Empower@Home: Community Implementation for Older Adults With Ambulatory Disabilities
Recruiting · NCT06721559 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Michigan
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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?
Who can take part
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
Where it is running
1 location listed across 1 US state.
- University of Michigan - Ann Arbor, Michigan, United States