinence rates at 12 months were 34.4% in the residential versus 14.6% in the outpatient group (OR = 3.08, 95% CI = 1.77–5.34, P < 0.0001) and 28.6% versus 10.3% (OR = 3.48, 95% CI = 1.85–6.52, P = 0.0001), respectively. Conclusions: Residential therapy exclusively for smoking cessation is feasible and effective and could be a beneficial new treatment for smokers. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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