Optimal Duration of Early Intervention for Psychosis
Recruitment status was Not yet recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Psychotic Disorders |
Behavioral: Community Case Management |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Community Case Management for Early Psychosis: is Two Year an Optimal Duration? A Randomized Controlled Study |
- Functioning (social and occupational) [ Time Frame: baseline, 12-month ] [ Designated as safety issue: No ]
- Symptoms, quality of life and health economics [ Time Frame: baseline, 12-month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 160 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Case Management (1 year) |
Behavioral: Community Case Management
Community case management for psychosis by designated key-worker according to specified protocol
|
| No Intervention: Standard Care (1 year) |
Behavioral: Community Case Management
Community case management for psychosis by designated key-worker according to specified protocol
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Eric YH Chen, MD | 852-22554488 | eyhchen@hku.hk |
| China | |
| The University of Hong Kong | Not yet recruiting |
| Hong Kong, China | |
| Principal Investigator: | Eric YH Chen, MD | The University of Hong Kong |
More Information
No publications provided
| Responsible Party: | Prof. Eric Y. H. Chen, The University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT01202357 History of Changes |
| Other Study ID Numbers: | CM-RCT |
| Study First Received: | September 13, 2010 |
| Last Updated: | September 13, 2010 |
| Health Authority: | Hong Kong: Ethics Committee |
Keywords provided by The University of Hong Kong:
|
Psychotic Disorders Psychosis |
Additional relevant MeSH terms:
|
Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
ClinicalTrials.gov processed this record on May 19, 2013