NCT04016896

Depression Prevention in Older Spousally-bereaved Adults

Efficacy of a Healthy Lifestyle Intervention to Reduce Depression in Older Spousally-bereaved Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The primary aim of this R01 application is to test the efficacy of a new behavioral intervention that targets the timing and regularity of sleep, meals, and physical activity to stabilize circadian rhythms, for reducing symptoms of depression in older acutely-bereaved adults. This trial began at the onset of the SARS-CoV-2/COVID-19 pandemic when grief and loss where ubiquitous and access to mourning services was limited. To test whether this intervention could reduce the severity of associated psychopathological conditions common after spousal death, we added secondary outcomes of anxiety, complicated grief, and posttraumatic stress.

Conditions

• Depression

Interventions

Type	Name	Description
BEHAVIORAL	WIdowed Elders' LIfestyle after Loss (WELL)	Digital monitoring of sleep, meals, physical activity (daily); motivational health coaching (weekly); and web-based performance feedback (in real-time) for 12 weeks.
OTHER	Enhanced Usual Care	Health education, referral to mental health support, and telephone-delivered support (weekly) for 12 weeks.

Timeline

• Start date: 2020-10-20
• Primary completion: 2025-01-17
• Completion: 2025-01-17
• First posted: 2019-07-12
• Last updated: 2026-01-28
• Results posted: 2026-01-28

Locations

1 site across 1 country: United States