Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-28 @ 2:06 AM
Study NCT ID:
NCT06086756
Status:
COMPLETED
Last Update Posted:
2023-12-13
First Post:
2023-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality Intervention for Speech Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013060', 'term': 'Speech'}, {'id': 'C000719203', 'term': 'Glossophobia'}], 'ancestors': [{'id': 'D014705', 'term': 'Verbal Behavior'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2023-10-02', 'studyFirstSubmitQcDate': '2023-10-11', 'lastUpdatePostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Public Speaking Anxiety', 'timeFrame': 'Comparison of pre-exposure scores to scores from post-treatment, approximately 2 week post-screen', 'description': 'Assessed using the Personal Report of Communication Apprehension, Public Speaking Subscale (PRCA-PS)'}], 'secondaryOutcomes': [{'measure': 'Valence', 'timeFrame': 'Comparison of pre-exposure scores to scores from follow up survey, 1 week post-exposure', 'description': 'Self-report measure of how participant feels about having to give a speech'}, {'measure': 'Social Phobia', 'timeFrame': 'Comparison of pre-exposure scores to scores from follow up survey, 1 week post-exposure', 'description': 'Assessed using the social phobia inventory (SPIN)'}, {'measure': 'Public Speaking Anxiety', 'timeFrame': 'Comparison of pre-exposure scores to scores from follow up survey, 1 week post-exposure', 'description': 'Assessed using the PRCA-PS'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Public Speaking', 'Speech Anxiety']}, 'descriptionModule': {'briefSummary': 'Exposure-based cognitive behavior therapy is an efficacious treatment for speech anxiety and has been delivered effectively in a virtual reality (VR) environment. The present study is designed to evaluate whether mood state moderates outcome to a brief VR exposure intervention.', 'detailedDescription': 'The goal of this clinical trial is to compare outcomes of VR exposure therapy for college students with public speaking anxiety following a positive or negative mood induction. The overarching aim of the present study is to determine whether mood state prior to engaging in a brief VR exposure therapy session for public speaking anxiety impacts treatment outcomes.\n\nThe study involves three phases: (1) initial screening, (2) in-person assessment and brief exposure intervention for a subset of participants with elevated public speaking anxiety, and (3) a one-week follow-up assessment conducted online. Students who choose to participate and screen high on a public speaking anxiety scale will be assigned to a positive or negative mood induction condition prior to undergoing VR based exposure therapy. Public speaking and social anxiety outcomes are measured immediately post-intervention and one week later.\n\nResearchers will compare participants given a positive mood induction to participants given a negative mood induction to see if public speaking anxiety outcomes differ.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-report of 18 years of age or older\n* Current student at Boston University\n* Ability to read English to provide informed consent\n* Familiarity with a computer keyboard and mouse or a touch screen device (e.g. phone, tablet).\n* For Phase 2: speech anxiety scale score of ≥ 14 on the Personal Report of Communication Apprehension, Public Speaking Subscale (PRCA-PS)\n\nExclusion Criteria:\n\n* Previous participation (i.e., no participant may take the survey more than once).'}, 'identificationModule': {'nctId': 'NCT06086756', 'briefTitle': 'Virtual Reality Intervention for Speech Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'Boston University Charles River Campus'}, 'officialTitle': 'The Influence of Mood on Response to Virtual Reality-Based Exposure for Public Speaking Anxiety', 'orgStudyIdInfo': {'id': '7164E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Positive Mood Induction via positive film clips', 'description': 'The standardized procedures outlined in our laboratory\'s previously conducted study (Stathopoulou, Pollack, \\& Otto, 2018) will be followed. Participants will be presented with two brief film clips on a computer monitor or TV screen. These film clips were selected to elicit positive affect. As utilized in past lab study procedures, participants will be asked to: "Let yourself experience whatever emotions you have, as fully as you can. Don\'t try to hold back, or hold in, your feelings" (Stathopoulou, Pollack, \\& Otto, 2018). Together, the two film clips will last for approximately 5 minutes.', 'interventionNames': ['Behavioral: Exposure intervention plus positive mood induction']}, {'type': 'EXPERIMENTAL', 'label': 'Negative Mood Induction via negative film clips', 'description': 'The standardized procedures outlined in our laboratory\'s previously conducted study (Stathopoulou, Pollack, \\& Otto, 2018) will be followed. Participants will be presented with two brief film clips on a computer monitor or TV screen. These film clips were selected to elicit negative affect. As utilized in past lab study procedures, participants will be asked to: "Let yourself experience whatever emotions you have, as fully as you can. Don\'t try to hold back, or hold in, your feelings" (Stathopoulou, Pollack, \\& Otto, 2018). Together, the two film clips will last for approximately 5 minutes.', 'interventionNames': ['Behavioral: Exposure intervention plus negative mood induction']}], 'interventions': [{'name': 'Exposure intervention plus positive mood induction', 'type': 'BEHAVIORAL', 'description': 'Positive mood induction followed by a brief VR exposure session for public speaking anxiety.', 'armGroupLabels': ['Positive Mood Induction via positive film clips']}, {'name': 'Exposure intervention plus negative mood induction', 'type': 'BEHAVIORAL', 'description': 'Negative mood induction followed by a brief VR exposure session for public speaking anxiety.', 'armGroupLabels': ['Negative Mood Induction via negative film clips']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Center for Anxiety and Related Disorders', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Elias Culver', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston University Charles River Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}