Benefits of Relaxation by Music Therapy on PTSD Symptoms

Not Applicable

Terminated

• Conditions: Stress Disorder, Post Traumatic
• Interventions: Other: musicotherapy

• Registration Number: NCT03990064
• Lead Sponsor: Institut de Recherche Biomedicale des Armees

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2019-05-08
• Study First Submitted QC: 2019-06-15
• Study First Posted: 2019-06-18
• Study Start: 2020-02-01
• Primary Completion: 2020-02-01
• Study Completion: 2022-07-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• PTSD

Exclusion Criteria

• neurological diseases
• addiction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
musicotherapy	musicotherapy	daily sessions of music listening during 2 months, associated with their standard treatment,

Primary Outcome Measures

Name	Time	Method
change in PTSD symptoms	change from PTSD symptoms at two months and at six months	questionnaire Posttraumatic CheckList 5 (PCL5; threshold =33)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Marion TROUSSELARD; 🇫🇷 Paris, IDF, France