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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04661228
Other study ID # PDB 2655
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2, 2018
Est. completion date September 18, 2020

Study information

Verified date December 2020
Source Norwegian Institute of Public Health
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 use disorders, iv) conduct a thorough nonparticipation analysis.


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.


Recruitment information / eligibility

Status Completed
Enrollment 4242
Est. completion date September 18, 2020
Est. primary completion date September 18, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria: - Sufficient understanding of Norwegian or English to conduct the interview Exclusion Criteria: - None

Study Design


Intervention

Diagnostic Test:
Composite International Diagnostic Interview 5th version (CIDI 5.0)
Observational study assessing prevalence of mental and substance use disorders in the general population

Locations

Country Name City State
Norway Norwegian Institute of Public Health Oslo

Sponsors (2)

Lead Sponsor Collaborator
Norwegian Institute of Public Health Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. November 2018 to September 2020
Secondary 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. November 2018 to September 2020
Secondary 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. November 2018 to September 2021
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