Computerized Cognitive Training in Middle-Aged Adults With Generalized Anxiety Disorder: A Pilot Study (COGMA)

Computerized Cognitive Training in Middle-Aged Adults With Generalized Anxiety Disorder: A Pilot Study (COGMA)

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.

Study Overview

• Status: Completed
• Conditions: Generalized Anxiety Disorder
• Intervention / Treatment: Behavioral: Cognitive Training; Behavioral: Trivia Training

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65201
      • University of Missouri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 59 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Training; 8 week computerized cognitive training	Behavioral: Cognitive Training; Participants (n=15) will complete computerized cognitive training games and activities online 3 times/week for 8 weeks.
Active Comparator: Trivia Training; 8 week computerized trivia training	Behavioral: Trivia Training; Participants (n=15) will receive computerized trivia questions to answer and submit 3 times/week for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Cognition - Computerized Cognitive Tasks	Complete computerized tasks. These tasks will measure cognitive functions (e.g., processing speed).	Up to 10 weeks
Objective Cognition - Computerized Cognitive Tasks	Complete computerized tasks. These tasks will measure cognitive functions (e.g., attention).	Up to 10 weeks
Objective Cognition - Computerized Cognitive Tasks	Complete computerized tasks. These tasks will measure cognitive functions (e.g., executive function).	Up to 10 weeks
Subjective Cognitive Self-Efficacy. -Cognitive Failures Questionnaire	A 25-item questionnaire. Participants rate from 0 (never) to 4 (very often) frequency of cognitive errors. Higher scores indicate lower cognitive self-efficacy.	Up to 10 weeks
Coronavirus Anxiety Scale	5- item questionnaire that assess anxiety related to the Coronavirus.	Up to 10 weeks
Anxiety - State-Trait Anxiety Inventory	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.	Up to 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Game-related experience- Sessions and duration played	During the intervention phase the cognitive training group will play games and will need to log the days and duration played.	Up to 10 weeks
Circadian Rhythm- Morningness-Eveningness Questionnaire	19-item questionnaire that assesses preference for morning, afternoon, and evening activities. Total score reflects degree of "morningness" or "eveningness" type.	Up to 10 weeks
Subjective Arousal- Global Cognitive Arousal-Perceived Stress Scale	Perceived Stress Scale is a self-report measure of how life situations are perceived as stressful. The scale consists of 15 items corresponding to everyday situation and participants are asked to rate on a likert scale from 0 (never) to 4 (very often) how often they felt or thought a specific way. Higher scores correspond to higher perceived stress.	Up to 10 weeks
Subjective Arousal- Pre-sleep Arousal Scale	Pre-sleep Arousal Scale is a 16-item self-report questionnaire comprising both cognitive and somatic manifestations of arousal.	Up to 10 weeks
Subjective Arousal- Arousal Predisposition Scale Subjective Arousal- Arousal Predisposition Scale Subjective Arousal- Arousal Predisposition Scale	Arousal Predisposition Scale is a 12-item inventory that has been designed to measure the degree to which an individual experiences arousal. Higher scores indicate greater predisposition to arousal.	Up to 10 weeks
Game Engagement Questionnaire	Questionnaire assessing the experience of the game.	Up to 10 weeks
Mood-Depression-Beck Depression Inventory-II	21-item inventory that asks respondents to rate on a scale of 0 (no depressive feelings) to 3 (most depressive feelings) their feelings towards various aspects of daily living/situations. Higher total scores indicate worse depressive symptoms.	Up to 10 weeks
Alcohol Use - Alcohol Use Disorder Test	10-item questionnaire that assess the frequency of alcohol use and problems associated with alcohol use over the past year.	Baseline
Physical Activity - International Physical Activity Questionnaire	7- item questionnaire assessing the different kinds of physical activities that the participant does as pat of their everyday life.	Up to 10 weeks
Personality - Big Five Inventory	10 question assessment measuring personality.	Baseline
COVID-19 related media exposure and risk questions	20- item questionnaire assessing the effects of news and social media on perception of COVID-19.	Up to 10 weeks
Subjective Intervention Efficacy- Internet Intervention Utility Questionnaire	16- item questionnaire about the use of the intervention.	Up to 10 weeks
Computer Proficiency- Computer Proficiency Questionnaire	This questionnaire asks about participants' ability to perform a number of tasks with a computer. Will be examined as a covariate.	Baseline
Subjective Behavioral Sleep- Insomnia Severity Index	Brief self-report measure of current perception of insomnia symptom severity, distress and daytime impairment. Commonly used in insomnia treatment outcome research.	Up to 10 weeks
Beck Depression Inventory-2nd Edition	21-item inventory that asks respondents to rate on a scale of 0 (no depressive feelings) to 3 (most depressive feelings) their feelings towards various aspects of daily living/situations. Higher total scores indicate worse depressive symptoms.	Up to 10 weeks
Subjective Behavioral Sleep - Electronic Daily Sleep Diaries	Online diaries completed each morning (~5 mins); diaries measure sleep onset latency, wake time after sleep onset, total sleep time, and sleep quality.	Up to 10 weeks
Subjective Behavioral Sleep - Electronic Daily Sleep Diaries	Online diaries completed each morning (~5 mins); diaries measure sleep onset latency	Up to 10 weeks
Subjective Behavioral Sleep - Electronic Daily Sleep Diaries	Online diaries completed each morning (~5 mins); diaries measure wake time after sleep onset	Up to 10 weeks
Subjective Behavioral Sleep - Electronic Daily Sleep Diaries	Online diaries completed each morning (~5 mins); diaries measure total sleep time	Up to 10 weeks
Subjective Behavioral Sleep - Electronic Daily Sleep Diaries	Online diaries completed each morning (~5 mins); diaries measure sleep quality	Up to 10 weeks

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2020
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: June 2, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Anxiety; Sleep; Older Adults; Cognition; Middle-Aged
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2021943

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No