NCT03273530

Brief Summary

In this randomized controlled trial, the researchers investigated the effectiveness of integrated supported employment (ISE) as compared with individual placement and support (IPS) and traditional vocational rehabilitation (TVR) for people with schizophrenia in mainland China.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
162

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Feb 2013

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
Last Updated

September 6, 2017

Status Verified

September 1, 2017

Enrollment Period

2.5 years

First QC Date

August 24, 2017

Last Update Submit

September 5, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Employment rate

    employment status, employed or unemployed

    4 months

Secondary Outcomes (1)

  • Job tenure, duration

    completion of the 3-mo program, and follow-up at 7, 11, and 15 mo.

Study Arms (3)

Integrated Supported Employment

EXPERIMENTAL

Individual placement support intervention plus work-related social skills training

Other: Integrated Supported Employment

Individualised Placement Support

NO INTERVENTION

Individual placement support intervention with pre-vocational training followed by placing individual participants to the job according to their preference and abilities

Traditional Vocational Rehabilitation

NO INTERVENTION

general pre-vocational training and placement

Interventions

vocational assessment followed by job placement and on-going work-related social skills revision and reinforcement

Integrated Supported Employment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18 years or older;
  • Diagnosis of schizophrenia for at least 2 years
  • Being unemployed
  • Willing to give informed consent
  • Having no obvious cognitive, learning, or neurological impairment
  • Having completed primary school education
  • Having a desire to work

You may not qualify if:

  • Having score lower than 18 on the 30-item Mini-Mental State Examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Zhang GF, Tsui CM, Lu AJB, Yu LB, Tsang HWH, Li D. Integrated Supported Employment for People With Schizophrenia in Mainland China: A Randomized Controlled Trial. Am J Occup Ther. 2017 Nov/Dec;71(6):7106165020p1-7106165020p8. doi: 10.5014/ajot.2017.024802.

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Hector WH Tsang, PhD

    HKPolyU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Department Head of Rehabilitation Sciences

Study Record Dates

First Submitted

August 24, 2017

First Posted

September 6, 2017

Study Start

February 1, 2013

Primary Completion

August 15, 2015

Study Completion

December 20, 2015

Last Updated

September 6, 2017

Record last verified: 2017-09