Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01966341
Recruitment Status : Withdrawn (Recruiting or enrolling participants has halted prematurely and will not resume)
First Posted : October 21, 2013
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Seton Healthcare Family

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome (IBS) Behavioral: CBT/ Hypnotherapy Drug: Routine Management Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Routine Management
All patients will be given a prescription for the use of antispasmodics. If patients demonstrate symptoms consistent with constipation predominant IBS they will be treated with laxatives. If symptoms are more consistent with diarrhea predominant IBS they will be treated with bulking agents (fiber) +/- antibiotics. Patient will be called every week while enrolled in the study in order to titrate doses, and answer questions.
Drug: Routine Management
Treatment with use of antispasmodics,laxatives, and/or bulking agents (fiber) +/- antibiotics.
Other Name: antispasmodics,laxatives,fiber,antibiotics.

Experimental: CBT/ Hypnotherapy
The CBT (cognitive behavior therapy) program will consist of 7 sessions that will encompass the following skills of Symptom monitoring, Stress Management, Coping Skills, Relaxation training, Problem solving, and Cognitive Restructuring.The hypnotherapy program will be modeled after the North Carolina Standardized Hypnosis Treatment for Irritable Bowel Syndrome
Behavioral: CBT/ Hypnotherapy
The CBT program will consist of 7 sessions that will encompass the following skills of Symptom monitoring, Stress Management, Coping Skills, Relaxation training, Problem solving, and Cognitive Restructuring.The hypnotherapy program will be modeled after the North Carolina Standardized Hypnosis Treatment for Irritable Bowel Syndrome




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).


Other Outcome Measures:
  1. Pain Response Inventory (PRI) [ Time Frame: 10 weeks ]
    The Pain Response Inventory (PRI) was developed as a multidimensional instrument to assess children's coping responses to recurrent pain

  2. Pain Frequency Score / Pain Intensity Score (PFS/PIS) [ Time Frame: 10 weeks ]
    Our primary outcome measure will be the PFS/PIS. It involves an aggregate score of pain intensity and frequency

  3. Abdominal Pain Index (API; Walker, Smith, Garber, & Van Slyke, 1997) [ Time Frame: 10 weeks ]
    Abdominal Pain Index comprises five items assessing the frequency, duration, and intensity of abdominal pain episodes experienced during the previous 2 weeks

  4. Children's Somatization Inventory (CSI) [ Time Frame: 10 weeks ]
    The CSI assesses a variety of nonspecific somatic symptoms



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966341


Locations
Layout table for location information
United States, Texas
'Specially for Children, Dell Children's Medical Center of Central Texas
Austin, Texas, United States, 78723
Sponsors and Collaborators
Seton Healthcare Family
Investigators
Layout table for investigator information
Principal Investigator: Anees Siddiqui, MD 'Specially for Children, Dell Children's Medical Center of Central Texas

Layout table for additonal information
Responsible Party: Seton Healthcare Family
ClinicalTrials.gov Identifier: NCT01966341     History of Changes
Other Study ID Numbers: CR-13-108
First Posted: October 21, 2013    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Irritable Bowel Syndrome
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Laxatives
Cathartics
Parasympatholytics
Anti-Infective Agents
Antitubercular Agents
Gastrointestinal Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs