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Идёт набор NCT06191484

Risk and Resilience to Suicide Following Late-Life Spousal Bereavement

Без фазы С лечением Suicide Bereavement

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: WELL Behavioral Probe.
Кому может быть актуально
Состояния в реестре: Suicide, Bereavement. Базовые параметры: от 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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.

Первичные конечные точки

  • Change in suicidal ideation over 12 months using the Beck Scale for Suicidal Ideation (BSSI) [Срок оценки: Baseline and at month 1, 2, 3, 6, 9, and 12.]
  • Change in perceived loneliness over 12 months using the UCLA Loneliness Scale [Срок оценки: Baseline and at month 1, 2, 3, 6, 9, and 12.]
Вторичные конечные точки (1)
  • Interdaily stability of the rest-activity rhythm [Срок оценки: Baseline and at month 1, 2, 3, 6, 9, and 12.]

Критерии участия

Older adults who recently lost their spouse or life partner and are high risk for suicidal thoughts and/or behavior.

Критерии включения

  • 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

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

США · 1 центр
  • University of Pittsburgh (UPMC) — Pittsburgh

Идентификаторы

NCT: NCT06191484 · STUDY23060037 · R01MH132114

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗