NCT04355065

The Secret Trail of Moon (Serious Videogame) and Chess on ADHD: a Clinal Trial

Randomized Study of Personalized Cognitive Training With Virtual Reality Technology (The Secret Trail of Moon) Versus Online Therapeutic Chess Cognitive Training Versus Usual Treatment (TAU) in Attention Deficit Hyperactivity Disorder (ADHD):a Clinical Trial"

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Puerta de Hierro University Hospital · Academic / Other
• Sex: All
• Age: 12 Years – 22 Years
• Healthy volunteers: Not accepted

Summary

Blackground: Currently research on alternative forms of cognitive training in patients diagnosed with ADHD is gaining interest. Especially, the use of Virtual Reality video games. Our team has developed an innovative video game based on Virtual Reality, "The Secret Trail of Moon (TSTM) as a cognitive tool to train 5 main areas of deficit in patients with ADHD. It is superiority study comparing TSTM with therapeutic chess and control group. Methods: This study is prospective, unicentric, randomized with a control group. 105 patients diagnosed with ADHD and pharmacologically stable, aged between 12 and 22 years. These patients will be randomized intro three groups: TSTM group (The Secret Trail of Moon); TC group (Therapeutic Chess) and CG (Control Group). Objective and subjective measures of the patient, parents and teachers will be included. Patients´visit will be different for each group. The TSTM group will have 15 face-to face visits: pre-inclusion visit, inclusion visit, 12 training visits and final visit. CT and GC group patients will have 3 face-to- face visits (pre-inclusion, initial visit and final visit) and 12 email or phone communications during training. Discussion: This study aims to demonstrate the added efficacy of cognitive training to drug treatment. It is a study that tries to demonstrate the superiority of cognitive training with TSTM compared to a traditional cognitive training (TC) and a control group. TSTM is presented as a new and powerful cognitive tool thanks to four factors that make it unique: the feeling of immersion in the scenarios, the variety of mechanics, the personalization and the playful aspect.

Conditions

• Attention Deficit Disorder With Hyperactivity

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Traning with The Secret Trail of Moon	Patients are pharmacologically stable and receive a cognitive intervention with our videogame once a week in the hospital.
BEHAVIORAL	Cognitive Traning with Therapeutic Chess	This group is pharmacologically stable. This group performs cognitive training through a therapeutic chess protocol designed by a chess psychologist. The training is done from home and we contact them weekly to correct the exercises done and to follow up.
DRUG	Control Group	These patients continue their stable pharmacological treatment and do not receive any additional cognitive intervention. They are contacted weekly by phone to follow up on the group.

Timeline

• Start date: 2019-12-09
• Primary completion: 2020-11-30
• Completion: 2021-01-22
• First posted: 2020-04-21
• Last updated: 2020-04-21

Locations

1 site across 1 country: Spain