Efficacy of a short-term residential smoking cessation therapy versus standard outpatient group therapy (‘START-Study’): study protocol of a randomized controlled trial

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.

Successful Smoking Cessation among Women Smokers Based on Utilizing National Smoking Cessation Service Type in Korea

“…An examination of the success rates for the period of four weeks to six months shows that participants in the residential 4-night 5-day program group had the highest success rates. Prior studies have also shown that smokers who participated in the residential smoking cessation program continue to have longer smoking cessation effects than smokers who have experienced other programs [ 23 ]. A previous study also demonstrated that a residential smoking cessation program is effective for heavy smokers who are highly dependent on nicotine [ 24 ].…”

Residential treatment exclusively for smoking cessation in patients with Crohn’s disease: Results from a pilot study

“…These are results from a pilot study. For healthy smokers, results from a larger prospective, randomized and controlled study will be available in late 2022 15 . These two studies will provide a good basis for implementing a larger, controlled study in CD patients in the near future.…”

Stationäre Behandlung exklusiv zur Raucherentwöhnung – Konzept einer intensivierten verhaltenstherapeutischen Gruppentherapie

“…Die Therapieform wurde in einer Pilotstudie (n = 20) erfolgreich mit dem Ergebnis einer kontinuierlichen 6-Monats-Abstinenzquote von 50 % erprobt [27]. Eine randomisiert-kontrollierte Studie zum Wirksamkeitsvergleich anhand der kontinuierlichen 12-Monats-Abstinenzquoten (biochemisch validiert) mit einer leitliniengemäßen ambulanten Raucherentwöhnungstherapie befindet sich in der Auswertungsphase [29] (Stand 01/2022).…”