Irritable Bowel SyndromeIBSNCT01297556
Patient Attributes for Optimal Treatment Outcome in Irritable Bowel Syndrome.
A study testing Cognitive Behavior Therapy(CBT) in people with Irritable Bowel Syndrome, run by Michigan Gastroenterology Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine if any specific patient characteristics lead to improved outcome of IBS treatment, when conventional treatment as well as Cognitive Behavioral Therapy is used in combination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Cognitive Behavior Therapy(CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Dec 2011
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All newly diagnosed IBS patients using Rome III criteria above the age of 18.
Who cannot join
- Patients with non-functional GI disorders, severe psychiatric disorders, including psychotic disorders, actively suicidal or alcoholism/other drug dependencies.
- Pregnant women and minors(under age 18) will also be excluded.
- Prisoners will also be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan Gastroenterology Institute
East Lansing, Michigan, 48823
Iftiker Ahmad, M.D., 517-332-1200 ext. 221
Iftiker Ahmad, M.D.
About this study
Official title: Examining Patient Attributes To Determine Optimal Treatment Outcome in Irritable Bowel Syndrome.
The purpose of this study is to determine if any specific patient characteristics lead to improved outcome of IBS treatment, when conventional treatment as well as Cognitive Behavioral Therapy is used in combination.
Read the detailed description
Although research has demonstrated the efficacy of various psychological and pharmacological treatments for irritable bowel syndrome (IBS)1, health professionals have limited information about how to determine which specific treatment regimens lead to optimal outcomes for specific IBS populations 2,3. A prevalent syndrome, with high healthcare costs, IBS is a debilitating chronic functional bowel disorder with increasingly interconnected psychosocial and gastrointestinal afflictions4. In general, IBS sufferers have not been found to respond consistently to a single medication or class of medications5. In the wake of the failures of medical therapies, many psychological interventions, adjunct to standard IBS treatments, have been examined1,6 such as Blanchard and Scharff's 2002 review of 12 random controlled trials that found strong evidence for the utility of hypnotherapy, cognitive behavioral therapy (CBT), and brief psychodynamic psychotherapy in helping to alleviate IBS symptoms7. Similarly, in a more recent study involving a meta-analysis of seventeen studies, with randomized trials comparing classes of psychological interventions, found that these psychological treatments also play a role in improving quality of life of IBS suffers1. Among these psychological interventions, cognitive behavioral therapy (CBT), a prescriptive therapy that specifically targets faulty thinking patterns, has been found to be quite effective in many empirical investigations. Recent evaluations of CBT interventions have found the therapy to have a direct effect on global improvements of IBS symptoms and quality of life8. Despite its demonstrated effectiveness, however, CBT does not work for all patients3,6,8. The successes of medical therapy alone compared to a treatment regimen combining psychological and pharmaceutical interventions have been greeted with mixed results- leading to the unnecessary waste of health resources in the course of treatment3,6. To decrease medical costs, as well to foster optimal treatment for IBS patients, there is a need for a better method of identifying which patients will most benefit from specific treatment options s (i.e. conventional medical treatment versus standard treatment and CBT)2,3.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Cognitive Behavior Therapy(CBT)
- Keywords
- Irritable Bowel Syndrome
- 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 Behavior Therapy(CBT)Behavioural
Cognitive Behavior Therapy(CBT) for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients in this group will receive conventional treatment for IBS, including anti-diarrhea agents, laxatives, bulking agents and anti-spasmodic. |
| Treatment | Experimental | Patients in this group will receive conventional treatment for IBS, but in addition will receive 6 weeks of CBT Receives: Behavioral: Cognitive Behavior Therapy(CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS Quality of Life Inventory(IBS QOLF)
Significant improvement in IBS QOLF score in the treatment group
Measured: 6 months
Secondary outcomes (1)
Behavioral Symptom Inventory
improvement in emotional function
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michigan Gastroenterology Institute
- Sponsor type
- University, hospital or other
- Investigators
- Iftiker Ahmad, M.D., Principal investigator, Michigan Gastroenterology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297556
- Sponsor's protocol ID
- MGI-IKA-IBS-2011
- Acronym
- IBS
- Status last verified
- Feb 2011
- First submitted
- 15 Feb 2011
- Last updated
- 16 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
1. Lackner JM, Mesmer C, Morley S, Dowzer C, Hamilton S. Psychological Lackner JM, Mesmer C, Morley S, Dowzer C, Hamilton S. Psychological Treatments for Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis. J Consult Psychol. 2004;72(6):1100-1113. 2. Spiller R, Aziz Q, Creed F, et al. Guidelines on the irritable bowel syndrome: mechanisms and practical management. Gut. 2007;56(12):1770-98. 3. Zijdenbos IL, de Wit NJ, van der Heijden GJ, Rubin G, Quartero AO. Psychological treatments for the management of irritable bowel syndrome. Cochrane Database Syst Rev. 2009;(1):CD006442. 4. Jones R, Latinovic R, Charlton J, Gulliford M. Physical and psychological co-morbidity in irritable bowel syndrome: a matched cohort study using the General Practice Research Database. Aliment Pharmachol Ther. 2006;24(5):879-886. 5.Jailwala J, Imperiale TF, Kroenke K. Pharmacologic treatment of the irritable bowel syndrome: a systematic review of randomized, controlled trials. Ann Intern Med. 2000 Jul 18;133(2):136-47. Review. PMID: 10896640 6. 6. Spanier JA, Howden CW, Jones MP. A Systematic Review of Alternative Therapies in the Irritable Bowel Syndrome. Arch Intern Med. 2003;163(3):265-674. 7.Blanchard EB, Scharf L. Psychosocial aspects of assessment and treatment of irritable bowel syndrome in adults and recurrent abdominal pain in children. J Consult Psychol. 2002;70(3):725-738. 8. Lackner JM, Jaccard J, Krasner SS, Katz LA, Gudleski GD, Blanchard EB. How does cognitive behavior therapy for irritable bowel syndrome work? A mediational analysis of a randomized clinical trial. Gastroenterology. 2007 Aug;133(2):433-44. Epub 2007 May 21. PMID: 17681164
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Patient Attributes To Determine Optimal Treatment Outcome in Irritable Bowel Syndrome.
- ClinicalTrials.gov ID
- NCT01297556
- Acronym / sponsor ID
- IBS / MGI-IKA-IBS-2011
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Michigan Gastroenterology InstituteUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 16 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if any specific patient characteristics lead to improved outcome of IBS treatment, when conventional treatment as well as Cognitive Behavioral Therapy is used in combination.
Detailed description
Although research has demonstrated the efficacy of various psychological and pharmacological treatments for irritable bowel syndrome (IBS)1, health professionals have limited information about how to determine which specific treatment regimens lead to optimal outcomes for specific IBS populations 2,3. A prevalent syndrome, with high healthcare costs, IBS is a debilitating chronic functional bowel disorder with increasingly interconnected psychosocial and gastrointestinal afflictions4. In general, IBS sufferers have not been found to respond consistently to a single medication or class of medications5. In the wake of the failures of medical therapies, many psychological interventions, adjunct to standard IBS treatments, have been examined1,6 such as Blanchard and Scharff's 2002 review of 12 random controlled trials that found strong evidence for the utility of hypnotherapy, cognitive behavioral therapy (CBT), and brief psychodynamic psychotherapy in helping to alleviate IBS symptoms7. Similarly, in a more recent study involving a meta-analysis of seventeen studies, with randomized trials comparing classes of psychological interventions, found that these psychological treatments also play a role in improving quality of life of IBS suffers1. Among these psychological interventions, cognitive behavioral therapy (CBT), a prescriptive therapy that specifically targets faulty thinking patterns, has been found to be quite effective in many empirical investigations. Recent evaluations of CBT interventions have found the therapy to have a direct effect on global improvements of IBS symptoms and quality of life8. Despite its demonstrated effectiveness, however, CBT does not work for all patients3,6,8. The successes of medical therapy alone compared to a treatment regimen combining psychological and pharmaceutical interventions have been greeted with mixed results- leading to the unnecessary waste of health resources in the course of treatment3,6. To decrease medical costs, as well to foster optimal treatment for IBS patients, there is a need for a better method of identifying which patients will most benefit from specific treatment options s (i.e. conventional medical treatment versus standard treatment and CBT)2,3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients in this group will receive conventional treatment for IBS, including anti-diarrhea agents, laxatives, bulking agents and anti-spasmodic. |
| Treatment | Experimental | Behavioral: Cognitive Behavior Therapy(CBT)Patients in this group will receive conventional treatment for IBS, but in addition will receive 6 weeks of CBT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All newly diagnosed IBS patients using Rome III criteria above the age of 18.
Key exclusion criteria (3 listed)
- Patients with non-functional GI disorders, severe psychiatric disorders, including psychotic disorders, actively suicidal or alcoholism/other drug dependencies.
- Pregnant women and minors(under age 18) will also be excluded.
- Prisoners will also be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavior Therapy(CBT)Cognitive Behavior Therapy(CBT) for 6 weeks. | Behavioural | Treatment |
Primary outcome
IBS Quality of Life Inventory(IBS QOLF)
Time frame: 6 months
Significant improvement in IBS QOLF score in the treatment group
1 secondary outcome
Behavioral Symptom Inventory
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2011.
- Background1. Lackner JM, Mesmer C, Morley S, Dowzer C, Hamilton S. Psychological Lackner JM, Mesmer C, Morley S, Dowzer C, Hamilton S. Psychological Treatments for Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis. J Consult Psychol. 2004;72(6):1100-1113. 2. Spiller R, Aziz Q, Creed F, et al. Guidelines on the irritable bowel syndrome: mechanisms and practical management. Gut. 2007;56(12):1770-98. 3. Zijdenbos IL, de Wit NJ, van der Heijden GJ, Rubin G, Quartero AO. Psychological treatments for the management of irritable bowel syndrome. Cochrane Database Syst Rev. 2009;(1):CD006442. 4. Jones R, Latinovic R, Charlton J, Gulliford M. Physical and psychological co-morbidity in irritable bowel syndrome: a matched cohort study using the General Practice Research Database. Aliment Pharmachol Ther. 2006;24(5):879-886. 5.Jailwala J, Imperiale TF, Kroenke K. Pharmacologic treatment of the irritable bowel syndrome: a systematic review of randomized, controlled trials. Ann Intern Med. 2000 Jul 18;133(2):136-47. Review. PMID: 10896640 6. 6. Spanier JA, Howden CW, Jones MP. A Systematic Review of Alternative Therapies in the Irritable Bowel Syndrome. Arch Intern Med. 2003;163(3):265-674. 7.Blanchard EB, Scharf L. Psychosocial aspects of assessment and treatment of irritable bowel syndrome in adults and recurrent abdominal pain in children. J Consult Psychol. 2002;70(3):725-738. 8. Lackner JM, Jaccard J, Krasner SS, Katz LA, Gudleski GD, Blanchard EB. How does cognitive behavior therapy for irritable bowel syndrome work? A mediational analysis of a randomized clinical trial. Gastroenterology. 2007 Aug;133(2):433-44. Epub 2007 May 21. PMID: 17681164
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iftiker Ahmad, M.D. principal investigator
Michigan Gastroenterology Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavior Therapy(CBT) in people with Irritable Bowel Syndrome, run by Michigan Gastroenterology Institute at 1 site 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 3 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: status not confirmed, as of the sponsor's last update on 16 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iftiker Ahmad, M.D. (517.332.1200 ext. 221, ahmadi@msu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBS Quality of Life Inventory(IBS QOLF) (time frame: 6 months). 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 NCT01297556, which also lists 1 linked publication.
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 16 Feb 2011.