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CompletedNCT00907790Updated May 4, 2017

Nursing Management of Irritable Bowel Syndrome (IBS) 2008

An interventional study of Usual Care (Control Group) and Comprehensive Self-Management (CSM) in Irritable Bowel Syndrome, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-05-04.

Sponsored by University of Washington · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The aim of this study is test the efficacy of a comprehensive self-management therapy to decrease abdominal pain/discomfort and improve quality of life in patients with irritable bowel syndrome (IBS) compared to IBS patients receiving their usual care.

02

Conditions studied

  • Irritable Bowel Syndrome

Keywords

  • Irritable Bowel Syndrome
  • Cognitive Therapy
  • Abdominal Pain
  • Quality of Life
03

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's enrollment of 92 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Men and women must be: 18-70 years old, have had symptoms of Irritable Bowel Syndrome (IBS) at least 6 mo prior to their diagnosis, and have had their diagnosis for at least 6 months, and the diagnosis had to be made by a health care provider (e.g., internist, gastroenterologist, family, nurse practitioner, physician assistant).
  • In addition, the subjects must be experiencing IBS symptoms as described in the Rome-III criteria.161 That is recurrent abdominal pain or discomfort at least 3 days a mo in the last 3 mo associated with 2 or more of the following: improvement with defecation, onset associated with a change in frequency or form (appearance) of their stool.
  • Adults 50 or older must have a negative colonoscopy, sigmoidoscopy, abdominal ultrasonography, or barium enema.
  • Anyone with a "red flag" symptom (e.g., lost 10 lbs without trying, blood in stool, anemia) will be contacted for additional clarification.

Exclusion criteria

Exclusion Criteria:

  • Participants will be excluded if they are taking the following medications: antibiotics, daily use of anticholinergics, tricyclic antidepressants, calcium-channel blockers
  • Have a medical history of abdominal surgery (except appendectomy, Caesarian section, tubal ligation, laparoscopic cholecystectomy, hysterectomy, or abdominal wall hernia repair)
  • Active organic GI disease, gluten intolerance (celiac disease), or chronic moderate to severe pain condition (e.g., low back pain, fibromyalgia)
  • Recent travel to regions with endemic parasitic diseases
  • Current mental health disorders (psychosis, bipolar disorder, current moderate to severe depressive episode, suicide attempt, drug or alcohol abuse or dependence within 2yrs)
  • Cardiac valvular disease, immune compromised immunologic disorders (e.g., autoimmune conditions)
  • Women who are pregnant, breast feeding, or planning to get pregnant in the next year
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
92 participants (actual)

Study arms

  • Experimental
    Comprehensive Self-Management (CSM)

    Comprehensive Self-Management includes 8 sessions that cover education, diet, relaxation training, and cognitive behavioral strategies as they related to symptoms of IBS --------------------------------------------------------------------------------

    Behavioral: Comprehensive Self-Management (CSM)

  • Other
    Usual Care (Control Group)

    Includes the usual care provided by the person and their health care provider.

    Behavioral: Usual Care (Control Group)

Interventions

  • BehavioralUsual Care (Control Group)
  • BehavioralComprehensive Self-Management (CSM)

    Comprehensive Self-Management includes 8 sessions that cover education, diet, relaxation training, and cognitive behavioral strategies as they related to symptoms of IBS

06

What researchers measure

Primary outcomes

  1. Daily abdominal pain

    Time frame: Baseline, three and six months post randomization

  2. IBS Quality of Life Questionnaire

    Time frame: Baseline, three and six months post randomization

Secondary outcomes

  1. Salivary cortisol

    Time frame: Baseline, three and six months post randomization

  2. Interleukin-10(IL-10) and Interleukin-12(IL-12)

    Time frame: Baseline, three and six months post randomization

  3. Fecal calprotectin

    Time frame: Baseline, three and six months post randomization

  4. Intestinal permeability (urine)

    Time frame: Baseline, three and six months post randomization

  5. Brief Symptom Inventory

    Time frame: Baseline, three and six months post randomization

  6. Cognitive Scale for Functional Bowel Disorders

    Time frame: Baseline three and six months post randomization

  7. Work Productivity & Activity Impairment

    Time frame: Baseline, three and six months post rand

  8. Daily symptoms(other GI and psychological)

    Time frame: Baseline, three and six months post randomization

07

Study locations

1 site
  • University of Washington
    Seattle, Washington 98195, United States
08

References and documents

Publications

  • 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. PubMed 32620184 ↗
  • 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. PubMed 31499231 ↗
  • 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. PubMed 28252569 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00907790
Lead sponsor
University of Washington
Collaborators
National Institute of Nursing Research (NINR)
Responsible party
Monica Jarrett (Professor, Co-PI, University of Washington) — Principal investigator
First posted
May 25, 2009
Start date
Mar 2009
Primary completion
Dec 2012
Completion
Jan 2013
Last update
May 4, 2017

Study contacts

Maargaret M Heitkemper, PhD
principal investigator · University of Washington

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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