Nursing Management of Irritable Bowel Syndrome:Improving Outcomes - Full Text View

Sponsors and Collaborators:	University of Washington National Institute of Nursing Research (NINR)
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00167635

Purpose

The purpose of this study is 1) to determine whether a comprehensive self-management intervention is effective in a sample that includes men and women with irritable bowel syndrome, and 2) to determine whether the comprehensive self-management intervention is as effective when delivered over the telephone as compared to a face-to-face approach.

Condition	Intervention	Phase
Irritable Bowel Syndrome	Behavioral: cognitive-behavioral	Phase II Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Nursing Management of Irritable Bowel Syndrome: Improving Outcomes

Further study details as provided by University of Washington:

Primary Outcome Measures:

Gastrointestinal symptoms [ Time Frame: baseline, and 3 months, 6 months, 12 months post randomization ] [ Designated as safety issue: No ]
Psychological distress [ Time Frame: baseline, and 3 months, 6 months, 12 months post randomization ] [ Designated as safety issue: No ]
Cognitive Scale for Functional Bowel Disorders (CFBD) describes 25 cognitive beliefs related to functional bowel disorders. [ Time Frame: baseline, and 3 months, 6 months, 12 months post randomization ] [ Designated as safety issue: No ]
Health Related Quality Of Life (HRQOL) will be measures with the Disease Specific Questionnaire-IBS (IBS-DSQ), a 42-item questionnaire. [ Time Frame: baseline, and 3 months, 6 months, 12 months post randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sleep disturbance [ Time Frame: baseline, and 3 months, 6 months, 12 months post randomization ] [ Designated as safety issue: No ]
Sexual dysfunction [ Time Frame: baseline, and 3 months, 6 months, 12 months post randomization ] [ Designated as safety issue: No ]
Catecholamine and cortisol levels (urine) [ Time Frame: baseline, and 3 months, 6 months, 12 months post randomization ] [ Designated as safety issue: No ]
Stool frequency/consistency [ Time Frame: baseline, and 3 months, 6 months, 12 months post randomization ] [ Designated as safety issue: No ]
Health care utilization [ Time Frame: baseline, and 3 months, 6 months, 12 months post randomization ] [ Designated as safety issue: No ]

Enrollment:	188
Study Start Date:	January 2003
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Face-to-Face Individualized Comprehensive Self-Management (CSM-FF) Group. Participants in the individualized CSM-FF group will be scheduled for 9 weekly sessions with the nurse therapist followed by post-intervention follow-up assessment.	Behavioral: cognitive-behavioral Cognitive-behavioral over 9 weeks
2: Experimental Telephone Individualized Comprehensive Self-Management (CSM-TEL) Group. Participants in the individualized CSM-FTF group will initially have 2 face-to-face meetings with the nurse therapist, 6 sessions over the phone and the final session face-to-face at 9 weeks.	Behavioral: cognitive-behavioral Cognitive-behavioral over 9 weeks
3: No Intervention Usual Care Control Group (UC). Following randomization the participants in the control group will receive two short phone calls to maintain contact during the comparable 9-week intervention in the treatment groups.	Behavioral: cognitive-behavioral Cognitive-behavioral over 9 weeks

Detailed Description:

Randomization and Intervention Phase. Upon completing the baseline assessment phase, participants will be randomized to one of 3 treatment groups. A customized computer program will be used to do the randomization in an adaptive manner that ensures the 3 groups remain fairly balanced with respect to possible important predictors of outcomes: age, sex, predominant stool pattern (alternating, constipation-predominant or diarrhea-predominant), and severity of IBS symptoms and psychological symptoms at baseline. When each new participant is randomized, the program will adjust the probabilities of assignment to the three groups so that there is a higher probability of assignment to the group that results in the best balance.

Intervention Groups. Face-to-Face Individualized Comprehensive Self-Management (CSM-FF) Group. Participants in the individualized CSM-FF group will be scheduled for 9 weekly sessions with the nurse therapist followed by post-intervention follow-up assessment.

Telephone Individualized Comprehensive Self-Management (CSM-TEL) Group. Participants in the individualized CSM-TEL group will initially have 2 face-to-face meetings with the nurse therapist, 6 sessions over the phone and the final session face-to-face at 9 weeks.

Usual Care Control Group (UC). Following randomization the participants in the control group will no receive any contacts during the comparable 9-week intervention in the treatment groups.

Follow-up Phase. Participants in all 3 groups will be reassessed at 3-mo, 6-mo, and 12-mo post randomization. At this time the participants will complete questionnaires, a 4 week diary and collect 4 urines.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Irritable Bowel Syndrome

Exclusion Criteria:

GI pathology (organic disease)
Co-morbid pain disorders

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00167635

Locations

United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Northgate Executive 1
Seattle, Washington, United States, 98125

Sponsors and Collaborators

University of Washington

National Institute of Nursing Research (NINR)

Investigators

Principal Investigator:

Margaret M Heitkemper

University of Washington

More Information

Publications:

Heitkemper MM, Jarrett ME, Levy RL, Cain KC, Burr RL, Feld A, Barney P, Weisman P. Self-management for women with irritable bowel syndrome. Clin Gastroenterol Hepatol. 2004 Jul;2(7):585-96.

Responsible Party:	University of Washington ( Margaret Heitkember )
Study ID Numbers:	97-3895-C/E11, 2R01NR04142-5
Study First Received:	September 9, 2005
Last Updated:	March 25, 2008
ClinicalTrials.gov Identifier:	NCT00167635
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Washington:

Irritable Bowel Syndrome
Cognitive-behavioral intervention
Psychological distress
Quality of life

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Irritable Bowel Syndrome

Quality of Life
Intestinal Diseases
Colonic Diseases, Functional

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 15, 2009