NCT06584422 Empower@Home: Hybrid Effectiveness-Implementation Randomized Controlled Trial (RCT)
| NCT ID | NCT06584422 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 256 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2029-07 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 256 participants in total. It began in 2024-10-01 with a primary completion date of 2029-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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 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 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
Contact & Investigator
Xiaoling Xiang, PhD
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT06584422 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06584422 currently recruiting?
Yes, NCT06584422 is actively recruiting participants. Contact the research team at xiangxi@umich.edu for enrollment information.
Where is the NCT06584422 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT06584422 clinical trial?
NCT06584422 is sponsored by University of Michigan. The principal investigator is Xiaoling Xiang, PhD at University of Michigan. The trial plans to enroll 256 participants.
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