Abstract
BackgroundMental 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).MethodsThis 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.DiscussionDespite 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 registrationThe study was registered in the German Clinical Trials Register (ID: DRKS00024152, 05/02/2021).
Highlights
Mental disorders are prevalent and cause considerable burden of disease
Despite its promising therapeutic effects, exercise programs are currently not provided within the outpatient mental health care system in Germany
Exercise therapy is currently not provided within the outpatient mental health care system in Germany, despite the promising effects of exercise found for different mental disorders [25], and despite its promise in bridging the severe gap of people in need and people receiving evidence-based treatment
Summary
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). Mental disorders account for 13.1% of total costs and represent the second highest cost group after cardiovascular disorders (46.4 billion euros, 13.7% of total costs). With 14.4 billion euros overall, mental disorders caused the second-highest lost production costs of all diagnosis groups in 2019 [18]. They further caused 117.2 million days (16.5% of all days) of incapacity to work, which is the longest absences per sick leave of all disorders [19]. Major depressive disorders accounted for the most days of incapacity to work (33.9 million days), followed by trauma- and stress-related disorders (21.6 million days). Anxiety disorders accounted for 7.6 million days and insomnia for 0.5 million days
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