Clinical trial NCT04566042: A Novel ACT-based Video Game
Official title: A Novel ACT-based Video Game to Support Mental Health Through Embedded Learning: A Mixed-methods Feasibility Study Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Stress, Emotional
Quality of Life
Psychological Flexibility
Social Connecedness
Lead sponsor: Swansea University
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants recruited for the study
timeFrame: 3 Weeks
measure: Number of participants who completed all aspects of the study
timeFrame: 3 Weeks
measure: Reflexive thematic analysis themes
timeFrame: 3 Weeks; Immediate post intervention, and 3-week follow-up
Secondary outcomes:
measure: Depression Anxiety Stress Scale-21 (Depression subscale)
timeFrame: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
measure: Depression Anxiety Stress Scale-21 (Anxiety subscale)
timeFrame: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
measure: Depression Anxiety Stress Scale-21 (Stress subscale)
timeFrame: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
measure: Acceptance and Action Questionnaire- second version
timeFrame: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
measure: Social Connectedness (adapted from Russell's (1996) University of California, Los Angeles Loneliness Scale)
timeFrame: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
measure: Warwick-Edinburgh Mental Well-Being Scale
timeFrame: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
measure: EuroQol five dimensions (Mobility Subscale)
timeFrame: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
measure: EuroQol five dimensions (Self-care Subscale)
timeFrame: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
measure: EuroQol five dimensions (Usual Activities Subscale)
timeFrame: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
measure: EuroQol five dimensions (Pain/Discomfort Subscale)
timeFrame: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
measure: EuroQol five dimensions (Anxiety/Depression Subscale)
timeFrame: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
measure: EuroQol five dimensions (Score to indicate how health is today)
timeFrame: 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
Other outcomes:
Locations:
city: Swansea
country: United Kingdom
facility: Swansea University
state: Wales
Study officials:
References:
citation: Edwards 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.