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临床试验/NCT06191484
NCT06191484招募中不适用

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

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2023年11月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
169
试验地点
2
主要终点
Change in suicidal ideation over 12 months using the Beck Scale for Suicidal Ideation (BSSI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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)

研究组 & 干预措施

WELL Behavioral Probe

Experimental

Digital monitoring of sleep, meals, and social activity, for 3 months.

干预措施: WELL Behavioral Probe (Behavioral)

结局指标

主要结局

Change in suicidal ideation over 12 months using the Beck Scale for Suicidal Ideation (BSSI)

时间窗: 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

时间窗: 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.

次要结局

  • Interdaily stability of the rest-activity rhythm(Baseline and at month 1, 2, 3, 6, 9, and 12.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah T. Stahl, PhD

Associate Professor of Psychiatry and Assistant Professor of Clinical and Translational Science

University of Pittsburgh

研究点 (2)

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