Movement Sonification as an add-on to Immediate Post-event Psychotherapeutic Intervention in the Management of Acute Stress Disorder: a Feasibility and Acceptability Study (SONICUMP)

December 19, 2025 updated by: Assistance Publique - Hôpitaux de Paris
Natural disasters, conflicts, persecution, population displacement, often traumatic migration experiences, and terrorist attacks are all factors that currently expose a significant proportion of the world's population to potentially traumatic events (PTEs). When a person is exposed to a PTE, symptoms of acute stress disorder (ASD) may occur in the immediate aftermath of the PTB, i.e., within the month following the event. These symptoms are dominated by dissociation, which includes depersonalization, i.e., the feeling of being disconnected from one's body. Managing these symptoms can prevent the subsequent onset of post-traumatic stress disorder (PTSD), a serious illness and public health concern. The recommended treatment combines an immediate post-event psychotherapeutic intervention (IPPI) and, where appropriate, medication with anxiolytics from the antihistamine class or antipsychotics

Study Overview

Detailed Description

In France, IPPI is carried out by the medical-psychological emergency units (CUMP) in each department. Patients are referred to these units by the CUMPs themselves when they are called out by the SAMU (emergency medical service) to the scene of mass accidents (attacks, fires, suicides in public places, etc.), or by departmental doctors and medico-legal emergency services for individual EPTs (sexual or physical assault, etc.). In Seine-Saint-Denis, the CUMP 93 receives 60 to 100 patients per year in the immediate post-traumatic phase.

The purpose of IPPI is to reconnect the traumatic experience with known representations. These interventions have demonstrated effectiveness,although their preventive impact on PTSD remains limited. Movement sonification is an augmented auditory reality technique that transforms a patient's movements into sound through connected wristbands and a speaker system. By enriching bodily perception, this technique may enhance the efficacy of trauma-focused psychotherapies.

This study aims to assess the acceptability and feasibility of using movement sonification in combination with IPPI for the treatment of ASD. It thereby addresses an urgent need for primary prevention of PTSD.

Study Type

Interventional

Enrollment (Estimated)

30

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 Contact

Study Contact Backup

Study Locations

      • Bobigny, France, 93000
        • Hôpital Avicenne
        • Contact:
        • Principal Investigator:
          • Nicolas BOSC

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 18 and over
  • Who have experienced a potentially traumatic event (PTE) other than the death of a loved one
  • Who have been referred to the medical-psychological emergency unit (CUMP 93) within one month of the PTE
  • Who are experiencing acute stress disorder (ASD) according to DSM-5 criteria
  • Have health insurance
  • Have signed a written informed consent form

Exclusion Criteria:

  • Severe motor impairment rendering the use of sonification technology impractical
  • Deaf, mute, or hearing-impaired patients
  • Adults under guardianship or conservatorship, under judicial protection, or deprived of liberty
  • Suffering from chronic psychotic disorder or bipolar disorder
  • Central neurological disease defined by a medical report (including brain damage, cortical or subcortical atrophy, dementia, stroke, transient ischemic attack, head trauma, epilepsy, or seizure)
  • Presenting a proven severe risk of suicide
  • Substance use disorder (excluding tobacco)
  • Pregnant or breastfeeding women
  • Participation in another interventional study on ESA

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sonification
The sonification of movement is an act studied in this research.
The sonification of movement is an act studied in this research at visit 1, visit 2 and visit 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the feasibility of movement sonification in association with IPPI in the treatment of ESA.
Time Frame: 6 weeks
Success rate, defined as an individual adherence rate of at least two sessions completed with movement sonification out of the three sessions planned.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dissociative symptoms
Time Frame: 6 weeks

1) Change in the severity of dissociative symptoms assessed by:

1a) • Clinician-Administered Dissociative States Scale from V1 to V4. A high score on the Clinician-Administered Dissociative States Scale (range 0 to 92) indicates a more severe degree of dissociative symptoms.

6 weeks
Dissociative symptoms
Time Frame: 6 weeks

1) Change in the severity of dissociative symptoms assessed by:

1b)• Multidimensional Assessment of Interoceptive Awareness-2 at V1 and V4. A high score on the Multidimensional Assessment of Interoceptive Awareness-2 (range 0 to 160) reflects more developed interoceptive awareness, with an increased ability to recognize and respond adaptively to bodily sensations.

6 weeks
Agency (sense of control over the external environment)
Time Frame: 6 weeks
Changes in agency assessed by the Fribourg Sense of Agency Scale from V1 to V4. A high score on the Fribourg Sense of Agency Scale (range 13 to 91) is associated with an increased perception of personal control and a stronger integration of conscious action with personal responsibility.
6 weeks
The overall clinical response
Time Frame: 6 weeks
Change in clinical impression assessed by the Clinical Global Impression-Severity from V1 to V4. The scale ranges from 1 to 7, where a low value indicates no symptoms and 7 indicates a terminal stage disorder.
6 weeks
The overall clinical response
Time Frame: 6 weeks
Change in clinical impression assessed by Clinical Global Impression-Improvement from V2 to V4. The scale ranges from 1 to 7, where a low value represents significant improvement and 7 indicates considerable deterioration.
6 weeks
Overall functioning
Time Frame: 6 weeks

Change in overall functioning assessed by the Global Assessment of Functioning from Visit 1 to Visit 4.

The Global Assessment of Functioning, scale is used to rate how serious a mental illness may be. It measures how much a person's symptoms affect their day-to-day life on a scale of 0 to 100.A high score on the Global Assessment of Functioning suggests very good or near-normal overall functioning.

6 weeks
Symptoms associated with ESA in patients with initial symptoms of traumatic dissociation, compared to those without
Time Frame: 6 weeks
Comparison of changes in scale between patients according to the level of dissociation assessed by the Clinician-Administered Dissociative States Scale. A high score on the Clinician-Administered Dissociative States Scale (range 0 to 92) indicates a more severe degree of dissociative symptoms.
6 weeks
Symptoms associated with ESA in patients with initial symptoms of traumatic dissociation, compared to those without
Time Frame: 6 weeks
Comparison of changes in scale between patients according to the level of dissociation assessed by the Multidimensional Assessment of Interoceptive Awareness 2. A high score on the Multidimensional Assessment of Interoceptive Awareness 2 (range 0 to 160) reflects more developed interoceptive awareness, with an increased ability to recognize and respond adaptively to bodily sensations.
6 weeks
Symptoms associated with ESA in patients with initial symptoms of traumatic dissociation, compared to those without
Time Frame: 6 weeks
Comparison of changes in scale between patients according to the level of dissociation assessed by Fribourg Sense of Agency Scale. A high score on the Fribourg Sense of Agency Scale (range 13 to 91) is associated with an increased perception of personal control and a stronger integration of conscious action with personal responsibility.
6 weeks
Symptoms associated with ESA in patients with initial symptoms of traumatic dissociation, compared to those without
Time Frame: 6 weeks
Comparison of changes in scale between patients according to the level of dissociation assessed by the Global Impression-Severity. The scale ranges from 1 to 7, where a low value indicates no symptoms, and 7 indicates a terminal condition.
6 weeks
Symptoms associated with ESA in patients with initial symptoms of traumatic dissociation, compared to those without
Time Frame: 6 weeks
Comparison of changes in scale between patients according to the level of dissociation assessed by the Clinical Global Impression-Improvement. The scale ranges from 1 to 7, where a low value represents a significant improvement, and 7 indicates a considerable deterioration.
6 weeks
Symptoms associated with ESA in patients with initial symptoms of traumatic dissociation, compared to those without
Time Frame: 6 weeks
Comparison of changes in scale between patients according to the level of dissociation assessed by the Global Assessment Functioning. A high Global Assessment of Functioning score (range from 0 to 100) suggests very good or near-normal overall functioning.
6 weeks
Evaluate the experience and acceptability of patients and caregivers (qualitative analysis).
Time Frame: 6 weeks
The evaluation of the experience and acceptability will be carried out using a semi-structured interview with the patient at Visit 4
6 weeks

Collaborators and Investigators

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

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 (Estimated)

January 15, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

August 20, 2025

First Submitted That Met QC Criteria

December 19, 2025

First Posted (Actual)

December 29, 2025

Study Record Updates

Last Update Posted (Actual)

December 29, 2025

Last Update Submitted That Met QC Criteria

December 19, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

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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