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

MAP Institute

Status: Begins enrollment in 10 months

Conditions: Depression

Treatments: Behavioral: Exergame-Based Training; Behavioral: Cognitive-Based Training; Behavioral: Wait-List

Study type: Interventional

Funder types: Other

Identifiers

NCT06536530

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Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups, including a placebo group

Exergame-Based Training

Experimental group

Description:

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.

Treatment:

Behavioral: Exergame-Based Training

Cognitive-Based Training

Active Comparator group

Description:

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.

Treatment:

Behavioral: Cognitive-Based Training

Wait-List

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Wait-List