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Completed

NCT Number: NCT00167635

Nursing Management of Irritable Bowel Syndrome:Improving Outcomes

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Northgate Executive 1, Seattle, Washington, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Irritable Bowel Syndrome

Exclusion criteria

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

Treatment and study plan

Cognitive-behavioral

Behavioral

Cognitive-behavioral over 9 weeks

Other names: Usual care

Primary outcomes

  1. Gastrointestinal symptoms

    Time frame: baseline, and 3 months, 6 months, 12 months post randomization

  2. Psychological distress

    Time frame: baseline, and 3 months, 6 months, 12 months post randomization

  3. Cognitive Scale for Functional Bowel Disorders (CFBD) describes 25 cognitive beliefs related to functional bowel disorders.

    Time frame: baseline, and 3 months, 6 months, 12 months post randomization

  4. Health Related Quality Of Life (HRQOL) will be measures with the Disease Specific Questionnaire-IBS (IBS-DSQ), a 42-item questionnaire.

    Time frame: baseline, and 3 months, 6 months, 12 months post randomization

Secondary outcomes

  1. Sleep disturbance

    Time frame: baseline, and 3 months, 6 months, 12 months post randomization

  2. Sexual dysfunction

    Time frame: baseline, and 3 months, 6 months, 12 months post randomization

  3. Catecholamine and cortisol levels (urine)

    Time frame: baseline, and 3 months, 6 months, 12 months post randomization

  4. Stool frequency/consistency

    Time frame: baseline, and 3 months, 6 months, 12 months post randomization

  5. Health care utilization

    Time frame: baseline, and 3 months, 6 months, 12 months post randomization

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Nursing Management of Irritable Bowel Syndrome: Improving Outcomes

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Sep 14, 2005
Registry last updated
May 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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