Risk and Resilience to Suicide Following Late-Life Spousal Bereavement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: WELL Behavioral Probe.
- Who it may be relevant to
- Registry conditions: Suicide, Bereavement. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Risk and Resilience to Late-life Suicidal Ideation and Behavior After Spousal Bereavement: Targeting Social Connectedness to Strengthen Circadian Rhythmicity
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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.]
- 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.]
Secondary outcome measures (1)
- Interdaily stability of the rest-activity rhythm [Time frame: Baseline and at month 1, 2, 3, 6, 9, and 12.]
Eligibility criteria
Older adults who recently lost their spouse or life partner and are high risk for suicidal thoughts and/or behavior.
Inclusion criteria
- Bereaved < or = to 12 months from spousal/partner loss
- > or = to 65 years old
- 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)
- No diagnosis of schizophrenia/schizoaffective disorders/bipolar/current psychosis
- Does not reside in nursing home
- Not a current shift worker
- No major cognitive impairment: TICS score of > or = to 27
Exclusion criteria
- Bereaved >12 months from spousal/partner bereavement
- < 65 years old
- Patient is not spousal/partner bereaved (ex: parent, sibling, etc.)
- Prior diagnosis of schizophrenia/schizoaffective disorders/bipolar/current psychosis or medications listed indicate diagnosis of these disorders/MDD or MDE with psychotic features
- Major cognitive impairment: TICS score of <27
- Current shift worker
- Resides in a nursing home
- Unstable medical condition (e.g., unstable angina, end stage renal disease)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Pittsburgh (UPMC) — Pittsburgh
Identifiers
NCT: NCT06191484 · STUDY23060037 · R01MH132114