- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04566042
A Novel ACT-based Video Game
February 29, 2024 updated by: Darren Edwards, Swansea University
A Novel ACT-based Video Game to Support Mental Health Through Embedded Learning: A Mixed-methods Feasibility Study Protocol
A feasibility study to explore whether an acceptance and commitment therapy (ACT) can reduce mental health outcomes (stress, anxiety, depression) and increase psychological flexibility.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
29
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
-
-
Wales
-
Swansea, Wales, United Kingdom, SA28PP
- Swansea University
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Adults reporting some existing form of anxiety, depression or ongoing stress.
- Need ability to read and write English.
- Need internet access to play the videogame.
Exclusion Criteria:
- Those who are under 18
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: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ACT video game
|
The intervention is a videogame which teaches the participant about acceptance and commitment therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants recruited for the study
Time Frame: 3 Weeks
|
Feasibility outcome for recruitment.
|
3 Weeks
|
Number of participants who completed all aspects of the study
Time Frame: 3 Weeks
|
Feasibility outcome for retention of participants.
|
3 Weeks
|
Reflexive thematic analysis themes
Time Frame: 3 Weeks; Immediate post intervention, and 3-week follow-up
|
Acceptability of the intervention assessed through qualitative analysis of semi-structured interviews.
|
3 Weeks; Immediate post intervention, and 3-week follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression Anxiety Stress Scale-21 (Depression subscale)
Time Frame: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
|
Quantitative psychometric measure for depression.
Score Range: Min=0, Max=21.
Higher scores indicate higher depression.
|
3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
|
Depression Anxiety Stress Scale-21 (Anxiety subscale)
Time Frame: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
|
Quantitative psychometric measure for anxiety.
Score Range: Min=0, Max=21.
Higher scores indicate higher anxiety.
|
3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
|
Depression Anxiety Stress Scale-21 (Stress subscale)
Time Frame: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
|
Quantitative psychometric measure for stress.
Score Range: Min=0, Max=21.
Higher score indicate higher stress.
|
3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
|
Acceptance and Action Questionnaire- second version
Time Frame: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
|
Quantitative psychometric measure for psychological inflexibility.
Score Range: Min=7, Max=49.
Higher scores indicate higher psychological inflexibility.
|
3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
|
Social Connectedness (adapted from Russell's (1996) University of California, Los Angeles Loneliness Scale)
Time Frame: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
|
Quantitative psychometric measure of Social Connectedness.
Score range: Min=2, Max=8.
Higher scores indicate higher social connectedness.
|
3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
|
Warwick-Edinburgh Mental Well-Being Scale
Time Frame: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
|
Quantitative psychometric measure of mental well-being with a focus on positive aspects of mental health.
Score Range: Min=14, Max=70.
Higher scores indicate higher wellbeing.
|
3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
|
EuroQol five dimensions (Mobility Subscale)
Time Frame: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
|
Score Range: Min=1, Max=5.
Higher scores indicate lower mobility.
|
3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
|
EuroQol five dimensions (Self-care Subscale)
Time Frame: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
|
Score Range: Min=1, Max=5.
Higher scores indicate lower self-care.
|
3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
|
EuroQol five dimensions (Usual Activities Subscale)
Time Frame: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
|
Score Range: Min=1, Max=5.
Higher scores indicate lower partaking in usual activities.
|
3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
|
EuroQol five dimensions (Pain/Discomfort Subscale)
Time Frame: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
|
Score Range: Min=1, Max=5.
Higher scores indicate lower pain/discomfort.
|
3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
|
EuroQol five dimensions (Anxiety/Depression Subscale)
Time Frame: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
|
Score Range: Min=1, Max=5.
Higher scores indicate lower anxiety/depression.
|
3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
|
EuroQol five dimensions (Score to indicate how health is today)
Time Frame: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
|
Score Range: Min=0, Max=100.
Higher scores indicate higher health.
|
3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
July 31, 2021
Primary Completion (Actual)
January 31, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
September 21, 2020
First Submitted That Met QC Criteria
September 24, 2020
First Posted (Actual)
September 28, 2020
Study Record Updates
Last Update Posted (Actual)
March 4, 2024
Last Update Submitted That Met QC Criteria
February 29, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Swansea U1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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