Exercise and Emotional Learning in Posttraumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Change in participant subjective emotional ratings
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with PTSD related to interpersonal violence
排除标准
- •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
结局指标
主要结局
Change in participant subjective emotional ratings
时间窗: 24 hours
Participant anxiety will be measured at baseline and after each imagery trial using a 10-point Likert-type scale with higher scores indicative of more subjective anxiety.
Change in Fear Circuit Blood Oxygen Level-Dependent (BOLD) Response
时间窗: 48 hours
Blood Oxygen Level-Dependent (BOLD) imaging will be measured during each imagery trial
Change in Heart Rate
时间窗: 24 hours
Participant heart rate will be measured at baseline and after each imagery trial using a Biopac MP160 system
次要结局
未报告次要终点
研究者
Christal L Badour
Associate Professor
University of Kentucky