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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Other: Cognitive behavior therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive behavior therapy<br>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<br>* Exposure-based cognitive behavior therapy in a 10 week face-to-face treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional gastrointestinal disorders, FGID, Recurrent abdominal pain, Abdominal pain, pain-predominant functional gastrointestinal disorders, Pediatric pain