- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06804525
LHC-CIDI-5 in Hong Kong
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.
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.
Study Overview
Status
Conditions
- Suicidal Ideation
- Panic Disorder
- Panic Attack
- Major Depressive Disorder (MDD)
- Bipolar I Disorder
- Alcohol Use Disorder (AUD)
- Bipolar II Disorder
- Posttraumatic Stress Disorder (PTSD)
- Manic Episode
- Obsessive-Compulsive Disorder (OCD)
- Substance Use Disorder (SUD)
- Generalized Anxiety Disorder (GAD)
- Nonsuicidal Self-Injury
- Suicidal Attempt
- Major Depressive Episode (MDE)
- Persistent Depressive Disorder (PDD)
- Suicidal Plan
- Suicidal Gesture
- Hypomanic
- Bipolar Sub Disorder
- Intermittent Explosive Disorder (IED)
- PCL-SC PTSD
- PCL-5 PTSD
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yoona Kim, PhD
- Phone Number: 852+39179109
- Email: yoonak@hku.hk
Study Contact Backup
- Name: Rusi Long, MHS
- Phone Number: 852+39102308
- Email: rlong36@hku.hk
Study Locations
-
-
-
Hong Kong, Hong Kong
- Recruiting
- The University of Hong Kong
-
Contact:
- Yoona Kim, PhD
- Phone Number: 852+39179109
- Email: yoonak@hku.hk
-
Principal Investigator:
- Michael Y. Ni, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Domestic workers
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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-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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression
Time Frame: Immediately following intervention or recruitment
|
The main outcomes in this module are the lifetime prevalence of Major Depressive Episode (MDE) and Major Depressive Disorder (MDD)
|
Immediately following intervention or recruitment
|
|
Persistent Depression
Time Frame: Immediately following intervention or recruitment
|
The main outcome in this module is the lifetime prevalence of Persistent Depressive Disorder (PDD)
|
Immediately following intervention or recruitment
|
|
Self Harm
Time Frame: Immediately following intervention or recruitment
|
The main outcomes in this module are the lifetime prevalence of Suicidal Ideation, Suicidal Plan, Suicidal Attempt, Suicidal Gesture, and Nonsuicidal Self-Injury.
|
Immediately following intervention or recruitment
|
|
High Mood
Time Frame: Immediately following intervention or recruitment
|
The main outcomes in this module are the lifetime prevalence of Manic Episode, Hypomanic, Bipolar I Disorder, Bipolar Sub Disorder, and Bipolar II Disorder
|
Immediately following intervention or recruitment
|
|
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)
|
Immediately following intervention or recruitment
|
|
Anger Attacks
Time Frame: Immediately following intervention or recruitment
|
The main outcome in this module is the lifetime prevalence of Intermittent Explosive Disorder (IED)
|
Immediately following intervention or recruitment
|
|
Panic Attacks
Time Frame: Immediately following intervention or recruitment
|
The main outcomes in this module are the lifetime prevalence of Panic Attack and Panic Disorder.
|
Immediately following intervention or recruitment
|
|
Obsessions and Compulsions
Time Frame: Immediately following intervention or recruitment
|
The main outcome in this module is the lifetime prevalence of Obsessive-Compulsive Disorder (OCD)
|
Immediately following intervention or recruitment
|
|
Stressful Experiences
Time Frame: Immediately following intervention or recruitment
|
The main outcomes in this module are the lifetime prevalence of Posttraumatic Stress Disorder (PTSD), PCL-SC PTSD, and PCL-5 PTSD.
|
Immediately following intervention or recruitment
|
|
Tobacco, Alcohol, and Drugs
Time Frame: Immediately following intervention or recruitment
|
The main outcomes in this module are the lifetime prevalence of Alcohol Use Disorder (AUD) and Substance Use Disorder (SUD)
|
Immediately following intervention or recruitment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Y. Ni, MD, The University of Hong Kong
Publications and helpful links
General 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.
- Axinn 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Trauma and Stressor Related Disorders
- Bipolar and Related Disorders
- Neurologic Manifestations
- Nervous System Diseases
- Behavioral Symptoms
- Neurobehavioral Manifestations
- Chemically-Induced Disorders
- Alcohol-Related Disorders
- Mood Disorders
- Suicide
- Anxiety Disorders
- Stress Disorders, Traumatic
- Depressive Disorder
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Mania
- Suicidal Ideation
- Alcoholism
- Bipolar Disorder
- Substance-Related Disorders
- Mental Disorders
- Depressive Disorder, Major
- Disruptive, Impulse Control, and Conduct Disorders
- Stress Disorders, Post-Traumatic
- Obsessive-Compulsive Disorder
- Panic Disorder
- Self-Injurious Behavior
- Generalized Anxiety Disorder
Other Study ID Numbers
- UW 24-771
- 2024-0089-004 (Other Grant/Funding Number: Hong Kong Jockey Club Charities Trust)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Suicidal Ideation
-
Northwestern UniversityNot yet recruitingSuicidal Ideation and Behavior
-
University GhentRecruitingSuicide | Suicidal Ideation and Behavior | Crisis InterventionBelgium
-
Shira BarzilaySchneider Children's Medical Center, IsraelRecruiting
-
University of WashingtonUnited States Department of Defense; Military Suicide Research ConsortiumCompletedSuicidal and Self-injurious Behavior | Suicidal Ideation ActiveUnited States
-
The Catholic University of AmericaUniversity of Washington; VA Office of Research and DevelopmentCompletedSuicidal and Self-injurious Behavior | Suicidal Ideation Active
-
Emory UniversityGeorgia Institute of TechnologyCompletedSuicide, Suicidal IdeationUnited States
-
Columbia UniversityNational Institute of Mental Health (NIMH)RecruitingSuicidal Ideation and BehaviorUnited States
-
Bradley HospitalNational Institute of Mental Health (NIMH); Instituto Nacional de Psiquiatría...Not yet recruitingSuicidal Ideation/BehaviorMexico
-
Oriana Arellano FaúndezActive, not recruitingSuicidal Ideation | Suicidal Ideation and BehaviorsChile
-
VA Office of Research and DevelopmentJames J. Peters Veterans Affairs Medical Center; VISN 2 Mental Illness Research... and other collaboratorsRecruitingHealth | Reintegration Difficulties | Suicidal Ideation and Behaviors | ConnectednessUnited States
Clinical Trials on CIDI-5
-
The University of Hong KongRecruitingMajor Depressive Disorder (MDD) | Posttraumatic Stress Disorder (PTSD) | Generalized Anxiety Disorder (GAD)Hong Kong
-
Norwegian Institute of Public HealthNorwegian University of Science and TechnologyCompletedMental Disorders | Substance Use Disorders | Treatment | ParticipationNorway
-
Norwegian Institute of Public HealthStatistics Norway; Society of Interventional OncologyCompletedMental Disorders | Substance Use Disorders | Treatment | ParticipationNorway
-
Fresenius Medical Care Deutschland GmbHCompleted
-
National Institute of Public Health, CambodiaEmory University; World Vision International; World Vision, Hong Kong; World Vision...CompletedUnderweight Children Aged 6-23 Month Old (WAZ < -1)Cambodia
-
ClinAmygateAswan University HospitalActive, not recruitingCholecystolithiasis | Cholecystitis; Gallstone | Cholecystitis, ChronicEgypt
-
Taipei Medical University Shuang Ho HospitalCompletedLower Urinary Tract Symptoms | Overactive Bladder SyndromeTaiwan
-
U.S. Army Medical Research and Development CommandRecruitingStress Disorders, Post-TraumaticUnited States
-
Suzhou Kintor Pharmaceutical Inc,Suzhou Koshine Biomedica, Inc.Active, not recruiting
-
UNC Lineberger Comprehensive Cancer CenterNational Cancer Institute (NCI); UNC Department of Obstetrics and GynecologyNot yet recruitingHIV Infections | Cervix Cancer | HPV Infection | CIN | Cervical Intraepithelial Neoplasia Grade 1 | CIN1 | CIN2 | CIN3 | Cervical Intraepithelial Neoplasia Grade 3 | Cervical Intraepithelial Neoplasia Grade 2/3Kenya