Validation of the CIDI 5.0 Against the SCID-5 for Lifetime Mental Disorders

NCT07604753 | Recruiting

• 1 other identifier: UW 24-771-2
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The World Health Organization Composite International Diagnostic Interview (CIDI) is a fully structured diagnostic tool designed for lay interviewers to assess the prevalence of mental and substance use disorders. Earlier versions, such as the CIDI 3.0, demonstrated acceptable individual-level concordance with clinical assessments based on DSM-IV criteria (Haro et al. 2006). The latest iteration (CIDI 5.0) has been updated to operationalize DSM-5 criteria. Recent evidence from a large-scale, community-based national study in Qatar suggests that under DSM-5 criteria (Khaled et al. 2024), after recalibration, the CIDI 5.0 maintains high specificity (91.9% for MDD, 94.7% for GAD, and 85.5% for PTSD). Sensitivity suggested CIDI diagnoses aligned closely with clinical "gold standard" diagnoses (51.5% for MDD, 50.7% for GAD, and 77.3% for PTSD). Despite the evidence from Qatar, there remains a lack of evidence regarding the validity of the CIDI 5.0 in population-based studies. Therefore, this study aims to evaluate the diagnostic validity of the CIDI 5.0 for Lifetime MDD, GAD, and PTSD, using the Structured Clinical Interview for DSM-5 (SCID-5) as the definitive clinical gold standard.

Conditions

Major Depressive Disorder (MDD); Generalized Anxiety Disorder (GAD); Posttraumatic Stress Disorder (PTSD)

Keywords

CIDI; Lifetime prevalence; Mental disorders; Clinical validation

Outcome Measures

Primary Outcomes (3)

• Depression

  The main outcome in this module is the lifetime prevalence of Major Depressive Disorder (MDD)

  Immediately following intervention or recruitment

• Worry and Anxiety

  The main outcome in this module is the lifetime prevalence of Generalized Anxiety Disorder (GAD)

  Immediately following intervention or recruitment

• Stressful Experiences

  The main outcome in this module is the lifetime prevalence of PTSD.

  Immediately following intervention or recruitment

Study Arms (1)

CIDI-5 Validation Cohort

This group consists of participants from the general population who will complete the CIDI-5 interview. A stratified subsample will be selected for a follow-up clinical reappraisal using the SCID-5 to determine diagnostic accuracy.

Diagnostic Test: CIDI-5

Interventions

CIDI-5 DIAGNOSTIC_TEST

The World Health Organization Composite International Diagnostic Interview-5th (CIDI-5) is a standardized diagnostic tool used to assess the prevalence of mental and substance use disorders over varying time frames (30 days, 12 months, and lifetime) based on the diagnostic criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) and International Classification of Diseases 10th edition (ICD-10). Trained interviewers will administer selected modules from the Hong Kong version of the CIDI-5 in a computer-assisted personal interview to measure the outcomes. To validate the diagnoses in the CIDI-5 group, investigators will conduct clinical re-interviews of 3 selected CIDI-5 diagnoses: major depressive disorder (MDD), generalized anxiety disorder (GAD), and post-traumatic stress disorder (PTSD) using the Structured Clinician Interview for DSM-5 (SCID) by a trained mental health professional with previous experience using SCID.

CIDI-5 Validation Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study is a sub-study of the District Health Profile (DHP), which is a district-level representative descriptive cross-sectional study. In DHP, 1% of households in selected Hong Kong districts will be randomly selected from the Census and Statistics Department's list of quarters, with stratification based on districts and housing types; all persons aged 18 and above in the recruited households will be included and surveyed. All individuals will complete the survey for the DHP study, including the CIDI-5 section. Based on prior studies (Haro et al., 2006; Khaled et al., 2024), to ensure adequate statistical power and control for Type I error, the clinical validation study will include 300 individuals. 77 participants will serve as controls with no history of mental disorders, and the remaining sample size will consist of participants with at least one lifetime diagnosis of MDD, GAD, or PTSD, as identified by CIDI-5, aiming to reach at least 112 samples for each diagnosis.

You may qualify if:

• All household members aged 18 years old and over are randomly sampled from the Census and Statistics Department List of Quarters
• Live in the address sampled from the Census and Statistics Department List of Quarters
• Reside in Hong Kong for at least six months in the past year
• Able to read and communicate in Chinese or English
• Without linguistic or cognitive difficulties

You may not qualify if:

• Domestic workers

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (2)

• Khaled SM, Amro I, Abdelkader M, Al Bahari D, Al Shawwaf M, Alabdulla M, Alhassan A, Ali A, Aly S, Amin A, Chiu WT, Currie J, El Fakki H, First MB, Hassan MHO, Hijawi Z, Mohammed R, Nofal M, Salman S, Sampson NA, Woodruff PW, Kessler RC. Clinical reappraisal of the composite international diagnostic interview version 3.3 in Qatar's National Mental Health Study. Int J Methods Psychiatr Res. 2024 May;33(S1):e2013. doi: 10.1002/mpr.2013.

  PMID: 38726881 BACKGROUND

• Haro JM, Arbabzadeh-Bouchez S, Brugha TS, de Girolamo G, Guyer ME, Jin R, Lepine JP, Mazzi F, Reneses B, Vilagut G, Sampson NA, Kessler RC. Concordance of the Composite International Diagnostic Interview Version 3.0 (CIDI 3.0) with standardized clinical assessments in the WHO World Mental Health surveys. Int J Methods Psychiatr Res. 2006;15(4):167-80. doi: 10.1002/mpr.196.

  PMID: 17266013 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major; Generalized Anxiety Disorder; Stress Disorders, Post-Traumatic; Mental Disorders

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Anxiety Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Central Study Contacts

Yoona Kim, PhD

CONTACT

+852 3917 9109; yoonak@hku.hk

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: May 22, 2026
• Study Start: May 14, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-04

Locations

HK (1)