Benefits of Exergames on Neurocognitive Functions in Adults Suffering From Depression

NCT06536530 | Not Yet Recruiting

• 1 other identifier: z4s9q
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Depression

Keywords

cognition; neuropsychology; neuroplasticity; event related potentials; exergames; video games

Outcome Measures

Primary Outcomes (12)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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 Outcomes (6)

• Change from Baseline in Placebo Effect measures (Motivation) after eight weeks of training.

  Baseline and after eight weeks of training (Pre-assessment, Post-assessment)

• Change from Baseline in Placebo Effect measures (Engagement) after eight weeks of training.

  Baseline and after eight weeks of training (Pre-assessment, Post-assessment)

• Change from Baseline in Placebo Effect measures (Expectations) after eight weeks of training.

  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.

  Three-month follow-up

• Change from post-assessment in Placebo Effect measures (Engagement) after 3-month follow-up.

  Three-month follow-up

Study Arms (3)

Exergame-Based Training

EXPERIMENTAL

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

Cognitive-Based Training

ACTIVE COMPARATOR

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

Wait-List

PLACEBO COMPARATOR

Participants will not train with any program and they will not assist to any specific session.

Behavioral: Wait-List

Interventions

Exergame-Based Training BEHAVIORAL

40-50 min sessions, two sessions per week, for a total of eight weeks.

Exergame-Based Training

Cognitive-Based Training BEHAVIORAL

40-50 min sessions, two sessions per week, for a total of eight weeks.

Cognitive-Based Training

Wait-List BEHAVIORAL

Participants will not train with any program and they will not assist to any specific session or intervention

Wait-List

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• A sufficient level of education to understand study procedures and be able to communicate with site personnel
• 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

Sponsors & Collaborators

• MAP Institute: lead

Related Publications (6)

• Ruiz-Marquez E. Neurophysiology of executive cognitive functions under depression. Explor Neurosci. 2025;4:100696. https://doi.org/10.37349/en.2025.100696

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• Ruiz-Marquez, E. (2025). Neurophysiology of executive cognitive functions under depression. Preprint. Open Science Framework. https://doi.org/10.37349/en.2025.100696

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Depression

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Central Study Contacts

Eloisa Ruiz-Marquez

CONTACT

643862849; sci@mapesinstitute.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This experiment is a single-blind design, where participants will be blind to the intervention, but researchers will not be blind to intervention allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This project consists in a three-arms parallel-group randomized study to measure the benefits of exergames on cognition, in adults suffering from depression. Researchers will compare three different interventions (training with an exergame, which combines cognitive and physical stimulation, training with a cognitive game, and a wait-list condition), by randomizing participants to each group with equal probability.

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: August 5, 2024
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available beginning 12 months and ending 3 years following articles publication.