Clinical trial NCT00167635: Nursing Management of Irritable Bowel Syndrome:Improving Outcomes
Official title: Nursing Management of Irritable Bowel Syndrome: Improving Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome
Cognitive-behavioral intervention
Psychological distress
Quality of life
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2005-09-14
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Irritable Bowel Syndrome

Exclusion Criteria:

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

Primary outcomes:
measure: Gastrointestinal symptoms
timeFrame: baseline, and 3 months, 6 months, 12 months post randomization
measure: Psychological distress
timeFrame: baseline, and 3 months, 6 months, 12 months post randomization
measure: Cognitive Scale for Functional Bowel Disorders (CFBD) describes 25 cognitive beliefs related to functional bowel disorders.
timeFrame: baseline, and 3 months, 6 months, 12 months post randomization
measure: Health Related Quality Of Life (HRQOL) will be measures with the Disease Specific Questionnaire-IBS (IBS-DSQ), a 42-item questionnaire.
timeFrame: baseline, and 3 months, 6 months, 12 months post randomization
Secondary outcomes:
measure: Sleep disturbance
timeFrame: baseline, and 3 months, 6 months, 12 months post randomization
measure: Sexual dysfunction
timeFrame: baseline, and 3 months, 6 months, 12 months post randomization
measure: Catecholamine and cortisol levels (urine)
timeFrame: baseline, and 3 months, 6 months, 12 months post randomization
measure: Stool frequency/consistency
timeFrame: baseline, and 3 months, 6 months, 12 months post randomization
measure: Health care utilization
timeFrame: baseline, and 3 months, 6 months, 12 months post randomization
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Northgate Executive 1
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Margaret M Heitkemper
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/s1542-3565(04)00242-3.
citation: Yang PL, Burr RL, Buchanan DT, Pike KC, Kamp KJ, Heitkemper MM. Indirect effect of sleep on abdominal pain through daytime dysfunction in adults with irritable bowel syndrome. J Clin Sleep Med. 2020 Oct 15;16(10):1701-1710. doi: 10.5664/jcsm.8658.
citation: Kamp KJ, Weaver KR, Sherwin LB, Barney P, Hwang SK, Yang PL, Burr RL, Cain KC, Heitkemper MM. Effects of a comprehensive self-management intervention on extraintestinal symptoms among patients with IBS. J Psychosom Res. 2019 Nov;126:109821. doi: 10.1016/j.jpsychores.2019.109821. Epub 2019 Aug 29.
citation: Han CJ, Kohen R, Jun S, Jarrett ME, Cain KC, Burr R, Heitkemper MM. COMT Val158Met Polymorphism and Symptom Improvement Following a Cognitively Focused Intervention for Irritable Bowel Syndrome. Nurs Res. 2017 Mar/Apr;66(2):75-84. doi: 10.1097/NNR.0000000000000199.