Trial record 9 of 15 for:    IBS and CBT

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Karolinska Institutet
Sponsor:
Information provided by (Responsible Party):
Ola Olen, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT02113605
First received: April 1, 2014
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exposure-Based CBT for Children With Functional Gastrointestinal Disorders - Development of a Protocol

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Change in Faces Pain Rating Scale (FACES) from baseline to 10 weeks [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
  • Change in Faces Pain Rating Scale (FACES) from baseline to 8 months. [ Time Frame: Baseline and 8 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Gastrointestinal Symptom Rating Scale (GSRS-IBS) from baseline to 10 weeks. [ Time Frame: Baseline and 10 weeks. ] [ Designated as safety issue: No ]
  • Change in Children´s Somatization Inventory (CSI 24) from baseline to 10 weeks [ Time Frame: Baseline and 10 weeks. ] [ Designated as safety issue: No ]
  • Change in Gastrointestinal Symptom Scale (PedsQL Gastro) from baseline to 10 weeks [ Time Frame: Baseline and 10 weeks. ] [ Designated as safety issue: No ]
  • Change in Functional Disability Index (FDI) from baseline to 10 weeks. [ Time Frame: Baseline and 10 weeks. ] [ Designated as safety issue: No ]
  • Change in Pain Reactivity Scale from baseline to 10 weeks. [ Time Frame: Baseline and 10 weeks. ] [ Designated as safety issue: No ]
  • Change in IBS-behavioral responses questionnaires (IBS-BRQ) from baseline to 10 weeks. [ Time Frame: Baseline and 10 weeks. ] [ Designated as safety issue: No ]
  • Change in Spence Children Anxiety Scale (SCAS) from baseline to 10 weeks. [ Time Frame: Baseline and 10 weeks. ] [ Designated as safety issue: No ]
  • Change in Child Depression Inventory (CDI) from baseline to 10 weeks. [ Time Frame: Baseline and 10 weeks. ] [ Designated as safety issue: No ]
  • Change in Pain Interference Index (PII) from baseline to 10 weeks. [ Time Frame: Baseline and 10 weeks. ] [ Designated as safety issue: No ]
  • Change in Pediatric Quality of Life Inventory (Peds QL) from baseline to 10 weeks. [ Time Frame: Baseline and 10 weeks. ] [ Designated as safety issue: No ]
  • Change in Gastrointestinal Symptom Rating Scale (GSRS-IBS) from baseline to 8 months. [ Time Frame: Baseline and 8 months ] [ Designated as safety issue: No ]
  • Change in Children´s Somatization Inventory (CSI 24) from baseline to 8 months [ Time Frame: Baseline and 8 months. ] [ Designated as safety issue: No ]
  • Change in Gastrointestinal Symptom Scale (PedsQL Gastro) from baseline to 8 months. [ Time Frame: Baseline and 8 months. ] [ Designated as safety issue: No ]
  • Change in Functional Disability Index (FDI) from baseline to 8 months. [ Time Frame: Baseline and 8 months. ] [ Designated as safety issue: No ]
  • Change in IBS-behavioral responses questionnaires (IBS-BRQ) from baseline to 8 months. [ Time Frame: Baseline and 8 months. ] [ Designated as safety issue: No ]
  • Change in Spence Children Anxiety Scale (SCAS) from baseline to 8 months. [ Time Frame: Baseline and 8 months. ] [ Designated as safety issue: No ]
  • Change in Child Depression Inventory (CDI) from baseline to 8 months. [ Time Frame: Baseline and 8 months. ] [ Designated as safety issue: No ]
  • Change in Pain Interference Index (PII) from baseline to 8 months. [ Time Frame: Baseline and 8 months. ] [ Designated as safety issue: No ]
  • Change in Pediatric Quality of Life Inventory (Peds QL) from baseline to 8 months. [ Time Frame: Baseline and 8 months. ] [ Designated as safety issue: No ]
  • Change in Pain Reactivity Scale from baseline to 8 months. [ Time Frame: Baseline and 8 months. ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change in Parental Behavior FGID (PB-FGID) from baseline to 10 weeks. [ Time Frame: Baseline and 10 weeks. ] [ Designated as safety issue: No ]
  • Change in Parental Behavior FGID (PB-FGID) from baseline to 8 months. [ Time Frame: Baseline and 8 months. ] [ Designated as safety issue: No ]
  • Change in Adult responses to children´s symptoms (ARCS) from baseline to 10 weeks. [ Time Frame: Baseline and 10 weeks. ] [ Designated as safety issue: No ]
  • Change in Adult responses to children´s symptoms (ARCS) from baseline to 8 months. [ Time Frame: Baseline and 8 months. ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: April 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02113605

Contacts
Contact: Ola Olén, MD, PhD ola.olen@ki.se
Contact: Brjann Ljotsson, PhD brjann.ljotsson@ki.se

Locations
Sweden
Child and Adolescent Psychiatry in Stockholm Recruiting
Stockholm, Sweden, 11330
Contact: Eva Serlachius, PhD         
Sub-Investigator: Maria Lalouni         
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Ola Olén, MD, PhD Karolinska Institutet
  More Information

No publications provided

Responsible Party: Ola Olen, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02113605     History of Changes
Other Study ID Numbers: FGID Child Pilot-0
Study First Received: April 1, 2014
Last Updated: June 9, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
Functional gastrointestinal disorders
FGID
Recurrent abdominal pain
Abdominal pain
pain-predominant functional gastrointestinal disorders
Pediatric pain

Additional relevant MeSH terms:
Abdominal Pain
Dyspepsia
Digestive System Diseases
Gastrointestinal Diseases
Irritable Bowel Syndrome
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 28, 2014