- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07604753
Validation of the CIDI 5.0 Against the SCID-5 for Lifetime Mental Disorders
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Yoona Kim, PhD
- Telefonnummer: +852 3917 9109
- E-post: yoonak@hku.hk
Studieorter
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Hong Kong, Hong Kong
- Rekrytering
- The University of Hong Kong
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Kontakt:
- Yoona Kim, PhD
- Telefonnummer: +852 3917 9109
- E-post: yoonak@hku.hk
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- 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
Exclusion Criteria:
- Domestic workers
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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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.
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Oro och ångest
Tidsram: Omedelbart efter ingripande eller rekrytering
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Det huvudsakliga resultatet i denna modul är livslängden för prevalens av generaliserad ångestsjukdom (GAD)
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Omedelbart efter ingripande eller rekrytering
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Depression
Tidsram: Immediately following intervention or recruitment
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The main outcome in this module is the lifetime prevalence of Major Depressive Disorder (MDD)
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Immediately following intervention or recruitment
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Stressful Experiences
Tidsram: Immediately following intervention or recruitment
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The main outcome in this module is the lifetime prevalence of PTSD.
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Immediately following intervention or recruitment
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Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- UW 24-771-2
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