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From Prevention to Community Integration: IPCST for Severe Mental Illness in Chinese Communities (Hong Kong and Beijing)

Primary Purpose

Psychosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IPCST
E.A.S.Y
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hong Kong/ China residents
  • Age between 18-55 years;
  • Primary diagnosis of psychosis (not more than 12 months of clinical diagnosis) by psychiatrist and confirmed with the SCID-I for DSM-IV TR Axis I Disorders (Biometrics Research, 2002);
  • Primary six or above education;
  • Mentally competent to follow the instructions and training and give informed written consent, as suggested by the attending psychiatrist;
  • Able to communicate in Chinese;
  • Intend to seek employment.

Exclusion Criteria:

  • Co-morbidity of learning disability, neurological disorder (e.g., epilepsy) and organic brain disease, or clinically significant medical diseases;
  • Recently participated or are participating in other structured psychosocial intervention, and/or
  • Visual, language or communication difficulty.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    IPCST

    E.A.S.Y

    Arm Description

    Intervention = Patients that participate in IPCST programme

    Treatment as usual = Patients of E.A.S.Y Programme in HK Kwai Chung Hospital

    Outcomes

    Primary Outcome Measures

    Change of Positive and Negative Syndrome Scale (PANSS) score
    The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia. Participants will be assessed by medical specialist who will complete their PANSS at baseline, immediately following the completion of the 3-month program, and at 6- & 12- months after completion of the program. The Change of PANSS score over the above time course is the study's primary outcome measure.
    Change of The Personal and Social Performance Scale (PSP) score
    The Personal and Social Performance scale (PSP) is widely used to assess social functioning in patients with schizophrenia. Participants will be assessed by medical specialist who will complete their PSP score at baseline, immediately following the completion of the 3-month program, and at 6- & 12- months after completion of the program. The Change of PSP score over the above time course is the study's primary outcome measure.

    Secondary Outcome Measures

    Change of Employment Outcome Checklist (EOC) score
    The Employment Outcome Checklist (EOC) is used to assess participants' employment outcomes such as the number of job interviews attended, the number of jobs obtained, number of hours per week worked, and salary received from each of the jobs that were obtained . Participants will be assessed by research assistant who will complete their EOC questionnaire at baseline, immediately following the completion of the 3-month program, and at 6- & 12- months after completion of the program. The Changes in EOC over the above time course is the study's secondary outcome measure.
    Change of The Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4) score
    The Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4) is a self-report quality of life measure for people with schizophrenia. Participants complete on their own the SQLS-R4 questionnaire at baseline, immediately following the completion of the 3-month program, and at 6- & 12- months after completion of the program. The Change of SQLS-R4 score over the above time course is the study's secondary outcome measure.
    Change of the Vocational Social Skills Assessment Scale (VSSS) score
    The Vocational Social Skills Assessment Scale (VSSS) is a self-administered checklist that measures the participants' subjective perception of their competence in handling work-related social situations. Participants complete on their own the VSSS questionnaire at baseline, immediately following the completion of the 3-month program, and at 6- & 12- months after completion of the program. The Change of VSSS score over the above time course is the study's secondary outcome measure.
    Change of Re-hospitalization rate
    Re-Hospitalization rate measured at Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
    Change of outpatient follow-up rate
    The changes in outpatient follow-up rate measured at Baseline, Completion of the 3-month program, and follow up at 6-, 12- month

    Full Information

    First Posted
    August 28, 2017
    Last Updated
    June 20, 2018
    Sponsor
    The Hong Kong Polytechnic University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03565055
    Brief Title
    From Prevention to Community Integration: IPCST for Severe Mental Illness in Chinese Communities (Hong Kong and Beijing)
    Official Title
    From Prevention to Community Integration: Service Models, Intervention Strategies, and Outcome Evaluation for Recovery From Severe Mental Illness in Chinese Communities (Hong Kong and Beijing)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2018 (Anticipated)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    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
    This research project aims at early detection, early intervention, and recovery of individuals with psychosis and prevention of their family members who are at high risk of having developmental problems and developing psychosis episode in later stages of their life. It consists of two major parts with the following study designs & aims: Part I : Developing a comprehensive and integrative psychosocial and community skills training programme (IPCST) and conducing a pilot randomised controlled trial to compare the study outcomes between the two settings in Hong Kong and Beijing. To develop IPCST as an innovative intervention model targeting individuals with first or recent onset of psychosis to reduce their stay in mental hospital and bridges them to independent living in the community with optimal social and professional support; To evaluate IPCST in terms of the clinical, vocational, and psychosocial outcomes of participants using a randomized controlled trial design and compare these outcomes between Hong Kong and Beijing; To examine the cost-effectiveness of IPCST in the two cities; and To train professionals and research personnel in Hong Kong and mainland for implementation Part II: Exploring the health needs of younger family members of individuals with early psychosis and the strategies in preventing this clinical high risk group from developing psychotic episode and developmental problems in later stages of their lives. To identify the potential developmental problems or sufferings of theses younger family members living with patients with mental illness; To provide baseline assessment of their psychosocial stress, mental health, and quality of life; To identify interventions that may prevent them from developing psychosis and other developmental problems and improve their mental health.
    Detailed Description
    This research is to develop and test on a pilot basis the clinical efficacy of the IPCST on the clinical and recovery outcomes of outpatients with first and recent-onset psychosis in one-year follow-up period in one regional outpatient care service of both Hong Kong and Beijing, China. All outcomes will be assessed by a trained Research Assistant who is blind to group assignment in each city separately. In Hong Kong, the study venue will be one Early Assessment Service for Young People with Early Psychosis (EASY) in Kwai Chung Hospital under the Kowloon West Hospital Cluster, Hospital Authority Hong Kong. In Beijing, the study venues consist of the Sixth Hospital of Peking University, the Chaoyang Third Hospital, and the Haidian Mental Health Hospital. In both sites, the study venues are serving for first or recent-onset psychosis residing in the community. Similar to previous psychosocial interventional studies, the primary outcomes of this study are patients' mental status and level of functioning. Secondary outcomes include the rate and length of psychiatric hospitalizations, vocational status, social skills, family functioning, and quality of life. A total of 100 participants would be recruited for this project, 50 to be recruited from Hong Kong Kwai Chung; 50 to be recruited from mainland China sites. Part I: Participants of this part will be randomly allocated to experimental or control group. Experimental group participants will receive a 12-week, 48-hours of IPCST programme which includes both individual and group training on psychoeducation, motivational interviewing skills, neurocognitive and social cognition, and augmented supported employment with social skills. Control group participants will receive the usual psychiatric treatment they have been receiving from the hospital. All participants will receive assessment on their primary (symptom severity and functioning) and secondary (re-hospitalisation rates, family functioning, social skills, and employment status and satisfaction, and quality of life) outcomes at baseline and immediately (Post-test 1), 6 months (Post-test 2), and 12 months (Post-test 3) after completion of the interventions by a research assistant. Each assessment episode lasts about 1.5 hours. Part II: Participants of this part will undergo a 30 minutes to 1 hour individual interview conducted by a research assistant that covers semi-structured open-ended questions and basic assessment of psychosocial stress, health and mental health status, and quality of life using quantitative measures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psychosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    IPCST
    Arm Type
    Experimental
    Arm Description
    Intervention = Patients that participate in IPCST programme
    Arm Title
    E.A.S.Y
    Arm Type
    Active Comparator
    Arm Description
    Treatment as usual = Patients of E.A.S.Y Programme in HK Kwai Chung Hospital
    Intervention Type
    Behavioral
    Intervention Name(s)
    IPCST
    Intervention Description
    Integrative Psychosocial & Community Skills Training (IPCST) programme The IPCST programme includes: psychoeducation, internalized stigma reduction, & strength and coping enhancement motivational interviewing skills Neurocognitive and social cognitive training (Au, Tsang, So, Bell, Cheung, et al., 2015) augmented supported employment with social skills training (Tsang, Fung, Li, Leung & Cheung, 2010) and family and patient involvement in care
    Intervention Type
    Behavioral
    Intervention Name(s)
    E.A.S.Y
    Intervention Description
    The E.A.S.Y. (Early Assessment Service for Young People with Early Psychosis) Programme is a service programme for people suffering from early psychosis. The E.A.S.Y programme includes: Extensive public education Early referral and assessment Ongoing treatment services
    Primary Outcome Measure Information:
    Title
    Change of Positive and Negative Syndrome Scale (PANSS) score
    Description
    The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia. Participants will be assessed by medical specialist who will complete their PANSS at baseline, immediately following the completion of the 3-month program, and at 6- & 12- months after completion of the program. The Change of PANSS score over the above time course is the study's primary outcome measure.
    Time Frame
    Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
    Title
    Change of The Personal and Social Performance Scale (PSP) score
    Description
    The Personal and Social Performance scale (PSP) is widely used to assess social functioning in patients with schizophrenia. Participants will be assessed by medical specialist who will complete their PSP score at baseline, immediately following the completion of the 3-month program, and at 6- & 12- months after completion of the program. The Change of PSP score over the above time course is the study's primary outcome measure.
    Time Frame
    Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
    Secondary Outcome Measure Information:
    Title
    Change of Employment Outcome Checklist (EOC) score
    Description
    The Employment Outcome Checklist (EOC) is used to assess participants' employment outcomes such as the number of job interviews attended, the number of jobs obtained, number of hours per week worked, and salary received from each of the jobs that were obtained . Participants will be assessed by research assistant who will complete their EOC questionnaire at baseline, immediately following the completion of the 3-month program, and at 6- & 12- months after completion of the program. The Changes in EOC over the above time course is the study's secondary outcome measure.
    Time Frame
    Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
    Title
    Change of The Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4) score
    Description
    The Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4) is a self-report quality of life measure for people with schizophrenia. Participants complete on their own the SQLS-R4 questionnaire at baseline, immediately following the completion of the 3-month program, and at 6- & 12- months after completion of the program. The Change of SQLS-R4 score over the above time course is the study's secondary outcome measure.
    Time Frame
    Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
    Title
    Change of the Vocational Social Skills Assessment Scale (VSSS) score
    Description
    The Vocational Social Skills Assessment Scale (VSSS) is a self-administered checklist that measures the participants' subjective perception of their competence in handling work-related social situations. Participants complete on their own the VSSS questionnaire at baseline, immediately following the completion of the 3-month program, and at 6- & 12- months after completion of the program. The Change of VSSS score over the above time course is the study's secondary outcome measure.
    Time Frame
    Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
    Title
    Change of Re-hospitalization rate
    Description
    Re-Hospitalization rate measured at Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
    Time Frame
    Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
    Title
    Change of outpatient follow-up rate
    Description
    The changes in outpatient follow-up rate measured at Baseline, Completion of the 3-month program, and follow up at 6-, 12- month
    Time Frame
    Baseline, Completion of the 3-month program, and follow up at 6-, 12- month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Hong Kong/ China residents Age between 18-55 years; Primary diagnosis of psychosis (not more than 12 months of clinical diagnosis) by psychiatrist and confirmed with the SCID-I for DSM-IV TR Axis I Disorders (Biometrics Research, 2002); Primary six or above education; Mentally competent to follow the instructions and training and give informed written consent, as suggested by the attending psychiatrist; Able to communicate in Chinese; Intend to seek employment. Exclusion Criteria: Co-morbidity of learning disability, neurological disorder (e.g., epilepsy) and organic brain disease, or clinically significant medical diseases; Recently participated or are participating in other structured psychosocial intervention, and/or Visual, language or communication difficulty.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hector Wing-Hong TSANG, PhD
    Phone
    27666704
    Email
    hector.tsang@polyu.edu.hk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tracy Li, BSc
    Phone
    27666770
    Email
    tracy.wy.li@polyu.edu.hk

    12. IPD Sharing Statement

    Learn more about this trial

    From Prevention to Community Integration: IPCST for Severe Mental Illness in Chinese Communities (Hong Kong and Beijing)

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