Recruiting

Observational StudyEmpower@Home: Hybrid Effectiveness-Implementation Randomized Controlled Trial (RCT)

Sponsor:

University of Michigan

Code:

NCT06584422

Conditions

Depression

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

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

Telephone friendly visits

Study Details

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 aging service providers, in comparison to enhanced usual care for homebound older adults with depressive symptoms. A total of 256 participants will be randomly assigned to either the treatment group (Empower@Home) or the control group (enhanced usual care) in a 1:1 allocation ratio, with randomization stratified by participating agencies.

The primary aim of this study is to determine the clinical effectiveness of the Empower@Home program. It is hypothesized that participants receiving Empower@Home will show greater improvements in depressive symptoms at 12, 24, and 36 weeks after entering the study compared to those receiving enhanced usual care. Additionally, treatment moderators will be explored and a cost-effectiveness analysis will be conducted to assess the economic viability of the intervention.

The second aim is to investigate the mechanisms of change facilitated by the intervention using a mixed-methods approach. Causal mediation analysis will examine whether the acquisition of CBT skills, reduction in cognitive distortions, and increased behavioral activation, as well as participant engagement and the therapeutic alliance with the coach, mediate the treatment effects. Qualitative interviews with participants will be conducted to provide deeper insights into these mechanisms and enhance the interpretation of the mediation analysis.

The third aim focuses on evaluating the implementation process using the updated Consolidated Framework for Implementation Research (CFIR). This will involve a qualitative process evaluation to identify barriers and facilitators to the implementation of Empower@Home, drawing on perspectives from multiple stakeholders.

Conditions

Depression

Study ID

NCT06584422

Start date

Oct 1, 2024

Status verified date

Nov, 2025

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

(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 moderate depressive symptoms at screening (≥ 8 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.

Exclusion Criteria:

(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

Study Design

Enrollment

256 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Empower@Home supported by aging service providers

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.

other: Attention call with friendly visitors

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.

Interventions

Empower@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.

Telephone 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.

Primary outcome measure

Change in Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Change from Baseline to follow-up assessments at 12, 24, and 36 weeks ]

Central Contacts and Locations

Central contacts

Xiaoling Xiang, PhD

734-763-6581 xiangxi@umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Xiaoling Xiang, PhD

xiangxi@umich.edu

Principal Investigator:

Xiaoling Xiang, PhD

More Information

Sponsor

University of Michigan

Last update posted

Nov 21, 2025

Last verified

Nov, 2025

Keywords

Cognitive behavioral therapy
Older Adults
Internet-based intervention
Depression
Social isolation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-17. This information was provided to ClinicalTrials.gov by University of Michigan on 2025-11-21.