RecruitingNot ApplicableNCT06721559

Empower@Home: Community Implementation for Older Adults With Ambulatory Disabilities

Sponsor

University of Michigan

Enrollment

64 participants

Start Date

Jan 8, 2025

Study Type

INTERVENTIONAL

Conditions

Depression

Summary

This study is a randomized Type I hybrid effectiveness-implementation trial aimed at evaluating the effectiveness of Empower@Home, an internet-delivered cognitive-behavioral therapy (CBT) program supported by social service providers, in comparison to enhanced usual care for depression in older adults with ambulatory disabilities. A total of 64 participants with ambulatory disabilities will be randomly assigned to either the treatment group (Empower@Home) or the control group (enhanced usual care) in a 1:1 allocation ratio. This project addresses the following research questions: 1. Does the intervention affect individuals' lives in the following expected areas? 1. Does participation in the intervention lead to greater improvement in depressive symptoms than enhanced care as usual? 2. Does participation in the intervention lead to greater improvement in social engagement and activities than enhanced care as usual? 3. Is the intervention's primary effect mediated by CBT-related (e.g., CBT skills acquisition, cognitive distortions, and behavioral activation), engagement-related (e.g., character or storyline relatedness), and coach-related factors (e.g., therapeutic alliance)? 2. How is the intervention being adopted? What are the barriers and facilitators encountered during the implementation process?

Eligibility

Min Age: 50 Years

Inclusion Criteria6

(1) be receiving or eligible to receive services at the recruitment sites
(2) read and speak English
(3) be at least 50 years old
(4) have at least mild depressive symptoms at screening (≥ 5 on the Patient Health Questionnaire-9 \[PHQ-9\]).
(5) Participants who are NOT currently receiving outside therapy must agree NOT to start outside therapy during study participation. Participants who are currently receiving outside therapy must agree NOT to increase their outside therapy frequency during study participation.
(6) have mobility limitations based on self-reported limitations in 10 mobility related questions (e.g., difficulty climbing stairs or walking)

Exclusion Criteria7

(1) probable dementia based on the Blessed Orientation and Memory Scale.
(2) moderate or high risk of suicide based on the 6-item Columbia-Suicide Severity Rating Scale
(3) a terminal illness with less than six months to live or unstable physical health conditions based on self-report
(4) a diagnosis of a psychotic disorder like schizophrenia or bipolar disorder based on self-report and medical chart review
(5) severe vision impairment based on self-report (i.e., legally blind)
(6) current substance use disorders or receiving substance use treatment.
(7) currently receiving outside therapy more frequently than once a month or have started a new therapy treatment less than 3 months ago

Interventions

BEHAVIORALEmpower@Home: An online cognitive-behavioral therapy self-care program for geriatric depression

Empower@Home is an online self-help intervention based on cognitive behavioral therapy principles designed to treat depressive symptoms in older adults. The intervention has three components: 9 interactive self-paced online sessions, printed workbook that goes along the online sessions for exercises and homework, and telephone coaching by a trained staff from a social service agency serving older adults. The online sessions contain entertainment elements in the form of a character-driven story of a homebound older adults, video-based psycho-educational content, voice-over instructions, interactive exercises, and weekly home practice assignments.

OTHERTelephone friendly visits

Participants in the waitlist control group will receive attention control through biweekly telephone-friendly visitors. Trained project staff will call participants to provide companionship, emotional support, and a friendly conversation. In addition, the callers will conduct a biweekly assessment of depressive symptoms using the patient health questionnaire (PHQ-9), to mirror the biweekly in-app PHQ-9 assessments with the experimental group.