Mental DisordersPsykHUNTNCT04661228
Diagnostic Survey of Mental and Substance Use Disorders in HUNT (PsykHUNT)
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 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… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Disorders, Substance Use Disorders, Treatment
- What is being tested?
- Composite International Diagnostic Interview 5th version (CIDI 5.0)
- How many people
- 4,242 participants
- Where
- 1 siteNorway
- Study dates
- 2 Nov 2018to 18 Sep 2020
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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: 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.
Read the 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.
- Conditions
- Mental Disorders, Substance Use Disorders, Treatment, Participation
- Being tested
- Composite International Diagnostic Interview 5th version (CIDI 5.0)
- Keywords
- Mental Disorders, Substance Use Disorders, Treatment, Participation
- 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.
Composite International Diagnostic Interview 5th version (CIDI 5.0)Diagnostic test
Observational study assessing prevalence of mental and substance use disorders in the general population
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of mental and substance use disorders in the general population, and by age, gender, educational attainment and urban/rural residency
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.
Measured: November 2018 to September 2020
Secondary outcomes (2)
The characteristics of nonparticipants in a psychiatric diagnostic survey
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.
Measured: November 2018 to September 2020
The treatment gap for mental and substance use disorders in the general population
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.
Measured: November 2018 to September 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start2 Nov 2018
- Primary completion18 Sep 2020
- Study completion18 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 4,242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Institute of Public Health
- Sponsor type
- Other government
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Anne Reneflot, PhD, Principal investigator, Norwegian IPH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661228
- Sponsor's protocol ID
- PDB 2655
- Acronym
- PsykHUNT
- Status last verified
- Dec 2020
- First submitted
- 3 Dec 2020
- Last updated
- 11 Dec 2020
- 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 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosebasert undersøkelse Psykiske Lidelser og Ruslidelser
- ClinicalTrials.gov ID
- NCT04661228
- Acronym / sponsor ID
- PsykHUNT / PDB 2655
- Conditions
- Mental Disorders, Substance Use Disorders, Treatment, Participation
- Keywords
- Mental Disorders, Substance Use Disorders, Treatment, Participation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,242 participants (actual)
- Lead sponsor
- Norwegian Institute of Public HealthOther government
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- 18 Sep 2020 (actual)
- Study completion
- 18 Sep 2020 (actual)
- First posted
- 10 Dec 2020 (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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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 |
|---|---|---|
| Composite International Diagnostic Interview 5th version (CIDI 5.0)Observational study assessing prevalence of mental and substance use disorders in the general population | Diagnostic test | – |
Primary outcome
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.
2 secondary outcomes
The characteristics of nonparticipants in a psychiatric diagnostic survey
Time frame: 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
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 11 Dec 2020.
- Information in Norwegian about the surveyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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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.
Anne Reneflot, PhD principal investigator
Norwegian IPH
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 1 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 11 Dec 2020. 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 in the general population, and by age, gender, educational attainment and urban/rural residency (time frame: November 2018 to September 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2020.