University of Pittsburgh (UPMC)
Pittsburgh, Pennsylvania, 15212, United States
Location status: Recruiting
Location contact
Emilee Croswell
CONTACT
Sarah Stahl
CONTACT
Sarah Stahl, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06191484
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.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15212, United States
Location status: Recruiting
Emilee Croswell
CONTACT
Sarah Stahl
CONTACT
Sarah Stahl, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Older adults who recently lost their spouse or life partner and are high risk for suicidal thoughts and/or behavior.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and at month 1, 2, 3, 6, 9, and 12.
Measured using 1-week of accelerometry recordings.
Contact information is provided by the study sponsor or research team.
University of Pittsburgh
Other
Risk and Resilience to Late-life Suicidal Ideation and Behavior After Spousal Bereavement: Targeting Social Connectedness to Strengthen Circadian Rhythmicity
Acronym: RISE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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