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Идёт набор NCT07351305

Non-Trauma Intervention to Treat PTSD for Veterans and Service Members Suffering From a TBI

Без фазы С лечением PTSD Post Traumatic Stress Disorder Traumatic Brain 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: Non-Trauma Treatment for TBI and PTSD.
Кому может быть актуально
Состояния в реестре: PTSD, Post Traumatic Stress Disorder, Traumatic Brain Injury. 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
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Официальное название

Non-Trauma Intervention to Treat Posttraumatic Stress Disorder (PTSD) for Veterans and Service Members Suffering From a Traumatic Brain Injury (TBI)

Обзор

The investigators want to test a treatment for posttraumatic stress disorder (PTSD) especially designed for military veterans and service members with mild or moderate traumatic brain injuries (TBI) and PTSD. The treatment will include individual psychotherapy sessions to manage PTSD.

Подробное описание

The objective of this study is to test a non-trauma intervention for PTSD tailored to military veterans and service members with TBI called Non-Trauma Treatment for TBI and comorbid PTSD (T3 PTSD).

Aim1:

Conduct a pilot study of the non-trauma intervention for comorbid TBI and PTSD in a sample of n = 20 veterans and service members seeking treatment at Fort Hood, Texas.

Aim2:

Establish the acceptability and feasibility of the non-trauma intervention in service members and veterans.

Вмешательства

  • Поведенческое Non-Trauma Treatment for TBI and PTSD
    The treatment includes 8 sessions with each session lasting approximately 60 minutes. Sessions will cover relaxation training, identifying stress, stress management, and problem solving.

Первичные конечные точки

  • PTSD Checklist-DSM-5 (PCL-5) [Срок оценки: Baseline to 6 months post treatment (approximately 8 months)]
Вторичные конечные точки (10)
  • Credibility and Expectancy Questionnaire [Срок оценки: Baseline to 2 weeks post treatment (approximately 10 weeks)]
  • Clinician Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders Version 5 (DSM-5) [Срок оценки: Baseline to 6 months post treatment (approximately 8 months)]
  • Generalized Anxiety Disorder-7 (GAD-7) [Срок оценки: Baseline to 6 months post treatment (approximately 8 months)]
  • Patient Global Impressions (PGI) Scale [Срок оценки: 2 weeks post treatment to 6 months post treatment]
  • Alcohol Use Disorders Identification Test (AUDIT) [Срок оценки: Baseline to 6 months post treatment (approximately 8 months)]
  • Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Baseline to 6 months post treatment (approximately 8 months)]
  • Depressive Symptom Index-Suicide Subscale (DSI-SS) [Срок оценки: Baseline to 6 months post treatment (approximately 8 months)]
  • Insomnia Severity Index (ISI) [Срок оценки: Baseline to 6 months post treatment (approximately 8 months)]
  • Life Events Checklist-5 (LEC-5) [Срок оценки: Baseline to 6 months post treatment (approximately 8 months)]
  • Satisfaction with Therapy and Therapist Scale (STTS) [Срок оценки: 2 weeks post treatment (approximately 10 weeks after the first treatment)]

Критерии участия

Критерии включения

  • Ability of participant to understand and the willingness to sign a written informed consent document based on interviewer assessment and clinical judgement.
  • Any veteran or active duty service member (age 18 or above) diagnosed with mild or moderate TBI as determined by the Ohio State University Brain Injury Identification Method
  • Participant meets diagnostic criteria for PTSD based on Clinician-Administered PTSD Scale (CAPS-5) interview as described by the National Center for PTSD which includes at least one Criterion B symptom, one Criterion C symptom, two Criterion D symptoms, and two Criterion E symptoms as well as meeting Criterions F and G.
  • Ability to read, write, and speak English based on interviewer assessment and clinical judgement.

Критерии исключения

  • Participant is actively engaged in a behavioral intervention primarily targeting PTSD.
  • Participant has a psychiatric problem that warrants immediate treatment as indicated in the electronic health record, flagged during testing, or confirmed by a clinician through screening or review of clinical notes.
  • Participant demonstrates significant cognitive impairment that could impact treatment adherence/benefit based on interviewer assessment and clinical judgement.

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 · 1 центр
  • Carl R Darnall Army Medical Center — Fort Hood

Идентификаторы

NCT: NCT07351305 · STUDY00001920 · HT94252411015

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗