Mental Health During the Whole Life Cycle of Community Patients With Schizophrenia

ConditionSchizophrenia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorShanghai Mental Health Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients with severe physical diseases and organic brain diseases.

The patient is about to settle outside Shanghai.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,200 Participants
are grouped into 2 trial groups
Group A: Exposed group
Group B: Non-exposed group

Trial outcomes

Primary outcomes

1

1-year BPRS reduction rate

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.

Time frame
Change from Baseline BPRS at 12 months
2

2-year BPRS reduction rate

The BPRS reduction rate during the 2-year follow-up period.

Time frame
Change from Baseline BPRS at 24 months
3

3-year BPRS reduction rate

The BPRS reduction rate during the 3-year follow-up period.

Time frame
Change from Baseline BPRS at 36 months
4

4-year BPRS reduction rate

The BPRS reduction rate during the 4-year follow-up period.

Time frame
Change from Baseline BPRS at 48 months

Secondary outcomes

1

MOAS

The Modified Overt Aggression Scale (MOAS) is a four-part behavior rating scale used to evaluate and document the "frequency and severity" of aggressive episodes. The rating scale is made up of four categories; verbal aggression, aggression against objects, aggression against self, and aggression against others. Each category consists of five responses, which over time can track the patient's aggressive behavior. The MOAS is one of the most widely used measures for violence and aggression, with 4 items in total, 0\~4 points for each item.

Time frame
Change from Baseline MOAS at 12 months, 24 months, 36 months, 48 months, and 60 months
2

WHOQOL-BREF

The WHO Quality of Life Scale-Brief (WHOQOL-BREF) was developed by the Word Health Organisation as a quality of life assessment that would be applicable cross-culturally. It is a 26 item self report measure, especially useful for measuring outcomes with adults with a psychosocial disability. The WHOQOL-BREF measures four factors: physical health, psychological Health, social relationships, and environment. The total score is presented between 26 and 156, where higher scores represent higher levels of quality of life.

Time frame
Change from Baseline WHOQOL-BREF at 12 months, 24 months, 36 months, 48 months, and 60 months
3

GAD-7

The Generalized Anxiety Disorder Screener (GAD-7) is a brief, 7-item self-report measure for anxiety symptoms in adolescents and adults. Although developed primarily as a screening tool for GAD, it can also be used as a diagnostic tool to monitor changes in symptoms over time, and as a screener for social anxiety, panic disorder, and post-traumatic stress disorder. Each item is rated on a likert-type scale from zero ("not at all") to three ("nearly every day"), with total scores ranging from 0 to 21.

Time frame
Change from Baseline GAD-7 at 12 months, 24 months, 36 months, 48 months, and 60 months
4

PHQ-9

The Patient Health Questionnaire-9 (PHQ-9) is a multipurpose instrument for screening , diagnosing , monitoring and measuring the severity of depression. The tool rates the frequency of the symptoms which factors into the scoring severity index. The PHQ -9 is brief and useful in clinical practice. The PHQ -9 can be administered repeatedly , which can reflect improvement or worsening of depression in response to treatment .Each item is rated on a likert-type scale from zero ("not at all") to three ("nearly every day").

Time frame
Change from Baseline PHQ-9 at 12 months, 24 months, 36 months, 48 months, and 60 months

Other outcomes

1

1-year Rate of rehospitalization

Relapse of patients with schizophrenia is defined as a clinical deterioration or an exacerbation of symptoms based on rehospitalization. Data from the Shanghai Mental Health Work Website.

Time frame
The rehospitalization rate from Baseline during the 1-year follow-up period.
2

2-year Rate of rehospitalization

The rehospitalization rate from Baseline during the 2-year follow-up period.

Time frame
From Baseline during the 2-year follow-up period.
3

3-year Rate of rehospitalization

The rehospitalization rate from Baseline during the 3-year follow-up period.

Time frame
From Baseline during the 3-year follow-up period.
4

4-year Rate of rehospitalization

The rehospitalization rate from Baseline during the 4-year follow-up period.

Time frame
From Baseline during the 4-year follow-up period.

Sponsors and contacts

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Shanghai Mental Health Center

Lead sponsor

Fudan University

Collaborator