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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mood Disturbance, Depressive Symptoms

Intervention / Treatment
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* Behavioral: LOH game- high dose
* Behavioral: LOH game- low dose
* Behavioral: LOH sham game


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active high dose treatment<br>Active LOH game training- high dose | Behavioral: LOH game- high dose<br>* 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.<br>|
| Active Comparator: Active low dose treatment<br>Acrive LOH game training - low dose | Behavioral: LOH game- low dose<br>* 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.<br>|
| Sham Comparator: Sham treatment<br>Sham LOH game- high dose | Behavioral: LOH sham game<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory (BDI-II) | 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. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ruminative Responses Scale-Short Version (RRS-10) | To assess level and change of ruminative responses. It is a 10-item self-report measure with a 4-point Likert scale (1=almost never; 4=almostalways) comprised of two subscales: Brooding (e.g., 'Think Why do I always react thisway?'; 'Think Why do I have problems other people don't have?') and Reflection (e.g.,'Write down what you are thinking and analyze it'; 'Go someplace alone to think aboutyour feelings'). Scores for each subscale are computed by summing its respective items.Higher scores indicate higher rumination levels. The internal consistency values observedin the original study werea=.77 anda=.72 for Brooding and Reflection subscales. | 3 weeks | 
| Generalised Anxiety Disorder-7 (GAD7) | To assess level and change of anxiety symptoms. It is a self-rated, validated screening instrument for anxiety and measures its severity. It has 7 items which are evaluated as 0 being not at all, to 3, nearly every day. Based on the total score of the individual, anxiety is categorised as none (0-4), mild (5-9), moderate (10-14), and severe (15-21) reflecting the degree of anxiety. | 3 weeks | 
| Adaptive Cognitive Evaluation (ACE) | To assess level and change of cognitive control. The ACE is a mobile assessment battery containing standard tests that assess different aspects of cognitive control (attention, working memory, and goal management). | 3 weeks | 
| WHO-5 Well-Being Index (WHO-5) | To assess level and change of well-being. The WHO-5 is a short, self-administered measure of well-being over the last two weeks. It consists of five positively worded items that are rated on 6-point Likert scale, ranging from 0 (at no the time) to 5 (all of the time). The raw scores are transformed to a score from 0 to 100, with lower scores indicating worse well-being. A score of ≤50 indicates poor wellbeing and suggests further investigation into possible symptoms of depression. A score of 28 or below is indicative of depression. | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitove Control, Video-games, Cognitive Control Training