An interventional study of Empower@Home in Depression, Depressive Disorder and Behavioral Symptoms, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-06-04.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
Among 71 studies in Depression by University of Michigan — 10 open to participants now, 11 under way, none of them phase 3. Depression · University of Michigan.
Among the 71 studies in Depression by University of Michigan, this one is the 33rd largest by enrollment of the 67 interventional ones that give a count, is one of 8 that started in 2023, is one of 59 with no phase, and was the 50th registered.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's enrollment of 70 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →10 of the 71 studies in Depression by University of Michigan are open now, in 1 country. Each count lists the studies.
Of the 1,088 Depression studies recruiting now, 469 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 310 take healthy volunteers.
This study: 60 Years and older · all sexes · no healthy volunteers.
The full table on the hub →71 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 4 · Phase 3 1 · Phase 4 3
First in 2005; this study’s year is marked. 8 started in 2023.
Median enrollment 70 across the 67 interventional studies, 489 across the 4 observational. Of the 57 that completed or were terminated, 19 (33%) have results posted.
University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
7 of the studies in Depression by University of Michigan that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06839859University of MichiganFamily Acceptance Project Online (Pilot RCT) | 2026-12 |
| NCT06721559University of MichiganEmpower@Home: Community Implementation for Older Adults With Ambulatory Disabilities | 2026-12 |
| NCT07865858University of MichiganLakota Family Acceptance Project Pilot RCT | 2027-01-31 |
| NCT07392879University of MichiganBringing the Outdoors In: Virtual Nature Walks for Depression in Multiple Sclerosis (MS) Patients | 2027-04 |
| NCT07685925University of MichiganIntern Health Study 2026 | 2027-06-30 |
Among the 71 studies in Depression by University of Michigan, from their registry updates:
This randomized pilot trial uses a waitlist control parallel design of a novel internet-based cognitive behavioral therapy program for older adults with elevated depressive symptoms. This study will enroll approximately 35 older adults per group throughout Michigan. The intervention will take approximately ten weeks to complete. Participants will have lower levels of depression after completing the intervention than before enrollment. Participants will be able to use the internet-based platform with minimal support.
Depression affects up to 40% of homebound seniors, but most homebound seniors do not receive psychotherapy due to various access barriers. The study team focuses on developing community-based solutions to reduce these access barriers. In a previously approved project HUM00207612, the study team tested the feasibility of a novel internet-based cognitive behavioral therapy (iCBT) program called Empower@Home. The pilot project allowed for refining study procedures and the web platform used to deliver the program. In this new project, the study team will conduct a pilot randomized control trial to test the effectiveness of Empower@Home with older adults. Recruitment methods include 1) referrals from social service agencies, 2) advertisements on social media, local news outlets, and the program website, and 3) research participant registries.
The intervention involves attending up to 9 pre-recorded online therapy sessions and receiving weekly coaching calls from trained research assistants for up to 10 weeks. Participants will engage in therapy in their private homes. Three assessments are scheduled, including a comprehensive baseline, a post-test, and a 10-week follow-up. Each assessment takes about 20-40 minutes to complete over the phone.
Between Jan and Sept 2023, about 70 subjects (35 in each group) will be recruited. Participants will be randomized into the treatment group or waitlist control. The treatment group will receive the intervention immediately, whereas the waitlist control will wait for ten weeks before starting the intervention (i.e., after the 10-week "post-test"). Therefore, this is a cross-over design.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Behavioral: Empower@Home
Participants will be provided with access to a 9-session online program and will receive supportive remote assistance throughout regarding technical and programmatic issues.
Change in Patient Health Questionnaire-9 (PHQ-9)
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.
Time frame: Change from Baseline PHQ-9 at 10 weeks
Modified Treatment Evaluation Inventory
11-item Likert scale relating to acceptability of program to participant modified for older adults and the study context. The score ranges from 11 to 55, and a higher score means higher acceptability.
Time frame: 10 weeks
Change in Generalized Anxiety Disorder Assessment-7 (GAD-7)
Change in 7-item standardized measure for severity of anxiety symptoms. GAD-7 score ranges from 0 to 21, higher score means more severe symptoms.
Time frame: Change from Baseline at 10 weeks
Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS)-Global Health
Change in 9 item standardized measure for global health. Total score ranges from 9 to 45, higher score means better global health.
Time frame: Change from Baseline at 10 weeks
Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS)-Social Isolation
Change in 8 item standardized measure for feelings of loneliness. Total score ranges from 8 to 40, higher score means higher levels of loneliness.
Time frame: Change from Baseline at 10 weeks
Change in EQ5D-5L
Change in 5 item EQ5D-5L. Higher score indicates better health-related quality of life.
Time frame: Change from Baseline at 10 weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2023 to primary completion in Jan 2024, 12 months.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 12 months is below that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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