NCT07093671Recruiting
Mentalization Based Treatment (MBT) in Help Seeking Youths With a Clinical High-Risk Condition for Psychosis (CHR-P)
Mentalization Based Treatment (MBT) in Help Seeking Youths With a Clinical High-Risk Condition for Psychosis (CHR-P): a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 212 (estimated)
- First submitted
- 7 Jul 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 31 Aug 2028
- Lead sponsor
- Marco Armando
- Diseases
- Schizophrenia
- NCT number
- NCT07093671
What you commit to
- Study type: Interventional
- Planned participants: 212
- From 1 Aug 2025 to the primary completion date, 31 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with a prior diagnosis of a psychotic disorder
Other illness
- Adult patient under guardianship
- Note: Comorbidities with other psychiatric disorders (e.g., Autism Spectrum Disorder, Personality Disorders) will not constitute an exclusion criterion.
Other
- 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)
Who the study is looking for
- Patients aged 14-30 years with a CHR-P condition, as defined by the SIPS criteria
- Patients who provide informed consent
Age in the registry: 14 years to 30 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHUV Coordinator of this site? Confirm its status | Lausanne | Switzerland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.