protocolSection identificationModule nctId: NCT06370793, orgStudyIdInfo id: NBU-2024-011, briefTitle: Ningbo Severe Mental Disorders Cohort, acronym: NEED, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2018-07-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Ningbo University, class: OTHER, collaborators name: The Affiliated Kangning Hospital of Ningbo University, descriptionModule briefSummary: 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., conditionsModule conditions: Severe Mental Disorder, conditions: Schizophrenia, conditions: Bipolar Disorder, conditions: Schizo-Affective Psychosis, conditions: Paranoid Psychoses, conditions: Mental Retardation, conditions: Epileptic Psychosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 57212, type: ACTUAL, armsInterventionsModule interventions name: Patient with severe mental disorder without intervention, outcomesModule primaryOutcomes measure: Risk of circulatory system diseases, primaryOutcomes measure: Risk of endocrine system diseases, primaryOutcomes measure: Risk of pulmonary system and allergy diseases, primaryOutcomes measure: Risk of gastrointestinal system diseases, primaryOutcomes measure: Risk of musculoskeletal system diseases, primaryOutcomes measure: Risk of urogenital system diseases, primaryOutcomes measure: Risk of hematological system diseases, primaryOutcomes measure: Risk of cancers, primaryOutcomes measure: Risk of neurological system diseases, primaryOutcomes measure: Risk of suicide, primaryOutcomes measure: Risk of violence, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ningbo Mental Health Information System, city: Ningbo, state: Zhejiang, zip: 315000, country: China, geoPoint lat: 29.87819, lon: 121.54945, hasResults: False