Depression Prevention in Older Spousally-bereaved Adults

NCT04016896 | Completed Results DMC

• 2 other identifiers: STUDY19080030R01MH118270
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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).

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Depression Symptom Burden at 3 Months

  Depression symptoms measured by the clinician administered Hamilton Rating Scale for Depression

  baseline vs. 3 months

Secondary Outcomes (3)

• Change From Baseline in Anxiety Symptom Burden at 3 Months

  baseline vs. 3 months

• Change From Baseline in Complicated Grief Symptom Burden at 3 Months

  baseline vs. 3 months

• Change From Baseline in Posttraumatic Stress Symptom Burden at 3 Months

  baseline vs. 3 months

Study Arms (2)

Widowed Elders' Lifestyle after Loss (WELL)

EXPERIMENTAL

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

Behavioral: WIdowed Elders' LIfestyle after Loss (WELL)

Enhanced Usual Care

ACTIVE COMPARATOR

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

Other: Enhanced Usual Care

Interventions

WIdowed Elders' LIfestyle after Loss (WELL) BEHAVIORAL

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

Widowed Elders' Lifestyle after Loss (WELL)

Enhanced Usual Care OTHER

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

Enhanced Usual Care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UPMC: WPIC- Bellefield Towers

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 36414207 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Sarah T. Stahl, PhD
• Organization: University of Pittsburgh

sts80@pitt.edu

4122466003

Study Officials

• sarah t stahl, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 12, 2019
• Study Start: October 20, 2020
• Primary Completion: January 17, 2025
• Study Completion: January 17, 2025
• Last Updated: January 28, 2026
• Results First Posted: January 28, 2026

Record last verified: 2025-04

Locations

US (1)