Status:
RECRUITING
Empower@Home: Hybrid Effectiveness-Implementation Randomized Controlled Trial (RCT)
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
NYU Silver School of Social Work
Conditions:
Depression
Eligibility:
All Genders
50+ years
Phase:
NA
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 supp...
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-...
Eligibility Criteria
Inclusion
- (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 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
- (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
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT06584422
Start Date
October 1 2024
End Date
July 1 2029
Last Update
November 21 2025
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109