Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT05987969
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2023-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of the Alena App as a Treatment for Social Anxiety Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072861', 'term': 'Phobia, Social'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-04', 'studyFirstSubmitDate': '2023-03-15', 'studyFirstSubmitQcDate': '2023-08-04', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Social Phobia Inventory (SPIN)', 'timeFrame': 'Change from baseline SPIN at 8 weeks', 'description': 'The SPIN was designed to assess the full spectrum of symptoms that characterise social anxiety, including fear, avoidance and physiological components.'}, {'measure': 'Change in Work and Social Adjustment Scale (WSAS)', 'timeFrame': 'Change from baseline WSAS at 8 weeks', 'description': "The WSAS measures the extent to which the respondent's problem impairs their ability to carry out day-to-day activities, such as work, home management and social leisure activities."}], 'secondaryOutcomes': [{'measure': 'Change in Social Phobia Inventory (SPIN)', 'timeFrame': 'Change from SPIN level at the end of the intervention period at 4 weeks later', 'description': 'The SPIN was designed to assess the full spectrum of symptoms that characterise social anxiety, including fear,'}, {'measure': 'Work and Social Adjustment Scale (WSAS)', 'timeFrame': 'At the follow-up point of 4 weeks after the end of the intervention period.', 'description': "The WSAS measures the extent to which the respondent's problem impairs their ability to carry out day-to-day"}, {'measure': 'Serious adverse events', 'timeFrame': 'Within the intervention period of 8 weeks', 'description': 'Serious adverse events are defined as those that meet the criteria for ISO:14155(A:14)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['RCT', 'mobile applications', 'social anxiety', 'mental health', 'social anxiety disorder'], 'conditions': ['Social Anxiety Disorder (Social Phobia)', 'Social Anxiety', 'Social Anxiety Disorder']}, 'referencesModule': {'references': [{'pmid': '40208666', 'type': 'DERIVED', 'citation': 'Garvert MM, McFadyen J, Linke S, McCloud T, Meyer SS, Sobanska S, Sharp PB, Long A, Huys QJM, Ahmadi M. Safety and Efficacy of Modular Digital Psychotherapy for Social Anxiety: Randomized Controlled Trial. J Med Internet Res. 2025 Apr 10;27:e64138. doi: 10.2196/64138.'}]}, 'descriptionModule': {'briefSummary': 'The present study is a randomised controlled trial that seeks to investigate the efficacy and safety of the Alena app as a treatment for social anxiety disorder.', 'detailedDescription': 'This will be a 10-week web-based parallel-group unblinded randomised controlled trial with an 8-week intervention period and a 2-week follow-up post-intervention. Participants will be randomly allocated to receive access to the Alena app or to a wait list control group, in a 1:1 ratio. The Alena app primarily comprises CBT-based therapy for social anxiety based on the Clark and Wells model, as well as cognitive assessments, calming exercises and a community forum.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Scored over 30 on the SPIN (indicating at least moderate social anxiety)\n* Aged 18 or over\n* Fluent in English\n* Has access to a smartphone (iOS or Android) and the internet\n* UK resident\n\nExclusion criteria:\n\n* Currently receiving therapy for their mental health\n* Mental health medication has changed (dosage or presence) in the last 8 weeks\n* Scores over 7 on the AUDIT-C and/or yes on either drug dependence question taken from the DUDIT (indicating drug or alcohol abuse)\n* Previous experience with the Alena app through prior studies or user testing'}, 'identificationModule': {'nctId': 'NCT05987969', 'briefTitle': 'Efficacy and Safety of the Alena App as a Treatment for Social Anxiety Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aya Technologies Limited'}, 'officialTitle': 'Efficacy, Tolerability and Safety of a Smartphone-delivered, Fully Automatic Cognitive Behavioural Therapy Programme for Social Anxiety', 'orgStudyIdInfo': {'id': 'Alena App RCT 2023 #1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Access to the "Alena" CBT-based mobile application intervention for 8 weeks. Instructed to complete one of the 4 main modules every 2 weeks. Also asked to complete one additional short exercise per week and engage with one forum post per week.', 'interventionNames': ['Other: "Alena" mobile application']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention', 'description': 'Wait list control - Given access to the intervention at the end of the 10-week trial period.'}], 'interventions': [{'name': '"Alena" mobile application', 'type': 'OTHER', 'description': 'This mobile application primarily comprises CBT-based therapy for social anxiety based on the Clark and Wells model, as well as cognitive assessments, calming exercises and a community forum.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'Aya Technologies Limited', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aya Technologies Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}