Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-01 @ 5:38 PM
Study NCT ID:
NCT00880256
Status:
COMPLETED
Last Update Posted:
2012-02-27
First Post:
2009-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mindfulness-Based Stress Reduction for Bowel Symptoms: Collection of Pilot Survey Data
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000099024', 'term': 'Mindfulness-Based Stress Reduction'}], 'ancestors': [{'id': 'D064866', 'term': 'Mindfulness'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.kearney@va.gov', 'phone': '206-764-2285', 'title': 'Dr. David Kearney', 'organization': 'VA Puget Sound Health Care System'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'MBSR', 'description': 'Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.', 'otherNumAtRisk': 93, 'otherNumAffected': 0, 'seriousNumAtRisk': 93, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'IBS (Irritable Bowel Syndrome) Symptom Severity Score (Total Score)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness-Based Stress Reduction (MBSR)', 'description': 'Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.'}], 'classes': [{'title': 'IBS (IBS) symptoms', 'categories': [{'measurements': [{'value': '256.9', 'spread': '90.6', 'groupId': 'OG000'}]}]}, {'title': 'Irritable Bowel Syndrome Quality of LIfe (QOL)', 'categories': [{'measurements': [{'value': '84.4', 'spread': '20.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The Irritable Bowel Severity Scoring System (IBSSS) provides a measure of the severity of IBS. The measure consists of five questions, which assess severity of abdominal pain, number of days with abdominal pain in past 10 days, severity of abdominal distension, satisfaction with bowel habits, and impact of IBS on life in general. The score on each of the 5 questions ranges from 0 to 100, and the scores are summed with a range of total possible scores from 0 to 500. Higher scores reflect more severe IBS. Total score was used in the analyses.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "We compared scores at baseline, 2-month, and 6-month time points, using t-tests. A two-sided P value of less than 0.05 was considered statistically significant. The standardized mean difference (Cohen's d effect size) from baseline to 2-months, and baseline to 6-months was calculated for each variable."}, {'type': 'SECONDARY', 'title': 'Irritable Bowel Syndrome (IBS) Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness-Based Stress Reduction (MBSR)', 'description': 'Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.'}], 'classes': [{'categories': [{'measurements': [{'value': '224.3', 'spread': '96.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The IBS-QOL is a disease specific Quality-of-Life Measure for IBS. IBS-QOL has been shown have a high level of content validity and to be responsive to change, and has been used in several outcome studies and clinical drug trials throughout the world. It consists of 34 questions that assess the influence of bowel habits on daily life. The response to each question is rated on a 5-point scale. A lower score indicates worse bowel-related quality of life. The summed total score is transformed to a 0-100 scale ranging from 0 (poor quality of life) to 100 (maximum quality of life).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed at 6 months were included'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MBSR', 'description': 'Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}]}]}], 'recruitmentDetails': 'During a 17-month period, we enrolled 93 patients who were referred or self-referred themselves to the Mindfulness-Based Stress Reduction (MBSR) program at VA Puget Sound.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MBSR', 'description': 'Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51', 'spread': '10.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '69', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-20', 'studyFirstSubmitDate': '2009-04-10', 'resultsFirstSubmitDate': '2011-11-25', 'studyFirstSubmitQcDate': '2009-04-10', 'lastUpdatePostDateStruct': {'date': '2012-02-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-01-20', 'studyFirstPostDateStruct': {'date': '2009-04-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IBS (Irritable Bowel Syndrome) Symptom Severity Score (Total Score)', 'timeFrame': '6 months', 'description': 'The Irritable Bowel Severity Scoring System (IBSSS) provides a measure of the severity of IBS. The measure consists of five questions, which assess severity of abdominal pain, number of days with abdominal pain in past 10 days, severity of abdominal distension, satisfaction with bowel habits, and impact of IBS on life in general. The score on each of the 5 questions ranges from 0 to 100, and the scores are summed with a range of total possible scores from 0 to 500. Higher scores reflect more severe IBS. Total score was used in the analyses.'}], 'secondaryOutcomes': [{'measure': 'Irritable Bowel Syndrome (IBS) Quality of Life', 'timeFrame': '6 months', 'description': 'The IBS-QOL is a disease specific Quality-of-Life Measure for IBS. IBS-QOL has been shown have a high level of content validity and to be responsive to change, and has been used in several outcome studies and clinical drug trials throughout the world. It consists of 34 questions that assess the influence of bowel habits on daily life. The response to each question is rated on a 5-point scale. A lower score indicates worse bowel-related quality of life. The summed total score is transformed to a 0-100 scale ranging from 0 (poor quality of life) to 100 (maximum quality of life).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['irritable bowel', 'mindfulness', 'stress', 'meditation'], 'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'Irritable bowel syndrome (IBS) is a very common, chronic disorder that significantly affects quality of life, and results in enormous expenditures each year in the United States. Therapy for IBS is generally unsatisfactory, and takes an additive approach whereby medications are prescribed according to each type of symptom the patient experiences. Accumulating evidence indicates that persons with IBS have a heightened perception of stress, and chronic stress has been shown to have a significant impact on IBS symptomatology. Mindfulness involves the ability to bring attention to the present moment without judgment; this ability is correlated with measures of mental health and decreased stress perception. The clinical literature suggests that mindfulness-based interventions may lead to improvement in many disorders including chronic pain, stress, anxiety, eating disorders and depressive relapse. The purpose of this study is to collect survey pilot data to determine whether an 8-week program of mindfulness-based stress reduction (MBSR) improves symptoms and quality of life for persons with IBS. Patients in the 8-week MBSR program are referred as part of their clinical care, and we seek approval only to collect survey data before and after the MBSR course. This study will evaluate whether there is sufficient evidence of efficacy to warrant a full clinical trial of MBSR.', 'detailedDescription': 'Aim 1: Apply measures of IBS symptom severity, depression and quality of life before and after the MBSR course, to assess whether there is evidence of benefit, and allow calculation of standardized effect sizes. Aim 2: Apply a validated measure of mindfulness before and after treatment. Aim 3: Explore the relationship between IBS symptoms, mindfulness score, and frequency of mindfulness practice.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patient who enroll in a MBSR course\n\nExclusion Criteria:\n\n* Psychosis, borderline personality, active substance abuse'}, 'identificationModule': {'nctId': 'NCT00880256', 'briefTitle': 'Mindfulness-Based Stress Reduction for Bowel Symptoms: Collection of Pilot Survey Data', 'organization': {'class': 'OTHER', 'fullName': 'Seattle Institute for Biomedical and Clinical Research'}, 'officialTitle': 'Mindfulness-Based Stress Reduction for Bowel Symptoms: Collection of Pilot Survey Data', 'orgStudyIdInfo': {'id': '0013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MBSR', 'description': 'Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.', 'interventionNames': ['Behavioral: mindfulness-based stress reduction']}], 'interventions': [{'name': 'mindfulness-based stress reduction', 'type': 'BEHAVIORAL', 'description': 'An 8-week course in mindfulness training', 'armGroupLabels': ['MBSR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98108', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'VA Puget Sound Health Care System', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'David Kearney, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Puget Sound Heatlh Care System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seattle Institute for Biomedical and Clinical Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Physician,', 'investigatorFullName': 'David Kearney', 'investigatorAffiliation': 'Seattle Institute for Biomedical and Clinical Research'}}}}