Empower@Home: Hybrid Effectiveness-Implementation Randomized Controlled Trial (RCT)
Community-Embedded, Layperson-Supported Digital Mental Health Intervention for Homebound Older Adults With Depression: A Type 1 Hybrid Effectiveness- Implementation RCT
2 other identifiers
interventional
256
1 country
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Oct 2024
Longer than P75 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2024
CompletedFirst Posted
Study publicly available on registry
September 4, 2024
CompletedStudy Start
First participant enrolled
October 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2029
November 21, 2025
November 1, 2025
4.8 years
August 30, 2024
November 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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, 24, and 36 weeks
Secondary Outcomes (6)
Change in Duke Social Support Index (DSSI)-10
Change from Baseline to follow-up assessments at 12, 24, and 36 weeks
Change in EuroQol 5-Dimension 5-level (EQ-5D-5L)
Change from Baseline to follow-up assessments at 12, 24, and 36 weeks
Change in Hamilton Depression Rating Scale (HAM-D)
Change from Baseline to follow-up assessments at 12, 24, and 36 weeks
Change in WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Change from Baseline at 12, 24, and 36 weeks
Change in Pain intensity assessed by the Pain, Enjoyment, and General Activity (PEG) Scale
Change from Baseline to follow-up assessments at 12, 24, and 36 weeks
- +1 more secondary outcomes
Study Arms (2)
Empower@Home supported by aging service providers
EXPERIMENTALParticipants 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.
Attention call with friendly visitors
OTHERParticipants 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 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.
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.
Eligibility Criteria
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 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.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- National Institute of Mental Health (NIMH)collaborator
- NYU Silver School of Social Workcollaborator
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
Related Publications (1)
Xiang X, Narbut E, Zhang X, Ash S, Turner S, An R, Jester JM, Park S, Habash S, Himle JA. Leveraging Aging Service Providers to Support Internet-Based Cognitive Behavioral Therapy for Depression in Homebound Older Adults: Protocol for a Type 1 Hybrid Effectiveness-Implementation Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 5;14:e72953. doi: 10.2196/72953.
PMID: 40910699DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaoling Xiang, PhD
University of Michigan
Central Study Contacts
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
- Xiaoling Xiang, PhD
Study Record Dates
First Submitted
August 30, 2024
First Posted
September 4, 2024
Study Start
October 1, 2024
Primary Completion (Estimated)
July 1, 2029
Study Completion (Estimated)
July 1, 2029
Last Updated
November 21, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ICF
- Time Frame
- Aligning with NIMH guidelines, all final IPD and supporting information will be deposited to NDA within one year of study completion.
- Access Criteria
- Researchers will apply for data access via the NDA.
Individual participant data (IPD) will be shared through the National Institute of Mental Health\'s (NIMH) Data Archive (NDA), in compliance with NIMH funding requirements. The data will be available to qualified researchers following appropriate data use agreements. All quantitatively collected, non-identifying IPD, along with data dictionaries will be deposited to the NDA.