xml: <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/NCT06002074</url>
    </required_header>
    <id_info>
      <org_study_id>23-004024</org_study_id>
      <nct_id>NCT06002074</nct_id>
    </id_info>
    <brief_title>SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases</brief_title>
    <official_title>Impact of the Stress Management and Resilience Training (SMART) Program on Quality of Life in Patients With Inflammatory Bowel Diseases</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mayo Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mayo Clinic</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>
        This research study is being done to look at the impact of a Stress Management and Resilience&#xD;
        Training (SMART) Program on the quality of life and healthcare utilization of patients with&#xD;
        inflammatory bowel disease.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Inflammatory Bowel Disease (IBD) Quality of Life (QOL)</measure>
      <time_frame>Baseline, approximately 20 weeks</time_frame>
      <description>Measured by self-reported 32-item Quality of Life in Inflammatory Bowel Disease Questionnaire (IBDQ) designed to assess feelings about symptoms as a results of IBD over the last 2 weeks. Responses to each question are scored on a 7-point Likert scale ranging from 1 (a very severe problem) to 7 (not a problem). Possible total scores range from 32 to 224, where higher scores indicate better outcome/better quality of life.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Inflammatory Bowel Diseases</condition>
    <condition>Stress</condition>
    <arm_group>
      <arm_group_label>Stress management and resilience training</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects will receive a 1.5 hour one-on-one stress management and resilience consult by a certified SMART trainer followed by 16 week self-guided on-line training.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Stress Management and Resilience Training Program</intervention_name>
      <description>One-on-one stress management and resilience consultation by a certified SMART trainer followed by self-guided on-line training consisting of 4 modules.</description>
      <arm_group_label>Stress management and resilience training</arm_group_label>
      <other_name>SMART</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  History of IBD defined by a physician global assessment (PGA) of quiescent, mild,&#xD;
               moderate, or severe disease.&#xD;
  &#xD;
            -  Access to internet/device such as smart phone, tablet, or computer&#xD;
  &#xD;
            -  Patient reports stress as a trigger to their GI symptoms&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Corticosteroids in the previous 3 months&#xD;
  &#xD;
            -  Elicit substance use (including medical marijuana)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Shayla Schoenoff, PA-C, MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mayo Clinic</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alana English</last_name>
      <phone>507-538-9459</phone>
      <email>Irlbeck.Alana@mayo.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Mayo Clinic Minnesota</name>
        <address>
          <city>Rochester</city>
          <state>Minnesota</state>
          <zip>55905</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.mayo.edu/research/clinical-trials</url>
      <description>Mayo Clinic Clinical Trials</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mayo Clinic</investigator_affiliation>
      <investigator_full_name>Shayla A. Schoenoff</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Intestinal Diseases</mesh_term>
      <mesh_term>Inflammatory Bowel Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06002074
  org study id: 23-004024
  nct id: NCT06002074
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This research study is being done to look at the impact of a Stress Management and Resilience
        Training (SMART) Program on the quality of life and healthcare utilization of patients with
        inflammatory bowel disease.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Change in Inflammatory Bowel Disease (IBD) Quality of Life (QOL)
  time frame: Baseline, approximately 20 weeks
  description: Measured by self-reported 32-item Quality of Life in Inflammatory Bowel Disease Questionnaire (IBDQ) designed to assess feelings about symptoms as a results of IBD over the last 2 weeks. Responses to each question are scored on a 7-point Likert scale ranging from 1 (a very severe problem) to 7 (not a problem). Possible total scores range from 32 to 224, where higher scores indicate better outcome/better quality of life.
  arm group label: Stress management and resilience training
  arm group type: Experimental
  description: Subjects will receive a 1.5 hour one-on-one stress management and resilience consult by a certified SMART trainer followed by 16 week self-guided on-line training.
  intervention type: Behavioral
  intervention name: Stress Management and Resilience Training Program
  description: One-on-one stress management and resilience consultation by a certified SMART trainer followed by self-guided on-line training consisting of 4 modules.
  arm group label: Stress management and resilience training
  other name: SMART
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Shayla Schoenoff, PA-C, MS
  role: Principal Investigator
  affiliation: Mayo Clinic
  last name: Alana English
  phone: 507-538-9459
  email: Irlbeck.Alana@mayo.edu
  facility: 
  status: Recruiting
  country: United States
  url: https://www.mayo.edu/research/clinical-trials
  description: Mayo Clinic Clinical Trials
  responsible party type: Principal Investigator
  investigator affiliation: Mayo Clinic
  investigator full name: Shayla A. Schoenoff
  investigator title: Principal Investigator
  mesh term: Intestinal Diseases
  mesh term: Inflammatory Bowel Diseases
  sharing ipd: No