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A Novel ACT-based Video Game

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ClinicalTrials.gov Identifier: NCT04566042
Recruitment Status : Not yet recruiting
First Posted : September 28, 2020
Last Update Posted : September 28, 2020
Sponsor:
Information provided by (Responsible Party):
Darren Edwards, Swansea University

Brief 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.

Condition or disease Intervention/treatment Phase
Depression Anxiety Stress, Emotional Quality of Life Psychological Flexibility Social Connecedness Behavioral: Acceptance and commitment therapy video game Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Novel ACT-based Video Game to Support Mental Health Through Embedded Learning: A Mixed-methods Feasibility Study Protocol
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ACT video game Behavioral: Acceptance and commitment therapy video game
The intervention is a videogame which teaches the participant about acceptance and commitment therapy.




Primary Outcome Measures :
  1. Depression Anxiety Stress Scales (DASS21) [ Time Frame: 1 year. ]
    A measure of general psychological distress (assesses current depression, anxiety, and stress).


Secondary Outcome Measures :
  1. Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) with a focus on positive aspects of mental health. This measure has good internal consistency with a Cronbach's alpha coefficient of 0.89 (student sample) and 0.91 [ Time Frame: 1 year ]
    A measure of mental well-being with a focus on positive aspects of mental health

  2. University of California, Los Angeles (UCLA) Loneliness Scale [ Time Frame: 1 Year ]
    This measure involves two questions; (1) "During these social interactions, I felt 'in tune' with the person/s around me", and (2) "During these social interactions, I felt close to the person/s."

  3. EuroQol five dimensions (EQ5D). [ Time Frame: 1 year ]
    A measure for health-related quality of life.

  4. Acceptance and Action Questionnaire- second version (AAQ-II). [ Time Frame: 1 year ]
    A measure psychological inflexibility, which involves the ability to accept and be open to difficult thoughts and feelings as well as to engage in valued behaviour in the presence of the difficult thoughts and feelings.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults with some existing form of anxiety, depression or ongoing stress. Need ability to read and write English. Need internet access to plat the videogame.

Exclusion Criteria:

  • Those who are under 18, and do not have any existing forms of anxiety, stress or depression.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Darren Edwards, Senior Lecturer, Swansea University
ClinicalTrials.gov Identifier: NCT04566042    
Other Study ID Numbers: Swansea U1
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms