<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/NCT04450147</url>
  </required_header>
  <id_info>
    <org_study_id>MP-05-2020-1825</org_study_id>
    <nct_id>NCT04450147</nct_id>
  </id_info>
  <brief_title>Tai Chi/Qigong for Subsyndromal Depression and Cognition in Older Age Bipolar Disorder</brief_title>
  <official_title>Efficacy of Tai Chi/Qigong for Subsyndromal Depression and Cognition in Older Age Bipolar Disorder: A Pilot Randomized Controlled Trial With an Active Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lady Davis Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lady Davis Institute</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>
      It is expected that by 2030, the percentage of patients with bipolar disorder (BD) in Canada&#xD;
      over 60 years of age will exceed 50%. In this population, poor cognition and persistent&#xD;
      sub-threshold depressive symptoms are particularly common, difficult to treat, associated&#xD;
      with increased mood episodes, and poor daily functioning. Mind-body interventions have&#xD;
      increasingly been found to be effective in treating several psychiatric condition including&#xD;
      BD. A few pilot studies examining mindfulness-based intervention in younger adult BD have&#xD;
      been promising for depressive symptoms, but some pilot research suggest that patients with&#xD;
      older age bipolar disorder (OABD) may benefit more from moving mindfulness. The investigators&#xD;
      will conduct a 12-week randomized controlled trial to assess whether tai-chi/qigong will be&#xD;
      associated with 1) greater reduction in depressive symptoms, and 2) greater improved&#xD;
      cognition, in comparison to a light exercise active control condition, 12- and 24-weeks from&#xD;
      baseline, in BD patients aged 40+.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 10, 2020</start_date>
  <completion_date type="Anticipated">May 2021</completion_date>
  <primary_completion_date type="Anticipated">February 2021</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Depression</measure>
    <time_frame>Baseline, 12-weeks, 24-weeks</time_frame>
    <description>Level of depression as measured by the Montgomery-Asberg Depression Rating Scale, at 12-weeks and 24-weeks post-intervention. Possible score range: 0-60, higher score indicates worse outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Processing Speed</measure>
    <time_frame>Baseline, 12-weeks, 24-weeks</time_frame>
    <description>Processing speed as measured by the Animal Fluency Test at 12-weeks and 24-weeks. Scored by number of animals named, higher score indicates better outcome.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Quality of Life</measure>
    <time_frame>Baseline, 12-weeks, 24-weeks</time_frame>
    <description>Quality of life as measured by the Quality of Life in Bipolar Disorder Questionnaire - Short Form, at 12-weeks and 24-weeks post-intervention. Possible score range: 12-60, higher score indicates worse outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Daily Functioning</measure>
    <time_frame>Baseline, 12-weeks, 24-weeks</time_frame>
    <description>Daily functioning as measured by the Functional Assessment Short Test, at 12-weeks and 24-weeks post-intervention. Possible score range: 0-72, higher score indicates worse outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Generalized Anxiety</measure>
    <time_frame>Baseline, 12-weeks, 24-weeks</time_frame>
    <description>Generalized anxiety as measured by the Generalized Anxiety Disorder 7-item scale, at 12-weeks and 24-weeks post-intervention. Possible score range: 0-21, higher score indicates worse outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Mindfulness</measure>
    <time_frame>Baseline, 12-weeks, 24-weeks</time_frame>
    <description>Mindfulness as measured by the Five Factor Mindfulness Questionnaire Short Form at 12-weeks and 24-weeks post-intervention. Possible score range = 49-110, higher score indicates worse outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Self-Compassion</measure>
    <time_frame>Baseline, 12-weeks, 24-weeks</time_frame>
    <description>Self-compassion as measured by the Self Compassion Scale Short Form at 12-weeks and 24-weeks post-intervention. Possible score range: 0-130, higher score indicates worse outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Mania</measure>
    <time_frame>Baseline, 12-weeks, 24-weeks</time_frame>
    <description>Mania as measured by the Young Mania Rating Scale at 12-weeks and 24-weeks post-intervention. Possible score range: 0-60, higher score indicates worse outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Self-Reported Depression</measure>
    <time_frame>Baseline, weekly throughout 12-weeks, 24-weeks</time_frame>
    <description>Level of depression as measured by the Quick Inventory of Depressive Symptomatology - Self Report, at 12-weeks and 24-weeks post-intervention. Possible score range: 0-45, higher score indicates worse outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Self-Reported Mania</measure>
    <time_frame>Baseline, weekly throughout 12-weeks, 24-weeks</time_frame>
    <description>Level of mania as measured by the Altman Self-Rating Mania Scale, at 12-weeks and 24-weeks post-intervention. Possible score range: 0-25, higher score indicates worse outcome</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Bipolar Disorder</condition>
  <arm_group>
    <arm_group_label>Tai Chi and Qigong</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50mins x 12 weeks of virtually-delivered group tai chi/qigong</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Walking and Stretching</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>50mins x 12 weeks of virtually-delivered group walking and stretching</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tai Chi/Qigong vs. Walking/Stretching</intervention_name>
    <description>Both interventions can be thought of as a form of movement and exercise.</description>
    <arm_group_label>Tai Chi and Qigong</arm_group_label>
    <arm_group_label>Walking and Stretching</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged greater than or equal to 40 years&#xD;
&#xD;
          -  history of diagnosis of bipolar I or II disorder&#xD;
&#xD;
          -  access to a computer with a functioning camera, microphone, and ability to run Zoom&#xD;
             software&#xD;
&#xD;
          -  English or French speaking&#xD;
&#xD;
          -  ability to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Young Mania Rating Scale score &gt; 5&#xD;
&#xD;
          -  current clinician diagnosis of substance abuse, unless currently in complete remission&#xD;
&#xD;
          -  risk of suicide as assessed by a score above 3 on item 10 of Montgomery Asberg&#xD;
             Depression Rating Scale&#xD;
&#xD;
          -  participation or plan to participate in any other concurrent psychosocial group&#xD;
             program during course of study&#xD;
&#xD;
          -  unstable psychiatric medication (less than 4-weeks since commencement)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Lady Davis Institute</name>
      <address>
        <city>Montréal</city>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Haley Park</last_name>
      <phone>514-581-3956</phone>
      <email>hyeon.park3@mail.mcgill.ca</email>
    </contact>
    <investigator>
      <last_name>Soham Rej</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/31081573</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Sajatovic M, Eyler LT, Rej S, Almeida OP, Blumberg HP, Forester BP, Forlenza OV, Gildengers A, Mulsant BH, Strejilevich S, Tsai S, Vieta E, Young RC, Dols A. The Global Aging &amp; Geriatric Experiments in Bipolar Disorder Database (GAGE-BD) project: Understanding older-age bipolar disorder by combining multiple datasets. Bipolar Disord. 2019 Nov;21(7):642-649. doi: 10.1111/bdi.12795. Epub 2019 May 30.</citation>
    <PMID>31081573</PMID>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>March 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>November 9, 2020</last_update_submitted>
  <last_update_submitted_qc>November 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lady Davis Institute</investigator_affiliation>
    <investigator_full_name>Soham Rej MD, MSc</investigator_full_name>
    <investigator_title>Geriatric Psychiatrist, Assistant Professor, Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>mindfulness</keyword>
  <keyword>older age bipolar disorder</keyword>
  <keyword>tai chi</keyword>
  <keyword>qigong</keyword>
  <keyword>randomized controlled trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bipolar Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data from the study will be sent to the Global Aging &amp; Geriatric Experiments in Bipolar Disorder Database (GAGE-BD). The objective of GAGE-BD is to gather data from research studies about older adults (age 50+) with bipolar disorder to allow researchers from the Douglas Institute, or other researchers, in Canada, the United States and around the world, to use the database for future research projects exploring possible relationships between age, medical conditions and bipolar symptoms. Following completion of data collection, the data including all outcomes and demographic and health information, anonymized and free of any identifying or personal information, will be sent to Dr. Betsy Wilson (more info on Dr. Wilson further below) via Box (https://case.edu/utech/help/knowledge-base/box/box-information), a secure cloud storage service managed by Case Western University.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>The data will be available June 2021 (anticipated), and will be kept at GAGE-BD indefinitely.</ipd_time_frame>
    <ipd_access_criteria>All researcher-users involved in GAGE-BD agree not to communicate or transfer data to anyone. They agree not to use the data for a research study that is not approved by the GAGE-BD management or a Research Ethics Board.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04450147
org study id: MP-05-2020-1825
nct id: NCT04450147
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It is expected that by 2030, the percentage of patients with bipolar disorder (BD) in Canada
      over 60 years of age will exceed 50%. In this population, poor cognition and persistent
      sub-threshold depressive symptoms are particularly common, difficult to treat, associated
      with increased mood episodes, and poor daily functioning. Mind-body interventions have
      increasingly been found to be effective in treating several psychiatric condition including
      BD. A few pilot studies examining mindfulness-based intervention in younger adult BD have
      been promising for depressive symptoms, but some pilot research suggest that patients with
      older age bipolar disorder (OABD) may benefit more from moving mindfulness. The investigators
      will conduct a 12-week randomized controlled trial to assess whether tai-chi/qigong will be
      associated with 1) greater reduction in depressive symptoms, and 2) greater improved
      cognition, in comparison to a light exercise active control condition, 12- and 24-weeks from
      baseline, in BD patients aged 40+.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in Depression
time frame: Baseline, 12-weeks, 24-weeks
description: Level of depression as measured by the Montgomery-Asberg Depression Rating Scale, at 12-weeks and 24-weeks post-intervention. Possible score range: 0-60, higher score indicates worse outcome
measure: Change in Processing Speed
time frame: Baseline, 12-weeks, 24-weeks
description: Processing speed as measured by the Animal Fluency Test at 12-weeks and 24-weeks. Scored by number of animals named, higher score indicates better outcome.
measure: Change in Quality of Life
time frame: Baseline, 12-weeks, 24-weeks
description: Quality of life as measured by the Quality of Life in Bipolar Disorder Questionnaire - Short Form, at 12-weeks and 24-weeks post-intervention. Possible score range: 12-60, higher score indicates worse outcome
measure: Change in Daily Functioning
time frame: Baseline, 12-weeks, 24-weeks
description: Daily functioning as measured by the Functional Assessment Short Test, at 12-weeks and 24-weeks post-intervention. Possible score range: 0-72, higher score indicates worse outcome
measure: Change in Generalized Anxiety
time frame: Baseline, 12-weeks, 24-weeks
description: Generalized anxiety as measured by the Generalized Anxiety Disorder 7-item scale, at 12-weeks and 24-weeks post-intervention. Possible score range: 0-21, higher score indicates worse outcome
measure: Change in Mindfulness
time frame: Baseline, 12-weeks, 24-weeks
description: Mindfulness as measured by the Five Factor Mindfulness Questionnaire Short Form at 12-weeks and 24-weeks post-intervention. Possible score range = 49-110, higher score indicates worse outcome
measure: Change in Self-Compassion
time frame: Baseline, 12-weeks, 24-weeks
description: Self-compassion as measured by the Self Compassion Scale Short Form at 12-weeks and 24-weeks post-intervention. Possible score range: 0-130, higher score indicates worse outcome
measure: Change in Mania
time frame: Baseline, 12-weeks, 24-weeks
description: Mania as measured by the Young Mania Rating Scale at 12-weeks and 24-weeks post-intervention. Possible score range: 0-60, higher score indicates worse outcome
measure: Change in Self-Reported Depression
time frame: Baseline, weekly throughout 12-weeks, 24-weeks
description: Level of depression as measured by the Quick Inventory of Depressive Symptomatology - Self Report, at 12-weeks and 24-weeks post-intervention. Possible score range: 0-45, higher score indicates worse outcome
measure: Change in Self-Reported Mania
time frame: Baseline, weekly throughout 12-weeks, 24-weeks
description: Level of mania as measured by the Altman Self-Rating Mania Scale, at 12-weeks and 24-weeks post-intervention. Possible score range: 0-25, higher score indicates worse outcome
arm group label: Tai Chi and Qigong
arm group type: Experimental
description: 50mins x 12 weeks of virtually-delivered group tai chi/qigong
arm group label: Walking and Stretching
arm group type: Active Comparator
description: 50mins x 12 weeks of virtually-delivered group walking and stretching
intervention type: Behavioral
intervention name: Tai Chi/Qigong vs. Walking/Stretching
description: Both interventions can be thought of as a form of movement and exercise.
arm group label: Tai Chi and Qigong
arm group label: Walking and Stretching
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: Canada
url: https://www.ncbi.nlm.nih.gov/pubmed/31081573
description: Related Info
citation: Sajatovic M, Eyler LT, Rej S, Almeida OP, Blumberg HP, Forester BP, Forlenza OV, Gildengers A, Mulsant BH, Strejilevich S, Tsai S, Vieta E, Young RC, Dols A. The Global Aging & Geriatric Experiments in Bipolar Disorder Database (GAGE-BD) project: Understanding older-age bipolar disorder by combining multiple datasets. Bipolar Disord. 2019 Nov;21(7):642-649. doi: 10.1111/bdi.12795. Epub 2019 May 30.
PMID: 31081573
responsible party type: Principal Investigator
investigator affiliation: Lady Davis Institute
investigator full name: Soham Rej MD, MSc
investigator title: Geriatric Psychiatrist, Assistant Professor, Principle Investigator
mesh term: Bipolar Disorder
sharing ipd: Yes
ipd description: Data from the study will be sent to the Global Aging & Geriatric Experiments in Bipolar Disorder Database (GAGE-BD). The objective of GAGE-BD is to gather data from research studies about older adults (age 50+) with bipolar disorder to allow researchers from the Douglas Institute, or other researchers, in Canada, the United States and around the world, to use the database for future research projects exploring possible relationships between age, medical conditions and bipolar symptoms. Following completion of data collection, the data including all outcomes and demographic and health information, anonymized and free of any identifying or personal information, will be sent to Dr. Betsy Wilson (more info on Dr. Wilson further below) via Box (https://case.edu/utech/help/knowledge-base/box/box-information), a secure cloud storage service managed by Case Western University.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: The data will be available June 2021 (anticipated), and will be kept at GAGE-BD indefinitely.
ipd access criteria: All researcher-users involved in GAGE-BD agree not to communicate or transfer data to anyone. They agree not to use the data for a research study that is not approved by the GAGE-BD management or a Research Ethics Board.