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

NCT06721559 | Recruiting

• 2 other identifiers: HUM0025959490IFRE0097
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does the intervention affect individuals' lives in the following expected areas?
2. 2.Does participation in the intervention lead to greater improvement in depressive symptoms than enhanced care as usual?
3. 3.Does participation in the intervention lead to greater improvement in social engagement and activities than enhanced care as usual?
4. 4.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)?
5. 5.How is the intervention being adopted? What are the barriers and facilitators encountered during the implementation process?

Conditions

Depression

Keywords

Cognitive behavioral therapy; Older adults; Internet-based intervention; Depression; Social isolation

Outcome Measures

Primary Outcomes (2)

• Change in Patient Health Questionnaire-9 (PHQ-9)

  Change in 9 item standardized measures of depressive symptom severity. PHQ-9 score ranges from 0 to 27, with a higher score indicating more severe symptoms.

  Change from Baseline to follow-up assessments at 12 and 24 weeks

• Change in Social Engagement and Activities Questionnaire (SEAQ)

  Change in 10 item standardized measures of participation in social activities and community participation. The total scores range from 0 to 50, and a higher score suggesting a higher level of participation.

  Change from Baseline to follow-up assessments at 12 and 24 weeks

Secondary Outcomes (1)

• Change in Duke Social Support Index (DSSI)-10

  Change from Baseline to follow-up assessments at 12 and 24 weeks

Study Arms (2)

Empower@Home supported by aging service providers

EXPERIMENTAL

Participants will be provided with access to a 9-session online program called Empower@Home, a self-help intervention based on cognitive behavioral therapy principles. 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. Participants will have up to 12 weeks to try to complete the program with the support of a trained coach.

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

Attention call with friendly visitors

OTHER

Participants will receive enhanced care as usual, including care as usual from their social service provider and a psycho-educational handout. In addition, they will receive telephone friendly calls from a research staff every other week to mimic the human interactions provided by coaches in the experimental group.

Other: Telephone friendly visits

Interventions

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

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.

Empower@Home supported by aging service providers

Telephone friendly visits OTHER

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.

Attention call with friendly visitors

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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)

You may not qualify if:

• (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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Related Links

• Intervention website

MeSH Terms

Conditions

Depression; Social Isolation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Social Behavior

Study Officials

• Xiaoling Xiang, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoling Xiang, PHD

CONTACT

734-763-6581; xiangxi@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding interventionalists and participants is not possible, given the nature of the intervention. However, assessment staff will be blinded when possible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: January 8, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Within one year of study conclusion
• Access Criteria: Apply through ICPSR

Locations

US (1)