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

Exposure-Based CBT for Children With Functional Gastrointestinal Disorders - Development of a Protocol

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.

Study Overview

• Status: Completed
• Conditions: Functional Dyspepsia; Functional Abdominal Pain; Irritable Bowel Syndrome (IBS); Functional Gastrointestinal Disorders (FGID); FGID According to the Rome III Criteria
• Intervention / Treatment: Other: Cognitive behavior therapy

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 11330
    • Child and Adolescent Psychiatry in Stockholm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive behavior therapy; All included children are treated with a face-to-face exposure-based cognitive behaviour therapy for 10 weeks. There will be no comparison arm.	Other: Cognitive behavior therapy; Exposure-based cognitive behavior therapy in a 10 week face-to-face treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Faces Pain Rating Scale (FACES) from baseline to 10 weeks	Baseline and 10 weeks
Change in Faces Pain Rating Scale (FACES) from baseline to 8 months.	Baseline and 8 months.

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Change in Parental Behavior FGID (PB-FGID) from baseline to 10 weeks.	Baseline and 10 weeks.
Change in Parental Behavior FGID (PB-FGID) from baseline to 8 months.	Baseline and 8 months.
Change in Adult responses to children´s symptoms (ARCS) from baseline to 10 weeks.	Baseline and 10 weeks.
Change in Adult responses to children´s symptoms (ARCS) from baseline to 8 months.	Baseline and 8 months.

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Ola Olén, MD, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: April 1, 2014
• First Submitted That Met QC Criteria: April 10, 2014
• First Posted (Estimate): April 14, 2014

Study Record Updates

• Last Update Posted (Estimate): December 2, 2015
• Last Update Submitted That Met QC Criteria: December 1, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Abdominal pain; FGID; Functional gastrointestinal disorders; Recurrent abdominal pain; pain-predominant functional gastrointestinal disorders; Pediatric pain
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Dyspepsia; Disease; Irritable Bowel Syndrome; Abdominal Pain; Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: FGID Child Pilot-0