NCT05447091

Examining the Effectiveness of a Tablet Video Game on Mood and Cognition

Examining the Effectiveness of a Custom-made Tablet-based Video Game Intervention on Mood and Cognition in Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Hebrew University of Jerusalem · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Sustained negative mood and depression are characterized by functional impairment, and significant reduction in quality of life. Cognitive models of depression emphasize the role of impaired cognitive control - the mental abilities determining goal directed behaviors - in contributing to depressive symptoms. Indeed, research findings from subclinical and clinical populations show that depressive symptoms are associated with decreased cognitive control abilities. The THRIVE trial is a double-blind, proof-of-concept randomized controlled trial (RCT). The aims of the study are to investigate the feasibility and efficacy of an innovative, custom-made tablet video game, Legends of Hoa'manu (LOH), which is designed to enhance cognitive control, in alleviating mood and improving cognitive control in adults. Participants with mild to major depressive symptoms will be randomized to receive either LoH or a control intervention. Cognitive control, mood and depressive symptoms will be assessed at baseline, post training, after at a 3-week and a 3-month follow up.

Detailed description

Persistent negative mood, melancholy and depression are becoming more and more prevalent worldwide. Depression is linked to severe functional impairment, which can last for years, and to a significant reduction in quality of life. Current theoretical models of depression suggest that negative mood and depressive symptoms are associated with decreases in cognitive control abilities - the same brain mechanisms in the prefrontal cortex that underlie goal-directed behaviors. Specifically, difficulty in delaying a response to irrelevant negative information, or difficulty in removing irrelevant negative information from working memory, have all been found to be associated with and predictive of depressive symptoms. Indeed, research findings from subclinical and clinical populations show that depressive symptoms are associated with decreased cognitive control ability and decreased activity in the prefrontal cortex regions. In the present study, the investigators will examine whether training of cognitive control improves mood. Specifically, the investigators will test whether several weeks of training using a tablet video game targeting cognitive control improves depressive symptoms, mood, and cognitive control abilities measures among adults. Participants will be randomized to receive either a high or low dose of the intervention or a control intervention, and will be asked to train with their intervention remotely from home for 3 weeks. Outcomes will be assessed at baseline, at the completion of training and at two follow up points: 3 weeks and 3 months.

Conditions

• Mood Disturbance
• Depressive Symptoms

Interventions

Type	Name	Description
BEHAVIORAL	LOH game- high dose	Participants will be asked to complete 15 half-hour training sessions, over 3 weeks, ie about 5 training sessions a week, and a total of 7.5 hours of training for 3 weeks.
BEHAVIORAL	LOH game- low dose	Participants will be asked to complete 6 half-hour training sessions, over 3 weeks, ie about 2 training sessions a week, and a total of 3 hours of training for 3 weeks.
BEHAVIORAL	LOH sham game	Participants will be asked to complete 15 half-hour training sessions, over three weeks, using sham version of the game. the sham version does not include components of cognitive training.

Timeline

• Start date: 2022-06-12
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2022-07-07
• Last updated: 2023-09-21

Locations

1 site across 1 country: Israel