<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04421690</url>
  </required_header>
  <id_info>
    <org_study_id>2021943</org_study_id>
    <nct_id>NCT04421690</nct_id>
  </id_info>
  <brief_title>Computerized Cognitive Training in Middle-Aged Adults With Generalized Anxiety Disorder: A Pilot Study</brief_title>
  <acronym>COGMA</acronym>
  <official_title>Computerized Cognitive Training in Middle-Aged Adults With Generalized Anxiety Disorder: A Pilot Study (COGMA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Missouri-Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Missouri-Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is to look at the effects of computerized cognitive training on&#xD;
      anxiety, sleep, mental abilities (cognition), and other aspects of daytime functioning, such&#xD;
      as arousal.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 8, 2020</start_date>
  <completion_date type="Actual">June 30, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective Cognition - Computerized Cognitive Tasks</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <description>Complete computerized tasks. These tasks will measure cognitive functions (e.g., processing speed).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Objective Cognition - Computerized Cognitive Tasks</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <description>Complete computerized tasks. These tasks will measure cognitive functions (e.g., attention).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Objective Cognition - Computerized Cognitive Tasks</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <description>Complete computerized tasks. These tasks will measure cognitive functions (e.g., executive function).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective Cognitive Self-Efficacy. -Cognitive Failures Questionnaire</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Coronavirus Anxiety Scale</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <description>5- item questionnaire that assess anxiety related to the Coronavirus.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety - State-Trait Anxiety Inventory</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Game-related experience- Sessions and duration played</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <description>During the intervention phase the cognitive training group will play games and will need to log the days and duration played.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circadian Rhythm- Morningness-Eveningness Questionnaire</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <description>19-item questionnaire that assesses preference for morning, afternoon, and evening activities. Total score reflects degree of &quot;morningness&quot; or &quot;eveningness&quot; type.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Arousal- Global Cognitive Arousal-Perceived Stress Scale</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Arousal- Pre-sleep Arousal Scale</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <description>Pre-sleep Arousal Scale is a 16-item self-report questionnaire comprising both cognitive and somatic manifestations of arousal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Arousal- Arousal Predisposition Scale Subjective Arousal- Arousal Predisposition Scale Subjective Arousal- Arousal Predisposition Scale</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Game Engagement Questionnaire</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <description>Questionnaire assessing the experience of the game.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood-Depression-Beck Depression Inventory-II</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol Use - Alcohol Use Disorder Test</measure>
    <time_frame>Baseline</time_frame>
    <description>10-item questionnaire that assess the frequency of alcohol use and problems associated with alcohol use over the past year.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity - International Physical Activity Questionnaire</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <description>7- item questionnaire assessing the different kinds of physical activities that the participant does as pat of their everyday life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Personality - Big Five Inventory</measure>
    <time_frame>Baseline</time_frame>
    <description>10 question assessment measuring personality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>COVID-19 related media exposure and risk questions</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <description>20- item questionnaire assessing the effects of news and social media on perception of COVID-19.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Intervention Efficacy- Internet Intervention Utility Questionnaire</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <description>16- item questionnaire about the use of the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Computer Proficiency- Computer Proficiency Questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <description>This questionnaire asks about participants' ability to perform a number of tasks with a computer. Will be examined as a covariate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Behavioral Sleep- Insomnia Severity Index</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <description>Brief self-report measure of current perception of insomnia symptom severity, distress and daytime impairment. Commonly used in insomnia treatment outcome research.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory-2nd Edition</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Behavioral Sleep - Electronic Daily Sleep Diaries</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <description>Online diaries completed each morning (~5 mins); diaries measure sleep onset latency, wake time after sleep onset, total sleep time, and sleep quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Behavioral Sleep - Electronic Daily Sleep Diaries</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <description>Online diaries completed each morning (~5 mins); diaries measure sleep onset latency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Behavioral Sleep - Electronic Daily Sleep Diaries</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <description>Online diaries completed each morning (~5 mins); diaries measure wake time after sleep onset</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Behavioral Sleep - Electronic Daily Sleep Diaries</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <description>Online diaries completed each morning (~5 mins); diaries measure total sleep time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Behavioral Sleep - Electronic Daily Sleep Diaries</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <description>Online diaries completed each morning (~5 mins); diaries measure sleep quality</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Generalized Anxiety Disorder</condition>
  <arm_group>
    <arm_group_label>Cognitive Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8 week computerized cognitive training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trivia Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>8 week computerized trivia training</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Training</intervention_name>
    <description>Participants (n=15) will complete computerized cognitive training games and activities online 3 times/week for 8 weeks.</description>
    <arm_group_label>Cognitive Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Trivia Training</intervention_name>
    <description>Participants (n=15) will receive computerized trivia questions to answer and submit 3 times/week for 8 weeks.</description>
    <arm_group_label>Trivia Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  45-59 yrs of age&#xD;
&#xD;
          -  no neurological or psychiatric illness, dementia, or loss of consciousness &gt; 5 mins&#xD;
&#xD;
          -  nongamers (i.e., report &lt;1 hour of video/cognitive training games/week over last 2&#xD;
             yrs)&#xD;
&#xD;
          -  proficient in English (reading and writing)&#xD;
&#xD;
          -  computer meets technology requirements (i.e. Windows: Windows 7 or above using&#xD;
             Internet Explorer 11 or Edge, Mozilla Firefox 41 and above, Google Chrome 48 and&#xD;
             above; Mac OS: Mac OS X v10.8 and above using Safari 10 and above, Mozilla Firefox 42&#xD;
             and above, Google Chrome 48 and above; Android App: Android 6 or higher version; iOS&#xD;
             App: iOS 10 or higher version&#xD;
&#xD;
          -  meet clinical dx criteria for Generalized Anxiety Disorder.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to provide informed consent&#xD;
&#xD;
          -  unable to undergo randomization&#xD;
&#xD;
          -  Telephone Interview for Cognitive Status-modified (TICS) score &lt;33, 2)&#xD;
&#xD;
          -  other sleep disorder (i.e., sleep apnea, Periodic Limb Movement Disorder-PLMD,&#xD;
             narcolepsy, REM Sleep Behavior Disorder)&#xD;
&#xD;
          -  severe untreated psychiatric comorbidity that renders randomization unethical&#xD;
&#xD;
          -  psychotropic, anxiolytic medications or other medications(e.g., beta-blockers) that&#xD;
             alter mood or sleep&#xD;
&#xD;
          -  uncorrected visual/auditory impairments&#xD;
&#xD;
          -  participation in nonpharmacological treatment for sleep/fatigue/mood outside the&#xD;
             current study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ashley Curtis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Missouri- School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Missouri</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>March 14, 2023</last_update_submitted>
  <last_update_submitted_qc>March 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Missouri-Columbia</investigator_affiliation>
    <investigator_full_name>Ashley Curtis</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Anxiety</keyword>
  <keyword>Middle-Aged</keyword>
  <keyword>Sleep</keyword>
  <keyword>Cognition</keyword>
  <keyword>Older Adults</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04421690
org study id: 2021943
nct id: NCT04421690
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention 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
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Objective Cognition - Computerized Cognitive Tasks
time frame: Up to 10 weeks
description: Complete computerized tasks. These tasks will measure cognitive functions (e.g., processing speed).
measure: Objective Cognition - Computerized Cognitive Tasks
time frame: Up to 10 weeks
description: Complete computerized tasks. These tasks will measure cognitive functions (e.g., attention).
measure: Objective Cognition - Computerized Cognitive Tasks
time frame: Up to 10 weeks
description: Complete computerized tasks. These tasks will measure cognitive functions (e.g., executive function).
measure: Subjective Cognitive Self-Efficacy. -Cognitive Failures Questionnaire
time frame: Up to 10 weeks
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.
measure: Coronavirus Anxiety Scale
time frame: Up to 10 weeks
description: 5- item questionnaire that assess anxiety related to the Coronavirus.
measure: Anxiety - State-Trait Anxiety Inventory
time frame: Up to 10 weeks
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.
measure: Game-related experience- Sessions and duration played
time frame: Up to 10 weeks
description: During the intervention phase the cognitive training group will play games and will need to log the days and duration played.
measure: Circadian Rhythm- Morningness-Eveningness Questionnaire
time frame: Up to 10 weeks
description: 19-item questionnaire that assesses preference for morning, afternoon, and evening activities. Total score reflects degree of "morningness" or "eveningness" type.
measure: Subjective Arousal- Global Cognitive Arousal-Perceived Stress Scale
time frame: Up to 10 weeks
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.
measure: Subjective Arousal- Pre-sleep Arousal Scale
time frame: Up to 10 weeks
description: Pre-sleep Arousal Scale is a 16-item self-report questionnaire comprising both cognitive and somatic manifestations of arousal.
measure: Subjective Arousal- Arousal Predisposition Scale Subjective Arousal- Arousal Predisposition Scale Subjective Arousal- Arousal Predisposition Scale
time frame: Up to 10 weeks
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.
measure: Game Engagement Questionnaire
time frame: Up to 10 weeks
description: Questionnaire assessing the experience of the game.
measure: Mood-Depression-Beck Depression Inventory-II
time frame: Up to 10 weeks
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.
measure: Alcohol Use - Alcohol Use Disorder Test
time frame: Baseline
description: 10-item questionnaire that assess the frequency of alcohol use and problems associated with alcohol use over the past year.
measure: Physical Activity - International Physical Activity Questionnaire
time frame: Up to 10 weeks
description: 7- item questionnaire assessing the different kinds of physical activities that the participant does as pat of their everyday life.
measure: Personality - Big Five Inventory
time frame: Baseline
description: 10 question assessment measuring personality.
measure: COVID-19 related media exposure and risk questions
time frame: Up to 10 weeks
description: 20- item questionnaire assessing the effects of news and social media on perception of COVID-19.
measure: Subjective Intervention Efficacy- Internet Intervention Utility Questionnaire
time frame: Up to 10 weeks
description: 16- item questionnaire about the use of the intervention.
measure: Computer Proficiency- Computer Proficiency Questionnaire
time frame: Baseline
description: This questionnaire asks about participants' ability to perform a number of tasks with a computer. Will be examined as a covariate.
measure: Subjective Behavioral Sleep- Insomnia Severity Index
time frame: Up to 10 weeks
description: Brief self-report measure of current perception of insomnia symptom severity, distress and daytime impairment. Commonly used in insomnia treatment outcome research.
measure: Beck Depression Inventory-2nd Edition
time frame: Up to 10 weeks
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.
measure: Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
time frame: Up to 10 weeks
description: Online diaries completed each morning (~5 mins); diaries measure sleep onset latency, wake time after sleep onset, total sleep time, and sleep quality.
measure: Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
time frame: Up to 10 weeks
description: Online diaries completed each morning (~5 mins); diaries measure sleep onset latency
measure: Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
time frame: Up to 10 weeks
description: Online diaries completed each morning (~5 mins); diaries measure wake time after sleep onset
measure: Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
time frame: Up to 10 weeks
description: Online diaries completed each morning (~5 mins); diaries measure total sleep time
measure: Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
time frame: Up to 10 weeks
description: Online diaries completed each morning (~5 mins); diaries measure sleep quality
arm group label: Cognitive Training
arm group type: Experimental
description: 8 week computerized cognitive training
arm group label: Trivia Training
arm group type: Active Comparator
description: 8 week computerized trivia training
intervention type: Behavioral
intervention name: Cognitive Training
description: Participants (n=15) will complete computerized cognitive training games and activities online 3 times/week for 8 weeks.
arm group label: Cognitive Training
intervention type: Behavioral
intervention name: Trivia Training
description: Participants (n=15) will receive computerized trivia questions to answer and submit 3 times/week for 8 weeks.
arm group label: Trivia Training
criteria: 
gender: All
minimum age: 45 Years
maximum age: 59 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ashley Curtis, PhD
role: Principal Investigator
affiliation: University of Missouri- School of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Missouri-Columbia
investigator full name: Ashley Curtis
investigator title: Assistant Professor
mesh term: Anxiety Disorders