Globally, mental health conditions pose a substantial burden of disease. Despite the availability of evidence-based pharmacological and psychological treatments, the symptoms of a substantial subgroup of patients do not respond to these interventions, and only a minority of patients have access to them. This study aimed to assess the efficacy of ImPuls, a 6-month transdiagnostic group exercise intervention, plus treatment-as-usual, compared with treatment-as-usual alone in outpatients with various mental disorders. In this pragmatic, two-arm, multisite, randomised controlled trial in Germany, ten outpatient rehabilitative and medical care facilities were involved as study sites. Participants were outpatients diagnosed according to ICD-10 with one or more of the following disorders based on structured clinical interviews: moderate or severe depression, primary insomnia, post-traumatic stress disorder (PTSD), panic disorder, or agoraphobia. Participants were required to be aged between 18 years and 65 years, insured by the health insurers Allgemeine Ortskrankenkasse Baden-Württemberg or Techniker Krankenkasse, fluent in German, and without medical contraindications for exercise. Blocks of six participants were randomly allocated to ImPuls plus treatment-as-usual or treatment-as-usual alone (allocation ratio: 1:1), stratified by study site. The randomisation sequence was generated by an external data manager. The team responsible for data collection and management was masked to the randomisation sequence. The ImPuls intervention comprised evidence-based outdoor exercises lasting 30 min, and aimed at achieving at least moderate intensity. It also incorporated behavioural change techniques targeting motivational and volitional determinants of exercise behaviour. Treatment-as-usual was representative of typical outpatient health care in Germany, allowing patients access to any standard treatments. The primary outcome was global symptom severity at 6 months after randomisation, measured using self-report on the Brief Symptom Inventory (BSI-18) and analysed in the intention-to-treat sample. No individuals with lived experience of mental illness were involved in conducting the study or writing the final publication. Safety was assessed in all participants. The trial was registered with the German Clinical Trials Register (DRKS00024152) with a completion date of June 30, 2024. 600 patients provided informed consent, were recruited to the study, and underwent a diagnostic interview between Jan 1, 2021, and May 31, 2022. Following this, 199 were excluded on the basis of inclusion and exclusion criteria and one withdrew consent during the baseline assessment. Of the 400 eligible participants, 284 (71%) self-identified as female, 106 (27%) self-identified as male, and nine (2%) self-identified as other. The mean age was 42·20 years (SD 13·23; range 19–65). Ethnicity data were not assessed. 287 (72%) participants met the criteria for moderate or severe depression, 81 (20%) for primary insomnia, 37 (9%) for agoraphobia, 46 (12%) for panic disorder, and 72 (18%) for PTSD. 199 participants were allocated to the intervention group of ImPuls plus treatment-as-usual and 201 to the control group of treatment-as-usual alone. 38 (19%) participants did not receive the minimum ImPuls intervention dose. ImPuls plus treatment-as-usual demonstrated superior efficacy to treatment-as-usual alone in reducing global symptom severity, with an adjusted difference on BSI-18 of 4·11 (95% CI 1·74–6·48; d=0·35 [95% CI 0·14–0·56]; p=0·0007) at 6 months. There were no significant differences in the total number of adverse events or serious adverse events between the two groups. There was one serious adverse event (male, torn ligament) related to the intervention. ImPuls is an efficacious transdiagnostic adjunctive treatment in outpatient mental health care. Our findings suggest that exercise therapy should be implemented in outpatient mental health care as an adjunctive transdiagnostic treatment for mental disorders such as depression, insomnia, panic disorder, agoraphobia, and PTSD. Transdiagnostic group exercise interventions might ameliorate the existing disparity in care provision between the many individuals in need of evidence-based treatment and the few who are receiving it. The German Innovation Fund of the Federal Joint Committee of Germany.

中文翻译：

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德国针对心理健康门诊患者的跨诊断团体运动干预 (ImPuls)：实用、多中心、分组随机、3 期对照试验的结果


在全球范围内，精神健康状况构成了巨大的疾病负担。尽管有基于证据的药物和心理治疗，但相当一部分患者的症状对这些干预措施没有反应，并且只有少数患者可以获得这些干预措施。本研究旨在评估 ImPuls 的疗效，这是一种为期 6 个月的跨诊断团体运动干预，加上常规治疗，与单独常规治疗相比，对患有各种精神障碍的门诊患者进行比较。在德国这项务实的、双组、多地点、随机对照试验中，十个门诊康复和医疗保健机构作为研究地点。参与者是根据 ICD-10 根据结构化临床访谈诊断为患有以下一种或多种疾病的门诊患者：中度或重度抑郁症、原发性失眠、创伤后应激障碍 (PTSD)、恐慌症或广场恐惧症。参与者要求年龄在 18 岁至 65 岁之间，由 Allgemeine Ortskrankenkasse Baden-Württemberg 或 Techniker Krankenkasse 健康保险公司投保，德语流利，并且没有运动禁忌症。六名参与者被随机分配到 ImPuls 加常规治疗组或单独常规治疗组（分配比例：1:1），按研究地点分层。随机序列由外部数据管理器生成。负责数据收集和管理的团队不了解随机序列。 ImPuls 干预措施包括持续 30 分钟的基于证据的户外锻炼，旨在至少达到中等强度。它还纳入了针对运动行为的动机和意志决定因素的行为改变技术。 照常治疗是德国典型的门诊医疗保健的代表，允许患者获得任何标准治疗。主要结局是随机分组后 6 个月时的总体症状严重程度，使用简短症状量表 (BSI-18) 的自我报告进行测量，并在意向治疗样本中进行分析。没有任何有精神疾病经历的人参与进行这项研究或撰写最终出版物。对所有参与者进行安全性评估。该试验在德国临床试验注册中心（DRKS00024152）注册，完成日期为2024年6月30日。600名患者提供了知情同意书，被招募到该研究中，并在2021年1月1日至5月31日期间接受了诊断访谈， 2022 年。此后，199 人根据纳入和排除标准被排除，其中 1 人在基线评估期间撤回同意。在 400 名符合资格的参与者中，284 名 (71%) 自认为是女性，106 名 (27%) 自认为是男性，9 名 (2%) 自认为是其他人。平均年龄为 42·20 岁（SD 13·23；范围 19-65）。未评估种族数据。 287 名（72%）参与者符合中度或重度抑郁症标准，81 名（20%）名参与者符合原发性失眠标准，37 名（9%）名参与者符合广场恐惧症标准，46 名（12%）名参与者符合恐慌症标准，72 名（18%）名参与者符合创伤后应激障碍标准。 199 名参与者被分配到 ImPuls 加常规治疗的干预组，201 名参与者被分配到仅常规治疗的对照组。 38 名 (19%) 参与者没有接受最低 ImPuls 干预剂量。 ImPuls 加照常治疗在降低整体症状严重程度方面表现出优于单独照常治疗的疗效，BSI-18 的调整后差异为 4·11（95% CI 1·74–6·48；d=0 ·35 [95% CI 0·14–0·56]；p=0·0007）6 个月时。 两组之间的不良事件或严重不良事件总数没有显着差异。发生了一项与干预相关的严重不良事件（男性，韧带撕裂）。 ImPuls 是门诊心理健康护理中一种有效的跨诊断辅助治疗。我们的研究结果表明，运动疗法应该在门诊心理保健中实施，作为抑郁症、失眠、恐慌症、广场恐怖症和创伤后应激障碍等精神障碍的辅助跨诊断治疗。跨诊断团体运动干预可能会改善许多需要循证治疗的人和少数接受循证治疗的人之间现有的护理差距。德国联邦联合委员会的德国创新基金。