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
BACKGROUND: In Germany, evidence-based outpatient smoking cessation therapies are widely available. Long-term abstinence rates, however, are limited. Studies suggest that short-term residential therapy enables a higher level of environmental control, more intense contact and greater support among patients and from therapists, which could result in higher abstinence rates. The aim of the current START-study is to investigate the long-term efficacy of a short-term residential therapy exclusively for smoking cessation, conducted by a mobile team of expert therapists. METHODS: A randomized controlled trial (RCT) is conducted to examine the efficacy of residential behavior therapeutic smoking cessation therapy compared to standard outpatient behavior therapeutic smoking cessation group therapy. Adult smokers consuming 10 or more cigarettes per day, who are willing to stop smoking, are randomized in a ratio of 1:1 between therapy groups. The primary endpoint is sustained abstinence for 6-month and 12-month periods. Secondary endpoints include smoking status after therapy, 7-day point abstinence after the 6-month and 12-month follow-ups, level of physical dependence, cost-effectiveness, use of nicotine replacement products, health-related quality of life, self-efficacy expectation for tobacco abstinence, motivational and volitional determinants of behavior change, self-reported depressive symptom severity, adverse events and possible side effects. Assessments will take place at baseline, post-therapy, and at 6-month and 12-month intervals after smoking cessation. DISCUSSION: There is a high demand for long-term effective smoking cessation therapies. This study represents the first prospective RCT to examine the long-term efficacy of a residential smoking cessation therapy program compared to standard outpatient group therapy as an active control condition. The residential therapeutic concept may serve as a new model to substantially enhance future cessation therapies and improve the understanding of therapeutic impact factors on tobacco abstinence. Utilizing a mobile team, the model could be applied efficiently to medical centers that do not have permanent and trained personnel for smoking cessation at their disposal. TRIAL REGISTRATION: German Register for Clinical Trials (Deutsches Register für Klinische Studien), DRKS00013466. Retrospectively registered on 1 April 2019. https://www.drks.de/drks_web/navigate.do?navigationId=start.
