- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04663594
Online Culture for Mental Health in People Aged 16-24 (O-ACEPOP)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oxfordshire
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Oxford, Oxfordshire, United Kingdom
- Ashmolean Museum Website
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
People ages 16-24
Exclusion Criteria:
- No access to a laptop or desktop computer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ways of Being online Experience
Ways of Being (WoB) every day for three days
|
Online experience designed to reduce anxiety and depression and support mental health and wellbeing
|
|
Other: Ashmolean Website
The Ashmolean Website every day for three days
|
A generic museum website owned by the Ashmolean Museum of Art and Archaeology at the University of Oxford.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PANAS
Time Frame: Baseline, Days 2-4 (morning and evening), Day 5, six weeks
|
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)
|
Baseline, Days 2-4 (morning and evening), Day 5, six weeks
|
|
K10
Time Frame: Baseline, Day 5, six weeks
|
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)
|
Baseline, Day 5, six weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Facial expression recognition task
Time Frame: Baseline, Day 5, six weeks
|
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)
|
Baseline, Day 5, six weeks
|
|
Probabilistic Incentive Learning Task
Time Frame: Baseline, Day 5, six weeks
|
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)
|
Baseline, Day 5, six weeks
|
|
Flourishing
Time Frame: Baseline, Day 5, six weeks
|
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)
|
Baseline, Day 5, six weeks
|
|
Loneliness
Time Frame: Baseline, Day 5, six weeks
|
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).
|
Baseline, Day 5, six weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0009275
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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