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临床试验/NCT04348812
NCT04348812已完成1 期

Transcranial Direct Current Stimulation (tDCS) Augments the Effects of Gamified, Mobile Attention Bias Modification

Hunter College of City University of New York2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
38
试验地点
2
主要终点
Self-reported subjective state anxiety

研究概览

简要总结

The present study tested whether transcranial direct current stimulation (tDCS) across the prefrontal cortex (PFC), versus sham stimulation, effectively augments the beneficial effects of a gamified attention bias modification training (ABMT) mobile app.

详细描述

Anxiety-related attentional bias (AB) is the preferential processing of threat observed in clinical and sub-clinical anxiety. Attention bias modification training (ABMT) is a computerized cognitive training technique designed to systematically direct attention away from threat and ameliorate AB, but mixed and null findings have highlighted gaps in our understanding of mechanisms underlying ABMT and how to design the most effective delivery systems. One neuromodulation technique, transcranial direct current stimulation (tDCS) across the prefrontal cortex (PFC) may augment the effects of ABMT by strengthening top-down cognitive control processes, but the evidence base is limited and has not been generalized to current approaches in digital therapeutics, such as mobile applications. The present study tested whether tDCS across the PFC, versus sham stimulation, effectively augments the beneficial effects of a gamified ABMT mobile app. Thirty-eight adults (Mage = 23.92, SD = 4.75; 18 females) evidencing low-to-moderate anxiety symptoms were randomly assigned to active or sham tDCS for 30-minutes while receiving ABMT via a mobile app. Participants reported on potential moderators of ABMT, including life stress and trait anxiety. ECG was recorded during a subsequent stressor to generate respiratory sinus arrhythmia (RSA) suppression as a metric of stress resilience.

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • mild - moderate anxiety

排除标准

  • psychotic disorder
  • substance use disorder

结局指标

主要结局

Self-reported subjective state anxiety

时间窗: Day 1

Self report of state anxiety using the State-Trait Anxiety Inventory (STAI); Higher scores mean greater anxiety severity/worse outcomes (scores ranging from 20-80).

Threat bias, or dsyregulated attention towards threat, measured via computer assay

时间窗: Day 1

Using the computerized, reaction time-based cognitive assessment task, the "dot probe", biased attention towards or away from threat-relevant information will be assessed based on reaction-time based scoring procedures. Higher scores mean greater bias/worse outcomes

Self-reported negative mood symptoms

时间窗: Day 1

Self report using the Depression, Anxiety, Stress Scale (DASS); Higher scores mean more severe negative mood/worse outcomes (scores ranging from 0-42)

次要结局

  • Magnitude of respiratory sinus arrhythmia, or variability in heart rate due to respiration rate(Day 1)

研究者

发起方
Hunter College of City University of New York
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tracy Dennis

Primary Investigator

Hunter College of City University of New York

研究点 (2)

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