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Depression Prevention in Older Spousally-bereaved Adults (WELL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04016896
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : April 26, 2021
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Sarah T. Stahl, PhD, University of Pittsburgh

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Depression Behavioral: WIdowed Elders' LIfestyle after Loss (WELL) Other: Enhanced Usual Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of a Healthy Lifestyle Intervention to Reduce Depression in Older Spousally-bereaved Adults
Actual Study Start Date : October 20, 2020
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Change from baseline in depression symptom burden at 3 months [ Time Frame: baseline vs. 3 months ]
    Depression symptom burden as measured by the clinician administered Hamilton Rating Scale for Depression

Secondary Outcome Measures :
  1. Change from baseline in the rest-activity rhythm at 3 months [ Time Frame: baseline vs. 3 months ]
    Rest-activity rhythm as measured by objective actigraphic technology

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • aged 60 years and older;
  • spousally (or partner) bereaved within 6 months post-loss or 12 months if 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 >/= 9), together with absence of current MDD, generalized anxiety disorder, 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, or anxiety disorder 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04016896

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Contact: sarah t stahl, PhD 4122466003
Contact: Emilee Croswell 412-440-8418

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United States, Pennsylvania
UPMC: WPIC- Bellefield Towers Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institute of Mental Health (NIMH)
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Principal Investigator: sarah t stahl, PhD University of Pittsburgh
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Responsible Party: Sarah T. Stahl, PhD, Assistant Professor of Psychiatry, University of Pittsburgh Identifier: NCT04016896    
Other Study ID Numbers: STUDY19080030
R01MH118270 ( U.S. NIH Grant/Contract )
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: April 26, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders