Exploration of Cerebral Metabolism and Connectivity in Post Traumatic Stress Disorder (PTSD): Exploratory Study of Neurofunctional Modulation of Emotions by Music Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- change in PTSD symptoms
研究概览
简要总结
PTSD is a debilitating mental disorder that may develop after experiencing or witnessing a life-threatening event. With appropriate care, treatment efficiency is variable and around 20% of the patients do not respond to psychological treatment. Complementary treatments are needed.
as PTSD implied autonomic nervous system (ANS) dysfonction, complementary treatment focusing on ANS regulation, as welle as musicotherapy, may have an interest.
详细描述
The aim is to evaluate the impact of musicotherapy on PTSD symptoms, and severity using a RCT Symptoms will be evaluated using questionaires (PCL and quality of life) severity will be measured using neurological soft signs assessment, connectomic functions and ANS regulation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •neurological diseases
- •addiction
结局指标
主要结局
change in PTSD symptoms
时间窗: change from PTSD symptoms at two months and at six months
questionnaire Posttraumatic CheckList 5 (PCL5; threshold =33)
次要结局
- change in neurological soft signs(change from neurological soft signs at two months and at six months)
- change in effective connectomic(change from effective connectomic at two months and at six months)
- Autonomous nervous system regulation(change from Autonomous nervous system regulation at two months and at six months)
- change in biological stress(change from biological stress at two months and at six months)
研究者
Marion Trousselard
principal investigator
Institut de Recherche Biomedicale des Armees