Nursing Management of Irritable Bowel Syndrome (IBS) 2008

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Monica Jarrett, University of Washington
ClinicalTrials.gov Identifier:
NCT00907790
First received: May 21, 2009
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Irritable Bowel Syndrome
Behavioral: Usual Care (Control Group)
Behavioral: Comprehensive Self-Management (CSM)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nursing Management of IBS:Improving Outcomes

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Daily abdominal pain [ Time Frame: Baseline, three and six months post randomization ] [ Designated as safety issue: No ]
  • IBS Quality of Life Questionnaire [ Time Frame: Baseline, three and six months post randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Salivary cortisol [ Time Frame: Baseline, three and six months post randomization ] [ Designated as safety issue: No ]
  • Interleukin-10(IL-10) and Interleukin-12(IL-12) [ Time Frame: Baseline, three and six months post randomization ] [ Designated as safety issue: No ]
  • Fecal calprotectin [ Time Frame: Baseline, three and six months post randomization ] [ Designated as safety issue: No ]
  • Intestinal permeability (urine) [ Time Frame: Baseline, three and six months post randomization ] [ Designated as safety issue: No ]
  • Brief Symptom Inventory [ Time Frame: Baseline, three and six months post randomization ] [ Designated as safety issue: No ]
  • Cognitive Scale for Functional Bowel Disorders [ Time Frame: Baseline three and six months post randomization ] [ Designated as safety issue: No ]
  • Work Productivity & Activity Impairment [ Time Frame: Baseline, three and six months post rand ] [ Designated as safety issue: No ]
  • Daily symptoms(other GI and psychological) [ Time Frame: Baseline, three and six months post randomization ] [ Designated as safety issue: No ]

Enrollment: 92
Study Start Date: March 2009
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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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)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00907790

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Maargaret M Heitkemper, PhD University of Washington
  More Information

No publications provided

Responsible Party: Monica Jarrett, Professor, Co-PI, University of Washington
ClinicalTrials.gov Identifier: NCT00907790     History of Changes
Other Study ID Numbers: 32722, 2R01NR004142
Study First Received: May 21, 2009
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014