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

Primary Purpose

Stress Disorder, Post Traumatic

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
musicotherapy
Sponsored by
Institut de Recherche Biomedicale des Armees
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stress Disorder, Post Traumatic focused on measuring effective connectomic neurological soft signs

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • PTSD

Exclusion Criteria:

  • neurological diseases
  • addiction

Sites / Locations

  • Marion TROUSSELARD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

musicotherapy

waiting list

Arm Description

daily sessions of music listening during 2 months, associated with their standard treatment,

waiting list

Outcomes

Primary Outcome Measures

change in PTSD symptoms
questionnaire Posttraumatic CheckList 5 (PCL5; threshold =33)

Secondary Outcome Measures

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

Full Information

First Posted
May 8, 2019
Last Updated
August 2, 2022
Sponsor
Institut de Recherche Biomedicale des Armees
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1. Study Identification

Unique Protocol Identification Number
NCT03990064
Brief Title
Benefits of Relaxation by Music Therapy on PTSD Symptoms
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
not enough patients
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut de Recherche Biomedicale des Armees

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorder, Post Traumatic
Keywords
effective connectomic neurological soft signs

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
musicotherapy versus waiting list
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
musicotherapy
Arm Type
Experimental
Arm Description
daily sessions of music listening during 2 months, associated with their standard treatment,
Arm Title
waiting list
Arm Type
No Intervention
Arm Description
waiting list
Intervention Type
Other
Intervention Name(s)
musicotherapy
Intervention Description
receptive music therapy. The musical style of the session was chosen by the patient. The validated 'U' technique was employed.
Primary Outcome Measure Information:
Title
change in PTSD symptoms
Description
questionnaire Posttraumatic CheckList 5 (PCL5; threshold =33)
Time Frame
change from PTSD symptoms at two months and at six months
Secondary Outcome Measure Information:
Title
change in neurological soft signs
Description
questionnaire EPSID " Psychomotor assessment scale of neurological soft signs no threshold
Time Frame
change from neurological soft signs at two months and at six months
Title
change in effective connectomic
Description
Magnetic Resonance Imaging
Time Frame
change from effective connectomic at two months and at six months
Title
Autonomous nervous system regulation
Description
heart rate variability during 5 min at rest
Time Frame
change from Autonomous nervous system regulation at two months and at six months
Title
change in biological stress
Description
blood cytokines, BDNF
Time Frame
change from biological stress at two months and at six months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: PTSD Exclusion Criteria: neurological diseases addiction
Facility Information:
Facility Name
Marion TROUSSELARD
City
Paris
State/Province
IDF
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Benefits of Relaxation by Music Therapy on PTSD Symptoms

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