Mentalization Based Treatment (MBT) in Help Seeking Youths With a Clinical High-Risk Condition fo… (NCT07093671) | Clinical Trial Compass
RecruitingNot Applicable
Mentalization Based Treatment (MBT) in Help Seeking Youths With a Clinical High-Risk Condition for Psychosis (CHR-P)
Switzerland212 participantsStarted 2025-08-01
Plain-language 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.
Who can participate
Age range
14 Years – 30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying a talk therapy called Mentalization Based Treatment for young people at clinical high risk for psychosis — can you explain what 'clinical high-risk for psychosis' means in my case, and whether you think my symptoms fit what this trial is looking for?
2The trial is measuring outcomes using something called the SIPS — what is that assessment, what does it measure about psychosis risk, and how might my scores on it affect my participation or what we learn from the results?
3Since this trial is listed as Phase NA, which often applies to behavioral or psychological interventions rather than drug trials, can you help me understand what is and isn't yet known about how safe and effective Mentalization Based Treatment is for young people at high risk of psychosis?
4The trial is actively recruiting right now — if I were to discuss joining, what would the time commitment look like in terms of therapy sessions and follow-up visits, and how might that fit around school or work?
5Before considering this trial, should I explore whether standard care options — like existing early intervention programs or other therapies — might be a better first step for someone in my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
SIPS
Timeframe: At Baseline (T0), at both end of treatment T2 : 24 weeks and at T3 : 48 weeks follow up evaluation