Benefits of Relaxation by Music Therapy on PTSD Symptoms

Stress Disorder, Post Traumatic Clinical Trial

— TRACER  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03990064
• Other study ID #: 2018-A02182-53
• Status: Terminated
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: August 2022
• Source: Institut de Recherche Biomedicale des Armees
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: July 1, 2022
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• PTSD

Exclusion Criteria:

• neurological diseases

• addiction

Related Conditions & MeSH terms

• Stress Disorder, Post Traumatic
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• musicotherapy
receptive music therapy. The musical style of the session was chosen by the patient. The validated 'U' technique was employed.

Locations

Country	Name	City	State
France	Marion TROUSSELARD	Paris	IDF

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Recherche Biomedicale des Armees

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in PTSD symptoms	questionnaire Posttraumatic CheckList 5 (PCL5; threshold =33)	change from PTSD symptoms at two months and at six months
Secondary	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
Secondary	change in effective connectomic	Magnetic Resonance Imaging	change from effective connectomic at two months and at six months
Secondary	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
Secondary	change in biological stress	blood cytokines, BDNF	change from biological stress at two months and at six months