Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT01886027
Status:
COMPLETED
Last Update Posted:
2015-05-06
First Post:
2013-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stress Management for Irritable Bowel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D012064', 'term': 'Relaxation Therapy'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-05', 'studyFirstSubmitDate': '2013-06-13', 'studyFirstSubmitQcDate': '2013-06-20', 'lastUpdatePostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IBS symptom severity scale (IBS-SSS)', 'timeFrame': 'Change from baseline symptom severity at 1 month and 3 months'}], 'secondaryOutcomes': [{'measure': 'McGill Pain Questionnaire, Short Form (SF-MPQ-2)', 'timeFrame': 'Change from baseline pain at 1 month and 3 months'}, {'measure': 'Bristol Stool Form Scale (BSFS)', 'timeFrame': 'Change from baseline stool form at 1 month and 3 months'}, {'measure': 'Irritable Bowel Syndrome, Quality of Life (IBS-QOL)', 'timeFrame': 'Change from baseline quality of life at 1 month and 3 months'}, {'measure': 'Positive and Negative Affect Scale (PANAS)', 'timeFrame': 'Change from baseline positive affect and negative affect at 1 month and 3 months'}, {'measure': 'Impact of Events Scale - Revised (IES-R)', 'timeFrame': 'Change from baseline impact of events at 1 month and 3 months'}, {'measure': 'Toronto Alexithymia Scale -20 (TAS-20)', 'timeFrame': 'Change from baseline alexithymia at 1 month and 3 months'}, {'measure': 'Rathus Assertiveness Schedule (RAS)', 'timeFrame': 'Change from baseline assertiveness at 1 month and 3 months'}, {'measure': 'Ambivalence over Emotional Expression Scale (AEQ)', 'timeFrame': 'Change from baseline ambivalence over emotional expression at 1 month and 3 months'}, {'measure': 'Emotional Approach Coping Scale (EAC)', 'timeFrame': 'Change from baseline emotional approach coping at 1 month and 3 months'}, {'measure': 'IBS self-efficacy questionnaire', 'timeFrame': 'Change from baseline self-efficacy at 1 month and 3 months'}, {'measure': 'Communicating Thoughts and Feelings Questionnaire', 'timeFrame': 'Change from baseline ability to communicate thoughts and feelings at 1 month and 3 months'}, {'measure': 'Clinical Global Impressions (CGI) Improvement Scale - IBS version', 'timeFrame': 'Change from baseline IBS symptoms at 1 month and 3 months'}, {'measure': 'Health care Utilization Scale', 'timeFrame': 'Change in health care utilization from baseline to 1-month and 3-month follow-ups'}, {'measure': 'Brief Symptom Inventory', 'timeFrame': 'Change in psychological symptoms from baseline to 1-month and 3-month follow-ups'}, {'measure': 'Early Trauma Inventory Self-Report Short Form', 'timeFrame': 'Change in Trauma reports from baseline to 1-month and 3-month follow-ups'}, {'measure': 'Experiences in Close Relationships Questionnaire', 'timeFrame': 'Change in attachment from baseline to 1-month and3-month follow-ups'}, {'measure': 'General Social Constraints Scale', 'timeFrame': 'Change in social constraints from baseline to 1-month and 3-month follow-ups'}, {'measure': 'Medication use', 'timeFrame': 'Change in medication use from baseline to 1-month and 3-month follow-ups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IBS', 'Relaxation', 'Emotional exposure', 'Emotional Processing'], 'conditions': ['Irritable Bowel Syndrome']}, 'referencesModule': {'references': [{'pmid': '28643436', 'type': 'DERIVED', 'citation': 'Thakur ER, Holmes HJ, Lockhart NA, Carty JN, Ziadni MS, Doherty HK, Lackner JM, Schubiner H, Lumley MA. Emotional awareness and expression training improves irritable bowel syndrome: A randomized controlled trial. Neurogastroenterol Motil. 2017 Dec;29(12):10.1111/nmo.13143. doi: 10.1111/nmo.13143. Epub 2017 Jun 22.'}]}, 'descriptionModule': {'briefSummary': 'The primary goal of this study is to test the efficacy of emotional awareness and expression training (EAET), a novel emotional processing intervention that the investigators have developed, for people with IBS. In this randomized, controlled trial, the investigators will compare EAET to a standard intervention that teaches the conceptually opposite approach-relaxation training (RT)-and test how both of these interventions compare to a wait-list control condition. The investigators hypothesize that individuals in the EAET group will demonstrate greater improvement in their IBS symptom severity, psychological functioning, quality of life, and health care utilization at 4 and 12-week follow-up time points, compared to individuals in the wait-list control group. It is also expected that both of the active interventions (EAET and RT) will be more efficacious than the wait-list control condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTo be eligible to participate, individuals must meet the Rome III criteria for IBS. That is, they must report that they have had:\n\n* recurrent abdominal pain or discomfort, or\n* a change in stool frequency or form,\n* at least three days per month, in the last three months, and\n* that they have been given this diagnosis by a physician. They must also report having pain and discomfort of at least two days per week at time of screening.\n\nExclusion Criteria:\n\n* Individuals who report having post-infectious IBS,\n* organic gastrointestinal diseases (e.g., inflammatory bowel disease), immunodeficiency,\n* a current psychotic disorder,\n* drug or alcohol dependence within the past two years, and\n* those who are unable to communicate in English will be excluded.'}, 'identificationModule': {'nctId': 'NCT01886027', 'briefTitle': 'Stress Management for Irritable Bowel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Wayne State University'}, 'officialTitle': 'Stress Management for Irritable Bowel Syndrome', 'orgStudyIdInfo': {'id': 'WSU-022413B3E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Emotional Awareness and Expression', 'description': 'Emotional awareness and expression training (EAET) is an emotional processing intervention.', 'interventionNames': ['Behavioral: Emotional Awareness and Expression Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Relaxation', 'description': 'Relaxation training will teach patients different relaxation training skills.', 'interventionNames': ['Behavioral: Relaxation Training']}, {'type': 'NO_INTERVENTION', 'label': 'Wait-list control', 'description': 'Standard medical care until the 3-month follow-up is completed'}], 'interventions': [{'name': 'Emotional Awareness and Expression Training', 'type': 'BEHAVIORAL', 'description': 'An emotional processing intervention, which aims to reduce stress by helping patients become aware of, and express emotions related to stressful life experiences, as well as teaching patients how to relate to others differently.', 'armGroupLabels': ['Emotional Awareness and Expression']}, {'name': 'Relaxation Training', 'type': 'BEHAVIORAL', 'description': 'Teaches patients different relaxation training skills to reduce their distress and discomfort (i.e., progressive muscle relaxation, applied relaxation, or guided imagery.', 'armGroupLabels': ['Relaxation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48067', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'overallOfficials': [{'name': 'Mark A. Lumley, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wayne State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wayne State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mark A. Lumley', 'investigatorAffiliation': 'Wayne State University'}}}}