Depression Prevention in Older Spousally-bereaved Adults (WELL)

Efficacy of a Healthy Lifestyle Intervention to Reduce Depression 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 6 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: usual care (EUC;n=125) and WELL (WELL; n=125).

Study Overview

• Status: Recruiting
• Conditions: Depression
• Intervention / Treatment: Behavioral: WIdowed Elders' LIfestyle after Loss (WELL); Other: Enhanced Usual Care

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 during the spousal bereavement period.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: sarah t stahl, PhD; Phone Number: 4122466003; Email: sts80@pitt.edu
• Study Contact Backup: Name: Emilee Croswell; Phone Number: 412-440-8418; Email: WELLstudy@pitt.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • UPMC: WPIC- Bellefield Towers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Widowed Elders' Lifestyle after Loss (WELL); digital monitoring of sleep, meals, physical activity; motivational health coaching; personalized feedback	Behavioral: WIdowed Elders' LIfestyle after Loss (WELL); Digital monitoring; motivational health coaching; personalized feedback
Active Comparator: Enhanced Usual Care; enhanced usual care	Other: Enhanced Usual Care; psychoeducation plus study assessments controlling for time and attention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in depression symptom burden at 3 months	Depression symptom burden as measured by the clinician administered Hamilton Rating Scale for Depression	baseline vs. 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the rest-activity rhythm at 3 months	Rest-activity rhythm as measured by objective actigraphic technology	baseline vs. 3 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: sarah t stahl, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2020
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 8, 2019
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (Actual): July 12, 2019

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: STUDY19080030; R01MH118270 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No