Evaluation of the Individual Early Psychoeducation Program for Schizophrenic Disorders in Inpatients: A Randomized, Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 11
- 主要终点
- Evolution of insight
研究概览
简要总结
Schizophrenia affects about 0.7% of the population. Poor insight, which is common in this disease, linked to poor drug compliance is leads to rehospitalisation with major impact on quality of life. Indeed, many patients relapse with exacerbation of symptoms.
Psychoeducation can improve therapeutic alliance and medication compliance.
In this context, an individual psycho-education program (PEPITS) has been developed. PEPITS carried out by nurses during the initial stages of hospitalisation.
The hypothesis is that PEPITS program will decrease relapse and improve the compliance and insight and and so the 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
- Supportive Care
- 盲法
- None
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
- •Age between 18 and 65 years
- •Patient with a diagnosed and reported schizophrenic disorder announced :
- •Schizophrenia
- •Schizoaffective disorder
- •Or a diagnosed and reported Delusional Disorder
- •Express written consent by the participant after receiving information about the study
- •Be able to communicate verbally
- •Participant affiliated to a social security scheme
排除标准
- •Pregnant or breastfeeding woman
- •Patient who does not speak French
- •Participation in a psycho-education group in the last 2 years
- •Patient under legal protection or guardianship
结局指标
主要结局
Evolution of insight
时间窗: From inclusion (T0) up to one year (T12) after randomisation
using the Introspection Self Assessment Questionnaire (IAQ)
次要结局
- Evolution of quality of life at work(From prior to their training in the programme up to 6 months after their first inclusion)
- Evolution of patient's quality of life(From inclusion (T0) up to one year (T12) after randomisation)
- Medication compliance(From inclusion (T0) up to one year (T12) after randomisation)
- Evolution of job satisfaction(From prior to their training in the programme up to 6 months after their first inclusion)
- Evolution of commitment to work(From prior to their training in the programme up to 6 months after their first inclusion)
- Evolution of psychological well-being at work(From prior to their training in the programme up to 6 months after their first inclusion)
- Evolution of sense of self-efficacy(From prior to their training in the programme up to 6 months after their first inclusion)