Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-30 @ 10:25 PM
Study NCT ID:
NCT03895957
Status:
COMPLETED
Last Update Posted:
2020-02-11
First Post:
2019-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VR Mind and VR Mind+ Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072861', 'term': 'Phobia, Social'}], 'ancestors': [{'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-10', 'studyFirstSubmitDate': '2019-03-26', 'studyFirstSubmitQcDate': '2019-03-27', 'lastUpdatePostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Subjective Units of Distress', 'timeFrame': 'Change from session to session with virtual reality exposure during the course of six weeks', 'description': 'Subjective Units of Distress (SUD) SUD is a subjective measure of perceived fear in certain situation. The scale range is from 0 ("Totally relaxed) to 100 ("Highest distress/fear/anxiety/discomfort that you have ever felt").'}], 'primaryOutcomes': [{'measure': 'Efficacy: Liebowitz Social Anxiety Scale - Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987)', 'timeFrame': 'change from baseline: Pre-treatment at session 1, to session 9 (5 weeks) and to post-treatment at session 14 (7 weeks)', 'description': 'The scale is composed of 24 items, depicting various social situations. For each item, participants assess their fear (from 1 - "No fear" to 4 - "Severe") and avoidance (from 1 - "Never" to 4 - "Usually"). LSAS has 3 scores, summing the results for particular items - fear (0-72), avoidance (0-72) and total score (0-144).'}, {'measure': 'Safety: Occurrence and severity of Simulator Sickness - Simulator Sickness Questionnaire (SSQ; Kennedy, Lane, Berbaum, Lilienthal, 1993)', 'timeFrame': 'Change from session to session with virtual reality exposure: at session 1, session 7 (4 weeks), session 8 (4 weeks), session 10 (5 weeks), session 11 (6 weeks) and session 12 (6 weeks)', 'description': 'Simulator sickness is expected adverse effect of the VR.Total SSQ score equal to or higher than 10 will be used as a preliminary cut-off for simulator sickness (Balk et al., 2013). Individual scores will be corrected for baseline (pre-VR) symptom severity. Only items with a pre-VR - post-VR increase will contribute to a final SSQ score. All post-intervention SSQ scores \\>10 will be analyzed further for its association with study drop-outs and other intervention required. The adverse effect will be classified as:\n\n* mild (no intervention required),\n* moderate (any intervention needed, e.g. session termination),\n* severe (hospitalization required),\n* life-threatening / death.\n\nSome of the symptoms of anxiety may produce similar side effects as a simulator sickness. The results obtained in this case will be false positive. Therefore assessment of side effects for each case will be verified if the increase in SSQ score was triggered by rapid relapse of phobia symptoms.'}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impression', 'timeFrame': 'Pre-treatment at session 1', 'description': 'Clinical Global Impression (CGI; Guy, 1976) - is a single item, 7 point scale used by clinicians to assess the severity of illness, where 1 is labeled as "Normal, not at all ill" and 7 is labeled as "Among the most extremely ill patients".'}, {'measure': 'Clinician Global Impressions of Improvement', 'timeFrame': 'Post-treatment, approximately 7 weeks after initial session', 'description': 'Global measure of change in severity of symptoms, ranging from 1 labeled as " Very much improved" to 7 labeled as "Very much worse".'}, {'measure': 'Patient Global Impression', 'timeFrame': 'Pre-treatment at session 1', 'description': 'Patient Global Impression - is a single item, 4 point scale used by patients to assess their impression of severity of their illness and quality of their functioning in everyday life, where 1 is labeled as "Normal" and 4 is labeled as "Severe".'}, {'measure': 'Patient Global Impressions of Improvement', 'timeFrame': 'Post-treatment, approximately 7 weeks after initial session', 'description': 'Global measure of change in severity of symptoms, where 1 is labeled as "No change" and 7 is labeled as " Very much improved ".'}, {'measure': 'Beck Depression Inventory', 'timeFrame': 'Pre-treatment at session 1 to post-treatment at session 14 (7 weeks)', 'description': 'A 21-question multiple-choice self-report inventory for measuring the severity of depression. Each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs used differ from the original:\n\n0-13: minimal depression 14-19: mild depression 20-28: moderate depression 29-63: severe depression'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['virtual reality', 'social phobia', 'vret', 'virtual reality exposure therapy'], 'conditions': ['Social Phobia']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess the safety and efficacy of VR Mind and VR Mind + interventions.', 'detailedDescription': 'In this study, investigators will test the software developed by Tomorrow Sp. z o. o., named VR Mind and VR Mind+. The software utilizes the concept of virtual reality exposure therapy to treat social anxiety disorder. The aim of the study is to assess the safety and efficacy of VR Mind and VR Mind + interventions.\n\nThe research consists of fourteen sessions. The first and the last session will be dedicated to participant assessment. Subsequent sessions 2-13 will be performed according to the therapy protocol for each arm. Control group of participants (active comparative arm) will receive standard treatment for social anxiety disorder - cognitive behavioral therapy based on the protocol developed by the Principal Investigator \\[protocol adapted from the approach of Clark and Wells (Mayo-Wilson, Dias, Mavranezouli, 2014)\\]. Experimental group 1 will receive cognitive behavioral therapy with exposure in virtual environment. Experimental group 1 and control group were designed to be as similar as possible, with the exception of the modality for the delivery of exposure. All treatment session will be led by licensed therapist.\n\nParticipants of the experimental group 2 will independently conducts the self-therapy process. The intervention will consist of 12 therapeutic sessions. At each of the 12 sessions, the participant will selects a specific scenario of social situations that arouse fear (e.g. public speaking, job interview or other situations from everyday life).\n\nBecause of the risk of simulator sickness (e.g., headaches, nausea), exposure trials will last no longer than 20 minutes for each session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed DSM-IV-TR criteria for Social Anxiety Disorder (SAD).\n* Signing informed consent\n* Unchanged doses of psychotropic medications within 3 months prior to baseline assessment and no change is anticipated\n\nExclusion Criteria:\n\n* occurrence of SAD symptoms inconsistent with DSM-IV-TR criteria and with psychiatric interview (SCID-I; Structured Clinical Interview)\n* psychosis,\n* bipolar disorder,\n* mental retardation\n* pregnancy,\n* drug addiction,\n* alcohol addiction,\n* psychoactive substances addiction,\n* participating in the experimental session while intoxicated\n* (current) neurological treatment of chronic disease of central nervous system,\n* epilepsy,\n* paroxysmal vertigo,\n* presence of suicidal thoughts, tendencies or attempts,\n* participant is taking drugs from benzodiazepine group, other sedatives, narcotic drugs\n* current CBT treatment for Social Anxiety Disorder'}, 'identificationModule': {'nctId': 'NCT03895957', 'briefTitle': 'VR Mind and VR Mind+ Intervention', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tomorrow Sp. z o.o.'}, 'officialTitle': 'VR Mind™ and VR Mind +™ Intervention - Randomized, Open Label, Single Masking, Parallel Group Clinical Trial', 'orgStudyIdInfo': {'id': 'TRR/POIR.01.01.01-00-0636'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: VR Mind+', 'description': 'Virtual Reality Exposure Therapy VR Mind+', 'interventionNames': ['Behavioral: Virtual Reality Exposure Therapy VR Mind+']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: VR Mind', 'description': 'Virtual Reality Exposure Therapy VR Mind', 'interventionNames': ['Behavioral: Virtual Reality Exposure Therapy VR Mind']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group: CBT', 'description': 'Cognitive Behavioral Therapy', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy']}], 'interventions': [{'name': 'Virtual Reality Exposure Therapy VR Mind+', 'type': 'BEHAVIORAL', 'description': 'Virtual Reality Exposure Self-Therapy led by a participant', 'armGroupLabels': ['Group 1: VR Mind+']}, {'name': 'Virtual Reality Exposure Therapy VR Mind', 'type': 'BEHAVIORAL', 'description': 'Treatment with Virtual Reality Exposure Therapy led by a therapist', 'armGroupLabels': ['Group 2: VR Mind']}, {'name': 'Cognitive Behavioral Therapy', 'type': 'BEHAVIORAL', 'description': 'Standard treatment for social phobia led by a therapist', 'armGroupLabels': ['Control group: CBT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03-913', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Tomorrow Sp. z o. o.', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Gabinet Psychoterapii', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Paweł Mierzejewski, prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Scientific Council'}, {'name': 'Przemysław Bieńkowski, prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Scientific Council'}, {'name': 'Tadeusz Parnowski, prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Scientific Council'}, {'name': 'Sławomir Murawiec, PH.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Scientific Council'}, {'name': 'Izabela Stefaniak, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Scientific Council'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tomorrow Sp. z o.o.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Center for Research and Development, Poland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}