Nursing Management of Irritable Bowel Syndrome:Improving Outcomes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Nursing Management of Irritable Bowel Syndrome: Improving Outcomes

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Behavioral: cognitive-behavioral


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Irritable Bowel Syndrome Exclusion Criteria: GI pathology (organic disease) Co-morbid pain disorders

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* Cognitive-behavioral over 9 weeks<br>* Other names: Usual care;|
| Experimental: 2<br>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<br>* Cognitive-behavioral over 9 weeks<br>* Other names: Usual care;|
| No Intervention: 3<br>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<br>* Cognitive-behavioral over 9 weeks<br>* Other names: Usual care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irritable Bowel Syndrome, Cognitive-behavioral intervention, Psychological distress, Quality of life