<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/NCT03252743</url>
  </required_header>
  <id_info>
    <org_study_id>FGID IMP 2017</org_study_id>
    <nct_id>NCT03252743</nct_id>
  </id_info>
  <brief_title>ICBT for Pain-predominant FGIDs in Children and Adolescents: an Implementation Study.</brief_title>
  <official_title>Internet-delivered Exposure-based Cognitive Behavior Therapy for Pain-predominant Functional Gastrointestinal Disorders in Children and Adolescents: an Implementation Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</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 open trial aims to evaluate feasibility and preliminary effectiveness of an&#xD;
      internet-delivered CBT-program for children and adolescents with functional gastrointestinal&#xD;
      disorders when implemented in regular care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pain predominant functional gastrointestinal disorders (P-FGIDs) are common in children and&#xD;
      adolescents and associated with impaired quality of life. Our research group have previously&#xD;
      in a series of efficacy-studies shown that internet-delivered exposure-based CBT leads to&#xD;
      reduced symptoms and increased quality of life in children and adolescents with P-FGIDs.&#xD;
      There is therefore reason to investigate how the treatment should be disseminated in regular&#xD;
      care. This open trial aim to evaluate feasibility and preliminary treatment effects in&#xD;
      regular care of the internet-delivered CBT-program for children and adolescents with P-FGIDs.&#xD;
&#xD;
      Method: Open trial with a pretest-posttest-design and no control group. The&#xD;
      internet-delivered CBT-program is 10 week long and include weekly therapist support,&#xD;
      consisting of online messages and telephone calls. Assessment points are baseline, weekly&#xD;
      during treatment, post-treatment and follow-up at 3 months and 6 months after treatment&#xD;
      completion.&#xD;
&#xD;
      Analysis: Effect sizes and within-group differences will be calculated in an intent-to-treat&#xD;
      analysis using Cohens' d and Student's t-test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">December 18, 2018</completion_date>
  <primary_completion_date type="Actual">June 17, 2018</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>
    <intervention_model_description>Open trial without control group to test feasibility and evaluate preliminary effects.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).</measure>
    <time_frame>Baseline to 10 weeks.</time_frame>
    <description>Change in global gastrointestinal symptoms from baseline to 10 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain intensity (Faces Pain rating scale)</measure>
    <time_frame>Baseline to 10 weeks</time_frame>
    <description>Change in pain intensity from baseline to 10 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity (Faces Pain rating scale)</measure>
    <time_frame>Baseline to 5 months.</time_frame>
    <description>Change in pain intensity from baseline to 3 months follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity (Faces Pain rating scale)</measure>
    <time_frame>Baseline to 8 months.</time_frame>
    <description>Change in pain intensity from baseline to 6 months follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).</measure>
    <time_frame>Baseline to 5 months.</time_frame>
    <description>Change in global gastrointestinal symptoms from baseline to 3 months follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).</measure>
    <time_frame>Baseline to 8 months.</time_frame>
    <description>Change in global gastrointestinal symptoms from baseline to 6 months follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal symptoms module (PedsQL Gastro)</measure>
    <time_frame>Baseline to 10 weeks</time_frame>
    <description>Change in different dimensions of gastrointestinal symptoms (e.g. pain-related symptoms, nausea, bloating) from baseline to 10 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal symptoms module (PedsQL Gastro)</measure>
    <time_frame>Baseline to 5 months.</time_frame>
    <description>Change in different dimensions of gastrointestinal symptoms (e.g. pain-related symptoms, nausea, bloating) from baseline to 3 months follow up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal symptoms module (PedsQL Gastro)</measure>
    <time_frame>Baseline to 8 months.</time_frame>
    <description>Change in different dimensions of gastrointestinal symptoms (e.g. pain-related symptoms, nausea, bloating) from baseline to 6 months follow up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear for symptoms (Visceral sensitivity index)</measure>
    <time_frame>Baseline to 10 weeks.</time_frame>
    <description>Change in fear for symptoms from baseline to 10 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear for symptoms (Visceral sensitivity index)</measure>
    <time_frame>Baseline to 5 months.</time_frame>
    <description>Change in fear for symptoms from baseline to 3 months follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear for symptoms (Visceral sensitivity index)</measure>
    <time_frame>Baseline to 8 months.</time_frame>
    <description>Change in fear for symptoms from baseline to 6 months follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Avoidant behavior (IBS-BRQ)</measure>
    <time_frame>Baseline to 10 weeks</time_frame>
    <description>Change in avoidant behavior from baseline to 10 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Avoidant behavior (IBS-BRQ)</measure>
    <time_frame>Baseline to 5 months.</time_frame>
    <description>Change in avoidant behavior from baseline to 3 months follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Avoidant behavior (IBS-BRQ)</measure>
    <time_frame>Baseline to 8 months.</time_frame>
    <description>Change in avoidant behavior from baseline to 6 months follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (PedsQL)</measure>
    <time_frame>Baseline to 10 weeks.</time_frame>
    <description>Change in quality of life from baseline to 10 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (PedsQL)</measure>
    <time_frame>Baseline to 5 months.</time_frame>
    <description>Change in quality of life from baseline to 3 months follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (PedsQL)</measure>
    <time_frame>Baseline to 8 months.</time_frame>
    <description>Change in quality of life from baseline to 6 months follow-up.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Parental responses to children´s symptom behavior (ARCS)</measure>
    <time_frame>Baseline to 10 weeks.</time_frame>
    <description>Change in parental responses from baseline to 10 weeks.</description>
  </other_outcome>
  <other_outcome>
    <measure>Parental responses to children´s symptom behavior (ARCS)</measure>
    <time_frame>Baseline to 5 months.</time_frame>
    <description>Change in parental responses from baseline to 3 months follow-up.</description>
  </other_outcome>
  <other_outcome>
    <measure>Parental responses to children´s symptom behavior (ARCS)</measure>
    <time_frame>Baseline to 8 months.</time_frame>
    <description>Change in parental responses from baseline to 6 months follow-up.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Functional Gastrointestinal Disorders</condition>
  <condition>Irritable Bowel Syndrome</condition>
  <condition>Dyspepsia</condition>
  <condition>Functional Abdominal Pain</condition>
  <arm_group>
    <arm_group_label>Internet-delivered CBT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exposure-based internet-delivered CBT with ten weekly modules distributed over the internet during ten weeks, and weekly therapist support over the internet.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exposure-based internet-delivered CBT</intervention_name>
    <description>The main target in treatment is exposure for abdominal symptoms by reducing avoidance and provoking symptoms. Participants are encouraged to gradually increase the difficulty by combining multiple challenges.&#xD;
The parents are taught how to reduce the risk for reinforcement of children's symptom behavior, and to support their child to complete the treatment.&#xD;
All treatment content is delivered over the internet, containing texts, videos, audio-files and examples. The modules are unlocked sequentially as participants worked their way through the treatment.&#xD;
Therapist support consists primarily of encouragement of any progress made in the treatment and support to find individual exercises.</description>
    <arm_group_label>Internet-delivered CBT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 8-17 at date of inclusion.&#xD;
&#xD;
          -  Fulfilling Rome IV-criteria for irritable bowel syndrome, functional dyspepsia or&#xD;
             functional abdominal pain with a written statement from patient's physician confirming&#xD;
             a diagnosis.&#xD;
&#xD;
          -  Stable psychotropic medication for at least 1 month.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  concurrent serious medical conditions.&#xD;
&#xD;
          -  a psychiatric diagnosis, judged to be a more important treatment target than the&#xD;
             abdominal pain.&#xD;
&#xD;
          -  on-going structured psychological treatment.&#xD;
&#xD;
          -  absence from school exceeding an average of 2 days a week the last month is a cause&#xD;
             for exclusion since high school absence demands more intensive interventions than can&#xD;
             be offered in ICBT.&#xD;
&#xD;
          -  on-going abuse or severe parental psychiatric illness in the family.&#xD;
&#xD;
          -  since treatment format assumes normal reading and writing skills, pronounced language&#xD;
             skill deficits and learning difficulties lead to exclusion from the study.&#xD;
&#xD;
          -  lack of regular internet-access.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marianne Bonnert, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Clinical Neuroscience, Karolinska Institutet</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>February 25, 2019</last_update_submitted>
  <last_update_submitted_qc>February 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Marianne Bonnert</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irritable Bowel Syndrome</mesh_term>
    <mesh_term>Gastrointestinal Diseases</mesh_term>
    <mesh_term>Digestive System Diseases</mesh_term>
    <mesh_term>Dyspepsia</mesh_term>
    <mesh_term>Abdominal Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03252743
org study id: FGID IMP 2017
nct id: NCT03252743
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This open trial aims to evaluate feasibility and preliminary effectiveness of an
      internet-delivered CBT-program for children and adolescents with functional gastrointestinal
      disorders when implemented in regular care.
Pain predominant functional gastrointestinal disorders (P-FGIDs) are common in children and
      adolescents and associated with impaired quality of life. Our research group have previously
      in a series of efficacy-studies shown that internet-delivered exposure-based CBT leads to
      reduced symptoms and increased quality of life in children and adolescents with P-FGIDs.
      There is therefore reason to investigate how the treatment should be disseminated in regular
      care. This open trial aim to evaluate feasibility and preliminary treatment effects in
      regular care of the internet-delivered CBT-program for children and adolescents with P-FGIDs.

      Method: Open trial with a pretest-posttest-design and no control group. The
      internet-delivered CBT-program is 10 week long and include weekly therapist support,
      consisting of online messages and telephone calls. Assessment points are baseline, weekly
      during treatment, post-treatment and follow-up at 3 months and 6 months after treatment
      completion.

      Analysis: Effect sizes and within-group differences will be calculated in an intent-to-treat
      analysis using Cohens' d and Student's t-test.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Open trial without control group to test feasibility and evaluate preliminary effects.
primary purpose: Treatment
masking: None (Open Label)
measure: Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).
time frame: Baseline to 10 weeks.
description: Change in global gastrointestinal symptoms from baseline to 10 weeks.
measure: Pain intensity (Faces Pain rating scale)
time frame: Baseline to 10 weeks
description: Change in pain intensity from baseline to 10 weeks
measure: Pain intensity (Faces Pain rating scale)
time frame: Baseline to 5 months.
description: Change in pain intensity from baseline to 3 months follow-up.
measure: Pain intensity (Faces Pain rating scale)
time frame: Baseline to 8 months.
description: Change in pain intensity from baseline to 6 months follow-up.
measure: Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).
time frame: Baseline to 5 months.
description: Change in global gastrointestinal symptoms from baseline to 3 months follow-up.
measure: Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).
time frame: Baseline to 8 months.
description: Change in global gastrointestinal symptoms from baseline to 6 months follow-up.
measure: Gastrointestinal symptoms module (PedsQL Gastro)
time frame: Baseline to 10 weeks
description: Change in different dimensions of gastrointestinal symptoms (e.g. pain-related symptoms, nausea, bloating) from baseline to 10 weeks.
measure: Gastrointestinal symptoms module (PedsQL Gastro)
time frame: Baseline to 5 months.
description: Change in different dimensions of gastrointestinal symptoms (e.g. pain-related symptoms, nausea, bloating) from baseline to 3 months follow up.
measure: Gastrointestinal symptoms module (PedsQL Gastro)
time frame: Baseline to 8 months.
description: Change in different dimensions of gastrointestinal symptoms (e.g. pain-related symptoms, nausea, bloating) from baseline to 6 months follow up.
measure: Fear for symptoms (Visceral sensitivity index)
time frame: Baseline to 10 weeks.
description: Change in fear for symptoms from baseline to 10 weeks.
measure: Fear for symptoms (Visceral sensitivity index)
time frame: Baseline to 5 months.
description: Change in fear for symptoms from baseline to 3 months follow-up.
measure: Fear for symptoms (Visceral sensitivity index)
time frame: Baseline to 8 months.
description: Change in fear for symptoms from baseline to 6 months follow-up.
measure: Avoidant behavior (IBS-BRQ)
time frame: Baseline to 10 weeks
description: Change in avoidant behavior from baseline to 10 weeks.
measure: Avoidant behavior (IBS-BRQ)
time frame: Baseline to 5 months.
description: Change in avoidant behavior from baseline to 3 months follow-up.
measure: Avoidant behavior (IBS-BRQ)
time frame: Baseline to 8 months.
description: Change in avoidant behavior from baseline to 6 months follow-up.
measure: Quality of life (PedsQL)
time frame: Baseline to 10 weeks.
description: Change in quality of life from baseline to 10 weeks.
measure: Quality of life (PedsQL)
time frame: Baseline to 5 months.
description: Change in quality of life from baseline to 3 months follow-up.
measure: Quality of life (PedsQL)
time frame: Baseline to 8 months.
description: Change in quality of life from baseline to 6 months follow-up.
measure: Parental responses to children´s symptom behavior (ARCS)
time frame: Baseline to 10 weeks.
description: Change in parental responses from baseline to 10 weeks.
measure: Parental responses to children´s symptom behavior (ARCS)
time frame: Baseline to 5 months.
description: Change in parental responses from baseline to 3 months follow-up.
measure: Parental responses to children´s symptom behavior (ARCS)
time frame: Baseline to 8 months.
description: Change in parental responses from baseline to 6 months follow-up.
arm group label: Internet-delivered CBT
arm group type: Experimental
description: Exposure-based internet-delivered CBT with ten weekly modules distributed over the internet during ten weeks, and weekly therapist support over the internet.
intervention type: Behavioral
intervention name: Exposure-based internet-delivered CBT
description: The main target in treatment is exposure for abdominal symptoms by reducing avoidance and provoking symptoms. Participants are encouraged to gradually increase the difficulty by combining multiple challenges.
The parents are taught how to reduce the risk for reinforcement of children's symptom behavior, and to support their child to complete the treatment.
All treatment content is delivered over the internet, containing texts, videos, audio-files and examples. The modules are unlocked sequentially as participants worked their way through the treatment.
Therapist support consists primarily of encouragement of any progress made in the treatment and support to find individual exercises.
arm group label: Internet-delivered CBT
criteria: 
gender: All
minimum age: 8 Years
maximum age: 17 Years
healthy volunteers: No
last name: Marianne Bonnert, PhD
role: Principal Investigator
affiliation: Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Marianne Bonnert
investigator title: PhD
mesh term: Irritable Bowel Syndrome
mesh term: Gastrointestinal Diseases
mesh term: Digestive System Diseases
mesh term: Dyspepsia
mesh term: Abdominal Pain
sharing ipd: Undecided