Clinical trial NCT06721559: Empower@Home: Community Implementation for Older Adults With Ambulatory Disabilities
Official title: Empower@Home: Community Implementation for Older Adults With Ambulatory Disabilities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Keywords: Cognitive behavioral therapy
Older adults
Internet-based intervention
Depression
Social isolation
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 64
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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.

Eligibility criteria: 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 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:

* (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

Primary outcomes:
measure: Change in Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Change from Baseline to follow-up assessments at 12 and 24 weeks
measure: Change in Social Engagement and Activities Questionnaire (SEAQ)
timeFrame: Change from Baseline to follow-up assessments at 12 and 24 weeks
Secondary outcomes:
measure: Change in Duke Social Support Index (DSSI)-10
timeFrame: Change from Baseline to follow-up assessments at 12 and 24 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Xiaoling Xiang, PhD
role: PRINCIPAL_INVESTIGATOR
References: