Depression Prevention in Older Spousally-bereaved Adults (WELL)
Primary Purpose
Depression
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WIdowed Elders' LIfestyle after Loss (WELL)
Enhanced Usual Care
Sponsored by
About this trial
This is an interventional prevention trial for Depression
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 >/= 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.
Sites / Locations
- UPMC: WPIC- Bellefield TowersRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Widowed Elders' Lifestyle after Loss (WELL)
Enhanced Usual Care
Arm Description
digital monitoring of sleep, meals, physical activity; motivational health coaching; personalized feedback
enhanced usual care
Outcomes
Primary Outcome Measures
Change from baseline in depression symptom burden at 3 months
Depression symptom burden as measured by the clinician administered Hamilton Rating Scale for Depression
Secondary Outcome Measures
Change from baseline in the rest-activity rhythm at 3 months
Rest-activity rhythm as measured by objective actigraphic technology
Full Information
NCT ID
NCT04016896
First Posted
July 8, 2019
Last Updated
December 2, 2022
Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT04016896
Brief Title
Depression Prevention in Older Spousally-bereaved Adults
Acronym
WELL
Official Title
Efficacy of a Healthy Lifestyle Intervention to Reduce Depression in Older Spousally-bereaved Adults
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Widowed Elders' Lifestyle after Loss (WELL)
Arm Type
Experimental
Arm Description
digital monitoring of sleep, meals, physical activity; motivational health coaching; personalized feedback
Arm Title
Enhanced Usual Care
Arm Type
Active Comparator
Arm Description
enhanced usual care
Intervention Type
Behavioral
Intervention Name(s)
WIdowed Elders' LIfestyle after Loss (WELL)
Intervention Description
Digital monitoring; motivational health coaching; personalized feedback
Intervention Type
Other
Intervention Name(s)
Enhanced Usual Care
Intervention Description
psychoeducation plus study assessments controlling for time and attention
Primary Outcome Measure Information:
Title
Change from baseline in depression symptom burden at 3 months
Description
Depression symptom burden as measured by the clinician administered Hamilton Rating Scale for Depression
Time Frame
baseline vs. 3 months
Secondary Outcome Measure Information:
Title
Change from baseline in the rest-activity rhythm at 3 months
Description
Rest-activity rhythm as measured by objective actigraphic technology
Time Frame
baseline vs. 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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 >/= 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sarah t stahl, PhD
Phone
4122466003
Email
sts80@pitt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Emilee Croswell
Phone
412-440-8418
Email
WELLstudy@pitt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sarah t stahl, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC: WPIC- Bellefield Towers
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Depression Prevention in Older Spousally-bereaved Adults
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