NCT01966341

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 21, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 21, 2019

Status Verified

May 1, 2019

Enrollment Period

2 years

First QC Date

September 19, 2013

Last Update Submit

May 17, 2019

Conditions

Irritable Bowel Syndrome (IBS)

Outcome Measures

Primary Outcomes (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.

    10 weeks

Secondary Outcomes (1)

  • Pain Beliefs Questionnaire

    10 weeks

Other Outcomes (4)

  • Pain Response Inventory (PRI)

    10 weeks

  • Pain Frequency Score / Pain Intensity Score (PFS/PIS)

    10 weeks

  • Abdominal Pain Index (API; Walker, Smith, Garber, & Van Slyke, 1997)

    10 weeks

  • +1 more other outcomes

Study Arms (2)

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.

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

Behavioral: CBT/ Hypnotherapy

Interventions

CBT/ HypnotherapyBEHAVIORAL

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

CBT/ Hypnotherapy
Routine ManagementDRUG

Treatment with use of antispasmodics,laxatives, and/or bulking agents (fiber) +/- antibiotics.

Also known as: antispasmodics,laxatives,fiber,antibiotics.
Routine Management

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

'Specially for Children, Dell Children's Medical Center of Central Texas

Austin, Texas, 78723, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

HypnosisParasympatholytics

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and ActivitiesAutonomic AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Anees Siddiqui, MD

    'Specially for Children, Dell Children's Medical Center of Central Texas

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2013

First Posted

October 21, 2013

Study Start

April 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 21, 2019

Record last verified: 2019-05

Locations

US(1)