Cognitive-behavioral
BehavioralCognitive-behavioral over 9 weeks
Other names: Usual care
NCT Number: NCT00167635
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.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 2 / Phase 3
Northgate Executive 1, Seattle, Washington, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cognitive-behavioral over 9 weeks
Other names: Usual care
Time frame: baseline, and 3 months, 6 months, 12 months post randomization
Time frame: baseline, and 3 months, 6 months, 12 months post randomization
Time frame: baseline, and 3 months, 6 months, 12 months post randomization
Time frame: baseline, and 3 months, 6 months, 12 months post randomization
Time frame: baseline, and 3 months, 6 months, 12 months post randomization
Time frame: baseline, and 3 months, 6 months, 12 months post randomization
Time frame: baseline, and 3 months, 6 months, 12 months post randomization
Time frame: baseline, and 3 months, 6 months, 12 months post randomization
Time frame: baseline, and 3 months, 6 months, 12 months post randomization
University of Washington
Other
Nursing Management of Irritable Bowel Syndrome: Improving Outcomes
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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