Clinical trial NCT04421690: Computerized Cognitive Training in Middle-Aged Adults With Generalized Anxiety Disorder: A Pilot Study
Official title: Computerized Cognitive Training in Middle-Aged Adults With Generalized Anxiety Disorder: A Pilot Study (COGMA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Keywords: Anxiety
Middle-Aged
Sleep
Cognition
Older Adults
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to cognitive training or trivia training and will complete measures of anxiety, sleep, cognition (objective, self-efficacy), and self-reported arousal at baseline, and post-intervention
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Objective Cognition - Computerized Cognitive Tasks
timeFrame: Up to 10 weeks
measure: Objective Cognition - Computerized Cognitive Tasks
timeFrame: Up to 10 weeks
measure: Objective Cognition - Computerized Cognitive Tasks
timeFrame: Up to 10 weeks
measure: Subjective Cognitive Self-Efficacy. -Cognitive Failures Questionnaire
timeFrame: Up to 10 weeks
measure: Coronavirus Anxiety Scale
timeFrame: Up to 10 weeks
measure: Anxiety - State-Trait Anxiety Inventory
timeFrame: Up to 10 weeks
Secondary outcomes:
measure: Game-related experience- Sessions and duration played
timeFrame: Up to 10 weeks
measure: Circadian Rhythm- Morningness-Eveningness Questionnaire
timeFrame: Up to 10 weeks
measure: Subjective Arousal- Global Cognitive Arousal-Perceived Stress Scale
timeFrame: Up to 10 weeks
measure: Subjective Arousal- Pre-sleep Arousal Scale
timeFrame: Up to 10 weeks
measure: Subjective Arousal- Arousal Predisposition Scale Subjective Arousal- Arousal Predisposition Scale Subjective Arousal- Arousal Predisposition Scale
timeFrame: Up to 10 weeks
measure: Game Engagement Questionnaire
timeFrame: Up to 10 weeks
measure: Mood-Depression-Beck Depression Inventory-II
timeFrame: Up to 10 weeks
measure: Alcohol Use - Alcohol Use Disorder Test
timeFrame: Baseline
measure: Physical Activity - International Physical Activity Questionnaire
timeFrame: Up to 10 weeks
measure: Personality - Big Five Inventory
timeFrame: Baseline
measure: COVID-19 related media exposure and risk questions
timeFrame: Up to 10 weeks
measure: Subjective Intervention Efficacy- Internet Intervention Utility Questionnaire
timeFrame: Up to 10 weeks
measure: Computer Proficiency- Computer Proficiency Questionnaire
timeFrame: Baseline
measure: Subjective Behavioral Sleep- Insomnia Severity Index
timeFrame: Up to 10 weeks
measure: Beck Depression Inventory-2nd Edition
timeFrame: Up to 10 weeks
measure: Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
timeFrame: Up to 10 weeks
measure: Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
timeFrame: Up to 10 weeks
measure: Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
timeFrame: Up to 10 weeks
measure: Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
timeFrame: Up to 10 weeks
measure: Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
timeFrame: Up to 10 weeks
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri- School of Medicine
name: Ashley Curtis, PhD
role: PRINCIPAL_INVESTIGATOR
References: