Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2026-03-04 @ 10:12 PM
Study NCT ID:
NCT01850433
Status:
COMPLETED
Last Update Posted:
2017-08-18
First Post:
2013-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet Cognitive Behavior Therapy (CBT) for Body Dysmorphic Disorder (BDD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-15', 'studyFirstSubmitDate': '2013-05-07', 'studyFirstSubmitQcDate': '2013-05-08', 'lastUpdatePostDateStruct': {'date': '2017-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body dysmorphic disorder symptoms', 'timeFrame': 'Measured after 12 weeks of treatment, and after 3 months after treatment'}], 'secondaryOutcomes': [{'measure': 'Functioning and life satisfaction', 'timeFrame': 'After 12 weeks of treatment, and 3 months after treatment'}, {'measure': 'Depressive symptoms', 'timeFrame': 'After 12 weeks of treatment, and 3 months after treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['BDD', 'CBT'], 'conditions': ['Body Dysmorhpic Disorder']}, 'referencesModule': {'references': [{'pmid': '25256187', 'type': 'RESULT', 'citation': 'Enander J, Ivanov VZ, Andersson E, Mataix-Cols D, Ljotsson B, Ruck C. Therapist-guided, Internet-based cognitive-behavioural therapy for body dysmorphic disorder (BDD-NET): a feasibility study. BMJ Open. 2014 Sep 25;4(9):e005923. doi: 10.1136/bmjopen-2014-005923.'}], 'seeAlsoLinks': [{'url': 'http://bmjopen.bmj.com/content/4/9/e005923', 'label': 'Results BMJ Open paper'}]}, 'descriptionModule': {'briefSummary': 'The primary aim is to develop, and test the feasibility, of a novel and protocol-based cognitive behaviour therapy (CBT) treatment for body dysmorphic disorder (BDD) administered via the Internet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* outpatients\n* male or female\n\n -≥ 18 years\n* currently living in Stockholm county\n* primary diagnosis of BDD according to the DSM-IV-TR\n* signed informed consent\n* regular access to a computer with Internet access and skills to use the web.\n\nExclusion Criteria:\n\n* psychotropic medication changes within two months prior to the treatment\n* completed CBT for BDD within the last 12 months\n* BDD-YBOCS \\< 12 at psychiatrist visit\n* other primary axis I diagnosis\n* current substance dependence\n* lifetime bipolar disorder or psychosis\n* suicidal ideation\n* Axis II diagnosis that could jeopardize treatment participation\n* other current psychological treatment that could affect BDD symptoms'}, 'identificationModule': {'nctId': 'NCT01850433', 'briefTitle': 'Internet Cognitive Behavior Therapy (CBT) for Body Dysmorphic Disorder (BDD)', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Internet-based Cognitive Behavior Therapy for Body Dysmorphic Disorder: A Pilot Study', 'orgStudyIdInfo': {'id': 'BDD-P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internet CBT', 'interventionNames': ['Behavioral: Internet based CBT for body dysmorphic disorder']}], 'interventions': [{'name': 'Internet based CBT for body dysmorphic disorder', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Internet CBT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '141 86', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'M46 Huddinge sjukhus, Internetpsykiatrienheten/mottagningen för tvångssyndrom', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Christian Rück, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor, M.D.', 'investigatorFullName': 'Christian Rück', 'investigatorAffiliation': 'Karolinska Institutet'}}}}