SMART-CPT for PTSD/Concussion Implementation

Официальное название

SMART-CPT for PTSD and History of Concussion: A Pragmatic Implementation Trial

Обзор

The clinical implementation trial will evaluate effectiveness and feasibility, acceptability, appropriateness, barriers, and facilitators of implementing SMART-CPT, a treatment targeting the two primary factors leading to poor outcomes following concussion, in Veterans. It will test effectiveness and broad implementation feasibility of SMART-CPT compared to standard Cognitive Processing Therapy (CPT).

Вмешательства

• Поведенческое SMART-CPT
  SMART-CPT T is a psychotherapy that combines Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder (PTSD) and Cognitive Symptom Management and Rehabilitation Training (CogSMART) for neurobehavioral and neurocognitive symptoms to simultaneously target persistent postconcussive symptoms and PTSD
• Поведенческое CPT
  CPT is a cognitive behavioral treatment specifically targeting PTSD and other corollary symptoms following traumatic events (Resick \& Schnicke, 1992). Based on a social cognitive theory of PTSD and trauma, CPT focuses on identifying the content of trauma-related thoughts, examining whether these thoughts are consistent or inconsistent with a patient's prior beliefs about the world, and addressing the impact these thoughts have on emotions and behaviors. Patients are taught to recognize and chal

Первичные конечные точки

• PTSD Checklist (PCL5) [Срок оценки: weekly through treatment completion, an average of 3 months]
• Neurobehavioral Symptom Inventory (NSI) [Срок оценки: weekly through treatment completion, an average of 3 months]
• The Patient Global Impression of Change (PGIC) [Срок оценки: at treatment completion, an average of three months]
• Brief Inventory of Psychosocial Functioning (B-IPF) [Срок оценки: at 3 primary assessment timepoints, week 0, week 12, week 24]
• World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) [Срок оценки: at 3 primary assessment timepoints; week 0, week 12, week 24]
• Traumatic Brain Injury Quality of Life Scale (TBI-QOL) [Срок оценки: at 3 primary assessment timepoints; week 0, week 12, week 24]

Критерии участия

Критерии включения

• PTSD diagnosis;
• mild TBI sustained greater than three months prior to enrollment;
• cognitive complaints;
• not medicated or stable on prescribed psychiatric medication for at least 6 weeks prior to study enrollment with no anticipated/pending medication changes;
• English literacy.

Критерии исключения

• mTBI sustained less than 3 months previously;
• history of moderate, severe, or penetrating TBI;
• history of other significant neurological condition unrelated to TBI;
• severe psychiatric disturbance expected to interfere with successful completion of the study;
• current severe alcohol or other substance use disorder;
• suicidal intent or attempt within the previous month;
• current homicidal ideation;
• impaired decision making capacity;
• prior completion of five or more sessions of CPT or cognitive rehabilitation; -concurrent participation in other intervention studies for PTSD or TBI;
• life threatening or unstable medical illness;
• inability to read;
• dementia

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 · 1 центр

• VA San Diego — San Diego

Идентификаторы

NCT: NCT06995612 · TP220123

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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