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

Not Applicable

Completed

• Conditions: Generalized Anxiety Disorder
• Interventions: Behavioral: Cognitive Training; Behavioral: Trivia Training

• Registration Number: NCT04421690
• Lead Sponsor: University of Missouri-Columbia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-02
• Study First Submitted QC: 2020-06-04
• Study Start: 2020-06-08
• Study First Posted: 2020-06-09
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Training	Cognitive Training	8 week computerized cognitive training
Trivia Training	Trivia Training	8 week computerized trivia training

Primary Outcome Measures

Name	Time	Method
Subjective Cognitive Self-Efficacy. -Cognitive Failures Questionnaire	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.
Coronavirus Anxiety Scale	Up to 10 weeks	5- item questionnaire that assess anxiety related to the Coronavirus.
Objective Cognition - Computerized Cognitive Tasks	Up to 10 weeks	Complete computerized tasks. These tasks will measure cognitive functions (e.g., executive function).
Anxiety - State-Trait Anxiety Inventory	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

Name	Time	Method
Alcohol Use - Alcohol Use Disorder Test	Baseline	10-item questionnaire that assess the frequency of alcohol use and problems associated with alcohol use over the past year.
COVID-19 related media exposure and risk questions	Up to 10 weeks	20- item questionnaire assessing the effects of news and social media on perception of COVID-19.
Subjective Intervention Efficacy- Internet Intervention Utility Questionnaire	Up to 10 weeks	16- item questionnaire about the use of the intervention.
Physical Activity - International Physical Activity Questionnaire	Up to 10 weeks	7- item questionnaire assessing the different kinds of physical activities that the participant does as pat of their everyday life.
Beck Depression Inventory-2nd Edition	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.
Circadian Rhythm- Morningness-Eveningness Questionnaire	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.
Subjective Arousal- Pre-sleep Arousal Scale	Up to 10 weeks	Pre-sleep Arousal Scale is a 16-item self-report questionnaire comprising both cognitive and somatic manifestations of arousal.
Game Engagement Questionnaire	Up to 10 weeks	Questionnaire assessing the experience of the game.
Game-related experience- Sessions and duration played	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.
Personality - Big Five Inventory	Baseline	10 question assessment measuring personality.
Computer Proficiency- Computer Proficiency Questionnaire	Baseline	This questionnaire asks about participants' ability to perform a number of tasks with a computer. Will be examined as a covariate.
Subjective Arousal- Global Cognitive Arousal-Perceived Stress Scale	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.
Subjective Arousal- Arousal Predisposition Scale Subjective Arousal- Arousal Predisposition Scale Subjective Arousal- Arousal Predisposition Scale	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.
Mood-Depression-Beck Depression Inventory-II	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.
Subjective Behavioral Sleep- Insomnia Severity Index	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.
Subjective Behavioral Sleep - Electronic Daily Sleep Diaries	Up to 10 weeks	Online diaries completed each morning (\~5 mins); diaries measure sleep quality

Trial Locations

Locations (1)

University of Missouri; 🇺🇸 Columbia, Missouri, United States