Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-28 @ 12:02 PM
Study NCT ID:
NCT06302868
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telemedicine-Based Virtual Reality Clinic for the Treatment of Phobias
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2025-12-19'}], 'estimatedResultsFirstSubmitDate': '2025-12-19'}}, 'conditionBrowseModule': {'meshes': [{'id': 'C000719193', 'term': 'Arachnophobia'}, {'id': 'C000719220', 'term': 'Zoophobia'}, {'id': 'D010698', 'term': 'Phobic Disorders'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014743', 'term': 'Videotape Recording'}], 'ancestors': [{'id': 'D013637', 'term': 'Tape Recording'}, {'id': 'D001296', 'term': 'Audiovisual Aids'}, {'id': 'D018961', 'term': 'Educational Technology'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D013690', 'term': 'Television'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-21', 'size': 451422, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-01-23T13:01', 'hasProtocol': True}, {'date': '2023-12-11', 'size': 14053932, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-01-23T12:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-06', 'studyFirstSubmitDate': '2024-01-12', 'studyFirstSubmitQcDate': '2024-03-06', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phobia symptom severity', 'timeFrame': '3 Month Follow-Up', 'description': "The Severity Measure for Specific Phobia (SMSP) will be used to assess changes in phobia symptom severity at the 3 Month Follow-Up.\n\nEach item on the measure is rated on a 5-point scale (0=Never; 1=Occasionally; 2=Half of the time; 3=Most of the time, and 4=All of the time). The total score can range from 0 to 40 with higher scores indicating greater severity of specific phobia. The clinician will use an average total score, which reduces the overall score to a 5-point scale, which allows the clinician to think of the severity of the individual's specific phobia in terms of none (0), mild (1), moderate (2), severe (3), or extreme (4)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['phobia', 'phobias', 'snakes', 'dogs', 'spiders'], 'conditions': ['Arachnophobia', 'Cynophobia', 'Ophidiophobia']}, 'referencesModule': {'references': [{'pmid': '40209221', 'type': 'DERIVED', 'citation': 'Schuler KR, Ong T, Welch BM, Craggs JG, Bunnell BE. Examining a Telemedicine-Based Virtual Reality Clinic in Treating Adults With Specific Phobia: Protocol for a Feasibility Randomized Controlled Efficacy Trial. JMIR Res Protoc. 2025 Apr 10;14:e65770. doi: 10.2196/65770.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the feasibility of conducting a randomized controlled efficacy trial comparing the delivery of exposure therapy via a telemedicine-based virtual reality clinic (Doxy.me VR) vs. standard telemental health (TMH) to adults with intense fear of dogs, snakes, and/or spiders. The secondary purpose is to preliminarily examine the efficacy of using Doxy.me VR vs. TMH in reducing phobia severity.', 'detailedDescription': 'This study aims to assess the feasibility of conducting a randomized controlled efficacy trial comparing the delivery of exposure therapy via a telemedicine-based virtual reality clinic (Doxy.me VR) vs. standard telemental health (TMH) to adults with intense fear of dogs, snakes, and/or spiders. This study will use feasibility randomized controlled efficacy trial design. This single-site trial will include up to 60 adults with self-reported fear of dogs, snakes, and/or spiders who will be randomly assigned via the REDCap Randomization Module using a 1:1 allocation ratio to receive 12 sessions of exposure therapy over the course of 3 months via standard telemental health (TMH; n=15) vs. Doxy.me VR (n=15), a telemedicine-based virtual reality clinic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Is an adult ≥ 18 years old\n2. Has a self-reported fear of dogs, snakes, and/or spiders\n3. Indicates Subthreshold or Present Specific Phobia symptoms as determined by the study therapist via administration of the Diagnostic Assessment Research Tool (DART) Specific Phobia Module\n4. Has access to the internet AND a computer OR smartphone with video conferencing capabilities\n5. Will reside in the state of Florida for the duration of the study\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Is participating in ongoing mental health therapy from a non-study therapist\n2. Has had changes to psychotropic medication use within six weeks preceding enrollment in the trial\n3. Reports active suicidal and/or homicidal intent or plan as determined by the study therapist via administration of the Diagnostic Assessment Research Tool (DART) Risk Assessment Module\n4. Reports active auditory, visual, and/or tactile hallucinations via the Diagnostic Assessment Research Tool (DART) Psychosis Module screening question\n5. Reports a history of epilepsy or seizures'}, 'identificationModule': {'nctId': 'NCT06302868', 'briefTitle': 'Telemedicine-Based Virtual Reality Clinic for the Treatment of Phobias', 'organization': {'class': 'OTHER', 'fullName': 'University of South Florida'}, 'officialTitle': 'Doxy.me VR vs. Telemental Health-Based Exposure Therapy', 'orgStudyIdInfo': {'id': '006215'}, 'secondaryIdInfos': [{'id': 'R43MH129065', 'link': 'https://reporter.nih.gov/quickSearch/R43MH129065', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Telemedicine-based Virtual Reality Exposure Therapy', 'description': 'This group will receive exposure therapy in a telemedicine-based Virtual Reality Clinic using virtual reality snakes, dogs, or spiders. The VR stimuli range from small to medium to large and have four activity levels: idle, calm, energetic, and aggressive.', 'interventionNames': ['Behavioral: Telemedicine-Based Virtual Reality Exposure Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Telemedicine Exposure Therapy', 'description': 'This group will receive exposure therapy via Doxy.me telemedicine platform using photos and videos of snakes, dogs, or spiders. The photo/video stimuli range from small to medium to large and have four activity levels: idle, calm, energetic, and aggressive.', 'interventionNames': ['Behavioral: Telemedicine Exposure Therapy Using Photos and Videos']}], 'interventions': [{'name': 'Telemedicine Exposure Therapy Using Photos and Videos', 'type': 'BEHAVIORAL', 'description': 'Participants will complete 12 60-minute exposure therapy sessions using photos/videos and progress to in vivo exposures.', 'armGroupLabels': ['Standard Telemedicine Exposure Therapy']}, {'name': 'Telemedicine-Based Virtual Reality Exposure Therapy', 'type': 'BEHAVIORAL', 'description': 'Participants will complete 12 60-minute exposure therapy sessions in a Virtual Reality Clinic using Virtual Reality stimuli and progress to in vivo exposures.', 'armGroupLabels': ['Telemedicine-based Virtual Reality Exposure Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brian Bunnell, PhD', 'role': 'CONTACT'}, {'name': 'Brian Bunnell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Triton Ong, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'centralContacts': [{'name': 'Kaitlyn R Schuler, PhD', 'role': 'CONTACT', 'email': 'krschuler@usf.edu', 'phone': '813-396-9169'}], 'overallOfficials': [{'name': 'Brian E Bunnell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}