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Completed

NCT Number: NCT04421690

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

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.

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Key information

Age range

45 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri

Columbia, Missouri, 65201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive training

Behavioral

Participants (n=15) will complete computerized cognitive training games and activities online 3 times/week for 8 weeks.

Trivia Training

Behavioral

Participants (n=15) will receive computerized trivia questions to answer and submit 3 times/week for 8 weeks.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

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

Acronym: COGMA

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 9, 2020
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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