Benefits of Relaxation by Music Therapy on PTSD Symptoms

NCT03990064 — Not applicable, Terminated, 15 participants, Institut de Recherche Biomedicale des Armees

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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

Registry	NCT03990064, acronym TRACER
Status	Terminated - not enough patients
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, supportive care
Enrollment	15 (Actual)
Sponsor	Institut de Recherche Biomedicale des Armees (Other gov)
Conditions	Stress Disorder, Post Traumatic
Interventions	musicotherapy (Other)
Dates	start 2020-02-01, primary completion 2020-02-01, completion 2022-07-01, first posted 2019-06-18, last updated 2022-08-04
Locations	1 site in France

-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.

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+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

+Arms and interventions

Arm	Type	Interventions	Description
musicotherapy	Experimental	Other: musicotherapy	daily sessions of music listening during 2 months, associated with their standard treatment,
waiting list	No intervention		waiting list

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

+Outcome measures

Primary outcomes

change in PTSD symptoms [change from PTSD symptoms at two months and at six months]: questionnaire Posttraumatic CheckList 5 (PCL5; threshold =33)

Secondary outcomes

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

+Eligibility

Sex: All, accepts healthy volunteers

Inclusion Criteria:

* PTSD

Exclusion Criteria:

* neurological diseases
* addiction

+Locations (1)

Facility	City	Country	Status
Marion TROUSSELARD	Paris, IDF	France