Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-26 @ 6:21 AM
Study NCT ID:
NCT06721559
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2024-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Empower@Home: Community Implementation for Older Adults With Ambulatory Disabilities
Sponsor:
University of Michigan
Organization:
Study Overview
Official Title:
Empower@Home: Community Implementation for Older Adults With Ambulatory Disabilities
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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. 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?
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?
Detailed Description:
This study is a randomized Type I hybrid effectiveness-implementation trial designed to evaluate the clinical effectiveness and implementation process of Empower@Home, an internet-delivered cognitive-behavioral therapy (CBT) program tailored for homebound older adults with depressive symptoms. The trial compares Empower@Home, supported by aging service providers, to an enhanced usual care condition. The study involves 64 participants with ambulatory disabilities who will be randomly assigned to either the treatment or control group.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 90IFRE0097 | OTHER_GRANT | ACL/NIDILRR | View |