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

NCT07093671 | Recruiting

• 1 other identifier: 2024-02579
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychosis

Keywords

Psychosis; MBT; Mentalization-Based Treatment

Outcome Measures

Primary Outcomes (1)

• SIPS

  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

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

Secondary Outcomes (6)

• MentS

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

• ETMCQ

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

• GF-R

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

• GF-S

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

• MADRS

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

Study Arms (2)

NBCI

NO INTERVENTION

Control intervention will consist of routine care based on Need-Based Clinical Intervention (NBCI). All NBCI treatments will be delivered by fully qualified mental health professionals and may include pharmacological treatment, psychotherapeutic sessions, case management, and occupational therapy.

MBT + NBCI

EXPERIMENTAL

Description: The MBT intervention consists of 24 weekly individual psychotherapy sessions, supplemented by monthly mentalization-based family therapy sessions spread across six phases. The individual sessions are manualized into six blocks, each comprising four weekly sessions. Each block typically begins with sessions that heavily incorporate psychoeducation and progressively transitions to a thematically guided session format. Both patient and family sessions will last 50 minutes, and may be audiotaped for quality control and intern supervision. Participants, along with their families or carers, will be informed of this procedure and retain the right to decline recording. 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.

Other: MBT + NBCI

Interventions

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.

MBT + NBCI

Eligibility Criteria

• Age: 14 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged 14-30 years with a CHR-P condition, as defined by the SIPS criteria
• Patients who provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Marco Armando: lead

Study Sites (1)

CHUV

Lausanne, 1011, Switzerland

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Marco Armando, PR

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Armando, Pr

CONTACT

+41 079 556 49 46; marco.armando@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PR

Model Details: This is a randomized, single-blinded, superiority, two-arm, parallel group-controlled trial. Participants will be randomized in a 1:1 ratio to either control or intervention group.

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 30, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)