Exercise and Emotional Learning in Posttraumatic Stress Disorder

Обзор

The goal of this clinical trial is to test how exercise affects learning and memory processes relevant to the treatment of PTSD. Participants will complete a baseline intake followed by two experimental sessions. During the first experimental session, participants will undergo an MRI session of imaginal exposure to traumatic memory cues followed by 30-minutes of moderate intensity exercise or low intensity exercise. Participants will complete a second session of imaginal exposure with MRI 24 hours later.

Подробное описание

The proposed project would build on our published pilot data and animal models to demonstrate that moderate intensity physical exercise delivered after exposure therapy engages fear circuitry and enhances the consolidation of therapeutic safety learning, thereby enabling enhanced symptom reduction for PTSD. Adults with PTSD related to interpersonal violence (IPV) exposure would complete an initial session of imaginal exposure to traumatic memory cues adapted for an MRI setting. This would be followed by 30-mins of moderate intensity exercise or low intensity exercise control. Participants would return 24-hrs later to complete a second session of imaginal exposure with MRI.

Вмешательства

• Поведенческое Moderate Intensity Exercise
  Participants will wear a heartrate monitor and cycle on a stationary bike at a slow speed for 5 minutes, then slowly cycle on a stationary bike for 30 minutes, then cycle on the stationary bike at a slow speed for 5 minutes.
• Поведенческое Low Intensity Exercise
  Participants will wear a heartrate monitor and cycle on a stationary bike at a slow speed for 40 minutes.

Первичные конечные точки

• Change in participant subjective emotional ratings [Срок оценки: 24 hours]
• Change in Heart Rate [Срок оценки: 24 hours]
• Change in Fear Circuit Blood Oxygen Level-Dependent (BOLD) Response [Срок оценки: 48 hours]

Критерии участия

Критерии включения

• Adults with PTSD related to interpersonal violence

Критерии исключения

• Active or recent (within the last 3 months) severe substance use disorder(s)
• Active or recent (within the last 3 months) suicidal, psychotic, or manic symptoms/ episodes
• Significant developmental disabilities
• Current daily benzodiazepine or stimulant use with inability to abstain for study sessions
• Recent changes in psychiatric medication or trauma focused cognitive-behavioral therapy (CBT) (past 4-weeks)
• Medical condition(s) that prohibit exercise
• History of traumatic brain injury (TBI) with loss of consciousness > 30 mins
• Magnetic resonance imaging (MRI) contraindication(s)
• Positive pregnancy test
• History of seizure disorder
• Spontaneous seizure(s) within the last 3 months

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 · 2 центра

• University of Kentucky — Lexington
• University of Texas — Austin

Идентификаторы

NCT: NCT06127342 · 90369 · R61MH132722

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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