Ningbo Severe Mental Disorders Cohort (NEED)

Ningbo Severe Mental Disorders Cohort, a Longitudinal Population-based Ambispective Cohort Study

In recent years, the prevalence of severe mental disorders in China has continued to grow, and the burden of disease in society has continued to rise. In order to improve the prognosis of patients with severe mental disorders and reduce the risk of disease relapse or readmission, researchers established a cohort based on the Ningbo Mental Health Information System in Ningbo, a sub-provincial city in the southern wing of the Yangtze River Delta of China, with a resident population of more than 9 million, and linked it to the residents' health records, and through the data linkage obtained data on patients in the full cycle of pre-diagnosis, diagnosis, follow-up, disease changes and death, realising full-cycle management of patients with severe mental disorders.

Currently, NEED has accumulated data on more than 50,000 patients with severe mental disorders and obtained multi-dimensional longitudinal information through long-term follow-up and data linkage. All diseases follow the World Health Organization International Classification of Diseases 10th Edition (ICD-10) for clinical coding, and available data include baseline demographics, past history, family history, social functioning deficit screening scale scores, risk assessment, and so on and longitudinal health information from electronic health records (EHR), providing a solid data base for future real-world studies.

Study Overview

• Status: Active, not recruiting
• Conditions: Schizophrenia; Bipolar Disorder; Mental Retardation; Severe Mental Disorder; Schizo-Affective Psychosis; Paranoid Psychoses; Epileptic Psychosis
• Intervention / Treatment: Other: Patient with severe mental disorder without intervention

• Study Type: Observational
• Enrollment (Actual): 57212

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Ningbo, Zhejiang, China, 315000
      • Ningbo Mental Health Information System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with severe mental disorder registered in the Ningbo Mental Health Information Management System

Description

Inclusion Criteria:

• Clinical diagnosis of schizophrenia (F20)
• Clinical diagnosis of schizo-affective disorder (F25)
• Clinical diagnosis of paranoid psychoses (F22)
• Clinical diagnosis of bipolar disorder (F30-F31)
• Clinical diagnosis of epileptic psychosis (F06.8)
• Clinical diagnosis of mental retardation (F70-F79)

Exclusion Criteria:

• None.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with severe mental disorders	Other: Patient with severe mental disorder without intervention; Patients with severe mental disorders identified based on exposures of interest to the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk of circulatory system diseases	At least one of the following diagnoses in the electronic health records : Primary hypertension (I10), Cerebral infarction (I63), Transient cerebral ischaemic attacks and related syndromes (G45), Intracerebral haemorrhage (I61), Subarachnoid haemorrhage (I60), Hemorrhagic stroke (I60-I61), Stroke (I60-I64, I69), Pulmonary embolism (I26), Aortic aneurysm and dissection (I71), Cardiovascular disease (I20-I25), Atrial fibrillation (I48), Cardiomyopathy (I42), Peripheral vascular diseases (I73), Myocardial infarction (I21-I22), Heart failure (I50). Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with severe mental disorders with those without severe mental disorders.	At least 1 year after being diagnosed with severe mental disorders during the study period (2019-2023)
Risk of endocrine system diseases	At least one of the following diagnoses in the electronic health records : Diabetes mellitus (E10-E14), Thyroid disorder (E00-E05, E61-E69, E07), Gout (E79, M10). Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with severe mental disorders with those without severe mental disorders.	At least 1 year after being diagnosed with severe mental disorders during the study period (2019-2023)
Risk of pulmonary system and allergy diseases	At least one of the following diagnoses in the electronic health records : Chronic pulmonary disease (J40-J47), Allergy (J30.1-J30.4, L23, L50.0, T78.0, T78.2, T78.4). Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with severe mental disorders with those without severe mental disorders.	At least 1 year after being diagnosed with severe mental disorders during the study period (2019-2023)
Risk of gastrointestinal system diseases	At least one of the following diagnoses in the electronic health records : Ulcer/chronic gastritis (K22.1, K25-K28, K29.3-K29.5), Chronic liver disease (B16-B19, K70, K74, K76.6, I85), Inflammatory bowel disease (K50-K51), Diverticular disease of intestine (K57). Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with severe mental disorders with those without severe mental disorders.	At least 1 year after being diagnosed with severe mental disorders during the study period (2019-2023)
Risk of musculoskeletal system diseases	At least one of the following diagnoses in the electronic health records :Connective tissue disorders (M05-M06, M08-M09, M30-M36, D86), Osteoporosis (M80-M82). Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with severe mental disorders with those without severe mental disorders.	At least 1 year after being diagnosed with severe mental disorders during the study period (2019-2023)
Risk of urogenital system diseases	At least one of the following diagnoses in the electronic health records : Chronic kidney disease (N03, N11, N18-N19), Prostate disorders (N40). Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with severe mental disorders with those without severe mental disorders.	At least 1 year after being diagnosed with severe mental disorders during the study period (2019-2023)
Risk of hematological system diseases	At least one of the following diagnoses in the electronic health records : HIV/AIDS (B20-B24), Anemias (D50-D53, D55-D59, D60-D61, D63-D64). Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with severe mental disorders with those without severe mental disorders.	At least 1 year after being diagnosed with severe mental disorders during the study period (2019-2023)
Risk of cancers	Diagnosed with cancer (C00-C43, C45-C97) in electronic health records. Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with severe mental disorders with those without severe mental disorders.	At least 1 year after being diagnosed with severe mental disorders during the study period (2019-2023)
Risk of neurological system diseases	At least one of the following diagnoses in the electronic health records :Vision problem (H40, H25, H54), Hearing problem (H90-H91, H93.1), Migraine (G43), Epilepsy (G40-G41), Parkinson's disease (G20-G22), Multiple sclerosis (G35), Neuropathies (G50-G64). Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with severe mental disorders with those without severe mental disorders.	At least 1 year after being diagnosed with severe mental disorders during the study period (2019-2023)
Risk of suicide	At least one of the following records in the Ningbo Mental Health Information System: attempted suicide, suicide, death by suicide. Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with severe mental disorders with those without severe mental disorders.	Recorded during the study period (2019-2023)
Risk of violence	At least one of the following records in the Ningbo Mental Health Information System: causing trouble, causing an accident, committing an offence, injuring another person. Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with severe mental disorders with those without severe mental disorders.	Recorded during the study period (2019-2023)

Collaborators and Investigators

• Sponsor: Ningbo University
• Collaborators: The Affiliated Kangning Hospital of Ningbo University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): December 31, 2023
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 12, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Severe Mental Disorder; Longitudinal study; Population-based healthcare database; Ambispective Cohort
• Additional Relevant MeSH Terms: Nervous System Diseases; Mood Disorders; Neurologic Manifestations; Neurobehavioral Manifestations; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Neurodevelopmental Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders; Bipolar Disorder; Paranoid Disorders; Intellectual Disability; Affective Disorders, Psychotic
• Other Study ID Numbers: NBU-2024-011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No