Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2026-02-22 @ 6:45 PM
Study NCT ID:
NCT00844961
Status:
COMPLETED
Last Update Posted:
2011-11-09
First Post:
2009-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Internet Delivered Cognitive Behavior Therapy (CBT) for Irritable Bowel Syndrome (IBS)
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-08', 'studyFirstSubmitDate': '2009-02-13', 'studyFirstSubmitQcDate': '2009-02-13', 'lastUpdatePostDateStruct': {'date': '2011-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Gastrointestinal Symptom Rating Scale - IBS Version (GSRS-IBS)', 'timeFrame': 'Before treatment'}, {'measure': 'The Gastrointestinal Symptom Rating Scale - IBS Version (GSRS-IBS)', 'timeFrame': 'After treatment'}, {'measure': 'The Gastrointestinal Symptom Rating Scale - IBS Version (GSRS-IBS)', 'timeFrame': '12 months after treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IBS', 'CBT', 'Internet treatment', 'Cognitive behavior therapy'], 'conditions': ['Irritable Bowel Syndrome']}, 'referencesModule': {'references': [{'pmid': '21992655', 'type': 'DERIVED', 'citation': 'Ljotsson B, Andersson G, Andersson E, Hedman E, Lindfors P, Andreewitch S, Ruck C, Lindefors N. Acceptability, effectiveness, and cost-effectiveness of internet-based exposure treatment for irritable bowel syndrome in a clinical sample: a randomized controlled trial. BMC Gastroenterol. 2011 Oct 12;11:110. doi: 10.1186/1471-230X-11-110.'}]}, 'descriptionModule': {'briefSummary': 'The study will recruit 80 out-patients diagnosed with Irritable Bowel Syndrome from a gastroenterological clinic. The recruitment will be consecutive with all patients receiving the diagnosis being offered to participate. After recruitment and 3 week baseline measure of IBS symptoms they will be randomised to either 10 weeks of internet delivered CBT or waiting list. After treatment IBS-symptoms are measured again to assess treatment effectiveness. All patients on waiting list are offered the same treatment as patients randomised to treatment.\n\nAll patients are assessed 12 months after completion of treatment.\n\nPatients in treatment condition are hypothesized to experience significant reduction IBS symptoms and quality of life compared to patients on waiting list.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Irritable Bowel Syndrome according to Rome III criteria\n\nExclusion Criteria:\n\n* History of inflammatory bowel disease (IBD)\n* Symptom debut after age of 50\n* Ongoing severe mental illness (psychosis, severe depression, suicidal ideation, bipolar disease)\n* Inability to participate in internet delivered treatment'}, 'identificationModule': {'nctId': 'NCT00844961', 'briefTitle': 'Effectiveness of Internet Delivered Cognitive Behavior Therapy (CBT) for Irritable Bowel Syndrome (IBS)', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Study of the Effectiveness of Internet Delivered Cognitive Behavior Therapy in a Sample of Consecutively Recruited Patients Diagnosed With Irritable Bowel Syndrome', 'orgStudyIdInfo': {'id': 'IBS-K'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internet CBT', 'description': '10 weeks of internet delivered cognitive behaviour therapy', 'interventionNames': ['Behavioral: Internet delivered cognitive behavior therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Waiting list', 'description': 'Waiting list which is offered treatment after completion of post intervention assessments'}], 'interventions': [{'name': 'Internet delivered cognitive behavior therapy', 'type': 'BEHAVIORAL', 'otherNames': ['CBT'], 'description': '10 weeks of internet delivered cognitive behavior therapy targeted at reducing experience of IBS symptoms and improving quality of life. Patients are offered guidance via email by a therapist.', 'armGroupLabels': ['Internet CBT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '181 86', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Internetpsykatrienheten, M57, Psykiatri sydväst', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Nils Lindefors, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Allmänna arvsfonden', 'class': 'UNKNOWN'}, {'name': 'Region Stockholm', 'class': 'OTHER_GOV'}, {'name': 'Königska-Söderströmska sjukhemmet', 'class': 'UNKNOWN'}, {'name': 'Aleris Helse', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Nils Lindefors', 'oldOrganization': 'Psykiatri Sydväst, Stockholms läns landsting'}}}}