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

March 14, 2023 updated by: Ashley Curtis, University of Missouri-Columbia

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65201
        • University of Missouri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cognitive Training
8 week computerized cognitive training
Behavioral: Cognitive Training
Participants (n=15) will complete computerized cognitive training games and activities online 3 times/week for 8 weeks.
Active Comparator: Trivia Training
8 week computerized trivia training
Behavioral: Trivia Training
Participants (n=15) will receive computerized trivia questions to answer and submit 3 times/week for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Cognition - Computerized Cognitive Tasks
Time Frame: Up to 10 weeks
Complete computerized tasks. These tasks will measure cognitive functions (e.g., processing speed).
Up to 10 weeks
Objective Cognition - Computerized Cognitive Tasks
Time Frame: Up to 10 weeks
Complete computerized tasks. These tasks will measure cognitive functions (e.g., attention).
Up to 10 weeks
Objective Cognition - Computerized Cognitive Tasks
Time Frame: Up to 10 weeks
Complete computerized tasks. These tasks will measure cognitive functions (e.g., executive function).
Up to 10 weeks
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.
Up to 10 weeks
Coronavirus Anxiety Scale
Time Frame: Up to 10 weeks
5- item questionnaire that assess anxiety related to the Coronavirus.
Up to 10 weeks
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.
Up to 10 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to 10 weeks
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.
Up to 10 weeks
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.
Up to 10 weeks
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.
Up to 10 weeks
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.
Up to 10 weeks
Game Engagement Questionnaire
Time Frame: Up to 10 weeks
Questionnaire assessing the experience of the game.
Up to 10 weeks
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.
Up to 10 weeks
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.
Baseline
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.
Up to 10 weeks
Personality - Big Five Inventory
Time Frame: Baseline
10 question assessment measuring personality.
Baseline
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.
Up to 10 weeks
Subjective Intervention Efficacy- Internet Intervention Utility Questionnaire
Time Frame: Up to 10 weeks
16- item questionnaire about the use of the intervention.
Up to 10 weeks
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.
Baseline
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.
Up to 10 weeks
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.
Up to 10 weeks
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.
Up to 10 weeks
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
Up to 10 weeks
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
Up to 10 weeks
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
Up to 10 weeks
Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
Time Frame: Up to 10 weeks
Online diaries completed each morning (~5 mins); diaries measure sleep quality
Up to 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Missouri-Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 8, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021943

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Generalized Anxiety Disorder

Clinical Trials on Cognitive Training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings