Back to resultsIntegrated Supported Employment in Mainland China
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Integrated Supported Employment
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
• Having score lower than 18 on the 30-item Mini-Mental State Examination
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
Integrated Supported Employment
Individualised Placement Support
Traditional Vocational Rehabilitation
Arm Description
Individual placement support intervention plus work-related social skills training
Individual placement support intervention with pre-vocational training followed by placing individual participants to the job according to their preference and abilities
general pre-vocational training and placement
Outcomes
Primary Outcome Measures
Employment rate
employment status, employed or unemployed
Secondary Outcome Measures
Job tenure, duration
how long the job lasts
Full Information
NCT ID
NCT03273530
First Posted
August 24, 2017
Last Updated
September 5, 2017
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT03273530
Brief Title
Integrated Supported Employment in Mainland China
Official Title
Integrated Supported Employment for People With Schizophrenia in Mainland China: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
February 1, 2013 (Actual)
Primary Completion Date
August 15, 2015 (Actual)
Study Completion Date
December 20, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
One hundred and sixty-two participants with schizophrenia were randomly assigned to ISE (n = 54), IPS (n = 54), and or TVR (n = 54). Blinded assessments of employment status, job tenure, and psychological outcomes were conducted at admission, completion of the 3-mo program, and follow-up at 7, 11, and 15 mo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Integrated Supported Employment
Arm Type
Experimental
Arm Description
Individual placement support intervention plus work-related social skills training
Arm Title
Individualised Placement Support
Arm Type
No Intervention
Arm Description
Individual placement support intervention with pre-vocational training followed by placing individual participants to the job according to their preference and abilities
Arm Title
Traditional Vocational Rehabilitation
Arm Type
No Intervention
Arm Description
general pre-vocational training and placement
Intervention Type
Other
Intervention Name(s)
Integrated Supported Employment
Intervention Description
vocational assessment followed by job placement and on-going work-related social skills revision and reinforcement
Primary Outcome Measure Information:
Title
Employment rate
Description
employment status, employed or unemployed
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Job tenure, duration
Description
how long the job lasts
Time Frame
completion of the 3-mo program, and follow-up at 7, 11, and 15 mo.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
• Having score lower than 18 on the 30-item Mini-Mental State Examination
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hector WH Tsang, PhD
Organizational Affiliation
HKPolyU
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Not yet decided
Citations:
PubMed Identifier
29135426
Citation
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.
Results Reference
derived
Learn more about this trial
Integrated Supported Employment in Mainland China
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