Clinical trial NCT05447091: Examining the Effectiveness of a Tablet Video Game on Mood and Cognition
Official title: Examining the Effectiveness of a Custom-made Tablet-based Video Game Intervention on Mood and Cognition in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mood Disturbance
Depressive Symptoms
Keywords: Cognitove Control
Video-games
Cognitive Control Training
Lead sponsor: Hebrew University of Jerusalem
Sponsor class: OTHER
Collaborators: name: aMoon fund
First posted: 2022-07-07
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Beck Depression Inventory (BDI-II)
timeFrame: 3 weeks
Secondary outcomes:
measure: Ruminative Responses Scale-Short Version (RRS-10)
timeFrame: 3 weeks
measure: Generalised Anxiety Disorder-7 (GAD7)
timeFrame: 3 weeks
measure: Adaptive Cognitive Evaluation (ACE)
timeFrame: 3 weeks
measure: WHO-5 Well-Being Index (WHO-5)
timeFrame: 3 weeks
Other outcomes:
measure: Satisfaction with the intervention questionnaire
timeFrame: 3 weeks
Locations:
city: Jerusalem
country: Israel
facility: Computerized Neurotherapy Lab, School of OT, Hebrew University, Mt. Scopus Campus
Study officials:
affiliation: Hebrew University of Jerusalem
name: Mor Nahum, PhD
role: PRINCIPAL_INVESTIGATOR
References: