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Clinical Trials/NCT04566042
NCT04566042CompletedNot Applicable

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

Swansea University1 site in 1 country29 target enrollmentStarted: July 31, 2021Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
29
Locations
1
Primary Endpoint
Number of participants who completed all aspects of the study
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

ACT video game

Experimental

Intervention: Acceptance and commitment therapy video game (Behavioral)

Outcomes

Primary Outcomes

Number of participants who completed all aspects of the study

Time Frame: 3 Weeks

Feasibility outcome for retention of participants.

Number of participants recruited for the study

Time Frame: 3 Weeks

Feasibility outcome for recruitment.

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

  • Depression Anxiety Stress Scale-21 (Anxiety subscale)(3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up)
  • Depression Anxiety Stress Scale-21 (Depression subscale)(3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up)
  • EuroQol five dimensions (Usual Activities Subscale)(3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up)
  • EuroQol five dimensions (Mobility Subscale)(3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up)
  • EuroQol five dimensions (Score to indicate how health is today)(3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up)
  • EuroQol five dimensions (Self-care Subscale)(3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up)
  • EuroQol five dimensions (Pain/Discomfort Subscale)(3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up)
  • EuroQol five dimensions (Anxiety/Depression Subscale)(3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up)
  • Warwick-Edinburgh Mental Well-Being Scale(3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up)
  • Depression Anxiety Stress Scale-21 (Stress subscale)(3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up)
  • Acceptance and Action Questionnaire- second version(3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up)
  • Social Connectedness (adapted from Russell's (1996) University of California, Los Angeles Loneliness Scale)(3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Darren Edwards

Senior Lecturer

Swansea University

Study Sites (1)

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