Benefits of Relaxation by Music Therapy on PTSD Symptoms

NCT03990064 | Terminated

• 1 other identifier: 2018-A02182-53
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorder, Post Traumatic

Keywords

effective connectomic neurological soft signs

Outcome Measures

Primary Outcomes (1)

• change in PTSD symptoms

  questionnaire Posttraumatic CheckList 5 (PCL5; threshold =33)

  change from PTSD symptoms at two months and at six months

Secondary Outcomes (4)

• change in neurological soft signs

  change from neurological soft signs at two months and at six months

• change in effective connectomic

  change from effective connectomic at two months and at six months

• Autonomous nervous system regulation

  change from Autonomous nervous system regulation at two months and at six months

• change in biological stress

  change from biological stress at two months and at six months

Study Arms (2)

musicotherapy

EXPERIMENTAL

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

Other: musicotherapy

waiting list

NO INTERVENTION

waiting list

Interventions

musicotherapy OTHER

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

musicotherapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• PTSD

You may not qualify if:

• neurological diseases
• addiction

Sponsors & Collaborators

• Institut de Recherche Biomedicale des Armees: lead

Study Sites (1)

Marion TROUSSELARD

Paris, IDF, 75013, France

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: musicotherapy versus waiting list

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: June 18, 2019
• Study Start: February 1, 2020
• Primary Completion: February 1, 2020
• Study Completion: July 1, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)