<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/NCT02259062</url>
  </required_header>
  <id_info>
    <org_study_id>GN13CP462</org_study_id>
    <nct_id>NCT02259062</nct_id>
  </id_info>
  <brief_title>Listening for Leisure After Stroke</brief_title>
  <acronym>MELLO</acronym>
  <official_title>Measuring the Effects of Listening for Leisure on Outcome After Stroke (MELLO)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NHS Greater Glasgow and Clyde</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Glasgow</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NHS Greater Glasgow and Clyde</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Stroke is the biggest cause of disability in older adults. Early poststroke rehabilitation&#xD;
      focuses primarily on physical disability and activities of daily living. By contrast,&#xD;
      relatively little research attention has been paid to the potential for cognitive&#xD;
      rehabilitation and mood enhancing interventions in the early stages after stroke. Low mood&#xD;
      and cognitive difficulties with attention and memory are common post stroke leading to poorer&#xD;
      recovery, emotional wellbeing and quality of life yet accessible and effective therapies are&#xD;
      lacking.&#xD;
&#xD;
      Engagement in leisure activities may enhance recovery after stroke but participation in&#xD;
      leisure activities is reduced following stroke. Music listening is a low cost and accessible&#xD;
      leisure activity that has been suggested to improve mood and cognition poststroke. The&#xD;
      investigators speculate that music listening may enhance control of attention in a similar&#xD;
      way to mindfulness interventions, that have been demonstrated to be beneficial in the&#xD;
      treatment of mood disorders. The investigators propose that adding a brief mindfulness&#xD;
      intervention to music listening might enhance the effect on control of attention, with&#xD;
      positive effects on cognition and mood poststroke but the feasibility and acceptability of&#xD;
      this intervention needs to be evaluated before attempting a further trial assessing the&#xD;
      effectiveness of this intervention. The investigators aim to recruit 100 patients within two&#xD;
      weeks poststroke.&#xD;
&#xD;
      Participants will be randomly assigned to receive an 8 week music listening alone, music&#xD;
      listening with brief mindfulness or audiobook listening intervention alongside treatment as&#xD;
      usual. Neuropsychological assessment of cognition and mood will be performed at baseline, 3&#xD;
      months, and 6 months poststroke In addition, participants will be interviewed about their&#xD;
      experience of engaging in the interventions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">September 2016</completion_date>
  <primary_completion_date type="Anticipated">September 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment rate at 6 month follow up from baseline</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment adherence at 6 month follow up from baseline</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>sample retention at 6 month follow up from baseline</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in overall cognition score at 6 months from baseline</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in attention, memory and executive function scores at 6 months from baseline</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Hospital Anxiety and Depression Scale (HADS) scores at 6 months from baseline</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Five Facet Mindfulness Questionnaire short form (FFMQ-sf)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Mayo Portland Adaptability Inventory 4 (MPAI-4) scores</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Brain Injury Rehabilitation Trust Regulation of Emotions Adaptability</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Metacognitions Questionnaire short form (MCQ-30)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Likert ratings of participants' and therapist's experiences of treatment delivery.</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Music listening</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Music listening with brief mindfulness</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Audio book intervention</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Music with brief mindfulness intervention</intervention_name>
    <description>Music listening with mindfulness therapy</description>
    <arm_group_label>Music listening with brief mindfulness</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Music listening alone</intervention_name>
    <arm_group_label>Music listening</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Audiobook listening</intervention_name>
    <arm_group_label>Audio book intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Ischaemic stroke (confirmed clinically and/or radiologically and&#xD;
             subclassified according to the Oxford Clinical Stroke Classification)&#xD;
&#xD;
          -  ≤14 days poststroke at time of recruitment (expression of interest to participate&#xD;
             either verbally or in writing)&#xD;
&#xD;
          -  Native English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Comorbid progressive neurological or neurodegenerative condition&#xD;
&#xD;
          -  Major psychiatric disorder (Prestroke history of mood disorder or stable&#xD;
             antidepressant medication will not lead to exclusion)&#xD;
&#xD;
          -  History of major substance abuse problems&#xD;
&#xD;
          -  Unable to give informed consent&#xD;
&#xD;
          -  Unable to cooperate with the study protocol (e.g. due to severe aphasia, uncorrected&#xD;
             impairment of hearing or vision, or illiteracy)&#xD;
&#xD;
          -  Clinically unstable (e.g. due to major intercurrent illness).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan Evans, BSc,Dip.Clin.Psychol. PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Glasgow</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NHS Greater Glasgow and Clyde</name>
      <address>
        <city>Glasgow</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>October 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>July 5, 2016</last_update_submitted>
  <last_update_submitted_qc>July 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT02259062
org study id: GN13CP462
nct id: NCT02259062
lead sponsor: 
collaborator: 
has dmc: No
Stroke is the biggest cause of disability in older adults. Early poststroke rehabilitation
      focuses primarily on physical disability and activities of daily living. By contrast,
      relatively little research attention has been paid to the potential for cognitive
      rehabilitation and mood enhancing interventions in the early stages after stroke. Low mood
      and cognitive difficulties with attention and memory are common post stroke leading to poorer
      recovery, emotional wellbeing and quality of life yet accessible and effective therapies are
      lacking.

      Engagement in leisure activities may enhance recovery after stroke but participation in
      leisure activities is reduced following stroke. Music listening is a low cost and accessible
      leisure activity that has been suggested to improve mood and cognition poststroke. The
      investigators speculate that music listening may enhance control of attention in a similar
      way to mindfulness interventions, that have been demonstrated to be beneficial in the
      treatment of mood disorders. The investigators propose that adding a brief mindfulness
      intervention to music listening might enhance the effect on control of attention, with
      positive effects on cognition and mood poststroke but the feasibility and acceptability of
      this intervention needs to be evaluated before attempting a further trial assessing the
      effectiveness of this intervention. The investigators aim to recruit 100 patients within two
      weeks poststroke.

      Participants will be randomly assigned to receive an 8 week music listening alone, music
      listening with brief mindfulness or audiobook listening intervention alongside treatment as
      usual. Neuropsychological assessment of cognition and mood will be performed at baseline, 3
      months, and 6 months poststroke In addition, participants will be interviewed about their
      experience of engaging in the interventions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Recruitment rate at 6 month follow up from baseline
time frame: 6 months
measure: Treatment adherence at 6 month follow up from baseline
time frame: 6 months
measure: sample retention at 6 month follow up from baseline
time frame: 6 months
measure: Change in overall cognition score at 6 months from baseline
time frame: 6 months
measure: Change in attention, memory and executive function scores at 6 months from baseline
time frame: 6 months
measure: Change in Hospital Anxiety and Depression Scale (HADS) scores at 6 months from baseline
time frame: 6 months
measure: Changes in Five Facet Mindfulness Questionnaire short form (FFMQ-sf)
time frame: 6 months
measure: Changes in Mayo Portland Adaptability Inventory 4 (MPAI-4) scores
time frame: 6 months
measure: Changes in Brain Injury Rehabilitation Trust Regulation of Emotions Adaptability
time frame: 6 months
measure: Changes in Metacognitions Questionnaire short form (MCQ-30)
time frame: 6 months
measure: Likert ratings of participants' and therapist's experiences of treatment delivery.
time frame: 6 months
arm group label: Music listening
arm group type: Active Comparator
arm group label: Music listening with brief mindfulness
arm group type: Experimental
arm group label: Audio book intervention
arm group type: Placebo Comparator
intervention type: Other
intervention name: Music with brief mindfulness intervention
description: Music listening with mindfulness therapy
arm group label: Music listening with brief mindfulness
intervention type: Other
intervention name: Music listening alone
arm group label: Music listening
intervention type: Other
intervention name: Audiobook listening
arm group label: Audio book intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jonathan Evans, BSc,Dip.Clin.Psychol. PhD
role: Principal Investigator
affiliation: University of Glasgow
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Stroke