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Completed

NCT Number: NCT04566042

A Novel ACT-based Video Game

A feasibility study to explore whether an acceptance and commitment therapy (ACT) can reduce mental health outcomes (stress, anxiety, depression) and increase psychological flexibility.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders Psychological Flexibility Quality of Life Social Connecedness Stress, Emotional Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Swansea University

Swansea, Wales, SA28PP, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Acceptance and commitment therapy video game

Behavioral

The intervention is a videogame which teaches the participant about acceptance and commitment therapy.

Primary outcomes

  1. Number of participants recruited for the study

    Time frame: 3 Weeks

    Feasibility outcome for recruitment.

  2. Number of participants who completed all aspects of the study

    Time frame: 3 Weeks

    Feasibility outcome for retention of participants.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

Swansea University

Other

Registry information

Official study title

A Novel ACT-based Video Game to Support Mental Health Through Embedded Learning: A Mixed-methods Feasibility Study Protocol

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 28, 2020
Registry last updated
Mar 4, 2024

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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