Veteran's Interdisciplinary Care for Traumatic Brain Injury and Co-Occurring Disorders Rehabilitation Trial

Официальное название

Veteran's Interdisciplinary Care for Traumatic Brain Injury & Co-Occurring Disorders Rehabilitation Trial - A Pragmatic, Randomized, Controlled Clinical Trial

Обзор

The goal of this clinical trial is to learn if the Avalon Action Alliance Interdisciplinary Outpatient Rehabilitation Program (IORP) can reduce long-lasting symptoms of traumatic brain injury (TBI) and co-occurring disorders in veterans and first responders. The main questions it aims to answer are: * Does a 3-week IORP reduce symptoms of long-lasting TBI and co-occurring disorders in military veterans and first responders? * Does the 3-week IORP improve life quality and function in military veterans and first responders? Researchers will compare the Control group to the Invention group to see if a 3-week of IORP reduced symptoms of TBI and co-occurring disorders in military veterans and first responders. Participants will complete the following activities. The items with an asterisk(\*) are not required or available at all sites. * Answer online survey questions about their TBI symptoms, life satisfaction, and life activities * Complete two blood draws\* * Complete two magnetic resonance imaging (MRI) brain scans\*

Вмешательства

• Поведенческое 3-week interdisciplinary outpatient rehab program (IORP)
  Interdisciplinary outpatient rehabilitation program (IORP) for military veterans and first responders experiencing chronic effects of traumatic brain injury (TBI) and co-occurring disorders (e.g., posttraumatic stress disorder, depression, substance use).

Первичные конечные точки

• Mean change in Neurobehavioral Symptom Inventory (NSI) [Срок оценки: Baseline enrollment to 3-month follow-up (post IORP)]

Вторичные конечные точки (3)

• Mean change in Satisfaction with Life Scale (SWLS) [Срок оценки: Baseline enrollment to 3 months post-IORP and 6 months post-IORP]
• Life Satisfaction Questionnaire (LISAT-11) [Срок оценки: Baseline enrollment to 3 months post-IORP and 6 months post-IORP]
• Participation Assessment with Recombined Tools-Objective (PART-O) [Срок оценки: Baseline enrollment to 3 months post-IORP and 6 months post-IORP]

Критерии участия

Критерии включения

• Meets general eligibility requirements for site specific 3-week IORP
• Capable of providing informed consent for IORP and study participation
• English speaking
• 18 to 65 years old

Критерии исключения

• History of TBI of any severity in the past 6 months
• Active substance use disorder that precludes study participation
• Neurologic, psychiatric, or other medical condition that would prohibit full study participation
• Active-duty military service member
• Any other circumstance that, in the opinion of the investigator, would undermine the integrity or success of the project

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

• BRAVE Program — Milwaukee

Идентификаторы

NCT: NCT07463027 · PRO00056712

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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