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

Plain Language Summary

Simplified for easier understanding

This study is evaluating a program called Empower@Home, which delivers mental health support (specifically a type of therapy called behavioral activation) to older adults with physical mobility limitations who are experiencing depression. The program is delivered in community settings like senior centers or adult day programs. **You may be eligible if...** - You are 50 years or older - You receive or are eligible to receive services at one of the study sites - You speak and read English - You have at least mild depression symptoms (scoring 5 or higher on a standard depression questionnaire) - You have some difficulty with mobility (e.g., climbing stairs or walking) **You may NOT be eligible if...** - You have probable dementia based on a memory screening test - You have a moderate or high risk of suicide - You have a terminal illness or very unstable health - You have a psychotic disorder such as schizophrenia or bipolar disorder - You have severely impaired vision (legally blind) - You currently have a substance use disorder - You are already receiving therapy more than once a month or recently started a new therapy program Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.