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Irritable Bowel SyndromePhase 2/3NCT00167635

Nursing Management of Irritable Bowel Syndrome:Improving Outcomes

A Phase 2/3 study testing cognitive-behavioral in people with Irritable Bowel Syndrome, run by University of Washington at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Irritable Bowel Syndrome
What is being tested?
cognitive-behavioral
Could I receive a placebo?
No, everyone receives an active treatment
How many people
188 participants
Where
2 sitesUnited States
Study dates
Jan 2003to Feb 2008
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Irritable Bowel Syndrome

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Northgate Executive 1

    Seattle, Washington, 98125

  • University of Washington

    Seattle, Washington, 98195

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
cognitive-behavioral
Keywords
Irritable Bowel Syndrome, Cognitive-behavioral intervention, Psychological distress, Quality of life
Medical subject headings
Irritable Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cognitive-behavioralBehavioural

    Also called Usual care

    Cognitive-behavioral over 9 weeks

Study groups in NCT00167635
Study groupRoleWhat they receive
1ExperimentalFace-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.
Receives: Behavioral: cognitive-behavioral
2ExperimentalTelephone Individualized Comprehensive Self-Management (CSM-TEL) Group. Participants in the individualized CSM-FTF 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.
Receives: Behavioral: cognitive-behavioral
3No interventionUsual Care Control Group (UC). Following randomization the participants in the control group will receive two short phone calls to maintain contact during the comparable 9-week intervention in the treatment groups.
Receives: Behavioral: cognitive-behavioral

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gastrointestinal symptoms

    Measured: baseline, and 3 months, 6 months, 12 months post randomization

  2. Psychological distress

    Measured: 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.

    Measured: 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.

    Measured: baseline, and 3 months, 6 months, 12 months post randomization

Secondary outcomes (5)

  1. Sleep disturbance

    Measured: baseline, and 3 months, 6 months, 12 months post randomization

  2. Sexual dysfunction

    Measured: baseline, and 3 months, 6 months, 12 months post randomization

  3. Catecholamine and cortisol levels (urine)

    Measured: baseline, and 3 months, 6 months, 12 months post randomization

  4. Stool frequency/consistency

    Measured: baseline, and 3 months, 6 months, 12 months post randomization

  5. Health care utilization

    Measured: baseline, and 3 months, 6 months, 12 months post randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2005 (estimated)
  2. Study startJan 2003
  3. Primary completionFeb 2008
  4. Study completionFeb 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00167635
Sponsor's protocol ID
12707-C
Other IDs
2R01NR04142-5, 97-3895-C 11, 2R01NR004142
Status last verified
May 2009
First submitted
9 Sep 2005
Last updated
25 May 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 15224283

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing cognitive-behavioral in people with Irritable Bowel Syndrome, run by University of Washington at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gastrointestinal symptoms (time frame: baseline, and 3 months, 6 months, 12 months post randomization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00167635, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2009.

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