Nursing Management of Irritable Bowel Syndrome (IBS) 2008
This study has been completed.
Sponsor:
University of Washington
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
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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 -------------------------------------------------------------------------------- |
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
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 Colonic Diseases, Functional Colonic Diseases |
Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013