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NCT Number: NCT07093671

Mentalization Based Treatment (MBT) in Help Seeking Youths With a Clinical High-Risk Condition for Psychosis (CHR-P)

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.

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Key information

Conditions

Psychosis Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

14 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHUV

Lausanne, 1011, Switzerland

Location status: Recruiting

Location contact

Marco Armando, PR

PRINCIPAL_INVESTIGATOR

Marco Armando, Pr

CONTACT

[email protected]

+41 079 556 49 46

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MBT + NBCI

Other

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.

Primary outcomes

  1. SIPS

    Time frame: At Baseline (T0), at both end of treatment T2 : 24 weeks and at T3 : 48 weeks follow up evaluation

    All primary outcomes will be assessed at baseline (T0) during routine evaluation, end of treatment (T2; 24 weeks), and at 48 weeks follow-up (T3). The primary outcome of this study is the incidence of transition to psychosis within 6 months post-intervention, as measured by the Structured Interview for Psychosis-Risk Syndromes (SIPS). The SIPS is a well-validated, interview-based tool designed to assess symptoms, functioning, and diagnostic criteria for prodromal or at-risk mental states indicative of psychosis. Transition to psychosis, as well as remission from CHR-P state, will be determined based on predefined criteria within the SIPS framework.

    SIPS: Structured Interview for Prodromal Symptoms. Subscales scores (0 to 30). High score = More and/or severe psychotic symptoms

Secondary outcomes

  1. 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).

    The sub-hypotheses associated with Hypothesis 2 will be assessed using the Mentalization Scale (MentS), which measures three subdomains of mentalizing: self-mentalizing (SM), other-mentalizing (OM), and motivation to mentalize (MM). We will examine both the MentS total score and the three subscale scores independently to test the respective sub-hypotheses.

    MentS: Mentalization Scale. Total score (28 to 140). High score = Better mentalization skills

  2. 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).

    The sub-hypotheses associated with Hypothesis 3 will be evaluated using the Epistemic Trust, Mistrust, and Credulity Questionnaire (ETMCQ), which includes three subdomains of epistemic trust: trust, mistrust, and credulity. We aim to test the hypotheses using each of the ETMCQ subscale scores separately.

    ETMCQ: Epistemic Trust, Mistrust, and Credulity Questionnaire Subscales scores (5 to 35). "High ""Trust"" score = stronger functional stance of trust High ""Mistrust"" score = stronger maladaptive stances of mistrust High ""Credulity"" score = stronger maladaptive stances of credulity"

  3. GAF

    Time frame: evaluated at baseline (T0), end of treatment (T2: 24 weeks), and at the T3 (48 weeks follow-up).

    The sub-hypotheses associated with Hypothesis 4 will be examined using the Global Assessment of Functioning (GAF) scale. This measure is included as part of the SIPS assessment to provide a single-item measure assessing overall psychosocial impairment due to mental health factors. GAF scale score ranges 0-100. High score = better functionning.

  4. GF-R

    Time frame: evaluated at baseline (T0), end of treatment (T2: 24 weeks), and at the T3 (48 weeks follow-up).

    The sub-hypotheses associated with Hypothesis 4 will be examined using the Global Assessment of Functioning - Role (GF-R) scale. This measure is included as part of the SIPS assessment to provide a single-item measure of role functioning.

    GF-R: Global Functioning - Role scale score ranges from 0 to10. High score = better functionning

  5. GF-S

    Time frame: evaluated at baseline (T0), end of treatment (T2:24 weeks) and at T3 (48 weeks follow-up)

    The sub-hypotheses associed with Hypothesis 4 will be examined using the Global Assessment of Functioning - Social (GF-S) scale. This measure is included as part of the SIPS assessment to provide a single-item measure of social functioning.

    GF-S: Global Functioning - Social scale ranges from 0 to10. High score = better functionning

  6. 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).

    The sub-hypotheses associated with Hypothesis 5 will be assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) 10 items Sum of each item (0 to 60) High score = more severe depressive symptoms

  7. OASIS

    Time frame: evaluated at baseline (T0), end of treatment (T2: 24 weeks), and at the T3 (48 weeks follow-up)

    The sub-hypotheses associated with Hypothesis 5 will be assessed using the Overall Anxiety Severity and Impairment Scale (OASIS).

    5 item, Sum of each item (0 to 20) High score = more severe anxiety symptoms

Study contacts

Contact information is provided by the study sponsor or research team.

Marco Armando, Pr

CONTACT

[email protected]

+41 079 556 49 46

Sponsors and collaborators

Lead sponsor

Marco Armando

Other

Registry information

Official study title

Mentalization Based Treatment (MBT) in Help Seeking Youths With a Clinical High-Risk Condition for Psychosis (CHR-P): a Randomized Controlled Trial

Acronym: MBT-Psychosis

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 30, 2025
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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