Mentalization-Based Treatment for young people at clinical high risk for psychosis
Mentalization Based Treatment (MBT) in Help Seeking Youths With a Clinical High-Risk Condition for Psychosis (CHR-P): a Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 212 (estimated) |
| Ages | 14 Years to 30 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Vaudois Academic / other |
| Locations | 1 site (Lausanne) |
| Trial ID | NCT07093671 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Lausanne
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.