Clinical trial NCT01966341: Collaborative Cognitive Behavioral Therapy / Hypnotherapy for Treatment of Pediatric Functional Gastrointestinal Disease
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 Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Irritable Bowel Syndrome (IBS)
Lead sponsor: Seton Healthcare Family
Sponsor class: OTHER
First posted: 2013-10-21
Enrollment: 0
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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 psychosocial 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 generally 11-14.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Functional Disability Inventory (FDI)
timeFrame: 10 weeks
Secondary outcomes:
measure: Pain Beliefs Questionnaire
timeFrame: 10 weeks
Other outcomes:
measure: Pain Response Inventory (PRI)
timeFrame: 10 weeks
measure: Pain Frequency Score / Pain Intensity Score (PFS/PIS)
timeFrame: 10 weeks
measure: Abdominal Pain Index (API; Walker, Smith, Garber, & Van Slyke, 1997)
timeFrame: 10 weeks
measure: Children's Somatization Inventory (CSI)
timeFrame: 10 weeks
Locations:
city: Austin
country: United States
facility: 'Specially for Children, Dell Children's Medical Center of Central Texas
state: Texas
Study officials:
affiliation: 'Specially for Children, Dell Children's Medical Center of Central Texas
name: Anees Siddiqui, MD
role: PRINCIPAL_INVESTIGATOR
References: