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Cognitive Behavior Therapy (CBT) for Children With Functional Gastrointestinal Disorders (CBT)

Primary Purpose

Functional Gastrointestinal Disorders (FGID), FGID According to the Rome III Criteria, Irritable Bowel Syndrome (IBS)

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cognitive behavior therapy
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Gastrointestinal Disorders (FGID) focused on measuring Functional gastrointestinal disorders, FGID, Recurrent abdominal pain, Abdominal pain, pain-predominant functional gastrointestinal disorders, Pediatric pain

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 8-12 years
  • A diagnosis of a functional gastrointestinal disorder by a treating physician

Exclusion Criteria:

  • Concurrent serious medical condition or gastrointestinal symptoms likely caused by an organic disorder.
  • Psychiatric disorder more urgent to treat than the abdominal pain.
  • On-going psychological treatment.
  • Absence from school more than 40 %.
  • Ongoing maltreatment, violence or severe parental psychiatric illness.
  • Pronounced language or learning difficulties that hinder the child to benefit from the treatment.

Sites / Locations

  • Child and Adolescent Psychiatry in Stockholm

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognitive behavior therapy

Arm Description

All included children are treated with a face-to-face exposure-based cognitive behaviour therapy for 10 weeks. There will be no comparison arm.

Outcomes

Primary Outcome Measures

Change in Faces Pain Rating Scale (FACES) from baseline to 10 weeks
Change in Faces Pain Rating Scale (FACES) from baseline to 8 months.

Secondary Outcome Measures

Change in Gastrointestinal Symptom Rating Scale (GSRS-IBS) from baseline to 10 weeks.
Change in Children´s Somatization Inventory (CSI 24) from baseline to 10 weeks
Change in Gastrointestinal Symptom Scale (PedsQL Gastro) from baseline to 10 weeks
Change in Functional Disability Index (FDI) from baseline to 10 weeks.
Change in Pain Reactivity Scale from baseline to 10 weeks.
Change in IBS-behavioral responses questionnaires (IBS-BRQ) from baseline to 10 weeks.
Change in Spence Children Anxiety Scale (SCAS) from baseline to 10 weeks.
Change in Child Depression Inventory (CDI) from baseline to 10 weeks.
Change in Pain Interference Index (PII) from baseline to 10 weeks.
Change in Pediatric Quality of Life Inventory (Peds QL) from baseline to 10 weeks.
Change in Gastrointestinal Symptom Rating Scale (GSRS-IBS) from baseline to 8 months.
Change in Children´s Somatization Inventory (CSI 24) from baseline to 8 months
Change in Gastrointestinal Symptom Scale (PedsQL Gastro) from baseline to 8 months.
Change in Functional Disability Index (FDI) from baseline to 8 months.
Change in IBS-behavioral responses questionnaires (IBS-BRQ) from baseline to 8 months.
Change in Spence Children Anxiety Scale (SCAS) from baseline to 8 months.
Change in Child Depression Inventory (CDI) from baseline to 8 months.
Change in Pain Interference Index (PII) from baseline to 8 months.
Change in Pediatric Quality of Life Inventory (Peds QL) from baseline to 8 months.
Change in Pain Reactivity Scale from baseline to 8 months.

Full Information

First Posted
April 1, 2014
Last Updated
December 1, 2015
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT02113605
Brief Title
Cognitive Behavior Therapy (CBT) for Children With Functional Gastrointestinal Disorders
Acronym
CBT
Official Title
Exposure-Based CBT for Children With Functional Gastrointestinal Disorders - Development of a Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the trial is to develop a treatment protocol to be used in trials studying internet-delivered CBT for children with functional gastrointestinal disorders (FGID). The study size is not based on power calculations but the estimated sample necessary to develop a treatment protocol. This study will include 20-30 children with FGID and their parents who will be treated individually (face-to-face). The treatment consists of 10 weekly sessions of exposure-based CBT. The study uses a pre- post-design with no control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Gastrointestinal Disorders (FGID), FGID According to the Rome III Criteria, Irritable Bowel Syndrome (IBS), Functional Abdominal Pain, Functional Dyspepsia
Keywords
Functional gastrointestinal disorders, FGID, Recurrent abdominal pain, Abdominal pain, pain-predominant functional gastrointestinal disorders, Pediatric pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive behavior therapy
Arm Type
Experimental
Arm Description
All included children are treated with a face-to-face exposure-based cognitive behaviour therapy for 10 weeks. There will be no comparison arm.
Intervention Type
Other
Intervention Name(s)
Cognitive behavior therapy
Intervention Description
Exposure-based cognitive behavior therapy in a 10 week face-to-face treatment
Primary Outcome Measure Information:
Title
Change in Faces Pain Rating Scale (FACES) from baseline to 10 weeks
Time Frame
Baseline and 10 weeks
Title
Change in Faces Pain Rating Scale (FACES) from baseline to 8 months.
Time Frame
Baseline and 8 months.
Secondary Outcome Measure Information:
Title
Change in Gastrointestinal Symptom Rating Scale (GSRS-IBS) from baseline to 10 weeks.
Time Frame
Baseline and 10 weeks.
Title
Change in Children´s Somatization Inventory (CSI 24) from baseline to 10 weeks
Time Frame
Baseline and 10 weeks.
Title
Change in Gastrointestinal Symptom Scale (PedsQL Gastro) from baseline to 10 weeks
Time Frame
Baseline and 10 weeks.
Title
Change in Functional Disability Index (FDI) from baseline to 10 weeks.
Time Frame
Baseline and 10 weeks.
Title
Change in Pain Reactivity Scale from baseline to 10 weeks.
Time Frame
Baseline and 10 weeks.
Title
Change in IBS-behavioral responses questionnaires (IBS-BRQ) from baseline to 10 weeks.
Time Frame
Baseline and 10 weeks.
Title
Change in Spence Children Anxiety Scale (SCAS) from baseline to 10 weeks.
Time Frame
Baseline and 10 weeks.
Title
Change in Child Depression Inventory (CDI) from baseline to 10 weeks.
Time Frame
Baseline and 10 weeks.
Title
Change in Pain Interference Index (PII) from baseline to 10 weeks.
Time Frame
Baseline and 10 weeks.
Title
Change in Pediatric Quality of Life Inventory (Peds QL) from baseline to 10 weeks.
Time Frame
Baseline and 10 weeks.
Title
Change in Gastrointestinal Symptom Rating Scale (GSRS-IBS) from baseline to 8 months.
Time Frame
Baseline and 8 months
Title
Change in Children´s Somatization Inventory (CSI 24) from baseline to 8 months
Time Frame
Baseline and 8 months.
Title
Change in Gastrointestinal Symptom Scale (PedsQL Gastro) from baseline to 8 months.
Time Frame
Baseline and 8 months.
Title
Change in Functional Disability Index (FDI) from baseline to 8 months.
Time Frame
Baseline and 8 months.
Title
Change in IBS-behavioral responses questionnaires (IBS-BRQ) from baseline to 8 months.
Time Frame
Baseline and 8 months.
Title
Change in Spence Children Anxiety Scale (SCAS) from baseline to 8 months.
Time Frame
Baseline and 8 months.
Title
Change in Child Depression Inventory (CDI) from baseline to 8 months.
Time Frame
Baseline and 8 months.
Title
Change in Pain Interference Index (PII) from baseline to 8 months.
Time Frame
Baseline and 8 months.
Title
Change in Pediatric Quality of Life Inventory (Peds QL) from baseline to 8 months.
Time Frame
Baseline and 8 months.
Title
Change in Pain Reactivity Scale from baseline to 8 months.
Time Frame
Baseline and 8 months.
Other Pre-specified Outcome Measures:
Title
Change in Parental Behavior FGID (PB-FGID) from baseline to 10 weeks.
Time Frame
Baseline and 10 weeks.
Title
Change in Parental Behavior FGID (PB-FGID) from baseline to 8 months.
Time Frame
Baseline and 8 months.
Title
Change in Adult responses to children´s symptoms (ARCS) from baseline to 10 weeks.
Time Frame
Baseline and 10 weeks.
Title
Change in Adult responses to children´s symptoms (ARCS) from baseline to 8 months.
Time Frame
Baseline and 8 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 8-12 years A diagnosis of a functional gastrointestinal disorder by a treating physician Exclusion Criteria: Concurrent serious medical condition or gastrointestinal symptoms likely caused by an organic disorder. Psychiatric disorder more urgent to treat than the abdominal pain. On-going psychological treatment. Absence from school more than 40 %. Ongoing maltreatment, violence or severe parental psychiatric illness. Pronounced language or learning difficulties that hinder the child to benefit from the treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ola Olén, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child and Adolescent Psychiatry in Stockholm
City
Stockholm
ZIP/Postal Code
11330
Country
Sweden

12. IPD Sharing Statement

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Cognitive Behavior Therapy (CBT) for Children With Functional Gastrointestinal Disorders

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