xml: <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/NCT05974605</url>
    </required_header>
    <id_info>
      <org_study_id>IRB-22-189</org_study_id>
      <nct_id>NCT05974605</nct_id>
    </id_info>
    <brief_title>Mindfulness and Attention Training Intervention to Lower Distractibility in Aging</brief_title>
    <acronym>MATILDA</acronym>
    <official_title>Mindfulness and Attention Training Intervention to Lower Distractibility in Aging</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The University of Texas at Dallas</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The University of Texas at Dallas</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 goal of this interventional study is to test the efficacy of combined mindfulness&#xD;
        meditation training and cognitive training on brain function and cognition in healthy older&#xD;
        adults. Participants will undergo cognitive and neuroimaging (MRI and fNIRS) assessments&#xD;
        before and after an 8-week (~20 hours) training intervention. The intervention will consist&#xD;
        of at-home mindfulness meditation followed by playing a cognitive game on a provided tablet.&#xD;
        The findings will be compared to an existing data from older adults who trained on the&#xD;
        cognitive game only (NCT03988829; Arms 1 and 2).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Nearly 14 million people are projected to develop Alzheimer's disease (AD) by 2050 in the USA&#xD;
        alone, with those affected by mild cognitive impairment (MCI) being especially at risk.&#xD;
        Therefore, interventions aimed at prevention of dementia and promotion of brain and cognitive&#xD;
        health in older adults need to be developed. One of the most successful types of&#xD;
        non-pharmacological intervention is cognitive training, where participants engage in mental&#xD;
        exercises targeting one or multiple cognitive domains. A recent meta-analysis has found that&#xD;
        both healthy older adults and older adults affected by MCI, benefit equally in cognitive&#xD;
        health from such training. Importantly, both populations showed improvements in cognitive&#xD;
        abilities that were beyond the trained skills, such as everyday cognition, suggesting that&#xD;
        cognitive training has a broad impact on independence in daily activities and quality of&#xD;
        life. The training of attentional control has proven to be the most effective type of&#xD;
        single-component training. Attentional control is the ability to focus attention to a task&#xD;
        while inhibiting distractors; this &quot;core&quot; ability is fundamental for many everyday tasks. In&#xD;
        addition to directly training attentional control, another promising approach to reducing&#xD;
        distractibility is mindfulness meditation. As for the neural effects of attentional control&#xD;
        training and meditation training, alterations in resting state brain function are reported,&#xD;
        esp. in Default Mode Network (DMN) regions that are related to memory and attentional&#xD;
        control. DMN is found to be engaged in older adults, but is disengaged in younger adults;&#xD;
        this overactivation is detrimental to cognitive performance. However, the combined benefits&#xD;
        of cognitive control training and mindfulness meditation on cognition and DMN are&#xD;
        understudied in older adults.&#xD;
  &#xD;
        In this project, there is a single training arm that will train healthy older adults on a&#xD;
        combination training composed of high attentional control and mindfulness meditation using&#xD;
        simulation based games. Neural and cognitive changes in near and far transfer tasks will be&#xD;
        examined immediately after the intervention. These changes will be compared with that of a&#xD;
        previously collected group of older adults who received only cognitive control training&#xD;
        (NCT03988829; Arms 1 and 2). Changes in overall cognition (primary cognitive outcome) and&#xD;
        changes in DMN connectivity during task (primary neuroimaging outcome) and rest (secondary&#xD;
        neuroimaging outcome) in this combination training group will be compared to the respective&#xD;
        changes in Arm 1 (low attentional control training) and Arm 2 (High Attentional Control&#xD;
        training) of the existing dataset. The protocol of participant recruitment, pre- and post-&#xD;
        training assessments (MRI and behavioral), and training platform remain same between this&#xD;
        study and the existing database. In this current study, participants also undergo a&#xD;
        functional near infra-red spectroscopy (fNIRS) session, after completion of behavioral and&#xD;
        MRI session, at pre-training and post-training. This clinical trial will result in the&#xD;
        development of more efficient behavioral intervention tools in older adults, based on&#xD;
        neuroimaging evidence, that can be readily used from the comfort of home.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 17, 2022</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>The trail will collect data from a single group. The results will be compared to a previously collected data from two arms of an RCT.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in composite score of overall cognition</measure>
      <time_frame>9-10 weeks (includes baseline assessment, training, and post-training assessment)</time_frame>
      <description>Change in composite score of overall cognition from baseline to post-training (after 8 weeks). Overall composite score calculated from standardized scores of tasks of executive control (EC), processing speed (PS), working memory capacity (WMC), reasoning (R), episodic memory (EM), everyday memory. Higher scores represent better outcomes.&#xD;
  The composite score for overall cognition will include correct responses (or their response times - RT) from:&#xD;
  7 EC tasks: Task Switching (RT; fMRI task behavioral data) Dimensional Change Flanker (RT) Stroop (RT) Visual N-back Random N-back (fMRI task behavioral data) List Sorting Working Memory&#xD;
  4 EM tasks: Picture Sequence Memory Rey Auditory Verbal Learning Test Story Recall Mnemonic Similarity Task (fMRI task behavioral data)&#xD;
  2 R tasks: Matrix Reasoning Visual Puzzle&#xD;
  WMC:&#xD;
  Complex span&#xD;
  PS tasks:&#xD;
  Digit Symbol Substitution Task 0-back RT&#xD;
  1 everyday cognition task: Rivermead Behavioural Memory Test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in task-related functional connectivity of the DMN</measure>
      <time_frame>9-10 weeks (includes baseline assessment, training, and post-training assessment)</time_frame>
      <description>Change in task-related functional connectivity of the default mode network from baseline to post-training (i.e., after 8 weeks of training) in the random n-back fMRI task and at rest (resting-state scan is considered as the baseline condition).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in task-related functional connectivity of the cognitive networks</measure>
      <time_frame>9-10 weeks (includes baseline assessment, training, and post-training assessment)</time_frame>
      <description>Change in task-related functional connectivity of the cognitive networks from baseline to post-training (i.e., after 8 weeks of training) in the random n-back fMRI task and at rest (resting-state scan is considered as the baseline condition).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the Composite Score of Psychosocial Functioning</measure>
      <time_frame>9-10 weeks (includes baseline assessment, training, and post-training assessment)</time_frame>
      <description>Change in composite score of Psychosocial Functioning from baseline to post-training (i.e., after 8 weeks). Overall composite score will be calculated from standardized scores of 3 questionnaires. Higher scores represent better outcomes.&#xD;
  MIDUS 2 (Midlife in the United States 2)&#xD;
  GDS (Geriatric Depression Scale)&#xD;
  New General Self-Efficacy Scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in white matter structural connectivity</measure>
      <time_frame>9-10 weeks (includes baseline assessment, training, and post-training assessment)</time_frame>
      <description>Change in white matter structural connectivity (number of tracts that pass two ROIs and the fractional anisotropy sampled by the tracks) from baseline to post-training (i.e., after 8 weeks of training).</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Change in composite score of executive control</measure>
      <time_frame>9-10 weeks (includes baseline assessment, training, and post-training assessment)</time_frame>
      <description>Change in executive control composite score will be calculated using the standardized measures from the following tasks. Higher scores represent better outcomes.&#xD;
  Task Switching Response Time (RT; Behavioral data from the fMRI scanner task)&#xD;
  Dimensional Change&#xD;
  Flanker (RT)&#xD;
  Stroop (RT)&#xD;
  Visual N-back&#xD;
  Random N-back (Behavioral data from the fMRI scanner task)&#xD;
  List Sorting Working Memory</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in composite score of processing speed</measure>
      <time_frame>9-10 weeks (includes baseline assessment, training, and post-training assessment)</time_frame>
      <description>Change in processing speed composite score will be calculated using the standardized measures from the following tasks. Higher scores represent better outcomes.&#xD;
  random 0-back RT&#xD;
  Digit Symbol Substitution Task (DSST)</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in composite score of reasoning</measure>
      <time_frame>9-10 weeks (includes baseline assessment, training, and post-training assessment)</time_frame>
      <description>Change in reasoning composite score will be calculated using the standardized measures from the following tasks. Higher scores represent better outcomes.&#xD;
  Visual Puzzles (from Wechsler Adult Intelligence Scale - WAIS-4)&#xD;
  Matrix Reasoning (from Wechsler Adult Intelligence Scale - WAIS-4).</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in composite score of episodic memory</measure>
      <time_frame>9-10 weeks (includes baseline assessment, training, and post-training assessment)</time_frame>
      <description>Change in episodic memory composite score will be calculated using the standardized measures from the following tasks. Higher scores represent better outcomes.&#xD;
  Mnemonic Similarity Task MST,&#xD;
  Picture Sequence Memory (from NIH Toolbox),&#xD;
  Story Memory (from Mini-Mental State Examination - MMSE-2)&#xD;
  Rey Auditory Verbal Learning Test (RAVLT)</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in composite score of working memory capacity</measure>
      <time_frame>9-10 weeks (includes baseline assessment, training, and post-training assessment)</time_frame>
      <description>Change in working memory capacity composite score will be calculated using the standardized measures from the following tasks. Higher scores represent better outcomes.&#xD;
  forward span (from Wechsler Adult Intelligence Scale - WAIS-4),&#xD;
  backward span (from Wechsler Adult Intelligence Scale - WAIS-4)</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in score of everyday cognition</measure>
      <time_frame>9-10 weeks (includes baseline assessment, training, and post-training assessment)</time_frame>
      <description>Change in everyday memory score will be calculated using the Rivermead Behavioural Memory Test (RBMT). Higher scores represent better outcomes.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in task-related functional connectivity of the motor networks</measure>
      <time_frame>9-10 weeks (includes baseline assessment, training, and post-training assessment)</time_frame>
      <description>Change in task-related functional connectivity of the motor networks from baseline to post-training (i.e., after 8 weeks of training) in the random n-back fMRI task and at rest (resting-state scan is considered as the baseline condition).</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">16</enrollment>
    <condition>Healthy Aging</condition>
    <arm_group>
      <arm_group_label>Combined mindfulness meditation and cognitive training</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants train at home for 20 hours over 8 weeks, splitting the time between mindfulness meditation and cognitive training. Participants train for 30 minutes per day, for 5 days a weeks on a provided tablet computer. The participants are to keep a paper log of dates and durations.&#xD;
  The mindfulness meditation portion of the training is a commercially available mobile app. Participants listen to guided meditations and follow the instructions. The program includes common mindfulness meditation exercises such as body scan or breath awareness.&#xD;
  The cognitive training portion of the intervention uses a highly demanding attentional control training program BirdWatch game (BWGU). BWGU is a &quot;gamified&quot; n-back paradigm where participants randomly switch the focus of attention to update or maintain an adaptively growing set of bird stimuli in their working memory and are sometimes required to inhibit their response.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>MM+HighC</intervention_name>
      <description>In this intervention, participants will be trained on a available mindfulness meditation app, followed by a working memory updating game, developed by Dr. Chandramallika Basak. This game requires high degree of attentional control (Unpredictable Bird Watch), also known as High-C. The app and the game are delivered through an Android tablet for this home-based training.</description>
      <arm_group_label>Combined mindfulness meditation and cognitive training</arm_group_label>
      <other_name>Combined Mindfulness Meditation and Unpredictable Bird Watch</other_name>
      <other_name>MM+CT</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  right-handed&#xD;
  &#xD;
            -  aged 65 to 85 years old&#xD;
  &#xD;
            -  at least high school education&#xD;
  &#xD;
            -  learned English before age 5.&#xD;
  &#xD;
            -  screening cognitive assessment (MoCA) score above the threshold&#xD;
  &#xD;
            -  physical and sensory capacity sufficient to undertake an fMRI study:&#xD;
  &#xD;
            -  the ability to stay still for the duration of the scan&#xD;
  &#xD;
            -  sufficient finger dexterity to press buttons on the provided button boxes during the&#xD;
               scan&#xD;
  &#xD;
            -  vision acuity of at least 20/30 after correction&#xD;
  &#xD;
            -  no color blindness&#xD;
  &#xD;
            -  no claustrophobia&#xD;
  &#xD;
            -  no metal implants above the waist&#xD;
  &#xD;
            -  if female, cannot be pregnant or likely to be pregnant.&#xD;
  &#xD;
            -  cannot have participated in similar training in the past two years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  left-handed or ambidextrous&#xD;
  &#xD;
            -  weigh over 300 lb&#xD;
  &#xD;
            -  did not attain at least high school education&#xD;
  &#xD;
            -  have not learned English before the age of 5&#xD;
  &#xD;
            -  screening cognitive assessment (MoCA) score below the threshold&#xD;
  &#xD;
            -  color blind&#xD;
  &#xD;
            -  have vision acuity worse than 20/30 after correction&#xD;
  &#xD;
            -  experience of excessive hand tremor or other motor impairment related to hand movement&#xD;
  &#xD;
            -  history of cardiovascular disease other than treated hypertension&#xD;
  &#xD;
            -  diabetes&#xD;
  &#xD;
            -  psychiatric disorders&#xD;
  &#xD;
            -  illness or trauma affecting the central nervous system, including stroke and head&#xD;
               trauma resulting in loss of consciousness over 5 seconds&#xD;
  &#xD;
            -  substance/alcohol abuse&#xD;
  &#xD;
            -  use of medication with anti-depressant, anti-psychotic effects (use of hypnotic&#xD;
               medication is allowed only occasionally at bedtime).&#xD;
  &#xD;
            -  certain medical devices or implants&#xD;
  &#xD;
            -  non-medical sources of metal, e.g., shrapnel, prior hobby/work with metal&#xD;
  &#xD;
            -  MRI image revealing evidence of pathology&#xD;
  &#xD;
            -  female participants that are pregnant or likely to become pregnant&#xD;
  &#xD;
            -  participated in similar training in the past two years&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Paulina Skolasinska, MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>The University of Texas at Dallas</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Chandramallika Basak, PhD</last_name>
      <role>Study Director</role>
      <affiliation>The University of Texas at Dallas</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Paulina Skolasinska, MS</last_name>
      <phone>+1 972-883-3760</phone>
      <email>pas170003@utdallas.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Chandramallika Basak, PhD</last_name>
      <phone>+1 (972) 883-3724</phone>
      <email>cbasak@utdallas.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Center for Vital Longevity</name>
        <address>
          <city>Dallas</city>
          <state>Texas</state>
          <zip>75235</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Paulina Skolasinska, MS</last_name>
        <phone>972-883-3760</phone>
        <email>pas170003@utdallas.edu</email>
      </contact>
      <contact_backup>
        <last_name>Chandramallika Basak, PhD</last_name>
        <phone>9728833724</phone>
        <email>cbasak@utdallas.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Paulina Skolasinska, MS</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Geda YE. Mild cognitive impairment in older adults. Curr Psychiatry Rep. 2012 Aug;14(4):320-7. doi: 10.1007/s11920-012-0291-x.</citation>
      <PMID>22773365</PMID>
    </reference>
    <reference>
      <citation>Basak C, Qin S, O'Connell MA. Differential effects of cognitive training modules in healthy aging and mild cognitive impairment: A comprehensive meta-analysis of randomized controlled trials. Psychol Aging. 2020 Mar;35(2):220-249. doi: 10.1037/pag0000442. Epub 2020 Feb 3.</citation>
      <PMID>32011155</PMID>
    </reference>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>cognitive training</keyword>
    <keyword>mindfulness meditation training</keyword>
    <keyword>functional magnetic resonance imaging</keyword>
    <keyword>improving cognition</keyword>
    <keyword>improving brain function</keyword>
    <keyword>simulation games</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>February 5, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT05974605/ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05974605
  org study id: IRB-22-189
  nct id: NCT05974605
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this interventional study is to test the efficacy of combined mindfulness
        meditation training and cognitive training on brain function and cognition in healthy older
        adults. Participants will undergo cognitive and neuroimaging (MRI and fNIRS) assessments
        before and after an 8-week (~20 hours) training intervention. The intervention will consist
        of at-home mindfulness meditation followed by playing a cognitive game on a provided tablet.
        The findings will be compared to an existing data from older adults who trained on the
        cognitive game only (NCT03988829; Arms 1 and 2).
  Nearly 14 million people are projected to develop Alzheimer's disease (AD) by 2050 in the USA
        alone, with those affected by mild cognitive impairment (MCI) being especially at risk.
        Therefore, interventions aimed at prevention of dementia and promotion of brain and cognitive
        health in older adults need to be developed. One of the most successful types of
        non-pharmacological intervention is cognitive training, where participants engage in mental
        exercises targeting one or multiple cognitive domains. A recent meta-analysis has found that
        both healthy older adults and older adults affected by MCI, benefit equally in cognitive
        health from such training. Importantly, both populations showed improvements in cognitive
        abilities that were beyond the trained skills, such as everyday cognition, suggesting that
        cognitive training has a broad impact on independence in daily activities and quality of
        life. The training of attentional control has proven to be the most effective type of
        single-component training. Attentional control is the ability to focus attention to a task
        while inhibiting distractors; this "core" ability is fundamental for many everyday tasks. In
        addition to directly training attentional control, another promising approach to reducing
        distractibility is mindfulness meditation. As for the neural effects of attentional control
        training and meditation training, alterations in resting state brain function are reported,
        esp. in Default Mode Network (DMN) regions that are related to memory and attentional
        control. DMN is found to be engaged in older adults, but is disengaged in younger adults;
        this overactivation is detrimental to cognitive performance. However, the combined benefits
        of cognitive control training and mindfulness meditation on cognition and DMN are
        understudied in older adults.
  
        In this project, there is a single training arm that will train healthy older adults on a
        combination training composed of high attentional control and mindfulness meditation using
        simulation based games. Neural and cognitive changes in near and far transfer tasks will be
        examined immediately after the intervention. These changes will be compared with that of a
        previously collected group of older adults who received only cognitive control training
        (NCT03988829; Arms 1 and 2). Changes in overall cognition (primary cognitive outcome) and
        changes in DMN connectivity during task (primary neuroimaging outcome) and rest (secondary
        neuroimaging outcome) in this combination training group will be compared to the respective
        changes in Arm 1 (low attentional control training) and Arm 2 (High Attentional Control
        training) of the existing dataset. The protocol of participant recruitment, pre- and post-
        training assessments (MRI and behavioral), and training platform remain same between this
        study and the existing database. In this current study, participants also undergo a
        functional near infra-red spectroscopy (fNIRS) session, after completion of behavioral and
        MRI session, at pre-training and post-training. This clinical trial will result in the
        development of more efficient behavioral intervention tools in older adults, based on
        neuroimaging evidence, that can be readily used from the comfort of home.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: The trail will collect data from a single group. The results will be compared to a previously collected data from two arms of an RCT.
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Change in composite score of overall cognition
  time frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
  description: Change in composite score of overall cognition from baseline to post-training (after 8 weeks). Overall composite score calculated from standardized scores of tasks of executive control (EC), processing speed (PS), working memory capacity (WMC), reasoning (R), episodic memory (EM), everyday memory. Higher scores represent better outcomes.
  The composite score for overall cognition will include correct responses (or their response times - RT) from:
  7 EC tasks: Task Switching (RT; fMRI task behavioral data) Dimensional Change Flanker (RT) Stroop (RT) Visual N-back Random N-back (fMRI task behavioral data) List Sorting Working Memory
  4 EM tasks: Picture Sequence Memory Rey Auditory Verbal Learning Test Story Recall Mnemonic Similarity Task (fMRI task behavioral data)
  2 R tasks: Matrix Reasoning Visual Puzzle
  WMC:
  Complex span
  PS tasks:
  Digit Symbol Substitution Task 0-back RT
  1 everyday cognition task: Rivermead Behavioural Memory Test
  measure: Change in task-related functional connectivity of the DMN
  time frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
  description: Change in task-related functional connectivity of the default mode network from baseline to post-training (i.e., after 8 weeks of training) in the random n-back fMRI task and at rest (resting-state scan is considered as the baseline condition).
  measure: Change in task-related functional connectivity of the cognitive networks
  time frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
  description: Change in task-related functional connectivity of the cognitive networks from baseline to post-training (i.e., after 8 weeks of training) in the random n-back fMRI task and at rest (resting-state scan is considered as the baseline condition).
  measure: Change in the Composite Score of Psychosocial Functioning
  time frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
  description: Change in composite score of Psychosocial Functioning from baseline to post-training (i.e., after 8 weeks). Overall composite score will be calculated from standardized scores of 3 questionnaires. Higher scores represent better outcomes.
  MIDUS 2 (Midlife in the United States 2)
  GDS (Geriatric Depression Scale)
  New General Self-Efficacy Scale
  measure: Change in white matter structural connectivity
  time frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
  description: Change in white matter structural connectivity (number of tracts that pass two ROIs and the fractional anisotropy sampled by the tracks) from baseline to post-training (i.e., after 8 weeks of training).
  measure: Change in composite score of executive control
  time frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
  description: Change in executive control composite score will be calculated using the standardized measures from the following tasks. Higher scores represent better outcomes.
  Task Switching Response Time (RT; Behavioral data from the fMRI scanner task)
  Dimensional Change
  Flanker (RT)
  Stroop (RT)
  Visual N-back
  Random N-back (Behavioral data from the fMRI scanner task)
  List Sorting Working Memory
  measure: Change in composite score of processing speed
  time frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
  description: Change in processing speed composite score will be calculated using the standardized measures from the following tasks. Higher scores represent better outcomes.
  random 0-back RT
  Digit Symbol Substitution Task (DSST)
  measure: Change in composite score of reasoning
  time frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
  description: Change in reasoning composite score will be calculated using the standardized measures from the following tasks. Higher scores represent better outcomes.
  Visual Puzzles (from Wechsler Adult Intelligence Scale - WAIS-4)
  Matrix Reasoning (from Wechsler Adult Intelligence Scale - WAIS-4).
  measure: Change in composite score of episodic memory
  time frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
  description: Change in episodic memory composite score will be calculated using the standardized measures from the following tasks. Higher scores represent better outcomes.
  Mnemonic Similarity Task MST,
  Picture Sequence Memory (from NIH Toolbox),
  Story Memory (from Mini-Mental State Examination - MMSE-2)
  Rey Auditory Verbal Learning Test (RAVLT)
  measure: Change in composite score of working memory capacity
  time frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
  description: Change in working memory capacity composite score will be calculated using the standardized measures from the following tasks. Higher scores represent better outcomes.
  forward span (from Wechsler Adult Intelligence Scale - WAIS-4),
  backward span (from Wechsler Adult Intelligence Scale - WAIS-4)
  measure: Change in score of everyday cognition
  time frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
  description: Change in everyday memory score will be calculated using the Rivermead Behavioural Memory Test (RBMT). Higher scores represent better outcomes.
  measure: Change in task-related functional connectivity of the motor networks
  time frame: 9-10 weeks (includes baseline assessment, training, and post-training assessment)
  description: Change in task-related functional connectivity of the motor networks from baseline to post-training (i.e., after 8 weeks of training) in the random n-back fMRI task and at rest (resting-state scan is considered as the baseline condition).
  arm group label: Combined mindfulness meditation and cognitive training
  arm group type: Experimental
  description: Participants train at home for 20 hours over 8 weeks, splitting the time between mindfulness meditation and cognitive training. Participants train for 30 minutes per day, for 5 days a weeks on a provided tablet computer. The participants are to keep a paper log of dates and durations.
  The mindfulness meditation portion of the training is a commercially available mobile app. Participants listen to guided meditations and follow the instructions. The program includes common mindfulness meditation exercises such as body scan or breath awareness.
  The cognitive training portion of the intervention uses a highly demanding attentional control training program BirdWatch game (BWGU). BWGU is a "gamified" n-back paradigm where participants randomly switch the focus of attention to update or maintain an adaptively growing set of bird stimuli in their working memory and are sometimes required to inhibit their response.
  intervention type: Behavioral
  intervention name: MM+HighC
  description: In this intervention, participants will be trained on a available mindfulness meditation app, followed by a working memory updating game, developed by Dr. Chandramallika Basak. This game requires high degree of attentional control (Unpredictable Bird Watch), also known as High-C. The app and the game are delivered through an Android tablet for this home-based training.
  arm group label: Combined mindfulness meditation and cognitive training
  other name: Combined Mindfulness Meditation and Unpredictable Bird Watch
  other name: MM+CT
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: 85 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Paulina Skolasinska, MS
  role: Principal Investigator
  affiliation: The University of Texas at Dallas
  last name: Chandramallika Basak, PhD
  role: Study Director
  affiliation: The University of Texas at Dallas
  last name: Paulina Skolasinska, MS
  phone: +1 972-883-3760
  email: pas170003@utdallas.edu
  last name: Chandramallika Basak, PhD
  phone: +1 (972) 883-3724
  email: cbasak@utdallas.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  citation: Geda YE. Mild cognitive impairment in older adults. Curr Psychiatry Rep. 2012 Aug;14(4):320-7. doi: 10.1007/s11920-012-0291-x.
  PMID: 22773365
  citation: Basak C, Qin S, O'Connell MA. Differential effects of cognitive training modules in healthy aging and mild cognitive impairment: A comprehensive meta-analysis of randomized controlled trials. Psychol Aging. 2020 Mar;35(2):220-249. doi: 10.1037/pag0000442. Epub 2020 Feb 3.
  PMID: 32011155
  responsible party type: Sponsor
  sharing ipd: No
  provided document: 