Background: Mental disorders impact both individuals and health systems. Symptoms and syndromes often remain undetected and untreated, resulting in chronification. Besides limited health care resources, within-person barriers such as the lack of trust in professionals, the fear of stigmatization, or the desire to cope with problems without professional help contribute to the treatment gap. Self-guided mental health apps may support treatment seeking by reducing within-person barriers and facilitating mental health literacy. Digital mental health interventions may also improve mental health related self-management skills and contribute to symptom reduction and the improvement of quality of life. Objective: This study aims to investigate the effects of a self-guided transdiagnostic app for mental health on help seeking, reduced stigma, mental health literacy, self-management skills, mental health symptoms, and quality of life using a randomized controlled design. Methods: Overall, 1045 participants (recruited via open, blinded, and web-based recruitment) with mild to moderate depression or anxiety-, sleep-, eating-, or somatization-related psychopathology were randomized to receive either access to a self-guided transdiagnostic mental health app (MindDoc) in addition to care as usual or care as usual only. The core features of the app were regular self-monitoring, automated feedback, and psychological courses and exercises. The coprimary outcomes were mental health literacy, mental health–related patient empowerment and self-management skills (MHPSS), attitudes toward help seeking, and actual mental health service use. The secondary outcomes were psychopathological symptom burden and quality of life. Data were collected at baseline and 8 weeks and 6 months after randomization. Treatment effects were investigated using analyses of covariance, including baseline variables as predictors and applying multiple imputation. Results: We found small but robust between-group effects for MHPSS (Cohen d=0.29), symptoms burden (Cohen d=0.28), and quality of life (Cohen d=0.19) 8 weeks after randomization. The effects on MHPSS were maintained at follow-up. Follow-up assessments also showed robust effects on mental health literacy and preliminary evidence for the improvement of help seeking. Predictors of attrition were lower age and higher personality dysfunction. Among the non-attritors, predictors for deterioration were less outpatient treatment and higher initial symptom severity. Conclusions: A self-guided transdiagnostic mental health app can contribute to lasting improvements in patient empowerment. Symptoms of common mental disorders and quality of life improved faster in the intervention group than in the control group. Therefore, such interventions may support individuals with symptoms of 1 or more internalizing disorders, develop health-centered coping skills, prevent chronification, and accelerate symptom improvement. Although the effects for individual users are small and predictors of attrition and deterioration need to be investigated further, the potential public health impact of a self-guided intervention can be large, given its high scalability. Trial Registration: German Clinical Trials Register DRKS00022531; https://drks.de/search/de/trial/DRKS00022531

中文翻译：

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自我引导跨诊断智能手机应用程序对患者赋权和心理健康的影响：随机对照试验

背景：精神障碍影响个人和卫生系统。症状和综合征常常未被发现和治疗，导致慢性化。除了有限的医疗保健资源之外，个人内部的障碍，例如对专业人士缺乏信任、害怕受到污名化或希望在没有专业帮助的情况下解决问题，也造成了治疗差距。自我引导的心理健康应用程序可以通过减少人际障碍和促进心理健康素养来支持寻求治疗。数字心理健康干预措施还可以提高心理健康相关的自我管理技能，并有助于减轻症状和提高生活质量。目的：本研究旨在采用随机对照设计，调查心理健康自我引导跨诊断应用程序对寻求帮助、减少耻辱、心理健康素养、自我管理技能、心理健康症状和生活质量的影响。方法：总体而言，1045 名患有轻度至中度抑郁或焦虑、睡眠、饮食或躯体化相关精神病理学的参与者（通过公开、盲法和网络招募招募）被随机分配接受自我引导的治疗除了照常护理或仅照常护理之外，还有跨诊断心理健康应用程序 (MindDoc)。该应用程序的核心功能是定期自我监控、自动反馈以及心理课程和练习。共同主要结果是心理健康素养、心理健康相关的患者赋权和自我管理技能（MHPSS）、对寻求帮助的态度以及实际心理健康服务的使用。次要结果是精神病理症状负担和生活质量。在基线以及随机化后 8 周和 6 个月收集数据。使用协方差分析来研究治疗效果，包括作为预测变量的基线变量和应用多重插补。结果：我们发现随机分组后 8 周对 MHPSS (Cohen d =0.29)、症状负担 (Cohen d =0.28) 和生活质量 (Cohen d =0.19)的组间影响虽小但很强。对 MHPSS 的影响在随访中得以维持。后续评估还显示出对心理健康素养的强大影响以及改善寻求帮助的初步证据。磨损的预测因素是较低的年龄和较高的人格障碍。在非流失者中，病情恶化的预测因素是较少的门诊治疗和较高的初始症状严重程度。结论：自我引导的跨诊断心理健康应用程序可以有助于持久改善患者的赋权。干预组常见精神障碍症状和生活质量的改善速度快于对照组。因此，此类干预措施可以支持具有一种或多种内化障碍症状的个体，培养以健康为中心的应对技能，防止慢性化，并加速症状改善。尽管对个人用户的影响很小，并且需要进一步研究磨损和恶化的预测因素，但鉴于其高可扩展性，自我引导干预的潜在公共卫生影响可能很大。试验注册：德国临床试验注册中心DRKS00022531；https://drks.de/search/de/Trial/DRKS00022531