AzTrials
AzTrials

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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

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
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

Other trials in United States

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.

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 groups in NCT01966341
Study groupRoleWhat they receive
Routine ManagementActive comparatorAll 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/ HypnotherapyExperimentalThe 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.

  1. 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)
  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.

  1. First posted21 Oct 2013 (estimated)
  2. Study startApr 2014
  3. Primary completionApr 2016
  4. Study completionApr 2016

Why it stopped: Recruiting or enrolling participants has halted prematurely and will not resume

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in