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

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.

Full Title of Study: “Exposure-Based CBT for Children With Functional Gastrointestinal Disorders – Development of a Protocol”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2015

Interventions

  • Other: Cognitive behavior therapy
    • Exposure-based cognitive behavior therapy in a 10 week face-to-face treatment

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 8 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Karolinska Institutet
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ola Olen, MD, PhD – Karolinska Institutet
  • Overall Official(s)
    • Ola Olén, MD, PhD, Principal Investigator, Karolinska Institutet

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.