<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/NCT04465422</url>
  </required_header>
  <id_info>
    <org_study_id>TCHIRB-10904021</org_study_id>
    <nct_id>NCT04465422</nct_id>
  </id_info>
  <brief_title>Development and Validation of the Client Centered Occupational Therapy Service Model</brief_title>
  <official_title>Development and Validation of the Client Centered Occupational Therapy Service Model</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei City Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei City Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to develop and validate Client-centered Occupational Therapy&#xD;
      Service at Taipei City Psychiatric Center (OT@tcpc) service model to assist clinicians to&#xD;
      provide and integrate comprehensive OT services.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Occupational Therapy (OT) is one of the mental health services. The service phase includes&#xD;
      acute/chronic hospitalization, daycare centers (adolescents, adults, and the elderly),&#xD;
      community mental rehabilitation institutions, psychiatric nursing home, and outpatient&#xD;
      assessment/treatments. OT provides holistic and continuous mental rehabilitation services at&#xD;
      each stage of mental health care. During the acute hospitalization and based on the Model of&#xD;
      Human Occupation (MOHO) model, the occupational therapist provides daily activities to assist&#xD;
      acute patients with mental illness to develop occupation adaptation to enable and prepare for&#xD;
      discharge.&#xD;
&#xD;
      However, the lack of a client-centered OT service model limits the interpretation of the&#xD;
      treatment effect and the process of change. This will seriously affect the integrity and&#xD;
      continuity of OT services and will limit the development of OT professions. Thus, the purpose&#xD;
      of the study is to develop and validate Client-centered Occupational Therapy Service at&#xD;
      Taipei City Psychiatric Center (OT@tcpc) service model to assist clinicians to provide and&#xD;
      integrate comprehensive OT services.&#xD;
&#xD;
      This project consists of 2 stages. First, based on the MOHO model we use 5 stages with 6&#xD;
      weeks program to develop the OT@tcpc service model. Second, validate the to indicate the&#xD;
      occupation identity and competence to validate the OT@tcpc service model. We will recruit 70&#xD;
      inpatients with schizophrenia and divided into intervention group, based on MOHO theory, and&#xD;
      control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 19, 2020</start_date>
  <completion_date type="Actual">July 16, 2020</completion_date>
  <primary_completion_date type="Actual">July 16, 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>
    <intervention_model_description>We will recruit 70 inpatients with schizophrenia and devided into intervention group, based on MOHO theory, and control group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Participants are blind during this clinical trial. They are prevented from having knowledge of the interventions.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Occupational Performance History Interview-II (OPHI-II) Total and Subscale Scores</measure>
    <time_frame>2 weeks</time_frame>
    <description>The Occupational Performance History Interview-Second Version(OPHI-II) was tested before and after in the intervention group and the control group to explain the intervention effect of the MOHO theory-based treatment model.&#xD;
OPHI-II is a semi-structured interview that gathers life history information. The OPHI-II contains 3 sub-domains: OPHI-II Occupational Identity(range 11~44)、OPHI-II Occupational Competence(range 9~36)、OPHI-II Occupational Behavior Settings(range 9~36).&#xD;
The three sub-domains are divided into 4 levels, in which 4 points indicate good performance, 3 points indicate good functions, 2 points indicate lack of certain functions, and 1 points indicate poor functions. The total score of OPHI-II is equal to the sum of the three sub-domains (scores 29 to 116; higher scores indicate higher performance).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occupational Therapy Evaluation Scales Measure</measure>
    <time_frame>2 weeks</time_frame>
    <description>Except for Mini-Menlal State Examination(MMSE), all other tools were tested before and after in the intervention group and the control group to explain the intervention effect of the MOHO theory-based treatment model&#xD;
The secondary outcome included the following instruments:&#xD;
Mini-Menlal State Examination, MMSE(range 0~30；the higher scores indicate greater ability)&#xD;
Canadian Occupational Performance Measure, COPM(performance and satisfaction, each range 1~10；the higher scores indicate greater performance)&#xD;
Personal and Social Performance scale , PSP(range 1~100；the higher scores indicate greater performance)&#xD;
Clinical Global Impressions Scale of Severity, CGIS(range 1~7；the lower scores indicate greater performance)&#xD;
Comprehensive Occupational Therapy Evaluation Scale, COTES(range 20~100；the higher scores indicate greater performance)&#xD;
Lawton Instrumental Activities Daily Living, LIADL(range 0~23；the higher scores indicate greater performance)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Occupational Therapy</condition>
  <condition>Psychiatric Rehabilitation</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>We will recruit 70 inpatients with schizophrenia and divided into intervention group and control group. The Intervention group provided Occupational therapy based on the MOHO theory, while the control group adopted the original Occupational therapy model.&#xD;
The research at this stage is based on the theoretical framework of the MOHO model and the clinical practice of OTPF-3. Clinical experts are requested to assist in providing relevant suggestions as a reference for modifying intervention activities. Design OT@tcpc service model for occupational therapy intervention activities. The event design is based on the 4 systems of determinationl, habits, performance and environment, and 2 events are designed for each to be carried out in a group. Each activity includes 4 parts: warm-up, activity, feedback and homework. Each activity group will be explained separately so that the occupational therapist of the group can complete it under the guidance.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>We will recruit 70 inpatients with schizophrenia and divided into intervention group and control group. The Intervention group provided Occupational therapy based on the MOHO theory, while the control group adopted the original Occupational therapy model.&#xD;
This study was approved by the Institutional Review Board of Taipei City Hospital. After informed consent, the patients signed the consent form for this study and became the participant of this study.&#xD;
Each activity group will be explained separately so that the participants of each group can complete it under the guidance. The group description includes: activity title, activity time (location), MOHO theory system, group purpose, activity content, equipment or materials, precautions, etc.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Occupational therapy based on the MOHO theory</intervention_name>
    <description>We selected two acute wards in the Songde hospital as the intervention group and the control group. At the same time, the demographic data of the participants were collected, including gender, age, age of onset, marital status, education level, work experience, etc., and the clinical records, including assessment of mental symptoms and medication records, etc. Continuity or categorical information on Occupational performance, personal and social performance, instrumental activities daily living, and clinical performance.&#xD;
OPHI-II, CGIS, PSP, LIADL, COPM, COTES were tested before and after in the intervention group and the control group to explain the intervention effect of the MOHO theory-based treatment model.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Occupational therapy</intervention_name>
    <description>The original Occupational therapy. OPHI-II, CGIS, PSP, LIADL, COPM, COTES were tested before and after in the intervention group and the control group to explain the intervention effect of the MOHO theory-based treatment model.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients diagnosed with schizophrenia according to DSM-5 diagnostic criteria.&#xD;
&#xD;
          2. Over 20 years old.&#xD;
&#xD;
          3. Agree to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Diagnosis of intellectual developmental disorders 2. History of severe brain injury&#xD;
             3. Cannot complete the study due to poor cognitive, vision or hand function&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shu-Chun Lee, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Occupational Therapy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Taipei City Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>110209</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Lee J. Achieving best practice: a review of evidence linked to occupation-focused practice models. Occup Ther Health Care. 2010 Jul;24(3):206-22. doi: 10.3109/07380577.2010.483270.</citation>
    <PMID>23898928</PMID>
  </reference>
  <reference>
    <citation>Lee SW, Taylor R, Kielhofner G, Fisher G. Theory use in practice: a national survey of therapists who use the Model of Human Occupation. Am J Occup Ther. 2008 Jan-Feb;62(1):106-17. doi: 10.5014/ajot.62.1.106.</citation>
    <PMID>18254437</PMID>
  </reference>
  <reference>
    <citation>Lee SW, Kielhofner G, Morley M, Heasman D, Garnham M, Willis S, Parkinson S, Forsyth K, Melton J, Taylor RR. Impact of using the Model of Human Occupation: a survey of occupational therapy mental health practitioners' perceptions. Scand J Occup Ther. 2012 Sep;19(5):450-6. doi: 10.3109/11038128.2011.645553. Epub 2012 Jan 3.</citation>
    <PMID>22214401</PMID>
  </reference>
  <reference>
    <citation>Melton J, Forsyth K, Metherall A, Robinson J, Hill J, Quick L. Program Redesign Based on the Model of Human Occupation: Inpatient Services for People Experiencing Acute Mental Illness in the UK. Occup Ther Health Care. 2008;22(2-3):37-50. doi: 10.1080/07380570801989382.</citation>
    <PMID>23941371</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <results_first_submitted>November 15, 2020</results_first_submitted>
  <results_first_submitted_qc>February 9, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 2, 2021</results_first_posted>
  <last_update_submitted>March 2, 2021</last_update_submitted>
  <last_update_submitted_qc>March 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>client-centered</keyword>
  <keyword>Model of Human Occupation</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 13, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT04465422/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Date of the recruitment period : 06/19/2020 - 07/16/2020 Recruitment type of location : medical clinical</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Intervention Group</title>
          <description>We will recruit 70 inpatients with schizophrenia and divided into intervention group and control group. The Intervention group provided Occupational therapy based on the MOHO theory.&#xD;
Occupational therapy based on the MOHO theory: We selected two acute wards in the Songde hospital as the intervention group and the control group. At the same time, the demographic data of the participants were collected, including gender, age, age of onset, marital status, education level, work experience, etc., and the clinical records, including assessment of mental symptoms and medication records, etc. Continuity or categorical information on Occupational performance, personal and social performance, instrumental activities daily living, and clinical performance.</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>We will recruit 70 inpatients with schizophrenia and divided into intervention group and control group. The control group adopted the original Occupational therapy model. Execution for two weeks.&#xD;
At the same time, the demographic data of the participants were collected, including gender, age, age of onset, marital status, education level, work experience, etc., and the clinical records, including assessment of mental symptoms and medication records, etc. Continuity or categorical information on Occupational performance, personal and social performance, instrumental activities daily living, and clinical performance.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention Group</title>
          <description>In order to indicate the occupation identity and competence to validate the OT@tcpc service model. We recruited 70 inpatients with schizophrenia and divided into intervention group and control group. The Intervention group provided Occupational therapy based on the MOHO theory.&#xD;
Occupational therapy based on the MOHO theory: We selected two acute wards in the Songde hospital as the intervention group and the control group. At the same time, the demographic data of the participants were collected, including gender, age, age of onset, marital status, education level, work experience, etc., and the clinical records, including assessment of mental symptoms and medication records, etc. Continuity or categorical information on Occupational performance, personal and social performance, instrumental activities daily living, and clinical performance.</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>In order to indicate the occupation identity and competence to validate the OT@tcpc service model. We recruited 70 inpatients with schizophrenia and divided into intervention group and control group. The control group adopted the original Occupational therapy model.&#xD;
At the same time, the demographic data of the participants were collected, including gender, age, age of onset, marital status, education level, work experience, etc., and the clinical records, including assessment of mental symptoms and medication records, etc. Continuity or categorical information on Occupational performance, personal and social performance, instrumental activities daily living, and clinical performance.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="17"/>
            <count group_id="B2" value="16"/>
            <count group_id="B3" value="33"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="17"/>
                    <count group_id="B2" value="16"/>
                    <count group_id="B3" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43.6" spread="9"/>
                    <measurement group_id="B2" value="43.4" spread="9.4"/>
                    <measurement group_id="B3" value="43.5" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="17"/>
                    <count group_id="B2" value="16"/>
                    <count group_id="B3" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Onset age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="17"/>
                    <count group_id="B2" value="16"/>
                    <count group_id="B3" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20.1" spread="4.8"/>
                    <measurement group_id="B2" value="19.0" spread="3.8"/>
                    <measurement group_id="B3" value="19.56" spread="4.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of illness</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="17"/>
                    <count group_id="B2" value="16"/>
                    <count group_id="B3" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.0" spread="8.6"/>
                    <measurement group_id="B2" value="24.4" spread="8.6"/>
                    <measurement group_id="B3" value="23.7" spread="8.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="17"/>
                    <count group_id="B2" value="16"/>
                    <count group_id="B3" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Single</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Married</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Divorced</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="17"/>
                    <count group_id="B2" value="16"/>
                    <count group_id="B3" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Junior high school</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Senior high school</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>College and above</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Occupational Performance History Interview-II (OPHI-II) Total and Subscale Scores</title>
        <description>The Occupational Performance History Interview-Second Version(OPHI-II) was tested before and after in the intervention group and the control group to explain the intervention effect of the MOHO theory-based treatment model.&#xD;
OPHI-II is a semi-structured interview that gathers life history information. The OPHI-II contains 3 sub-domains: OPHI-II Occupational Identity(range 11~44)、OPHI-II Occupational Competence(range 9~36)、OPHI-II Occupational Behavior Settings(range 9~36).&#xD;
The three sub-domains are divided into 4 levels, in which 4 points indicate good performance, 3 points indicate good functions, 2 points indicate lack of certain functions, and 1 points indicate poor functions. The total score of OPHI-II is equal to the sum of the three sub-domains (scores 29 to 116; higher scores indicate higher performance).</description>
        <time_frame>2 weeks</time_frame>
        <population>Individuals with schizophrenia were recruited from acute ward of the Psychiatric Department of Taipei City Hospital.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>We will recruit 70 inpatients with schizophrenia and divided into intervention group and control group. The Intervention group provided Occupational therapy based on the MOHO theory.&#xD;
Occupational therapy based on the MOHO theory: We selected two acute wards in the Songde hospital as the intervention group and the control group. At the same time, the demographic data of the participants were collected, including gender, age, age of onset, marital status, education level, work experience, etc., and the clinical records, including assessment of mental symptoms and medication records, etc. Continuity or categorical information on Occupational performance, personal and social performance, instrumental activities daily living, and clinical performance.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>We will recruit 70 inpatients with schizophrenia and divided into intervention group and control group. The control group adopted the original Occupational therapy model. Execution for two weeks.&#xD;
At the same time, the demographic data of the participants were collected, including gender, age, age of onset, marital status, education level, work experience, etc., and the clinical records, including assessment of mental symptoms and medication records, etc. Continuity or categorical information on Occupational performance, personal and social performance, instrumental activities daily living, and clinical performance.</description>
          </group>
        </group_list>
        <measure>
          <title>Occupational Performance History Interview-II (OPHI-II) Total and Subscale Scores</title>
          <description>The Occupational Performance History Interview-Second Version(OPHI-II) was tested before and after in the intervention group and the control group to explain the intervention effect of the MOHO theory-based treatment model.&#xD;
OPHI-II is a semi-structured interview that gathers life history information. The OPHI-II contains 3 sub-domains: OPHI-II Occupational Identity(range 11~44)、OPHI-II Occupational Competence(range 9~36)、OPHI-II Occupational Behavior Settings(range 9~36).&#xD;
The three sub-domains are divided into 4 levels, in which 4 points indicate good performance, 3 points indicate good functions, 2 points indicate lack of certain functions, and 1 points indicate poor functions. The total score of OPHI-II is equal to the sum of the three sub-domains (scores 29 to 116; higher scores indicate higher performance).</description>
          <population>Individuals with schizophrenia were recruited from acute ward of the Psychiatric Department of Taipei City Hospital.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>OPHI-II Total score (pretest)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.2" spread="8.0"/>
                    <measurement group_id="O2" value="69.4" spread="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>OPHI-II Occupational Identity (pretest)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.9" spread="4.8"/>
                    <measurement group_id="O2" value="25.7" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>OPHI-II Occupational Competence (pretest)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.7" spread="2.6"/>
                    <measurement group_id="O2" value="22.1" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>OPHI-II Occupational Behavior Settings (pretest)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.7" spread="2.7"/>
                    <measurement group_id="O2" value="21.6" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>OPHI-II Total score (posttest 2 weeks)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.1" spread="8.3"/>
                    <measurement group_id="O2" value="67.6" spread="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>OPHI-II Occupational Identity (posttest 2 weeks)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.3" spread="5.3"/>
                    <measurement group_id="O2" value="25.0" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>OPHI-II Occupational Competence (posttest 2 weeks)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.9" spread="2.7"/>
                    <measurement group_id="O2" value="21.5" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>OPHI-II Occupational Behavior Settings (posttest 2 weeks)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.9" spread="2.2"/>
                    <measurement group_id="O2" value="21.1" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Anaiysis 1 is according to Occupational Performance History Interview - II (OPHI-II) total score.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>3.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.97</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.65</ci_lower_limit>
            <ci_upper_limit>5.55</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis 2 is based on Occupational Identity(range 11~44；higher scores indicates better performance), a sub-domain of OPHI-II. The Occupational Identity scale is designed to measure the degree to which a client has internalized a positive occupational identity (i.e., has values, interests, and confidence; sees self in various occupational roles; has an image of the kind of life desired)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.019</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.53</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.23</ci_lower_limit>
            <ci_upper_limit>2.37</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis 3 is based on Occupational Competence(range 9~36；higher scores indicate better performance), a sub-domain of OPHI-II. The Occupational Competence scale is designed to measure the degree to which a client is able to sustain a pattern of occupational behavior that is productive and satisfying.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.006</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.43</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.38</ci_lower_limit>
            <ci_upper_limit>2.11</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis 4 is based on Occupational Behavior Settings(range 9~36；higher scores indicate greater performance), a sub-domain of OPHI-II. The Occupational Behavior Settings scale addresses the impact of the environment on the person's occupational life.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.136</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.38</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.19</ci_lower_limit>
            <ci_upper_limit>1.35</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Occupational Therapy Evaluation Scales Measure</title>
        <description>Except for Mini-Menlal State Examination(MMSE), all other tools were tested before and after in the intervention group and the control group to explain the intervention effect of the MOHO theory-based treatment model&#xD;
The secondary outcome included the following instruments:&#xD;
Mini-Menlal State Examination, MMSE(range 0~30；the higher scores indicate greater ability)&#xD;
Canadian Occupational Performance Measure, COPM(performance and satisfaction, each range 1~10；the higher scores indicate greater performance)&#xD;
Personal and Social Performance scale , PSP(range 1~100；the higher scores indicate greater performance)&#xD;
Clinical Global Impressions Scale of Severity, CGIS(range 1~7；the lower scores indicate greater performance)&#xD;
Comprehensive Occupational Therapy Evaluation Scale, COTES(range 20~100；the higher scores indicate greater performance)&#xD;
Lawton Instrumental Activities Daily Living, LIADL(range 0~23；the higher scores indicate greater performance)</description>
        <time_frame>2 weeks</time_frame>
        <population>Individuals with schizophrenia were recruited from acute ward of the Psychiatric Department of Taipei City Hospital.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>In order to indicate the occupation identity and competence to validate the OT@tcpc service model. We recruited 70 inpatients with schizophrenia and divided into intervention group and control group. The Intervention group provided Occupational therapy based on the MOHO theory.&#xD;
Occupational therapy based on the MOHO theory: We selected two acute wards in the Songde hospital as the intervention group and the control group. At the same time, the demographic data of the participants were collected, including gender, age, age of onset, marital status, education level, work experience, etc., and the clinical records, including assessment of mental symptoms and medication records, etc. Continuity or categorical information on Occupational performance, personal and social performance, instrumental activities daily living, and clinical performance.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>In order to indicate the occupation identity and competence to validate the OT@tcpc service model. We recruited 70 inpatients with schizophrenia and divided into intervention group and control group. The control group adopted the original Occupational therapy model.&#xD;
At the same time, the demographic data of the participants were collected, including gender, age, age of onset, marital status, education level, work experience, etc., and the clinical records, including assessment of mental symptoms and medication records, etc. Continuity or categorical information on Occupational performance, personal and social performance, instrumental activities daily living, and clinical performance.</description>
          </group>
        </group_list>
        <measure>
          <title>Occupational Therapy Evaluation Scales Measure</title>
          <description>Except for Mini-Menlal State Examination(MMSE), all other tools were tested before and after in the intervention group and the control group to explain the intervention effect of the MOHO theory-based treatment model&#xD;
The secondary outcome included the following instruments:&#xD;
Mini-Menlal State Examination, MMSE(range 0~30；the higher scores indicate greater ability)&#xD;
Canadian Occupational Performance Measure, COPM(performance and satisfaction, each range 1~10；the higher scores indicate greater performance)&#xD;
Personal and Social Performance scale , PSP(range 1~100；the higher scores indicate greater performance)&#xD;
Clinical Global Impressions Scale of Severity, CGIS(range 1~7；the lower scores indicate greater performance)&#xD;
Comprehensive Occupational Therapy Evaluation Scale, COTES(range 20~100；the higher scores indicate greater performance)&#xD;
Lawton Instrumental Activities Daily Living, LIADL(range 0~23；the higher scores indicate greater performance)</description>
          <population>Individuals with schizophrenia were recruited from acute ward of the Psychiatric Department of Taipei City Hospital.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MMSE(pretest)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.5" spread="2.5"/>
                    <measurement group_id="O2" value="27.8" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGIS(pretest)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="0.8"/>
                    <measurement group_id="O2" value="4.0" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LIADL(pretest)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.1" spread="4.8"/>
                    <measurement group_id="O2" value="17.8" spread="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>COTES(pretest)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.8" spread="7.9"/>
                    <measurement group_id="O2" value="74.9" spread="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>COPM-C performance(pretest)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" spread="2.6"/>
                    <measurement group_id="O2" value="5.1" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>COPM-C satisfaction(pretest)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" spread="2.9"/>
                    <measurement group_id="O2" value="4.8" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSP(pretest)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.1" spread="15.9"/>
                    <measurement group_id="O2" value="51.9" spread="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGIS(posttest 2 weeks)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="1.0"/>
                    <measurement group_id="O2" value="3.4" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LIADL(posttest 2 weeks)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.2" spread="4.3"/>
                    <measurement group_id="O2" value="18.6" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>COTES(posttest 2 weeks)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.9" spread="7.1"/>
                    <measurement group_id="O2" value="74.3" spread="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>COPM-C performance(posttest 2 weeks)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2" spread="2.5"/>
                    <measurement group_id="O2" value="5.1" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>COPM-C satisfaction(posttest 2 weeks)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2" spread="2.6"/>
                    <measurement group_id="O2" value="4.7" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSP(posttest 2 weeks)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.4" spread="15.4"/>
                    <measurement group_id="O2" value="55.4" spread="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis 1 is based on Lawton Instrumental Activities Daily Living (range 0~23；the higher scores indicate greater performance) total scores.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.592</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.53</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.90</ci_lower_limit>
            <ci_upper_limit>2.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis 2 is based on Comprehensive Occupational Therapy Evaluation Scale (range 20~100；the higher scores indicate greater performance) total scores.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.302</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>4.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.37</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.29</ci_lower_limit>
            <ci_upper_limit>7.23</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis 3 is based on Personal and Social Performance scale (range 1~100；the higher scores indicate greater performance) total scores.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.931</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.25</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.25</ci_lower_limit>
            <ci_upper_limit>6.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis 4 is based on Canadian Occupational Performance Measure (range 1~10；the higher scores indicate greater performance) total scores.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.981</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.85</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.73</ci_lower_limit>
            <ci_upper_limit>1.69</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>two weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intervention Group</title>
          <description>In order to indicate the occupation identity and competence to validate the OT@tcpc service model. We recruited 70 inpatients with schizophrenia and divided into intervention group and control group. The Intervention group provided Occupational therapy based on the MOHO theory.&#xD;
Occupational therapy based on the MOHO theory: We selected two acute wards in the Songde hospital as the intervention group and the control group. At the same time, the demographic data of the participants were collected, including gender, age, age of onset, marital status, education level, work experience, etc., and the clinical records, including assessment of mental symptoms and medication records, etc. Continuity or categorical information on Occupational performance, personal and social performance, instrumental activities daily living, and clinical performance.</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>In order to indicate the occupation identity and competence to validate the OT@tcpc service model. We recruited 70 inpatients with schizophrenia and divided into intervention group and control group. The control group adopted the original Occupational therapy model.&#xD;
At the same time, the demographic data of the participants were collected, including gender, age, age of onset, marital status, education level, work experience, etc., and the clinical records, including assessment of mental symptoms and medication records, etc. Continuity or categorical information on Occupational performance, personal and social performance, instrumental activities daily living, and clinical performance.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Shu Chun Lee</name_or_title>
      <organization>Taipei City Hospital</organization>
      <phone>+886 2 27263141 ext 1004</phone>
      <email>A1057@tpech.gov.tw</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04465422
org study id: TCHIRB-10904021
nct id: NCT04465422
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to develop and validate Client-centered Occupational Therapy
      Service at Taipei City Psychiatric Center (OT@tcpc) service model to assist clinicians to
      provide and integrate comprehensive OT services.
Occupational Therapy (OT) is one of the mental health services. The service phase includes
      acute/chronic hospitalization, daycare centers (adolescents, adults, and the elderly),
      community mental rehabilitation institutions, psychiatric nursing home, and outpatient
      assessment/treatments. OT provides holistic and continuous mental rehabilitation services at
      each stage of mental health care. During the acute hospitalization and based on the Model of
      Human Occupation (MOHO) model, the occupational therapist provides daily activities to assist
      acute patients with mental illness to develop occupation adaptation to enable and prepare for
      discharge.

      However, the lack of a client-centered OT service model limits the interpretation of the
      treatment effect and the process of change. This will seriously affect the integrity and
      continuity of OT services and will limit the development of OT professions. Thus, the purpose
      of the study is to develop and validate Client-centered Occupational Therapy Service at
      Taipei City Psychiatric Center (OT@tcpc) service model to assist clinicians to provide and
      integrate comprehensive OT services.

      This project consists of 2 stages. First, based on the MOHO model we use 5 stages with 6
      weeks program to develop the OT@tcpc service model. Second, validate the to indicate the
      occupation identity and competence to validate the OT@tcpc service model. We will recruit 70
      inpatients with schizophrenia and divided into intervention group, based on MOHO theory, and
      control group.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: We will recruit 70 inpatients with schizophrenia and devided into intervention group, based on MOHO theory, and control group.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Participants are blind during this clinical trial. They are prevented from having knowledge of the interventions.
measure: Occupational Performance History Interview-II (OPHI-II) Total and Subscale Scores
time frame: 2 weeks
description: The Occupational Performance History Interview-Second Version(OPHI-II) was tested before and after in the intervention group and the control group to explain the intervention effect of the MOHO theory-based treatment model.
OPHI-II is a semi-structured interview that gathers life history information. The OPHI-II contains 3 sub-domains: OPHI-II Occupational Identity(range 11~44)、OPHI-II Occupational Competence(range 9~36)、OPHI-II Occupational Behavior Settings(range 9~36).
The three sub-domains are divided into 4 levels, in which 4 points indicate good performance, 3 points indicate good functions, 2 points indicate lack of certain functions, and 1 points indicate poor functions. The total score of OPHI-II is equal to the sum of the three sub-domains (scores 29 to 116; higher scores indicate higher performance).
measure: Occupational Therapy Evaluation Scales Measure
time frame: 2 weeks
description: Except for Mini-Menlal State Examination(MMSE), all other tools were tested before and after in the intervention group and the control group to explain the intervention effect of the MOHO theory-based treatment model
The secondary outcome included the following instruments:
Mini-Menlal State Examination, MMSE(range 0~30；the higher scores indicate greater ability)
Canadian Occupational Performance Measure, COPM(performance and satisfaction, each range 1~10；the higher scores indicate greater performance)
Personal and Social Performance scale , PSP(range 1~100；the higher scores indicate greater performance)
Clinical Global Impressions Scale of Severity, CGIS(range 1~7；the lower scores indicate greater performance)
Comprehensive Occupational Therapy Evaluation Scale, COTES(range 20~100；the higher scores indicate greater performance)
Lawton Instrumental Activities Daily Living, LIADL(range 0~23；the higher scores indicate greater performance)
arm group label: Intervention Group
arm group type: Experimental
description: We will recruit 70 inpatients with schizophrenia and divided into intervention group and control group. The Intervention group provided Occupational therapy based on the MOHO theory, while the control group adopted the original Occupational therapy model.
The research at this stage is based on the theoretical framework of the MOHO model and the clinical practice of OTPF-3. Clinical experts are requested to assist in providing relevant suggestions as a reference for modifying intervention activities. Design OT@tcpc service model for occupational therapy intervention activities. The event design is based on the 4 systems of determinationl, habits, performance and environment, and 2 events are designed for each to be carried out in a group. Each activity includes 4 parts: warm-up, activity, feedback and homework. Each activity group will be explained separately so that the occupational therapist of the group can complete it under the guidance.
arm group label: Control Group
arm group type: Active Comparator
description: We will recruit 70 inpatients with schizophrenia and divided into intervention group and control group. The Intervention group provided Occupational therapy based on the MOHO theory, while the control group adopted the original Occupational therapy model.
This study was approved by the Institutional Review Board of Taipei City Hospital. After informed consent, the patients signed the consent form for this study and became the participant of this study.
Each activity group will be explained separately so that the participants of each group can complete it under the guidance. The group description includes: activity title, activity time (location), MOHO theory system, group purpose, activity content, equipment or materials, precautions, etc.
intervention type: Behavioral
intervention name: Occupational therapy based on the MOHO theory
description: We selected two acute wards in the Songde hospital as the intervention group and the control group. At the same time, the demographic data of the participants were collected, including gender, age, age of onset, marital status, education level, work experience, etc., and the clinical records, including assessment of mental symptoms and medication records, etc. Continuity or categorical information on Occupational performance, personal and social performance, instrumental activities daily living, and clinical performance.
OPHI-II, CGIS, PSP, LIADL, COPM, COTES were tested before and after in the intervention group and the control group to explain the intervention effect of the MOHO theory-based treatment model.
arm group label: Intervention Group
intervention type: Behavioral
intervention name: Occupational therapy
description: The original Occupational therapy. OPHI-II, CGIS, PSP, LIADL, COPM, COTES were tested before and after in the intervention group and the control group to explain the intervention effect of the MOHO theory-based treatment model.
arm group label: Control Group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Shu-Chun Lee, Master
role: Principal Investigator
affiliation: Department of Occupational Therapy
facility: 
country: Taiwan
citation: Lee J. Achieving best practice: a review of evidence linked to occupation-focused practice models. Occup Ther Health Care. 2010 Jul;24(3):206-22. doi: 10.3109/07380577.2010.483270.
PMID: 23898928
citation: Lee SW, Taylor R, Kielhofner G, Fisher G. Theory use in practice: a national survey of therapists who use the Model of Human Occupation. Am J Occup Ther. 2008 Jan-Feb;62(1):106-17. doi: 10.5014/ajot.62.1.106.
PMID: 18254437
citation: Lee SW, Kielhofner G, Morley M, Heasman D, Garnham M, Willis S, Parkinson S, Forsyth K, Melton J, Taylor RR. Impact of using the Model of Human Occupation: a survey of occupational therapy mental health practitioners' perceptions. Scand J Occup Ther. 2012 Sep;19(5):450-6. doi: 10.3109/11038128.2011.645553. Epub 2012 Jan 3.
PMID: 22214401
citation: Melton J, Forsyth K, Metherall A, Robinson J, Hill J, Quick L. Program Redesign Based on the Model of Human Occupation: Inpatient Services for People Experiencing Acute Mental Illness in the UK. Occup Ther Health Care. 2008;22(2-3):37-50. doi: 10.1080/07380570801989382.
PMID: 23941371
responsible party type: Sponsor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 