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/NCT05980286</url>
    </required_header>
    <id_info>
      <org_study_id>1R61AG073669</org_study_id>
      <secondary_id>1R61AG073669</secondary_id>
      <nct_id>NCT05980286</nct_id>
    </id_info>
    <brief_title>Impact of Musical Improvisation Training on Cognitive Function in Older Adults</brief_title>
    <official_title>Impact of Musical Improvisation Training on Cognitive Function in Older Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, San Francisco</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Aging (NIA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of California, San Francisco</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>
        This project will develop and test the effects and mechanisms of a music improvisation&#xD;
        training intervention on self-regulation of older adults with and without MCI. The&#xD;
        investigator's overall hypothesis is that improvisation training will lead to improvements in&#xD;
        self-regulation, compared to controls, and that improvisation training will be associated&#xD;
        with specific changes in prefrontal brain networks and ultimately cognitive engagement.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Approximately 5.8 million adults age 60 and over in the United States live with Alzheimer&#xD;
        disease and related dementias (AD/ADRD) at a cost of $290 billion per year. Older adults with&#xD;
        mild cognitive impairment (MCI), an intermediate stage between typical aging and dementia,&#xD;
        are 3-5 times more likely to progress to AD than those with normal cognition. Late-life&#xD;
        engagement in cognitively challenging activities is associated with decreased risk of&#xD;
        cognitive decline, and there is a need to address cognitive inactivity. Music interventions&#xD;
        are a promising strategy to address late-life cognitive inactivity. Music training can change&#xD;
        brain structure and function in non-musician adults, thereby leading to cognitive,&#xD;
        perceptual, and psychosocial advantages. These changes in cognitive function are thought to&#xD;
        occur because the multimodal, complex nature of music facilitates training-induced neural&#xD;
        plasticity. However, the mechanisms are not yet understood, and most studies used traditional&#xD;
        or rote keyboard training techniques. Music training based on improvisation principles-the&#xD;
        spontaneous generation of musical melodies and rhythms-will likely have more potent effects&#xD;
        on cognition and brain function. Improvisation facilitates cognitive flexibility,&#xD;
        self-monitoring, novel idea generation, execution of unplanned motor sequences and entrance&#xD;
        into a state of flow. Biologically, improvisation is associated with distinct neural patterns&#xD;
        involving activation of prefrontal networks and other brain networks that are affected by&#xD;
        aging. As a mechanism of behavior change, it is likely that improvisation training will&#xD;
        uniquely improve self-regulation (the ability to monitor and control one's own behavior,&#xD;
        emotions, or thoughts and modify to situational demands). Yet, no research has tested whether&#xD;
        improvisation training can improve self-regulation and facilitate maintenance of cognitively&#xD;
        challenging activities among older adults with and without MCI. This project will develop and&#xD;
        test the effects and mechanisms of a music improvisation training intervention on&#xD;
        self-regulation of older adults with and without MCI. Our overall hypothesis is that&#xD;
        improvisation training will lead to improvements in self-regulation, compared to controls,&#xD;
        and that improvisation training will be associated with specific changes in prefrontal brain&#xD;
        networks and ultimately cognitive engagement. Our project has two phases. In the R61 phase,&#xD;
        the study will develop a music improvisation training intervention that aims to improve&#xD;
        self-regulation among older adults with and without MCI and conduct a 2-arm randomized pilot&#xD;
        study to (i) examine feasibility and acceptability of the intervention and study methods and&#xD;
        (ii) determine its effects on the hypothesized mechanism of self-regulation. If milestones&#xD;
        are met, the study will proceed to the R33 phase and conduct a randomized mechanistic trial&#xD;
        to examine the effects of the intervention, compared to an attention control, on&#xD;
        self-regulation and cognitive engagement among older adults with and without MCI. The&#xD;
        findings from this study will improve our understanding of the underlying mechanisms of how&#xD;
        music training interventions can facilitate behavior change to maintain health of older&#xD;
        adults.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 15, 2022</start_date>
    <completion_date type="Actual">June 28, 2023</completion_date>
    <primary_completion_date type="Actual">June 28, 2023</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>We will conduct a 2-arm randomized pilot trial.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Short Self-Regulation Questionnaire</measure>
      <time_frame>Baseline and 12-week Post Intervention</time_frame>
      <description>Self-report measure of the ability to regulate one's behavior in a goal-oriented way. This self-reported questionnaire contains 31 items, each item was scored on a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The questionnaire scores ranged from 31 to 155, with higher scores indicating better self-regulation behavior.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Florida Cognitive Activities Scale</measure>
      <time_frame>Baseline and 12-week Post Intervention</time_frame>
      <description>The Florida Cognitive Activities Scale is a 25-item scale (0-never to 5-daily) used to assess the cognitive activity in elderly populations. There are two subscales, the Higher Cognitive Abilities and Frequent Cognitive Abilities, and also a measure of self-reported maintenance of cognitive activity.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>National Institutes of Health ToolBox Self-Efficacy</measure>
      <time_frame>Baseline and 12-week Post Intervention</time_frame>
      <description>The NIH Toolbox Self-Efficacy Scale is a 10-item self-reported measure that assesses belief in one's capacity to manage and have control over meaningful events in life. Scores for each item range from 1 to 5 (never to very often). Higher scores indicate higher self-efficacy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Short GRIT Scale</measure>
      <time_frame>Baseline and 12-week Post Intervention</time_frame>
      <description>The Grist-S is a self-report, 8-item questionnaire that measures the extent to which individuals are able to maintain focus and interest and persevere in obtaining long-term goals. Scores for each item range from 1 to 5, with overall scores being calculated by added up all points and dividing by 8. Higher scores indicate a higher level of &quot;grit,&quot; or perseverance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Five Facets of Mindfulness</measure>
      <time_frame>Baseline and 12-week Post Intervention</time_frame>
      <description>Measures components of mindfulness, which is a tendency to attend to the present moment with a non-judgemental attitude. Scores for each item range from 1 to 6 (never to always true). Mindfulness and self-regulation ability have been identified as closely aligned in recent theoretical frameworks (e.g., the self- awareness, -regulation, and -transcendence model of mindfulness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>National Institutes of Health Toolbox Loneliness Scale</measure>
      <time_frame>Baseline and 12-week Post Intervention</time_frame>
      <description>Self-report measure that assesses perceptions of loneliness and assesses the extent to which an individual feels alone or socially isolated from other individuals. The NIH Toolbox Loneliness Survey is a self-report measure that assesses perceptions of loneliness using a 5-item fixed length form.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>National Institutes of Health Toolbox Apathy</measure>
      <time_frame>Baseline and 12-week Post Intervention</time_frame>
      <description>Instruments measuring deficits in-goal directed behavior and decrements in in-goal related thought content. It is 7 items, each item is scored on a 4-point Likert scale (not at all true to very true). The total score ranges from 18 to 72, with higher scores indicating more apathy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Geriatric Depression Scale - Short Form</measure>
      <time_frame>Baseline and 12-week Post Intervention</time_frame>
      <description>A short form comprising of 15-items, which is effective for the diagnosis of depression of elderly, is more simple, brief and time-effective.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>10-item Personality Inventory</measure>
      <time_frame>Baseline Only</time_frame>
      <description>Brief assessment of the Big Five Personality Dimensions: 1. Extraversion, 2. Agreeableness, 3. Conscientiousness, 4. Emotional Stability, and 5. Openness to Experience consisting of 10 items. Scores range from 1 (disagree strongly) to 7 (agree strongly).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">53</enrollment>
    <condition>Aging</condition>
    <condition>Cognitive Aging</condition>
    <condition>Cognitive Impairment</condition>
    <condition>Cognitive Training</condition>
    <condition>Cognitively Normal Older Adults</condition>
    <condition>Mild Cognitive Impairment</condition>
    <arm_group>
      <arm_group_label>Piano Improvisation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This intervention will involve group piano improvisation training sessions once a week for 12 weeks, in addition to daily in-home practice for 4-5 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Music Listening</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The music listening condition will involve group music listening sessions (led by a trained instructor) once a week for 12 weeks and daily in-home music listening practice.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Piano Improvisation</intervention_name>
      <description>Piano Improvisation taught by a professional instructor for 16 weeks.</description>
      <arm_group_label>Piano Improvisation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Music Listening</intervention_name>
      <description>Music Listening facilitated by a professional instructor for 16 weeks.</description>
      <arm_group_label>Music Listening</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 60 and over&#xD;
  &#xD;
            -  Living independently in the community&#xD;
  &#xD;
            -  Sufficient visual and hearing acuity (age-related to normal hearing loss, with&#xD;
               assistive devices) as measured by audiometer&#xD;
  &#xD;
            -  Less than three years of formal music training (as indicated by private music lessons&#xD;
               does not include group or ensemble classes) and not currently reading or engaging in&#xD;
               music performance&#xD;
  &#xD;
            -  English fluency rated fairly well to well&#xD;
  &#xD;
            -  MoCA score of 22-30 or diagnosis of &quot;mild cognitive impairment&#xD;
  &#xD;
            -  Not currently taking psychoactive medications, antidepressants, or sleep medications&#xD;
               that could adversely affect cognitive abilities.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Medical diagnosis of dementia (any etiology)&#xD;
  &#xD;
            -  Inability to move the hands or use all 10 digits (extensive arthritis, neuropathy,&#xD;
               missing digits)&#xD;
  &#xD;
            -  Score &lt; 22 on MoCA&#xD;
  &#xD;
            -  Current (but not prior) severe psychiatric disorder, serious medical condition (e.g.,&#xD;
               stroke, TIA) that would interfere with participation in the study&#xD;
  &#xD;
            -  Poor English fluency&#xD;
  &#xD;
            -  Musician or previously trained in jazz improvisation, more than three years of formal&#xD;
               music instruction or training and/or currently engaged in musical performance&#xD;
  &#xD;
            -  Plans to move out of the area within six months&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Julene Johnson, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of California, San Francisco</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Potrero Hill Neighborhood House</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94107</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Third Baptist Church</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94107</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Aquatic Park Senior Center</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94109</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Aging</keyword>
    <keyword>Brain Aging</keyword>
    <keyword>Cognition</keyword>
    <keyword>Cognitive Engagement</keyword>
    <keyword>Mild Cognitive Impairment</keyword>
    <keyword>Music</keyword>
    <keyword>Music-based Intervention</keyword>
    <keyword>Music Training</keyword>
    <keyword>Older Adults</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cognitive Dysfunction</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05980286
  org study id: 1R61AG073669
  secondary id: 1R61AG073669
  nct id: NCT05980286
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This project will develop and test the effects and mechanisms of a music improvisation
        training intervention on self-regulation of older adults with and without MCI. The
        investigator's overall hypothesis is that improvisation training will lead to improvements in
        self-regulation, compared to controls, and that improvisation training will be associated
        with specific changes in prefrontal brain networks and ultimately cognitive engagement.
  Approximately 5.8 million adults age 60 and over in the United States live with Alzheimer
        disease and related dementias (AD/ADRD) at a cost of $290 billion per year. Older adults with
        mild cognitive impairment (MCI), an intermediate stage between typical aging and dementia,
        are 3-5 times more likely to progress to AD than those with normal cognition. Late-life
        engagement in cognitively challenging activities is associated with decreased risk of
        cognitive decline, and there is a need to address cognitive inactivity. Music interventions
        are a promising strategy to address late-life cognitive inactivity. Music training can change
        brain structure and function in non-musician adults, thereby leading to cognitive,
        perceptual, and psychosocial advantages. These changes in cognitive function are thought to
        occur because the multimodal, complex nature of music facilitates training-induced neural
        plasticity. However, the mechanisms are not yet understood, and most studies used traditional
        or rote keyboard training techniques. Music training based on improvisation principles-the
        spontaneous generation of musical melodies and rhythms-will likely have more potent effects
        on cognition and brain function. Improvisation facilitates cognitive flexibility,
        self-monitoring, novel idea generation, execution of unplanned motor sequences and entrance
        into a state of flow. Biologically, improvisation is associated with distinct neural patterns
        involving activation of prefrontal networks and other brain networks that are affected by
        aging. As a mechanism of behavior change, it is likely that improvisation training will
        uniquely improve self-regulation (the ability to monitor and control one's own behavior,
        emotions, or thoughts and modify to situational demands). Yet, no research has tested whether
        improvisation training can improve self-regulation and facilitate maintenance of cognitively
        challenging activities among older adults with and without MCI. This project will develop and
        test the effects and mechanisms of a music improvisation training intervention on
        self-regulation of older adults with and without MCI. Our overall hypothesis is that
        improvisation training will lead to improvements in self-regulation, compared to controls,
        and that improvisation training will be associated with specific changes in prefrontal brain
        networks and ultimately cognitive engagement. Our project has two phases. In the R61 phase,
        the study will develop a music improvisation training intervention that aims to improve
        self-regulation among older adults with and without MCI and conduct a 2-arm randomized pilot
        study to (i) examine feasibility and acceptability of the intervention and study methods and
        (ii) determine its effects on the hypothesized mechanism of self-regulation. If milestones
        are met, the study will proceed to the R33 phase and conduct a randomized mechanistic trial
        to examine the effects of the intervention, compared to an attention control, on
        self-regulation and cognitive engagement among older adults with and without MCI. The
        findings from this study will improve our understanding of the underlying mechanisms of how
        music training interventions can facilitate behavior change to maintain health of older
        adults.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: We will conduct a 2-arm randomized pilot trial.
  primary purpose: Other
  masking: Single (Investigator)
  measure: Short Self-Regulation Questionnaire
  time frame: Baseline and 12-week Post Intervention
  description: Self-report measure of the ability to regulate one's behavior in a goal-oriented way. This self-reported questionnaire contains 31 items, each item was scored on a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The questionnaire scores ranged from 31 to 155, with higher scores indicating better self-regulation behavior.
  measure: Florida Cognitive Activities Scale
  time frame: Baseline and 12-week Post Intervention
  description: The Florida Cognitive Activities Scale is a 25-item scale (0-never to 5-daily) used to assess the cognitive activity in elderly populations. There are two subscales, the Higher Cognitive Abilities and Frequent Cognitive Abilities, and also a measure of self-reported maintenance of cognitive activity.
  measure: National Institutes of Health ToolBox Self-Efficacy
  time frame: Baseline and 12-week Post Intervention
  description: The NIH Toolbox Self-Efficacy Scale is a 10-item self-reported measure that assesses belief in one's capacity to manage and have control over meaningful events in life. Scores for each item range from 1 to 5 (never to very often). Higher scores indicate higher self-efficacy.
  measure: Short GRIT Scale
  time frame: Baseline and 12-week Post Intervention
  description: The Grist-S is a self-report, 8-item questionnaire that measures the extent to which individuals are able to maintain focus and interest and persevere in obtaining long-term goals. Scores for each item range from 1 to 5, with overall scores being calculated by added up all points and dividing by 8. Higher scores indicate a higher level of "grit," or perseverance.
  measure: Five Facets of Mindfulness
  time frame: Baseline and 12-week Post Intervention
  description: Measures components of mindfulness, which is a tendency to attend to the present moment with a non-judgemental attitude. Scores for each item range from 1 to 6 (never to always true). Mindfulness and self-regulation ability have been identified as closely aligned in recent theoretical frameworks (e.g., the self- awareness, -regulation, and -transcendence model of mindfulness.
  measure: National Institutes of Health Toolbox Loneliness Scale
  time frame: Baseline and 12-week Post Intervention
  description: Self-report measure that assesses perceptions of loneliness and assesses the extent to which an individual feels alone or socially isolated from other individuals. The NIH Toolbox Loneliness Survey is a self-report measure that assesses perceptions of loneliness using a 5-item fixed length form.
  measure: National Institutes of Health Toolbox Apathy
  time frame: Baseline and 12-week Post Intervention
  description: Instruments measuring deficits in-goal directed behavior and decrements in in-goal related thought content. It is 7 items, each item is scored on a 4-point Likert scale (not at all true to very true). The total score ranges from 18 to 72, with higher scores indicating more apathy.
  measure: Geriatric Depression Scale - Short Form
  time frame: Baseline and 12-week Post Intervention
  description: A short form comprising of 15-items, which is effective for the diagnosis of depression of elderly, is more simple, brief and time-effective.
  measure: 10-item Personality Inventory
  time frame: Baseline Only
  description: Brief assessment of the Big Five Personality Dimensions: 1. Extraversion, 2. Agreeableness, 3. Conscientiousness, 4. Emotional Stability, and 5. Openness to Experience consisting of 10 items. Scores range from 1 (disagree strongly) to 7 (agree strongly).
  arm group label: Piano Improvisation
  arm group type: Experimental
  description: This intervention will involve group piano improvisation training sessions once a week for 12 weeks, in addition to daily in-home practice for 4-5 days.
  arm group label: Music Listening
  arm group type: Active Comparator
  description: The music listening condition will involve group music listening sessions (led by a trained instructor) once a week for 12 weeks and daily in-home music listening practice.
  intervention type: Behavioral
  intervention name: Piano Improvisation
  description: Piano Improvisation taught by a professional instructor for 16 weeks.
  arm group label: Piano Improvisation
  intervention type: Behavioral
  intervention name: Music Listening
  description: Music Listening facilitated by a professional instructor for 16 weeks.
  arm group label: Music Listening
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Julene Johnson, PhD
  role: Principal Investigator
  affiliation: University of California, San Francisco
  facility: 
  facility: 
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Cognitive Dysfunction
  sharing ipd: No