Mentalization-Based Treatment for young people at clinical high risk for psychosis
Official title: Mentalization Based Treatment (MBT) in Help Seeking Youths With a Clinical High-Risk Condition for Psychosis (CHR-P): a Randomized Controlled Trial
Run by Centre Hospitalier Universitaire Vaudois · NCT07093671 · Data updated 2026-11-12
This project will test whether adding Mentalization-Based Treatment to usual need-based clinical care helps young people (ages 14–30) at high risk for psychosis reduce symptoms and avoid developing full psychosis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 14 Years to 30 Years |
| Sex | All |
| Enrollment | 212 (estimated) |
| Sponsor | Centre Hospitalier Universitaire Vaudois Academic / other |
| Locations | 1 site (Lausanne) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | August 31, 2028 |
| Study ends | August 31, 2028 |
| Registry record updated | July 8, 2026 |
| Trial ID | NCT07093671 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are young people aged 14–30 who meet SIPS criteria for CHR-P, have no prior psychotic disorder, can consent (or have parental consent), and do not have severe intellectual disability or primary substance-induced psychotic symptoms.
✕Probably not a fit
Patients with an established psychotic disorder, severe intellectual disability (IQ <70), psychotic symptoms primarily due to substance misuse, major language barriers, or who are under guardianship are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial compares Mentalization-Based Treatment (MBT) combined with need-based clinical interventions (NBCI) versus NBCI alone in help-seeking youths meeting SIPS criteria for a clinical high-risk state for psychosis. Outcomes include a three-level diagnostic status (transition to psychosis, CHR-P status quo, remission from CHR-P) and measures of psychotic symptom severity at end of treatment and at follow-up. Participants aged 14–30 without a prior psychotic disorder and able to provide consent (or with parental consent for minors) will be enrolled, with exclusions for intellectual disability (IQ <70), primary substance-induced symptoms, major language barriers, or guardianship. The study is conducted at CHUV in Lausanne and uses standardized clinical interviews and symptom scales to track diagnostic and symptomatic change over time.
Why it matters
Potential benefit: If successful, adding MBT could reduce psychotic symptoms and lower the risk of progression to full psychosis, improving clinical and functional outcomes for at-risk youth.
How similar studies have gone: MBT has demonstrated benefits in personality disorders and there is emerging, limited evidence for psychotherapeutic approaches in early psychosis, but MBT specifically for CHR-P is relatively novel with limited direct evidence.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Chuv
Lausanne, Switzerland Recruiting
Study contacts
- Principal investigator: Marco Armando, PR — Centre Hospitalier Universitaire Vaudois
- Study coordinator: Marco Armando, Pr
- Email: marco.armando@chuv.ch
- Phone: +41 079 556 49 46
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Examining the effects of combined therapy for schizophrenia
This study is testing whether combining two therapies, one for managing thoughts and another for improving cognitive skills, can help people with schizophrenia do better in their daily lives compared to using just one of the therapies.
-
State Representation in Early Psychosis 2
This observational study tests how people with early psychosis and healthy individuals use state information during tasks and how brain activity supports it.
-
Recovery-oriented suicide prevention for young people at clinical high risk for psychosis
This program tests a peer-supported, clinician-led suicide prevention group for young people at clinical high risk for psychosis to see if it helps reduce suicidal thoughts and support recovery.
-
Combined brain stimulation and yoga for improving cognition in psychosis
This study tests whether active brain stimulation plus yoga can improve thinking skills and daily function in adults with psychosis.
-
See if an early-detection program reduces time to treatment for first-episode psychosis
We test whether a large, region-wide early-detection program can shorten the time from first psychotic symptoms to treatment and help people function better later.
-
Cerebellar imaging markers to predict antipsychotic response in first-episode psychosis
This will test whether cerebellar brain scans can predict how people with first-episode psychosis respond to 12 weeks of treatment with risperidone or aripiprazole.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.