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

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Training
Trivia Training
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Anxiety, Middle-Aged, Sleep, Cognition, Older Adults

Eligibility Criteria

45 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Missouri

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Training

Trivia Training

Arm Description

8 week computerized cognitive training

8 week computerized trivia training

Outcomes

Primary Outcome Measures

Objective Cognition - Computerized Cognitive Tasks
Complete computerized tasks. These tasks will measure cognitive functions (e.g., processing speed).
Objective Cognition - Computerized Cognitive Tasks
Complete computerized tasks. These tasks will measure cognitive functions (e.g., attention).
Objective Cognition - Computerized Cognitive Tasks
Complete computerized tasks. These tasks will measure cognitive functions (e.g., executive function).
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.
Coronavirus Anxiety Scale
5- item questionnaire that assess anxiety related to the Coronavirus.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
Game Engagement Questionnaire
Questionnaire assessing the experience of the game.
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.
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.
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.
Personality - Big Five Inventory
10 question assessment measuring personality.
COVID-19 related media exposure and risk questions
20- item questionnaire assessing the effects of news and social media on perception of COVID-19.
Subjective Intervention Efficacy- Internet Intervention Utility Questionnaire
16- item questionnaire about the use of the intervention.
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.
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.
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.
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.
Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
Online diaries completed each morning (~5 mins); diaries measure sleep onset latency
Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
Online diaries completed each morning (~5 mins); diaries measure wake time after sleep onset
Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
Online diaries completed each morning (~5 mins); diaries measure total sleep time
Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
Online diaries completed each morning (~5 mins); diaries measure sleep quality

Full Information

First Posted
June 2, 2020
Last Updated
March 14, 2023
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT04421690
Brief Title
Computerized Cognitive Training in Middle-Aged Adults With Generalized Anxiety Disorder: A Pilot Study
Acronym
COGMA
Official Title
Computerized Cognitive Training in Middle-Aged Adults With Generalized Anxiety Disorder: A Pilot Study (COGMA)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 8, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
Anxiety, Middle-Aged, Sleep, Cognition, Older Adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Training
Arm Type
Experimental
Arm Description
8 week computerized cognitive training
Arm Title
Trivia Training
Arm Type
Active Comparator
Arm Description
8 week computerized trivia training
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training
Intervention Description
Participants (n=15) will complete computerized cognitive training games and activities online 3 times/week for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Trivia Training
Intervention Description
Participants (n=15) will receive computerized trivia questions to answer and submit 3 times/week for 8 weeks.
Primary Outcome Measure Information:
Title
Objective Cognition - Computerized Cognitive Tasks
Description
Complete computerized tasks. These tasks will measure cognitive functions (e.g., processing speed).
Time Frame
Up to 10 weeks
Title
Objective Cognition - Computerized Cognitive Tasks
Description
Complete computerized tasks. These tasks will measure cognitive functions (e.g., attention).
Time Frame
Up to 10 weeks
Title
Objective Cognition - Computerized Cognitive Tasks
Description
Complete computerized tasks. These tasks will measure cognitive functions (e.g., executive function).
Time Frame
Up to 10 weeks
Title
Subjective Cognitive Self-Efficacy. -Cognitive Failures Questionnaire
Description
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
Title
Coronavirus Anxiety Scale
Description
5- item questionnaire that assess anxiety related to the Coronavirus.
Time Frame
Up to 10 weeks
Title
Anxiety - State-Trait Anxiety Inventory
Description
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 Outcome Measure Information:
Title
Game-related experience- Sessions and duration played
Description
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
Title
Circadian Rhythm- Morningness-Eveningness Questionnaire
Description
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
Title
Subjective Arousal- Global Cognitive Arousal-Perceived Stress Scale
Description
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
Title
Subjective Arousal- Pre-sleep Arousal Scale
Description
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
Title
Subjective Arousal- Arousal Predisposition Scale Subjective Arousal- Arousal Predisposition Scale Subjective Arousal- Arousal Predisposition Scale
Description
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
Title
Game Engagement Questionnaire
Description
Questionnaire assessing the experience of the game.
Time Frame
Up to 10 weeks
Title
Mood-Depression-Beck Depression Inventory-II
Description
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
Title
Alcohol Use - Alcohol Use Disorder Test
Description
10-item questionnaire that assess the frequency of alcohol use and problems associated with alcohol use over the past year.
Time Frame
Baseline
Title
Physical Activity - International Physical Activity Questionnaire
Description
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
Title
Personality - Big Five Inventory
Description
10 question assessment measuring personality.
Time Frame
Baseline
Title
COVID-19 related media exposure and risk questions
Description
20- item questionnaire assessing the effects of news and social media on perception of COVID-19.
Time Frame
Up to 10 weeks
Title
Subjective Intervention Efficacy- Internet Intervention Utility Questionnaire
Description
16- item questionnaire about the use of the intervention.
Time Frame
Up to 10 weeks
Title
Computer Proficiency- Computer Proficiency Questionnaire
Description
This questionnaire asks about participants' ability to perform a number of tasks with a computer. Will be examined as a covariate.
Time Frame
Baseline
Title
Subjective Behavioral Sleep- Insomnia Severity Index
Description
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
Title
Beck Depression Inventory-2nd Edition
Description
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
Title
Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
Description
Online diaries completed each morning (~5 mins); diaries measure sleep onset latency, wake time after sleep onset, total sleep time, and sleep quality.
Time Frame
Up to 10 weeks
Title
Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
Description
Online diaries completed each morning (~5 mins); diaries measure sleep onset latency
Time Frame
Up to 10 weeks
Title
Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
Description
Online diaries completed each morning (~5 mins); diaries measure wake time after sleep onset
Time Frame
Up to 10 weeks
Title
Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
Description
Online diaries completed each morning (~5 mins); diaries measure total sleep time
Time Frame
Up to 10 weeks
Title
Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
Description
Online diaries completed each morning (~5 mins); diaries measure sleep quality
Time Frame
Up to 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley Curtis, PhD
Organizational Affiliation
University of Missouri- School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States

12. IPD Sharing Statement

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

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