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

• ClinicalTrials.gov Identifier: NCT04421690
• Recruitment Status: Recruiting
• First Posted: June 9, 2020
• Last Update Posted: November 2, 2020
• Sponsor: University of Missouri-Columbia
• Information provided by (Responsible Party): Ashley Curtis, University of Missouri-Columbia

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Generalized Anxiety Disorder	Behavioral: Cognitive Training; Behavioral: Trivia Training	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Computerized Cognitive Training in Middle-Aged Adults With Generalized Anxiety Disorder: A Pilot Study (COGMA)
• Actual Study Start Date: June 8, 2020
• Estimated Primary Completion Date: May 31, 2021
• Estimated Study Completion Date: May 31, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Objective Cognition - Computerized Cognitive Tasks [ Time Frame: Up to 10 weeks ]
   Complete computerized tasks. These tasks will measure cognitive functions (e.g., processing speed).
2. Objective Cognition - Computerized Cognitive Tasks [ Time Frame: Up to 10 weeks ]
   Complete computerized tasks. These tasks will measure cognitive functions (e.g., attention).
3. Objective Cognition - Computerized Cognitive Tasks [ Time Frame: Up to 10 weeks ]
   Complete computerized tasks. These tasks will measure cognitive functions (e.g., executive function).
4. 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.
5. Coronavirus Anxiety Scale [ Time Frame: Up to 10 weeks ]
   5- item questionnaire that assess anxiety related to the Coronavirus.
6. 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 Outcome Measures :

1. Game-related experience- Sessions and duration played [ Time Frame: Up to 10 weeks ]
   During the intervention phase the cognitive training group will play games and will need to log the days and duration played.
2. Circadian Rhythm- Morningness-Eveningness Questionnaire [ Time Frame: Up to 10 weeks ]
   19-item questionnaire that assesses preference for morning, afternoon, and evening activities. Total score reflects degree of "morningness" or "eveningness" type.
3. Subjective Arousal- Global Cognitive Arousal-Perceived Stress Scale [ Time Frame: Up to 10 weeks ]
   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.
4. Subjective Arousal- Pre-sleep Arousal Scale [ Time Frame: Up to 10 weeks ]
   Pre-sleep Arousal Scale is a 16-item self-report questionnaire comprising both cognitive and somatic manifestations of arousal.
5. Subjective Arousal- Arousal Predisposition Scale Subjective Arousal- Arousal Predisposition Scale Subjective Arousal- Arousal Predisposition Scale [ Time Frame: Up to 10 weeks ]
   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.
6. Game Engagement Questionnaire [ Time Frame: Up to 10 weeks ]
   Questionnaire assessing the experience of the game.
7. Mood-Depression-Beck Depression Inventory-II [ Time Frame: Up to 10 weeks ]
   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.
8. Alcohol Use - Alcohol Use Disorder Test [ Time Frame: Baseline ]
   10-item questionnaire that assess the frequency of alcohol use and problems associated with alcohol use over the past year.
9. Physical Activity - International Physical Activity Questionnaire [ Time Frame: Up to 10 weeks ]
   7- item questionnaire assessing the different kinds of physical activities that the participant does as pat of their everyday life.
10. Personality - Big Five Inventory [ Time Frame: Baseline ]
    10 question assessment measuring personality.
11. COVID-19 related media exposure and risk questions [ Time Frame: Up to 10 weeks ]
    20- item questionnaire assessing the effects of news and social media on perception of COVID-19.
12. Subjective Intervention Efficacy- Internet Intervention Utility Questionnaire [ Time Frame: Up to 10 weeks ]
    16- item questionnaire about the use of the intervention.
13. Computer Proficiency- Computer Proficiency Questionnaire [ Time Frame: Baseline ]
    This questionnaire asks about participants' ability to perform a number of tasks with a computer. Will be examined as a covariate.
14. Subjective Behavioral Sleep- Insomnia Severity Index [ Time Frame: Up to 10 weeks ]
    Brief self-report measure of current perception of insomnia symptom severity, distress and daytime impairment. Commonly used in insomnia treatment outcome research.
15. Beck Depression Inventory-2nd Edition [ Time Frame: Up to 10 weeks ]
    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.
16. Subjective Behavioral Sleep - Electronic Daily Sleep Diaries [ Time Frame: Up to 10 weeks ]
    Online diaries completed each morning (~5 mins); diaries measure sleep onset latency, wake time after sleep onset, total sleep time, and sleep quality.
17. Subjective Behavioral Sleep - Electronic Daily Sleep Diaries [ Time Frame: Up to 10 weeks ]
    Online diaries completed each morning (~5 mins); diaries measure sleep onset latency
18. Subjective Behavioral Sleep - Electronic Daily Sleep Diaries [ Time Frame: Up to 10 weeks ]
    Online diaries completed each morning (~5 mins); diaries measure wake time after sleep onset
19. Subjective Behavioral Sleep - Electronic Daily Sleep Diaries [ Time Frame: Up to 10 weeks ]
    Online diaries completed each morning (~5 mins); diaries measure total sleep time
20. Subjective Behavioral Sleep - Electronic Daily Sleep Diaries [ Time Frame: Up to 10 weeks ]
    Online diaries completed each morning (~5 mins); diaries measure sleep quality

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Contact: Jacob Wilhelm; 573-884-3293; cashlab@health.missouri.edu

Locations

United States, Missouri

University of Missouri; Recruiting

Columbia, Missouri, United States, 65201

Contact: Ashley Curtis, PhD

Principal Investigator: Ashley Curtis, PhD

Sponsors and Collaborators

University of Missouri-Columbia

Investigators

• Principal Investigator: Ashley Curtis, PhD; University of Missouri- School of Medicine

More Information

• Responsible Party: Ashley Curtis, Assistant Professor, University of Missouri-Columbia
• ClinicalTrials.gov Identifier: NCT04421690
• Other Study ID Numbers: 2021943
• First Posted: June 9, 2020
• Last Update Posted: November 2, 2020
• Last Verified: October 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ashley Curtis, University of Missouri-Columbia:

Anxiety; Middle-Aged; Sleep; Cognition; Older Adults

Additional relevant MeSH terms:

Anxiety Disorders; Mental Disorders