<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/NCT02219620</url>
  </required_header>
  <id_info>
    <org_study_id>14-953118</org_study_id>
    <nct_id>NCT02219620</nct_id>
  </id_info>
  <brief_title>Examining the Effects of (MiM) Treatment on Emotional and Cognitive Functioning of Residents in Long-term Care</brief_title>
  <acronym>MiM</acronym>
  <official_title>Examining the Effects of (MiM) Treatment on Emotional and Cognitive Functioning of Residents in Long-term Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>George Mason University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>George Mason University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To examine the effects of a music, imagery, and movement (MiM) intervention on emotional and&#xD;
      cognitive functioning in residents living in a community-based adult long-term care facility.&#xD;
&#xD;
      Hypothesis 1: Residents who participate in the MiM group will improve in emotional&#xD;
      functioning, as compared to residents in the control group.&#xD;
&#xD;
      Hypothesis 2: Residents who participate in the MiM group will improve in cognitive&#xD;
      functioning, as compared to residents in the control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To implement a community-based integrated music, art and imagery, and movement intervention&#xD;
      to improve mood and promote cognitive functioning in older adult residents living in a&#xD;
      long-term care facility.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>emotional functioning</measure>
    <time_frame>pre-post 10 week treatment and 6 week FU</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>cognitive functioning</measure>
    <time_frame>pre-post 10 week intervention and 6 week FU</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Emotion</condition>
  <condition>Impaired Cognition</condition>
  <arm_group>
    <arm_group_label>Music, Imagery, Movement intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Music, Imagery, Movement intervention: psychosocial intervention incorporating Music, Imagery and Movement</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Social Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>social control/interaction group</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Music, Imagery, Movement</intervention_name>
    <description>Implementation of music, art and imagery activation, and movement in group modality</description>
    <arm_group_label>Music, Imagery, Movement intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Social Control</intervention_name>
    <description>social conversational group facilitated by care counselor</description>
    <arm_group_label>Social Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Resident in assisted living at long-term care facility with MMSE score above 20&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  co-morbid psychiatric diagnosis and/or staff clinical evaluation that determines&#xD;
             inappropriateness for study inclusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Holly Matto, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>George Mason University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cathy Tompkins, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>George Mason University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Emily Ihara, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>George Mason University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assisted Living at Birmingham Green</name>
      <address>
        <city>Manassas</city>
        <state>Virginia</state>
        <zip>20110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>June 20, 2016</last_update_submitted>
  <last_update_submitted_qc>June 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>George Mason University</investigator_affiliation>
    <investigator_full_name>Holly Matto</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>creative arts</keyword>
  <keyword>older adults</keyword>
  <keyword>intervention study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</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/NCT02219620
org study id: 14-953118
nct id: NCT02219620
lead sponsor: 
has dmc: Yes
To examine the effects of a music, imagery, and movement (MiM) intervention on emotional and
      cognitive functioning in residents living in a community-based adult long-term care facility.

      Hypothesis 1: Residents who participate in the MiM group will improve in emotional
      functioning, as compared to residents in the control group.

      Hypothesis 2: Residents who participate in the MiM group will improve in cognitive
      functioning, as compared to residents in the control group.
To implement a community-based integrated music, art and imagery, and movement intervention
      to improve mood and promote cognitive functioning in older adult residents living in a
      long-term care facility.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: emotional functioning
time frame: pre-post 10 week treatment and 6 week FU
measure: cognitive functioning
time frame: pre-post 10 week intervention and 6 week FU
arm group label: Music, Imagery, Movement intervention
arm group type: Experimental
description: Music, Imagery, Movement intervention: psychosocial intervention incorporating Music, Imagery and Movement
arm group label: Social Control
arm group type: Active Comparator
description: social control/interaction group
intervention type: Behavioral
intervention name: Music, Imagery, Movement
description: Implementation of music, art and imagery activation, and movement in group modality
arm group label: Music, Imagery, Movement intervention
intervention type: Behavioral
intervention name: Social Control
description: social conversational group facilitated by care counselor
arm group label: Social Control
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Holly Matto, Ph.D.
role: Principal Investigator
affiliation: George Mason University
last name: Cathy Tompkins, Ph.D.
role: Principal Investigator
affiliation: George Mason University
last name: Emily Ihara, Ph.D.
role: Principal Investigator
affiliation: George Mason University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: George Mason University
investigator full name: Holly Matto
investigator title: Associate Professor
mesh term: Cognitive Dysfunction