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

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: Suicide; Bereavement
• Intervention / Treatment: Behavioral: WELL Behavioral Probe

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 60+ 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

• Study Contact: Name: Emilee Croswell, BA; Phone Number: 4124408418; Email: croswellej@upmc.edu
• Study Contact Backup: Name: Sarah Stahl, PhD; Email: sts80@pitt.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Recruiting
      • University of Pittsburgh (UPMC)
      • Contact: Emilee Croswell; Phone Number: 412-440-8418; Email: RISE_research@pitt.edu
      • Contact: Sarah Stahl; Email: sts80@pitt.edu
      • Principal Investigator: Sarah Stahl, PhD

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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)	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	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	Measured using 1-week of accelerometry recordings.	Baseline and at month 1, 2, 3, 6, 9, and 12.

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Sarah Stahl, PhD, University of Pittsburgh

Study record dates

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): November 12, 2025
• Last Update Submitted That Met QC Criteria: November 7, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: health; depression; suicide; geriatric; technology; grief; bereavement
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Behavior; Suicide; Depression
• 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
• product manufactured in and exported from the U.S.: No