Faculty of Economics and Social Sciences, Department of Education & Health Research, Institute of Sports Science, University of Tuebingen, Tuebingen, Germany.
Faculty of Science, Department of Clinical Psychology and Psychotherapy, Psychological Institute, University of Tuebingen, Tuebingen, Germany.
BMC Psychiatry. 2021 Oct 30;21(1):540. doi: 10.1186/s12888-021-03541-3.
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).
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.
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.
The study was registered in the German Clinical Trials Register (ID: DRKS00024152 , 05/02/2021).
精神障碍普遍存在，且疾病负担较大。运动已被证明对治疗重度抑郁症、失眠、伴有或不伴有广场恐怖症的惊恐障碍和创伤后应激障碍（PTSD）有效。
本项实用、双臂、多中心随机对照试验将在德国自然主义门诊环境中，评估针对身体活动不足的伴有重度抑郁症、失眠、惊恐障碍、广场恐怖症和 PTSD 的患者，开展手册化、基于团体的六个月运动干预“ImPuls”的疗效和成本效益，入组患者均为来自 10 个不同研究地点的至少 375 名合格门诊患者，将其按区组随机分组，分别接受 ImPuls 联合常规治疗（TAU）或仅 TAU。ImPuls 将由经过培训的运动治疗师进行，并以 6 名患者为一组开展。该方案将结合（a）每周至少 2-3 次，每次至少 30 分钟的中等至剧烈有氧运动，以及（b）用于持续运动行为改变的行为改变技术。所有结局将在治疗前（随机分组前）、治疗后（随机分组后 6 个月）和随访时（随机分组后 12 个月）进行评估。主要结局为采用Brief Symptom Inventory（BSI-18）自报的总体症状严重程度。次要结局为基于加速度计的中等至剧烈体力活动、自报运动、障碍特异性症状、质量调整生命年（QALY）和医疗保健成本。采用混合模型进行意向治疗分析。采用增量成本效果比和成本效用比进行成本效果分析和成本效用分析。
尽管运动方案具有很有前景的治疗效果，但在德国的门诊心理健康护理系统中，目前并未提供运动方案。本试验将为服务提供者和决策者提供关于基于团体的运动干预“ImPuls”在自然主义门诊医疗保健环境中的疗效和成本效益的信息。基于团体的运动干预可能为缩小门诊心理健康护理环境中的治疗差距提供一种选择。
该研究已在德国临床试验注册中心（DRKS00024152，2021 年 5 月 2 日）注册。
