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



Status:Completed
Conditions:Irritable Bowel Syndrome (IBS), Gastrointestinal, Digestive Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:8 - 18
Updated:4/2/2016
Start Date:April 2014
End Date:November 2015
Contact:Anees Siddiqui, MD
Phone:(512) 628-1800

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

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.

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 hypnotherapy to standard medical therapy in 53
children with irritable bowel syndrome. They found that, while both interventions resulted
in improved pain scores, the hypnotherapy group demonstrated lasting clinical improvement at
1 year followup 9. Five year follow-up data has recently been published and revealed that
significantly more of the hypnotherapy group remained in remission without any further
intervention 10. A growing body of literature is available validating the use of
hypnotherapy in irritable bowel syndrome in adults, and pain syndromes more generally11-14.

These therapies can be viewed as complementary to one another. CBT involves a very
deliberate conscious understanding of ones disease process and triggers and focuses on
successful pain mitigation measures. HT recruits the imagination with utilization of
therapeutic imagery to down regulate inappropriate pain responses. Our center has developed
a collaborative approach, utilizing both CBT and HT for the treatment of refractory IBS. To
our knowledge no work has been done assessing the efficacy of such a collaborative approach
using both CBT and HT in children with functional gastrointestinal disease. We therefore
propose the following randomized case-control crossover trial to assess the efficacy our
combined program.

Inclusion Criteria:

- Age 8 - 18

- Meets Rome III Criteria for Pediatric Irritable Bowel Syndrome

- Abdominal discomfort or pain associated with 2 or more of the following at least
25% of the time

- Improved with defecation

- Onset associated with a change in frequency of stool

- Onset associated with a change in form of the stool

- No evidence of inflammatory, anatomic, metabolic, or neoplastic process that
explains the subject's symptoms

- Criteria fulfilled once per week for at least 2 months before diagnosis

Exclusion Criteria: Unwillingness / Inability to engage in cognitive behavioral therapy
arm of study (weekly encounters with psychologist)
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