Benefits of Exergames on Neurocognitive Functions in Adults Suffering From Depression (MUDGAME)

July 16, 2025 updated by: PhD Prof. Eloisa Ruiz-Marquez, MAP Institute

MUDgame A Randomized Multi-Arm Controlled Experiment for Measuring the Benefits of an Exergame-based Intervention on Neuro-cognitive Functions in Adults Suffering From Depression

The purpose of this study is to analyse the changes derived from exergames (videogames that include cognitive and physical stimulation simultaneously), in terms of cognitive functioning, psychomotor abilities, and its neural substrate, in adults suffering from depression.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The experiment will consist in a randomized three-arms controlled study. After being informed about the study and potential risks, and given written informed consent, adult participants with depression will be randomly distributed into three experimental groups: an intervention group that will train with exergames, an active control group that will train only with cognitive games, and a passive control group or wait-list.

Cognitive Functions will be evaluated in three different moments: before the training intervention, after the intervention, and three months after finishing the training intervention.

Researchers will collect cognitive-behavioral and neural information (event-related potentials), and performing analysis of variance to compare the outcomes of the diverse groups at the three different time points, scientists will analyse the benefits of exergames on cognition.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

The inclusion and exclusion criteria for persons suffering from depression, will be validated by a professional (psychologist), through an interview and the use of reliable and valid psychological assessment tools.

Inclusion Criteria:

  • Using the Beck Depression Inventory-Second Edition (BDI-II), a scored considered for inclusion criteria where depression (≥ 28 points on BDI-II), confirmed by psychological interview.
  • A sufficient level of education to understand study procedures and be able to communicate with site personnel

Exclusion Criteria:

  • Participants suffering from depression with comorbidities (bipolar disorder, obsessive-compulsion disorder, neurological disorder, or traumatic brain injury) will be excluded.
  • <20/60 vision with or without correction
  • Inability to complete the activities
  • Communication problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exergame-Based Training
Participants train with exergames (video games that include cognitive and physical training simultaneously), The training regime consists of 40-50 min sessions, two sessions per week, for a total of eight weeks of individual training.
Behavioral: Exergame-Based Training
40-50 min sessions, two sessions per week, for a total of eight weeks.
Active Comparator: Cognitive-Based Training
Participants will train only with cognitive video games. The training regime consists of 40-50 min sessions, two sessions per week, for a total of eight weeks of individual training.
Behavioral: Cognitive-Based Training
40-50 min sessions, two sessions per week, for a total of eight weeks.
Placebo Comparator: Wait-List
Participants will not train with any program and they will not assist to any specific session.
Behavioral: Wait-List
Participants will not train with any program and they will not assist to any specific session or intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Neuropsychological and Cognitive Functions (Executive Functions measured with the Wisconsin Card Sorting Test) after eight weeks of training intervention or placebo condition.
Time Frame: Baseline and after eight weeks of training (Pre-assessment and Post-assessment)

Researchers will use valid and realiable experimental tasks to measure the psychological functions after eight weeks of training. Executive functions (Wisconsin Card Sorting Test). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials).

(This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Baseline and after eight weeks of training (Pre-assessment and Post-assessment)
Change from Baseline in Neuropsychological and Cognitive Functions (Memory will be measured with the tests Digit Spam Forward and Digit Spam Backward, from the Wechsler Memory Scale) after eight weeks of training intervention or placebo condition.
Time Frame: Baseline and after eight weeks of training (Pre-assessment and Post-assessment)

Researchers will use valid and realiable experimental tasks to measure the psychological functions after eight weeks of training. Memory (measured with the tests Digit Spam Forward and Digit Spam Backward, from the Wechsler Memory Scale). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials).

(This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Baseline and after eight weeks of training (Pre-assessment and Post-assessment)
Change from Baseline in Neuropsychological and Cognitive Functions (Attention; sustained attention will be measured with the Sustained Attention to Response Task, SART) after eight weeks of training intervention or placebo condition.
Time Frame: Baseline and after eight weeks of training (Pre-assessment and Post-assessment)

Researchers will use valid and realiable experimental tasks to measure the psychological functions after eight weeks of training. Attention (measured with the Sustained Attention to Response Task). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials).

(This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Baseline and after eight weeks of training (Pre-assessment and Post-assessment)
Change from Baseline in Neuropsychological and Cognitive Functions (Perception, visual perception will be measured with a classical Visual Search Task) after eight weeks of training intervention or placebo condition.
Time Frame: Baseline and after eight weeks of training (Pre-assessment and Post-assessment)

Researchers will use valid and realiable experimental tasks to measure the psychological functions after eight weeks of training. Perception (measured with a classical Visual Search Task). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials).

(This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Baseline and after eight weeks of training (Pre-assessment and Post-assessment)
Change from Baseline in Neuropsychological and Cognitive Functions (Processing Speed, measured with a Simple Reaction Times Task) after eight weeks of training intervention or placebo condition.
Time Frame: Baseline and after eight weeks of training (Pre-assessment and Post-assessment)

Researchers will use valid and realiable experimental tasks to measure the psychological functions after eight weeks of training. Processing Speed (measured with a Simple Reaction Times Task). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials).

(This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Baseline and after eight weeks of training (Pre-assessment and Post-assessment)
Change from Baseline in Neuropsychological and Cognitive Functions (Psychomotor functions, measured with the Salpêtrière Retardation Rating Scale) after eight weeks of training intervention or placebo condition.
Time Frame: Baseline and after eight weeks of training (Pre-assessment and Post-assessment)

Researchers will use valid and realiable experimental tasks to measure the psychological functions after eight weeks of training. Psychomotor functions (measured with the Salpetriere Retardation Rating Scale). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials).

(This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Baseline and after eight weeks of training (Pre-assessment and Post-assessment)
Change from Post-assessment in Neuropsychological and Cognitive Functions (Executive functions measured with Wisconsin Card Sorting Test) after 3-month follow-up.
Time Frame: Three-month follow-up

Researchers will use valid and realiable experimental tasks to measure the psychological functions after 3-month follow-up. Executive functions (measured with Wisconsin Card Sorting Test). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials).

(This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Three-month follow-up
Change from Post-assessment in Neuropsychological and Cognitive Functions (Memory will be measured with the tests Digit Spam Forward and Digit Spam Backward, from the Wechsler Memory Scale) after 3-month follow-up.
Time Frame: Three-month follow-up

Researchers will use valid and realiable experimental tasks to measure the psychological functions after 3-month follow-up. Memory (measured with the tests Digit Spam Forward and Digit Spam Backward, from the Wechsler Memory Scale). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials).

(This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Three-month follow-up
Change from Post-assessment in Neuropsychological and Cognitive Functions (Attention; sustained attention will be measured with the Sustained Attention to Response Task) after 3-month follow-up.
Time Frame: Three-month follow-up

Researchers will use valid and realiable experimental tasks to measure the psychological functions after 3-month follow-up. Attention (measured with the Sustained Attention to Response Task). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials).

(This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Three-month follow-up
Change from Post-assessment in Neuropsychological and Cognitive Functions (Perception, visual perception will be measured with a classical Visual Search Task) after 3-month follow-up.
Time Frame: Three-month follow-up

Researchers will use valid and realiable experimental tasks to measure the psychological functions after 3-month follow-up. Perception (measured with a classical Visual Search Task). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials).

(This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Three-month follow-up
Change from Post-assessment in Neuropsychological and Cognitive Functions (Processing Speed, measured with a Simple Reaction Times Task) after 3-month follow-up.
Time Frame: Three-month follow-up

Researchers will use valid and realiable experimental tasks to measure the psychological functions after 3-month follow-up. Processing Speed (measured with a Simple Reaction Times Task). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials).

(This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Three-month follow-up
Change from Post-assessment in Neuropsychological and Cognitive Functions (Psychomotor functions, measured with the Salpêtrière Retardation Rating Scale) after 3-month follow-up.
Time Frame: Three-month follow-up

Researchers will use valid and realiable experimental tasks to measure the psychological functions after 3-month follow-up. Psychomotor functions (measured with the Salpetriere Retardation Rating Scale). The task mentioned here may be subject of modification. The measures include behavioral data (accuracy and reaction times) and neural data (event related potentials).

(This test is going to be used as an experimental psychological task and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value in accuracy or reaction times).
Three-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Placebo Effect measures (Motivation) after eight weeks of training.
Time Frame: Baseline and after eight weeks of training (Pre-assessment, Post-assessment)

To measure the changes form baseline to the post-intervention, researchers will use to measure motivation a self-report 5-point Likert-type scale (1 = not motivated, to 5 = extremely motivated)

(This test is going to be used as a experimental self-report and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value regarding the results).
Baseline and after eight weeks of training (Pre-assessment, Post-assessment)
Change from Baseline in Placebo Effect measures (Engagement) after eight weeks of training.
Time Frame: Baseline and after eight weeks of training (Pre-assessment, Post-assessment)

To measure the changes form baseline to the post-intervention, researchers will use to measure engagement a self-report 5-point Likert-type scale (1 = not engaged, to 5 = extremely immersed).

(This test is going to be used as a experimental self-report and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value regarding the results).
Baseline and after eight weeks of training (Pre-assessment, Post-assessment)
Change from Baseline in Placebo Effect measures (Expectations) after eight weeks of training.
Time Frame: Baseline and after eight weeks of training (Pre-assessment, Post-assessment)

To measure the changes form baseline to the post-intervention, researchers will use to measure expectations, a self-report 5-point Likert-type (1 = the results will be much worse, 3 = there will not be any change, 5 = the results will be much better).

(This test is going to be used as a experimental self-report and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value regarding the results).
Baseline and after eight weeks of training (Pre-assessment, Post-assessment)
Change from post-assessment in Placebo Effect measures (Motivation) after 3-month follow-up.
Time Frame: Three-month follow-up

To measure the changes form post-test to the 3-month follow-up, researchers will use to measure motivation a self-report 5-point Likert-type scale (1 = not motivated, to 5 = extremely motivated)

(This test is going to be used as a experimental self-report and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value regarding the results).
Three-month follow-up
Change from post-assessment in Placebo Effect measures (Engagement) after 3-month follow-up.
Time Frame: Three-month follow-up

To measure the changes form post-test to the 3-month follow-up, researchers will use to measure engagement a self-report 5-point Likert-type scale (1 = not engaged, to 5 = extremely immersed).

(This test is going to be used as a experimental self-report and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value regarding the results).
Three-month follow-up
Change from post-assessment in Placebo Effect measures (Expectations) after 3-month follow-up.
Time Frame: Three-month follow-up

To measure the changes form post-test to the 3-month follow-up, researchers will use to measure expectations, a self-report 5-point Likert-type (1 = the results will be much worse, 3 = there will not be any change, 5 = the results will be much better).

(This test is going to be used as a experimental self-report and it is not going to be used as a screening psychological tool, then, there are not cut-off values, a minimun or maximum value regarding the results).
Three-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MAP Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Ruiz-Marquez E. Neurophysiology of executive cognitive functions under depression. Explor Neurosci. 2025;4:100696. https://doi.org/10.37349/en.2025.100696
  • Ruiz-Marquez E. Protocol for measuring the benefits of exergames on executive functions under depression through a randomized multi-arm controlled experiment. Explor Neurosci. 2024;3:564-83. https://doi.org/10.37349/en. 2024.00068
  • Ruiz-Marquez, E. (2023). Protocol for measuring the benefits of exergames on executive functions under depression through a randomized multi-arm controlled experiment. Preprint. Open Science Framework.https://doi.org/10.31234/osf.io/m7s2t_v1
  • Ruiz-Marquez, E. (2025). Neurophysiology of executive cognitive functions under depression. Preprint. Open Science Framework. https://doi.org/10.37349/en.2025.100696
  • Ruiz-Marquez, E.,(2024). MUDgame. Measuring the Benefits of an Exergame-based intervention on Neuro-Cognitive Functions in adults suffering from Depression. A Randomized Multi-Arm Controlled Experiment. Project. Open Science Framework. https://doi.org/10.17605/OSF.IO/YBDCT
  • Ruiz-Marquez, E. (2023). MUDgame. Measuring the Benefits of an Exergame-based intervention on Neuro-Cognitive Functions in adults suffering from Depression. A Randomized Multi-Arm Controlled Experiment. Preregistration. Open Science Framework. https://doi.org/10.17605/OSF.IO/Z4S9Q

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

July 23, 2024

First Submitted That Met QC Criteria

July 31, 2024

First Posted (Actual)

August 5, 2024

Study Record Updates

Last Update Posted (Actual)

July 17, 2025

Last Update Submitted That Met QC Criteria

July 16, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • z4s9q

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The available data will be individual participant data that underlie the results reported in the articles, after deidentification (text, tables, figures, and appendices), Study Protocol, Statistical Analysis Plan and Informed Consent Form.

IPD Sharing Time Frame

Data will be available beginning 12 months and ending 3 years following articles publication.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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