Clinical Trial: Collaborative Cognitive Behavioral Therapy / Hypnotherapy for Treatment of Pediatric Functional Gastrointestinal Disease

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Randomized Controlled Trial Comparing a Collaborative Cognitive Behavioral Therapy / Hypnotherapy Program to Standard Medical Management in the Treatment of Pediatric Functional Gastrointestinal Dis

Brief Summary: This program has been created to help patients with irritable bowel syndrome manage their symptoms and increase their functioning by using cognitive therapy skills and hypnosis.

Detailed Summary:

Functional Gastrointestinal Diseases (FGID) are a family disorders that are characterized by gastrointestinal symptoms in the absence of readily identifiable organic pathology. Examples of FGID include irritable bowel syndrome, rumination syndrome, and function constipation. These disorders are classically thought to stem from dysfunction of the enteric nervous system. However, there is a growing recognition that multiple factors play a role in the genesis of FGIDs. This idea is encapsulated by the "biopsychosocial" model of disease, and is supported by a body of literature which has identified higher rates of FGID in patients with anxiety, depression, post-traumatic stress disorder, agoraphobia, and other pychosocial dysfunction.

Recurrent Abdominal Pain and Irritable Bowel Syndrome are major causes of pediatric morbidity. Over a third of children and adolescents report recurrent abdominal pain, and the overall prevalence of non-organic abdominal pain has been noted to be over 75% 1 2. A large subset of these children report symptoms that are consistent with irritable bowel syndrome. Management of these children is complex and includes medical, dietary, and behavioral interventions. Medical therapy often revolves around the use of antispasmodics, probiotics, and antidepressants. The data supporting their use, however has been mixed.

Over the last twenty years behavioral therapies such as cognitive behavioral therapy (CBT) and hypnotherapy (HT) have come to light as major treatment modalities for functional gastrointestinal disease. In a large multicenter randomized controlled trial Levy et al compared 3-session CBT to a control intervention and noted significant improvements and pain and function in children 3. Similar results have been published in multiple smaller trials 4-8. Likewise, Vlieger et al compared h
Sponsor: Seton Healthcare Family

Current Primary Outcome: Functional Disability Inventory (FDI) [ Time Frame: 10 weeks ]

The FDI is a measure of the degree to which children experience difficulty in physical and psychosocial functioning due to their physical health status. Respondents are asked to rate how much physical difficulty was perceived for a variety of everyday activities. Both child-report and parent-report versions are composed of 15 questions.


Original Primary Outcome: Same as current

Current Secondary Outcome: Pain Beliefs Questionnaire [ Time Frame: 10 weeks ]

The Pain Beliefs Questionnaire is a 32-item measure assessing characteristic appraisals of pediatric abdominal pain severity (primary coping appraisals) and characteristic appraisals of ability to cope with pediatric abdominal pain (secondary coping appraisals).


Original Secondary Outcome: Same as current

Information By: Seton Healthcare Family

Dates:
Date Received: September 19, 2013
Date Started: April 2014
Date Completion: November 2015
Last Updated: May 14, 2014
Last Verified: May 2014