Optimal Duration of Early Intervention for Psychosis

NCT ID: NCT01202357

Last Updated: 2010-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-06-30

Brief Summary

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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

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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.

Conditions

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Psychotic Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Case Management (1 year)

Group Type EXPERIMENTAL

Community Case Management

Intervention Type BEHAVIORAL

Community case management for psychosis by designated key-worker according to specified protocol

Standard Care (1 year)

Group Type NO_INTERVENTION

Community Case Management

Intervention Type BEHAVIORAL

Community case management for psychosis by designated key-worker according to specified protocol

Interventions

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Community Case Management

Community case management for psychosis by designated key-worker according to specified protocol

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen Mary Hospital, Hong Kong

OTHER

Sponsor Role collaborator

Pamela Youde Nethersole Eastern Hospital

OTHER

Sponsor Role collaborator

Kwai Chung Hospital

OTHER

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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The University of Hong Kong

Principal Investigators

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Eric YH Chen, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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The University of Hong Kong

Hong Kong, , China

Site Status

Countries

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China

Central Contacts

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Eric YH Chen, MD

Role: CONTACT

852-22554488

References

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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.

Reference Type DERIVED
PMID: 28385705 (View on PubMed)

Other Identifiers

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CM-RCT

Identifier Type: -

Identifier Source: org_study_id