Irritable Bowel Syndrome
Conditions
Keywords
Irritable Bowel Syndrome, Cognitive-behavioral intervention, Psychological distress, Quality of life
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.
Interventions
BEHAVIORALcognitive-behavioral
Cognitive-behavioral over 9 weeks
Sponsors
National Institute of Nursing Research (NINR)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Irritable Bowel Syndrome
Exclusion criteria
* GI pathology (organic disease) * Co-morbid pain disorders
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Sleep disturbance | baseline, and 3 months, 6 months, 12 months post randomization |
| Health care utilization | 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 |
Countries
United States
Outcome results
None listed