Benefits of Exergames on Neurocognitive Functions in Adults Suffering From Depression

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Exergame-Based Training
  40-50 min sessions, two sessions per week, for a total of eight weeks.
• Поведенческое Cognitive-Based Training
  40-50 min sessions, two sessions per week, for a total of eight weeks.
• Поведенческое Wait-List
  Participants will not train with any program and they will not assist to any specific session or intervention

Первичные конечные точки

• 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: Three-month follow-up]

Вторичные конечные точки (6)

• Change from Baseline in Placebo Effect measures (Motivation) after eight weeks of training. [Срок оценки: Baseline and after eight weeks of training (Pre-assessment, Post-assessment)]
• Change from Baseline in Placebo Effect measures (Engagement) after eight weeks of training. [Срок оценки: Baseline and after eight weeks of training (Pre-assessment, Post-assessment)]
• Change from Baseline in Placebo Effect measures (Expectations) after eight weeks of training. [Срок оценки: 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. [Срок оценки: Three-month follow-up]
• Change from post-assessment in Placebo Effect measures (Engagement) after 3-month follow-up. [Срок оценки: Three-month follow-up]
• Change from post-assessment in Placebo Effect measures (Expectations) after 3-month follow-up. [Срок оценки: Three-month follow-up]

Критерии участия

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.

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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

Идентификаторы

NCT: NCT06536530 · z4s9q

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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