Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2026-03-14 @ 5:28 AM
Study NCT ID:
NCT02792127
Status:
COMPLETED
Last Update Posted:
2017-12-29
First Post:
2016-06-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Online Program for Social Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-27', 'studyFirstSubmitDate': '2016-06-02', 'studyFirstSubmitQcDate': '2016-06-06', 'lastUpdatePostDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Social Anxiety', 'timeFrame': 'six months', 'description': 'A self-report measure that assesses symptoms of distress experienced when socializing with others.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Social Anxiety', 'Cognitive Behaviour Therapy', 'Online Program'], 'conditions': ['Social Anxiety']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "Helgadottir FD, Ross MG, Onslow M, Packman A, O'Brian, S. Online CBT II: A phase I trial of a standalone, online CBT Treatment Program for Social Anxiety in Stuttering. Behaviour Change 26(4): 254-270. 2009."}, {'type': 'BACKGROUND', 'citation': "Helgadottir FD, Menzies RG, Onslow M, Packman A, O'Brian S. Online CBT I: Bridging the gap between Eliza and modern online CBT treatment packages. Behaviour Change 26(4): 245-253, 2009."}, {'pmid': '29563078', 'type': 'DERIVED', 'citation': 'McCall HC, Richardson CG, Helgadottir FD, Chen FS. Evaluating a Web-Based Social Anxiety Intervention Among University Students: Randomized Controlled Trial. J Med Internet Res. 2018 Mar 21;20(3):e91. doi: 10.2196/jmir.8630.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the efficacy of an online program in reducing symptoms of social anxiety, unhelpful thoughts, avoidance behaviours, fear of negative evaluations and improving quality of life in students with above-average social anxiety.', 'detailedDescription': 'While there are many benefits to online programs in treating a variety of health issues (i.e., implementation in remote areas, cost-effectiveness, etc.), the primary challenge for online formats is to imitate real-life interactions while promoting a reduction in symptoms. This will be attempted in a six-month online program for social anxiety.\n\nThe present study will assess the efficacy of a six-month online program through measures of social anxiety, fear of negative evaluations, unhelpful thoughts, avoidance behaviours and quality of life. This information will be collected from students at baseline and upon completion of the online program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Registered UBC student\n* Achieve an above-average score on a validated screening tool for social anxiety\n\nExclusion Criteria:\n\n* Not a registered UBC student\n* Clinical diagnosis of a mental illness'}, 'identificationModule': {'nctId': 'NCT02792127', 'briefTitle': 'Online Program for Social Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Online Cognitive Behavioural Therapy Program for Social Anxiety', 'orgStudyIdInfo': {'id': 'H16-00319'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'These participants will be given access to a six-month online program for social anxiety.', 'interventionNames': ['Behavioral: Online Program for Social Anxiety']}, {'type': 'NO_INTERVENTION', 'label': 'Wait List Control', 'description': 'These participants will not be given an intervention until after they have completed the study.'}], 'interventions': [{'name': 'Online Program for Social Anxiety', 'type': 'BEHAVIORAL', 'description': "This program will be completed from participants' homes using their own computers. This online format is based on a Cognitive Behaviour Therapy framework (CBT) and involves seven modules that ask participants to engage in a variety of thinking exercises and activities.", 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Frances Chen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Frances Chen', 'investigatorAffiliation': 'University of British Columbia'}}}}