Efficacy of Mindfulness in PREventing Progression to Psychosis in Individuals With an Ultra High Risk for Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Distress related to psychotic symptoms
研究概览
简要总结
The main objective is to evaluate the efficacy of a group-based mindfulness therapy programme in reducing distress associated with symptoms of UHR (Ultra High Risk) or FEP (first psychotic episode) compared with usual treatment. The secondary objectives were to study the efficacy of a group-based mindfulness intervention: on the reduction of psychotic symptoms; on the maintenance over time (6 months of follow-up) of the efficacy of the intervention on the distress associated with the symptoms of the UHR or PEP state; and on various dimensions associated with care: cognitive functions, anxiety, 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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People aged between 18 and 30 validating the criteria for UHR or PEP status on the CAARMS scale and having a social functional impact (SOFAS score below 50 or a reduction of more than 30% in the score)
排除标准
- •Previous episode of schizophrenic disorder, schizoaffective disorder or bipolar disorder
- •Previous antipsychotic treatment for more than 12 months
- •Organic mental disorder or intellectual disability
- •Serious suicidal/homicidal risk (but admissible if this risk has been resolved)
- •Insufficient French language skills
- •Adult incapable of giving consent and not under legal protection
- •Protection measure (guardianship/curatorship/court supervision) or under court supervision
- •Person deprived of liberty by judicial or administrative decision (including forced hospitalisation)
- •Persons in a life-threatening emergency
- •Not affiliated to a social security regime
研究组 & 干预措施
MBTP group
干预措施: MBTP : Mindflulness based training for psychosis (Other)
TAU group
结局指标
主要结局
Distress related to psychotic symptoms
时间窗: 3 months
Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention
Distress related to psychotic symptoms
时间窗: 4 months
Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention
Distress related to psychotic symptoms
时间窗: 6 months
Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention
Distress related to psychotic symptoms
时间窗: 9 months
Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention
次要结局
- Cognitive functions(9 months)
- Health-related quality of life (HRQoL)(9 months)
- Intensity of psychotic symptoms(3 months)
- Intensity of psychotic symptoms(4 months)
- Intensity of psychotic symptoms(6 months)
- Distress related to psychotic symptoms(3 months)
- Distress related to psychotic symptoms(4 months)
- Distress related to psychotic symptoms(6 months)
- Number of patients making a transition to psychosis(3 months)
- Number of patients making a transition to psychosis(4 months)
- Number of patients making a transition to psychosis(6 months)
- Cognitive functions(3 months)
- Cognitive functions(4 months)
- Cognitive functions(6 months)
- Anxiety(3 months)
- Anxiety(4 months)
- Anxiety(6 months)
- Functioning(3 months)
- Functioning(4 months)
- Functioning(6 months)
- Health-related quality of life (HRQoL)(3 months)
- Health-related quality of life (HRQoL)(4 months)
- Health-related quality of life (HRQoL)(6 months)
- Depressive symptoms(3 months)
- Depressive symptoms(4 months)
- Depressive symptoms(6 months)
- Intensity of psychotic symptoms(9 months)
- Distress related to psychotic symptoms(9 months)
- Number of patients making a transition to psychosis(9 months)
- Anxiety(9 months)
- Functioning(9 months)
- Depressive symptoms(9 months)