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Nursing Management of Irritable Bowel Syndrome (IBS) 2008

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: NCT00907790
Recruitment Status : Completed
First Posted : May 25, 2009
Last Update Posted : May 4, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The aim of this study is test the efficacy of a comprehensive self-management therapy to decrease abdominal pain/discomfort and improve quality of life in patients with irritable bowel syndrome (IBS) compared to IBS patients receiving their usual care.

Condition or disease Intervention/treatment
Irritable Bowel Syndrome Behavioral: Usual Care (Control Group) Behavioral: Comprehensive Self-Management (CSM)

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nursing Management of IBS:Improving Outcomes
Study Start Date : March 2009
Primary Completion Date : December 2012
Study Completion Date : January 2013
Arms and Interventions

Arm Intervention/treatment
Experimental: Comprehensive Self-Management (CSM)

Comprehensive Self-Management includes 8 sessions that cover education, diet, relaxation training, and cognitive behavioral strategies as they related to symptoms of IBS

Behavioral: Comprehensive Self-Management (CSM)
Comprehensive Self-Management includes 8 sessions that cover education, diet, relaxation training, and cognitive behavioral strategies as they related to symptoms of IBS
Usual Care (Control Group)
Includes the usual care provided by the person and their health care provider.
Behavioral: Usual Care (Control Group)


Outcome Measures

Primary Outcome Measures :
  1. Daily abdominal pain [ Time Frame: Baseline, three and six months post randomization ]
  2. IBS Quality of Life Questionnaire [ Time Frame: Baseline, three and six months post randomization ]

Secondary Outcome Measures :
  1. Salivary cortisol [ Time Frame: Baseline, three and six months post randomization ]
  2. Interleukin-10(IL-10) and Interleukin-12(IL-12) [ Time Frame: Baseline, three and six months post randomization ]
  3. Fecal calprotectin [ Time Frame: Baseline, three and six months post randomization ]
  4. Intestinal permeability (urine) [ Time Frame: Baseline, three and six months post randomization ]
  5. Brief Symptom Inventory [ Time Frame: Baseline, three and six months post randomization ]
  6. Cognitive Scale for Functional Bowel Disorders [ Time Frame: Baseline three and six months post randomization ]
  7. Work Productivity & Activity Impairment [ Time Frame: Baseline, three and six months post rand ]
  8. Daily symptoms(other GI and psychological) [ Time Frame: Baseline, three and six months post randomization ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women must be: 18-70 years old, have had symptoms of Irritable Bowel Syndrome (IBS) at least 6 mo prior to their diagnosis, and have had their diagnosis for at least 6 months, and the diagnosis had to be made by a health care provider (e.g., internist, gastroenterologist, family, nurse practitioner, physician assistant).
  • In addition, the subjects must be experiencing IBS symptoms as described in the Rome-III criteria.161 That is recurrent abdominal pain or discomfort at least 3 days a mo in the last 3 mo associated with 2 or more of the following: improvement with defecation, onset associated with a change in frequency or form (appearance) of their stool.
  • Adults 50 or older must have a negative colonoscopy, sigmoidoscopy, abdominal ultrasonography, or barium enema.
  • Anyone with a "red flag" symptom (e.g., lost 10 lbs without trying, blood in stool, anemia) will be contacted for additional clarification.

Exclusion Criteria:

  • Participants will be excluded if they are taking the following medications: antibiotics, daily use of anticholinergics, tricyclic antidepressants, calcium-channel blockers
  • Have a medical history of abdominal surgery (except appendectomy, Caesarian section, tubal ligation, laparoscopic cholecystectomy, hysterectomy, or abdominal wall hernia repair)
  • Active organic GI disease, gluten intolerance (celiac disease), or chronic moderate to severe pain condition (e.g., low back pain, fibromyalgia)
  • Recent travel to regions with endemic parasitic diseases
  • Current mental health disorders (psychosis, bipolar disorder, current moderate to severe depressive episode, suicide attempt, drug or alcohol abuse or dependence within 2yrs)
  • Cardiac valvular disease, immune compromised immunologic disorders (e.g., autoimmune conditions)
  • Women who are pregnant, breast feeding, or planning to get pregnant in the next year
Contacts and Locations

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): NCT00907790


Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Maargaret M Heitkemper, PhD University of Washington
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Monica Jarrett, Professor, Co-PI, University of Washington
ClinicalTrials.gov Identifier: NCT00907790     History of Changes
Other Study ID Numbers: 32722
2R01NR004142 ( U.S. NIH Grant/Contract )
First Posted: May 25, 2009    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017

Keywords provided by Monica Jarrett, University of Washington:
Irritable Bowel Syndrome
Cognitive Therapy
Abdominal Pain
Quality of Life

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases