Clinical trial NCT06536530: Benefits of Exergames on Neurocognitive Functions in Adults Suffering From Depression
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Keywords: cognition
neuropsychology
neuroplasticity
event related potentials
exergames
video games
Lead sponsor: MAP Institute
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Baseline and after eight weeks of training (Pre-assessment and Post-assessment)
measure: 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.
timeFrame: Baseline and after eight weeks of training (Pre-assessment and Post-assessment)
measure: 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.
timeFrame: Baseline and after eight weeks of training (Pre-assessment and Post-assessment)
measure: 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.
timeFrame: Baseline and after eight weeks of training (Pre-assessment and Post-assessment)
measure: 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.
timeFrame: Baseline and after eight weeks of training (Pre-assessment and Post-assessment)
measure: 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.
timeFrame: Baseline and after eight weeks of training (Pre-assessment and Post-assessment)
measure: Change from Post-assessment in Neuropsychological and Cognitive Functions (Executive functions measured with Wisconsin Card Sorting Test) after 3-month follow-up.
timeFrame: Three-month follow-up
measure: 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.
timeFrame: Three-month follow-up
measure: 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.
timeFrame: Three-month follow-up
measure: 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.
timeFrame: Three-month follow-up
measure: Change from Post-assessment in Neuropsychological and Cognitive Functions (Processing Speed, measured with a Simple Reaction Times Task) after 3-month follow-up.
timeFrame: Three-month follow-up
measure: Change from Post-assessment in Neuropsychological and Cognitive Functions (Psychomotor functions, measured with the Salpêtrière Retardation Rating Scale) after 3-month follow-up.
timeFrame: Three-month follow-up
Secondary outcomes:
measure: Change from Baseline in Placebo Effect measures (Motivation) after eight weeks of training.
timeFrame: Baseline and after eight weeks of training (Pre-assessment, Post-assessment)
measure: Change from Baseline in Placebo Effect measures (Engagement) after eight weeks of training.
timeFrame: Baseline and after eight weeks of training (Pre-assessment, Post-assessment)
measure: Change from Baseline in Placebo Effect measures (Expectations) after eight weeks of training.
timeFrame: Baseline and after eight weeks of training (Pre-assessment, Post-assessment)
measure: Change from post-assessment in Placebo Effect measures (Motivation) after 3-month follow-up.
timeFrame: Three-month follow-up
measure: Change from post-assessment in Placebo Effect measures (Engagement) after 3-month follow-up.
timeFrame: Three-month follow-up
measure: Change from post-assessment in Placebo Effect measures (Expectations) after 3-month follow-up.
timeFrame: Three-month follow-up
Other outcomes:
Locations:
Study officials:
References:
citation: Ruiz-Marquez, E.(2023). Project. MUDgame. Measuring the Benefits of an Exergame-based intervention on Neuro-Cognitive Functions in adults suffering from Depression. A Randomized Multi-Arm Controlled Experiment. https://doi.org/10.17605/OSF.IO/YBDCT
citation: Ruiz-Marquez, E. (2023). Measuring the Benefits of an exergame-based intervention on Executive Functions in people suffering from Depression. Protocol for a Randomized Multi-Arm Controlled Experiment. https://doi.org/10.31234/osf.io/m7s2t
citation: Ruiz-Marquez, E. Neurophysiology of Executive Cognitive Functions under depression: A Theoretical Review. The Open Science Framework. 2024; https://doi.org/10.31219/osf.io/f5dhq
citation: 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