An interventional study of LOH game- high dose and LOH game- low dose in Mood Disturbance and Depressive Symptoms, sponsored by Hebrew University of Jerusalem. Completed at 1 site in Israel. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by Hebrew University of Jerusalem · Not applicable, Interventional, and Treatment
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 180 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Hebrew University of Jerusalem is the lead sponsor of 31 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Active LOH game training- high dose
Behavioral: LOH game- high dose
Acrive LOH game training - low dose
Behavioral: LOH game- low dose
Sham LOH game- high dose
Behavioral: LOH sham game
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.
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.
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.
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.
Time frame: 3 weeks
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 3 weeks
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)
Time frame: 3 weeks
Plan to share: No
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Hebrew University of Jerusalem