Clinical trial NCT04663594: Online Culture for Mental Health in People Aged 16-24
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 463
Sex: ALL
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arm study, 1:1 randomisation (stratified by gender)
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Consenting 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

Randomisation 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.

Ways 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.

The 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.

Statistical 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.

Eligibility criteria: Inclusion Criteria:

People ages 16-24

Exclusion Criteria:

* No access to a laptop or desktop computer

Primary outcomes:
measure: PANAS
timeFrame: Baseline, Days 2-4 (morning and evening), Day 5, six weeks
measure: K10
timeFrame: Baseline, Day 5, six weeks
Secondary outcomes:
measure: Facial expression recognition task
timeFrame: Baseline, Day 5, six weeks
measure: Probabilistic Incentive Learning Task
timeFrame: Baseline, Day 5, six weeks
measure: Flourishing
timeFrame: Baseline, Day 5, six weeks
measure: Loneliness
timeFrame: Baseline, Day 5, six weeks
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Ashmolean Museum Website
state: Oxfordshire
Study officials:
References:
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.