Irritable Bowel Syndrome (IBS)CAPPNCT01966341
Collaborative Cognitive Behavioral Therapy / Hypnotherapy for Treatment of Pediatric Functional Gastrointestinal Disease
A study testing CBT/ Hypnotherapy and Routine Management in people with Irritable Bowel Syndrome (IBS), run by Seton Healthcare Family at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Irritable Bowel Syndrome (IBS)
- What is being tested?
- CBT/ Hypnotherapy and Routine Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
'Specially for Children, Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
About this study
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
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.
Read the 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.
- Conditions
- Irritable Bowel Syndrome (IBS)
- Being tested
- CBT/ Hypnotherapy, Routine Management
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT/ HypnotherapyBehavioural
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
Routine ManagementDrug
Also called antispasmodics,laxatives,fiber,antibiotics.
Treatment with use of antispasmodics,laxatives, and/or bulking agents (fiber) +/- antibiotics.
| Study group | Role | What they receive |
|---|---|---|
| Routine Management | Active comparator | 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. Receives: Drug: Routine Management |
| CBT/ Hypnotherapy | Experimental | 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 Receives: Behavioral: CBT/ Hypnotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Disability Inventory (FDI)
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.
Measured: 10 weeks
Secondary outcomes (1)
Pain Beliefs Questionnaire
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).
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2013 (estimated)
- Study startApr 2014
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: Recruiting or enrolling participants has halted prematurely and will not resume
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome (IBS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seton Healthcare Family
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anees Siddiqui, MD, Principal investigator, 'Specially for Children, Dell Children's Medical Center of Central Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01966341
- Sponsor's protocol ID
- CR-13-108
- Acronym
- CAPP
- Status last verified
- May 2019
- First submitted
- 19 Sep 2013
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01966341
- Acronym / sponsor ID
- CAPP / CR-13-108
- Conditions
- Irritable Bowel Syndrome (IBS)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruiting or enrolling participants has halted prematurely and will not resume
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seton Healthcare FamilyUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 21 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Management | Active comparator | Drug: Routine ManagementAll 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. |
| CBT/ Hypnotherapy | Experimental | Behavioral: CBT/ HypnotherapyThe 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 |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Age 8 - 18
- Meets Rome III Criteria for Pediatric Irritable Bowel Syndrome
- Exclusion Criteria: Unwillingness / Inability to engage in cognitive behavioral therapy arm of study (weekly encounters with psychologist)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT/ HypnotherapyThe 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 | Behavioural | CBT/ Hypnotherapy |
| Routine ManagementAlso: antispasmodics,laxatives,fiber,antibiotics.Treatment with use of antispasmodics,laxatives, and/or bulking agents (fiber) +/- antibiotics. | Drug | Routine Management |
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.
1 secondary outcome
Pain Beliefs Questionnaire
Time frame: 10 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anees Siddiqui, MD principal investigator
'Specially for Children, Dell Children's Medical Center of Central Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT/ Hypnotherapy and Routine Management in people with Irritable Bowel Syndrome (IBS), run by Seton Healthcare Family at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Disability Inventory (FDI) (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2019.