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NCT06584422 · ClinicalTrials.gov registry record · NA
Empower@Home: Hybrid Effectiveness-Implementation Randomized Controlled Trial (RCT)
A NA study of Depression, sponsored by University of Michigan.
- Recruiting
- Registry status
- NA
- Development phase
- 256
- Enrollment target
- 1
- Study location
NCT06584422: Recruiting NA study of Depression, sponsored by University of Michigan.
NCT06584422 is a NA study of Depression that is actively recruiting participants, run by University of Michigan. The registered enrollment target is 256 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06584422, a NA study of Depression, is actively recruiting participants, sponsored by University of Michigan.
- RECRUITING
- Registry status
- NA
- Development phase
- 256 participants
- Enrollment target
- 1
- Study location
Study 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 aging service providers, in comparison to enhanced usual care for homebound older adults with depressive symptoms. A total of 256 participants will be randomly assigned to either the treatment group (Empower@Home) or the control group (enhanced usual care) in a 1:1 allocation ratio, with randomization stratified by participating agencies. The primary aim of this study is to determine the clinical effectiveness of the Empower@Home program. It is hypothesized that participants receiving Empower@Home will show greater improvements in depressive symptoms at 12, 24, and 36 weeks after entering the study compared to those receiving enhanced usual care. Additionally, treatment moderators will be explored and a cost-effectiveness analysis will be conducted to assess the economic viability of the intervention. The second aim is to investigate the mechanisms of change facilitated by the intervention using a mixed-methods approach. Causal mediation analysis will examine whether the acquisition of CBT skills, reduction in cognitive distortions, and increased behavioral activation, as well as participant engagement and the therapeutic alliance with the coach, mediate the treatment effects. Qualitative interviews with participants will be conducted to provide deeper insights into these mechanisms and enhance the interpretation of the mediation analysis. The third aim focuses on evaluating the implementation process using the updated Consolidated Framework for Implementation Research (CFIR). This will involve a qualitative process evaluation to identify barriers and facilitators to the implementation of Empower@Home, drawing on perspectives from multiple stakeholders.
Primary Outcome
Change in 9 item standardized measures of depressive symptom severity. PHQ-9 score ranges from 0 to 27, with a higher score indicating more severe symptoms.
Conditions Studied
Interventions
- BEHAVIORAL Empower@Home: An online cognitive-behavioral therapy self-care program for geriatric depression
- OTHER Telephone friendly visits
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 256 participants |
| Start Date | 2024-10-01 |
| Est. Completion | 2029-07 |
| Phase | NA |
What NCT06584422 shows while recruiting
NCT06584422 is an interventional study that assigns participants to a tested intervention. The registered 256 participants enrollment target is mid-sized for trials with a published cap, below the 786-participant average among 679 other Depression trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Empower@Home: An online cognitive-behavioral therapy self-care program for geriatric depression is the first listed.
NCT06584422 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT06584422 about?
NCT06584422 is a clinical study titled "Empower@Home: Hybrid Effectiveness-Implementation Randomized Controlled Trial (RCT)". 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 aging service providers, in comparison to enhanced usual care for homebound older adults wi...
What is the current status of trial NCT06584422?
This trial is currently recruiting. It is a NA study. The enrollment target is 256 participants. The study started on 2024-10-01. Estimated completion is 2029-07.
What conditions does trial NCT06584422 study?
This clinical trial studies the following conditions: Depression.
What interventions are being tested in trial NCT06584422?
The interventions under investigation include: Empower@Home: An online cognitive-behavioral therapy self-care program for geriatric depression (BEHAVIORAL), Telephone friendly visits (OTHER).
Who is sponsoring clinical trial NCT06584422?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06584422 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06584422's enrollment target sits among peer trials
256 171st of 679 higher than 508 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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