Patient Attributes for Optimal Treatment Outcome in Irritable Bowel Syndrome. (IBS)
Recruitment status was Not yet recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | February 15, 2011 | ||||||||
| Last Updated Date | February 15, 2011 | ||||||||
| Start Date ICMJE | April 2011 | ||||||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
IBS Quality of Life Inventory(IBS QOLF) [ Time Frame: 6 months ] [ Designated as safety issue: No ] Significant improvement in IBS QOLF score in the treatment group |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
Behavioral Symptom Inventory [ Time Frame: 6 months ] [ Designated as safety issue: No ] improvement in emotional function |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Patient Attributes for Optimal Treatment Outcome in Irritable Bowel Syndrome. | ||||||||
| Official Title ICMJE | Examining Patient Attributes To Determine Optimal Treatment Outcome in Irritable Bowel Syndrome. | ||||||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Irritable Bowel Syndrome | ||||||||
| Intervention ICMJE | Behavioral: Cognitive Behavior Therapy(CBT)
Cognitive Behavior Therapy(CBT) for 6 weeks.
Other Name: Cognitive Behavior Therapy(CBT) |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||
| Estimated Completion Date | December 2011 | ||||||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01297556 | ||||||||
| Other Study ID Numbers ICMJE | MGI-IKA-IBS-2011 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Iftiker Ahmad, M.D., Michigan Gastroenterology Institute | ||||||||
| Study Sponsor ICMJE | Michigan Gastroenterology Institute | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Michigan Gastroenterology Institute | ||||||||
| Verification Date | February 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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