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Nursing Management of Irritable Bowel Syndrome (IBS) 2008

Primary Purpose

Irritable Bowel Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Usual Care (Control Group)

Comprehensive Self-Management (CSM)

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, Cognitive Therapy, Abdominal Pain, Quality of Life

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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

Sites / Locations

University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Comprehensive Self-Management (CSM)

Usual Care (Control Group)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Daily abdominal pain

IBS Quality of Life Questionnaire

Secondary Outcome Measures

Salivary cortisol

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

Fecal calprotectin

Intestinal permeability (urine)

Brief Symptom Inventory

Cognitive Scale for Functional Bowel Disorders

Work Productivity & Activity Impairment

Daily symptoms(other GI and psychological)

Full Information

NCT ID

NCT00907790

First Posted

May 21, 2009

Last Updated

May 1, 2017

Sponsor

University of Washington

Collaborators

National Institute of Nursing Research (NINR)

1. Study Identification

Unique Protocol Identification Number

NCT00907790

Brief Title

Nursing Management of Irritable Bowel Syndrome (IBS) 2008

Official Title

Nursing Management of IBS:Improving Outcomes

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Washington

Collaborators

National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome, Cognitive Therapy, Abdominal Pain, Quality of Life

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

92 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Comprehensive Self-Management (CSM)

Arm Type

Experimental

Arm Description

Arm Title

Usual Care (Control Group)

Arm Type

Other

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Usual Care (Control Group)

Intervention Type

Behavioral

Intervention Name(s)

Comprehensive Self-Management (CSM)

Intervention Description

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

Primary Outcome Measure Information:

Title

Daily abdominal pain

Time Frame

Baseline, three and six months post randomization

Title

IBS Quality of Life Questionnaire

Time Frame

Baseline, three and six months post randomization

Secondary Outcome Measure Information:

Title

Salivary cortisol

Time Frame

Baseline, three and six months post randomization

Title

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

Time Frame

Baseline, three and six months post randomization

Title

Fecal calprotectin

Time Frame

Baseline, three and six months post randomization

Title

Intestinal permeability (urine)

Time Frame

Baseline, three and six months post randomization

Title

Brief Symptom Inventory

Time Frame

Baseline, three and six months post randomization

Title

Cognitive Scale for Functional Bowel Disorders

Time Frame

Baseline three and six months post randomization

Title

Work Productivity & Activity Impairment

Time Frame

Baseline, three and six months post rand

Title

Daily symptoms(other GI and psychological)

Time Frame

Baseline, three and six months post randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maargaret M Heitkemper, PhD

Organizational Affiliation

University of Washington

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Washington

City

Seattle

State/Province

Washington

ZIP/Postal Code

98195

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

32620184

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.

Results Reference

derived

PubMed Identifier

31499231

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.

Results Reference

derived

PubMed Identifier

28252569

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.

Results Reference

derived

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Nursing Management of Irritable Bowel Syndrome (IBS) 2008

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