NCT04661228

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,242

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 10, 2020

Completed
Last Updated

December 11, 2020

Status Verified

December 1, 2020

Enrollment Period

1.9 years

First QC Date

December 3, 2020

Last Update Submit

December 9, 2020

Conditions

Keywords

Mental DisordersSubstance Use DisordersTreatmentParticipation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • The characteristics of nonparticipants in a psychiatric diagnostic survey

    November 2018 to September 2020

  • The treatment gap for mental and substance use disorders in the general population

    November 2018 to September 2021

Interventions

Observational study assessing prevalence of mental and substance use disorders in the general population

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Sufficient understanding of Norwegian or English to conduct the interview

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian Institute of Public Health

Oslo, Norway

Location

Related Links

MeSH Terms

Conditions

Mental DisordersSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

  • Anne Reneflot, PhD

    Norwegian IPH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2020

First Posted

December 10, 2020

Study Start

November 2, 2018

Primary Completion

September 18, 2020

Study Completion

September 18, 2020

Last Updated

December 11, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
June 2021 to September 2030.
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.

Locations