Examining the Effectiveness of a Custom-made Tablet-based Video Game Intervention on Mood and Cognition in Adults
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 LOH game training- high dose
Intervention: LOH game- high dose (Behavioral)
Active low dose treatment
Acrive LOH game training - low dose
Intervention: LOH game- low dose (Behavioral)
Sham treatment
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
Mor Nahum
Principal Investigator
Hebrew University of Jerusalem
