Status:
NOT_YET_RECRUITING
Cost-utility Study of Cognitive-behavioral Management of Auditory Hallucinations in Schizophrenic Disorder
Lead Sponsor:
University Hospital, Montpellier
Collaborating Sponsors:
Assistance Publique Hopitaux De Marseille
Centre Hospitalier Universitaire de Nîmes
Conditions:
Auditory Hallucinations
Schizophrenia Spectrum
Eligibility:
All Genders
15-45 years
Phase:
NA
Brief Summary
The aim of the study is to assess the effectiveness and costs of a cognitive-behavioral treatment (CBT) for auditory hallucinations (psychotherapy) as an adjunct to usual care, comparing it to the eff...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT07134816
Start Date
August 1 2025
End Date
March 1 2028
Last Update
August 21 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital, Montpellier
Montpellier, Occitanie, France, 34000