Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT01442805
Status:
COMPLETED
Last Update Posted:
2017-03-15
First Post:
2011-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Virtual Reality in the Treatment of Flying Phobia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C000719189', 'term': 'Aerophobia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D063367', 'term': 'Virtual Reality Exposure Therapy'}], 'ancestors': [{'id': 'D003887', 'term': 'Desensitization, Psychologic'}, {'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': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-13', 'studyFirstSubmitDate': '2011-09-15', 'studyFirstSubmitQcDate': '2011-09-28', 'lastUpdatePostDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flight taken', 'timeFrame': '6 months', 'description': 'Participants are expected to take a real flight'}], 'secondaryOutcomes': [{'measure': 'Physiological Measures', 'timeFrame': '6 months', 'description': 'Heart Rate, Breathing frequency, Skin conductance, Skin Temperature, Heart Rate Variability'}, {'measure': 'Specific Questionnaires', 'timeFrame': '6 months', 'description': 'Specific Questionnaires: SUD, Motivational Scale, Fear Questionnaire Marks 1979, Sheehan Disability Scale, STAI I \\& II, BDI, BAI, GAF, Flight Anxiety Situations Questionnaire FAS, Flight Anxiety Modality Questionnaire FAM'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cognitive Behavior Therapy', 'Virtual Reality Exposure Therapy', 'Psychophysiological Measures', 'Driving Phobia', 'Flying Phobia'], 'conditions': ['Flying Phobia']}, 'descriptionModule': {'briefSummary': 'The project aims to explore the potential of Virtual Reality Exposure Therapy (VRET) for the treatment of the fear of driving, the fear of flying and the fear of public speaking.\n\nThe study is a randomized controlled trial (RCT) designed to compare the efficiency of cognitive behavioural therapy with exposures in imagination to behavioural therapy with exposures in virtual reality. Anxiety levels are measured using specific questionnaires, SUD ratings and physiological measures (heart rate, skin conductance, skin temperature, breathing frequency, heart rate variability).\n\nHypothesis: Treatments with exposures in virtual reality are more efficient than treatments with exposures in imagination.', 'detailedDescription': 'In the past, several studies have demonstrated the effectiveness of virtual reality exposure therapy in the treatment of flying phobia and driving phobia. As an objective tool, psychophysiological recordings help demonstrate the decrease of physiological aspects of anxiety reactions (heart rate, skin conductance, skin temperature, heart rate variability and breathing pattern).\n\nThe aim of the present study is to examine the effects of cognitive behavioural therapy with exposures in imagination to behavioural therapy with exposures in virtual reality in the treatment of patients with flying phobia. Thirty patients will be randomized into either an imagination exposure group or a virtual reality exposure group after having received four sessions of cognitive behavioural therapy for coping with panic attacks. Respective exposure therapies consist in four sessions.\n\nAnxiety levels will be measured before and after the cognitive behavioural therapy for coping with panic attacks as well as before and after the exposure therapy sessions and after 3 months using specific questionnaires, SUD ratings and psychophysiological measures (heart rate, skin conductance, skin temperature, breathing frequency and heart rate variability). The exposure stimuli will consist in a 10min movie of a flight with an insight-cabin viewing perspective.\n\nThe investigators hypothesize that virtual reality exposure therapies will be more effective than imagination exposure therapy in terms of decrease of anxiety self-ratings and psychophysiological fear reactions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of a specific phobia (DSM-IV-TR)\n\nExclusion Criteria:\n\n* Pregnant women\n* Subjects with severe pulmonary / cardiovascular problems; Asthma, epilepsy, vertigo\n* Drug abuse\n* Subjects under on-stabilized anti-depressant treatment\n* Psychotic subjects\n* Subjects with suicidal ideas\n* Subjects presenting insufficient intellectual capabilities'}, 'identificationModule': {'nctId': 'NCT01442805', 'briefTitle': 'Use of Virtual Reality in the Treatment of Flying Phobia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Luxembourg Institute of Health'}, 'officialTitle': 'Etude contrôlée Des Effets de la réalité Virtuelle Sur Les symptômes et Les paramètres Physiologiques de Certaines Phobies spécifiques', 'orgStudyIdInfo': {'id': '20080102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RV', 'description': 'Cognitive Behavioral Therapy with Virtual Reality Exposures', 'interventionNames': ['Behavioral: Virtual Reality Exposure Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'IMAGO', 'description': 'Cognitive Behavioral Therapy with Exposure Therapy through Imagination', 'interventionNames': ['Behavioral: Exposure Therapy through Imagination']}], 'interventions': [{'name': 'Virtual Reality Exposure Therapy', 'type': 'BEHAVIORAL', 'description': 'Participants are exposed to the feared situation (flying) through the virtual reality technology', 'armGroupLabels': ['RV']}, {'name': 'Exposure Therapy through Imagination', 'type': 'BEHAVIORAL', 'description': 'Participants are exposed to the feared situation (flying) through exposure technique of imagination.', 'armGroupLabels': ['IMAGO']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L-1445', 'city': 'Strassen', 'country': 'Luxembourg', 'facility': 'Centre de Recherche Public de la Santé', 'geoPoint': {'lat': 49.62056, 'lon': 6.07333}}], 'overallOfficials': [{'name': 'Charles Pull, Prof.Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre de Recherche Public de la Santé'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Luxembourg Institute of Health', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Centre Hospitalier du Luxembourg', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}