Online Culture for Mental Health in People Aged 16-24 (O-ACEPOP)

May 5, 2022 updated by: University of Oxford

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

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.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

463

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom
        • Ashmolean Museum Website

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

People ages 16-24

Exclusion Criteria:

  • No access to a laptop or desktop computer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2020

Primary Completion (Actual)

February 10, 2021

Study Completion (Actual)

February 10, 2021

Study Registration Dates

First Submitted

November 27, 2020

First Submitted That Met QC Criteria

December 4, 2020

First Posted (Actual)

December 11, 2020

Study Record Updates

Last Update Posted (Actual)

May 6, 2022

Last Update Submitted That Met QC Criteria

May 5, 2022

Last Verified

May 1, 2022

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)?

Yes

IPD Plan Description

The data will be made available on OSF once peer reviewed

IPD Sharing Time Frame

The data will be made available on OSF once peer reviewed

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

No

Studies a U.S. FDA-regulated device product

No

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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