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Depression Prevention in Older Spousally-bereaved Adults
NA trial testing WIdowed Elders' LIfestyle after Loss (WELL) in Depression in 151 participants. Completed in 17 January 2025.
| Lead sponsor | University of Pittsburgh |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 151 |
| Start date | 20 October 2020 |
| Primary completion | 17 January 2025 |
| Estimated completion | 17 January 2025 |
| Sites | 1 location across United States |
University of Pittsburgh
60 and older, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Depression symptoms measured by the clinician administered Hamilton Rating Scale for Depression
| Group | Value | 95% CI |
|---|---|---|
| Widowed Elders' Lifestyle After Loss (WELL) | 5.6 | ± 4.0 |
| Enhanced Usual Care | 7.4 | ± 3.9 |
Anxiety symptoms measured with the Generalized Anxiety Disorder - 7
| Group | Value | 95% CI |
|---|---|---|
| Widowed Elders' Lifestyle After Loss (WELL) | 1.6 | ± 2.5 |
| Enhanced Usual Care | 2.1 | ± 2.8 |
Complicated grief symptoms measured with the Inventory of Complicated Grief
| Group | Value | 95% CI |
|---|---|---|
| Widowed Elders' Lifestyle After Loss (WELL) | 16.5 | ± 9.1 |
| Enhanced Usual Care | 16.5 | ± 9.7 |
Posttraumatic stress symptoms measured with the PTSD Checklist for DSM-5
| Group | Value | 95% CI |
|---|---|---|
| Widowed Elders' Lifestyle After Loss (WELL) | 9.5 | ± 9.0 |
| Enhanced Usual Care | 10.2 | ± 8.3 |
Time frame: from enrollment until end of intervention, up to 3 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Widowed Elders' Lifestyle … | Enhanced Usual Care |
|---|---|---|---|
| Surgery | Surgical and medical procedures | — | — |
| Cancer | Reproductive system and breast disorders | — | — |
| Respiratory illness | Infections and infestations | — | — |
| Personal injury | Cardiac disorders | — | — |
| Myocardial infarction | Cardiac disorders | — | — |
| Hernia | Gastrointestinal disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Reaction | System | Widowed Elders' Lifestyle … | Enhanced Usual Care |
|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | — | — |
| Infections | Infections and infestations | — | — |
| Alcohol use disorders | Psychiatric disorders | — | — |
| Arthritis and/or Pain | Musculoskeletal and connective tissue disorders | — | — |
| Mood/anxiety disorder | Psychiatric disorders | — | — |
| Personal injury | General disorders | — | — |
| Surgery | Surgical and medical procedures | — | — |
| Gastrointestinal problems | Gastrointestinal disorders | — | — |
| Nervous system disorders | Nervous system disorders | — | — |
| Hyperglycemia | Endocrine disorders | — | — |
| Bladder Infection | Renal and urinary disorders | — | — |
| Fatigue | General disorders | — | — |
| Cancer | Blood and lymphatic system disorders | — | — |
| Lupus | Immune system disorders | — | — |
| Cardiovascular problems | Cardiac disorders | — | — |
Most-reported serious reactions: Surgery, Cancer, Respiratory illness, Personal injury, Myocardial infarction, Hernia, Urinary tract infection.
Data from ClinicalTrials.gov NCT04016896 adverse events section.
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).
3 peer-reviewed publications reference this trial (live from Europe PMC):
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