Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-03-08 @ 1:54 AM
Study NCT ID:
NCT03098134
Status:
UNKNOWN
Last Update Posted:
2017-03-31
First Post:
2017-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of a VR Enhanced Video Exposure Therapy for Dental Phobia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001521', 'term': 'Behavior Therapy'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2018-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-27', 'studyFirstSubmitDate': '2017-03-14', 'studyFirstSubmitQcDate': '2017-03-27', 'lastUpdatePostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in dental avoidance behavior', 'timeFrame': 'within three month after the therapy took place', 'description': 'Each participant will be asked to arrange an appointment in a cooperating dental Hospital. It will be assessed (1) if participant makes a - (2) and attends to - first appointment (3) if participant tolerates oral inspection and dental treatment (4) how many further appointments will be made'}], 'primaryOutcomes': [{'measure': 'Change in Subjective Dental Anxiety', 'timeFrame': '4 month', 'description': 'Assessed at time 0 (at inclusion) 1 (pre therapy, two weeks after inclusion), 2(post therapy, 2 weeks after time 1) and at follow up (4 month after time 0) with Dental Anxiety Scale (DAS, 4-item scale, range 4-20)'}, {'measure': 'Change in Dysfunctional Dental Cognitions', 'timeFrame': '4 months', 'description': 'Assessed with Dental Cognition Questionnaire (DCQ, 38 dichotomous items, range 0-38) Assessed at time 0 (at inclusion), time 1 (pre therapy, two weeks after time 0), time 2 (post therapy, 2 weeks after time 1) and at follow up (4 month after time 0)'}], 'secondaryOutcomes': [{'measure': 'Change in Psychophysiological defensive reactivity', 'timeFrame': '4 weeks', 'description': 'Participants will take part in a passive Picture viewing paradigm. They will be exposed to dental anxiety related Pictures, generally negative pictures, neutral, and positive pictures. Outcome measures will be withdrawal-related motor responding (assessed with the startle-reflex), as well as heart frequency change towards the pictures, The task will be applied at inclusion (time 0) and post therapy (4 weeks after inclusion)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Phobia']}, 'descriptionModule': {'briefSummary': 'Evaluation of a one session VR - enhanced Video exposure therapy for dental phobia. Diagnosed dental phobics will be randomly assigned to one of two conditions: (1) Psychoeducation + VR exposure (2) Psychoeducation + Video Control treatment. Prior to getting the therapy, participants will be evaluated with a questionnaire battery, diagnosed with a structured clinical interview and will participate in a psychophysiological symptom assessment. Then, after a 2-week waiting period, participants again fill in questionnaires, and the Intervention will take place. Within 2-weeks after the second questionnaire assessment participants will be screened with the structured interview again and will fill in questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- diagnosed Specific Dental Phobia\n\nExclusion Criteria:\n\n* Schizophrenia or other Psychotic Illnesses\n* Bipolar Disorder\n* Chronic Headache\n* other neurological disorders such as epilepsy\n* Hearing problems'}, 'identificationModule': {'nctId': 'NCT03098134', 'acronym': 'VR-DENT', 'briefTitle': 'The Efficacy of a VR Enhanced Video Exposure Therapy for Dental Phobia', 'organization': {'class': 'OTHER', 'fullName': 'Ruhr University of Bochum'}, 'officialTitle': 'The Efficacy of a VR Enhanced Video Exposure Therapy for Dental Phobia - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'VR-DENT-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VR-Video-Exposure', 'interventionNames': ['Behavioral: Behavior Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Education-Video-', 'interventionNames': ['Other: Health Education']}], 'interventions': [{'name': 'Behavior Therapy', 'type': 'BEHAVIORAL', 'description': 'Virtual Reality and Video based Exposure Therapy', 'armGroupLabels': ['VR-Video-Exposure']}, {'name': 'Health Education', 'type': 'OTHER', 'description': 'Video based health education covering common myths and false believes about dental surgeries', 'armGroupLabels': ['Education-Video-']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dirk Adolph, Dr.', 'role': 'CONTACT', 'email': 'dirk.adolph@rub.de', 'phone': '+492343223177'}, {'name': 'Andre Wannemueller, Dr.', 'role': 'CONTACT', 'email': 'andre.wannemueller@rub.de', 'phone': '+492343223106'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruhr University of Bochum', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ruhr University of Bochum (Dr. Andre Wannemüller)', 'class': 'UNKNOWN'}, {'name': 'Zahnklinik Bochum, Augusta Hospital (Prof. Dr. Peter Jöhren)', 'class': 'UNKNOWN'}, {'name': 'Ruhr University of Bochum (Prof. Dr. Jürgen Margraf)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Clinical Psychophysiology Lab', 'investigatorFullName': 'Dirk Adolph', 'investigatorAffiliation': 'Ruhr University of Bochum'}}}}