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Clinical Trials/NCT05447091
NCT05447091CompletedNot Applicable

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

Hebrew University of Jerusalem1 site in 1 country180 target enrollmentStarted: June 12, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
180
Locations
1
Primary Endpoint
Beck Depression Inventory (BDI-II)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Masking Description

Participants are not aware of the treatment group they are assigned to. The PI is not aware of the treatment condition in which participants are. Finally, the assessors are blinded to the group assignment as well.

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Active high dose treatment

Active Comparator

Active LOH game training- high dose

Intervention: LOH game- high dose (Behavioral)

Active low dose treatment

Active Comparator

Acrive LOH game training - low dose

Intervention: LOH game- low dose (Behavioral)

Sham treatment

Sham Comparator

Sham LOH game- high dose

Intervention: LOH sham game (Behavioral)

Outcomes

Primary Outcomes

Beck Depression Inventory (BDI-II)

Time Frame: 3 weeks

To assess levels and change of depressive symptoms. The BDI-II consists of 21-items, scored on a Likert scale from 0 to 3 (range 0-63), and has demonstrated high reliability and good concurrent, content, and structural validity for screening depression in outpatient and student samples.

Secondary Outcomes

  • Ruminative Responses Scale-Short Version (RRS-10)(3 weeks)
  • Generalised Anxiety Disorder-7 (GAD7)(3 weeks)
  • Adaptive Cognitive Evaluation (ACE)(3 weeks)
  • WHO-5 Well-Being Index (WHO-5)(3 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mor Nahum

Principal Investigator

Hebrew University of Jerusalem

Study Sites (1)

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