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

Karolinska Institutet20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Cognitive behavior therapyOTHER

Exposure-based cognitive behavior therapy in a 10 week face-to-face treatment

Eligibility

Sex: ALLMin age: 8 YearsMax age: 12 Years

Medical Language ↔ Plain English

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.

Locations (1)

Child and Adolescent Psychiatry in Stockholm

Stockholm, Sweden

Outcomes

Primary Outcomes

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

Time frame: Baseline and 10 weeks

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

Time frame: Baseline and 8 months.

Secondary Outcomes

Change in Gastrointestinal Symptom Rating Scale (GSRS-IBS) from baseline to 10 weeks.

Time frame: Baseline and 10 weeks.

Change in Children´s Somatization Inventory (CSI 24) from baseline to 10 weeks

Time frame: Baseline and 10 weeks.

Change in Gastrointestinal Symptom Scale (PedsQL Gastro) from baseline to 10 weeks

Time frame: Baseline and 10 weeks.

Change in Functional Disability Index (FDI) from baseline to 10 weeks.

Time frame: Baseline and 10 weeks.

Change in Pain Reactivity Scale from baseline to 10 weeks.

Time frame: Baseline and 10 weeks.

Change in IBS-behavioral responses questionnaires (IBS-BRQ) from baseline to 10 weeks.

Time frame: Baseline and 10 weeks.

Change in Spence Children Anxiety Scale (SCAS) from baseline to 10 weeks.

Time frame: Baseline and 10 weeks.

Change in Child Depression Inventory (CDI) from baseline to 10 weeks.

Time frame: Baseline and 10 weeks.

Change in Pain Interference Index (PII) from baseline to 10 weeks.

Time frame: Baseline and 10 weeks.

Change in Pediatric Quality of Life Inventory (Peds QL) from baseline to 10 weeks.

Time frame: Baseline and 10 weeks.

Change in Gastrointestinal Symptom Rating Scale (GSRS-IBS) from baseline to 8 months.

Time frame: Baseline and 8 months

Change in Children´s Somatization Inventory (CSI 24) from baseline to 8 months

Time frame: Baseline and 8 months.

Change in Gastrointestinal Symptom Scale (PedsQL Gastro) from baseline to 8 months.

Time frame: Baseline and 8 months.

Change in Functional Disability Index (FDI) from baseline to 8 months.

Time frame: Baseline and 8 months.

Change in IBS-behavioral responses questionnaires (IBS-BRQ) from baseline to 8 months.

Time frame: Baseline and 8 months.

Change in Spence Children Anxiety Scale (SCAS) from baseline to 8 months.

Time frame: Baseline and 8 months.

Change in Child Depression Inventory (CDI) from baseline to 8 months.

Time frame: Baseline and 8 months.

Change in Pain Interference Index (PII) from baseline to 8 months.

Time frame: Baseline and 8 months.

Change in Pediatric Quality of Life Inventory (Peds QL) from baseline to 8 months.

Time frame: Baseline and 8 months.

Change in Pain Reactivity Scale from baseline to 8 months.

Time frame: Baseline and 8 months.

Data from ClinicalTrials.gov

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