Xiang Xiaoling, Narbut Elyse, Zhang Xinyin, Ash Samson, Turner Skyla, An Ruopeng, Jester Jennifer M, Park Sunggeun, Habash Salma, Himle Joseph A
School of Social Work, University of Michigan-Ann Arbor, Ann Arbor, MI, United States.
Department of Psychology, University of Michigan-Ann Arbor, Ann Arbor, MI, United States.
JMIR Res Protoc. 2025 Sep 5;14:e72953. doi: 10.2196/72953.
Homebound older adults face a high burden of depression and substantial barriers to accessing mental health treatments. Few interventions address their specific needs. Empower@Home, an internet-based cognitive behavioral therapy program, was co-designed with stakeholders and tailored to older adults. The program includes 9 self-paced online sessions to be completed within 12 weeks, augmented by telephone-based human support. Efficacy studies have demonstrated its acceptability and effectiveness in reducing depression when supported by trained research staff. However, its real-world effects and feasibility for integration into community aging service settings remain unknown.
This study aims to assess the real-world effectiveness of Empower@Home integrated into aging services, using nonclinician agency staff as coaches to support older adults. A secondary objective is to evaluate the implementation process through a qualitative process evaluation.
The study is a type 1 hybrid effectiveness-implementation trial with a 2-arm randomized controlled design. A total of 256 homebound older adults will be recruited from 3 community aging service agencies, and agency staff will be trained as coaches to support internet-based cognitive behavioral therapy use. Participants in the treatment group will receive Empower@Home immediately, while the control group will receive biweekly friendly calls and enhanced care as usual, including the provision of psychoeducational materials and usual care. Outcomes will be assessed at baseline, after the intervention (12 weeks), and at 2 follow-up points (24 and 36 weeks). The primary outcome is a change in depressive symptoms as measured by the 9-item Patient Health Questionnaire. Secondary outcomes include changes in social isolation, health-related quality of life, disability burden, pain intensity, and anxiety symptoms.
Institutional review board approval was obtained in August 2024, and recruitment began in October 2024. Recruitment is expected to conclude by April 2028. Upon trial completion, the effectiveness of Empower@Home on primary and secondary outcomes will be analyzed.
This study will provide critical insights into the real-world effectiveness of Empower@Home. If successful, this study will provide a scalable, cost-effective model for integrating technology-assisted mental health treatments into community aging services, thereby improving access to care for an underserved, hard-to-reach population.
ClinicalTrials.gov NCT06584422; https://clinicaltrials.gov/study/NCT06584422.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/72953.
居家的老年人面临着沉重的抑郁负担以及获得心理健康治疗的重大障碍。很少有干预措施能满足他们的特殊需求。“居家赋权”是一项基于互联网的认知行为疗法项目，它是与利益相关者共同设计的，并针对老年人进行了量身定制。该项目包括9个自定进度的在线课程，需在12周内完成，并辅以电话人工支持。疗效研究表明，在经过培训的研究人员的支持下，该项目在减轻抑郁方面具有可接受性和有效性。然而，其在现实世界中的效果以及整合到社区老龄服务环境中的可行性仍然未知。
本研究旨在评估整合到老龄服务中的“居家赋权”在现实世界中的有效性，使用非临床机构工作人员作为指导者来支持老年人。第二个目的是通过定性过程评估来评价实施过程。
本研究是一项1型混合有效性-实施性试验，采用双臂随机对照设计。将从3个社区老龄服务机构招募总共256名居家老年人，机构工作人员将接受培训成为指导者，以支持基于互联网的认知行为疗法的使用。治疗组的参与者将立即接受“居家赋权”项目，而对照组将像往常一样每两周接受一次友好电话并获得强化护理，包括提供心理教育材料和常规护理。将在基线、干预后（12周）以及2个随访点（24周和36周）评估结果。主要结果是用9项患者健康问卷测量的抑郁症状变化。次要结果包括社交隔离、健康相关生活质量、残疾负担、疼痛强度和焦虑症状的变化。
2024年8月获得了机构审查委员会的批准，2024年10月开始招募。预计招募将于2028年4月结束。试验完成后，将分析“居家赋权”在主要和次要结果方面的有效性。
本研究将为“居家赋权”在现实世界中的有效性提供关键见解。如果成功，本研究将提供一个可扩展、具有成本效益的模式，用于将技术辅助的心理健康治疗整合到社区老龄服务中，从而改善对服务不足、难以接触到的人群的护理可及性。
ClinicalTrials.gov NCT06584422；https://clinicaltrials.gov/study/NCT06584422。
国际注册报告识别码（IRRID）：DERR1-10.2196/72953。
