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

N/ANot Yet RecruitingNCT07307937

Assistance Publique - Hôpitaux de Paris30 enrolled

Overview

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

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

Allocation

Purpose

PREVENTION

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 6 weeks

Secondary Outcomes

Dissociative symptoms

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.

Time frame: 6 weeks

Dissociative symptoms

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 6 weeks