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Completed

NCT Number: NCT05447091

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

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.

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Key information

Conditions

Mood Disturbance Behavior Behavioral Symptoms Depression Depressive Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Jerusalem, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LOH game- high dose

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.

LOH game- low dose

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.

LOH sham game

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.

Primary outcomes

  1. 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

  1. Ruminative Responses Scale-Short Version (RRS-10)

    Time frame: 3 weeks

    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.

  2. Generalised Anxiety Disorder-7 (GAD7)

    Time frame: 3 weeks

    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. Adaptive Cognitive Evaluation (ACE)

    Time frame: 3 weeks

    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).

  4. WHO-5 Well-Being Index (WHO-5)

    Time frame: 3 weeks

    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.

Other outcomes

  1. Satisfaction with the intervention questionnaire

    Time frame: 3 weeks

    It is a 20-item self-report questionnaire with a 7-point Likert scale (1=Do not agree at all; 4=Agree most)

Sponsors and collaborators

Lead sponsor

Hebrew University of Jerusalem

Other

Collaborators

  • aMoon fund

Registry information

Official study title

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

Acronym: THRIVE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 7, 2022
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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