Optimal Duration of Early Intervention for Psychosis
Primary Purpose
Psychotic Disorders
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Community Case Management
Sponsored by
About this trial
This is an interventional treatment trial for Psychotic Disorders focused on measuring Psychotic Disorders, Psychosis
Eligibility Criteria
Inclusion Criteria:
- DSM-IV diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, psychosis not otherwise specified or delusional disorder
- Received EASY service for 2 years following a first-episode psychosis
- Cantonese-speaking Chinese
- Ability to understand the study and to provide written informed consent
Exclusion Criteria:
- Organic brain disorder
- Known history of intellectual disability
- Drug-induced psychosis
Sites / Locations
- The University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Case Management (1 year)
Standard Care (1 year)
Arm Description
Outcomes
Primary Outcome Measures
Functioning (social and occupational)
Secondary Outcome Measures
Symptoms, quality of life and health economics
Full Information
NCT ID
NCT01202357
First Posted
September 13, 2010
Last Updated
September 13, 2010
Sponsor
The University of Hong Kong
Collaborators
Queen Mary Hospital, Hong Kong, Pamela Youde Nethersole Eastern Hospital, Kwai Chung Hospital, Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01202357
Brief Title
Optimal Duration of Early Intervention for Psychosis
Official Title
Community Case Management for Early Psychosis: is Two Year an Optimal Duration? A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
The University of Hong Kong
Collaborators
Queen Mary Hospital, Hong Kong, Pamela Youde Nethersole Eastern Hospital, Kwai Chung Hospital, Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A total of 160 subjects, who aged 18-35 and had completed the first 2 years of case management in the EASY programme will be randomized in 1:1 ratio into either (1) receiving an additional year of case management, or (2) terminating case management for the next 12 months. The current study aims to investigate whether an additional year of case management in year 3 will confer additional benefits in outcome, in terms of functioning, symptoms, quality of life and health economics.
Detailed Description
Psychotic disorders involve disturbances in perceptual, cognitive and motivational processes central to the human life experience, which resulting in long-term and pervasive functional disability. In order to achieve the best possible long-term community outcome of psychotic disorders, early intervention service is set up, focusing on the first few years (the critical period) of the illness.
In Hong Kong, early intervention for psychotic disorder was provided since 2001. The integrated Early Assessment Service for Young people with psychosis (EASY) provide specialized care to early psychosis patients up to age 25. Evaluation of the EASY programme using a matched historical control suggesting that early intervention is a promising approach to promote community care for patients with psychosis.
In the current service, case management for patients will terminate after two years, and the patients will make transition to general psychiatric care afterwards. It is not clear whether the provision of additional case management in the community (e.g., for another year) will significantly enhance outcome further.
The proposed study aims to investigate the effectiveness of providing community based case management for an additional year for patients with psychotic disorders by using a randomized controlled design. The study recruit patients who had completed the first 2 years of case management in the EASY programme and randomized them to receive either an additional year of case management, or to terminate case management for the next 12 months. The hypothesis is that better outcome are found in patients who had 3-year case management compared with those who had only 2 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders
Keywords
Psychotic Disorders, Psychosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Case Management (1 year)
Arm Type
Experimental
Arm Title
Standard Care (1 year)
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Community Case Management
Intervention Description
Community case management for psychosis by designated key-worker according to specified protocol
Primary Outcome Measure Information:
Title
Functioning (social and occupational)
Time Frame
baseline, 12-month
Secondary Outcome Measure Information:
Title
Symptoms, quality of life and health economics
Time Frame
baseline, 12-month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
DSM-IV diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, psychosis not otherwise specified or delusional disorder
Received EASY service for 2 years following a first-episode psychosis
Cantonese-speaking Chinese
Ability to understand the study and to provide written informed consent
Exclusion Criteria:
Organic brain disorder
Known history of intellectual disability
Drug-induced psychosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric YH Chen, MD
Phone
852-22554488
Email
eyhchen@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric YH Chen, MD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
28385705
Citation
Chang WC, Kwong VWY, Lau ESK, So HC, Wong CSM, Chan GHK, Jim OTT, Hui CLM, Chan SKW, Lee EHM, Chen EYH. Sustainability of treatment effect of a 3-year early intervention programme for first-episode psychosis. Br J Psychiatry. 2017 Jul;211(1):37-44. doi: 10.1192/bjp.bp.117.198929. Epub 2017 Apr 6.
Results Reference
derived
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Optimal Duration of Early Intervention for Psychosis
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