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/NCT06028815</url>
    </required_header>
    <id_info>
      <org_study_id>NeuroemotionMusicCares</org_study_id>
      <nct_id>NCT06028815</nct_id>
    </id_info>
    <brief_title>Group Music Therapy Intervention With Informal Carers of Elderly Dependents</brief_title>
    <acronym>MUSIC CARES</acronym>
    <official_title>Effects of Group Music Therapy Intervention for Informal Caregivers of Elderly Dependents</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Deusto</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Deusto</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>
        To evaluate the effects of a group music therapy intervention with informal caregivers of&#xD;
        elderly people on clinical psychological symptoms, taking into account variables such as&#xD;
        caregiver burden, anxiety and depression.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 31, 2021</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Actual">January 1, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Health-related quality of life</measure>
      <time_frame>3 months</time_frame>
      <description>For evaluating Health-Related Quality of Life is going to use the 36-Item Short Form Health Survey questionnaire (SF-36).&#xD;
  The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Component analyses showed that there are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).&#xD;
  The correct calculation of SF-36 summary measures PCS and MCS requires the use of special algorithms.&#xD;
  The scores obtained in this questionnaire range from 0 to 100, with 0 being the worst state of health and 100 the best state of health for the dimension assessed. Thus, the higher the score obtained, the better the quality of life of the person assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Anxiety Stay and Trait</measure>
      <time_frame>3 months</time_frame>
      <description>The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety that also is often used in research as an indicator of caregiver distress.&#xD;
  It has 20 items for assessing trait anxiety and 20 for state anxiety, on a 4-point Likert scale.&#xD;
  Scores range from 20 to 80, with higher scores correlating with greater anxiety</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Depression</measure>
      <time_frame>3 months</time_frame>
      <description>Assessed with the BDI-II that contains 21 items and identifies symptoms and attitudes associated with depression.&#xD;
  Each item is evaluated on a severity scale ranging from 0-3, with a total score ranging from 0-63.&#xD;
  Higher total scores indicate more severe depressive symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Burden</measure>
      <time_frame>3 months</time_frame>
      <description>To assess the burden, it is using the Burden Zarit Interview that is a self-report instrument that assesses the level of caregiver burden. It consists of 22 items that are assessed using a Likert-type scale, where higher scores indicate greater burnout.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Coping strategies</measure>
      <time_frame>3 months</time_frame>
      <description>Coping strategies are evaluated with the COPE-28 that is the brief version inventory of 28 items and 14 subscales that is applied on an ordinal Likert-type scale with four response alternatives (from 0 to 3) between &quot;I never do this&quot; and &quot;I always do this&quot;, with intermediate scores.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Spirituality</measure>
      <time_frame>3 months</time_frame>
      <description>The outcome spirituality is assessed with the WHOQOL-SRPB,a 32-item instrument that measures spiritual, religious, and personal beliefs in 8 dimensions. Each item has a 5-point Likert format for responses from 1 (&quot;not at all&quot;) to 5 (&quot;completely&quot;).&#xD;
  The WHOQOL-SRPB total score ranges from 0 to 100, with higher scores indicating higher spirituality.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Care Burden</condition>
    <condition>Anxiety</condition>
    <condition>Depression</condition>
    <condition>Coping Strategies</condition>
    <condition>Quality of Life</condition>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Informal carers receive 10 music therapy sessions</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Informal carers do not receive music therapy sessions</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Group music therapy</intervention_name>
      <description>Music therapy intervention using active and receptive techniques, focusing on the technique of songwriting.</description>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  to be the main informal caregiver of an elderly dependant&#xD;
  &#xD;
            -  the dependant person has to be over 60 years of age&#xD;
  &#xD;
            -  to be over 18 years of age&#xD;
  &#xD;
            -  having signed the informed consent form accepting the assessment and intervention&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  not residing in Spain&#xD;
  &#xD;
            -  being under 18 years&#xD;
  &#xD;
            -  having uncompensated sensory deficits that prevented the administration of the&#xD;
               assessment protocol;&#xD;
  &#xD;
            -  illiteracy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>University of Deusto</name>
        <address>
          <city>Bilbao</city>
          <state>Bizkaia</state>
          <zip>48007</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Oscar Martínez, PhD.</last_name>
        <phone>944 13 90 00</phone>
        <email>oscar.martinez@deusto.es</email>
      </contact>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Group music therapy</keyword>
    <keyword>Informal caregivers</keyword>
    <keyword>Health-related quality of life (HRQOL)</keyword>
    <keyword>Anxiety</keyword>
    <keyword>Depression</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>The data is available from now until 2025</ipd_time_frame>
    </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/NCT06028815
  org study id: NeuroemotionMusicCares
  nct id: NCT06028815
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate the effects of a group music therapy intervention with informal caregivers of
        elderly people on clinical psychological symptoms, taking into account variables such as
        caregiver burden, anxiety and depression.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Health-related quality of life
  time frame: 3 months
  description: For evaluating Health-Related Quality of Life is going to use the 36-Item Short Form Health Survey questionnaire (SF-36).
  The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Component analyses showed that there are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).
  The correct calculation of SF-36 summary measures PCS and MCS requires the use of special algorithms.
  The scores obtained in this questionnaire range from 0 to 100, with 0 being the worst state of health and 100 the best state of health for the dimension assessed. Thus, the higher the score obtained, the better the quality of life of the person assessed.
  measure: Anxiety Stay and Trait
  time frame: 3 months
  description: The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety that also is often used in research as an indicator of caregiver distress.
  It has 20 items for assessing trait anxiety and 20 for state anxiety, on a 4-point Likert scale.
  Scores range from 20 to 80, with higher scores correlating with greater anxiety
  measure: Depression
  time frame: 3 months
  description: Assessed with the BDI-II that contains 21 items and identifies symptoms and attitudes associated with depression.
  Each item is evaluated on a severity scale ranging from 0-3, with a total score ranging from 0-63.
  Higher total scores indicate more severe depressive symptoms
  measure: Burden
  time frame: 3 months
  description: To assess the burden, it is using the Burden Zarit Interview that is a self-report instrument that assesses the level of caregiver burden. It consists of 22 items that are assessed using a Likert-type scale, where higher scores indicate greater burnout.
  measure: Coping strategies
  time frame: 3 months
  description: Coping strategies are evaluated with the COPE-28 that is the brief version inventory of 28 items and 14 subscales that is applied on an ordinal Likert-type scale with four response alternatives (from 0 to 3) between "I never do this" and "I always do this", with intermediate scores.
  measure: Spirituality
  time frame: 3 months
  description: The outcome spirituality is assessed with the WHOQOL-SRPB,a 32-item instrument that measures spiritual, religious, and personal beliefs in 8 dimensions. Each item has a 5-point Likert format for responses from 1 ("not at all") to 5 ("completely").
  The WHOQOL-SRPB total score ranges from 0 to 100, with higher scores indicating higher spirituality.
  arm group label: Experimental group
  arm group type: Experimental
  description: Informal carers receive 10 music therapy sessions
  arm group label: Control group
  arm group type: No Intervention
  description: Informal carers do not receive music therapy sessions
  intervention type: Behavioral
  intervention name: Group music therapy
  description: Music therapy intervention using active and receptive techniques, focusing on the technique of songwriting.
  arm group label: Experimental group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: Spain
  responsible party type: Sponsor
  mesh term: Depression
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: The data is available from now until 2025