Optimal Duration of Early Intervention for Psychosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by The University of Hong Kong.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Queen Mary Hospital, Hong Kong
Pamela Youde Nethersole Eastern Hospital
Kwai Chung Hospital, Hong Kong
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01202357
First received: September 13, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Functioning (social and occupational) [ Time Frame: baseline, 12-month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01202357

Contacts
Contact: Eric YH Chen, MD 852-22554488 eyhchen@hku.hk

Locations
China
The University of Hong Kong Not yet recruiting
Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
Queen Mary Hospital, Hong Kong
Pamela Youde Nethersole Eastern Hospital
Kwai Chung Hospital, Hong Kong
Investigators
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 July 22, 2014