NCT00907790

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 25, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

3.8 years

First QC Date

May 21, 2009

Last Update Submit

May 1, 2017

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel SyndromeCognitive TherapyAbdominal PainQuality of Life

Outcome Measures

Primary Outcomes (2)

  • Daily abdominal pain

    Baseline, three and six months post randomization

  • IBS Quality of Life Questionnaire

    Baseline, three and six months post randomization

Secondary Outcomes (8)

  • Salivary cortisol

    Baseline, three and six months post randomization

  • Interleukin-10(IL-10) and Interleukin-12(IL-12)

    Baseline, three and six months post randomization

  • Fecal calprotectin

    Baseline, three and six months post randomization

  • Intestinal permeability (urine)

    Baseline, three and six months post randomization

  • Brief Symptom Inventory

    Baseline, three and six months post randomization

  • +3 more secondary outcomes

Study Arms (2)

Comprehensive Self-Management (CSM)

EXPERIMENTAL

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)

Usual Care (Control Group)

OTHER

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

Behavioral: Usual Care (Control Group)

Interventions

Usual Care (Control Group)BEHAVIORAL
Usual Care (Control Group)
Comprehensive Self-Management (CSM)BEHAVIORAL

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

Comprehensive Self-Management (CSM)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (3)

  • 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.

    PMID: 32620184DERIVED

  • 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.

    PMID: 31499231DERIVED

  • 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.

    PMID: 28252569DERIVED

MeSH Terms

Conditions

Irritable Bowel SyndromeAbdominal Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Maargaret M Heitkemper, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Co-PI

Study Record Dates

First Submitted

May 21, 2009

First Posted

May 25, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

May 4, 2017

Record last verified: 2017-05

Locations

US(1)