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

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

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.

Study Overview

• Status: Completed
• Conditions: Depressive Symptoms; Mood Disturbance
• Intervention / Treatment: Behavioral: LOH game- high dose; Behavioral: LOH game- low dose; Behavioral: LOH sham game

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 Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active high dose treatment; Active LOH game training- high dose	Behavioral: 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.
Active Comparator: Active low dose treatment; Acrive LOH game training - low dose	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.
Sham Comparator: Sham treatment; Sham LOH game- high dose	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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with the intervention questionnaire	It is a 20-item self-report questionnaire with a 7-point Likert scale (1=Do not agree at all; 4=Agree most)	3 weeks

Collaborators and Investigators

• Sponsor: Hebrew University of Jerusalem
• Collaborators: aMoon fund
• Investigators: Principal Investigator: Mor Nahum, PhD, Hebrew University of Jerusalem

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: July 3, 2022
• First Submitted That Met QC Criteria: July 3, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Cognitove Control; Video-games; Cognitive Control Training
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: THRIVE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No