Status:
COMPLETED
Depression Prevention in Older Spousally-bereaved Adults
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Depression
Eligibility:
All Genders
60+ years
Phase:
NA
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 ...
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 rh...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2025
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT04016896
Start Date
October 20 2020
End Date
January 17 2025
Last Update
December 17 2025
Active Locations (1)
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1
UPMC: WPIC- Bellefield Towers
Pittsburgh, Pennsylvania, United States, 15213