Optimal Duration of Early Intervention for Psychosis

Psychotic Disorders Clinical Trial

Official title:

Community Case Management for Early Psychosis: is Two Year an Optimal Duration? A Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01202357
• Other study ID #: CM-RCT
• Status: Not yet recruiting
• Phase: N/A
• First received: September 13, 2010
• Last updated: September 13, 2010
• Start date: July 2010
• Est. completion date: June 2012

Study information

• Verified date: September 2010
• Source: The University of Hong Kong
• Contact: Eric YH Chen, MD
• Phone: 852-22554488
• Email: eyhchen[@]hku.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Intervention

Behavioral:
• Community Case Management
Community case management for psychosis by designated key-worker according to specified protocol

Locations

Country	Name	City	State
China	The University of Hong Kong	Hong Kong

Sponsors (4)

Lead Sponsor	Collaborator
The University of Hong Kong	Kwai Chung Hospital, Hong Kong, Pamela Youde Nethersole Eastern Hospital, Queen Mary Hospital, Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functioning (social and occupational)		baseline, 12-month	No
Secondary	Symptoms, quality of life and health economics		baseline, 12-month	No