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WELL Program for Depression Prevention in Bereaved Older Adults (WELL Trial)

N/A
Recruiting
Led By sarah t stahl, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
aged 60 years and older;
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline vs. 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will enroll 150 spousally-bereaved adults aged 60 years and older in the first 6 months after spousal death who are at high risk for major depression disorder because of subthreshold symptoms of depression. 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).

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial focuses on lifestyle interventions like monitoring daily activities and motivational coaching rather than medication, significant side effects are not anticipated. However, participants may experience emotional discomfort discussing their bereavement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 60 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline vs. 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline vs. 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in depression symptom burden at 3 months
Secondary study objectives
Change from baseline in the rest-activity rhythm at 3 months

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,918 Previous Clinical Trials
2,739,922 Total Patients Enrolled
701 Trials studying Depression
260,858 Patients Enrolled for Depression
University of PittsburghLead Sponsor
1,789 Previous Clinical Trials
16,359,373 Total Patients Enrolled
122 Trials studying Depression
34,219 Patients Enrolled for Depression
sarah t stahl, PhDPrincipal InvestigatorUniversity of Pittsburgh

Media Library

Enhanced Usual Care Clinical Trial Eligibility Overview. Trial Name: NCT04016896 — N/A
Depression Research Study Groups: Enhanced Usual Care, Widowed Elders' Lifestyle after Loss (WELL)
Depression Clinical Trial 2023: Enhanced Usual Care Highlights & Side Effects. Trial Name: NCT04016896 — N/A
Enhanced Usual Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT04016896 — N/A
~49 spots leftby Nov 2025
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