NCT06804525

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Jan 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress64%
Jan 2025Apr 2027

Study Start

First participant enrolled

January 18, 2025

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

January 24, 2025

Last Update Submit

March 9, 2026

Conditions

Keywords

Life History CalendarCIDIRecall biasRetrospective reportingLifetime prevalenceMental disorders

Outcome Measures

Primary Outcomes (10)

  • Depression

    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

    The main outcome in this module is the lifetime prevalence of Persistent Depressive Disorder (PDD)

    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.

    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

    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

  • Anger Attacks

    The main outcome in this module is the lifetime prevalence of Intermittent Explosive Disorder (IED)

    Immediately following intervention or recruitment

  • Panic Attacks

    The main outcomes in this module are the lifetime prevalence of Panic Attack and Panic Disorder.

    Immediately following intervention or recruitment

  • Obsessions and Compulsions

    The main outcome in this module is the lifetime prevalence of Obsessive-Compulsive Disorder (OCD)

    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.

    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)

    Immediately following intervention or recruitment

Study Arms (2)

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.

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.

Diagnostic Test: LHC-CIDI-5

Interventions

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.

CIDI-5
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.

LHC-CIDI-5

Eligibility Criteria

Age25 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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. 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.

You may qualify if:

  • 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

You may not qualify if:

  • Domestic workers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (2)

  • 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.

    PMID: 36654500BACKGROUND
  • 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.

    PMID: 30854987BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, MajorSuicidal IdeationSelf-Injurious BehaviorManiaBipolar DisorderGeneralized Anxiety DisorderDisruptive, Impulse Control, and Conduct DisordersPanic DisorderObsessive-Compulsive DisorderStress Disorders, Post-TraumaticAlcoholismSubstance-Related DisordersMental Disorders

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersSuicideBehavioral SymptomsBehaviorNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBipolar and Related DisordersAnxiety DisordersStress Disorders, TraumaticTrauma and Stressor Related DisordersAlcohol-Related DisordersChemically-Induced Disorders

Study Officials

  • Michael Y. Ni, MD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoona Kim, PhD

CONTACT

Rusi Long, MHS

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

January 24, 2025

First Posted

February 3, 2025

Study Start

January 18, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations