Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT01119469
Status:
COMPLETED
Last Update Posted:
2014-08-06
First Post:
2010-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing Cognitive Therapy and Exposure Therapy in Individuals With Hypochondriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006998', 'term': 'Hypochondriasis'}, {'id': 'D013001', 'term': 'Somatoform Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D007171', 'term': 'Implosive Therapy'}], 'ancestors': [{'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D003887', 'term': 'Desensitization, Psychologic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-05', 'studyFirstSubmitDate': '2010-05-05', 'studyFirstSubmitQcDate': '2010-05-06', 'lastUpdatePostDateStruct': {'date': '2014-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypochondriasis Yale-Brown Obsessive-Compulsive Scale (H-YBOCS)', 'timeFrame': '3 months', 'description': 'clinician-rated measure that assesses hypochondriacal obsessions, compulsions and avoidance'}], 'secondaryOutcomes': [{'measure': 'Illness Attitude Scales (IAS)', 'timeFrame': '3 months', 'description': 'self-report measure that assesses attitudes, fears, and beliefs associated with the psychopathology of hypochondriasis and that of abnormal illness behavior'}, {'measure': 'Beck-Depression Inventory II (BDI-II)', 'timeFrame': '3 months', 'description': 'self-report measure that assesses depressive symptoms'}, {'measure': 'Beck Anxiety Inventory (BAI)', 'timeFrame': '3 months', 'description': 'self-report measure that asessses anxiety symptoms'}, {'measure': 'Brief Symptom Inventory (BSI)', 'timeFrame': '3 months', 'description': 'self-report measure that assesses aspects of general psychopathology'}, {'measure': 'Scale for the Assessment of Illness Behavior (SAIB)', 'timeFrame': '3 months', 'description': 'self-report measure that focuses on illness behavior'}, {'measure': 'Health-related quality of life (SF-12)', 'timeFrame': '3 months', 'description': 'self-report measure the assesses the health-related quality of life'}, {'measure': 'Cognitions About Body and Health Questionnaire (CABAH)', 'timeFrame': '3 months', 'description': 'self-rated measure that focuses on attitudes related to the cognitive concept of hypochondriasis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypochondriasis', 'Health Anxiety', 'randomized controlled trial', 'Cognitive Therapy', 'Exposure Therapy'], 'conditions': ['Hypochondriasis', 'Somatoform Disorders']}, 'descriptionModule': {'briefSummary': 'This study will compare the efficacy of cognitive therapy and exposure therapy for treating hypochondriasis.', 'detailedDescription': "Hypochondriasis is defined as a preoccupation with the fear of having a serious disease based on the person's misinterpretation of bodily symptoms (APA). For a long time hypochondriasis was seen as difficult to treat. Meanwhile effective psychological treatment for hypochondriasis exists. Psychotherapies using cognitive therapy (CT), cognitive behavioral therapy (CBT), exposure therapy (ET) or behavioral stress management approaches are effective in reducing symptoms of hypochondriasis. However, few studies compare different types of psychotherapy. In addition, in these studies numbers of participants were small, no differences between different treatments were found, and one third of the participants showed no satisfactory change. This study will compare the efficacy of CT and ET in a larger sample of 84 participants.\n\nParticipants in this randomized controlled trial (RCT) will first undergo baseline assessment. Then they will be randomly assigned to either CT, ET or a waiting list (WL), all conditions are for the duration of 12 weeks. CT includes psychoeducation, attention training, cognitive restructuring, behavioral experiments, imagery rescripting and relapse prevention. ET includes change of safety behavior, exposition (in sensu and in vivo), and relapse prevention. Both treatment trials contain the identical number of sessions. Treatment response will be assessed at week 12 and additionally one and three years after treatment. Participants of the WL will be assigned to CT or ET after the waiting period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meets DSM-IV criteria for hypochondriasis\n* German fluency and literacy\n* Informed consent\n\nExclusion Criteria:\n\n* Major medical illness expected to worsen significantly\n* Currently in psychotherapy\n* Suicidal tendency\n* Clinical diagnosis of alcohol or drug addiction, schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-IV'}, 'identificationModule': {'nctId': 'NCT01119469', 'briefTitle': 'Comparing Cognitive Therapy and Exposure Therapy in Individuals With Hypochondriasis', 'organization': {'class': 'OTHER', 'fullName': 'Goethe University'}, 'officialTitle': 'Dysfunctional Illness-related Cognitions in Individuals With Hypochondriasis and Change Thereof', 'orgStudyIdInfo': {'id': 'WE 4654/2-1, WE 4654/2-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Therapy (CT)', 'description': 'There will be 12 50-minute individual sessions conducted at weekly intervals. Booster sessions will be conducted one, three and six months after treatment. Sessions include psychoeducation, attention training, cognitive restructuring, behavioral experiments, imagery rescripting and relapse prevention.', 'interventionNames': ['Behavioral: Psychotherapy (CT or ET)']}, {'type': 'EXPERIMENTAL', 'label': 'Exposure Therapy (ET)', 'description': 'There will be 12 50-minute individual sessions conducted at weekly intervals. Booster sessions will be conducted one, three and six months after treatment. Sessions include change of safety behavior, exposition (in sensu and in vivo), and response prevention.', 'interventionNames': ['Behavioral: Psychotherapy (CT or ET)']}, {'type': 'NO_INTERVENTION', 'label': 'Waiting List (WL)', 'description': '12 weeks waiting time'}], 'interventions': [{'name': 'Psychotherapy (CT or ET)', 'type': 'BEHAVIORAL', 'otherNames': ['Cognitive Therapy', 'Exposure Therapy'], 'description': 'weekly 50-minute sessions for 12 weeks', 'armGroupLabels': ['Cognitive Therapy (CT)', 'Exposure Therapy (ET)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-60486', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Department of Clinical Psychology and Psychotherapy of the Wolfgang Goethe University', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}], 'overallOfficials': [{'name': 'Florian Weck, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Goethe University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Goethe University', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Florian Weck', 'investigatorAffiliation': 'Goethe University'}}}}