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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06584422
The ClinicalTrials.gov registry entry for NCT06584422 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 256 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (67% lower). The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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