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

University of Missouri-Columbia30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Generalized Anxiety Disorder

Interventions

Cognitive TrainingBEHAVIORAL

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

Trivia TrainingBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 45 YearsMax age: 59 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Missouri

Columbia, Missouri, United States

Outcomes

Primary Outcomes

Objective Cognition - Computerized Cognitive Tasks

Complete computerized tasks. These tasks will measure cognitive functions (e.g., processing speed).

Time frame: Up to 10 weeks

Objective Cognition - Computerized Cognitive Tasks

Complete computerized tasks. These tasks will measure cognitive functions (e.g., attention).

Time frame: Up to 10 weeks

Objective Cognition - Computerized Cognitive Tasks

Complete computerized tasks. These tasks will measure cognitive functions (e.g., executive function).

Time frame: 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.

Time frame: Up to 10 weeks

Coronavirus Anxiety Scale

5- item questionnaire that assess anxiety related to the Coronavirus.

Time frame: 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.

Time frame: Up to 10 weeks

Secondary Outcomes

Game-related experience- Sessions and duration played

Data from ClinicalTrials.gov

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During the intervention phase the cognitive training group will play games and will need to log the days and duration played.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 10 weeks

Game Engagement Questionnaire

Questionnaire assessing the experience of the game.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 10 weeks

Personality - Big Five Inventory

10 question assessment measuring personality.

Time frame: 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.

Time frame: Up to 10 weeks

Subjective Intervention Efficacy- Internet Intervention Utility Questionnaire

16- item questionnaire about the use of the intervention.

Time frame: 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.

Time frame: 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.

Time frame: Up to 10 weeks

Beck Depression Inventory-2nd Edition

Time frame: Up to 10 weeks