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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Taiwan

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 groups in NCT04767204
Study groupRoleWhat they receive
Peer support serviceExperimentalPeer 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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)
  1. Change of weekly wedges

    totally earned incomes through the vocational rehabilitation services

    Measured: Change from Baseline weekly wedges at 4 months

  2. 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.

  1. First posted23 Feb 2021
  2. Study start1 Apr 2017
  3. Primary completion28 Sep 2018
  4. Study completion30 Dec 2019

Resources

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)
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 24528545
  • Yam 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 27884479
  • Kern 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 23750760
  • Cheng 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

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.

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