Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT05731102
Status:
COMPLETED
Last Update Posted:
2023-12-07
First Post:
2023-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnostic Survey of Mental and Substance Use Disorders Among Norwegian College and University Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9585}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-30', 'studyFirstSubmitDate': '2023-02-07', 'studyFirstSubmitQcDate': '2023-02-07', 'lastUpdatePostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of mental and substance use disorders', 'timeFrame': 'January 2023 to February 2023', 'description': 'Mental and substance use disorders assessed in standardised diagnostic interviews employing the Composite International Diagnostic Interview (CIDI 5.0). Diagnostic criteria after ICD-10 and DSM-5.'}], 'secondaryOutcomes': [{'measure': 'The characteristics of nonparticipants in a psychiatric diagnostic survey', 'timeFrame': 'January 2023 to February 2023', 'description': 'Compare characteristics of participants versus nonparticipants in the survey in terms of age, gender, mental health symptoms, alcohol use, and use of health services for mental health problems. Data will be retrieved from the SHOT 2022 study, and official administrative registries and health registries.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mental Disorders', 'Substance Use Disorders', 'Treatment', 'Participation']}, 'referencesModule': {'references': [{'pmid': '37927428', 'type': 'RESULT', 'citation': 'Sivertsen B, Knudsen AKS, Kirkoen B, Skogen JC, Lagerstrom BO, Lonning KJ, Kessler RC, Reneflot A. Prevalence of mental disorders among Norwegian college and university students: a population-based cross-sectional analysis. Lancet Reg Health Eur. 2023 Sep 19;34:100732. doi: 10.1016/j.lanepe.2023.100732. eCollection 2023 Nov.'}]}, 'descriptionModule': {'briefSummary': 'The aims of this observational survey are to 1) collect data on the prevalence of mental and substance use disorders, and 2) investigate risk factors and consequences of mental and substance use disorder', 'detailedDescription': "This project focuses on mental health, quality of life and alcohol and substance use in students pursuing higher education. The targeted population, all Norwegian college and university students, are in an important and vulnerable period of life transitions. The overall aim of the current project is two-fold: First, the investigators will conduct a clinical assessment of mental disorders by using the newly developed electronic version of the World Health Organization (WHO) Composite International Diagnostic Interview, fifth version (CIDI 5.0), developed for the WHO World Mental Health Surveys. CIDI 5.0 is a standardized interview assessing 30-days,12 months and lifetime prevalence for several mental and substance use disorders according to diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) and International Classification of Diseases 10th edition (ICD-10). The overall aim of this will be to obtain accurate prevalence rates of disorders, as well as to validate and compare the briefer instrument used in the Students' Health and Wellbeing Study (SHOT), including the Hopkins Symptom Checklist-25 (HSCL-25). Second, the investigators will examine risk factors based on data from the SHoT, which is one of the world's largest epidemiological studies of student health."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The base study population of the current study stem from the SHoT 2022 study, a large national survey of students enrolled in higher education in Norway. The SHoT 2022 was a comprehensive survey of several domains of mental health and lifestyle factors, distributed electronically through a web-based platform. In short, SHoT 2022 was conducted between February 8 and April 19, 2022, and invited all full-time Norwegian students pursuing higher education. In all, 169,572 students fulfilled the inclusion criteria, of whom 59,544 students completed the online questionnaires, yielding a response rate of 35.1%.\n\nWhen consenting to participate in the SHOT2022, the students were also asked to indicate if they wished be invited to a follow-up study of mental disorders, of whom 26,311 consented.', 'genderDescription': 'Sexes Eligible for Study: All', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being a fulltime college or university student\n* Norwegian citizenship\n* Ages 18-35 years\n* Sufficient understanding of Norwegian or English to conduct the interview\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT05731102', 'briefTitle': 'Diagnostic Survey of Mental and Substance Use Disorders Among Norwegian College and University Students', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Norwegian Institute of Public Health'}, 'officialTitle': "Students' Health and Wellbeing Study (SHOT) 2022", 'orgStudyIdInfo': {'id': 'PDB1841'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Electronic version of the Composite International Diagnostic Interview 5th version (E-CIDI 5.0)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Observational study assessing prevalence of mental and substance use disorders among college and university students'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Bergen', 'country': 'Norway', 'facility': 'Norwegian Institute of Public Health', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'August 2023 to September 2030.', 'ipdSharing': 'YES', 'description': 'Researchers may gain access to participant data by contacting the SHOT publication committee. Approval from the Norwegian Regional Committee for Medical and Health Research Ethics is a pre-requirement. The SHOT dataset is administrated by the Norwegian Institute of Public Health.', 'accessCriteria': 'Approval from the Norwegian Regional Committee for Medical and Health Research Ethics. The data must be stored in secure servers which require log in and from which no data can be extracted and copied.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian Institute of Public Health', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Statistics Norway', 'class': 'INDUSTRY'}, {'name': 'Society of Interventional Oncology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}