Major Depressive Episode (MDE)NCT06804525
LHC-CIDI-5 in Hong Kong
An observational study of Major Depressive Episode (MDE) and Major Depressive Disorder (MDD), run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Major Depressive Episode (MDE), Major Depressive Disorder (MDD), Persistent Depressive Disorder (PDD)
- What is being tested?
- CIDI-5 and LHC-CIDI-5
- How many people
- 2,500 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 Jan 2025to Apr 2027
- Phase
- Observational
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 25 years and older
- All sexes
- 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. For participants who consent to join the DHP study, a sub-sample of 2,500 participants aged 25 or above will be randomly selected and assigned to two groups through a random process. All 2,500 individuals will complete the survey for the DHP study, including the CIDI-5 section. When administering the CIDI-5, one group of 1,250 individuals will be interviewed using only the CIDI-5, while the other group of 1,250 individuals will be interviewed with LHC first, followed by the CIDI-5.
Who may be able to join
- All household members aged 25 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+39179109, yoonak@hku.hk
Michael Y. Ni, MD
About this study
Official title: Use of Life History Calendars to Enhance Measurement of Lifetime Experience With Mental Disorders in Hong Kong.
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). However, retrospective measurements like the CIDI-5 are susceptible to recall bias, especially for the lifetime experience, which can hinder the reporting accuracy with mental disorders.
To mitigate this issue, the life history calendar (LHC) was introduced as an aid to assist respondents in recalling the timing of life events, enhancing the ability of the CIDI-5 to measure the lifetime prevalence of mental disorders. The LHC is a grid structure with columns representing time units and rows representing life domains under study.
Read more
In a study conducted in Nepal, combining the CIDI-5 with the LHC resulted in a significant increase in the detection of mental disorders compared to using the CIDI-5 alone. This approach did not lead to an increase in false positives after clinical validation.
This experiment aims to adapt a Hong Kong version of the LHC based on the Nepalese model and evaluate the effectiveness of the LHC-assisted CIDI-5 (LHC-CIDI-5) compared to the CIDI-5 alone in assessing mental disorders.
- Conditions
- Major Depressive Episode (MDE), Major Depressive Disorder (MDD), Persistent Depressive Disorder (PDD), Suicidal Ideation, Suicidal Plan, Suicidal Attempt
- Being tested
- CIDI-5, LHC-CIDI-5
- Keywords
- Life History Calendar, CIDI, Recall bias, Retrospective reporting, Lifetime prevalence, Mental disorders
- Medical subject headings
- Depressive Disorder, Major, Suicidal Ideation, Self-Injurious Behavior, Mania, Bipolar Disorder, Generalized Anxiety Disorder, Disruptive, Impulse Control, and Conduct Disorders, Panic Disorder
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 administrate selected modules from the Hong Kong version of the CIDI-5 in a computer-assisted personal interview to measure the outcomes.
LHC-CIDI-5Diagnostic test
The interviewer will start by asking the respondent's age and significant personal experiences, which is expected to take 15 minutes. Remembering and recording the experiences provide cognitive engagement and information which can further serve as memory cues for respondents in the following screening of CIDI-5. Subsequently, the respondents will proceed to the screening section for CIDI-5 and will refer to the completed calendar from the LHC section when they are asked to report lifetime experience or age-of-onset for mental disorders. Trained interviewers will conduct all interviews in a computer-assisted personal interview. To validate the diagnoses in the LHC-CIDI-5 group, clinical re-interviews for MDD, GAD, and PTSD will be conducted by a trained mental health professional with previous experience using DSM-5.
| Study group | Role | What they receive |
|---|---|---|
| CIDI-5 | For the CIDI-5 group, respondents will directly partake in the CIDI-5 interview without responding to any inquiries regarding their life history. Receives: Diagnostic Test: CIDI-5 | |
| LHC-CIDI-5 | For the LHC-CIDI-5 group, respondents, before initiating the CIDI-5, will begin with LHC, completing a calendar by answering questions about important personal experiences since birth until the interview year. Receives: Diagnostic Test: LHC-CIDI-5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
The main outcomes in this module are the lifetime prevalence of Major Depressive Episode (MDE) and Major Depressive Disorder (MDD)
Measured: Immediately following intervention or recruitment
Persistent Depression
The main outcome in this module is the lifetime prevalence of Persistent Depressive Disorder (PDD)
Measured: Immediately following intervention or recruitment
Self Harm
The main outcomes in this module are the lifetime prevalence of Suicidal Ideation, Suicidal Plan, Suicidal Attempt, Suicidal Gesture, and Nonsuicidal Self-Injury.
Measured: Immediately following intervention or recruitment
High Mood
The main outcomes in this module are the lifetime prevalence of Manic Episode, Hypomanic, Bipolar I Disorder, Bipolar Sub Disorder, and Bipolar II Disorder
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
Anger Attacks
The main outcome in this module is the lifetime prevalence of Intermittent Explosive Disorder (IED)
Measured: Immediately following intervention or recruitment
Panic Attacks
The main outcomes in this module are the lifetime prevalence of Panic Attack and Panic Disorder.
Measured: Immediately following intervention or recruitment
Obsessions and Compulsions
The main outcome in this module is the lifetime prevalence of Obsessive-Compulsive Disorder (OCD)
Measured: Immediately following intervention or recruitment
Stressful Experiences
The main outcomes in this module are the lifetime prevalence of Posttraumatic Stress Disorder (PTSD), PCL-SC PTSD, and PCL-5 PTSD.
Measured: Immediately following intervention or recruitment
Tobacco, Alcohol, and Drugs
The main outcomes in this module are the lifetime prevalence of Alcohol Use Disorder (AUD) and Substance Use Disorder (SUD)
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 posted3 Feb 2025
- Study start18 Jan 2025
- Primary completionSep 2026 (estimated)
- Study completionApr 2027 (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 Episode (MDE)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
- 2,500 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
- Investigators
- Michael Y. Ni, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804525
- Sponsor's protocol ID
- UW 24-771
- Other IDs
- 2024-0089-004
- Status last verified
- Mar 2026
- First submitted
- 24 Jan 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Amro I, Ali A, Hassan MHMO, Al Shawwaf M, Alhassan A, Al Bahari D, El Fakki H, Hijawi Z, Aly S, Amin A, Mohammed R, Nofal M, Abdelkader M, Salman S, Currie J, Alabdulla M, Sampson NA, First M, Kessler RC, Woodruff PW, Khaled SM. Design and field procedures for the clinical reappraisal of the Composite International Diagnostic Interview version 3.3 in Qatar's national mental health study. Int J Methods Psychiatr Res. 2023 Sep;32(3):e1958. doi: 10.1002/mpr.1958. Epub 2023 Jan 18.
PubMed 36654500Axinn WG, Chardoul S, Gatny H, Ghimire DJ, Smoller JW, Zhang Y, Scott KM. Using life history calendars to improve measurement of lifetime experience with mental disorders. Psychol Med. 2020 Feb;50(3):515-522. doi: 10.1017/S0033291719000394. Epub 2019 Mar 11.
PubMed 30854987