CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 151 enrolled
Drug / intervention
WIdowed Elders' LIfestyle after Loss (WELL) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04016896
NCT04016896N/ACompleted

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

University of Pittsburgh·interventional·Posted Jul 12, 2019·Updated Jan 28, 2026

In Brief

A clinical study evaluating WIdowed Elders' LIfestyle after Loss (WELL) and Enhanced Usual Care for Depression. Completed, enrolled 151 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 12, 2019
Enrollment StartOct 20, 2020
Primary CompletionJan 17, 2025
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 7.0 years ago

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 Careother

Health education, referral to mental health support, and telephone-delivered support (weekly) for 12 weeks.