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NCT07093671
Mentalization Based Treatment (MBT) in Help Seeking Youths With a Clinical High-Risk Condition for Psychosis (CHR-P)
Conditions: Psychosis
Sex: All
Ages: 14 Years – 30 Years
Healthy volunteers: No
Phase: NA
Enrollment: 212
Sponsor: Marco Armando
Location: CHUV Lausanne
Summary
The primary objective of this study is to evaluate the efficacy of Mentalization-Based Treatment (MBT) combined with Need-Based Clinical Interventions (NBCI) compared to NBCI alone, on CHR-P diagnostic statuses and symptom expression (Hypothesis 1). Specifically, the investigator will assess diagnostic outcomes using a 3-level variable: transition to psychosis, CHR-P status quo, and remission out of CHR-P, as well as CHR-P symptom expression. The investigator hypothesize that: (1a) the experimental treatment (MBT + NBCI) will have a significant effect on diagnostic status (i.e. transition to psychosis) at the end of treatment and follow-up; (1b) the experimental treatment (MBT + NBCI) will significantly reduce the severity of psychotic symptoms at the end of treatment and follow-up.
Eligibility Criteria
Inclusion Criteria:
* Patients aged 14-30 years with a CHR-P condition, as defined by the SIPS criteria
* Patients who provide informed consent
Exclusion Criteria:
* Patients with a prior diagnosis of a psychotic disorder
* Intellectual disability (IQ \< 70).
* Patients whose psychotic symptoms are primarily induced by substance misuse.
* Patients with significant language barriers
* Parents/legal authority who do not provide informed consent (only minors)
* Adult patient under guardianship
Note: Comorbidities with other psychiatric disorders (e.g., Autism Spectrum Disorder, Personality Disorders) will not constitute an exclusion criterion.
Source: ClinicalTrials.gov (NCT07093671). StuddyBuddy aggregates publicly available trial information.