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Completed

NCT Number: NCT04663594

Online Culture for Mental Health in People Aged 16-24

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.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders

Age range

16 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ashmolean Museum Website

Oxford, Oxfordshire, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

People ages 16-24

Exclusion criteria

  • No access to a laptop or desktop computer

Treatment and study plan

WofB

Other

Online experience designed to reduce anxiety and depression and support mental health and wellbeing

Ashmolean Website

Other

A generic museum website owned by the Ashmolean Museum of Art and Archaeology at the University of Oxford.

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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).

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study 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

Acronym: O-ACEPOP

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 11, 2020
Registry last updated
May 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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