NCT04566042

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 28, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

July 31, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 4, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

September 21, 2020

Last Update Submit

February 29, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Number of participants recruited for the study

    Feasibility outcome for recruitment.

    3 Weeks

  • Number of participants who completed all aspects of the study

    Feasibility outcome for retention of participants.

    3 Weeks

  • 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 Outcomes (12)

  • Depression Anxiety Stress Scale-21 (Depression subscale)

    3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up

  • Depression Anxiety Stress Scale-21 (Anxiety subscale)

    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

  • +7 more secondary outcomes

Study Arms (1)

ACT video game

EXPERIMENTAL
Behavioral: Acceptance and commitment therapy video game

Interventions

The intervention is a videogame which teaches the participant about acceptance and commitment therapy.

ACT video game

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Those who are under 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swansea University

Swansea, Wales, SA28PP, United Kingdom

Location

Related Publications (2)

  • Gordon TC, Kemp AH, Edwards DJ. Mixed-methods feasibility outcomes for a novel ACT-based video game 'ACTing Minds' to support mental health. BMJ Open. 2024 Mar 29;14(3):e080972. doi: 10.1136/bmjopen-2023-080972.

  • 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.

MeSH Terms

Conditions

DepressionAnxiety DisordersStress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

September 21, 2020

First Posted

September 28, 2020

Study Start

July 31, 2021

Primary Completion

January 31, 2022

Study Completion

December 31, 2022

Last Updated

March 4, 2024

Record last verified: 2024-02

Locations