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Набор скоро начнётся NCT06620900

Expanding Access to mTBI Treatment for Veterans and Service Members With Co-occurring Substance Use

Без фазы С лечением Concussion, Mild Traumatic Brain Injury Brain Injury Traumatic Brain Injury Substance Use

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: Integrated Model of Care.
Кому может быть актуально
Состояния в реестре: Concussion, Mild Traumatic Brain Injury, Brain Injury, Traumatic Brain Injury, Substance Use. 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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Обзор

The purpose of this research is to determine whether military veterans and service members with mild traumatic brain injury with and without co-occurring substance use can complete and benefit from integrated interdisciplinary care individualized to their symptoms, goals, and needs. Participants will complete surveys about substance use and other symptoms at the beginning and end of treatment in an intensive outpatient program and 6 months after discharge.

Подробное описание

This pragmatic clinical trial will (1) assess treatment retention and treatment outcomes at the completion of interdisciplinary intensive outpatient program (IOP) and at a 6-month follow-up comparing service members and veterans (SM/Vs) with mild traumatic brain injury (mTBI) + substance use (SU) and a TBI -control group; and (2) assess SU-related outcomes at the end of IOP treatment and durability of SU outcomes at 6-months follow-up among SM/Vs with co-occurring SU. Analyses of these key treatment outcomes along with input from lived experience consultants and other key stakeholders, will be used to refine and disseminate a scalable approach to treating individuals with mTBI and co-occurring SU.

Вмешательства

  • Другое Integrated Model of Care
    The Integrated Model of Care was developed and piloted by the study team provide support for individuals seeking care in an interdisciplinary intensive outpatient program for mild traumatic brain injury to receive support for co-occurring substance use-related needs.

Первичные конечные точки

  • Neurobehavioral Symptom Inventory (NSI) [Срок оценки: Study enrollment, immediately after the intervention, and at 6 months follow-up]
  • Short Inventory of Problems- Revised (SIP-R) [Срок оценки: Study enrollment, immediately after the intervention, and at 6 months follow-up]
Вторичные конечные точки (11)
  • Life-Satisfaction Questionnaire -11 (LISAT-11) [Срок оценки: Study enrollment, immediately after the intervention, and at 6 months follow-up]
  • Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) [Срок оценки: Study enrollment, immediately after the intervention, and at 6 months follow-up]
  • Patient Health Questionnaire (PHQ-8) [Срок оценки: Study enrollment, immediately after the intervention, and at 6 months follow-up]
  • Generalized Anxiety Disorder Scale (GAD-7) [Срок оценки: Study enrollment, immediately after the intervention, and at 6 months follow-up]
  • Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS Update) [Срок оценки: Study enrollment and immediately after the intervention]
  • Sensory Organization Test (SOT) [Срок оценки: Study enrollment and immediately after the intervention]
  • Behavior Rating Inventory of Executive Functioning - Adult Version (BRIEF-A) [Срок оценки: Study enrollment and immediately after the intervention]
  • Alcohol Use Disorders Identification Test- Concise (AUDIT-C) [Срок оценки: Study enrollment and at 6 months follow-up]
  • Drug Abuse Screening Test (DAST-10) [Срок оценки: Study enrollment and at 6 months follow-up]
  • Cannabis Use Disorder Identification Test (CUDIT-R) [Срок оценки: Study enrollment and at 6 months follow-up]
  • National Survey on Drug Use and Health (NSDUH)- 30-day use: Alcohol and Substances [Срок оценки: Study enrollment, immediately after the intervention, and at 6 months follow-up]

Критерии участия

Критерии включения

  • At least 18 years of age
  • US military service member or veteran
  • Diagnosis of mild traumatic brain injury (mTBI) and/or repetitive head impact/blast exposures
  • Participating in the SHARE Military Initiative intensive outpatient program

Критерии исключения

  • History of brain injury other than mTBI or progressive neurological disorder
  • Active psychosis
  • Not able to provide consent

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
  • Shepherd Center — Atlanta

Публикации

  • Wallace TD, McCauley KL, Hodge AT, Moran TP, Porter ST, Whaley MC, Gore RK. Use of person-centered goals to direct interdisciplinary care for military service members and Veterans with chronic mTBI and co-occurring psychological conditions. Front Neurol. 2022 Nov 16;13:1015591. doi: 10.3389/fneur.2022.1015591. eCollection 2022. PMID 36523344

Идентификаторы

NCT: NCT06620900 · 2156344 · TP230246

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗