Depression Prevention in Older Spousally-bereaved Adults

Depression Clinical Trial

— WELL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04016896
• Other study ID #: STUDY19080030
• Secondary ID: R01MH118270
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2020
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: University of Pittsburgh
• Contact: sarah t stahl, PhD
• Phone: 4122466003
• Email: sts80[@]pitt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• WIdowed Elders' LIfestyle after Loss (WELL)
Digital monitoring; motivational health coaching; personalized feedback

Other:
• Enhanced Usual Care
psychoeducation plus study assessments controlling for time and attention

Locations

Country	Name	City	State
United States	UPMC: WPIC- Bellefield Towers	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline in the rest-activity rhythm at 3 months	Rest-activity rhythm as measured by objective actigraphic technology	baseline vs. 3 months