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TerminatedNCT03990064TRACERUpdated Aug 4, 2022

Benefits of Relaxation by Music Therapy on PTSD Symptoms

An interventional study of musicotherapy in Stress Disorder, Post Traumatic, sponsored by Institut de Recherche Biomedicale des Armees. Terminated at 1 site in France. Per ClinicalTrials.gov, last updated 2022-08-04.

Sponsored by Institut de Recherche Biomedicale des Armees · Not applicable, Interventional, and Supportive care

Why this study was terminated
not enough patients
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Stress Disorder, Post Traumatic

Keywords

  • effective connectomic neurological soft signs
03

In context

Stress Disorders, Post-Traumatic

2,284 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 557 are open to participants now.

This study's enrollment of 15 is below the median of 70 across 1,897 interventional studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

Institut de Recherche Biomedicale des Armees is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • PTSD

Exclusion criteria

Exclusion Criteria:

  • neurological diseases
  • addiction
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    musicotherapy

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

    Other: musicotherapy

  • No intervention
    waiting list

    waiting list

Interventions

  • Othermusicotherapy

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

06

What researchers measure

Primary outcomes

  1. change in PTSD symptoms

    questionnaire Posttraumatic CheckList 5 (PCL5; threshold =33)

    Time frame: change from PTSD symptoms at two months and at six months

Secondary outcomes

  1. change in neurological soft signs

    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

  2. change in effective connectomic

    Magnetic Resonance Imaging

    Time frame: change from effective connectomic at two months and at six months

  3. Autonomous nervous system regulation

    heart rate variability during 5 min at rest

    Time frame: change from Autonomous nervous system regulation at two months and at six months

  4. change in biological stress

    blood cytokines, BDNF

    Time frame: change from biological stress at two months and at six months

07

Study locations

1 site
  • Marion TROUSSELARD
    Paris, IDF 75013, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03990064
Lead sponsor
Institut de Recherche Biomedicale des Armees
Responsible party
Marion Trousselard (principal investigator, Institut de Recherche Biomedicale des Armees) — Principal investigator
First posted
Jun 18, 2019
Start date
Feb 1, 2020
Primary completion
Feb 1, 2020
Completion
Jul 1, 2022
Last update
Aug 4, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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