Risk and Resilience to Suicide Following Late-Life Spousal Bereavement (RISE)

January 3, 2024 updated by: Sarah T. Stahl, PhD, University of Pittsburgh

Risk and Resilience to Late-life Suicidal Ideation and Behavior After Spousal Bereavement: Targeting Social Connectedness to Strengthen Circadian Rhythmicity

The purpose of the RISE study is to examine how the 24-hour rhythm of sleep and social activity relate to mood and suicidal ideation among older adults that recently lost a spouse or life partner.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Experiencing the death of a spouse or life partner is a profoundly distressing event that may cause abrupt changes in one's daily routine, including decreased self-care and withdrawal from social activities. While most individuals adapt over time, a substantial number of older bereaved spouses (20-35%) experience depression, loneliness, suicidal thoughts, and early mortality, including death by suicide.

The objective of this study is to examine the risk for and resilience to late life suicide during the early spousal bereavement period by investigating the extent to which (1) social connectedness influences suicide risk and (2) whether circadian rhythm instability (inconsistent patterns of sleep, activity, meals, and socialization) helps explain this association.

The investigators will enroll 169 adults aged 65+ years who experienced the death of a spouse or life partner within the previous 12 months. All participants will complete repeated assessments of social connectedness, clinical assessments of depression and suicide ideation, and accelerometry recordings of the 24-hour pattern of sleep and activity. Participants will also complete a 3-month behavioral probe, designed to promote self-care behaviors in older bereaved spouses using technology and motivational health coaching. The behavioral probe targets circadian rhythm stability by focusing on regular routine of sleep, meals, and social activities. The behavioral probe will determine whether modifying social connectedness reduces suicide risk and whether circadian rhythm stability explains part of this association.

Study Type

Interventional

Enrollment (Estimated)

169

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • University of Pittsburgh (UPMC)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sarah Stahl, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Older adults who recently lost their spouse or life partner and are high risk for suicidal thoughts and/or behavior.

Inclusion Criteria:

  1. Bereaved < or = to 12 months from spousal/partner loss
  2. > or = to 65 years old
  3. Verified history of suicide attempt/attempts and/or current or past history of Major Depressive Disorder/Major Depressive Episode (MDD/MDE) (without psychotic features), or history of depression severe enough to trigger treatment, or current subsyndromal depression (> or = to 9 HDRS)
  4. No diagnosis of schizophrenia/schizoaffective disorders/bipolar/current psychosis
  5. Does not reside in nursing home
  6. Not a current shift worker
  7. No major cognitive impairment: TICS score of > or = to 27

Exclusion Criteria:

  1. Bereaved >12 months from spousal/partner bereavement
  2. < 65 years old
  3. Patient is not spousal/partner bereaved (ex: parent, sibling, etc.)
  4. Prior diagnosis of schizophrenia/schizoaffective disorders/bipolar/current psychosis or medications listed indicate diagnosis of these disorders/MDD or MDE with psychotic features
  5. Major cognitive impairment: TICS score of <27
  6. Current shift worker
  7. Resides in a nursing home
  8. Unstable medical condition (e.g., unstable angina, end stage renal disease)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WELL Behavioral Probe
Digital monitoring of sleep, meals, and social activity, for 3 months.
Behavioral: WELL Behavioral Probe
Participant record the timing and regularity of sleep, meals, and social activity twice daily, for 3 months, using a digital diary. Participants also receive weekly motivational health coaching.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in suicidal ideation over 12 months using the Beck Scale for Suicidal Ideation (BSSI)
Time Frame: Baseline and at month 1, 2, 3, 6, 9, and 12.
The BSSI is one of the most commonly used clinician-administered scales to assess presence and severity of suicidality. The total BSS score can range from 0 to 38, with higher values indicating a greater risk of suicide.
Baseline and at month 1, 2, 3, 6, 9, and 12.
Change in perceived loneliness over 12 months using the UCLA Loneliness Scale
Time Frame: Baseline and at month 1, 2, 3, 6, 9, and 12.
The UCLA Loneliness Scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. The total score ranges from 20 to 80. Higher scores indicate higher loneliness.
Baseline and at month 1, 2, 3, 6, 9, and 12.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interdaily stability of the rest-activity rhythm
Time Frame: Baseline and at month 1, 2, 3, 6, 9, and 12.
Measured using 1-week of accelerometry recordings.
Baseline and at month 1, 2, 3, 6, 9, and 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Sarah Stahl, PhD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

December 19, 2023

First Submitted That Met QC Criteria

December 20, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY23060037
  • R01MH132114 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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