Depression Prevention in Older Spousally-bereaved Adults

NCT ID: NCT04016896

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-20
• Study Completion Date: 2025-01-17

Brief Summary

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: enhanced usual care (EUC; n=75) and WELL (WELL; n=75).

Detailed Description

The primary aim of this R01 application is to test the efficacy of a new behavioral intervention that targets the timing and regularity of sleep, meals, and physical activity to stabilize circadian rhythms, for reducing symptoms of depression in older acutely-bereaved adults. This trial began at the onset of the SARS-CoV-2/COVID-19 pandemic when grief and loss where ubiquitous and access to mourning services was limited. To test whether this intervention could reduce the severity of associated psychopathological conditions common after spousal death, we added secondary outcomes of anxiety, complicated grief, and posttraumatic stress.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Widowed Elders' Lifestyle after Loss (WELL)

Digital monitoring of sleep, meals, physical activity (daily); motivational health coaching (weekly); and web-based performance feedback (in real-time) for 12 weeks.

Group Type: EXPERIMENTAL

WIdowed Elders' LIfestyle after Loss (WELL)

Intervention Type: BEHAVIORAL

Digital monitoring of sleep, meals, physical activity (daily); motivational health coaching (weekly); and web-based performance feedback (in real-time) for 12 weeks.

Enhanced Usual Care

Health education, referral to mental health support, and telephone-delivered support (weekly) for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type: OTHER

Health education, referral to mental health support, and telephone-delivered support (weekly) for 12 weeks.

Interventions

WIdowed Elders' LIfestyle after Loss (WELL)

Digital monitoring of sleep, meals, physical activity (daily); motivational health coaching (weekly); and web-based performance feedback (in real-time) for 12 weeks.

Intervention Type: BEHAVIORAL

Enhanced Usual Care

Health education, referral to mental health support, and telephone-delivered support (weekly) for 12 weeks.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• aged 60 years and older;
• spousally (or partner) bereaved up to 12 months (includes bereaved as a result of COVID-19);
• at-risk for major depressive disorder (MDD), based on high-risk markers defined as subthreshold symptoms of depression (Hamilton Depression Rating Scale score of > or = 9), together with absence of current MDD, post-traumatic stress disorder, or persistent complex bereavement disorder

Exclusion Criteria

• current Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-5) criteria for syndromal mood, psychosis within the last 12 months;
• dementia/cognitive impairment; Telephone Interview Cognitive Screening (TICS) <19;
• acute suicide risk; based on Herbeck et al. protocol for suicide risk management;
• patients taking new psychotropic medications after spousal death to stabilize depression including antidepressants and benzodiazepines >4 days/week for more than two months. Individuals who have been on a stable dose for at least 1 month and agree not to change during participation, unless it is medically necessary, will be included.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Sarah T. Stahl, PhD

Assistant Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

sarah t stahl, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC: WPIC- Bellefield Towers

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Kazan J, Lyew T, Croswell E, Buysse DJ, Gebara MA, Karp JF, Krafty RT, Rashied AA, Reynolds CF 3rd, Rollman BL, Smagula SF, Stahl ST. A digital health intervention to stabilize the 24-hour rhythm of sleep, meals, and physical activity for reducing depression among older bereaved spouses: Protocol for a randomized controlled trial. Contemp Clin Trials. 2023 Jan;124:107016. doi: 10.1016/j.cct.2022.107016. Epub 2022 Nov 19.

Reference Type: DERIVED

PMID: 36414207 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R01MH118270

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY19080030

Identifier Type: -

Identifier Source: org_study_id