Computerized Cognitive Training in Middle-Aged Adults With Generalized Anxiety Disorder: A Pilot Study (COGMA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Coronavirus Anxiety Scale
研究概览
简要总结
The purpose of this research is to look at the effects of computerized cognitive training on anxiety, sleep, mental abilities (cognition), and other aspects of daytime functioning, such as arousal.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •45-59 yrs of age
- •no neurological or psychiatric illness, dementia, or loss of consciousness > 5 mins
- •nongamers (i.e., report <1 hour of video/cognitive training games/week over last 2 yrs)
- •proficient in English (reading and writing)
- •computer meets technology requirements (i.e. Windows: Windows 7 or above using Internet Explorer 11 or Edge, Mozilla Firefox 41 and above, Google Chrome 48 and above; Mac OS: Mac OS X v10.8 and above using Safari 10 and above, Mozilla Firefox 42 and above, Google Chrome 48 and above; Android App: Android 6 or higher version; iOS App: iOS 10 or higher version
- •meet clinical dx criteria for Generalized Anxiety Disorder.
排除标准
- •unable to provide informed consent
- •unable to undergo randomization
- •Telephone Interview for Cognitive Status-modified (TICS) score <33, 2)
- •other sleep disorder (i.e., sleep apnea, Periodic Limb Movement Disorder-PLMD, narcolepsy, REM Sleep Behavior Disorder)
- •severe untreated psychiatric comorbidity that renders randomization unethical
- •psychotropic, anxiolytic medications or other medications(e.g., beta-blockers) that alter mood or sleep
- •uncorrected visual/auditory impairments
- •participation in nonpharmacological treatment for sleep/fatigue/mood outside the current study.
研究组 & 干预措施
Cognitive Training
8 week computerized cognitive training
干预措施: Cognitive Training (Behavioral)
Trivia Training
8 week computerized trivia training
干预措施: Trivia Training (Behavioral)
结局指标
主要结局
Coronavirus Anxiety Scale
时间窗: Up to 10 weeks
5- item questionnaire that assess anxiety related to the Coronavirus.
Objective Cognition - Computerized Cognitive Tasks
时间窗: Up to 10 weeks
Complete computerized tasks. These tasks will measure cognitive functions (e.g., processing speed).
Subjective Cognitive Self-Efficacy. -Cognitive Failures Questionnaire
时间窗: Up to 10 weeks
A 25-item questionnaire. Participants rate from 0 (never) to 4 (very often) frequency of cognitive errors. Higher scores indicate lower cognitive self-efficacy.
Anxiety - State-Trait Anxiety Inventory
时间窗: Up to 10 weeks
Inventory that asks respondents to rate how true 20 self-descriptive statements (e.g., I feel calm) are on a 4-point scale (1 = not at all, 4 = very much so). Typically, respondents are asked to rate statements according to how they generally feel (trait-anxiety scale) and how they feel in the current moment (state-anxiety scale). Total scores range from 20 to 80, with higher scores indicating greater maladjustment.
次要结局
- Subjective Behavioral Sleep - Electronic Daily Sleep Diaries(Up to 10 weeks)
- Circadian Rhythm- Morningness-Eveningness Questionnaire(Up to 10 weeks)
- Subjective Arousal- Pre-sleep Arousal Scale(Up to 10 weeks)
- Game Engagement Questionnaire(Up to 10 weeks)
- Game-related experience- Sessions and duration played(Up to 10 weeks)
- Personality - Big Five Inventory(Baseline)
- Computer Proficiency- Computer Proficiency Questionnaire(Baseline)
- Subjective Arousal- Global Cognitive Arousal-Perceived Stress Scale(Up to 10 weeks)
- Subjective Arousal- Arousal Predisposition Scale Subjective Arousal- Arousal Predisposition Scale Subjective Arousal- Arousal Predisposition Scale(Up to 10 weeks)
- Mood-Depression-Beck Depression Inventory-II(Up to 10 weeks)
- Subjective Behavioral Sleep- Insomnia Severity Index(Up to 10 weeks)
- Alcohol Use - Alcohol Use Disorder Test(Baseline)
- COVID-19 related media exposure and risk questions(Up to 10 weeks)
- Subjective Intervention Efficacy- Internet Intervention Utility Questionnaire(Up to 10 weeks)
- Physical Activity - International Physical Activity Questionnaire(Up to 10 weeks)
- Beck Depression Inventory-2nd Edition(Up to 10 weeks)
研究者
Ashley Curtis
Assistant Professor
University of Missouri-Columbia