Benefits of Exergames on Neurocognitive Functions in Adults Suffering From Depression
NCT Number: NCT06536530
Acronym: MUDGAME
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression
Interventions: BEHAVIORAL: Exergame-Based Training|BEHAVIORAL: Cognitive-Based Training|BEHAVIORAL: Wait-List
Sponsor: MAP Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2026-01
Completion Date: 2028-03

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.

Primary Outcome Measures: 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 Outcome Measures: Change from Baseline in Placebo Effect measures (Motivation) after eight weeks of training., 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., 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., 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., 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., 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., 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