WELL Program for Depression Prevention in Bereaved Older Adults

(WELL Trial)

Overseen By Emilee Croswell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must not be taking: New antidepressants, benzodiazepines

Disqualifiers: Mood disorders, Psychosis, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

250 Participants Needed

What You Need to Know Before You Apply

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).

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

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;

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Widowed Elders' Lifestyle after Loss (WELL) Experimental Treatment 1 Intervention

digital monitoring of sleep, meals, physical activity; motivational health coaching; personalized feedback

Group II: Enhanced Usual Care Active Control 1 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

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+