<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/NCT04476836</url>
  </required_header>
  <id_info>
    <org_study_id>202000549B0</org_study_id>
    <nct_id>NCT04476836</nct_id>
  </id_info>
  <brief_title>Animal-Assisted Therapy in Patients With Schizophrenia</brief_title>
  <official_title>Animal-Assisted Therapy in Middle-aged and Older Patients With Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial 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>
      Animal-assisted therapy (AAT) can be helpful to improve the psychiatric, emotional,&#xD;
      physical,and social status in patients with physical and mental illness and the elderly.&#xD;
&#xD;
      The study aims to investigate the effects of AAT program in middle-aged and older patients&#xD;
      with schizophrenia. The investigators will recruit 40 patients with schizophrenia in&#xD;
      psychiatric ward randomised into AAT group and control group. AAT group will complete the&#xD;
      12-week program. This study contains two assessment sessions before and after intervention,&#xD;
      including PANSS, ACIS, MoCA-T, CHI, DASS-21, CST, TUG and 5MWT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Animal-assisted therapy (AAT) can be helpful to improve the outcomes of psychiatric and&#xD;
      emotional symptoms, physical activeness, social skills, well-beings in patients with physical&#xD;
      and mental illness and the elderly.&#xD;
&#xD;
      The study aims to assess the applications and outcomes of psychiatric symptoms, social&#xD;
      skills, cognitive function, well-beings, emotional status and physical fitness of AAT program&#xD;
      applied to middle-aged and older patients with chronic schizophrenia.&#xD;
&#xD;
      The investigators will recruit 40 patients with chronic schizophrenia who were admitted to&#xD;
      day care ward and rehabilitation ward, and conduct a randomized, controlled study. 40&#xD;
      patients will be stratified by the ward into AAT group and control group. AAT group will&#xD;
      complete the 12-week program. This study contains two assessment sessions completed within&#xD;
      one week before and after 12-week program. Subjects will be evaluated by the PANSS, ACIS,&#xD;
      MoCA-T, CHI, DASS-21, CST, TUG and 5MWT in both sessions. Statistical analysis is examined&#xD;
      using paired t-test to see whether there is a significant difference (based on p-value)&#xD;
      between the scores of two assessment sessions in the AAT and control group, and using&#xD;
      independent t-test to see whether there is a significant difference in the change scores of&#xD;
      two assessment sessions between the 2 groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 24, 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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change scores of Positive and Negative Syndrome Scale</measure>
    <time_frame>Baseline, immediate after treatment</time_frame>
    <description>This test is used for measuring symptom severity of patients with schizophrenia.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change scores of The Assessment of Communication and Interaction Skills</measure>
    <time_frame>Baseline, immediate after treatment</time_frame>
    <description>This test is an observational rating scale designed to measure communication and interaction skills.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of The Taiwanese version of Montreal Cognitive Assessment</measure>
    <time_frame>Baseline, immediate after treatment</time_frame>
    <description>This test is a cognitive screening test in the detection of mild cognitive impairment and Alzheimer's disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Chinese Happiness Inventory</measure>
    <time_frame>Baseline, immediate after treatment</time_frame>
    <description>This test is a subjective measure of well-being.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Depression Anxiety Stress Scales-21</measure>
    <time_frame>Baseline, immediate after treatment</time_frame>
    <description>This test is a 21-item self report instrument for measuring depression, anxiety and tension/stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Chair Stand Test</measure>
    <time_frame>Baseline, immediate after treatment</time_frame>
    <description>This test is to measure leg strength.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Timed Up and Go</measure>
    <time_frame>Baseline, immediate after treatment</time_frame>
    <description>This test is to assess mobility, balance, walking ability, and fall risk in older adults.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of The 5-Meter Walk Test</measure>
    <time_frame>Baseline, immediate after treatment</time_frame>
    <description>This test is to assess walking speed.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Animal-assisted Therapy</condition>
  <arm_group>
    <arm_group_label>AAT group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Animal-assisted therapy will be provided one 1-hour session per week for 48 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>routine care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Animal-Assisted Therapy</intervention_name>
    <description>Animal-Assisted Therapy is when animals are used in goal-directed treatment sessions. These goals can be physical, mental, emotional or social.</description>
    <arm_group_label>AAT group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Having a diagnosis of schizophrenia according to the DSM-5.&#xD;
&#xD;
          2. Adult aged 40 years or older.&#xD;
&#xD;
          3. Having stable physical and psychological health conditions based on master clinician&#xD;
             judgment.&#xD;
&#xD;
          4. Having the will to participate in the study after thorough comprehension of the&#xD;
             content.&#xD;
&#xD;
          5. Not receiving treatment protocol last half a year.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe cognitive impairment e.g. aphasia, being unable to follow 3 or more orders.&#xD;
&#xD;
          2. Being allergic to animals.&#xD;
&#xD;
          3. History of Asthma.&#xD;
&#xD;
          4. Coagulation disorders&#xD;
&#xD;
          5. presenting symptoms of specific phobia, anxiety disorder and obsessive-compulsive&#xD;
             disorder in context of dog, infection and contamination.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Chyi-Rong Chen, Master</last_name>
    <phone>+886-7-7317123</phone>
    <phone_ext>8755</phone_ext>
    <email>ccr776@cgmh.org.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital, Kaohsiung Medical Center</name>
      <address>
        <city>Kaohsiung</city>
        <zip>833</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 17, 2020</last_update_submitted>
  <last_update_submitted_qc>July 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>schizophrenia</keyword>
  <keyword>animal-assisted therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>May 10, 2021</submitted>
    <returned>June 3, 2021</returned>
  </pending_results>
  <!-- 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/NCT04476836
org study id: 202000549B0
nct id: NCT04476836
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Animal-assisted therapy (AAT) can be helpful to improve the psychiatric, emotional,
      physical,and social status in patients with physical and mental illness and the elderly.

      The study aims to investigate the effects of AAT program in middle-aged and older patients
      with schizophrenia. The investigators will recruit 40 patients with schizophrenia in
      psychiatric ward randomised into AAT group and control group. AAT group will complete the
      12-week program. This study contains two assessment sessions before and after intervention,
      including PANSS, ACIS, MoCA-T, CHI, DASS-21, CST, TUG and 5MWT.
Animal-assisted therapy (AAT) can be helpful to improve the outcomes of psychiatric and
      emotional symptoms, physical activeness, social skills, well-beings in patients with physical
      and mental illness and the elderly.

      The study aims to assess the applications and outcomes of psychiatric symptoms, social
      skills, cognitive function, well-beings, emotional status and physical fitness of AAT program
      applied to middle-aged and older patients with chronic schizophrenia.

      The investigators will recruit 40 patients with chronic schizophrenia who were admitted to
      day care ward and rehabilitation ward, and conduct a randomized, controlled study. 40
      patients will be stratified by the ward into AAT group and control group. AAT group will
      complete the 12-week program. This study contains two assessment sessions completed within
      one week before and after 12-week program. Subjects will be evaluated by the PANSS, ACIS,
      MoCA-T, CHI, DASS-21, CST, TUG and 5MWT in both sessions. Statistical analysis is examined
      using paired t-test to see whether there is a significant difference (based on p-value)
      between the scores of two assessment sessions in the AAT and control group, and using
      independent t-test to see whether there is a significant difference in the change scores of
      two assessment sessions between the 2 groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Change scores of Positive and Negative Syndrome Scale
time frame: Baseline, immediate after treatment
description: This test is used for measuring symptom severity of patients with schizophrenia.
measure: Change scores of The Assessment of Communication and Interaction Skills
time frame: Baseline, immediate after treatment
description: This test is an observational rating scale designed to measure communication and interaction skills.
measure: Change scores of The Taiwanese version of Montreal Cognitive Assessment
time frame: Baseline, immediate after treatment
description: This test is a cognitive screening test in the detection of mild cognitive impairment and Alzheimer's disease.
measure: Change scores of Chinese Happiness Inventory
time frame: Baseline, immediate after treatment
description: This test is a subjective measure of well-being.
measure: Change scores of Depression Anxiety Stress Scales-21
time frame: Baseline, immediate after treatment
description: This test is a 21-item self report instrument for measuring depression, anxiety and tension/stress.
measure: Change scores of Chair Stand Test
time frame: Baseline, immediate after treatment
description: This test is to measure leg strength.
measure: Change scores of Timed Up and Go
time frame: Baseline, immediate after treatment
description: This test is to assess mobility, balance, walking ability, and fall risk in older adults.
measure: Change scores of The 5-Meter Walk Test
time frame: Baseline, immediate after treatment
description: This test is to assess walking speed.
arm group label: AAT group
arm group type: Experimental
description: Animal-assisted therapy will be provided one 1-hour session per week for 48 weeks.
arm group label: control group
arm group type: No Intervention
description: routine care
intervention type: Other
intervention name: Animal-Assisted Therapy
description: Animal-Assisted Therapy is when animals are used in goal-directed treatment sessions. These goals can be physical, mental, emotional or social.
arm group label: AAT group
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Chyi-Rong Chen, Master
phone: +886-7-7317123
phone ext: 8755
email: ccr776@cgmh.org.tw
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Schizophrenia
submitted: May 10, 2021
returned: June 3, 2021