WELL Program for Depression Prevention in Bereaved Older Adults
(WELL Trial)
Trial Summary
What is the purpose of this trial?
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: usual care (EUC;n=125) and WELL (WELL; n=125).
Research Team
Sarah Stahl, PhD
Principal Investigator
University of Pittsburgh
Eligibility Criteria
This trial is for people aged 60 or older who have recently lost a spouse and are showing signs of depression, but do not yet have major depression. They should not be experiencing severe cognitive issues, taking new mood-stabilizing medications post-bereavement, or have had psychosis in the last year.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomly assigned to either self-monitor sleep, meals, and physical activity for 12 weeks using digital monitoring plus motivational health coaching or receive enhanced usual care.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 3, 6, 12, and 18 months post-intervention.
Treatment Details
Interventions
- Enhanced Usual Care
- WIdowed Elders' LIfestyle after Loss (WELL)
Enhanced Usual Care is already approved in United States, European Union, China for the following indications:
- Hepatic encephalopathy
- Constipation
- Hepatic encephalopathy
- Constipation
- Hepatic encephalopathy
- Constipation
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pittsburgh
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator