Clinical trial NCT05159349: Mental Health During the Whole Life Cycle of Community Patients with Schizophrenia
Official title: Mental Health During the Whole Life Cycle of Community Patients with Schizophrenia: a Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Schizophrenia
Keywords: Schizophrenia
Cohort study
The whole life cycle
Mental health
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
Collaborators: name: Fudan University
First posted: 2021-12-16
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Since the start of the project, all schizophrenia patients in management who meet the inclusion criteria in this district have been continuously included in Hongkou, Jinshan, Minhang, and Xuhui districts, and at least 300 patients in each district will be included until the corresponding sample size is reached.

Brief summary: 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.

Detailed description: 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.

1. 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.

3.2 At baseline, the patient's demographic information and a complete health history (include personal history, family history, and medical history) will be taken. The questionnaire survey includes the Brief Psychiatric Rating Scale (BPRS)，the Patient Health Questionnaire-9 (PHQ-9)，the Generalized Anxiety Disorder Screener (GAD-7), the Pittsburgh Sleep Quality Index (PSQI) , the WHO Quality of Life Scale-Brief (WHOQOL-BREF) , the Modified Overt Aggression Scale (MOAS), the 10-item social disability screening schedule (SDSS) and the Perceived social support scale(PSSS),etc. Within six months of the completion of the baseline survey, the district-level mental health center arranges for patients in the district to participate in physical examinations. All measures will be administered at baseline and 12, 24, 36 and 48 months follow-up except for the health history and PSSS, which will be administered only at baseline. Besides, the study will focus on the patients' recurrence events, violent behavior, various impacts on society and family, emergency response events, and prognosis by carrying out active follow-up every three months.

Eligibility criteria: Inclusion Criteria:

* 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.
* Age 18 years or older.

Exclusion Criteria:

* Patients with severe physical diseases and organic brain diseases.
* The patient is about to settle outside Shanghai.

Primary outcomes:
measure: 1-year BPRS reduction rate
timeFrame: Change from Baseline BPRS at 12 months
measure: 2-year BPRS reduction rate
timeFrame: Change from Baseline BPRS at 24 months
measure: 3-year BPRS reduction rate
timeFrame: Change from Baseline BPRS at 36 months
measure: 4-year BPRS reduction rate
timeFrame: Change from Baseline BPRS at 48 months
Secondary outcomes:
measure: 1-year MOAS
timeFrame: Change from Baseline MOAS at 12 months
measure: 2-year MOAS
timeFrame: Change from Baseline MOAS at 24 months
measure: 3-year MOAS
timeFrame: Change from Baseline MOAS at 36 months
measure: 4-year MOAS
timeFrame: Change from Baseline MOAS at 48 months
measure: 1-year WHOQOL-BREF
timeFrame: Change from Baseline WHOQOL-BREF at 12 months
measure: 2-year WHOQOL-BREF
timeFrame: Change from Baseline WHOQOL-BREF at 24 months
measure: 3-year WHOQOL-BREF
timeFrame: Change from Baseline WHOQOL-BREF at 36 months
measure: 4-year WHOQOL-BREF
timeFrame: Change from Baseline WHOQOL-BREF at 48 months
measure: 1-year GAD-7
timeFrame: Change from Baseline GAD-7 at 12 months
measure: 2-year GAD-7
timeFrame: Change from Baseline GAD-7 at 24 months
measure: 3-year GAD-7
timeFrame: Change from Baseline GAD-7 at 36 months
measure: 4-year GAD-7
timeFrame: Change from Baseline GAD-7 at 48 months
measure: 1-year PHQ-9
timeFrame: Change from Baseline PHQ-9 at 12 months
measure: 2-year PHQ-9
timeFrame: Change from Baseline PHQ-9 at 24 months
measure: 3-year PHQ-9
timeFrame: Change from Baseline PHQ-9 at 36 months
measure: 4-year PHQ-9
timeFrame: Change from Baseline PHQ-9 at 48 months
measure: 1-year PSQI
timeFrame: Change from Baseline PSQI at 12 months
measure: 2-year PSQI
timeFrame: Change from Baseline PSQI at 24 months
measure: 3-year PSQI
timeFrame: Change from Baseline PSQI at 36 months
measure: 4-year PSQI
timeFrame: Change from Baseline PSQI at 48 months
measure: 1-year SDSS
timeFrame: Change from Baseline SDSS at 12 months
measure: 2-year SDSS
timeFrame: Change from Baseline SDSS at 24 months
measure: 3-year SDSS
timeFrame: Change from Baseline SDSS at 36 months
measure: 4-year SDSS
timeFrame: Change from Baseline SDSS at 48 months
Other outcomes:
measure: 1-year Rate of rehospitalization
timeFrame: The rehospitalization rate from Baseline during the 1-year follow-up period.
measure: 2-year Rate of rehospitalization
timeFrame: From Baseline during the 2-year follow-up period.
measure: 3-year Rate of rehospitalization
timeFrame: From Baseline during the 3-year follow-up period.
measure: 4-year Rate of rehospitalization
timeFrame: From Baseline during the 4-year follow-up period.
measure: 1-year the number of violent incidents
timeFrame: From Baseline during the 1-year follow-up period.
measure: 2-year the number of violent incidents
timeFrame: From Baseline during the 2-year follow-up period.
measure: 3-year the number of violent incidents
timeFrame: From Baseline during the 3-year follow-up period.
measure: 4-year the number of violent incidents
timeFrame: From Baseline during the 4-year follow-up period.
measure: 1-year the number of suicides
timeFrame: From Baseline during the 1-year follow-up period.
measure: 2-year the number of suicides
timeFrame: From Baseline during the 2-year follow-up period.
measure: 3-year the number of suicides
timeFrame: From Baseline during the 3-year follow-up period.
measure: 4-year the number of suicides
timeFrame: From Baseline during the 4-year follow-up period.
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
Study officials:
affiliation: Shanghai Mental Health Center
name: Jun Cai
role: STUDY_DIRECTOR
References: