Acute Stress Disorder SymptomsSONICUMPNCT07307937
Movement Sonification as an add-on to Immediate Post-event Psychotherapeutic Intervention in the Management of Acute Stress Disorder: a Feasibility and Acceptability Study
A study testing The sonification of movement is an act studied in this research. in people with Acute Stress Disorder Symptoms, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stress Disorder Symptoms
- What is being tested?
- The sonification of movement is an act studied in this research.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Substance use disorder (excluding tobacco)
- Pregnant or breastfeeding women
- Participation in another interventional study on ESA
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Avicenne
Bobigny, 93000
Vladimir Adrien, +33 1 48 95 59 37, vladimir.adrien@aphp.fr
Nicolas BOSC
About this study
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
Read the 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.
- Conditions
- Acute Stress Disorder Symptoms
- Being tested
- The sonification of movement is an act studied in this research.
- Keywords
- post-traumatic stress disorder, potentially traumatic events, transforming the patient's movement into sound information
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The sonification of movement is an act studied in this research.Device
The sonification of movement is an act studied in this research at visit 1, visit 2 and visit 3
| Study group | Role | What they receive |
|---|---|---|
| Sonification | Experimental | The sonification of movement is an act studied in this research. Receives: Device: The sonification of movement is an act studied in this research. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the feasibility of movement sonification in association with IPPI in the treatment of ESA.
Success rate, defined as an individual adherence rate of at least two sessions completed with movement sonification out of the three sessions planned.
Measured: 6 weeks
Secondary outcomes (13)
Dissociative symptoms
- 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.
Measured: 6 weeks
Dissociative symptoms
- 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.
Measured: 6 weeks
Agency (sense of control over the external environment)
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.
Measured: 6 weeks
The overall clinical response
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.
Measured: 6 weeks
The overall clinical response
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.
Measured: 6 weeks
Overall functioning
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.
Measured: 6 weeks
Symptoms associated with ESA in patients with initial symptoms of traumatic dissociation, compared to those without
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.
Measured: 6 weeks
Symptoms associated with ESA in patients with initial symptoms of traumatic dissociation, compared to those without
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.
Measured: 6 weeks
Symptoms associated with ESA in patients with initial symptoms of traumatic dissociation, compared to those without
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.
Measured: 6 weeks
Symptoms associated with ESA in patients with initial symptoms of traumatic dissociation, compared to those without
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.
Measured: 6 weeks
Symptoms associated with ESA in patients with initial symptoms of traumatic dissociation, compared to those without
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.
Measured: 6 weeks
Symptoms associated with ESA in patients with initial symptoms of traumatic dissociation, compared to those without
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.
Measured: 6 weeks
Evaluate the experience and acceptability of patients and caregivers (qualitative analysis).
The evaluation of the experience and acceptability will be carried out using a semi-structured interview with the patient at Visit 4
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start15 Jan 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Stress Disorder SymptomsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307937
- Sponsor's protocol ID
- APHP241593
- Acronym
- SONICUMP
- Status last verified
- Sep 2025
- First submitted
- 20 Aug 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Movement Sonification as an add-on to Immediate Post-event Psychotherapeutic Intervention in the Management of Acute Stress Disorder: a Feasibility and Acceptability Study
- ClinicalTrials.gov ID
- NCT07307937
- Acronym / sponsor ID
- SONICUMP / APHP241593
- Conditions
- Acute Stress Disorder Symptoms
- Keywords
- post-traumatic stress disorder, potentially traumatic events, transforming the patient's movement into sound information
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sonification | Experimental | Device: The sonification of movement is an act studied in this research.The sonification of movement is an act studied in this research. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Sonification |
Primary outcome
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.
13 secondary outcomes
Dissociative symptoms
Time frame: 6 weeks
Dissociative symptoms
Time frame: 6 weeks
Agency (sense of control over the external environment)
Time frame: 6 weeks
The overall clinical response
Time frame: 6 weeks
The overall clinical response
Time frame: 6 weeks
Overall functioning
Time frame: 6 weeks
Symptoms associated with ESA in patients with initial symptoms of traumatic dissociation, compared to those without
Time frame: 6 weeks
Symptoms associated with ESA in patients with initial symptoms of traumatic dissociation, compared to those without
Time frame: 6 weeks
Symptoms associated with ESA in patients with initial symptoms of traumatic dissociation, compared to those without
Time frame: 6 weeks
Symptoms associated with ESA in patients with initial symptoms of traumatic dissociation, compared to those without
Time frame: 6 weeks
Symptoms associated with ESA in patients with initial symptoms of traumatic dissociation, compared to those without
Time frame: 6 weeks
Symptoms associated with ESA in patients with initial symptoms of traumatic dissociation, compared to those without
Time frame: 6 weeks
Evaluate the experience and acceptability of patients and caregivers (qualitative analysis).
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The sonification of movement is an act studied in this research. in people with Acute Stress Disorder Symptoms, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas BOSC (+33 1 48 95 53 74, nicolas.bosc@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the feasibility of movement sonification in association with IPPI in the treatment of ESA. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.