Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-29 @ 9:39 AM
Study NCT ID:
NCT04450303
Status:
COMPLETED
Last Update Posted:
2021-09-23
First Post:
2020-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Social Anxiety Telehealth Therapy Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-21', 'studyFirstSubmitDate': '2020-06-24', 'studyFirstSubmitQcDate': '2020-06-24', 'lastUpdatePostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Liebowitz Social Anxiety Scale (LSAS)', 'timeFrame': '12 weeks', 'description': 'Social anxiety severity, lower scores are better (indicating less anxiety). Minimum score is 0, maximum score is 144.'}, {'measure': 'Satisfaction with Therapy and Therapists Scale (STTS)', 'timeFrame': '12 weeks', 'description': 'Therapy satisfaction subscale, higher scores are better (indicating greater satisfaction). Minimum score is 6, maximum score is 30.'}, {'measure': 'UCLA Loneliness Scale version 3', 'timeFrame': '12 weeks', 'description': 'Loneliness, lower scores are better (indicating less loneliness). Minimum score is 20, maximum score is 80.'}], 'secondaryOutcomes': [{'measure': 'Liebowitz Social Anxiety Scale (LSAS)', 'timeFrame': '24 weeks', 'description': 'Social anxiety severity, lower scores are better (indicating less anxiety). Minimum score is 0, maximum score is 144.'}, {'measure': 'UCLA Loneliness Scale version 3', 'timeFrame': '24 weeks', 'description': 'Loneliness, lower scores are better (indicating less loneliness). Minimum score is 20, maximum score is 80.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Social Anxiety']}, 'descriptionModule': {'briefSummary': 'The COVID-19 pandemic has substantially increased the risk of adverse mental health outcomes; while physical distancing is required to reduce infection risk, it also increases loneliness and isolation and prevents access to traditional in-person therapy, which further contribute to risk of adverse mental health outcomes. These problems may be especially acute for individuals with social anxiety disorder (as many as 12% of Americans), however there is a limited evidence-base for telehealth options to directly address social anxiety. This project aims to adapt exposure therapy for social anxiety to a telehealth and physical distancing-compatible intervention, and test whether this effectively decreases loneliness in adults with elevated social anxiety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18+,\n* Liebowitz Social Anxiety Scale (LSAS) total score \\> 50\n* Fluent spoken and written English\n* Access to the internet via a smartphone or computer with a camera\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* History of mania or psychosis\n* Moderate or severe substance use disorder within the past year\n* Current psychiatric diagnosis of greater impairment than that arising from social anxiety\n* High risk for suicide (\\>8 on the Mini International Neuropsychiatric Interview suicidality section)\n* Prior exposure therapy (more than 2 sessions)\n* Current psychotropic medication use\n* Current psychotherapy other than couples counseling.'}, 'identificationModule': {'nctId': 'NCT04450303', 'briefTitle': 'Social Anxiety Telehealth Therapy Study', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Social Anxiety Telehealth Therapy Study', 'orgStudyIdInfo': {'id': '56697'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telehealth Therapy', 'interventionNames': ['Behavioral: Telehealth CBT']}], 'interventions': [{'name': 'Telehealth CBT', 'type': 'BEHAVIORAL', 'otherNames': ['CALM'], 'description': 'The Coordinated Anxiety Learning and Management (CALM) program is an evidence-based, computer-assisted protocol for cognitive behavioral therapy (CBT) for anxiety, depression, and/or post-traumatic stress. CALM will be implemented via secure and HIPAA compliant video-conferencing software (enterprise Zoom), following modifications to address obstacles associated with physical distancing and the tele-health medium.', 'armGroupLabels': ['Telehealth Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Tali Ball, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Instructor', 'investigatorFullName': 'Tali Manber Ball, PhD', 'investigatorAffiliation': 'Stanford University'}}}}