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NCT04016896 · ClinicalTrials.gov registry record · NA
Depression Prevention in Older Spousally-bereaved Adults
A NA study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- NA
- Development phase
- 151
- Enrollment target
NCT04016896 is a NA study that has completed, run by University of Pittsburgh. The registered enrollment target is 151 participants.
The verdict
NCT04016896, a NA study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- NA
- Development phase
- 151 participants
- Enrollment target
Study Summary
Using an indicated prevention approach, investigators propose to enroll 150 spousally-bereaved adults aged 60 years and older in the first 12 months after spousal death who are at high risk for major depression disorder because of subthreshold symptoms of depression. A confirmatory efficacy trial will be conducted in which participants will be randomly assigned to (a) self-monitor sleep, meals, and physical activity for 12 weeks using digital monitoring plus motivational health coaching (WELL; n=75); or (b) enhanced usual care (EUC, usual care plus study assessments, n=75). Objective actigraphic measures of the 24-hour pattern of day and nighttime activity - known as the rest-activity rhythm - will be measured to evaluate circadian rhythms as a mediator of treatment outcomes. Participants will be assessed at baseline, months 1 \& 2, post-intervention, and 3, 6,12, 18-months post-intervention. In addition, the investigators will include a subset of participants bereaved by COVID-19 (or suspected as bereaved by COVID-19). Participants in this subset will undergo the same research procedures as the main cohort. Participants in both the main cohort and subset determined to be fully eligible will be randomized into two groups with a total of: enhanced usual care (EUC; n=75) and WELL (WELL; n=75).
Interventions
- OTHER Enhanced Usual Care
- BEHAVIORAL WIdowed Elders' LIfestyle after Loss (WELL)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2020-10-20 |
| Est. Completion | 2025-01-17 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04016896
The ClinicalTrials.gov registry entry for NCT04016896 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 151 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Enhanced Usual Care is the first listed.
NCT04016896 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04016896 about?
NCT04016896 is a clinical study titled "Depression Prevention in Older Spousally-bereaved Adults". Using an indicated prevention approach, investigators propose to enroll 150 spousally-bereaved adults aged 60 years and older in the first 12 months after spousal death who are at high risk for major depression disorder because of subthreshold symptoms of depression. A confirmatory efficacy trial wi...
What is the current status of trial NCT04016896?
This trial is currently completed. It is a NA study. The enrollment target is 151 participants. The study started on 2020-10-20. Estimated completion is 2025-01-17.
What interventions are being tested in trial NCT04016896?
The interventions under investigation include: Enhanced Usual Care (OTHER), WIdowed Elders' LIfestyle after Loss (WELL) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04016896?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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