Mentalization Based Treatment (MBT) in Help Seeking Youths With a Clinical High-Risk Condition for Psychosis (CHR-P)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MBT + NBCI.
- Who it may be relevant to
- Registry conditions: Psychosis. Basic parameters: 14 years — 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Mentalization Based Treatment (MBT) in Help Seeking Youths With a Clinical High-Risk Condition for Psychosis (CHR-P): a Randomized Controlled Trial
Overview
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.
Detailed description
Schizophrenia incidence peaks between 20 and 24 years, yet approximately one-third of cases manifest before age 18 as Early Onset Psychosis (EOP), which is associated with poorer outcomes compared to adult-onset cases, as reported in most of the literature. Psychoses are among the most severe disorders in children and adolescents (CAD), representing the second leading cause of years lost due to disability worldwide. Evidence suggests that early intervention in psychosis may improve outcomes, and there is increasing consensus among clinicians to initiate treatment as soon as sustained positive psychotic symptoms emerge. Within this early intervention framework, there is a strong hypothesis that intervening during the clinical high risk for psychosis (CHR-P) phase may mitigate, delay, or even prevent the onset of a full psychotic disorder. Reflecting these specific needs, the EPA guidelines recommend psychotherapeutic interventions as the first-line treatment for CHR-P conditions. Despite progress in early identification of psychosis risk states, advancements in psychotherapeutic interventions targeting the so-called "psychosis prodrome" remain limited. Importantly, existing interventions often fall short in addressing predictors of functional outcomes in the long term. Recent psychological, clinical, and neuroscientific studies underscore that socio-emotional difficulties are critical determinants of clinical and functional outcomes in CHR-P individuals. Furthermore, research in social cognition has highlighted that mentalization abilities, which continue to develop through adolescence and into adulthood, depend on complex cerebral connectivity to support functions such as mentalizing, perspective-taking, and moral judgment. These mentalizing processes are fundamental to adult social adaptation and have been shown to play a crucial role in maintaining good mental health. Mentalization-Based Treatment (MBT), a highly effective psychotherapeutic model for addressing socio-emotional difficulties, has been recently adapted for youth at clinical high risk for psychosis.
Interventions
- Other MBT + 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 Socrat
Primary outcome measures
- SIPS [Time frame: At Baseline (T0), at both end of treatment T2 : 24 weeks and at T3 : 48 weeks follow up evaluation]
Secondary outcome measures (7)
- MentS [Time frame: evaluated at baseline (T0), mid-treatment (T1: 12 weeks), end of treatment (T2: 24 weeks), and at the T3 (48 weeks follow-up).]
- ETMCQ [Time frame: evaluated at baseline (T0), mid-treatment (T1: 12 weeks), end of treatment (T2: 24 weeks), and at the T3 (48 weeks follow-up).]
- GAF [Time frame: evaluated at baseline (T0), end of treatment (T2: 24 weeks), and at the T3 (48 weeks follow-up).]
- GF-R [Time frame: evaluated at baseline (T0), end of treatment (T2: 24 weeks), and at the T3 (48 weeks follow-up).]
- GF-S [Time frame: evaluated at baseline (T0), end of treatment (T2:24 weeks) and at T3 (48 weeks follow-up)]
- MADRS [Time frame: evaluated at baseline (T0), mid-treatment (T1: 12 weeks), end of treatment (T2: 24 weeks), and at the T3 (48 weeks follow-up).]
- OASIS [Time frame: evaluated at baseline (T0), end of treatment (T2: 24 weeks), and at the T3 (48 weeks follow-up)]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- CHUV — Lausanne
Identifiers
NCT: NCT07093671 · 2024-02579