SchizophreniaNCT03273530
Integrated Supported Employment in Mainland China
A study testing Integrated Supported Employment in people with Schizophrenia, run by The Hong Kong Polytechnic University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Integrated Supported Employment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2013to 20 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Having score lower than 18 on the 30-item Mini-Mental State Examination
About this study
Official title: Integrated Supported Employment for People With Schizophrenia in Mainland China: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Integrated Supported Employment
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Supported EmploymentOther
vocational assessment followed by job placement and on-going work-related social skills revision and reinforcement
| Study group | Role | What they receive |
|---|---|---|
| Integrated Supported Employment | Experimental | Individual placement support intervention plus work-related social skills training Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Employment rate
employment status, employed or unemployed
Measured: 4 months
Secondary outcomes (1)
Job tenure, duration
how long the job lasts
Measured: completion of the 3-mo program, and follow-up at 7, 11, and 15 mo.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start1 Feb 2013
- Primary completion15 Aug 2015
- Study completion20 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TSANG Hector Wing-Hong, The Hong Kong Polytechnic University
- Investigators
- Hector WH Tsang, PhD, Principal investigator, HKPolyU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273530
- Sponsor's protocol ID
- 201415
- Status last verified
- Sep 2017
- First submitted
- 24 Aug 2017
- Last updated
- 6 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not yet decided
Publications
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.
PubMed 29135426
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Supported Employment for People With Schizophrenia in Mainland China: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03273530
- Acronym / sponsor ID
- 201415
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 15 Aug 2015 (actual)
- Study completion
- 20 Dec 2015 (actual)
- First posted
- 6 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Integrated Supported Employment | Experimental | Other: Integrated Supported EmploymentIndividual placement support intervention plus work-related social skills training |
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Having score lower than 18 on the 30-item Mini-Mental State Examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Supported Employmentvocational assessment followed by job placement and on-going work-related social skills revision and reinforcement | Other | Integrated Supported Employment |
Primary outcome
Employment rate
Time frame: 4 months
employment status, employed or unemployed
1 secondary outcome
Job tenure, duration
Time frame: completion of the 3-mo program, and follow-up at 7, 11, and 15 mo.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
- Derived from this study: PubMed 29135426Zhang 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.
- Individual participant dataSharing planned: Undecided. Not yet decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hector WH Tsang, PhD principal investigator
HKPolyU
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Supported Employment in people with Schizophrenia, run by The Hong Kong Polytechnic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Employment rate (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03273530, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2017.