Mental Health During the Whole Life Cycle of Community Patients With Schizophrenia: a Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- 1-year BPRS reduction rate
研究概览
简要总结
Schizophrenia is one of the components of severe mental disorders. It has the characteristics of prolonged course, low cure rate, high recurrence rate and high disability rate. It brings many short-term and long-term effects to individuals, families and society. Studies on patients with schizophrenia mainly focus on cross-sectional and case-control studies, but there is a lack of long-term follow-up of patients with schizophrenia in the community. Therefore, this study would establish a cohort study to solve the chronological relationship between exposure and effect, focus on community schizophrenia, and establish a community schizophrenia patient biobank that has been tracked for a long time from diagnosis.
详细描述
Schizophrenia is one of the components of severe mental disorders. It has the characteristics of prolonged course, low cure rate, high recurrence rate and high disability rate. It brings many short-term and long-term effects to individuals, families and society.Studies on patients with schizophrenia mainly focus on cross-sectional and case-control studies, but there is a lack of long-term follow-up of patients with schizophrenia in the community. Therefore, this study would establish a cohort study to solve the chronological relationship between exposure and effect, focus on community schizophrenia, and establish a community schizophrenia patient biobank that has been tracked for a long time from diagnosis.
- Aim of the study:
1.1 Based on previous studies, this study will focus on patients with schizophrenia in the community. Establishing a biobank of new cases to monitor the occurrence of disease recurrences, violent behaviours and other outcome events during the whole life cycle of schizophrenia patients. Exploring the predictive effects of biological, psychosocial, imaging and other indicators on patient recurrence and other events.
1.2 At the same time, establishing a sample database of patients with schizophrenia in the community to lay a working foundation and reserve sample resources for subsequent related mechanism research, drug research, and intervention research. 2. Content of the study 2.1 At least 1,200 patients with schizophrenia diagnosed within five years will be recruited. On the basis of community follow-up and health examination, this study will expand biological sample collection and professional scale evaluation, establish a schizophrenia community cohort.
2.2 Based on the establishment of the cohort, this study will carry out statistical description according to the type of data. The differences will be compared between the exposed group and the unexposed group in demographic information, family and past disease history, personal living habits, condition and treatment, psychological evaluation, social support evaluation, sleep quality, functional evaluation, quality of life and other content. Repeated measures analysis of variance will be used to compare the differences in blood pressure, blood glucose and other indicators between the exposed group and the unexposed group. The generalized estimating equation will be used to analyze the relationship between the outcome of recurrence and emergency about physical activity, related biochemical indicators, and social support. On the basis of statistical results, this study will carry out research on the prognostic factors and related physiological mechanisms of schizophrenia. 3. Study design 3.1 Pay attention to multiple prognostic outcomes such as relapse, dangerous behaviours, suicide and self-harm, calculate the included sample size based on this. After the start of the project, in Hongkou, Jinshan, Minhang, and Xuhui districts, all schizophrenic patients in management who meet the inclusion criteria will be continuously included in the district.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Registered in the Shanghai Mental Health Information Management System.
- •Meets criteria for the diagnosis of schizophrenia (ICD-10 or ICD-11).
- •Patients with schizophrenia diagnosed within five years.
- •Aged between 18 and 65 years.
排除标准
- •Patients with severe physical diseases and organic brain diseases.
- •The patient is about to settle outside Shanghai.
结局指标
主要结局
1-year BPRS reduction rate
时间窗: Change from Baseline BPRS at 12 months
The Brief Psychiatric Rating Scale (BPRS) was used to measure the presence and severity of psychiatric symptoms entailing positive symptoms, general psychopathology, and affective symptoms (e.g., thought disturbance, emotional withdrawal, hostility, and suspiciousness) for patients with mental illness, particularly schizophrenia. Each of the 18 items are designed to represent a discrete symptom area. Items are rated on a 7-point Likert scale, from 1 = "not present" to 7 = "extremely severe", with scores ranging from 18 to 126 (achieved through summing the item scores). Higher scores indicated more severity of psychiatric symptoms. Reduction rate was calculated using the following formula: reduction rate= (Score before treatment - Score after treatment)/(Score before treatment - 18) × 100%. A reduction rate of BPRS score \> 25% was considered as a clinically meaningful improvement.
2-year BPRS reduction rate
时间窗: Change from Baseline BPRS at 24 months
The BPRS reduction rate during the 2-year follow-up period.
3-year BPRS reduction rate
时间窗: Change from Baseline BPRS at 36 months
The BPRS reduction rate during the 3-year follow-up period.
4-year BPRS reduction rate
时间窗: Change from Baseline BPRS at 48 months
The BPRS reduction rate during the 4-year follow-up period.
次要结局
- 4-year WHOQOL-BREF(Change from Baseline WHOQOL-BREF at 48 months)
- 1-year GAD-7(Change from Baseline GAD-7 at 12 months)
- 2-year GAD-7(Change from Baseline GAD-7 at 24 months)
- 1-year MOAS(Change from Baseline MOAS at 12 months)
- 2-year MOAS(Change from Baseline MOAS at 24 months)
- 3-year MOAS(Change from Baseline MOAS at 36 months)
- 1-year WHOQOL-BREF(Change from Baseline WHOQOL-BREF at 12 months)
- 4-year MOAS(Change from Baseline MOAS at 48 months)
- 2-year WHOQOL-BREF(Change from Baseline WHOQOL-BREF at 24 months)
- 3-year WHOQOL-BREF(Change from Baseline WHOQOL-BREF at 36 months)
- 3-year GAD-7(Change from Baseline GAD-7 at 36 months)
- 4-year GAD-7(Change from Baseline GAD-7 at 48 months)
- 1-year PHQ-9(Change from Baseline PHQ-9 at 12 months)
- 2-year PHQ-9(Change from Baseline PHQ-9 at 24 months)
- 3-year PHQ-9(Change from Baseline PHQ-9 at 36 months)
- 4-year PHQ-9(Change from Baseline PHQ-9 at 48 months)
- 1-year PSQI(Change from Baseline PSQI at 12 months)
- 2-year PSQI(Change from Baseline PSQI at 24 months)
- 3-year PSQI(Change from Baseline PSQI at 36 months)
- 4-year PSQI(Change from Baseline PSQI at 48 months)
- 1-year SDSS(Change from Baseline SDSS at 12 months)
- 2-year SDSS(Change from Baseline SDSS at 24 months)
- 3-year SDSS(Change from Baseline SDSS at 36 months)
- 4-year SDSS(Change from Baseline SDSS at 48 months)