Benefits of Relaxation by Music Therapy on PTSD Symptoms

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Exploration of Cerebral Metabolism and Connectivity in Post Traumatic Stress Disorder (PTSD): Exploratory Study of Neurofunctional Modulation of Emotions by Music Therapy

Conditions
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Stress Disorder, Post Traumatic

Intervention / Treatment
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* Other: musicotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PTSD Exclusion Criteria: neurological diseases addiction
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: musicotherapy versus waiting list
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: musicotherapy<br>daily sessions of music listening during 2 months, associated with their standard treatment, | Other: musicotherapy<br>* receptive music therapy. The musical style of the session was chosen by the patient. The validated 'U' technique was employed.<br>|
| No Intervention: waiting list<br>waiting list | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in PTSD symptoms | questionnaire Posttraumatic CheckList 5 (PCL5; threshold =33) | change from PTSD symptoms at two months and at six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in neurological soft signs | questionnaire EPSID  Psychomotor assessment scale of neurological soft signs no threshold | change from neurological soft signs at two months and at six months | 
| change in effective connectomic | Magnetic Resonance Imaging | change from effective connectomic at two months and at six months | 
| Autonomous nervous system regulation | heart rate variability during 5 min at rest | change from Autonomous nervous system regulation at two months and at six months | 
| change in biological stress | blood cytokines, BDNF | change from biological stress at two months and at six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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effective connectomic neurological soft signs