ACTing Minds: An ACT-based Videogame for Mental Health

NCT07272096 | Completed

• 1 other identifier: SU-PSY-ACTM-RCT-01
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test whether a single-session Acceptance and Commitment Therapy (ACT) videogame (ACTing Minds) improves psychological flexibility and mental health in adults who report mild to moderate depression, anxiety or stress. The main questions are whether ACTing Minds increases psychological flexibility (CompACT Total) more than a time- and engagement-matched neutral commercial game at the end of the session and again at short-term follow-up (10-13 days), and whether it produces favourable changes in symptoms, wellbeing, social connectedness, health-related quality of life, and short seated heart-rate variability recordings. Researchers will compare ACTing Minds with the neutral game to determine whether the ACT-based experience leads to greater improvements. Participants attend one laboratory visit of about 60 minutes, complete brief questionnaires at baseline, immediately after the session and at short-term follow-up, and provide a short seated ECG at each timepoint for heart-rate variability analysis. The study uses a single-blind, two-arm, randomised, parallel-group design at Swansea University (UK).

Conditions

Anxiety; Stress (Psychology); Psychological Flexibility; Quality of Life; Social Connectedness; Wellbeing; Depression

Keywords

Acceptance and Commitment Therapy; ACT; Psychological flexibility; Digital mental health; Serious game; Videogame intervention; Single-session intervention; Randomised controlled trial; CompACT; DASS-21; Flourishing Scale; Social Connectedness Scale; EQ-5D; Heart rate variability; HRV; ECG

Outcome Measures

Primary Outcomes (2)

• Psychological flexibility (CompACT Total)

  CompACT total score; higher scores indicate greater psychological flexibility. Primary estimand is the between-group difference in change from baseline to short-term follow-up (10-13 days post-intervention); post-session estimates will also be reported.

  Baseline (Day 0); Immediately post-intervention (≈60 minutes after Baseline); short-term follow-up (10-13 days post-intervention).

• Mental-health symptoms (DASS-21 Total)

  DASS-21 total score; higher scores indicate greater symptom severity.

  Baseline (Day 0); Immediately post-intervention (≈60 minutes after Baseline); Short-term follow-up (10-13 days post-intervention).

Secondary Outcomes (13)

• Depressive symptoms (DASS-21 Depression)

  Baseline (Day 0); Immediately post-intervention (≈60 minutes after Baseline); Short-term follow-up (10-13 days post-intervention).

• Anxiety symptoms (DASS-21 Anxiety)

  Baseline (Day 0); Immediately post-intervention (≈60 minutes after Baseline); Short-term follow-up (10-13 days post-intervention).

• Stress symptoms (DASS-21 Stress)

  Baseline (Day 0); Immediately post-intervention (≈60 minutes after Baseline); Short-term follow-up (10-13 days post-intervention).

• Wellbeing (Flourishing Scale)

  Baseline (Day 0); Immediately post-intervention (≈60 minutes after Baseline); Short-term follow-up (10-13 days post-intervention).

• Social connectedness (Social Connectedness Scale)

  Baseline (Day 0); Immediately post-intervention (≈60 minutes after Baseline); Short-term follow-up (10-13 days post-intervention).

Study Arms (2)

ACTing Minds (ACT videogame)

EXPERIMENTAL

Single \~60-minute session on a study-supplied smartphone in the lab; assessments at baseline, post-session, and short-term follow-up (10-13 days post-intervention).

Behavioral: ACTing Minds (ACT videogame)

Neutral commercial puzzle game (Monument Valley)

ACTIVE COMPARATOR

Engagement- and time-matched \~60-minute smartphone session in the lab; assessments at baseline, post-session, and short-term follow-up (10-13 days post-intervention).

Behavioral: Monument Valley (mobile; neutral control)

Interventions

ACTing Minds (ACT videogame) BEHAVIORAL

Single-session (\~60 min) ACT-based videogame integrating acceptance/openness, cognitive defusion, present-moment awareness, values and values-guided action via structured chapters. Delivered on a study-supplied Samsung Galaxy S9+ (Android) under standardised instructions; no therapist guidance during play.

ACTing Minds (ACT videogame)

Monument Valley (mobile; neutral control) BEHAVIORAL

Commercial mobile puzzle game used as an engagement- and time-matched control (\~60 min) with no therapeutic content. Delivered on a study-supplied Samsung Galaxy S9+ (Android) in the lab. Title/version fixed for the trial; procedures and environment identical to the experimental arm. No data are collected within the app.

Neutral commercial puzzle game (Monument Valley)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older
• Able to read and understand English
• Self-reported mild to moderate symptoms of depression, anxiety, or stress
• Provides written informed consent
• Willing and able to attend one \~60-minute laboratory session and complete online follow-up questionnaires 10-13 days later
• Agrees to ECG recording (seated \~5 minutes at each timepoint)
• Willing to play either study videogame on a study-supplied Samsung Galaxy S9+ (Android)

You may not qualify if:

• Current or past severe mental illness (e.g., psychotic disorder, bipolar disorder)
• Current psychotropic medication use (e.g., antidepressants, anxiolytics, antipsychotics, mood stabilisers, stimulants)
• Concurrent psychological therapy (any modality)
• Pregnancy
• Cardiovascular conditions or clinically significant arrhythmias that could affect ECG or HRV measurement or be exacerbated by study procedures
• Implanted cardiac devices (e.g., pacemaker or ICD)
• Any neurological condition, medical condition, or skin condition that would preclude safe ECG electrode placement or comfortable seated recording
• Insufficient English proficiency to provide informed consent or complete study measures
• Any other factor that, in the judgement of the investigators, would compromise safety, data quality, or protocol compliance

Sponsors & Collaborators

• Swansea University: lead

Study Sites (1)

Swansea University, School of Psychology (Singleton Park)

Swansea, Wales, SA2 8PP, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 33199427 BACKGROUND

• 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.

  PMID: 38553053 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Darren J Edwards, PhD

  Swansea University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants masked to allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Two-arm, 1:1 randomised, single-session, laboratory-based trial.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 9, 2025
• Study Start: November 26, 2025
• Primary Completion: December 9, 2025
• Study Completion: December 9, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data and documents will be made available at article acceptance/publication. If journal processes impose a brief embargo, release will occur within 3 months of acceptance. Materials will be retained indefinitely with versioning; any material updates (e.g., errata, code revisions) will be posted to the same repository. The registry will be updated with the dataset DOI/URL on release.
• Access Criteria: Open access: no application required. De-identified IPD (questionnaire outcomes, HRV summary indices, mean heart rate, allocation group, age band, gender), data dictionary, SAP, protocol, consent template, and analysis code will be downloadable from a public repository.

Locations

GB (1)