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
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.033 | 0.027 |
| Meta-epidemiology (narrow) | 0.007 | 0.004 |
| Meta-epidemiology (broad) | 0.012 | 0.008 |
| Bibliometrics | 0.004 | 0.004 |
| Science and technology studies | 0.004 | 0.004 |
| Scholarly communication | 0.005 | 0.004 |
| Open science | 0.004 | 0.003 |
| Research integrity | 0.008 | 0.008 |
| Insufficient payload (model declined to judge) | 0.060 | 0.011 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".