Dickreuter Jonas Levin, Schmoor Claudia, Jähne Andreas, Bengel Jürgen, Pschichholz Barbara, Lorz Christina, Schulz Christina, Vozelj Jana, Leifert Jens Albert
Comprehensive Cancer Center (CCCF), Medical Center and Faculty of Medicine, University of Freiburg, Freiburg im Breisgau, Germany.
Clinical Trials Unit, Medical Center and Faculty of Medicine, University of Freiburg, Freiburg im Breisgau, Germany.
Addiction. 2024 Oct;119(10):1762-1773. doi: 10.1111/add.16594. Epub 2024 Jul 10.
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.
Prospective parallel-group open-label randomized superiority trial, with assessments at baseline, 6 and 12 months.
Recruitment throughout Germany via media advertisements.
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.
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.
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.
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.
Residential therapy exclusively for smoking cessation is feasible and effective and could be a beneficial new treatment for smokers.
吸烟是可预防死亡和发病的主要原因。非随机研究结果表明，住院环境下的戒烟治疗可能是促进戒烟的一种新的可行方法。我们旨在测试与门诊小组治疗相比，住院多成分小组戒烟治疗的效果。
前瞻性平行组开放标签随机优势试验，在基线、6个月和12个月时进行评估。
通过媒体广告在德国各地招募。
成年吸烟者（每天≥10支香烟）随机分配接受住院治疗（n = 157）或门诊治疗（n = 158）。女性占51.8%；平均年龄53.2岁；平均吸烟年限34.4年。
住院9天的戒烟小组治疗，包括每天6次治疗课程以及在躯体康复中心日常活动中的戒烟支持干预措施和日常安排，与在参与者居住地附近的常规护理课程中提供的每周门诊戒烟小组治疗（3 - 7周）进行比较，两者均包括至少9小时的行为治疗。
共同主要结局是自我报告的连续6个月和12个月戒烟情况（分层排序）。主要分析在接受治疗的人群中进行，包括开始治疗的参与者，并在所有随机参与者的意向性治疗人群中进行敏感性分析。
住院组的干预接受率为87.3%（n = 137），门诊组为60.1%（n = 95）。在接受治疗的人群中，6个月时住院组的戒烟率为46.7%，门诊组为26.3%（优势比[OR] = 2.46，95%置信区间[CI] = 1.39 - 4.33，P = 0.0019）；12个月时分别为39.4%和24.2%（OR = 2.04，95% CI = 1.14 - 3.64，P = 0.017）。12个月时经生化验证的戒烟率住院组为33.1%，门诊组为17.4%（OR = 2.35，95% CI = 1.22 - 4.51，P = 0.011）。在意向性治疗人群中，12个月时自我报告和经生化验证的戒烟率住院组分别为34.4%和28.6%，门诊组分别为14.6%和10.3%（OR分别为3.08，95% CI = 1.77 - 5.34，P < 0.0001；OR为3.48，95% CI = 1.85 - 6.52，P = 0.0001）。
专门用于戒烟的住院治疗是可行且有效的，可能是吸烟者的一种有益新疗法。
