跳至主要内容
临床试验/NCT05923944
NCT05923944招募中不适用

Evaluating the Effect of Gamified Cognitive Training and of Casual Videogame Play on Anxiety in Adolescents: Protocol for a Randomized Controlled Trial

School of Health Sciences Geneva3 个研究点 分布在 2 个国家目标入组 150 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
3
主要终点
Anxiety assessed through the Screen for Child Anxiety Related Emotional Disorders Child Version (SCARED-C; Birmaher et al. 1999)

研究概览

简要总结

Adolescence is a critical period for the onset and maintenance of anxiety disorders, which raises the importance of intervening early; one possibility of doing so is via digital interventions. At least two lines of research have been explored in the past years in this area. First, studies have tested the anxiolytic effects of casual video games, hypothesizing that, through the induction of flow, these games can effectively distract individuals from anxiety-related thoughts and feelings. Second, the bidirectional link between poor attentional control and higher anxiety has led to the design of novel interventions aiming to improve attentional control such as working memory training studies. Importantly, action video games, classified as a distinct gaming genre, have been shown to enhance attentional control. In this study, we aim to compare the effects of action video game play and casual game play to a no-training group, assessing their potential to alleviate anxiety when delivered entirely online. The goal of this three- arms randomized controlled trial is to evaluate the feasibility of a 6-week video game training intervention to reduce adolescent anxiety-related symptoms. We will also examine the efficacy of the proposed treatment when entirely deployed at adolescents' home.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
11 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Adolescents aged 11-15 years
  • High-anxious score from the 41 items SCARED-Parent version (i.e. total score equal or above 17)
  • Access to a computer (at least Windows 7 or Mac OSX) at home and a reliable internet connection

排除标准

  • DSM diagnoses of Bipolar, Psychosis, Autism Spectrum Disorder, present or past.
  • Neurological injury (i.e. head injury)
  • Currently enrolled in another cognitive training intervention

结局指标

主要结局

Anxiety assessed through the Screen for Child Anxiety Related Emotional Disorders Child Version (SCARED-C; Birmaher et al. 1999)

时间窗: Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3)

The SCARED-C is a 41 items self-report anxiety questionnaire with subscales measuring General Anxiety Disorder, Social Phobia Disorder, Panic Disorder, Separation Anxiety Disorder and School Avoidance. Participants are asked to rate each statement, referring to the past four weeks, on a scale ranging from 0 (Not True or Hardly Ever True) to 2 (Very True or Often True). A score of 25 or higher may indicate the presence of an Anxiety Disorder. Analysis of primary outcome will be based on this total score.

次要结局

  • Attentional Control assessed through the Multiple Objects Tracking Task (MOT; Yung et al., 2015)(Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3))
  • Affective Control assessed through the Affective Backward Digit Span Task (ABDS; modified version of Schweizer et al. 2019)(Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3))
  • Attentional Control assessed through the Useful Field of View Task (UFOV; Yung et al., 2015)(Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3))
  • Attentional Control assessed through an adaptation of the Test of Variables of Attention (TOVA) as implemented in the ACE-X battery (Mars-UFO and Venus-UFO; https://neuroscape.ucsf.edu/researchers-ace/)(Change from baseline (T1) at 1 week after training completion (T2), and at 4 months after training completion (T3))

研究者

发起方
School of Health Sciences Geneva
申办方类型
Other
责任方
Sponsor

研究点 (3)

Loading locations...

相似试验