DepressionNCT04566042
A Novel ACT-based Video Game
A study testing Acceptance and commitment therapy video game in people with Depression and Anxiety, run by Swansea University at 1 site in United Kingdom.
Trial summary
A feasibility study to explore whether an acceptance and commitment therapy (ACT) can reduce mental health outcomes (stress, anxiety, depression) and increase psychological flexibility. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Stress, Emotional
- What is being tested?
- Acceptance and commitment therapy video game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Jul 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Those who are under 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Depression, Anxiety, Stress, Emotional, Quality of Life, Psychological Flexibility, Social Connecedness
- Being tested
- Acceptance and commitment therapy video game
- Medical subject headings
- Depression, Anxiety Disorders, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and commitment therapy video gameBehavioural
The intervention is a videogame which teaches the participant about acceptance and commitment therapy.
| Study group | Role | What they receive |
|---|---|---|
| ACT video game | Experimental | Not described Receives: Behavioral: Acceptance and commitment therapy video game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants recruited for the study
Feasibility outcome for recruitment.
Measured: 3 Weeks
Number of participants who completed all aspects of the study
Feasibility outcome for retention of participants.
Measured: 3 Weeks
Reflexive thematic analysis themes
Acceptability of the intervention assessed through qualitative analysis of semi-structured interviews.
Measured: 3 Weeks; Immediate post intervention, and 3-week follow-up
Secondary outcomes (12)
Depression Anxiety Stress Scale-21 (Depression subscale)
Quantitative psychometric measure for depression. Score Range: Min=0, Max=21. Higher scores indicate higher depression.
Measured: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
Depression Anxiety Stress Scale-21 (Anxiety subscale)
Quantitative psychometric measure for anxiety. Score Range: Min=0, Max=21. Higher scores indicate higher anxiety.
Measured: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
Depression Anxiety Stress Scale-21 (Stress subscale)
Quantitative psychometric measure for stress. Score Range: Min=0, Max=21. Higher score indicate higher stress.
Measured: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
Acceptance and Action Questionnaire- second version
Quantitative psychometric measure for psychological inflexibility. Score Range: Min=7, Max=49. Higher scores indicate higher psychological inflexibility.
Measured: 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)
Quantitative psychometric measure of Social Connectedness. Score range: Min=2, Max=8. Higher scores indicate higher social connectedness.
Measured: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
Warwick-Edinburgh Mental Well-Being Scale
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.
Measured: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
EuroQol five dimensions (Mobility Subscale)
Score Range: Min=1, Max=5. Higher scores indicate lower mobility.
Measured: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
EuroQol five dimensions (Self-care Subscale)
Score Range: Min=1, Max=5. Higher scores indicate lower self-care.
Measured: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
EuroQol five dimensions (Usual Activities Subscale)
Score Range: Min=1, Max=5. Higher scores indicate lower partaking in usual activities.
Measured: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
EuroQol five dimensions (Pain/Discomfort Subscale)
Score Range: Min=1, Max=5. Higher scores indicate lower pain/discomfort.
Measured: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
EuroQol five dimensions (Anxiety/Depression Subscale)
Score Range: Min=1, Max=5. Higher scores indicate lower anxiety/depression.
Measured: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
EuroQol five dimensions (Score to indicate how health is today)
Score Range: Min=0, Max=100. Higher scores indicate higher health.
Measured: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start31 Jul 2021
- Primary completion31 Jan 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swansea University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darren Edwards, Swansea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566042
- Sponsor's protocol ID
- Swansea U1
- Status last verified
- Feb 2024
- First submitted
- 21 Sep 2020
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gordon TC, Kemp AH, Edwards DJ. Mixed-methods feasibility outcomes for a novel ACT-based video game 'ACTing Minds' to support mental health. BMJ Open. 2024 Mar 29;14(3):e080972. doi: 10.1136/bmjopen-2023-080972.
PubMed 38553053Edwards DJ, Kemp AH. A novel ACT-based video game to support mental health through embedded learning: a mixed-methods feasibility study protocol. BMJ Open. 2020 Nov 16;10(11):e041667. doi: 10.1136/bmjopen-2020-041667.
PubMed 33199427
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel ACT-based Video Game to Support Mental Health Through Embedded Learning: A Mixed-methods Feasibility Study Protocol
- ClinicalTrials.gov ID
- NCT04566042
- Acronym / sponsor ID
- Swansea U1
- Conditions
- Depression, Anxiety, Stress, Emotional, Quality of Life, Psychological Flexibility, Social Connecedness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Swansea UniversityUniversity, hospital or other
- Study start
- 31 Jul 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACT video game | Experimental | Behavioral: Acceptance and commitment therapy video game |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Those who are under 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and commitment therapy video gameThe intervention is a videogame which teaches the participant about acceptance and commitment therapy. | Behavioural | ACT video game |
Primary outcome
Number of participants recruited for the study
Time frame: 3 Weeks
Feasibility outcome for recruitment.
Number of participants who completed all aspects of the study
Time frame: 3 Weeks
Feasibility outcome for retention of participants.
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.
12 secondary outcomes
Depression Anxiety Stress Scale-21 (Depression subscale)
Time frame: 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
Depression Anxiety Stress Scale-21 (Stress subscale)
Time frame: 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
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
Warwick-Edinburgh Mental Well-Being Scale
Time frame: 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
EuroQol five dimensions (Self-care Subscale)
Time frame: 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
EuroQol five dimensions (Pain/Discomfort Subscale)
Time frame: 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
EuroQol five dimensions (Score to indicate how health is today)
Time frame: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Derived from this study: PubMed 38553053Gordon TC, Kemp AH, Edwards DJ. Mixed-methods feasibility outcomes for a novel ACT-based video game 'ACTing Minds' to support mental health. BMJ Open. 2024 Mar 29;14(3):e080972. doi: 10.1136/bmjopen-2023-080972.
- Derived from this study: PubMed 33199427Edwards DJ, Kemp AH. A novel ACT-based video game to support mental health through embedded learning: a mixed-methods feasibility study protocol. BMJ Open. 2020 Nov 16;10(11):e041667. doi: 10.1136/bmjopen-2020-041667.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and commitment therapy video game in people with Depression and Anxiety, run by Swansea University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants recruited for the study (time frame: 3 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04566042, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.