NCT01202357

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

September 15, 2010

Status Verified

September 1, 2010

Enrollment Period

1.9 years

First QC Date

September 13, 2010

Last Update Submit

September 13, 2010

Conditions

Keywords

Psychotic DisordersPsychosis

Outcome Measures

Primary Outcomes (1)

  • Functioning (social and occupational)

    baseline, 12-month

Secondary Outcomes (1)

  • Symptoms, quality of life and health economics

    baseline, 12-month

Study Arms (2)

Case Management (1 year)

EXPERIMENTAL
Behavioral: Community Case Management

Standard Care (1 year)

NO INTERVENTION
Behavioral: Community Case Management

Interventions

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

Case Management (1 year)Standard Care (1 year)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Organic brain disorder
  • Known history of intellectual disability
  • Drug-induced psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Eric YH Chen, MD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric YH Chen, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2010

First Posted

September 15, 2010

Study Start

July 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

September 15, 2010

Record last verified: 2010-09

Locations