Nursing Management of Irritable Bowel Syndrome (IBS) 2008

University of Washington

Status: Completed

Conditions: Irritable Bowel Syndrome

Treatments: Behavioral: Usual Care (Control Group); Behavioral: Comprehensive Self-Management (CSM)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00907790

32722

2R01NR004142 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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92 participants in 2 patient groups

Comprehensive Self-Management (CSM)

Experimental group

Description:

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

Treatment:

Behavioral: Comprehensive Self-Management (CSM)

Usual Care (Control Group)

Other group

Description:

Includes the usual care provided by the person and their health care provider.

Treatment:

Behavioral: Usual Care (Control Group)