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ICBT for Pain-predominant FGIDs in Children and Adolescents: an Implementation Study.

Primary Purpose

Functional Gastrointestinal Disorders, Irritable Bowel Syndrome, Dyspepsia

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Exposure-based internet-delivered CBT
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Gastrointestinal Disorders

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 8-17 at date of inclusion.
  • Fulfilling Rome IV-criteria for irritable bowel syndrome, functional dyspepsia or functional abdominal pain with a written statement from patient's physician confirming a diagnosis.
  • Stable psychotropic medication for at least 1 month.

Exclusion Criteria:

  • concurrent serious medical conditions.
  • a psychiatric diagnosis, judged to be a more important treatment target than the abdominal pain.
  • on-going structured psychological treatment.
  • absence from school exceeding an average of 2 days a week the last month is a cause for exclusion since high school absence demands more intensive interventions than can be offered in ICBT.
  • on-going abuse or severe parental psychiatric illness in the family.
  • since treatment format assumes normal reading and writing skills, pronounced language skill deficits and learning difficulties lead to exclusion from the study.
  • lack of regular internet-access.

Sites / Locations

  • Department of Clinical Neuroscience, Karolinska Institutet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Internet-delivered CBT

Arm Description

Exposure-based internet-delivered CBT with ten weekly modules distributed over the internet during ten weeks, and weekly therapist support over the internet.

Outcomes

Primary Outcome Measures

Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).
Change in global gastrointestinal symptoms from baseline to 10 weeks.

Secondary Outcome Measures

Pain intensity (Faces Pain rating scale)
Change in pain intensity from baseline to 10 weeks
Pain intensity (Faces Pain rating scale)
Change in pain intensity from baseline to 3 months follow-up.
Pain intensity (Faces Pain rating scale)
Change in pain intensity from baseline to 6 months follow-up.
Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).
Change in global gastrointestinal symptoms from baseline to 3 months follow-up.
Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).
Change in global gastrointestinal symptoms from baseline to 6 months follow-up.
Gastrointestinal symptoms module (PedsQL Gastro)
Change in different dimensions of gastrointestinal symptoms (e.g. pain-related symptoms, nausea, bloating) from baseline to 10 weeks.
Gastrointestinal symptoms module (PedsQL Gastro)
Change in different dimensions of gastrointestinal symptoms (e.g. pain-related symptoms, nausea, bloating) from baseline to 3 months follow up.
Gastrointestinal symptoms module (PedsQL Gastro)
Change in different dimensions of gastrointestinal symptoms (e.g. pain-related symptoms, nausea, bloating) from baseline to 6 months follow up.
Fear for symptoms (Visceral sensitivity index)
Change in fear for symptoms from baseline to 10 weeks.
Fear for symptoms (Visceral sensitivity index)
Change in fear for symptoms from baseline to 3 months follow-up.
Fear for symptoms (Visceral sensitivity index)
Change in fear for symptoms from baseline to 6 months follow-up.
Avoidant behavior (IBS-BRQ)
Change in avoidant behavior from baseline to 10 weeks.
Avoidant behavior (IBS-BRQ)
Change in avoidant behavior from baseline to 3 months follow-up.
Avoidant behavior (IBS-BRQ)
Change in avoidant behavior from baseline to 6 months follow-up.
Quality of life (PedsQL)
Change in quality of life from baseline to 10 weeks.
Quality of life (PedsQL)
Change in quality of life from baseline to 3 months follow-up.
Quality of life (PedsQL)
Change in quality of life from baseline to 6 months follow-up.

Full Information

First Posted
August 14, 2017
Last Updated
February 25, 2019
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT03252743
Brief Title
ICBT for Pain-predominant FGIDs in Children and Adolescents: an Implementation Study.
Official Title
Internet-delivered Exposure-based Cognitive Behavior Therapy for Pain-predominant Functional Gastrointestinal Disorders in Children and Adolescents: an Implementation Study.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
June 17, 2018 (Actual)
Study Completion Date
December 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Gastrointestinal Disorders, Irritable Bowel Syndrome, Dyspepsia, Functional Abdominal Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open trial without control group to test feasibility and evaluate preliminary effects.
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet-delivered CBT
Arm Type
Experimental
Arm 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(s)
Exposure-based internet-delivered CBT
Intervention 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.
Primary Outcome Measure Information:
Title
Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).
Description
Change in global gastrointestinal symptoms from baseline to 10 weeks.
Time Frame
Baseline to 10 weeks.
Secondary Outcome Measure Information:
Title
Pain intensity (Faces Pain rating scale)
Description
Change in pain intensity from baseline to 10 weeks
Time Frame
Baseline to 10 weeks
Title
Pain intensity (Faces Pain rating scale)
Description
Change in pain intensity from baseline to 3 months follow-up.
Time Frame
Baseline to 5 months.
Title
Pain intensity (Faces Pain rating scale)
Description
Change in pain intensity from baseline to 6 months follow-up.
Time Frame
Baseline to 8 months.
Title
Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).
Description
Change in global gastrointestinal symptoms from baseline to 3 months follow-up.
Time Frame
Baseline to 5 months.
Title
Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).
Description
Change in global gastrointestinal symptoms from baseline to 6 months follow-up.
Time Frame
Baseline to 8 months.
Title
Gastrointestinal symptoms module (PedsQL Gastro)
Description
Change in different dimensions of gastrointestinal symptoms (e.g. pain-related symptoms, nausea, bloating) from baseline to 10 weeks.
Time Frame
Baseline to 10 weeks
Title
Gastrointestinal symptoms module (PedsQL Gastro)
Description
Change in different dimensions of gastrointestinal symptoms (e.g. pain-related symptoms, nausea, bloating) from baseline to 3 months follow up.
Time Frame
Baseline to 5 months.
Title
Gastrointestinal symptoms module (PedsQL Gastro)
Description
Change in different dimensions of gastrointestinal symptoms (e.g. pain-related symptoms, nausea, bloating) from baseline to 6 months follow up.
Time Frame
Baseline to 8 months.
Title
Fear for symptoms (Visceral sensitivity index)
Description
Change in fear for symptoms from baseline to 10 weeks.
Time Frame
Baseline to 10 weeks.
Title
Fear for symptoms (Visceral sensitivity index)
Description
Change in fear for symptoms from baseline to 3 months follow-up.
Time Frame
Baseline to 5 months.
Title
Fear for symptoms (Visceral sensitivity index)
Description
Change in fear for symptoms from baseline to 6 months follow-up.
Time Frame
Baseline to 8 months.
Title
Avoidant behavior (IBS-BRQ)
Description
Change in avoidant behavior from baseline to 10 weeks.
Time Frame
Baseline to 10 weeks
Title
Avoidant behavior (IBS-BRQ)
Description
Change in avoidant behavior from baseline to 3 months follow-up.
Time Frame
Baseline to 5 months.
Title
Avoidant behavior (IBS-BRQ)
Description
Change in avoidant behavior from baseline to 6 months follow-up.
Time Frame
Baseline to 8 months.
Title
Quality of life (PedsQL)
Description
Change in quality of life from baseline to 10 weeks.
Time Frame
Baseline to 10 weeks.
Title
Quality of life (PedsQL)
Description
Change in quality of life from baseline to 3 months follow-up.
Time Frame
Baseline to 5 months.
Title
Quality of life (PedsQL)
Description
Change in quality of life from baseline to 6 months follow-up.
Time Frame
Baseline to 8 months.
Other Pre-specified Outcome Measures:
Title
Parental responses to children´s symptom behavior (ARCS)
Description
Change in parental responses from baseline to 10 weeks.
Time Frame
Baseline to 10 weeks.
Title
Parental responses to children´s symptom behavior (ARCS)
Description
Change in parental responses from baseline to 3 months follow-up.
Time Frame
Baseline to 5 months.
Title
Parental responses to children´s symptom behavior (ARCS)
Description
Change in parental responses from baseline to 6 months follow-up.
Time Frame
Baseline to 8 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 8-17 at date of inclusion. Fulfilling Rome IV-criteria for irritable bowel syndrome, functional dyspepsia or functional abdominal pain with a written statement from patient's physician confirming a diagnosis. Stable psychotropic medication for at least 1 month. Exclusion Criteria: concurrent serious medical conditions. a psychiatric diagnosis, judged to be a more important treatment target than the abdominal pain. on-going structured psychological treatment. absence from school exceeding an average of 2 days a week the last month is a cause for exclusion since high school absence demands more intensive interventions than can be offered in ICBT. on-going abuse or severe parental psychiatric illness in the family. since treatment format assumes normal reading and writing skills, pronounced language skill deficits and learning difficulties lead to exclusion from the study. lack of regular internet-access.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne Bonnert, PhD
Organizational Affiliation
Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Neuroscience, Karolinska Institutet
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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ICBT for Pain-predominant FGIDs in Children and Adolescents: an Implementation Study.

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