Empower@Home: Hybrid Effectiveness-Implementation Randomized Controlled Trial (RCT)
NCT ID: NCT06584422
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
256 participants
INTERVENTIONAL
2024-10-01
2029-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Empower@Home: Community Implementation for Older Adults With Ambulatory Disabilities
NCT06721559
Digital Technology in the Home of Elderly Patients With Multimorbidity
NCT04955600
Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems
NCT05080777
Testing Tele-Savvy, an On-line Psychoeducation Program for Dementia Family Caregivers
NCT03033875
In-Home Technology for Caregivers of People With Dementia and Mild Cognitive Impairment
NCT04206670
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Rationale: Depression is a significant public health concern among homebound older adults, with approximately 50% experiencing clinically significant depressive symptoms and 14% facing major depression-rates significantly higher than those of non-homebound counterparts. Homebound older adults often encounter barriers to accessing traditional mental health services, including physical disabilities, socioeconomic disadvantages, and racial or ethnic minority status. Empower@Home addresses these challenges by leveraging the existing workforce of aging service providers to support digital mental health interventions (DMHIs).
Intervention: Empower@Home is a nine-session, computerized CBT program enhanced with entertainment elements to increase engagement. The program is specifically designed for homebound older adults, incorporating age-relevant examples and a simplified user interface. It includes features such as a character-driven storyline, short videos, and interactive exercises to facilitate learning and engagement. The program is supported by lay coaches-aging service providers trained to offer weekly support calls, enhancing program adherence and personalization.
Study Aims:
Effectiveness: The primary aim is to determine the clinical effectiveness of Empower@Home compared to enhanced usual care. The hypothesis is that participants in the Empower@Home group will show greater improvements in depressive symptoms at 12, 24, and 36 weeks post-enrollment. Secondary clinical outcomes include improvements in anxiety, loneliness, social support, quality of life, disability burden, and pain severity.
Mechanisms of Change: The study will also explore the mechanisms through which the intervention produces change. Using a mixed-methods approach, the study will investigate whether CBT-related factors (e.g., skill acquisition, behavioral activation), engagement-related factors (e.g., narrative engagement), and coach-related factors (e.g., therapeutic alliance) mediate treatment effects. Qualitative interviews will complement these findings by providing participant perspectives on how the program facilitated behavioral change.
Implementation: The study will assess the implementation process using the updated Consolidated Framework for Implementation Research (CFIR). This qualitative process evaluation will identify barriers and facilitators to implementation from the perspectives of multiple stakeholders, including older adults, coaches, and agency staff. Data will be collected through interviews, meeting minutes, field observations, and other relevant sources, and analyzed using both traditional qualitative methods and natural language processing techniques.
Study Design: Participants will be recruited from 3 to 4 aging service agencies that serve as implementation sites. These agencies represent diverse service delivery models, enhancing the study's external validity. Participants will undergo remote assessments via phone at baseline, post-intervention, and follow-up intervals at 12, 24, and 36 weeks. The study will also employ a cost-effectiveness analysis, evaluating the economic viability of the Empower@Home program from a public healthcare payer perspective.
Expected Outcomes: The study is expected to demonstrate that Empower@Home, when supported by aging service providers, is more effective and cost-effective than enhanced usual care in reducing depressive symptoms and improving other psychosocial outcomes. Additionally, the findings will provide valuable insights into the barriers and facilitators to implementing DMHIs in community settings, offering guidance for future scalability and sustainability of such interventions.
Innovation: Empower@Home integrates user-centered design principles, community participatory research, and innovative engagement strategies, such as character-driven storytelling, to enhance user experience and therapeutic outcomes. The use of aging service providers as lay coaches not only addresses the shortage of mental health professionals but also aligns with the existing infrastructure of aging services, making the program highly scalable and sustainable.
This trial will contribute significantly to the growing body of evidence on the effectiveness of DMHIs in real-world settings and inform strategies for broader implementation within community-based aging services.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* (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
* (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
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Mental Health (NIMH)
NIH
NYU Silver School of Social Work
OTHER
University of Michigan
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xiaoling Xiang
Xiaoling Xiang, PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xiaoling Xiang, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Michigan
Ann Arbor, Michigan, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form
Related Links
Access external resources that provide additional context or updates about the study.
Intervention website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HUM00254688
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.