250 Participants Needed

WELL Program for Depression Prevention in Bereaved Older Adults

(WELL Trial)

st
EC
Overseen ByEmilee Croswell
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

st

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

I lost my spouse or partner within the last year, including due to COVID-19.
I am at risk for depression but do not currently have depression, PTSD, or complex bereavement disorder.
I am 60 years old or older.

Exclusion Criteria

You are currently at high risk of attempting suicide according to a specific protocol used to manage suicide risk.
I've been on stable doses of depression medication for over a month after my spouse's death.
dementia/cognitive impairment; Telephone Interview Cognitive Screening (TICS) <19;
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

12 weeks
Baseline, months 1 & 2, post-intervention

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3, 6, 12, and 18 months post-intervention.

18 months
3, 6, 12, 18 months post-intervention

Treatment Details

Interventions

  • Enhanced Usual Care
  • WIdowed Elders' LIfestyle after Loss (WELL)
Trial Overview The study tests two approaches to prevent depression: WELL involves self-monitoring sleep, meals, physical activity with health coaching; EUC is usual care plus assessments. Participants will be randomly assigned to one of these groups and followed up for up to 18 months.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Widowed Elders' Lifestyle after Loss (WELL)Experimental Treatment1 Intervention
digital monitoring of sleep, meals, physical activity; motivational health coaching; personalized feedback
Group II: Enhanced Usual CareActive Control1 Intervention
enhanced usual care

Enhanced Usual Care is already approved in United States, European Union, China for the following indications:

🇺🇸
Approved in United States as Lactulose for:
  • Hepatic encephalopathy
  • Constipation
🇪🇺
Approved in European Union as Lactulose for:
  • Hepatic encephalopathy
  • Constipation
🇨🇳
Approved in China as Lactulose for:
  • Hepatic encephalopathy
  • Constipation

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials
1,820
Recruited
16,360,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security