<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03246932</url>
  </required_header>
  <id_info>
    <org_study_id>CWai-Tong</org_study_id>
    <nct_id>NCT03246932</nct_id>
  </id_info>
  <brief_title>Peer-led Psycho-education for Schizophrenia</brief_title>
  <official_title>The Effectiveness of a Peer-led Psycho-education Group in Schizophrenia: A Multi-site Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Authority, Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jilin University Medical Science Division</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Taipei Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Profession-led psycho-education programs for people with schizophrenia are evidenced to&#xD;
      improve patients' knowledge about the illness, mental state and relapse rate. Nevertheless,&#xD;
      other benefits to patients, for example, their functioning and insight into illness or to be&#xD;
      substantive in a longer term (&gt;12 months) are inconsistent and uncertain, especially in Asian&#xD;
      populations. This single-blind multi-site randomized clinical trial was to test the effects&#xD;
      of a peer-expert-led psycho-education group intervention (in addition to usual care) for&#xD;
      adult patients with schizophrenia spectrum disorders over a 24-month follow-up, in comparison&#xD;
      to a profession-led psycho-education group or treatment-as-usual only.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives: This study is to test the effectiveness of a peer-expert-led psycho-education&#xD;
      group programme for Chinese outpatients with schizophrenia spectrum disorders over an&#xD;
      24-month follow-up. The program is an integrated,psycho-education program that addresses&#xD;
      patients' knowledge and self-management of schizophrenia and problem-solving skills. Methods:&#xD;
      A single-blind, multi-site randomized controlled trial will be conducted with 342 Chinese&#xD;
      patients with schizophrenia in Hong Kong, China and Taiwan. In each of three study sites, the&#xD;
      participants will be randomly selected from the eligible patient list (i.e., 114 subjects&#xD;
      from each study site) and after baseline measurement, be assigned to either the peer-led&#xD;
      psycho-education program, profession-led psycho-education group, or usual psychiatric care.&#xD;
      The patients' mental and psychosocial functioning, insights into illness, and their&#xD;
      re-hospitalization rates will be measured at recruitment and at one week, and 6, 12 and 24&#xD;
      months after completing the interventions. Hypothesis: The patients in the peer-led&#xD;
      psycho-education program will report significantly greater improvements in their symptoms and&#xD;
      re-hospitalisation rates (primary outcomes) and other secondary outcomes (e.g., insight into&#xD;
      illness and functioning) over the 24-month follow-up, when compared with those in&#xD;
      profession-led psycho-education group and/or usual care. Conclusions: The findings will&#xD;
      provide evidence whether the peer-led psycho-education group program can better improve&#xD;
      Chinese schizophrenia sufferers' psychosocial functioning and reduce their illness relapse.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 1, 2020</start_date>
  <completion_date type="Anticipated">March 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The outcome assessor will be blinded to the group assignments.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Positive and Negative Syndrome Scale</measure>
    <time_frame>from recruitment to 24-month follow-up</time_frame>
    <description>The Positive and Negative Syndrome Scale assesses the severity of psychotic symptoms on three subscales: positive symptoms (7 items), negative symptoms (7 items) and general psychopathology (16 items). will be assessed at recruitment and one week, 6 months, 12 months and 24 months after the interventions completed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Specific Level of Functioning Scale</measure>
    <time_frame>from recruitment to 24-month follow-up</time_frame>
    <description>Patients' levels of psychosocial functioning will be assessed with the Specific Level of Functioning Scale at baseline and one week, 6 months, 12 months and 24 months follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Re-hospitalization rate</measure>
    <time_frame>from recruitment to 24-month follow-up</time_frame>
    <description>Average amount (number) and length of hospital stay of the patients over previous six months will be assessed at recruitment and one week, 6 months, 12 months and 24 months after the interventions completed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six-item Social Support Questionnaire</measure>
    <time_frame>from recruitment to 24-month follow-up</time_frame>
    <description>Patients' perceived social support will be assessed with the Six-item Social Support Questionnaire at baseline and one week, 6 months, 12 months and 24 months follow-up.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Insights to illness and treatment</measure>
    <time_frame>from recruitment to 24-month follow-up</time_frame>
    <description>Patients' insight and attitudes to illness and treatment will be measured with the Insight and Treatment Attitudes Questionnaire at recruitment and one week, 6 months, 12 months and 24 months after the interventions completed.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">342</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Peer-led psycho-education group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A structured, researcher-designed peer expert-led psycho-education program (6 months), comprised of 12 bi-weekly, 2-hour group sessions (10-12 patients per group). The program was based on the psycho-education and self-help, problem-solving programs by Chien et al. (2010) and Lehman et al. (2004).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine psychiatric care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Routine psychiatric outpatient care, including medication, psychiatric consultation in outpatient clinic, brief education by psychiatric nurses, financial and social welfare advices by social workers, and individual counseling by clinical psychologist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Profession-led psycho-education group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A psycho-education group program (12 sessions, bi-weekly) based on Dr. Macpherson's Family Psychoeducation Program in 1996 and Chien and Bressington's one in 2014/15 will be used.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Peer-led psycho-education group</intervention_name>
    <description>A structured, researcher-designed peer-led psycho-education program (6 months), comprising of 12 bi-weekly, 2-hour group sessions.</description>
    <arm_group_label>Peer-led psycho-education group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Profession-led psycho-education group</intervention_name>
    <description>A psychoeducation group program (12 sessions, bi-weekly).</description>
    <arm_group_label>Profession-led psycho-education group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Routine psychiatric care</intervention_name>
    <description>Routine psychiatric outpatient care, or Treatment-as-usual (TAU).</description>
    <arm_group_label>Peer-led psycho-education group</arm_group_label>
    <arm_group_label>Profession-led psycho-education group</arm_group_label>
    <arm_group_label>Routine psychiatric care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients, aged 18+, attending one psychiatric outpatient clinic under study;&#xD;
&#xD;
          -  diagnosed as schizophrenia and its subtypes according to the Diagnostic and&#xD;
             Statistical Manual, 4th Text-Revised Edition, as ascertained by the Structured&#xD;
             Clinical Interview (SCID-I);&#xD;
&#xD;
          -  having onset of the illness for not &gt;5 years; and&#xD;
&#xD;
          -  able to communicate in Cantonese language.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  mentally unstable and unfit for study participation at recruitment;&#xD;
&#xD;
          -  with co-morbidity of other severe mental health problems such as depression and&#xD;
             substance misuse; and&#xD;
&#xD;
          -  have recently received or are receiving any structured psychosocial intervention.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>WT Chien, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CUHK</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jilin Medical College</name>
      <address>
        <city>Jilin</city>
        <state>Jilin</state>
        <zip>0432</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TM Psy Centre</name>
      <address>
        <city>Tuen Mun</city>
        <state>NT</state>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>Hong Kong</country>
  </location_countries>
  <reference>
    <citation>Chien WT, Norman I. The effectiveness and active ingredients of mutual support groups for family caregivers of people with psychotic disorders: a literature review. Int J Nurs Stud. 2009 Dec;46(12):1604-23. doi: 10.1016/j.ijnurstu.2009.04.003. Epub 2009 May 28.</citation>
    <PMID>19481205</PMID>
  </reference>
  <reference>
    <citation>Chien WT, Leung SF, Yeung FK, Wong WK. Current approaches to treatments for schizophrenia spectrum disorders, part II: psychosocial interventions and patient-focused perspectives in psychiatric care. Neuropsychiatr Dis Treat. 2013;9:1463-81. doi: 10.2147/NDT.S49263. Epub 2013 Sep 25.</citation>
    <PMID>24109184</PMID>
  </reference>
  <reference>
    <citation>Chien WT, Clifton AV, Zhao S, Lui S. Peer support for people with schizophrenia or other serious mental illness. Cochrane Database Syst Rev. 2019 Apr 4;4(4):CD010880. doi: 10.1002/14651858.CD010880.pub2.</citation>
    <PMID>30946482</PMID>
  </reference>
  <reference>
    <citation>Chien WT, Bressington D. A randomized controlled clinical trial of a nurse-led structured psychosocial intervention program for people with first-onset mental illness in psychiatric outpatient clinics. Psychiatry Res. 2015 Sep 30;229(1-2):277-86. doi: 10.1016/j.psychres.2015.07.012. Epub 2015 Jul 10.</citation>
    <PMID>26193827</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>August 28, 2023</last_update_submitted>
  <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Prof. Wai Tong CHIEN</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>peer expert or specialist</keyword>
  <keyword>psycho-education</keyword>
  <keyword>schizophrenia</keyword>
  <keyword>outpatients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03246932
org study id: CWai-Tong
nct id: NCT03246932
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Profession-led psycho-education programs for people with schizophrenia are evidenced to
      improve patients' knowledge about the illness, mental state and relapse rate. Nevertheless,
      other benefits to patients, for example, their functioning and insight into illness or to be
      substantive in a longer term (>12 months) are inconsistent and uncertain, especially in Asian
      populations. This single-blind multi-site randomized clinical trial was to test the effects
      of a peer-expert-led psycho-education group intervention (in addition to usual care) for
      adult patients with schizophrenia spectrum disorders over a 24-month follow-up, in comparison
      to a profession-led psycho-education group or treatment-as-usual only.
Objectives: This study is to test the effectiveness of a peer-expert-led psycho-education
      group programme for Chinese outpatients with schizophrenia spectrum disorders over an
      24-month follow-up. The program is an integrated,psycho-education program that addresses
      patients' knowledge and self-management of schizophrenia and problem-solving skills. Methods:
      A single-blind, multi-site randomized controlled trial will be conducted with 342 Chinese
      patients with schizophrenia in Hong Kong, China and Taiwan. In each of three study sites, the
      participants will be randomly selected from the eligible patient list (i.e., 114 subjects
      from each study site) and after baseline measurement, be assigned to either the peer-led
      psycho-education program, profession-led psycho-education group, or usual psychiatric care.
      The patients' mental and psychosocial functioning, insights into illness, and their
      re-hospitalization rates will be measured at recruitment and at one week, and 6, 12 and 24
      months after completing the interventions. Hypothesis: The patients in the peer-led
      psycho-education program will report significantly greater improvements in their symptoms and
      re-hospitalisation rates (primary outcomes) and other secondary outcomes (e.g., insight into
      illness and functioning) over the 24-month follow-up, when compared with those in
      profession-led psycho-education group and/or usual care. Conclusions: The findings will
      provide evidence whether the peer-led psycho-education group program can better improve
      Chinese schizophrenia sufferers' psychosocial functioning and reduce their illness relapse.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The outcome assessor will be blinded to the group assignments.
measure: Positive and Negative Syndrome Scale
time frame: from recruitment to 24-month follow-up
description: The Positive and Negative Syndrome Scale assesses the severity of psychotic symptoms on three subscales: positive symptoms (7 items), negative symptoms (7 items) and general psychopathology (16 items). will be assessed at recruitment and one week, 6 months, 12 months and 24 months after the interventions completed.
measure: Specific Level of Functioning Scale
time frame: from recruitment to 24-month follow-up
description: Patients' levels of psychosocial functioning will be assessed with the Specific Level of Functioning Scale at baseline and one week, 6 months, 12 months and 24 months follow-up.
measure: Re-hospitalization rate
time frame: from recruitment to 24-month follow-up
description: Average amount (number) and length of hospital stay of the patients over previous six months will be assessed at recruitment and one week, 6 months, 12 months and 24 months after the interventions completed.
measure: Six-item Social Support Questionnaire
time frame: from recruitment to 24-month follow-up
description: Patients' perceived social support will be assessed with the Six-item Social Support Questionnaire at baseline and one week, 6 months, 12 months and 24 months follow-up.
measure: Insights to illness and treatment
time frame: from recruitment to 24-month follow-up
description: Patients' insight and attitudes to illness and treatment will be measured with the Insight and Treatment Attitudes Questionnaire at recruitment and one week, 6 months, 12 months and 24 months after the interventions completed.
arm group label: Peer-led psycho-education group
arm group type: Experimental
description: A structured, researcher-designed peer expert-led psycho-education program (6 months), comprised of 12 bi-weekly, 2-hour group sessions (10-12 patients per group). The program was based on the psycho-education and self-help, problem-solving programs by Chien et al. (2010) and Lehman et al. (2004).
arm group label: Routine psychiatric care
arm group type: Other
description: Routine psychiatric outpatient care, including medication, psychiatric consultation in outpatient clinic, brief education by psychiatric nurses, financial and social welfare advices by social workers, and individual counseling by clinical psychologist.
arm group label: Profession-led psycho-education group
arm group type: Active Comparator
description: A psycho-education group program (12 sessions, bi-weekly) based on Dr. Macpherson's Family Psychoeducation Program in 1996 and Chien and Bressington's one in 2014/15 will be used.
intervention type: Behavioral
intervention name: Peer-led psycho-education group
description: A structured, researcher-designed peer-led psycho-education program (6 months), comprising of 12 bi-weekly, 2-hour group sessions.
arm group label: Peer-led psycho-education group
intervention type: Behavioral
intervention name: Profession-led psycho-education group
description: A psychoeducation group program (12 sessions, bi-weekly).
arm group label: Profession-led psycho-education group
intervention type: Other
intervention name: Routine psychiatric care
description: Routine psychiatric outpatient care, or Treatment-as-usual (TAU).
arm group label: Peer-led psycho-education group
arm group label: Profession-led psycho-education group
arm group label: Routine psychiatric care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: WT Chien, PhD
role: Principal Investigator
affiliation: CUHK
facility: 
facility: 
country: China
country: Hong Kong
citation: Chien WT, Norman I. The effectiveness and active ingredients of mutual support groups for family caregivers of people with psychotic disorders: a literature review. Int J Nurs Stud. 2009 Dec;46(12):1604-23. doi: 10.1016/j.ijnurstu.2009.04.003. Epub 2009 May 28.
PMID: 19481205
citation: Chien WT, Leung SF, Yeung FK, Wong WK. Current approaches to treatments for schizophrenia spectrum disorders, part II: psychosocial interventions and patient-focused perspectives in psychiatric care. Neuropsychiatr Dis Treat. 2013;9:1463-81. doi: 10.2147/NDT.S49263. Epub 2013 Sep 25.
PMID: 24109184
citation: Chien WT, Clifton AV, Zhao S, Lui S. Peer support for people with schizophrenia or other serious mental illness. Cochrane Database Syst Rev. 2019 Apr 4;4(4):CD010880. doi: 10.1002/14651858.CD010880.pub2.
PMID: 30946482
citation: Chien WT, Bressington D. A randomized controlled clinical trial of a nurse-led structured psychosocial intervention program for people with first-onset mental illness in psychiatric outpatient clinics. Psychiatry Res. 2015 Sep 30;229(1-2):277-86. doi: 10.1016/j.psychres.2015.07.012. Epub 2015 Jul 10.
PMID: 26193827
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Prof. Wai Tong CHIEN
investigator title: Professor
mesh term: Schizophrenia
sharing ipd: No