Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
NCT ID:
NCT07134816
Eligibility Criteria:
Inclusion Criteria:
* Patients with a diagnosis of schizophrenic disorder according to DSM 5 as assessed by the investigating psychiatrist during the screening medical examination
* Age between 15 and 45 years inclusive
* Patients hearing AVHs for at least 3 months
* Patient with a score of at least 2 on the distress intensity item of the hallucinations subscale of the Psychotic Symptom Rating Scale (PSYRATS-AH).
Exclusion Criteria :
* Patients hospitalized full-time for acute decompensation of their schizophrenic disorder
* Patients with a history of severe head trauma and/or neurological pathology with cognitive impact
* Patients with a characterized depressive state (Calgary scale score\>9)
* Patients unable to understand, speak and read French
* Patients with moderate to severe intellectual disability (pre-morbid IQ estimated by fNART\<70)
* Hallucinations of organic or toxic origin
* Suicidal ideation type 4 or 5
* Pregnant and breastfeeding women
* Main diagnosis of substance abuse or dependence, having received full CBT care (minimum 16 hours) for psychotic symptoms in the past year
* Participation in another interventional study in which the patient benefits from psychological intervention
* Patient unable to give written informed consent, for minors, absence of signatures of the legal representative(s), for adults patients benefiting from guardianship, absence of written consent from the guardian, for patients under curatorship, failure to inform the curator, for patients in psychiatric care at the request of a third party, absence of consent from the trusted person
* Not able to carry out all visits and follow the study procedures
* Not affiliated or beneficiary of a social security scheme
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
45 Years
Study:
NCT07134816
Study Brief:
Protocol Section:
NCT07134816