Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-31 @ 4:16 PM
Study NCT ID:
NCT00788658
Status:
COMPLETED
Last Update Posted:
2016-04-13
First Post:
2008-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Behaviour Therapy for Patients With IBS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D003248', 'term': 'Constipation'}, {'id': 'D015746', 'term': 'Abdominal Pain'}, {'id': 'D003863', 'term': 'Depression'}], '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'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'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': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-12', 'studyFirstSubmitDate': '2008-11-10', 'studyFirstSubmitQcDate': '2008-11-10', 'lastUpdatePostDateStruct': {'date': '2016-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom score', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Quality of life assessment', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obstructed constipation', 'Quality of life'], 'conditions': ['Irritable Bowel Syndrome', 'Constipation', 'Abdominal Pain', 'Depression']}, 'descriptionModule': {'briefSummary': 'Irritable bowel syndrome (IBS) affects approximately 10-15% of the adult population. This condition is characterized by abdominal pain, altered bowel habit, abdominal bloating and reduced quality of life. Options for treating IBS include pharmacotherapy, psychotherapy, hypnotherapy and cognitive behavior therapy (CBT). Available data on the effectiveness of CBT in IBS patients in Israel are scarce.\n\nThe aim of the present study is to assess effectiveness of CBT as compared with standard therapy for IBS patients in Israel The course of CBT consisted of up to six 40 min sessions, and included education about IBS and techniques to reduce focusing on symptoms and to manage stress.Standard therapy includs life style modifications.\n\nThe primary outcome measure was the score on a symptom-severity scale specific to IBS.', 'detailedDescription': 'Symptomatic treatment of patients would not be modified'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-75\n* IBS\n\nExclusion Criteria:\n\n* Malignancy\n* Known psychiatric disorders'}, 'identificationModule': {'nctId': 'NCT00788658', 'acronym': 'EFI', 'briefTitle': 'Cognitive Behaviour Therapy for Patients With IBS', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'Cognitive Behavior Therapy (CBT) as Compared With Standard Therapy for Patients With IBS and Other Functional Gastrointestinal Disorders', 'orgStudyIdInfo': {'id': 'RMC 5139'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Diet modifications', 'description': 'Diet consultation and life style modifications for 6 sessions', 'interventionNames': ['Behavioral: Diet modifications']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive therapy', 'description': '6 sessions of cognitive behavioral therapy', 'interventionNames': ['Behavioral: Cognitive behavioral therapy']}], 'interventions': [{'name': 'Diet modifications', 'type': 'BEHAVIORAL', 'otherNames': ['Diet'], 'description': 'Diet consultation', 'armGroupLabels': ['Diet modifications']}, {'name': 'Cognitive behavioral therapy', 'type': 'BEHAVIORAL', 'otherNames': ['CBT'], 'description': 'Cognitive behavioral therapy', 'armGroupLabels': ['Cognitive therapy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ram Dickman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Ram Dickman', 'investigatorAffiliation': 'Rabin Medical Center'}}}}