Abstract

Background:

Homebound older adults experience a high burden of depression and significant barriers to accessing mental health treatments. Few interventions to address their specific needs have been developed. Existing treatment modalities can be challenging to scale up, are not tailored to unique population concerns, and require significant staffing support. Technologyassisted, layperson-facilitated psychotherapy has the potential to overcome these challenges.

Objective:

The aim of this study is to assess the efficacy of a layperson-facilitated internet-delivered cognitive behavioral therapy program tailored for homebound older adults. The novel intervention, Empower@Home, was developed based on usercentered design principles and partnerships with social services agencies serving low-income homebound older adults.

Methods:

This 2-arm, 20-week pilot randomized controlled trial (RCT) with a waitlist control crossover design aims to enroll 70 older adults with elevated depressive symptoms. The treatment group will receive the 10-week intervention immediately, whereas the waitlist control group will cross over and receive the intervention after 10 weeks. This pilot RCT is a part of a multiphase project involving an ongoing single-group feasibility study (anticipated to end in December 2022). This project consists of a pilot RCT (described in this protocol) and an implementation feasibility study running in parallel with the pilot RCT. The primary clinical outcome of the pilot is change in depressive symptoms post-intervention and at 20-week post- randomization follow-up. Additional outcomes include changes in anxiety, social isolation, and quality of life.

Results:

Institutional Review Board approval was obtained for the proposed trial in April 2022. Recruitment for the pilot RCT will begin in January of 2023 and is anticipated to end in September 2023. Upon completion of the pilot trial, we will examine the preliminary efficacy of the intervention on primary and secondary clinical outcomes.

Conclusions:

Although internet-based cognitive behavioral therapy programs are available, most programs have low adherence, and very few are tailored for older adults. Older adults, particularly those with mobility difficulties, could benefit from internetbased psychotherapy. This approach can be cost-effective, scalable, and convenient. This pilot RCT builds upon a nearly completed single-group feasibility study by determining the preliminary effects of the intervention compared to the control condition. The findings will provide a foundation for a future fully-powered randomized controlled efficacy trial. Clinical Trial: ClinicalTrials.gov. NCT05593276. Registered on 24 October 2022. https://clinicaltrials.gov/ct2/show/NCT05593276