Mentalization Based Treatment (MBT) in Help Seeking Youths With a Clinical High-Risk Condition for Psychosis (CHR-P): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 212
- 试验地点
- 2
- 主要终点
- SIPS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 14-30 years with a CHR-P condition, as defined by the SIPS criteria
- •Patients who provide informed consent
排除标准
- •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.
研究组 & 干预措施
NBCI
Control intervention will consist of Need-Based Clinical Intervention (NBCI). NBCI reflects routine, community-based mental health services as delivered in real-world clinical settings. NBCI are not protocol-driven or manualized. Instead, following a structured baseline assessment of risk and clinical needs, treatment recommendations are formulated in accordance with internationally recognized clinical guidelines. A referral mental health professional, not involved in this study, is expected to conduct an initial assessment of each patient's personal needs.
These interventions will be tailored according to these needs which will determine the type of treatments and theirs frequencies. These interventions include a large range of treatments such as pharmacological treatment, psychotherapeutic sessions (including psychoeducation), case management, or occupational support, delivered by patient's usual therapists, who are fully qualified mental health professionals.
MBT + NBCI
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.
干预措施: MBT + NBCI (Other)
结局指标
主要结局
SIPS
时间窗: 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
次要结局
- MentS(evaluated at baseline (T0), mid-treatment (T1: 12 weeks), end of treatment (T2: 24 weeks), and at the T3 (48 weeks follow-up).)
- MADRS(evaluated at baseline (T0), mid-treatment (T1: 12 weeks), 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))
- ETMCQ(evaluated at baseline (T0), mid-treatment (T1: 12 weeks), end of treatment (T2: 24 weeks), and at the T3 (48 weeks follow-up).)
- GAF(evaluated at baseline (T0), end of treatment (T2: 24 weeks), and at the T3 (48 weeks follow-up).)
- 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).)
- OASIS(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).)
- MADRS(evaluated at baseline (T0), end of treatment (T2: 24 weeks), and at the T3 (48 weeks follow-up).)
研究者
Marco Armando
PR
Centre Hospitalier Universitaire Vaudois