N/A
Completed N=151
Depression Prevention in Older Spousally-bereaved Adults
Source: ClinicalTrials.gov NCT04016896 ↗Enrolled (actual)
151
Serious AEs
5.3%
Results posted
Jan 2026
Primary outcomePrimary: Change From Baseline in Depression Symptom Burden at 3 Months — 5.6; 7.4 score on a scale — p=<.05
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Depression Symptom Burden at 3 Months |
5.6; 7.4 | <.05 sig |
| SECONDARY Change From Baseline in Anxiety Symptom Burden at 3 Months |
1.6; 2.1 | <.05 sig |
| SECONDARY Change From Baseline in Complicated Grief Symptom Burden at 3 Months |
16.5; 16.5 | <.05 sig |
| SECONDARY Change From Baseline in Posttraumatic Stress Symptom Burden at 3 Months |
9.5; 10.2 | <.05 sig |
Eligibility Criteria
Inclusion Criteria
- aged 60 years and older;
- spousally (or partner) bereaved up to 12 months (includes bereaved as a result of COVID-19);
- at-risk for major depressive disorder (MDD), based on high-risk markers defined as subthreshold symptoms of depression (Hamilton Depression Rating Scale score of > or = 9), together with absence of current MDD, post-traumatic stress disorder, or persistent complex bereavement disorder
Exclusion Criteria
- current Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-5) criteria for syndromal mood, psychosis within the last 12 months;
- dementia/cognitive impairment; Telephone Interview Cognitive Screening (TICS) 4 days/week for more than two months. Individuals who have been on a stable dose for at least 1 month and agree not to change during participation, unless it is medically necessary, will be included.
Data sourced from ClinicalTrials.gov (NCT04016896). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.