<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/NCT03831750</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00082125; Pro00079377</org_study_id>
    <nct_id>NCT03831750</nct_id>
  </id_info>
  <brief_title>Assessing the Effectiveness of a Stress Reduction Intervention in Inflammatory Bowel Disease (IBD)</brief_title>
  <official_title>Assessing the Effectiveness of a Stress Reduction Intervention in Inflammatory Bowel Disease (IBD): a Prospective Randomized Controlled Trial (RCT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alberta</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 investigators have designed a guided, online, tri-component, stress reduction&#xD;
      intervention for participants with inflammatory bowel diseases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In a randomized controlled trial, the investigators assessed the impact of an online, 3-month&#xD;
      stress reduction intervention (yoga, breathwork, and meditation). The primary outcome was the&#xD;
      change in Cohen's Perceived Stress Scale (PSS) between the control and intervention arms. The&#xD;
      following secondary outcomes were also assessed: anxiety, depression, IBD disease activity&#xD;
      (e.g., changes in CRP, fecal calprotectin, medication, hospitalization, or surgery), serum&#xD;
      inflammatory markers, serum and salivary markers of stress, stress-resilience, and health-&#xD;
      related quality of life. Participant satisfaction and adherence to the intervention were also&#xD;
      evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 22, 2019</start_date>
  <completion_date type="Actual">January 15, 2021</completion_date>
  <primary_completion_date type="Actual">March 1, 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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Sealed envelopes</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Perceived stress</measure>
    <time_frame>3 months</time_frame>
    <description>Between group changes in the stress index from baseline to end of study using the Cohen's Perceived Stress Scale (PSS)-10 item. Summed scores range from 0-40 where lower scores are associated with less perceived stress compared to higher scores.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mental health</measure>
    <time_frame>3 months</time_frame>
    <description>Change from baseline to end of study using the Hospital and Anxiety Depression Scale (HADS). Summed scores (range: 0-21) are separate for anxiety and depression; lower scores are assocated with less perceived anxiety or depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>3 months</time_frame>
    <description>Change from baseline to end of study using the: (1) Short IBD Quality of Life Questionnaire (SIBDQ). Scores (range 1-7) for the 7 questions are summed where higher scores related to a higher perceived health-related quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Markers of inflammation and stress</measure>
    <time_frame>3 months</time_frame>
    <description>Changes from baseline to end of study for 6 serum pro- and anti-inflammatory immune biomarkers relevant to IBD (IL-10, IL-12, IL-1ß, IL-4, IL-6, TNF-α) and markers of stress, including CABS1 and cortisol, with the Connor Davidson Resilience Scale (score range: 0 to 100). Higher scores with the Connor Davidson Resilience Scare are indicative of greater stress resiliency.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IBD levels of activity</measure>
    <time_frame>3 months</time_frame>
    <description>Changes from baseline to end of study for fecal calprotectin and Partial Mayo Score (score range 0-9; lower scores mean less or no disease activity) or the Harvey Bradshaw Index (HBI) (range=0-16+; where lower scores indicate less or no disease activity).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <condition>Remission</condition>
  <condition>Perceived Stress</condition>
  <arm_group>
    <arm_group_label>Stress Reduction Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive the standard of care for IBD and training and access to an online stress reduction intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will receive the standard of care for IBD.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stress Reduction Intervention</intervention_name>
    <description>The tri-component intervention is comprised of guided videos for breath-work (5-15 min), stretching (5-15 min), and meditation (10-30 min). The intervention will be delivered online via an access restricted website.</description>
    <arm_group_label>Stress Reduction Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (RCT):&#xD;
&#xD;
          -  Adults (≥18 years)&#xD;
&#xD;
          -  with IBD in remission (UC - partial Mayo &lt;2 and fecal calprotectin &lt;250 μg/g; CD&#xD;
             regular HBI &lt;5 or CRP &lt;8)&#xD;
&#xD;
          -  on stable therapy for the past 3 months&#xD;
&#xD;
          -  the last flare &lt;24 months prior to enrollment&#xD;
&#xD;
          -  PSS-10 score ≥ 7 at time of screening&#xD;
&#xD;
        Inclusion Criteria (Substudy):&#xD;
&#xD;
          -  Adults (≥18 years)&#xD;
&#xD;
          -  IBD&#xD;
&#xD;
          -  on stable therapy for the past 3 months.&#xD;
&#xD;
        Exclusion Criteria (RCT or Substudy):&#xD;
&#xD;
          -  Major medical co-morbidity&#xD;
&#xD;
          -  Steroid use in past 3 months&#xD;
&#xD;
          -  Clostridium difficile infection in the last 3 months&#xD;
&#xD;
          -  Unstable dose of psychiatric medications for the last 3 months&#xD;
&#xD;
          -  Inability to provide informed written consent&#xD;
&#xD;
          -  Severe psychiatric disorders (HADS scores &gt;10 or suicidal ideation)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Farhad Peerani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Puneeta Tandon, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alberta</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Ritz T, Rosenfield D, St Laurent CD, Trueba AF, Werchan CA, Vogel PD, Auchus RJ, Reyes-Serratos E, Befus AD. A novel biomarker associated with distress in humans: calcium-binding protein, spermatid-specific 1 (CABS1). Am J Physiol Regul Integr Comp Physiol. 2017 Jun 1;312(6):R1004-R1016. doi: 10.1152/ajpregu.00393.2016. Epub 2017 Apr 5.</citation>
    <PMID>28381457</PMID>
  </reference>
  <reference>
    <citation>Bernstein CN, Singh S, Graff LA, Walker JR, Miller N, Cheang M. A prospective population-based study of triggers of symptomatic flares in IBD. Am J Gastroenterol. 2010 Sep;105(9):1994-2002. doi: 10.1038/ajg.2010.140. Epub 2010 Apr 6.</citation>
    <PMID>20372115</PMID>
  </reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>May 10, 2021</last_update_submitted>
  <last_update_submitted_qc>May 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ulcerative colitis</keyword>
  <keyword>remission</keyword>
  <keyword>perceived stress</keyword>
  <keyword>fecal calprotectin</keyword>
  <keyword>salivary stress biomarker</keyword>
  <keyword>psychological stress</keyword>
  <keyword>stress reduction</keyword>
  <keyword>Crohn's disease</keyword>
  <keyword>Inflammatory bowel diseases</keyword>
  <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>
  <!-- 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/NCT03831750
org study id: Pro00082125; Pro00079377
nct id: NCT03831750
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators have designed a guided, online, tri-component, stress reduction
      intervention for participants with inflammatory bowel diseases.
In a randomized controlled trial, the investigators assessed the impact of an online, 3-month
      stress reduction intervention (yoga, breathwork, and meditation). The primary outcome was the
      change in Cohen's Perceived Stress Scale (PSS) between the control and intervention arms. The
      following secondary outcomes were also assessed: anxiety, depression, IBD disease activity
      (e.g., changes in CRP, fecal calprotectin, medication, hospitalization, or surgery), serum
      inflammatory markers, serum and salivary markers of stress, stress-resilience, and health-
      related quality of life. Participant satisfaction and adherence to the intervention were also
      evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
masking description: Sealed envelopes
measure: Perceived stress
time frame: 3 months
description: Between group changes in the stress index from baseline to end of study using the Cohen's Perceived Stress Scale (PSS)-10 item. Summed scores range from 0-40 where lower scores are associated with less perceived stress compared to higher scores.
measure: Mental health
time frame: 3 months
description: Change from baseline to end of study using the Hospital and Anxiety Depression Scale (HADS). Summed scores (range: 0-21) are separate for anxiety and depression; lower scores are assocated with less perceived anxiety or depression.
measure: Health-related quality of life
time frame: 3 months
description: Change from baseline to end of study using the: (1) Short IBD Quality of Life Questionnaire (SIBDQ). Scores (range 1-7) for the 7 questions are summed where higher scores related to a higher perceived health-related quality of life.
measure: Markers of inflammation and stress
time frame: 3 months
description: Changes from baseline to end of study for 6 serum pro- and anti-inflammatory immune biomarkers relevant to IBD (IL-10, IL-12, IL-1ß, IL-4, IL-6, TNF-α) and markers of stress, including CABS1 and cortisol, with the Connor Davidson Resilience Scale (score range: 0 to 100). Higher scores with the Connor Davidson Resilience Scare are indicative of greater stress resiliency.
measure: IBD levels of activity
time frame: 3 months
description: Changes from baseline to end of study for fecal calprotectin and Partial Mayo Score (score range 0-9; lower scores mean less or no disease activity) or the Harvey Bradshaw Index (HBI) (range=0-16+; where lower scores indicate less or no disease activity).
arm group label: Stress Reduction Intervention
arm group type: Experimental
description: Participants will receive the standard of care for IBD and training and access to an online stress reduction intervention.
arm group label: Control
arm group type: No Intervention
description: Participants will receive the standard of care for IBD.
intervention type: Other
intervention name: Stress Reduction Intervention
description: The tri-component intervention is comprised of guided videos for breath-work (5-15 min), stretching (5-15 min), and meditation (10-30 min). The intervention will be delivered online via an access restricted website.
arm group label: Stress Reduction Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Farhad Peerani, MD
role: Principal Investigator
affiliation: University of Alberta
last name: Puneeta Tandon, MD, MSc
role: Principal Investigator
affiliation: University of Alberta
facility: 
country: Canada
citation: Ritz T, Rosenfield D, St Laurent CD, Trueba AF, Werchan CA, Vogel PD, Auchus RJ, Reyes-Serratos E, Befus AD. A novel biomarker associated with distress in humans: calcium-binding protein, spermatid-specific 1 (CABS1). Am J Physiol Regul Integr Comp Physiol. 2017 Jun 1;312(6):R1004-R1016. doi: 10.1152/ajpregu.00393.2016. Epub 2017 Apr 5.
PMID: 28381457
citation: Bernstein CN, Singh S, Graff LA, Walker JR, Miller N, Cheang M. A prospective population-based study of triggers of symptomatic flares in IBD. Am J Gastroenterol. 2010 Sep;105(9):1994-2002. doi: 10.1038/ajg.2010.140. Epub 2010 Apr 6.
PMID: 20372115
responsible party type: Sponsor
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases