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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

WELL Trial 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.Check my eligibility

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.See study design

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.

WELL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 60 years old or older.

WELL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline vs. 3 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in depression symptom burden at 3 months

Secondary outcome measures

Change from baseline in the rest-activity rhythm at 3 months

WELL 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH

2,785 Previous Clinical Trials

2,689,506 Total Patients Enrolled

666 Trials studying Depression

251,334 Patients Enrolled for Depression

University of PittsburghLead Sponsor

1,722 Previous Clinical Trials

16,342,686 Total Patients Enrolled

119 Trials studying Depression

33,845 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are there in this experiment?

"Affirmative. Clinicaltrials.gov reveals that this research study, initially posted on October 20th 2020, is actively seeking participants. Up to 250 people are required for the single clinical trial site."

Answered by AI

Is this research endeavor currently enrolling participants?

"Affirmative. According to clinicaltrials.gov, this trial is currently recruiting participants and was initially posted on October 20th 2020. The study needs 250 individuals from 1 site in order to complete its data collection goals."

Answered by AI