SchizophreniaNCT04767204
The Outcomes Among Persons With Schizophrenia Under the Peer-support Service in Vocational Rehabilitation Program
A study testing peer co-delivered vocational rehabilitation service in people with Schizophrenia, run by Yu-Li Hospital at 1 site in Taiwan.
Trial summary
There are few programs related to vocational peer support services in persons with psychiatric disability in Taiwan. This study aims to develop a peer co-lead services in the community rehabilitation center and evaluate the outcomes among service users with schizophrenia under the integrated peer-support services in a… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- peer co-delivered vocational rehabilitation service
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2017to 30 Dec 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnoses of schizophrenia
- Living in half-way houses or community home
- Under the services of sheltered or supported employment
- The reading ability of graduated elementary school at least
Who cannot join
- Acute psychosis
- Severe physical illness
- Legally incompetence to make major decision
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taipei Veterans General Hospital Yuli Branch
Yuli, Haulein County, 981
About this study
Official title: The Factors Related to Occupational Outcome Among Persons With Mental Illness Under the Peer-support Service in Vocational Rehabilitation Program: a Pilot Study
There are few programs related to vocational peer support services in persons with psychiatric disability in Taiwan. This study aims to develop a peer co-lead services in the community rehabilitation center and evaluate the outcomes among service users with schizophrenia under the integrated peer-support services in a supported employment program.
Read the detailed description
Background
In Taiwan, mental health services are provisioned through hospital-based treatment majorly and shifted to community care gradually in recent decades. In 2020, the totally 7,350 beds of acute wards and 13,559 beds of chronic wards covered the general population in Taiwan with 3.12/10,000 persons and 5.75/10,000 persons rates, respectively. In contrast to hospital treatment, there were 71 community rehabilitation centers and 155 halfway houses in local communities with coverage rate of 1.45/10,000 persons and 2.82/10,000 persons respectively. The sheltered or supported employment in Taiwan is still primarily delivered by trained professionals or paraprofessionals in the community facilities for the persons with severe mental illness. Although the trained peers can deliver vocational supports based on recovery concept as well as professionals at least in the supported employment services, the large absence of peer support workers is rooted in the lack of insurance coverage and limited government budgets in Taiwan. Accordingly, further investigations are warranted to evaluate the effectiveness of peer support services in vocational rehabilitation among persons with severe mental illness under the development of peer-deliver services in Taiwan.
Therefore, the investigators designed a 2-phase pilot program: establishment of peer support training curriculum in Phase I to develop peer support services in vocational rehabilitation system feasibly, and measurement of effectiveness under peer codelivered services in Phase II (Protocol). The investigated effectiveness among persons with schizophrenia in this study included the received social supports, mental health, psychiatric symptoms, functional and occupational outcome.
Methods
Participants
The pilot program was held from April 2017 to December 2018 at the Taipei Veterans General Hospital Yuli Branch (TVGH-YL). The hospital provides treatment and community care for patients with mental illness who reside in the rural area of eastern Taiwan. The TVGH-YL administers a half-way house, a community rehabilitation center, and a supported housing program. The hospital also provides sheltered and supported employment as part of its community care services for persons with mental illness. In one month before the program of Phase I or II, the investigators recruited the participants by presenting poster on bulletins in the half-way house and community rehabilitation center. The investigators also invited the participants who had cared elderly persons in the past to join the training curriculum in the Phase I program, because these persons were the candidates of peer support workers to share the previous work experiences in the Phase II program.
Pilot program
Training for peer support workers
Initially, there were 7 professionals who had the experiences in the community facilities for at least 5 years discussing about the framework and contents of training curriculum for peer support workers in the focus groups. These seven professionals specializing in 6 medical disciplines were also the teachers in the curriculum. Table 2 details the themes of curriculum at various intervention levels. In the end of each lecture session, there were four questions being proposed by the teacher to exam the trainees about the core concepts of class.
In the practice session, the performance of trainees would be examined by the case discussion or practice in roles playing or situation simulation. No final exam in Phase I program. However, the trainee should pass all class after the teachers' agreement. If someone needed to improve the knowledge or skills, he or she had gotten the personal time to receive more helps from the teacher.
The extended vocational rehabilitation services co-led \& assisted by peer support workers
The program in Phase II was held twice in August of 2017 and April of 2018. Based on the needs of elderly persons with disability or dementia in local community, the 2 occupational therapists (Ching-Hui Wu \& Meng-Ping Kao) organized the extended work training course which focused on improvements of care skills of Phase II program participants (service users). The 2 occupational therapists also held workplace problem-solving group once per 2 weeks for the service users. The above interventions were originally parts of supported employment service in the community rehabilitation center, but the participated rate was not satisfied previously. Therefore, the investigators integrated the peer support service into this service system. Before each training session, peer support workers discussed with 2 occupational therapists ("stakeholders") to decide on the content and process of the session. Peer support workers' involvement should account for at least 50% of the session time to ensure the intensity of support. The supervisor (Kan Yuan Cheng) discussed with the occupational therapy weekly and the peer support worker monthly based on the feedback in satisfaction questionnaire by service users and the records in group. Four times of observation by the supervision were also arranged to audit the performance of the occupational therapist and peer support workers in the all sessions of Phase II program. More specifics about this phase of the program can be found in study protocol.
Process of assessment
The pre- and post-intervention self-report questionnaire was assisted by the occupational therapist ( Meng-Ping Kao). The Brief Psychiatric Rating Scale-18 and Global Assessment of Function scale were measured by board psychiatrist (Kan Yuan Cheng) who had experiences in the multiple-center clinical trial. The assistant and investigator both belonged to the intervention group because there was no control group or blind procedure in the study design.
Statistical methods
As all indicators examined in this study were continuous variables, the investigators used paired t-test to compare the measurements before and after the intervention. IBM (International Business Machines Corporation) SPSS Statistics 16.0 was employed for statistical analysis.
- Conditions
- Schizophrenia
- Being tested
- peer co-delivered vocational rehabilitation service
- Keywords
- Peer support, Vocational rehabilitation, Social function
- Medical subject headings
- Schizophrenia, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peer co-delivered vocational rehabilitation serviceBehavioural
Also called vocational peer support service
The services provided by the trained peers in the work training or problem-solving group, which integrates into a supported employment services
| Study group | Role | What they receive |
|---|---|---|
| Peer support service | Experimental | Peer support workers co-lead and assist workplace problem-solving and care skills training in an extended vocational rehabilitation program Receives: Behavioral: peer co-delivered vocational rehabilitation service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Social Support Scale
SSS. Social supports from family or relatives, professionals or staffs and peers or friends. Ranges from 45 to 225. Higher score means better support.
Measured: Changes from Baseline Social Support Scale at 4 months
Change of Chinese Health Questionnaire-12
CHQ-12. Positive and Negative Mental health. Ranges from 0 to 12. Lower score means better health.
Measured: Change from Baseline Chinese Health Questionnaire-12 at 4 months
Change of Brief Psychiatric Rating Scale-18
BPRS-18. Mood, Psychotic and General symptoms. Ranges from 18 to 126. Higher score means worse psychiatric symptom.
Measured: Change from Baseline Brief Psychiatric Rating Scale-18 at 4 months
Change of Global Assessment of Function
GAF. Globally social and occupational function under the influences by the mental illness. Ranges from 1 to 100. Higher score means better function.
Measured: Change from Baseline Global Assessment of Function at 4 months
Change of Chinese version of the Social Functioning Scale
C-SFS. Self-reported social function for the persons with schizophrenia. Ranges from 0 to 100. Higher score means better function
Measured: Change from Baseline Chinese version of the Social Functioning Scale at 4 months
Secondary outcomes (2)
Change of weekly wedges
totally earned incomes through the vocational rehabilitation services
Measured: Change from Baseline weekly wedges at 4 months
Change of weekly working hours
totally working hours through the vocational rehabilitation services
Measured: Change from Baseline weekly working hours at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Apr 2017
- Primary completion28 Sep 2018
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yu-Li Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Workforce Development Agency of Minister of Labor, Taiwan, Tzu-Chi University, Department of Public Health, Taipei Veterans General Hospital Yuli Branch, Department of Psychiatry
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767204
- Sponsor's protocol ID
- VHYL-107-11
- Status last verified
- Feb 2021
- First submitted
- 8 Feb 2021
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Any share of data related to persons with mental illness in Taiwan should be permitted by the Institute Review Board. Under the asking of IRB, we must destroyed any kinds of study data when three years after completed collection. This requirement was also described in the informed consent.
Publications
Lloyd-Evans B, Mayo-Wilson E, Harrison B, Istead H, Brown E, Pilling S, Johnson S, Kendall T. A systematic review and meta-analysis of randomised controlled trials of peer support for people with severe mental illness. BMC Psychiatry. 2014 Feb 14;14:39. doi: 10.1186/1471-244X-14-39.
PubMed 24528545Yam KKN, Lo WTL, Chiu RLP, Lau BSY, Lau CKS, Wu JKY, Wan SM. A pilot training program for people in recovery of mental illness as vocational peer support workers in Hong Kong - Job Buddies Training Program (JBTP): A preliminary finding. Asian J Psychiatr. 2018 Jun;35:132-140. doi: 10.1016/j.ajp.2016.10.002. Epub 2016 Oct 24.
PubMed 27884479Kern RS, Zarate R, Glynn SM, Turner LR, Smith KM, Mitchell SS, Becker DR, Drake RE, Kopelowicz A, Tovey W, Liberman RP. A demonstration project involving peers as providers of evidence-based, supported employment services. Psychiatr Rehabil J. 2013 Jun;36(2):99-107. doi: 10.1037/h0094987.
PubMed 23750760Cheng KY, Yen CF. The social support, mental health, psychiatric symptoms, and functioning of persons with schizophrenia participating in peer co-delivered vocational rehabilitation: a pilot study in Taiwan. BMC Psychiatry. 2021 May 25;21(1):268. doi: 10.1186/s12888-021-03277-0.
PubMed 34034693
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Factors Related to Occupational Outcome Among Persons With Mental Illness Under the Peer-support Service in Vocational Rehabilitation Program: a Pilot Study
- ClinicalTrials.gov ID
- NCT04767204
- Acronym / sponsor ID
- VHYL-107-11
- Conditions
- Schizophrenia
- Keywords
- Peer support, Vocational rehabilitation, Social function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Yu-Li HospitalUniversity, hospital or other
- Collaborators
- Workforce Development Agency of Minister of Labor, Taiwan, Tzu-Chi University, Department of Public Health, Taipei Veterans General Hospital Yuli Branch, Department of Psychiatry
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 28 Sep 2018 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 23 Feb 2021 (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.
There are few programs related to vocational peer support services in persons with psychiatric disability in Taiwan. This study aims to develop a peer co-lead services in the community rehabilitation center and evaluate the outcomes among service users with schizophrenia under the integrated peer-support services in a supported employment program.
Detailed description
Background
In Taiwan, mental health services are provisioned through hospital-based treatment majorly and shifted to community care gradually in recent decades. In 2020, the totally 7,350 beds of acute wards and 13,559 beds of chronic wards covered the general population in Taiwan with 3.12/10,000 persons and 5.75/10,000 persons rates, respectively. In contrast to hospital treatment, there were 71 community rehabilitation centers and 155 halfway houses in local communities with coverage rate of 1.45/10,000 persons and 2.82/10,000 persons respectively. The sheltered or supported employment in Taiwan is still primarily delivered by trained professionals or paraprofessionals in the community facilities for the persons with severe mental illness. Although the trained peers can deliver vocational supports based on recovery concept as well as professionals at least in the supported employment services, the large absence of peer support workers is rooted in the lack of insurance coverage and limited government budgets in Taiwan. Accordingly, further investigations are warranted to evaluate the effectiveness of peer support services in vocational rehabilitation among persons with severe mental illness under the development of peer-deliver services in Taiwan.
Therefore, the investigators designed a 2-phase pilot program: establishment of peer support training curriculum in Phase I to develop peer support services in vocational rehabilitation system feasibly, and measurement of effectiveness under peer codelivered services in Phase II (Protocol). The investigated effectiveness among persons with schizophrenia in this study included the received social supports, mental health, psychiatric symptoms, functional and occupational outcome.
Methods
Participants
The pilot program was held from April 2017 to December 2018 at the Taipei Veterans General Hospital Yuli Branch (TVGH-YL). The hospital provides treatment and community care for patients with mental illness who reside in the rural area of eastern Taiwan. The TVGH-YL administers a half-way house, a community rehabilitation center, and a supported housing program. The hospital also provides sheltered and supported employment as part of its community care services for persons with mental illness. In one month before the program of Phase I or II, the investigators recruited the participants by presenting poster on bulletins in the half-way house and community rehabilitation center. The investigators also invited the participants who had cared elderly persons in the past to join the training curriculum in the Phase I program, because these persons were the candidates of peer support workers to share the previous work experiences in the Phase II program.
Pilot program
Training for peer support workers
Initially, there were 7 professionals who had the experiences in the community facilities for at least 5 years discussing about the framework and contents of training curriculum for peer support workers in the focus groups. These seven professionals specializing in 6 medical disciplines were also the teachers in the curriculum. Table 2 details the themes of curriculum at various intervention levels. In the end of each lecture session, there were four questions being proposed by the teacher to exam the trainees about the core concepts of class.
In the practice session, the performance of trainees would be examined by the case discussion or practice in roles playing or situation simulation. No final exam in Phase I program. However, the trainee should pass all class after the teachers' agreement. If someone needed to improve the knowledge or skills, he or she had gotten the personal time to receive more helps from the teacher.
The extended vocational rehabilitation services co-led \& assisted by peer support workers
The program in Phase II was held twice in August of 2017 and April of 2018. Based on the needs of elderly persons with disability or dementia in local community, the 2 occupational therapists (Ching-Hui Wu \& Meng-Ping Kao) organized the extended work training course which focused on improvements of care skills of Phase II program participants (service users). The 2 occupational therapists also held workplace problem-solving group once per 2 weeks for the service users. The above interventions were originally parts of supported employment service in the community rehabilitation center, but the participated rate was not satisfied previously. Therefore, the investigators integrated the peer support service into this service system. Before each training session, peer support workers discussed with 2 occupational therapists ("stakeholders") to decide on the content and process of the session. Peer support workers' involvement should account for at least 50% of the session time to ensure the intensity of support. The supervisor (Kan Yuan Cheng) discussed with the occupational therapy weekly and the peer support worker monthly based on the feedback in satisfaction questionnaire by service users and the records in group. Four times of observation by the supervision were also arranged to audit the performance of the occupational therapist and peer support workers in the all sessions of Phase II program. More specifics about this phase of the program can be found in study protocol.
Process of assessment
The pre- and post-intervention self-report questionnaire was assisted by the occupational therapist ( Meng-Ping Kao). The Brief Psychiatric Rating Scale-18 and Global Assessment of Function scale were measured by board psychiatrist (Kan Yuan Cheng) who had experiences in the multiple-center clinical trial. The assistant and investigator both belonged to the intervention group because there was no control group or blind procedure in the study design.
Statistical methods
As all indicators examined in this study were continuous variables, the investigators used paired t-test to compare the measurements before and after the intervention. IBM (International Business Machines Corporation) SPSS Statistics 16.0 was employed for statistical analysis.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peer support service | Experimental | Behavioral: peer co-delivered vocational rehabilitation servicePeer support workers co-lead and assist workplace problem-solving and care skills training in an extended vocational rehabilitation program |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnoses of schizophrenia
- Living in half-way houses or community home
- Under the services of sheltered or supported employment
- The reading ability of graduated elementary school at least
Key exclusion criteria (3 listed)
- Acute psychosis
- Severe physical illness
- Legally incompetence to make major decision
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 |
|---|---|---|
| peer co-delivered vocational rehabilitation serviceAlso: vocational peer support serviceThe services provided by the trained peers in the work training or problem-solving group, which integrates into a supported employment services | Behavioural | Peer support service |
Primary outcome
Change of Social Support Scale
Time frame: Changes from Baseline Social Support Scale at 4 months
SSS. Social supports from family or relatives, professionals or staffs and peers or friends. Ranges from 45 to 225. Higher score means better support.
Change of Chinese Health Questionnaire-12
Time frame: Change from Baseline Chinese Health Questionnaire-12 at 4 months
CHQ-12. Positive and Negative Mental health. Ranges from 0 to 12. Lower score means better health.
Change of Brief Psychiatric Rating Scale-18
Time frame: Change from Baseline Brief Psychiatric Rating Scale-18 at 4 months
BPRS-18. Mood, Psychotic and General symptoms. Ranges from 18 to 126. Higher score means worse psychiatric symptom.
Change of Global Assessment of Function
Time frame: Change from Baseline Global Assessment of Function at 4 months
GAF. Globally social and occupational function under the influences by the mental illness. Ranges from 1 to 100. Higher score means better function.
Change of Chinese version of the Social Functioning Scale
Time frame: Change from Baseline Chinese version of the Social Functioning Scale at 4 months
C-SFS. Self-reported social function for the persons with schizophrenia. Ranges from 0 to 100. Higher score means better function
2 secondary outcomes
Change of weekly wedges
Time frame: Change from Baseline weekly wedges at 4 months
Change of weekly working hours
Time frame: Change from Baseline weekly working hours at 4 months
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 23 Feb 2021.
- Background: PubMed 24528545Lloyd-Evans B, Mayo-Wilson E, Harrison B, Istead H, Brown E, Pilling S, Johnson S, Kendall T. A systematic review and meta-analysis of randomised controlled trials of peer support for people with severe mental illness. BMC Psychiatry. 2014 Feb 14;14:39. doi: 10.1186/1471-244X-14-39.
- Background: PubMed 27884479Yam KKN, Lo WTL, Chiu RLP, Lau BSY, Lau CKS, Wu JKY, Wan SM. A pilot training program for people in recovery of mental illness as vocational peer support workers in Hong Kong - Job Buddies Training Program (JBTP): A preliminary finding. Asian J Psychiatr. 2018 Jun;35:132-140. doi: 10.1016/j.ajp.2016.10.002. Epub 2016 Oct 24.
- Background: PubMed 23750760Kern RS, Zarate R, Glynn SM, Turner LR, Smith KM, Mitchell SS, Becker DR, Drake RE, Kopelowicz A, Tovey W, Liberman RP. A demonstration project involving peers as providers of evidence-based, supported employment services. Psychiatr Rehabil J. 2013 Jun;36(2):99-107. doi: 10.1037/h0094987.
- Derived from this study: PubMed 34034693Cheng KY, Yen CF. The social support, mental health, psychiatric symptoms, and functioning of persons with schizophrenia participating in peer co-delivered vocational rehabilitation: a pilot study in Taiwan. BMC Psychiatry. 2021 May 25;21(1):268. doi: 10.1186/s12888-021-03277-0.
- Individual participant dataSharing planned: No. Any share of data related to persons with mental illness in Taiwan should be permitted by the Institute Review Board. Under the asking of IRB, we must destroyed any kinds of study data when three years after completed collection. This requirement was also described in the informed consent.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peer co-delivered vocational rehabilitation service in people with Schizophrenia, run by Yu-Li Hospital at 1 site in Taiwan.
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 4 inclusion and 3 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 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change of Social Support Scale (time frame: Changes from Baseline Social Support Scale at 4 months). The study lists 5 primary outcomes in all. 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 NCT04767204, which also lists 4 linked publications.
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 23 Feb 2021.