Nursing Management of Irritable Bowel Syndrome (IBS) 2008

Study Overview
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Brief Summary
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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.

Official Title
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Nursing Management of IBS:Improving Outcomes

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Behavioral: Usual Care (Control Group)
* Behavioral: Comprehensive Self-Management (CSM)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Comprehensive Self-Management (CSM)<br>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)<br>* Comprehensive Self-Management includes 8 sessions that cover education, diet, relaxation training, and cognitive behavioral strategies as they related to symptoms of IBS<br>|
| Other: Usual Care (Control Group)<br>Includes the usual care provided by the person and their health care provider. | Behavioral: Usual Care (Control Group)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily abdominal pain |  | Baseline, three and six months post randomization | 
| IBS Quality of Life Questionnaire |  | Baseline, three and six months post randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary cortisol |  | Baseline, three and six months post randomization | 
| Interleukin-10(IL-10) and Interleukin-12(IL-12) |  | Baseline, three and six months post randomization | 
| Fecal calprotectin |  | Baseline, three and six months post randomization | 
| Intestinal permeability (urine) |  | Baseline, three and six months post randomization | 
| Brief Symptom Inventory |  | Baseline, three and six months post randomization | 
| Cognitive Scale for Functional Bowel Disorders |  | Baseline three and six months post randomization | 
| Work Productivity & Activity Impairment |  | Baseline, three and six months post rand | 
| Daily symptoms(other GI and psychological) |  | Baseline, three and six months post randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irritable Bowel Syndrome, Cognitive Therapy, Abdominal Pain, Quality of Life