<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/NCT02991443</url>
  </required_header>
  <id_info>
    <org_study_id>MindfulnessSMCIBD</org_study_id>
    <nct_id>NCT02991443</nct_id>
  </id_info>
  <brief_title>Mindfulness Based Stress Reduction for Parents of Children With IBD</brief_title>
  <acronym>Mindful</acronym>
  <official_title>The Effect of Mindfulness Based Stress Reduction on Parents of Children With Inflammatory Bowel Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Schneider Children's Medical Center, Israel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Schneider Children's Medical Center, Israel</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Parents of children with chronic diseases often report increased level of stress and anxiety.&#xD;
      The aim of the study is to assess the effect of mindfulness based stress reduction (MBSR)&#xD;
      intervention on stress and anxiety of parents of children with inflammatory bowel diseases&#xD;
      (IBD). The intervention is consisted of 8 group sessions managed by a certified psychologist.&#xD;
      30 parents will participate. The efficacy of the intervention will be assessed by 3 validated&#xD;
      questionnaires which will be filled by each participant prior to intervention, at the end of&#xD;
      intervention and 3 months following interventions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Parents of children with chronic diseases often report increased level of stress and anxiety.&#xD;
      Inflammatory bowel diseases (IBD), including crohn's disease and ulcerative colitis are&#xD;
      chronic debilitating conditions with significant implications of both patients and parents.&#xD;
      Thus, there is a necessity to address the stress and anxiety derived from parenting a child&#xD;
      with IBD.&#xD;
&#xD;
      Mindfulness is the psychological process of bringing one's attention to the internal and&#xD;
      external experiences occurring in the present moment,which can be developed through the&#xD;
      practice of meditation and other training. Clinical studies have documented both physical and&#xD;
      mental health benefits of mindfulness in different patient categories as well as in healthy&#xD;
      adults and children.&#xD;
&#xD;
      The aim of the study is to assess the effect of mindfulness based stress reduction (MBSR)&#xD;
      intervention on stress and anxiety of parents of children with inflammatory bowel diseases&#xD;
      (IBD). The intervention is consisted of 8 group sessions managed by a certified psychologist.&#xD;
      30 parents will participate in 4 separated courses. The efficacy of the intervention will be&#xD;
      assessed by 3 validated questionnaires which will be filled by each participant prior to&#xD;
      intervention, at the end of intervention and 3 months following interventions: Profile of&#xD;
      mood states (POMS), The brief symptom inventory (BSI) and perceived stress scale (PSS).&#xD;
      Differences in questionnaires' scores will be analyzed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">October 15, 2020</completion_date>
  <primary_completion_date type="Actual">July 31, 2020</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>The change in perceived stress scale</measure>
    <time_frame>At baseline and 3 months following intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The change in profile of mood states (POMS) score</measure>
    <time_frame>At week 0 following intervention and 3 months following intervention compared with baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change in brief symptom inventory (BSI) score</measure>
    <time_frame>At week 0 following intervention and 3 months following intervention compared with baseline</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <arm_group>
    <arm_group_label>Mindfulness based stress reduction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Parents of children with IBD will undergo mindfulness based stress reduction (MBSR) intervention consisted of 8 group sessions. The effect on stress and anxiety will be assessed using 3 validated questionnaires which will be filled prior to intervention, at the end of intervention and 3 months following intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness based stress reduction</intervention_name>
    <description>Mindfulness based stress reduction consisted of 8 group sessions for parents of children with IBD</description>
    <arm_group_label>Mindfulness based stress reduction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A parent to an IBD patient who is younger than 18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raanan Shamir, MD</last_name>
    <role>Study Director</role>
    <affiliation>Schneider Children's Medical Center, Israel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Schneider Children's Hospital</name>
      <address>
        <city>Petach Tikva</city>
        <zip>4920235</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>September 25, 2021</last_update_submitted>
  <last_update_submitted_qc>September 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Schneider Children's Medical Center, Israel</investigator_affiliation>
    <investigator_full_name>Amit Assa</investigator_full_name>
    <investigator_title>Head of IBD program</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>


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/NCT02991443
org study id: MindfulnessSMCIBD
nct id: NCT02991443
lead sponsor: 
has dmc: No
Parents of children with chronic diseases often report increased level of stress and anxiety.
      The aim of the study is to assess the effect of mindfulness based stress reduction (MBSR)
      intervention on stress and anxiety of parents of children with inflammatory bowel diseases
      (IBD). The intervention is consisted of 8 group sessions managed by a certified psychologist.
      30 parents will participate. The efficacy of the intervention will be assessed by 3 validated
      questionnaires which will be filled by each participant prior to intervention, at the end of
      intervention and 3 months following interventions.
Parents of children with chronic diseases often report increased level of stress and anxiety.
      Inflammatory bowel diseases (IBD), including crohn's disease and ulcerative colitis are
      chronic debilitating conditions with significant implications of both patients and parents.
      Thus, there is a necessity to address the stress and anxiety derived from parenting a child
      with IBD.

      Mindfulness is the psychological process of bringing one's attention to the internal and
      external experiences occurring in the present moment,which can be developed through the
      practice of meditation and other training. Clinical studies have documented both physical and
      mental health benefits of mindfulness in different patient categories as well as in healthy
      adults and children.

      The aim of the study is to assess the effect of mindfulness based stress reduction (MBSR)
      intervention on stress and anxiety of parents of children with inflammatory bowel diseases
      (IBD). The intervention is consisted of 8 group sessions managed by a certified psychologist.
      30 parents will participate in 4 separated courses. The efficacy of the intervention will be
      assessed by 3 validated questionnaires which will be filled by each participant prior to
      intervention, at the end of intervention and 3 months following interventions: Profile of
      mood states (POMS), The brief symptom inventory (BSI) and perceived stress scale (PSS).
      Differences in questionnaires' scores will be analyzed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: The change in perceived stress scale
time frame: At baseline and 3 months following intervention
measure: The change in profile of mood states (POMS) score
time frame: At week 0 following intervention and 3 months following intervention compared with baseline
measure: The change in brief symptom inventory (BSI) score
time frame: At week 0 following intervention and 3 months following intervention compared with baseline
arm group label: Mindfulness based stress reduction
arm group type: Experimental
description: Parents of children with IBD will undergo mindfulness based stress reduction (MBSR) intervention consisted of 8 group sessions. The effect on stress and anxiety will be assessed using 3 validated questionnaires which will be filled prior to intervention, at the end of intervention and 3 months following intervention.
intervention type: Behavioral
intervention name: Mindfulness based stress reduction
description: Mindfulness based stress reduction consisted of 8 group sessions for parents of children with IBD
arm group label: Mindfulness based stress reduction
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Raanan Shamir, MD
role: Study Director
affiliation: Schneider Children's Medical Center, Israel
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Schneider Children's Medical Center, Israel
investigator full name: Amit Assa
investigator title: Head of IBD program
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases
sharing ipd: No