Nursing Management of Irritable Bowel Syndrome:Improving Outcomes

Phase 2

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Behavioral: cognitive-behavioral

• Registration Number: NCT00167635
• Lead Sponsor: University of Washington

Brief Summary

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.

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.

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-14
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-21
• Last Update Posted: 2009-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

Inclusion Criteria

• Irritable Bowel Syndrome

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Exclusion Criteria

• GI pathology (organic disease)
• Co-morbid pain disorders

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	cognitive-behavioral	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.
2	cognitive-behavioral	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.
3	cognitive-behavioral	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.

Primary Outcome Measures

Name	Time	Method
Gastrointestinal symptoms	baseline, and 3 months, 6 months, 12 months post randomization
Psychological distress	baseline, and 3 months, 6 months, 12 months post randomization
Cognitive Scale for Functional Bowel Disorders (CFBD) describes 25 cognitive beliefs related to functional bowel disorders.	baseline, and 3 months, 6 months, 12 months post randomization
Health Related Quality Of Life (HRQOL) will be measures with the Disease Specific Questionnaire-IBS (IBS-DSQ), a 42-item questionnaire.	baseline, and 3 months, 6 months, 12 months post randomization

Secondary Outcome Measures

Name	Time	Method
Sleep disturbance	baseline, and 3 months, 6 months, 12 months post randomization
Sexual dysfunction	baseline, and 3 months, 6 months, 12 months post randomization
Catecholamine and cortisol levels (urine)	baseline, and 3 months, 6 months, 12 months post randomization
Stool frequency/consistency	baseline, and 3 months, 6 months, 12 months post randomization
Health care utilization	baseline, and 3 months, 6 months, 12 months post randomization

Trial Locations

Locations (2)

University of Washington; 🇺🇸 Seattle, Washington, United States

Northgate Executive 1; 🇺🇸 Seattle, Washington, United States