Trauma BPE Prolonged Exposure Therapy for Injured Individuals Admitted to a Level I Trauma Center

Официальное название

Prevention of Posttraumatic Stress: A Randomized Controlled Trial of Brief Prolonged Exposure Therapy for Injured Individuals Admitted to a Level I Trauma Center

Обзор

The purpose of this research is to determine if a brief treatment method is effective for preventing posttraumatic stress disorder (PTSD) and a number of other concerns following injury.

Подробное описание

This is a prospective randomized controlled trial examining the efficacy of brief Prolonged Exposure Therapy (Brief PE) delivered to individuals admitted to a Level I Trauma Center to reduce PTSD symptoms. The overall goal of this project is to test a Brief PE (three 60-minute sessions) to reduce psychological distress after injury and to mitigate long-term post-injury distress including PTSD as well as secondary health outcomes (including depression, general anxiety, pain, and quality of life) at 1, 3, and 6 months from baseline. The intervention group (Brief PE) will be compared to standard clinical care with treatment as usual (TAU).

Вмешательства

• Поведенческое Treatment as Usual
  Standard clinical treatment received by all patients admitted to BUMC, BSWMC Temple or FH/MCW trauma centers. At BUMC and FH/MCW, this may include an evaluation by a licensed psychologist or psychiatrist and continued follow-up psychotherapy and/or medication as needed. At BSWMC Temple this may include an evaluation by a licensed psychiatrist and follow up treatment as needed. In all locations this therapy does not consist of trauma-focused therapy and will be summarized in the analysis as a par
• Поведенческое Brief Prolonged Exposure Therapy
  Brief PE will include 3 therapy sessions, each lasting approximately 60 minutes. The treatment is manualized and has been successfully implemented and evaluated in other challenging environments (i.e., Emergency Department. Trauma center). Brief PE includes education about common reactions to trauma, breathing retraining, prolonged (repeated) imaginal exposure to trauma memories, repeated in vivo/behavioral exposure to situations that participants are avoiding due to trauma-related fear, and dis

Первичные конечные точки

• Clinician Administered PTSD Scale for DSM-5 (CAPS-5) [Срок оценки: Baseline, 1-month, 3-month, 6-months]
• PTSD Checklist for DSM-5 (PCL-5) [Срок оценки: Baseline, 1-month, 3-month, 6-months]

Вторичные конечные точки (4)

• Patient Health Questionnaire (PHQ-9) [Срок оценки: Baseline, 1-month, 3-month, 6-months]
• The Generalized Anxiety Disorder 7-Item (GAD-7) [Срок оценки: Baseline, 1-month, 3-month, 6-months]
• Brief Pain Inventory-Short Form (BPI-SF) [Срок оценки: Baseline, 1-month, 3-month, 6-months]
• Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) [Срок оценки: 1-month, 3-month, 6-months]

Критерии участия

Критерии включения

• Between the ages of 18 and 75 years old.
• Admitted to Baylor University Medical Center at Dallas (BUMC), Baylor Scott \& White Medical Center at Temple (BSWMC), or Froedtert Hospital and the Medical College of Wisconsin (FH/MCW) Level 1 Trauma Center

Критерии исключения

• Patients in police custody
• Patients not fluent in English
• Patients with severe cognitive impairment
• Patients who are acutely suicidal
• Patients with active psychosis

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

Открытое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Baylor University Medical Center — Dallas
• Baylor Scott & White Medical Center - Temple — Temple
• Froedtert & Medical College of Wisconsin — Milwaukee

Идентификаторы

NCT: NCT06210711 · 024-127

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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