Computerized Cognitive Training in Middle-Aged Adults With Generalized Anxiety Disorder: A Pilot Study (COGMA)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Generalized Anxiety Disorder
- Sponsor
- University of Missouri-Columbia
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Subjective Cognitive Self-Efficacy. -Cognitive Failures Questionnaire
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Ashley Curtis
Assistant Professor
University of Missouri-Columbia
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Subjective Cognitive Self-Efficacy. -Cognitive Failures Questionnaire
Time Frame: 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.
Coronavirus Anxiety Scale
Time Frame: Up to 10 weeks
5- item questionnaire that assess anxiety related to the Coronavirus.
Objective Cognition - Computerized Cognitive Tasks
Time Frame: Up to 10 weeks
Complete computerized tasks. These tasks will measure cognitive functions (e.g., executive function).
Anxiety - State-Trait Anxiety Inventory
Time Frame: 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.
Secondary Outcomes
- 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 Intervention Efficacy- Internet Intervention Utility Questionnaire(Up to 10 weeks)
- 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)
- Subjective Behavioral Sleep - Electronic Daily Sleep Diaries(Up to 10 weeks)
- Alcohol Use - Alcohol Use Disorder Test(Baseline)
- COVID-19 related media exposure and risk questions(Up to 10 weeks)
- Physical Activity - International Physical Activity Questionnaire(Up to 10 weeks)
- Beck Depression Inventory-2nd Edition(Up to 10 weeks)