<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/NCT04430868</url>
  </required_header>
  <id_info>
    <org_study_id>B20190705</org_study_id>
    <nct_id>NCT04430868</nct_id>
  </id_info>
  <brief_title>Lifestyle Redesign For Schizophrenia</brief_title>
  <official_title>The Impact of Lifestyle Redesign Program in Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan</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>
      This study aimed to investigate the effects of lifestyle redesign program plus treatment as&#xD;
      usual versus treatment as usual on cognition, psychiatric symptoms, quality of life, and&#xD;
      occupational engagement for schizophrenia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2020</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change scores of Brief Psychiatric Symptom Rating Scale (BSRS)</measure>
    <time_frame>3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention</time_frame>
    <description>The Chinese version of BSRS with 50 items is administered to measure psychiatric symptoms. BSRS items were evaluated on a five-point Likert scale from 0 (not present) to 4 (extremely severe). The total score ranged from 0 to 200, with higher scores reflecting more severe of psychiatric symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change scores of Occupational Self Assessment (OSA)</measure>
    <time_frame>3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention</time_frame>
    <description>The OSA with 29 items is administered to measure occupational engagement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change scores of Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4)</measure>
    <time_frame>3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention</time_frame>
    <description>The Chinese version of Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4) was administered to measure subjective quality of life. The total scores ranged from 33-165, with higher scores indicating comparatively lower quality of life.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change scores of Montreal Cognitive Assessment (MoCA)</measure>
    <time_frame>3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention</time_frame>
    <description>The Chinese version of MoCA was administered to measure cognition, with higher scores indicating better cognition.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Rehabilitation</condition>
  <arm_group>
    <arm_group_label>LRP group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants in LRP group receive lifestyle redesign program plus treatment as usual. The LRP intervention consisted of one 90-minute session each week for 10 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAU group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The participants in TAU group received usual treatment at the same time as LRP group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>lifestyle redesign program</intervention_name>
    <description>In this group, it starts with health education, the participants then change their opinions and experience health activities, and it ends with discussion and sharing their experience.</description>
    <arm_group_label>LRP group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of schizophrenia, based on the ICD-10 diagnostic criteria for research&#xD;
             (World Health Organization, 1992)&#xD;
&#xD;
          -  age from 20 to 65&#xD;
&#xD;
          -  attending day care center regularly for at least 1 month and taking stable dose of&#xD;
             medication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  comorbid other mental disorder (e.g. depression, anxiety, ADHD...etc.)&#xD;
&#xD;
          -  comorbid mental retardation&#xD;
&#xD;
          -  lacking the reading and writing skills&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan</investigator_affiliation>
    <investigator_full_name>YU SHIUAN LIAW</investigator_full_name>
    <investigator_title>Occupational Therapist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <!-- 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/NCT04430868
org study id: B20190705
nct id: NCT04430868
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aimed to investigate the effects of lifestyle redesign program plus treatment as
      usual versus treatment as usual on cognition, psychiatric symptoms, quality of life, and
      occupational engagement for schizophrenia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change scores of Brief Psychiatric Symptom Rating Scale (BSRS)
time frame: 3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention
description: The Chinese version of BSRS with 50 items is administered to measure psychiatric symptoms. BSRS items were evaluated on a five-point Likert scale from 0 (not present) to 4 (extremely severe). The total score ranged from 0 to 200, with higher scores reflecting more severe of psychiatric symptoms.
measure: Change scores of Occupational Self Assessment (OSA)
time frame: 3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention
description: The OSA with 29 items is administered to measure occupational engagement.
measure: Change scores of Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4)
time frame: 3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention
description: The Chinese version of Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4) was administered to measure subjective quality of life. The total scores ranged from 33-165, with higher scores indicating comparatively lower quality of life.
measure: Change scores of Montreal Cognitive Assessment (MoCA)
time frame: 3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention
description: The Chinese version of MoCA was administered to measure cognition, with higher scores indicating better cognition.
arm group label: LRP group
arm group type: Experimental
description: The participants in LRP group receive lifestyle redesign program plus treatment as usual. The LRP intervention consisted of one 90-minute session each week for 10 weeks
arm group label: TAU group
arm group type: No Intervention
description: The participants in TAU group received usual treatment at the same time as LRP group.
intervention type: Behavioral
intervention name: lifestyle redesign program
description: In this group, it starts with health education, the participants then change their opinions and experience health activities, and it ends with discussion and sharing their experience.
arm group label: LRP group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
investigator full name: YU SHIUAN LIAW
investigator title: Occupational Therapist
mesh term: Schizophrenia