Risk and Resilience to Suicide Following Late-Life Spousal Bereavement

Not Applicable

Recruiting

• Conditions: Suicide; Bereavement
• Interventions: Behavioral: WELL Behavioral Probe

• Registration Number: NCT06191484
• Lead Sponsor: University of Pittsburgh

Brief Summary

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.

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 Timeline

• Study Start: 2023-11-20
• Study First Submitted: 2023-12-19
• Study First Submitted QC: 2023-12-20
• Study First Posted: 2024-01-05
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-16
• Primary Completion: 2028-12-31
• Study Completion: 2029-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 169

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
WELL Behavioral Probe	WELL Behavioral Probe	Digital monitoring of sleep, meals, and social activity, for 3 months.

Primary Outcome Measures

Name	Time	Method
Change in suicidal ideation over 12 months using the Beck Scale for Suicidal Ideation (BSSI)	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.
Change in perceived loneliness over 12 months using the UCLA Loneliness Scale	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.

Secondary Outcome Measures

Name	Time	Method
Interdaily stability of the rest-activity rhythm	Baseline and at month 1, 2, 3, 6, 9, and 12.	Measured using 1-week of accelerometry recordings.

Trial Locations

Locations (1)

University of Pittsburgh (UPMC); 🇺🇸 Pittsburgh, Pennsylvania, United States