Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-01-09 @ 7:22 PM
Study NCT ID:
NCT03101332
Status:
COMPLETED
Last Update Posted:
2020-10-30
First Post:
2017-03-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality for Panic Disorder With Agoraphobia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000379', 'term': 'Agoraphobia'}], 'ancestors': [{'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-29', 'studyFirstSubmitDate': '2017-03-30', 'studyFirstSubmitQcDate': '2017-03-30', 'lastUpdatePostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Presence Questionnaire', 'timeFrame': 'Week 1, week, 2, week3, week 4, week 5, week 6, week 7, week 8, week 9, week 10', 'description': 'Means and standard deviations will be presented. No change is hypothesized for this measure'}], 'primaryOutcomes': [{'measure': 'Mobility Inventory', 'timeFrame': 'Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up', 'description': 'Change at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline'}], 'secondaryOutcomes': [{'measure': 'Panic disorder severity scale', 'timeFrame': 'Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up', 'description': 'Change at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline'}, {'measure': 'Patient Health Questionnaire', 'timeFrame': 'Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up', 'description': 'Change at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline'}, {'measure': 'World Health Organisation Disability Assessment Schedule', 'timeFrame': 'Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up', 'description': 'Change at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline'}, {'measure': 'The World Health Organisation Quality of Life', 'timeFrame': 'Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up', 'description': 'Change at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Panic; Agoraphobia']}, 'descriptionModule': {'briefSummary': 'Panic disorder with agoraphobia (PDA) is associated with considerable personal distress, functional disability and societal costs. A large number of studies have shown that Cognitive Behavior Therapy (CBT) is a highly effective treatment for PDA. However, the CBT-protocols proven to be most effective involves repeated exposure to the particular environments the agoraphobic patient fears such as trains, tunnels, lifts and shops. This cause great practical problems for health care services as such therapeutic efforts involves spending considerable time outside the clinic. For primary care services this is particularly challenging due to the large number of patients expected to be seen. Normally clinicians meet up to 7 patients daily which makes it almost practically impossible to offer 2-hour sessions, which is necessary to carry out the relevant exposure tasks. Hence, the treatment proven to be most effective, which primary care services are commissioned to deliver, is too comprehensive and time consuming to be applied in real practice.\n\nThe investigators believe that a possible solution to the above problem is to provide evidence-based CBT but with the exposure components carried out through Virtual Reality (VR) rather than in vivo. Some research has already been done with virtual reality and exposure therapy for anxiety disorders with promising results. The aim of this pilot study is to treat patients with agoraphobia with or with a history of panic disorder with a standardized exposure-based CBT-protocol through VR. The virtual environments that are used for the study are live sequences filmed in 360°. The investigators hypothesize that CBT with VR will be effective and lead to improvements on measures of panic disorder and agoraphobia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n* A primary diagnosis of Agoraphobia with or with a history of panic disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5).\n* Minimum 18 years of age.\n* Able to read and write in Swedish\n\nExclusion:\n\n* Other primary axis-I disorder\n* Ongoing substance abuse or addiction\n* Current or previous episode of psychosis or bipolar disorder\n* Severe major depressive disorder:\n* Moderate to severe suicidal risk\n* Non-stable antidepressant medication (changed during the last month) or not agreeing to keep dosage constant throughout the study\n* Ongoing concurrent psychological treatment\n* Having received previous high quality Cognitive Therapy or Cognitive Behavior Therapy for agoraphobia during the recent year'}, 'identificationModule': {'nctId': 'NCT03101332', 'briefTitle': 'Virtual Reality for Panic Disorder With Agoraphobia', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Virtual Reality for Panic Disorder With Agoraphobia: a Clinical Trial', 'orgStudyIdInfo': {'id': 'VR for panic with agoraphobia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VR-CBT', 'description': 'Virtual Reality cognitive behavior therapy. 10-12 sessions of individual Cognitive Behavior Therapy with exposure tasks carried out through Virtual Reality.', 'interventionNames': ['Behavioral: Virtual Reality cognitive behavior therapy']}], 'interventions': [{'name': 'Virtual Reality cognitive behavior therapy', 'type': 'BEHAVIORAL', 'description': 'Cognitive interventions targeted to change catastrophic misinterpretations of the physiological symptoms that occur during a panic attack.\n\nExposure via Virtual Reality to filmed sequences of environments typically feared by agoraphobic patients such as underground station/train, a tunnel, a lift and a public square, as well as exposure to the feared symptoms that occur in a typical panic attack.\n\nInterventions are delivered by a psychologist in face-to-face sessions.', 'armGroupLabels': ['VR-CBT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13440', 'city': 'Gustavsberg', 'state': 'Stockholm County', 'country': 'Sweden', 'facility': 'Gustavsberg primary care center', 'geoPoint': {'lat': 59.32684, 'lon': 18.38975}}, {'zip': '17177', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Institutet', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Erik Hedman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, PhD', 'investigatorFullName': 'Erik Hedman', 'investigatorAffiliation': 'Karolinska Institutet'}}}}