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

Not Applicable

Completed

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

• Registration Number: NCT02113605
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-01
• Study First Submitted QC: 2014-04-10
• Study First Posted: 2014-04-14
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cognitive behavior therapy	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in Spence Children Anxiety Scale (SCAS) 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 Pain Reactivity Scale 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 Children´s Somatization Inventory (CSI 24) from baseline to 8 months	Baseline and 8 months.
Change in Gastrointestinal Symptom Rating Scale (GSRS-IBS) 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 Children´s Somatization Inventory (CSI 24) 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 Pediatric Quality of Life Inventory (Peds QL) 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 Gastrointestinal Symptom Rating Scale (GSRS-IBS) 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 Pediatric Quality of Life Inventory (Peds QL) from baseline to 10 weeks.	Baseline and 10 weeks.
Change in Pain Reactivity Scale from baseline to 8 months.	Baseline and 8 months.

Trial Locations

Locations (1)

Child and Adolescent Psychiatry in Stockholm; 🇸🇪 Stockholm, Sweden