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

Study Overview
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Brief Summary
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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.

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

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Behavioral: Cognitive Training
* Behavioral: Trivia Training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Middle-Aged, Sleep, Cognition, Older Adults