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Completed

NCT Number: NCT04016896

Depression Prevention in Older Spousally-bereaved Adults

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).

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC: WPIC- Bellefield Towers

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Enhanced usual care

Other

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

Primary outcomes

  1. Change From Baseline in Depression Symptom Burden at 3 Months

    Time frame: baseline vs. 3 months

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

Secondary outcomes

  1. Change From Baseline in Anxiety Symptom Burden at 3 Months

    Time frame: baseline vs. 3 months

    Anxiety symptoms measured with the Generalized Anxiety Disorder - 7

  2. Change From Baseline in Complicated Grief Symptom Burden at 3 Months

    Time frame: baseline vs. 3 months

    Complicated grief symptoms measured with the Inventory of Complicated Grief

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

    Time frame: baseline vs. 3 months

    Posttraumatic stress symptoms measured with the PTSD Checklist for DSM-5

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Efficacy of a Healthy Lifestyle Intervention to Reduce Depression in Older Spousally-bereaved Adults

Acronym: WELL

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jul 12, 2019
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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