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临床试验/NCT05447091
NCT05447091已完成不适用

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

Hebrew University of Jerusalem1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2022年6月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
180
试验地点
1
主要终点
Beck Depression Inventory (BDI-II)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Participants are not aware of the treatment group they are assigned to. The PI is not aware of the treatment condition in which participants are. Finally, the assessors are blinded to the group assignment as well.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Video game addiction disorder.
  • Neurological diseases that cause cognitive decline (such as dementia), based on self-report.

结局指标

主要结局

Beck Depression Inventory (BDI-II)

时间窗: 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.

次要结局

  • Ruminative Responses Scale-Short Version (RRS-10)(3 weeks)
  • Generalised Anxiety Disorder-7 (GAD7)(3 weeks)
  • Adaptive Cognitive Evaluation (ACE)(3 weeks)
  • WHO-5 Well-Being Index (WHO-5)(3 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mor Nahum

Principal Investigator

Hebrew University of Jerusalem

研究点 (1)

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