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.
Patients aged 14-30 years with a CHR-P condition, as defined by the SIPS criteria
Patients who provide informed consent
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
Parallel
MBT + NBCI
Other interventionThe 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.
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
MentS
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
ETMCQ
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"
GAF
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.
GF-R
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
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Marco Armando
Lead sponsor
Centre Hospitalier Universitaire Vaudois
Sponsor institution
