Optimal Duration of Early Intervention for Psychosis

Not Applicable

• Conditions: Psychotic Disorders
• Interventions: Behavioral: Community Case Management

• Registration Number: NCT01202357
• Lead Sponsor: The University of Hong Kong

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.

Study Timeline

• Study Start: 2010-07
• Status Verified: 2010-09
• Study First Submitted: 2010-09-13
• Study First Submitted QC: 2010-09-13
• Last Update Submitted: 2010-09-13
• Study First Posted: 2010-09-15
• Last Update Posted: 2010-09-15
• Primary Completion: 2012-06
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Case Management (1 year)	Community Case Management	-
Standard Care (1 year)	Community Case Management	-

Primary Outcome Measures

Name	Time	Method
Functioning (social and occupational)	baseline, 12-month

Secondary Outcome Measures

Name	Time	Method
Symptoms, quality of life and health economics	baseline, 12-month

Trial Locations

Locations (1)

The University of Hong Kong; 🇨🇳 Hong Kong, China