Major Depressive Disorder (MDD)NCT07604753
Validation of the CIDI 5.0 Against the SCID-5 for Lifetime Mental Disorders
An observational study of Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD), run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), Posttraumatic Stress Disorder (PTSD)
- What is being tested?
- CIDI-5
- How many people
- 300 participants
- Where
- 1 siteHong Kong
- Study dates
- 14 May 2025to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Domestic workers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
Yoona Kim, PhD, +852 3917 9109, yoonak@hku.hk
About this study
Official title: Validity of the World Health Organization CIDI 5.0 for Assessing Lifetime Prevalence of Mental Disorders: A Clinical Reappraisal Study Using the SCID-5
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)
- Being tested
- CIDI-5
- Keywords
- CIDI, Lifetime prevalence, Mental disorders, Clinical validation
- Medical subject headings
- Depressive Disorder, Major, Generalized Anxiety Disorder, Stress Disorders, Post-Traumatic, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIDI-5Diagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: CIDI-5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
The main outcome in this module is the lifetime prevalence of Major Depressive Disorder (MDD)
Measured: Immediately following intervention or recruitment
Worry and Anxiety
The main outcome in this module is the lifetime prevalence of Generalized Anxiety Disorder (GAD)
Measured: Immediately following intervention or recruitment
Stressful Experiences
The main outcome in this module is the lifetime prevalence of PTSD.
Measured: Immediately following intervention or recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start14 May 2025
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Y. Ni, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604753
- Sponsor's protocol ID
- UW 24-771-2
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38726881Haro 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.
PubMed 17266013
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of the World Health Organization CIDI 5.0 for Assessing Lifetime Prevalence of Mental Disorders: A Clinical Reappraisal Study Using the SCID-5
- ClinicalTrials.gov ID
- NCT07604753
- Acronym / sponsor ID
- UW 24-771-2
- Conditions
- Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), Posttraumatic Stress Disorder (PTSD)
- Keywords
- CIDI, Lifetime prevalence, Mental disorders, Clinical validation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 14 May 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 22 May 2026 (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 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CIDI-5 Validation Cohort | – | Diagnostic Test: CIDI-5This 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Domestic workers
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 |
|---|---|---|
| CIDI-5The 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. | Diagnostic test | CIDI-5 Validation Cohort |
Primary outcome
Depression
Time frame: Immediately following intervention or recruitment
The main outcome in this module is the lifetime prevalence of Major Depressive Disorder (MDD)
Worry and Anxiety
Time frame: Immediately following intervention or recruitment
The main outcome in this module is the lifetime prevalence of Generalized Anxiety Disorder (GAD)
Stressful Experiences
Time frame: Immediately following intervention or recruitment
The main outcome in this module is the lifetime prevalence of PTSD.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 38726881Khaled 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.
- Background: PubMed 17266013Haro 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.
- Individual participant dataSharing planned: Undecided
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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.
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 Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD), run by The University of Hong Kong at 1 site in Hong Kong.
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 5 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: looking for participants now, as of the sponsor's last update on 22 May 2026. 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 Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yoona Kim, PhD (+852 3917 9109, yoonak@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: Immediately following intervention or recruitment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07604753, which also lists 2 linked publications.
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 22 May 2026.