Layperson-Facilitated Internet-Delivered Cognitive Behavioral Therapy for Homebound Older Adults With Depression: Protocol for a Randomized Controlled Trial

Abstract

Background Depression in older adults has serious biological, psychological, and social consequences. 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. Technology-assisted, 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 user-centered design principles and partnerships between researchers, social service agencies, care recipients, and other stakeholders 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 community-dwelling 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 is part of a multiphase project involving a single-group feasibility study (completed 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 the change in depressive symptoms after the intervention and at the 20-week postrandomization follow-up. Additional outcomes include acceptability, adherence, and 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 began in January 2023 and is anticipated to end in September 2023. On completion of the pilot trial, we will examine the preliminary efficacy of the intervention on depression symptoms and other secondary clinical outcomes in an intention-to-treat analysis. Conclusions Although web-based cognitive behavioral therapy programs are available, most programs have low adherence and very few are tailored for older adults. Our intervention addresses this gap. Older adults, particularly those with mobility difficulties and multiple chronic health conditions, could benefit from internet-based psychotherapy. This approach can serve a pressing need in society while being cost-effective, scalable, and convenient. This pilot RCT builds on a completed single-group feasibility study by determining the preliminary effects of the intervention compared with a control condition. The findings will provide a foundation for a future fully-powered randomized controlled efficacy trial. If our intervention is found to be effective, implications extend to other digital mental health interventions and populations with physical disabilities and access restrictions who face persistent disparities in mental health. Trial Registration ClinicalTrials.gov NCT05593276; https://clinicaltrials.gov/ct2/show/NCT05593276 International Registered Report Identifier (IRRID) PRR1-10.2196/44210

Layperson-Supported, Web-Delivered Cognitive Behavioral Therapy for Depression in Older Adults: Randomized Controlled Trial

“…This study was limited by its small sample size, rendering it underpowered for the detection of small effect sizes. Although our study was powered to detect a medium effect in the primary clinical outcome of depression based on a linear mixed effects model with up to 7 assessments [ 3 ], it was not powered to detect a small effect in the secondary clinical outcomes based on 2-sample 2-tailed t tests. We performed an ad hoc power analysis and found that a sample size of 204 is necessary to identify an effect size of 0.35 with a power of 80%, using a 2-sample 2-tailed t test, as per G*Power 3.1.9.7 [ 53 ].…”

“…The study protocol has been published elsewhere [ 3 ]. An abbreviated description of the study methods has been provided in this study to inform the readers.…”

“…Depression is the most prevalent mental health condition among older adults and is particularly common among those with chronic physical health conditions and functional limitations [ 1 ]. Although evidence-based pharmacological and nonpharmacological treatments exist, not every option is readily accessible to all populations of older adults [ 2 , 3 ]. For example, older adults with mobility difficulties face significant logistical barriers to accessing office-based treatments in addition to common access barriers such as cost, provider shortages, and stigma [ 2 ].…”

Web-Based Cognitive Behavioral Therapy for Depression Among Homebound Older Adults: Development and Usability Study

“…Furthermore, although our longitudinal field testing was conducted with chronically ill, low-income homebound older adults, the sample size was small and lacked diversity. As our development process continues, we will continue to integrate feedback from participants from more diverse backgrounds and determine the efficacy of the intervention [ 39 , 40 ]. While we proactively considered implementation challenges during the design phase, future studies should systematically investigate implementation.…”