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

NCT ID: NCT04421690

Last Updated: 2023-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-08

Study Completion Date

2022-06-30

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.

Detailed Description

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Conditions

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Generalized Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cognitive Training

8 week computerized cognitive training

Group Type EXPERIMENTAL

Cognitive Training

Intervention Type BEHAVIORAL

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

Trivia Training

8 week computerized trivia training

Group Type ACTIVE_COMPARATOR

Trivia Training

Intervention Type BEHAVIORAL

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

Interventions

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Cognitive Training

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

Intervention Type BEHAVIORAL

Trivia Training

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

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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Ashley Curtis

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ashley Curtis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri- School of Medicine

Locations

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University of Missouri

Columbia, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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2021943

Identifier Type: -

Identifier Source: org_study_id

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