Maximizing Treatment Outcome and Examining Sleep in Post-traumatic Stress Disorder (PTSD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- PTSD Symptoms
研究概览
简要总结
The purpose of this study is to examine the efficacy of exercise in comparison to wellness education to determine if they can improve the effects of prolonged exposure therapy (PE) in reducing symptoms of anxiety associated with Post-traumatic Stress Disorder (PTSD). In addition, the two strategies (i.e., exercise and wellness education) will be compared in terms of improvements in sleep as well as levels of brain-derived neurotrophic factor (BDNF). BDNF is a protein that helps to support the survival of existing neurons and stimulate the growth new neurons and synapses. BDNF is important to learning and memory in general and therefore may be associated with the learning and memory as it relates to PE and corresponding symptom PTSD improvement.
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 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •You have PTSD
- •You are between the age of 18 and 54 if female or between ages 18 and 44 if male.
- •You have written physician approval/medical clearance to participate in an exercise protocol.
- •Are currently taking no psychotropic medications or are able and willing to discontinue these medications prior to the first PE session.
排除标准
- •You are currently participating in a structured exercise program
- •You have severe depression
- •You have any history of bipolar disorder, psychotic disorder, or obsessive compulsive disorder;
- •You have a diagnosis of eating disorder, or substance abuse or dependence (excluding nicotine) within the past six months
- •You have any history of a suicide attempt, or are at significant risk of self-harm or harm to others
- •You have ever been diagnosed with organic brain syndrome, mental retardation, or other cognitive dysfunction
研究组 & 干预措施
Prolonged Exposure + Wellness Intervention
干预措施: Prolonged Exposure (Behavioral)
Prolonged Exposure + Wellness Intervention
干预措施: Wellness Intervention (Behavioral)
Prolonged Exposure + Exercise
干预措施: Prolonged Exposure (Behavioral)
Prolonged Exposure + Exercise
干预措施: Exercise (Behavioral)
结局指标
主要结局
PTSD Symptoms
时间窗: 3 months
Self-report measure that assesses PTSD Symptoms. Will be assessed at each visit throughout the 3 month protocol.
次要结局
- BDNF (by blood sample)(3 months)
- Sleep Quality(3 months)
- General Mood and Anxiety Symptoms(3 months)
研究者
Jasper Smits, Ph.D.
Principal Investigator
Southern Methodist University