Mental DisordersNCT05731102
Diagnostic Survey of Mental and Substance Use Disorders Among Norwegian College and University Students
An observational study of Mental Disorders and Substance Use Disorders, run by Norwegian Institute of Public Health at 1 site in Norway.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Disorders, Substance Use Disorders, Treatment
- What is being tested?
- Electronic version of the Composite International Diagnostic Interview 5th version (E-CIDI 5.0)
- How many people
- 9,585 participants
- Where
- 1 siteNorway
- Study dates
- 24 Jan 2023to 20 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 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%. When 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.
Who may be able to join
- Being a fulltime college or university student
- Norwegian citizenship
- Ages 18-35 years
- Sufficient understanding of Norwegian or English to conduct the interview
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Students' Health and Wellbeing Study (SHOT) 2022
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
Read the detailed description
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.
- Conditions
- Mental Disorders, Substance Use Disorders, Treatment, Participation
- Being tested
- Electronic version of the Composite International Diagnostic Interview 5th version (E-CIDI 5.0)
- Medical subject headings
- Mental Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic version of the Composite International Diagnostic Interview 5th version (E-CIDI 5.0)Diagnostic test
Observational study assessing prevalence of mental and substance use disorders among college and university students
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of mental and substance use disorders
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.
Measured: January 2023 to February 2023
Secondary outcomes (1)
The characteristics of nonparticipants in a psychiatric diagnostic survey
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.
Measured: January 2023 to February 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start24 Jan 2023
- Primary completion20 Feb 2023
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 9,585 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Institute of Public Health
- Sponsor type
- Other government
- Collaborators
- Statistics Norway, Society of Interventional Oncology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731102
- Sponsor's protocol ID
- PDB1841
- Status last verified
- Nov 2023
- First submitted
- 7 Feb 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 37927428Jacobsen LM, Haugan G, Patten S, Braaten T, Sivertsen B, Bjerkeset O. Suicide attempts, self-harm and suicidal ideation among Norwegian university students with eating disorders and disordered eating: the SHoT study 2018 and 2022. BMC Psychiatry. 2026 May 30. doi: 10.1186/s12888-026-08229-0. Online ahead of print.
PubMed 42218456
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Students' Health and Wellbeing Study (SHOT) 2022
- ClinicalTrials.gov ID
- NCT05731102
- Acronym / sponsor ID
- PDB1841
- Conditions
- Mental Disorders, Substance Use Disorders, Treatment, Participation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,585 participants (actual)
- Lead sponsor
- Norwegian Institute of Public HealthOther government
- Collaborators
- Statistics Norway, Society of Interventional Oncology
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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%. When 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.
Key inclusion criteria (4 listed)
- Being a fulltime college or university student
- Norwegian citizenship
- Ages 18-35 years
- Sufficient understanding of Norwegian or English to conduct the interview
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic version of the Composite International Diagnostic Interview 5th version (E-CIDI 5.0)Observational study assessing prevalence of mental and substance use disorders among college and university students | Diagnostic test | – |
Primary outcome
Prevalence of mental and substance use disorders
Time frame: January 2023 to February 2023
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.
1 secondary outcome
The characteristics of nonparticipants in a psychiatric diagnostic survey
Time frame: January 2023 to February 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Results publication: PubMed 37927428Sivertsen 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.
- Derived from this study: PubMed 42218456Jacobsen LM, Haugan G, Patten S, Braaten T, Sivertsen B, Bjerkeset O. Suicide attempts, self-harm and suicidal ideation among Norwegian university students with eating disorders and disordered eating: the SHoT study 2018 and 2022. BMC Psychiatry. 2026 May 30. doi: 10.1186/s12888-026-08229-0. Online ahead of print.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Disorders and Substance Use Disorders, run by Norwegian Institute of Public Health at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of mental and substance use disorders (time frame: January 2023 to February 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05731102, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.