Depression Prevention in Older Spousally-bereaved Adults

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT04016896
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Oct 20, 2020
Status verified
Apr 2025
Primary completion
Jan 17, 2025
Completion
Jan 17, 2025

Study Design

Enrollment
151 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: Enhanced Usual Care
    Health education, referral to mental health support, and telephone-delivered support (weekly) for 12 weeks.

Primary Outcome Measure

Change From Baseline in Depression Symptom Burden at 3 Months [ Time Frame: baseline vs. 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC: WPIC- Bellefield TowersPittsburghPennsylvania15213-

Find similar trials in Pittsburgh, PA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
UPMC: WPIC- Bellefield Towers· Pittsburgh, PA

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