Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-06 @ 1:22 PM
Study NCT ID:
NCT04663594
Status:
COMPLETED
Last Update Posted:
2022-05-06
First Post:
2020-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Online Culture for Mental Health in People Aged 16-24
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two arm study, 1:1 randomisation (stratified by gender)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 463}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-05', 'studyFirstSubmitDate': '2020-11-27', 'studyFirstSubmitQcDate': '2020-12-04', 'lastUpdatePostDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PANAS', 'timeFrame': 'Baseline, Days 2-4 (morning and evening), Day 5, six weeks', 'description': 'Is a widely used scale of emotion and comprises 20 items, 10 measuring positive affect (excited, inspired etc) and 10 measuring negative affect (upset, afraid etc), on a Likert Scale of 1 (very slightly) to 5 (extremely). We will be measuring change between baseline and time-points (in Timeframe)'}, {'measure': 'K10', 'timeFrame': 'Baseline, Day 5, six weeks', 'description': 'The K10 is a well validated self-report measure of distress (depression and anxiety). We will be measuring change between baseline and time-points (in Timeframe)'}], 'secondaryOutcomes': [{'measure': 'Facial expression recognition task', 'timeFrame': 'Baseline, Day 5, six weeks', 'description': 'The facial expression recognition task provides an objective measure of emotional bias which is associated with vulnerability to depression. We will be measuring change between baseline and time-points (in Timeframe)'}, {'measure': 'Probabilistic Incentive Learning Task', 'timeFrame': 'Baseline, Day 5, six weeks', 'description': 'This is an instrumental learning task in which the participant gains or loses points by choosing between two paired images. The participant is told that some images are more likely (but not always) to be associated with gains and some with losses. The explicit aim is to maximize points. We will be measuring change between baseline and time-points (in Timeframe)'}, {'measure': 'Flourishing', 'timeFrame': 'Baseline, Day 5, six weeks', 'description': 'The Flourishing Scale is an 8-item measure of self-perceived success in domains such as self-esteem, relationships, optimism and purpose. We will be measuring change between baseline and time-points (in Timeframe)'}, {'measure': 'Loneliness', 'timeFrame': 'Baseline, Day 5, six weeks', 'description': 'The UCLA Loneliness Scale is a self-report inventory that uses a Likert-type scale to assess subjective feelings of loneliness. In addition we will add an item directly asking about loneliness. We will be measuring change between baseline and time-points (in Timeframe).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression', 'Anxiety']}, 'referencesModule': {'references': [{'pmid': '34294126', 'type': 'DERIVED', 'citation': 'Syed Sheriff RJ, Vuorre M, Riga E, Przybylski AK, Adams H, Harmer CJ, Geddes JR. A cultural experience to support mental health in people aged 16-24 during the COVID-19 pandemic compared to a typical museum website: study protocol of an online randomised controlled trial. Trials. 2021 Jul 22;22(1):482. doi: 10.1186/s13063-021-05441-z.'}]}, 'descriptionModule': {'briefSummary': 'O-ACE POP is a randomised controlled trial of an online cultural experience named Ways of Being, compared to a typical museum website (the Ashmolean Museum). The primary aim is to compare these two interventions by efficacy on mood, distress (depression and anxiety), flourishing and investigate potential mechanisms of action, as well as the feasibility of a larger scale RCT.', 'detailedDescription': "People of target age will be actively recruited with a link to Participant information and E-consent procedures for those who fulfil inclusion criteria and consent to entering their email address.\n\nConsenting participants will enter a demographic questionnaire. Participants will then be emailed a unique ID number and requested to complete a baseline assessment on a computer, including self-report measures and online tasks. Participants will then be randomised to WoB or the Ashmolean Website. Once randomised participants will be requested to log on to the intervention at least once a day for the next three days\n\nRandomisation and blinding Randomisation procedures will be followed. The participants will be aware of which intervention they have been allocated to. All measures are online and self-report.\n\nWays of Being (WoB) is an online cultural experience designed to reduce distress (symptoms of anxiety and depression) and promote positive mental health in people aged 16-24. It is a web-experience based on qualitative research and co-production with people aged 16-24. The experience is based on human centred narratives related to the objects and artworks of the Ashmolean Museum in Oxford and partner museums. In addition, other people's viewpoints on the objects and artworks or narrative, are a focus of the experience. The experience combines text, audio and aesthetic elements.\n\nThe Ashmolean Website is a generic museum website owned by the Ashmolean Museum of Art and Archaeology at the University of Oxford. The Ashmolean is the oldest public museum in the UK, and has incredibly rich and diverse collections from around the globe, ranging from classical civilisation to the Pre-Raphaelites and modern art. The website is aimed at general museum visitors, tourists, families, primary, secondary and tertiary learners, teachers, and those with specialist cultural interests.\n\nStatistical Analysis Plan The main outcome will be the mean PANAS score at each time point. These will be regressed on time (pre-intervention vs. during, exit and follow up), a group indicator (WoB vs. the Ashmolean Website), and their interaction."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPeople ages 16-24\n\nExclusion Criteria:\n\n* No access to a laptop or desktop computer'}, 'identificationModule': {'nctId': 'NCT04663594', 'acronym': 'O-ACEPOP', 'briefTitle': 'Online Culture for Mental Health in People Aged 16-24', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'An Online Cultural Experience to Support Mental Health in People Aged 16-24 During COVID-19: the O-ACEPOP (Online Active Community Engagement Proof of Principle) Study', 'orgStudyIdInfo': {'id': '0009275'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ways of Being online Experience', 'description': 'Ways of Being (WoB) every day for three days', 'interventionNames': ['Other: WofB']}, {'type': 'OTHER', 'label': 'Ashmolean Website', 'description': 'The Ashmolean Website every day for three days', 'interventionNames': ['Other: Ashmolean Website']}], 'interventions': [{'name': 'WofB', 'type': 'OTHER', 'description': 'Online experience designed to reduce anxiety and depression and support mental health and wellbeing', 'armGroupLabels': ['Ways of Being online Experience']}, {'name': 'Ashmolean Website', 'type': 'OTHER', 'description': 'A generic museum website owned by the Ashmolean Museum of Art and Archaeology at the University of Oxford.', 'armGroupLabels': ['Ashmolean Website']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oxford', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'Ashmolean Museum Website', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'The data will be made available on OSF once peer reviewed', 'ipdSharing': 'YES', 'description': 'The data will be made available on OSF once peer reviewed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}