Empower@Home: Community Implementation for Older Adults With Ambulatory Disabilities
NCT ID: NCT06721559
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
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RECRUITING
NA
64 participants
INTERVENTIONAL
2025-01-08
2026-12-31
Brief Summary
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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?
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Detailed Description
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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.
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?
Study Design: Participants will be recruited from an aging service agencies that serve as implementation sites. Participants will undergo remote assessments via phone at baseline, post-intervention, and a follow-up at 24 weeks.
Expected Outcomes: The study is expected to demonstrate that Empower@Home, when supported by aging service providers, is more effective than usual care and friendly calls in reducing depressive symptoms and improving social engagement and activities participation. 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 and disability services.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
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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
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Inclusion Criteria
* (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)
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
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University of Michigan
OTHER
Responsible Party
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Xiaoling Xiang
Associate Professor
Principal Investigators
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Xiaoling Xiang, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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Intervention website
Other Identifiers
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90IFRE0097
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HUM00259594
Identifier Type: -
Identifier Source: org_study_id
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