- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04661228
Diagnostic Survey of Mental and Substance Use Disorders in HUNT (PsykHUNT) (PsykHUNT)
December 9, 2020 updated by: Norwegian Institute of Public Health
Diagnosebasert undersøkelse Psykiske Lidelser og Ruslidelser
The aims of this observational survey are to i) gather experience on how to conduct a prevalence study of mental disorders in the Norwegian setting, ii) collect data on the prevalence, risk factors and consequences of mental and substance use disorders, iii) collect data on treatment coverage for mental and substance use disorders, iv) conduct a thorough nonparticipation analysis.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The psychiatric survey was a sub-project in the fourth wave of the Trøndelag Health Study (HUNT4), conducted on HUNT4 participants aged 20 to 65 years from the geographical areas Nord-Trøndelag and the city of Trondheim.
The targeted sample size was 4,000 participants, and 16,602 persons from the study population of HUNT4 participants were invited to reach this goal.
The only exclusion criterion was insufficient understanding of Norwegian or English.
The investigators had complete lists with postal addresses and mobile phone numbers for all eligible participants as well as information about date of birth and gender.
Potential participants were sampled in repeated probability sampling draws over the course of the data-collection period, which lasted from November 2nd 2018 to September 18th 2020.
Younger persons were oversampled to adjust for the expected larger nonparticipation among these age-groups.
The predesignated participants were informed about the project through postal letters.
A week after receipt of the letter, each received an SMS with information on how to sign up for the psychiatric interview.
One SMS reminder was sent to persons who did not respond to the initial invitation.
The investigators made four contact attempts to schedule the interview amongst those who registered; three by phone and one final by SMS.
All participants received a $30 gift card as a token of appreciation.
Computer assisted face-to-face or telephone interviews were conducted by trained and certified interviewers at local field stations.
The World Health Organization (WHO) Composite International Diagnostic Interview, fifth version (CIDI 5.0) was used as instrument in the data-collection.
Study Type
Observational
Enrollment (Actual)
4242
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Oslo, Norway
- Norwegian Institute of Public Health
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Sub-sample of participants from the fourth round of the Trøndelag Health Study (HUNT4).
All residents in Trøndelag county of Norway above age 18 were invited to the HUNT4 study.
Description
Inclusion Criteria:
- Sufficient understanding of Norwegian or English to conduct the interview
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of mental and substance use disorders in the general population, and by age, gender, educational attainment and urban/rural residency
Time Frame: November 2018 to September 2020
|
Mental and substance use disorders assessed in standardised diagnostic interviews employing the Composite International Diagnostic Interview (CIDI 5.0).
Diagnostis criteria after ICD-10 and DSM-V.
|
November 2018 to September 2020
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The characteristics of nonparticipants in a psychiatric diagnostic survey
Time Frame: November 2018 to September 2020
|
Compare characteristics of participants versus nonparticipants in the survey in terms of age, gender, educational attainment, mental health symptoms, alcohol use, and use of health services for mental health problems.
Data will be retrieved from the HUNT4 study, and official administrative registries and health registries.
|
November 2018 to September 2020
|
|
The treatment gap for mental and substance use disorders in the general population
Time Frame: November 2018 to September 2021
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Quantify the gap between perceived need for treatment for mental health problems and received adequate treatment using data from CIDI in linkage with data from official health registries.
|
November 2018 to September 2021
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Anne Reneflot, PhD, Norwegian IPH
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 2, 2018
Primary Completion (Actual)
September 18, 2020
Study Completion (Actual)
September 18, 2020
Study Registration Dates
First Submitted
December 3, 2020
First Submitted That Met QC Criteria
December 3, 2020
First Posted (Actual)
December 10, 2020
Study Record Updates
Last Update Posted (Actual)
December 11, 2020
Last Update Submitted That Met QC Criteria
December 9, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PDB 2655
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Researchers may gain access to participant data by contacting the PsykHUNT publication committee (anne.reneflot@fhi.no).
Approval from the Norwegian Regional Committee for Medical and Health Research Ethics (https://helseforskning.etikkom.no) is a pre-requirement.
The PsykHUNT dataset is administrated by the HUNT databank.
Guidelines for access to PsykHUNT data are found at https://www.ntnu.edu/hunt/data.
IPD Sharing Time Frame
June 2021 to September 2030.
IPD Sharing Access Criteria
Approval from the Norwegian Regional Committee for Medical and Health Research Ethics (https://helseforskning.etikkom.no).
The data must be stored in secure servers which require log in and from which no data can be extracted and copied.
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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