Benefits of Relaxation by Music Therapy on PTSD Symptoms (TRACER)

August 2, 2022 updated by: Marion Trousselard, Institut de Recherche Biomedicale des Armees

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • IDF
      • Paris, IDF, France, 75013
        • Marion Trousselard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • PTSD

Exclusion Criteria:

  • neurological diseases
  • addiction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in PTSD symptoms
Time Frame: change from PTSD symptoms at two months and at six months
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
Time Frame: change from neurological soft signs at two months and at six months
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
Time Frame: change from effective connectomic at two months and at six months
Magnetic Resonance Imaging
change from effective connectomic at two months and at six months
Autonomous nervous system regulation
Time Frame: change from Autonomous nervous system regulation at two months and at six months
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
Time Frame: change from biological stress at two months and at six months
blood cytokines, BDNF
change from biological stress at two months and at six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Recherche Biomedicale des Armees

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

February 1, 2020

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

May 8, 2019

First Submitted That Met QC Criteria

June 15, 2019

First Posted (Actual)

June 18, 2019

Study Record Updates

Last Update Posted (Actual)

August 4, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-A02182-53

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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