Project
ImPuls – a Group Therapeutic Exercise Intervention for the Outpatient Psychotherapeutic Context
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Background
Mental disorders are prevalent and cause considerable burden of disease. Exercise has been shown to be efficacious to treat major depressive disorders, insomnia, panic disorder with and without agoraphobia and post traumatic stress disorder (PTSD).
Methods
This pragmatic, two arm, multi-site randomised controlled trial will evaluate the efficacy and cost-effectiveness of the manualized, group-based six-months exercise intervention “ImPuls”, among physically inactive patients with major depressive disorders, insomnia, panic disorder, agoraphobia and PTSD within a naturalistic outpatient context in Germany. A minimum of 375 eligible outpatients from 10 different study sites will be block- randomized to either ImPuls in addition to treatment as usual (TAU) or TAU only. ImPuls will be conducted by trained exercise therapists and delivered in groups of six patients. The program will combine (a) moderate to vigorous aerobic exercise carried out two-three times a week for at least 30 min with (b) behavior change techniques for sustained exercise behavior change. All outcomes will be assessed pre-treatment, post-treatment (six months after randomization) and at follow-up (12 months after randomization). Primary outcome will be self-reported global symptom severity assessed with the Brief Symptom Inventory (BSI-18). Secondary outcomes will be accelerometry-based moderate to vigorous physical activity, self-reported exercise, disorder-specific symptoms, quality-adjusted life years (QALY) and healthcare costs. Intention-to-treat analyses will be conducted using mixed models. Cost-effectiveness and cost-utility analysis will be conducted using incremental cost-effectiveness and cost-utility ratios.
Discussion
Despite its promising therapeutic effects, exercise programs are currently not provided within the outpatient mental health care system in Germany. This trial will inform service providers and policy makers about the efficacy and cost-effectiveness of the group-based exercise intervention ImPuls within a naturalistic outpatient health care setting. Group-based exercise interventions might provide an option to close the treatment gap within outpatient mental health care settings.
Trial registration
The study was registered in the German Clinical Trials Register (ID: DRKS00024152 , 05/02/2021).
Sebastian Wolf
Johanna-Marie Zeibig
Martin Hautzinger
Gorden Sudeck
Regelmäßige sportliche Aktivität wirkt sich nicht
nur auf das körperliche Wohlbefinden aus, sondern
hat auch positive Effekte auf die psychische
Verfassung. Sport verringert bei Depressionen,
Angststörungen, Schlafstörungen und ADHS
die Symptomatik deutlich. Trotz dieser klinisch
relevanten Effekte gibt es bisher vor allem im
ambulanten Versorgungskontext von Patienten mit psychischen Erkrankungen kaum sporttherapeutische
Ansätze oder Programme.
Das erprobte und evaluierte Programm ImPuls
schließt diese Lücke, indem es sport- und bewegungstherapeutische
Interventionen für Menschen
mit psychischen Erkrankungen anbietet.
Im Rahmen des Programms werden die Teilnehmerinnen
und Teilnehmer motiviert, sportliche
Aktivität zu initiieren und langfristig aufrechtzuerhalten.
Der Einbezug des sozialen Umfeldes
sowie eine intensive Nachbetreuung unterstützen
den Transfer der regelmäßigen sportlichen
Aktivität in den Alltag. Umfangreiches Arbeitsmaterial,
darunter Handouts, Übungen und ein
Trainingsvideo, wird zum Download angeboten.