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

NCT ID: NCT05447091

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-12
• Study Completion Date: 2023-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active high dose treatment

Active LOH game training- high dose

Group Type: ACTIVE_COMPARATOR

LOH game- high dose

Intervention Type: BEHAVIORAL

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.

Active low dose treatment

Acrive LOH game training - low dose

Group Type: ACTIVE_COMPARATOR

LOH game- low dose

Intervention Type: BEHAVIORAL

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.

Sham treatment

Sham LOH game- high dose

Group Type: SHAM_COMPARATOR

LOH sham game

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Men and woman 18-60 years of age.
• Symptoms at a minimal level and above of depression, according to a score of 5 or higher in the Personal Health Questionnaire Depression Scale (PHQ-8).
• Able and interested in signing an informed consent form.
• speak and read Hebrew, English or Russian.

Exclusion Criteria

• Video game addiction disorder.
• Neurological diseases that cause cognitive decline (such as dementia), based on self-report.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

aMoon fund

UNKNOWN

Sponsor Role: collaborator

Hebrew University of Jerusalem

OTHER

Sponsor Role: lead

Responsible Party

Mor Nahum

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mor Nahum, PhD

Role: PRINCIPAL_INVESTIGATOR

Hebrew University of Jerusalem

Locations

Computerized Neurotherapy Lab, School of OT, Hebrew University, Mt. Scopus Campus

Jerusalem, , Israel

Countries

Israel

Other Identifiers

Thrive

Identifier Type: -

Identifier Source: org_study_id