A Novel ACT-based Video Game

• Sponsor: Swansea University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04566042
• Collaborator: (none)
• Enrollment: 30
• Arm: 1
• Anticipated Duration (Months): 20

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Jan 1, 2021
• Anticipated Primary Completion Date: Jan 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Depression Anxiety Stress Scales (DASS21) [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 [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 [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). [1 year]

   A measure for health-related quality of life.

4. Acceptance and Action Questionnaire- second version (AAQ-II). [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Swansea University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Darren Edwards, Senior Lecturer, Swansea University
• ClinicalTrials.gov Identifier: NCT04566042
• Other Study ID Numbers: Swansea U1
• First Posted: Sep 28, 2020
• Last Update Posted: Sep 28, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 28, 2020