Risk and Resilience to Suicide Following Late-Life Spousal Bereavement

Suicide Clinical Trial

— RISE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06191484
• Other study ID #: STUDY23060037
• Secondary ID: R01MH132114
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2023
• Est. completion date: December 1, 2029

Study information

• Verified date: January 2024
• Source: University of Pittsburgh
• Contact: Emilee Croswell, BA
• Phone: 4124408418
• Email: croswellej[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 169
• Est. completion date: December 1, 2029
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bereavement
• Suicide

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pittsburgh (UPMC)	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 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.
Primary	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	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.