Leveraging Aging Service Providers to Support Internet-Based Cognitive Behavioral Therapy for Depression in Homebound Older Adults: Protocol for a Type 1 Hybrid Effectiveness-Implementation Randomized Controlled Trial.

Background: 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.

Objective: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Trial Registration: ClinicalTrials.gov NCT06584422; https://clinicaltrials.gov/study/NCT06584422.

International Registered Report Identifier (irrid): DERR1-10.2196/72953.