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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06330467
Other study ID # 2023-A02442-43
Secondary ID RIPH 2023-02
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date June 30, 2026

Study information

Verified date March 2024
Source Centre Psychothérapique de Nancy
Contact Lori PETROCELLI
Phone +33383852377
Email petrocelli.psy@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators will study the prevalence of dissociative identity disorder (DID) in three populations at risk in cases of childhood psychotrauma : patients with a diagnosis of borderline personality, patients with a diagnosis of functional dissociative crises (FDC) and patients with early psychosis. The investigators will also study the prevalence of other dissociative disorders and the frequency of complex post-traumatic stress disorder. The investigators will also look for correlations between the type of maltreatment in childhood, the age of onset of trauma and the type of diagnosis of dissociative disorders. The investigators hope to include 150 borderline patients, 150 FDC patients and 50 early psychosis patients. Data collection will be done via a psychometric administration of 7 self-completion questionnaires as well as the completion of the SCID-D semi-structured interview.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 350
Est. completion date June 30, 2026
Est. primary completion date March 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility I - Inclusion Criteria: I-1: For all groups: - Male or female - Age > or = 18 - Enrolled in or benefiting from a social security scheme - Patient fluent in French - Patient willing to undergo a psychological evaluation between 1h30 and 3h30 - Patient with a known history of psychotrauma in childhood before the age of 18 (sexual abuse, mistreatment, school harassment, natural disasters, attacks, etc.). - Patient having received and understood complete information on the organization of the research and having given written free and informed consent prior to participation in the study. I-2 : Patients in the borderline group - Patients with main diagnosis of emotionally labile personality - Patients with at least one psychiatric hospitalization in the last 3 years I-3 : Patients in the early psychosis group Patient with a diagnosis of mental state at risk of psychosis according to the criteria defined by CAARMS (Comprehensive Assessment of At Risk Mental State) OR Patients diagnosed with a first psychotic episode on an outpatient basis or following a hospital stay I-4 : Patients in the functional dissociative crises group Patients diagnosed with functional dissociative crises by a specialized epileptologist II- Non-inclusion criteria - Impairment of the subject making it difficult or not impossible to participate in the trial or to understand the information provided to him/her - Patients with specific difficulties in understanding SCID-D questions - Psychiatric condition requiring hospitalization - Patients with symptoms of recent toxic consumption (alcohol, cannabis, other ...) disrupting assessment responses - Patient taking part in a pharmacological study involving a pro-dissociative molecule of the psychedelic type - Pregnant, parturient or nursing mothers - Person deprived of liberty by judicial or administrative decision - Person in a life-threatening emergency - An adult under legal protection (guardianship, curatorship, safeguard of justice) - Person unable to give consent and not subject to a legal protection measure

Study Design


Intervention

Diagnostic Test:
psychometric assessment
Psychometric testing to assess trauma and dissociative disorders, and in particular dissociative identity disorder.
semi-structured clinical interview
Semi-structured interview for the assessment of dissociative disorders (SCID-D : Semi-structured Clinical Interview for diagnosing DSM-5 and ICD-11 Dissociative Disorders)

Locations

Country Name City State
France Centre Psychothérapique de Nancy - CLIP Nancy
France Centre Psychothérapique de Nancy - CMP Jacquard et Des Près Nancy
France CHRU Nancy - Neurology department Nancy

Sponsors (1)

Lead Sponsor Collaborator
Centre Psychothérapique de Nancy

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary SCID-D : Semi-structured Clinical Interview for diagnosing DSM-5 and ICD-11 Dissociative Disorders / DSM = Diagnostic and Statistical Manual of Mental Disorders / ICD = International Classification of Diseases assesses the dissociative identity disorder Inclusion visit
Secondary SCID-D : Semi-structured Clinical Interview for diagnosing DSM-5 and ICD-11 Dissociative Disorders assesses the 4 others domains of dissociative disorders Inclusion visit
Secondary CTQ-28 : Childhood Trauma Questionnaire assesses history of childhood abuse and childhood trauma. For the CTQ-28, the overall score is not really relevant, but rather the scores for each type of abuse. For each type of maltreatment, there are differences in severity, ranging from "none" to "severe", with threshold scores for each level. In fact, there is no real overall minimum or maximum score. Inclusion visit
Secondary life events inventory DSM-5 assesses history of potentially traumatic life events. There is no numerical score, it's simply an inventory of potentially traumatic life events. Inclusion visit
Secondary PCL-5 : Posttraumatic stress disorder CheckList-5 assess the Post Traumatic Stress Disorder. For the PCL-5, the threshold score is 33, so a score of 33 or more suggests the presence of PTSD : the higher the score, the greater the symptomatology. The score is not a value used for interpretation purposes. The investigators use only threshold scores, or diagnostic criteria. Inclusion visit
Secondary ITQ : International Trauma Questionnaire assesses simple and complex post-traumatic stress syndrome. For the ITQ, there is no real numerical score; the diagnosis of PTSD or complex PTSD is made on the basis of the diagnostic criteria met.
Scores are not given with numbers, but only with the presence or absence of simple or complex PTSD. There is no minimum or maximum score.
Inclusion visit
Secondary SDQ-20 : Somatoform Dissociative questionnaire assess somatoform dissociation. For the SDQ-20, the threshold score is 28, and there are no levels of severity: the higher the score, the more severe the somatoform dissociative disorders. However, the score should be treated with caution, as if the symptoms reported by the patient are explained by a medical cause, we cannot conclude that dissociative disorders are present despite the score. Inclusion visit
Secondary DIS-Q : Dissociation Questionnaire assess the dissociative disorders. For the DIS-Q, the threshold score is 2.5. The score is not a value used for interpretation purposes. The investigators use only threshold scores, or diagnostic criteria. Inclusion visit
Secondary DES : Dissociative Experience Scale assess the dissociative disorder. For the DES, there is a threshold score of 15, and the higher the score, the more severe the dissociative disorders, but there are no multiple levels of severity. The score is not a value used for interpretation purposes. The investigators use only threshold scores, or diagnostic criteria. Inclusion visit
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