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Идёт набор NCT07579143

Mental Health Clinician / Chaplain Collaboration

Без фазы С лечением Moral Injury

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: facilitate forgiveness and community connection to address symptoms of moral injury.
Кому может быть актуально
Состояния в реестре: Moral Injury. Базовые параметры: 18 лет — 80 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 →
Официальное название

Mental Health Clinician / Chaplain Collaboration (MC3): A Pilot Study

Обзор

The goal of this clinical trial is to learn if the intervention can be delivered by VA chaplains and if it is acceptable for veterans who have symptoms of moral injury (guilt, shame, isolation) and are receiving VA mental health treatment. The main questions it aims to answer are: Can the study team enroll veterans for this intervention and complete data collection? Will veterans complete the intervention? There is no comparison group. Participants will will complete a baseline and 6-month interview and participate in up to 12 intervention sessions with a VA chaplain. The intervention will focus on facilitating forgiveness and community connection.

Подробное описание

Moral injury symptoms include guilt, shame, and self-isolation. Moral injury is also associated with increased suicide risk. Moral injury symptoms are common in Veterans being treated for posttraumatic stress disorder (PTSD) or substance use disorder (SUD) and current treatments do not always improve these symptoms. The Mental Health Clinician / Chaplain Collaboration (MC3) intervention is delivered by VA chaplains who facilitate forgiveness and community reintegration. MC3 is a collaboration between resources in the mental health clinic, chaplain service, and community to support moral injury symptom recovery.

Specific Aims:

1. Pre-implementation: Adapt the intervention that was originally delivered by community clergy for delivery by VA chaplains. Stakeholders in this process will include VA chaplains and mental health clinicians at the Little Rock and Pittsburgh VAMCs. 2. Conduct a single arm pilot study (total N = 20 across 2 sites) of the MC3 intervention to assess feasibility, acceptability, and fidelity (primary outcomes). 3. Post-implementation: Conduct a formative evaluation with stakeholders of the recruitment methods, MC3 intervention, and outcome measures. This information will be used to refine the MC3 intervention and study procedures for a subsequent RCT.

Methodology: The study design is a two site one arm trial. The population is Veterans being treated in specialty mental health or substance use disorder clinics who have symptoms of moral injury. MC3 will be delivered by VA chaplains who will facilitate forgiveness and community reintegration. The primary outcomes are feasibility and acceptability. Quantitative and qualitative data will be collected at baseline and 6-months (end of intervention). Evidence-based quality improvement methods will be used to implement MC3 at the Little Rock and Pittsburgh VA Medical Centers.

Вмешательства

  • Поведенческое facilitate forgiveness and community connection to address symptoms of moral injury
    VA chaplain delivered intervention to facilitate forgiveness and community connection in collaboration with mental health clinicians

Первичные конечные точки

  • Number referred, enrolled, baseline and 6-month [Срок оценки: 6 months]
  • intervention retention [Срок оценки: 6 months]
Вторичные конечные точки (10)
  • moral injury distress [Срок оценки: baseline and 6 months]
  • Religious and spiritual struggles [Срок оценки: baseline and 6 months]
  • Forgiving others [Срок оценки: baseline and 6-months]
  • Self forgiveness [Срок оценки: baseline and 6-months]
  • PTSD symptom severity [Срок оценки: baseline and 6-months]
  • Depression symptom serverity [Срок оценки: baseline and 6-months]
  • Functioning [Срок оценки: baseline and 6-months]
  • Post-traumatic growth [Срок оценки: baseline and 6-months]
  • Social satisfaction [Срок оценки: baseline and 6-months]
  • Loneliness [Срок оценки: baseline and 6-months]

Критерии участия

Критерии включения

  • age 18 to 80 years
  • plan to follow-up with a VA mental health clinician for PTSD or SUD treatment within the next three months (therefore allowing for collaboration)
  • positive screen using the 6-item Moral Injury Distress Scale (MIDS) screener. A positive MIDS screen will be defined as being bothered at least moderately by exposure to at least one potentially morally injurious event (witnessing, omission, commission).

Критерии исключения

  • diagnosis of schizophrenia, bipolar disorder, borderline personality disorder, or severe neurocognitive disorder (e.g., dementia, severe TBI). Veterans with borderline personality disorder will be eligible for participation in this study following DBT completion.
  • Planning to start or current participation in a moral injury treatment group or evidence-based psychotherapy (e.g., Prolonged Exposure or Cognitive Processing Therapy).

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
Лечение

Центры проведения

США · 2 центра
  • Central Arkansas Veterans Healthcare System — Little Rock
  • VA Pittsburgh Healthcare System — Pittsburgh

Идентификаторы

NCT: NCT07579143 · 1750298 · PPO 22-211

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗