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Идёт набор NCT07143357

Mind-body Resilience Program for Cardiac Arrest Survivors and Their Caregivers: Recovering Together After Cardiac Arrest

Без фазы С лечением Emotional Distress Cardiac Arrest (CA) Anxiety Depression

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: Recovering Together after Cardiac Arrest 1, Recovering Together after Cardiac Arrest 2.
Кому может быть актуально
Состояния в реестре: Emotional Distress, Cardiac Arrest (CA), Anxiety, Depression. Базовые параметры: от 18 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Development of a Dyadic Mind-body Program for Cardiac Arrest Survivors and Their Caregivers: Recovering Together After Cardiac Arrest (RT-CA).

Обзор

The purpose of this study is to pilot two resilience interventions for cardiac arrest survivors and their informal caregivers, Recovering Together after Cardiac Arrest 1 and Recovering Together after Cardiac Arrest 2 . The data the investigators gather in this study will be used to further refine the interventions.

Подробное описание

The goal of this study is to test the feasibility of our proposed interventions through a pilot RCT. The investigators will deliver the RCT intervention (N=42 dyads; 84 participants total) and evaluate feasibility and acceptability based on a priori benchmarks.

The RCT will initially take place at Massachusetts General Hospital intensive care units and step-down units. Cardiac arrest survivor-caregiver dyads will be randomly assigned to one of two groups - Recovering Together after Cardiac Arrest 1 (RT-CA 1) or Recovering Together after Cardiac Arrest 2 (RT-CA 2).

RT-CA 1 involves six, 30-minute weekly sessions beginning at bedside and continuing over Zoom after the survivor is discharged. RT-CA 2 involves one, 30 minute session at bedside.

All participants will complete psychosocial survey measures at baseline, six weeks, and 3 months.

Вмешательства

  • Поведенческое Recovering Together after Cardiac Arrest 1
    The intervention will teach resiliency skills (mindfulness and coping) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions will take place in person until the survivor is discharged; remaining sessions will occur over Zoom.
  • Другое Recovering Together after Cardiac Arrest 2
    In this minimally enhanced usual care control, dyads will participate in one 30-minute session with a clinician at beside to review a pamphlet of available psychosocial resources for cardiac arrest survivors and their caregivers.

Первичные конечные точки

  • Feasibility of Recruitment [Срок оценки: pre-test]
  • Feasibility of Randomization [Срок оценки: The end of treatment at 6 weeks]
  • Feasibility of Assessment Completion [Срок оценки: pre-test, the end of treatment at 6 weeks, and 3 months after the end of treatment]
  • Feasibility of Program Adherence (RT-CA 1) [Срок оценки: the end of treatment at 6 weeks]
  • Therapist Fidelity [Срок оценки: the end of treatment at 6 weeks]
  • Treatment Satisfaction (RT-CA 1) [Срок оценки: the end of treatment at 6 weeks]
  • Credibility (RT-CA 1) [Срок оценки: pre-test]
  • Expectancy (RT-CA 1) [Срок оценки: pre-test]
  • Study safety [Срок оценки: at the end of treatment at 6 weeks and 3 months after the end of treatment]

Критерии участия

Критерии включения

  • Out-of-hospital or in-hospital CA survivor (must have new diagnosis of "cardiac arrest" in electronic medical record from index hospitalization with documented loss of pulse) with an identified caregiver (identified by the survivor who is their primary source of emotional and functional support)
  • survivor must score >5 on Short Form of the Mini Mental State Exam for sufficient cognitive function for meaningful participation
  • ability and willingness to participate in a hybrid in-person/live video intervention
  • English speaking adults (18 year or older)
  • at least one member of the dyad endorses clinically significant emotional distress during screening (>7 on either of the Hospital Anxiety and Depression Scale subscales).

Критерии исключения

  • active psychosis, mania, substance dependence, or suicidal intent or plan that would require a higher level of care
  • any other psychiatric or neurological condition that would preclude meaningful participation
  • the caregiver must not be a cardiac arrest survivor

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT07143357 · 2025P002063 · 5K23AT012487

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗