Towards a Personalized Medicine Approach to Psychological Treatment for Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- P-MCT benefits on total psychotic symptoms
研究概览
简要总结
This study aims to compare the efficacy of classical Metacognitive Training (MCT) and personalized Metacognitive Training (P-MCT) for individuals with psychosis. MCT is a psychoeducational program derived from cognitive-behavioral therapy (CBT) that targets cognitive biases associated with psychotic symptoms. The goal is to assess which intervention is more effective to improve the overall functioning of individuals with psychosis. The study will use machine learning to personalize the treatment approach and evaluate its impact on clinical symptoms, cognitive functions, and quality of life.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults, 18 - 65 years of age.
- •Patient affiliated to health insurance
- •Inpatients and outpatients with DSM-5 diagnosis of schizophrenia spectrum disorder.
- •Presence of positive symptoms at inclusion (PANSS delusions, suspiciousness or grandiosity ≥3).
- •Stable condition with no expected changes in medication or symptoms during the last 3 months (information from clinical services, note that stable condition includes lack of suicidality).
- •Patient providing informed consent.
排除标准
- •Having received MCT in the previous year.
- •Neurological disorder, or severe medical condition other than psychosis
- •A score above 5 in the "Hostility" and the "Suspiciousness" items of the PANSS Positive subscale (to preserve group dynamics).
- •Patient considered by his psychiatrist to be at serious risk of harm to self or others (e.g. previous aggressive or suicidal behaviors)
- •Patient in an exclusion period defined by another research protocol
- •Patient involved in another Investigational Medicinal Product trial
- •Patient under guardianship (i.e. French "tutelle")
- •Patients deprived of freedom because of a judicial measure.
研究组 & 干预措施
Classical MCT (MCT)
In this arm, participants will follow the standard Metacognitive Training (MCT) protocol. They will receive 10 one-hour sessions of classical MCT delivered in a group setting, following the current standard program. In addition to the sessions, participants will be given standardized homework tasks to reinforce the skills learned between sessions. This group serves as the active control in the study.
干预措施: Metacognitive Training (MCT) for psychosis (Behavioral)
Personalized MCT (P-MCT)
Participants in this arm will receive Personalized Metacognitive Training (P-MCT), an experimental intervention that uses a machine learning (ML) predictive platform to personalize the homework assignments. While the core MCT program remains unchanged, P-MCT customizes the homework based on individual patient profiles, specifically targeting areas where the patient is predicted to benefit the least. The goal is to enhance the effects of the standard MCT by providing personalized support through tailored exercises.
干预措施: Metacognitive Training (MCT) for psychosis (Behavioral)
结局指标
主要结局
P-MCT benefits on total psychotic symptoms
时间窗: Months 6
To compare the benefits of P-MCT with classical MCT, we will compare total positive symptoms subscale score of the Positive and Negative Syndromes Scale (PANSS; Kay et al., 1987) -To compare the benefits of P-MCT with classical MCT, we will compare total positive symptoms subscale score of the Positive and Negative Syndromes Scale (PANSS; Kay et al., 1987) -). The subscale includes 7 items, each rated from 1 to 7, for a total score ranging from 7 to 49. Higher scores indicate more severe positive symptoms.
P-MCT benefits on total psychotic symptoms
时间窗: Months 6
To compare the benefits of P-MCT with classical MCT, we will compare total positive symptoms subscale score of the Positive and Negative Syndromes Scale (PANSS; Kay et al., 1987) -To compare the benefits of P-MCT with classical MCT, we will compare total positive symptoms subscale score of the Positive and Negative Syndromes Scale (PANSS; Kay et al., 1987) -). The subscale includes 7 items, each rated from 1 to 7, for a total score ranging from 7 to 49. Higher scores indicate more severe positive symptoms.
次要结局
未报告次要终点