Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
360 participants
INTERVENTIONAL
2009-06-30
2015-12-31
Brief Summary
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Detailed Description
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Many previous studies of effectiveness of early intervention used the historical control approach and are subjected to cohort effects. For example, change of medication pattern over time could potentially lead to differences in outcome. In addition, few studies provide longer-term outcome data of treatment program beyond two years. The optimal length of intervention has not been determined, and many programmes used 12-24 month intervention mainly based on resources available. It is also important to ask whether favorable effects of early intervention could be sustained over time. Further analyses will be done to assess whether EI effects are more pronounced in particular subgroups including DUP, age, sex and diagnosis.
The proposed study aims to address these issues by using a randomized controlled design to investigate the longer-term (4 year) outcome of patients with first episode psychosis. The study randomizes 360 patients with first episode psychotic disorders into 3 groups: (1) standard care (outpatient based care with inpatient and community care as required); (2) standard care with 2 years of add-on stage specific case-management (individualized care delivered by designated case managers according to specific protocol); and (3) standard care with 4 years of add-on stage specific case management.
The study hypothesis are: (1) both 2 years and 4 years of case management produce better outcomes than standard care alone; (2) 4 years of case management produces better outcome than 2 years of case management.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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case management (4 yrs)
4-year case management and standard care
stage-specific case-management
Stage-specific case-management for psychosis by designated key-workers according to specified protocol
case management (2 yrs) and standard care (2 yrs)
2-year case management and standard care
stage-specific case-management
Stage-specific case-management for psychosis by designated key-workers according to specified protocol
standard care (4 yrs)
standard care for 4 years
No interventions assigned to this group
Interventions
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stage-specific case-management
Stage-specific case-management for psychosis by designated key-workers according to specified protocol
Eligibility Criteria
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Inclusion Criteria
* Cantonese-speaking Chinese
* Ability to understand the nature of the study and sign informed consent
* Capacity to participate in cognitive testing
Exclusion Criteria
* Known history of intellectual disability
26 Years
55 Years
ALL
No
Sponsors
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Queen Mary Hospital, Hong Kong
OTHER
Kwai Chung Hospital
OTHER
Kowloon Hospital, Hong Kong
OTHER
Castle Peak Hospital
OTHER_GOV
Shatin Hospital
OTHER
Tai Po Hospital
OTHER_GOV
North District Hospital, Hong Kong
UNKNOWN
United Christian Hospital
OTHER
Queen Elizabeth Hospital, Hong Kong
OTHER
The University of Hong Kong
OTHER
Responsible Party
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Professor Eric Y.H. Chen
Professor and Head of Department of Psychiatry
Principal Investigators
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Eric YH Chen, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Locations
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The University of Hong Kong
Hong Kong, , China
Countries
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References
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Hui CLM, Wong AKH, Ho ECN, Lam BST, Hui PWM, Tao TJ, Chang WC, Chan SKW, Lee EHM, Suen YN, Lam MML, Chiu CPY, Li FWS, Leung KF, McGhee SM, Law CW, Chung DWS, Yeung WS, Yiu MGC, Pang EPF, Tso S, Lui SSY, Hung SF, Lee WK, Yip KC, Kwan KL, Ng RMK, Sham PC, Honer WG, Chen EYH. Effectiveness and optimal duration of early intervention treatment in adult-onset psychosis: a randomized clinical trial. Psychol Med. 2023 Apr;53(6):2339-2351. doi: 10.1017/S0033291721004189. Epub 2022 Feb 11.
Puntis S, Minichino A, De Crescenzo F, Cipriani A, Lennox B, Harrison R. Specialised early intervention teams for recent-onset psychosis. Cochrane Database Syst Rev. 2020 Nov 2;11(11):CD013288. doi: 10.1002/14651858.CD013288.pub2.
Other Identifiers
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jcep-rct
Identifier Type: -
Identifier Source: org_study_id