RecruitingNot ApplicableNCT07093671

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

Sponsor

Marco Armando

Enrollment

212 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Psychosis

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

Min Age: 14 YearsMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a type of therapy called Mentalization-Based Treatment (MBT) — a form of talking therapy that helps people understand their own and others' feelings — in young people who show early warning signs that they may be at risk of developing psychosis (a condition that can cause loss of touch with reality). The goal is to see if this therapy can reduce distress and lower the chance of developing a full psychotic episode. **You may be eligible if...** - You are aged 14 to 30 years old - You have been identified as being at clinical high risk for psychosis based on a structured assessment tool (SIPS criteria) - You are seeking help and willing to participate **You may NOT be eligible if...** - You have already been diagnosed with a psychotic disorder - You have an intellectual disability (IQ below 70) - Your symptoms are primarily caused by substance misuse - You have significant language barriers that would prevent you from participating - You are a minor and your parents or legal guardians do not consent to participation Note: Having other mental health conditions such as autism spectrum disorder or personality disorders does not automatically exclude you. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERMBT + NBCI

The MBT for CHR-P intervention consists of 24 weekly individual psychotherapy sessions, supplemented by monthly mentalization-based family therapy sessions. Both patient and family sessions will last 50 minutes. These psychotherapeutic sessions will complement those received though NBCI by strengthening mentalizing abilities aiming to reduce or prevent detrimental outcomes, by prohibiting or restricting some usual techniques in NBCI treatment (e.g., interpretation, cognitive challenge and Socratic dialogue) and by emphasizing certain techniques (e.g., empathic validation, active management of emotional arousal) which are only sporadically and irregularly used during NBCI treatment. Overall, the program is designed to improve patients' capacity to understand their own and others' mental states and, within interpersonal settings, how these patterns contribute to conflict and psychological distress.