Clinical trial NCT06191484: Risk and Resilience to Suicide Following Late-Life Spousal Bereavement
Official title: Risk and Resilience to Late-life Suicidal Ideation and Behavior After Spousal Bereavement: Targeting Social Connectedness to Strengthen Circadian Rhythmicity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide
Bereavement
Keywords: grief
bereavement
suicide
geriatric
health
technology
depression
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-01-05
Enrollment: 169
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in suicidal ideation over 12 months using the Beck Scale for Suicidal Ideation (BSSI)
timeFrame: Baseline and at month 1, 2, 3, 6, 9, and 12.
measure: Change in perceived loneliness over 12 months using the UCLA Loneliness Scale
timeFrame: Baseline and at month 1, 2, 3, 6, 9, and 12.
Secondary outcomes:
measure: Interdaily stability of the rest-activity rhythm
timeFrame: Baseline and at month 1, 2, 3, 6, 9, and 12.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh (UPMC)
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Sarah Stahl, PhD
role: PRINCIPAL_INVESTIGATOR
References: