<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/NCT01667601</url>
  </required_header>
  <id_info>
    <org_study_id>HSEARS20121211001</org_study_id>
    <nct_id>NCT01667601</nct_id>
  </id_info>
  <brief_title>Mindfulness-based Illness Management Program for Schizophrenia</brief_title>
  <acronym>MBPP</acronym>
  <official_title>The Effectiveness of a Mindfulness-based Illness Management Program for Chinese Patients With Schizophrenia: An Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Authority, Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jilin Medical College, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Taipei Medical University, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Hong Kong Polytechnic University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Only a few intervention studies have also focused on changing patients' negative thoughts and&#xD;
      feelings towards the illness and their relationship to the suffering caused by those&#xD;
      thoughts, which is evidenced to empower psychosocial functioning and control of distressing&#xD;
      thoughts in severe depression and psychotic disorders by using the Mindfulness-Based Stress&#xD;
      Reduction program. This controlled trial is designed to test the effects of a&#xD;
      mindfulness-based Illness management program (MBPP) for Chinese patients with schizophrenia&#xD;
      on their symptom severity, illness insight and psychosocial functioning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives: This study is to test the effectiveness of a mindfulness-based illness management&#xD;
      program for Chinese outpatients with schizophrenia over a 24-month follow-up. The program is&#xD;
      an integrated, insight-inducing educational program that addresses patients' awareness and&#xD;
      knowledge of schizophrenia and skills of illness management.&#xD;
&#xD;
      Methods: A two-phase, single-blind, multi-site randomized controlled trial will be conducted&#xD;
      with 449 Chinese patients with schizophrenia in Hong Kong, China and Taiwan. In the first&#xD;
      phase, 107 participants will be randomly selected from the eligible patient lists of three&#xD;
      outpatient clinics in Hong Kong only (i.e., 38 subjects from each clinic), and after baseline&#xD;
      measurement, be assigned to either the mindfulness-based illness management program,&#xD;
      conventional psycho-education group, or usual psychiatric care. For the second phase, the&#xD;
      participants will be randomly selected from the eligible patient list in three study venues&#xD;
      or countries (i.e., 114 subjects from each study site/ country) and after baseline&#xD;
      measurement, be assigned similar to the first phase to one of the three study groups. The&#xD;
      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.&#xD;
&#xD;
      Hypothesis: The patients in the mindfulness-based psycho-education program will report&#xD;
      significantly greater improvements in their symptoms and re-hospitalization rates (primary&#xD;
      outcomes) and other secondary outcomes (e.g., insight into illness and functioning) over the&#xD;
      24-month follow-up, when compared with those in psycho-education group or usual care.&#xD;
&#xD;
      Conclusions: The findings will provide evidence whether the mindfulness-based&#xD;
      psycho-education program can better improve Chinese schizophrenia sufferers' psychosocial&#xD;
      functioning and reduce their illness relapse.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2010</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">June 2016</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rehospitalization rates</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>
  </primary_outcome>
  <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. Symptom remission rate over the follow-up periods are also assessed. Complete remission was defined as 4-month simultaneous ratings of all individual items in PANSS as score ≤3.</description>
  </primary_outcome>
  <secondary_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>
  </secondary_outcome>
  <other_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>
  </other_outcome>
  <other_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>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">449</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Mindfulness-based program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A structured, researcher-designed mindfulness-based 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 programs by Chien et al. (2010) and Lehman et al. (2004), as well as the 8-session Mindfulness-Based Stress Reduction Program by Kabat-Zinn (1990).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine 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>Psychoeducation group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A psychoeducation 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.&#xD;
References:&#xD;
Chien WT, Bressington D. A randomized controlled trial of a nurse-led structured psychosocial intervention program for people with first-onset mental illness in psychiatric outpatient clinics. Psychiatry Res 2015;229:277-86.&#xD;
Macpherson R, Jerrom B, Hughes AA. controlled study of education about drug treatment in schizophrenia. Br J Psychiatry 1996;168:709-17.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Routine Care</intervention_name>
    <description>Psychiatric outpatient care provided by the outpatient departments, e.g., medical consultation, brief education by psychiatric nurses and financial advices or referrals by social workers.</description>
    <arm_group_label>Routine Care</arm_group_label>
    <other_name>Routine Psychiatric Care</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness-based program</intervention_name>
    <description>The program was based on the psychoeducation programs by Chien et al and Lehman et al, as well as the 8-session Mindfulness-Based Stress Reduction Program by Kabat-Zinn(1990).</description>
    <arm_group_label>Mindfulness-based program</arm_group_label>
    <arm_group_label>Routine Care</arm_group_label>
    <other_name>Mindfulness-based illness management program</other_name>
    <other_name>Mindfulness-based care for schizophrenia program</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychoeducation group</intervention_name>
    <description>A 5-month patient psychoeducation group program (12 sessions) led by the research team will be provided.</description>
    <arm_group_label>Psychoeducation group</arm_group_label>
    <arm_group_label>Routine Care</arm_group_label>
    <other_name>Conventional psychoeducation group</other_name>
    <other_name>Psychoeducation group intervention</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  outpatients;&#xD;
&#xD;
          -  aged 18+; and&#xD;
&#xD;
          -  diagnosed as schizophrenia and other psychotic disorders (&lt; or =5 years) according to&#xD;
             the Diagnostic and Statistical Manual, 4th edition, as ascertained by the Structured&#xD;
             Clinical Interview (SCID-I).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not able to understand the psycho-education content and Chinese;&#xD;
&#xD;
          -  mentally unstable at recruitment; and&#xD;
&#xD;
          -  with co-morbidity of other severe mental health problems such as depression and&#xD;
             substance misuse.&#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>Chien WT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The HK Polytechnic University</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>KH/LKS Specialty OPD</name>
      <address>
        <city>Shatin</city>
        <state>NT</state>
        <country>Hong Kong</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>
    <facility>
      <name>Taipei Medical University</name>
      <address>
        <city>Taipei</city>
        <state>Xinyi</state>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>Hong Kong</country>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Chien WT, Lee IY. The mindfulness-based psychoeducation program for Chinese patients with schizophrenia. Psychiatr Serv. 2013 Apr 1;64(4):376-9. doi: 10.1176/appi.ps.002092012.</citation>
    <PMID>23412024</PMID>
  </reference>
  <reference>
    <citation>Chien WT, Thompson DR. Effects of a mindfulness-based psychoeducation programme for Chinese patients with schizophrenia: 2-year follow-up. Br J Psychiatry. 2014 Jul;205(1):52-9. doi: 10.1192/bjp.bp.113.134635. Epub 2014 May 8.</citation>
    <PMID>24809397</PMID>
  </reference>
  <reference>
    <citation>Lam, A.H.Y., &amp; Chien, W.T. (2016). The effectiveness of mindfulness-based intervention for people with schizophrenia: A systematic review. Neuropsychiatry (London), 6(5), 208-222.</citation>
  </reference>
  <results_reference>
    <citation>Chien WT, Bressington D, Yip A, Karatzias T. An international multi-site, randomized controlled trial of a mindfulness-based psychoeducation group programme for people with schizophrenia. Psychol Med. 2017 Sep;47(12):2081-2096. doi: 10.1017/S0033291717000526. Epub 2017 Apr 4. Erratum In: Psychol Med. 2023 Apr;53(6):2720.</citation>
    <PMID>28374661</PMID>
  </results_reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>December 16, 2019</last_update_submitted>
  <last_update_submitted_qc>December 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hong Kong Polytechnic University</investigator_affiliation>
    <investigator_full_name>Wai-Tong Chien</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>mindfulness-based program</keyword>
  <keyword>Psychoeducation</keyword>
  <keyword>schizophrenia</keyword>
  <keyword>Chinese</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/NCT01667601
org study id: HSEARS20121211001
nct id: NCT01667601
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Only a few intervention studies have also focused on changing patients' negative thoughts and
      feelings towards the illness and their relationship to the suffering caused by those
      thoughts, which is evidenced to empower psychosocial functioning and control of distressing
      thoughts in severe depression and psychotic disorders by using the Mindfulness-Based Stress
      Reduction program. This controlled trial is designed to test the effects of a
      mindfulness-based Illness management program (MBPP) for Chinese patients with schizophrenia
      on their symptom severity, illness insight and psychosocial functioning.
Objectives: This study is to test the effectiveness of a mindfulness-based illness management
      program for Chinese outpatients with schizophrenia over a 24-month follow-up. The program is
      an integrated, insight-inducing educational program that addresses patients' awareness and
      knowledge of schizophrenia and skills of illness management.

      Methods: A two-phase, single-blind, multi-site randomized controlled trial will be conducted
      with 449 Chinese patients with schizophrenia in Hong Kong, China and Taiwan. In the first
      phase, 107 participants will be randomly selected from the eligible patient lists of three
      outpatient clinics in Hong Kong only (i.e., 38 subjects from each clinic), and after baseline
      measurement, be assigned to either the mindfulness-based illness management program,
      conventional psycho-education group, or usual psychiatric care. For the second phase, the
      participants will be randomly selected from the eligible patient list in three study venues
      or countries (i.e., 114 subjects from each study site/ country) and after baseline
      measurement, be assigned similar to the first phase to one of the three study groups. 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 mindfulness-based psycho-education program will report
      significantly greater improvements in their symptoms and re-hospitalization 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 psycho-education group or usual care.

      Conclusions: The findings will provide evidence whether the mindfulness-based
      psycho-education program can better improve Chinese schizophrenia sufferers' psychosocial
      functioning and reduce their illness relapse.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Rehospitalization rates
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: 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. Symptom remission rate over the follow-up periods are also assessed. Complete remission was defined as 4-month simultaneous ratings of all individual items in PANSS as score ≤3.
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.
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: 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.
arm group label: Mindfulness-based program
arm group type: Experimental
description: A structured, researcher-designed mindfulness-based 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 programs by Chien et al. (2010) and Lehman et al. (2004), as well as the 8-session Mindfulness-Based Stress Reduction Program by Kabat-Zinn (1990).
arm group label: Routine 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: Psychoeducation group
arm group type: Active Comparator
description: A psychoeducation 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.
References:
Chien WT, Bressington D. A randomized controlled trial of a nurse-led structured psychosocial intervention program for people with first-onset mental illness in psychiatric outpatient clinics. Psychiatry Res 2015;229:277-86.
Macpherson R, Jerrom B, Hughes AA. controlled study of education about drug treatment in schizophrenia. Br J Psychiatry 1996;168:709-17.
intervention type: Other
intervention name: Routine Care
description: Psychiatric outpatient care provided by the outpatient departments, e.g., medical consultation, brief education by psychiatric nurses and financial advices or referrals by social workers.
arm group label: Routine Care
other name: Routine Psychiatric Care
intervention type: Behavioral
intervention name: Mindfulness-based program
description: The program was based on the psychoeducation programs by Chien et al and Lehman et al, as well as the 8-session Mindfulness-Based Stress Reduction Program by Kabat-Zinn(1990).
arm group label: Mindfulness-based program
arm group label: Routine Care
other name: Mindfulness-based illness management program
other name: Mindfulness-based care for schizophrenia program
intervention type: Behavioral
intervention name: Psychoeducation group
description: A 5-month patient psychoeducation group program (12 sessions) led by the research team will be provided.
arm group label: Psychoeducation group
arm group label: Routine Care
other name: Conventional psychoeducation group
other name: Psychoeducation group intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Chien WT, PhD
role: Principal Investigator
affiliation: The HK Polytechnic University
facility: 
facility: 
facility: 
facility: 
country: China
country: Hong Kong
country: Taiwan
citation: Chien WT, Lee IY. The mindfulness-based psychoeducation program for Chinese patients with schizophrenia. Psychiatr Serv. 2013 Apr 1;64(4):376-9. doi: 10.1176/appi.ps.002092012.
PMID: 23412024
citation: Chien WT, Thompson DR. Effects of a mindfulness-based psychoeducation programme for Chinese patients with schizophrenia: 2-year follow-up. Br J Psychiatry. 2014 Jul;205(1):52-9. doi: 10.1192/bjp.bp.113.134635. Epub 2014 May 8.
PMID: 24809397
citation: Lam, A.H.Y., & Chien, W.T. (2016). The effectiveness of mindfulness-based intervention for people with schizophrenia: A systematic review. Neuropsychiatry (London), 6(5), 208-222.
citation: Chien WT, Bressington D, Yip A, Karatzias T. An international multi-site, randomized controlled trial of a mindfulness-based psychoeducation group programme for people with schizophrenia. Psychol Med. 2017 Sep;47(12):2081-2096. doi: 10.1017/S0033291717000526. Epub 2017 Apr 4. Erratum In: Psychol Med. 2023 Apr;53(6):2720.
PMID: 28374661
responsible party type: Principal Investigator
investigator affiliation: The Hong Kong Polytechnic University
investigator full name: Wai-Tong Chien
investigator title: Professor
mesh term: Schizophrenia
sharing ipd: No