A Novel ACT-based Video Game

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04566042
• Other study ID #: Swansea U1
• Status: Completed
• Phase: N/A
• Start date: July 31, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2024
• Source: Swansea University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Psychological Flexibility
• Quality of Life
• Social Connecedness
• Stress, Emotional
• Stress, Psychological

Intervention

Behavioral:
• Acceptance and commitment therapy video game
The intervention is a videogame which teaches the participant about acceptance and commitment therapy.

Locations

Country	Name	City	State
United Kingdom	Swansea University	Swansea	Wales

Sponsors (1)

Lead Sponsor	Collaborator
Swansea University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants recruited for the study	Feasibility outcome for recruitment.	3 Weeks
Primary	Number of participants who completed all aspects of the study	Feasibility outcome for retention of participants.	3 Weeks
Primary	Reflexive thematic analysis themes	Acceptability of the intervention assessed through qualitative analysis of semi-structured interviews.	3 Weeks; Immediate post intervention, and 3-week follow-up
Secondary	Depression Anxiety Stress Scale-21 (Depression subscale)	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
Secondary	Depression Anxiety Stress Scale-21 (Anxiety subscale)	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
Secondary	Depression Anxiety Stress Scale-21 (Stress subscale)	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
Secondary	Acceptance and Action Questionnaire- second version	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
Secondary	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.	3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
Secondary	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.	3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
Secondary	EuroQol five dimensions (Mobility Subscale)	Score Range: Min=1, Max=5. Higher scores indicate lower mobility.	3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
Secondary	EuroQol five dimensions (Self-care Subscale)	Score Range: Min=1, Max=5. Higher scores indicate lower self-care.	3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
Secondary	EuroQol five dimensions (Usual Activities Subscale)	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
Secondary	EuroQol five dimensions (Pain/Discomfort Subscale)	Score Range: Min=1, Max=5. Higher scores indicate lower pain/discomfort.	3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
Secondary	EuroQol five dimensions (Anxiety/Depression Subscale)	Score Range: Min=1, Max=5. Higher scores indicate lower anxiety/depression.	3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
Secondary	EuroQol five dimensions (Score to indicate how health is today)	Score Range: Min=0, Max=100. Higher scores indicate higher health.	3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up