WELL Program for Depression Prevention in Bereaved Older Adults
(WELL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores ways to prevent major depression in older adults who have recently lost their spouse. Researchers compare two approaches: one group uses digital tools to track sleep, meals, and physical activity, paired with motivational health coaching, while the other receives enhanced usual care (a standard care approach with added assessments). The goal is to determine if these lifestyle adjustments can help manage depressive symptoms by influencing daily activity patterns. The trial seeks individuals aged 60 and older who have lost their spouse within the last year and are experiencing signs of depression but do not have a current diagnosis of major depression or other severe mental health conditions.
As an unphased trial, this study offers participants the chance to contribute to innovative research aimed at improving mental health care for older adults.
Do I need to stop my current medications to join the trial?
If you are taking new medications for depression, like antidepressants or benzodiazepines, more than four days a week for over two months, you might not be eligible. However, if you've been on a stable dose for at least a month and agree not to change it during the trial, you can participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the WELL program, which aids older adults who have lost a spouse in adopting healthy lifestyles, is generally safe. Previous studies found that digital tools for tracking sleep, meals, and exercise, combined with motivational coaching, are well-received by participants. No serious side effects have been reported. The program aims to support mental health by promoting healthy habits and is designed to be low-risk. Although the WELL program is still under study, its methods rely on widely accepted health practices, suggesting it is likely safe.12345
Why are researchers excited about this trial?
Researchers are excited about the WELL Program because it offers a fresh approach to preventing depression in bereaved older adults by integrating lifestyle changes with digital monitoring. Unlike traditional treatments that might rely on medication or therapy alone, the WELL Program emphasizes holistic health by tracking sleep, meals, and physical activity, coupled with motivational health coaching and personalized feedback. This method not only supports mental health but also encourages overall well-being, providing a comprehensive strategy to help widowed elders navigate their loss.
What evidence suggests that this trial's treatments could be effective for preventing depression in bereaved older adults?
Research has shown that the WELL program, one of the treatments in this trial, uses digital tools and motivational health coaching to help older adults avoid depression after losing a spouse. Early results suggest this program can boost mental health by promoting healthy habits like regular sleep, balanced meals, and exercise. Maintaining a steady routine of activity and rest is important, as it affects mood and emotional well-being. Some studies indicate that these methods can lower the risk of major depression in older adults who have lost a spouse. While more research is underway, initial signs are positive for the WELL program's effect on mental health in this situation. Participants in this trial may receive either the WELL program or Enhanced Usual Care, which serves as a comparator.15678
Who Is on the Research Team?
Sarah Stahl, PhD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
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 for a Trial Participant
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.
What Are the Treatments Tested in This Trial?
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