Clinical trial NCT04016896: Depression Prevention in Older Spousally-bereaved Adults
Official title: Efficacy of a Healthy Lifestyle Intervention to Reduce Depression in Older Spousally-bereaved Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-07-12
Enrollment: 250
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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: usual care (EUC;n=125) and WELL (WELL; n=125).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in depression symptom burden at 3 months
timeFrame: baseline vs. 3 months
Secondary outcomes:
measure: Change from baseline in the rest-activity rhythm at 3 months
timeFrame: baseline vs. 3 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC: WPIC- Bellefield Towers
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: sarah t stahl, PhD
role: PRINCIPAL_INVESTIGATOR
References: