Trial results for a study investigating depression prevention in older spousally-bereaved adults were posted on ClinicalTrials.gov on 2026-01-28, indicating that the Widowed Elders' Lifestyle After Loss (WELL) intervention group showed a mean change of 5.6 in depression symptom burden compared to 7.4 in the Enhanced Usual Care group at 3 months.
Background
Depression is a significant concern among older adults, particularly those who have recently experienced spousal bereavement. This population is at an elevated risk for developing major depressive disorder, often presenting with subthreshold symptoms that can progress if not addressed. Interventions focused on prevention are crucial to mitigate the impact of grief and reduce the incidence of clinical depression in this vulnerable demographic.
Trial design
This completed study, designated as Phase NA, enrolled 151 participants to investigate Depression prevention. The trial focused on spousally-bereaved adults aged 60 years and older within 12 months after spousal death, who were at high risk for major depressive disorder due to subthreshold symptoms. Participants were randomly assigned to one of two groups: (a) Widowed Elders' Lifestyle After Loss (WELL), which involved self-monitoring sleep, meals, and physical activity for 12 weeks using digital monitoring plus motivational health coaching (n=75); or (b) Enhanced Usual Care (EUC), which included usual care plus study assessments (n=75).
Key results
The trial reported several key measurements at 3 months for both intervention groups:
- Change From Baseline in Depression Symptom Burden:
- Widowed Elders' Lifestyle After Loss (WELL) group: mean of 5.6 (Standard Deviation 4.0) on a score scale.
- Enhanced Usual Care group: mean of 7.4 (Standard Deviation 3.9) on a score scale.
- Change From Baseline in Anxiety Symptom Burden:
- WELL group: mean of 1.6 (Standard Deviation 2.5) on a score scale.
- Enhanced Usual Care group: mean of 2.1 (Standard Deviation 2.8) on a score scale.
- Change From Baseline in Complicated Grief Symptom Burden:
- WELL group: mean of 16.5 (Standard Deviation 9.1) on a score scale.
- Enhanced Usual Care group: mean of 16.5 (Standard Deviation 9.7) on a score scale.
- Change From Baseline in Posttraumatic Stress Symptom Burden:
- WELL group: mean of 9.5 (Standard Deviation 9.0) on a score scale.
- Enhanced Usual Care group: mean of 10.2 (Standard Deviation 8.3) on a score scale.
Key analyses using ANCOVA reported several findings with a p-value of 0.05:
- A Mean Difference (Final Values) of 3.7.
- A Mean Difference (Final Values) of 11.39.
- A Mean Difference (Final Values) of 2.01.
- A Median Difference (Final Values) of 2.38.
What this means
The results suggest that the Widowed Elders' Lifestyle After Loss (WELL) intervention may be associated with a greater reduction in depression symptom burden compared to enhanced usual care in older spousally-bereaved adults. The WELL group demonstrated a numerically lower mean change in depression symptoms, as well as slightly lower mean changes in anxiety and posttraumatic stress symptom burdens. While complicated grief symptom burden was similar between groups, the reported p-values of 0.05 from ANCOVA analyses for various mean and median differences indicate statistically significant findings for some measured outcomes, supporting the potential efficacy of the lifestyle intervention in this vulnerable population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04016896, titled "Depression Prevention in Older Spousally-bereaved Adults", were posted on 2026-01-28 on clinicaltrials.gov.