<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/NCT03759171</url>
  </required_header>
  <id_info>
    <org_study_id>PRO00019269</org_study_id>
    <nct_id>NCT03759171</nct_id>
  </id_info>
  <brief_title>Music-instruction Intervention for Treatment of Post-traumatic Stress Disorder</brief_title>
  <official_title>Music-instruction Intervention for Treatment of Post-traumatic Stress Disorder: A Randomized Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical College of Wisconsin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Milwaukee VA Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical College of Wisconsin</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 purpose of this study was to examine the feasibility and potential effectiveness of an&#xD;
      active, music-instruction intervention in improving psychological health and social&#xD;
      functioning among Veterans suffering from moderate to severe Post-traumatic Stress Disorder&#xD;
      (PTSD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study was designed as a prospective, delayed-entry randomized pilot trial.&#xD;
      Regression-adjusted difference in means were used to examine the intervention's effectiveness&#xD;
      with respect to PTSD symptomatology (primary outcome) as well as depression, perceptions of&#xD;
      cognitive failures, social functioning and isolation, and health-related quality of life&#xD;
      (secondary outcomes).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2010</start_date>
  <completion_date type="Actual">September 30, 2011</completion_date>
  <primary_completion_date type="Actual">September 30, 2011</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Delayed entry, randomized trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-Traumatic Stress Disorder (PTSD) Symptoms</measure>
    <time_frame>6 weeks</time_frame>
    <description>Post-Traumatic Stress Disorder (PTSD) symptoms as measured by the PTSD Checklist Civilian (PCLC), a self-report scale that measures PTSD presence and severity. The 17 items correspond to Diagnostic and Statistical Manual DSM-IV symptoms of PTSD. The level of distress produced by each symptom is rated from 1 (not at all) to 5 (extremely). A score &gt;50 on this measure is considered clinically significant (maximum score = 85).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>6 weeks</time_frame>
    <description>Depression was assessed using the Beck Depression Inventory-II (BDI-II), a 21-item self-report scale measuring the presence and severity of depressive symptoms over the two weeks preceding test administration. Each answer ranges in score from 0-3. Total scores indicate minimal (0-13), mild (14-19), moderate (20-28), and severe (29-63; maximum = 63) levels of reported depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceptions of Cognitive Failures</measure>
    <time_frame>6 weeks</time_frame>
    <description>The Cognitive Failures Questionnaire (CFQ) was used as a self-reported measure of everyday cognitive lapses for perception, memory, and motor function, such as forgetting appointments or having word finding difficulty. Total scores range from 0 to 100 with higher numbers indicating worse outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Functioning</measure>
    <time_frame>6 weeks</time_frame>
    <description>The University of California, Los Angeles (UCLA) Loneliness Scale was administered to assess subjective feelings of social isolation. This is a 20-item scale summed to give a total score ranging from 0-60 with higher numbers indicating worse outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-Related Quality of Life</measure>
    <time_frame>6 weeks</time_frame>
    <description>The European Quality of Life (EuroQoL) Scale, a validated preference-based scale for which population norms are available in the US and elsewhere, was used as the global evaluation of veteran's health-related quality of life. The 5-item EuroQoL measure combines data on activity restrictions (ADL, IADL limitations), limitations in participation (usual major activity and other social activities) and self- perceived health status (excellent, good, fair or poor) to measure one's overall satisfaction with health and well-being. Scores range from -0.594 to 1.000, higher values represent better outcomes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Stress Disorders, Post-Traumatic</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Immediate Entry Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Following the baseline interview, veterans randomized to the immediate entry group directly engaged in the Guitars for Vets Intervention and were interviewed at the end of the intervention period, roughly 6 weeks later. The intervention content and duration (6 weeks) was the same across both groups.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed Entry Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Those randomized to the delayed entry group had their baseline interview repeated at the end of the delayed entry period (4 weeks) prior to receiving the 6-week Guitars for Vets Intervention as well as after intervention completion. The intervention content and duration (6 weeks) was the same across both groups.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Guitars for Vets Intervention</intervention_name>
    <description>This was an active intervention providing veterans with an acoustic guitar, guitar pick, tuning instruments, a music book, practice CDs, and individual and group sessions of music instruction during a 6-week intervention period. Six tailored 1-hour individual guitar instruction sessions were scheduled (1 session per week). In addition to the 6 tailored individual lessons, the intervention provided 3 group sessions. Veterans were given a guitar that they could keep upon completion of the program. The same instructor was assigned to a subject for the duration of the study, and group sessions were supervised by the Education Director of Guitars for Vets.</description>
    <arm_group_label>Delayed Entry Group</arm_group_label>
    <arm_group_label>Immediate Entry Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Veterans who (i) had at least one visit for mental health treatment in the prior six&#xD;
             months with a primary diagnosis of PTSD (ICD9CM 309.81-83) and (ii) exhibited moderate&#xD;
             to severe PTSD symptoms at the time of enrollment (Posttraumatic Stress Disorder&#xD;
             Checklist &gt;=50)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Veterans who were currently participating in an intense psychotherapy program&#xD;
             (residential or outpatient)&#xD;
&#xD;
          -  Veterans who were already receiving guitar lessons from a Guitars for Vets volunteer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical College of Wisconsin</investigator_affiliation>
    <investigator_full_name>Liliana Pezzin</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03759171
org study id: PRO00019269
nct id: NCT03759171
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study was to examine the feasibility and potential effectiveness of an
      active, music-instruction intervention in improving psychological health and social
      functioning among Veterans suffering from moderate to severe Post-traumatic Stress Disorder
      (PTSD).
The study was designed as a prospective, delayed-entry randomized pilot trial.
      Regression-adjusted difference in means were used to examine the intervention's effectiveness
      with respect to PTSD symptomatology (primary outcome) as well as depression, perceptions of
      cognitive failures, social functioning and isolation, and health-related quality of life
      (secondary outcomes).
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Delayed entry, randomized trial
primary purpose: Treatment
masking: None (Open Label)
measure: Post-Traumatic Stress Disorder (PTSD) Symptoms
time frame: 6 weeks
description: Post-Traumatic Stress Disorder (PTSD) symptoms as measured by the PTSD Checklist Civilian (PCLC), a self-report scale that measures PTSD presence and severity. The 17 items correspond to Diagnostic and Statistical Manual DSM-IV symptoms of PTSD. The level of distress produced by each symptom is rated from 1 (not at all) to 5 (extremely). A score >50 on this measure is considered clinically significant (maximum score = 85).
measure: Depression
time frame: 6 weeks
description: Depression was assessed using the Beck Depression Inventory-II (BDI-II), a 21-item self-report scale measuring the presence and severity of depressive symptoms over the two weeks preceding test administration. Each answer ranges in score from 0-3. Total scores indicate minimal (0-13), mild (14-19), moderate (20-28), and severe (29-63; maximum = 63) levels of reported depression.
measure: Perceptions of Cognitive Failures
time frame: 6 weeks
description: The Cognitive Failures Questionnaire (CFQ) was used as a self-reported measure of everyday cognitive lapses for perception, memory, and motor function, such as forgetting appointments or having word finding difficulty. Total scores range from 0 to 100 with higher numbers indicating worse outcomes.
measure: Social Functioning
time frame: 6 weeks
description: The University of California, Los Angeles (UCLA) Loneliness Scale was administered to assess subjective feelings of social isolation. This is a 20-item scale summed to give a total score ranging from 0-60 with higher numbers indicating worse outcomes.
measure: Health-Related Quality of Life
time frame: 6 weeks
description: The European Quality of Life (EuroQoL) Scale, a validated preference-based scale for which population norms are available in the US and elsewhere, was used as the global evaluation of veteran's health-related quality of life. The 5-item EuroQoL measure combines data on activity restrictions (ADL, IADL limitations), limitations in participation (usual major activity and other social activities) and self- perceived health status (excellent, good, fair or poor) to measure one's overall satisfaction with health and well-being. Scores range from -0.594 to 1.000, higher values represent better outcomes.
arm group label: Immediate Entry Group
arm group type: Experimental
description: Following the baseline interview, veterans randomized to the immediate entry group directly engaged in the Guitars for Vets Intervention and were interviewed at the end of the intervention period, roughly 6 weeks later. The intervention content and duration (6 weeks) was the same across both groups.
arm group label: Delayed Entry Group
arm group type: Experimental
description: Those randomized to the delayed entry group had their baseline interview repeated at the end of the delayed entry period (4 weeks) prior to receiving the 6-week Guitars for Vets Intervention as well as after intervention completion. The intervention content and duration (6 weeks) was the same across both groups.
intervention type: Other
intervention name: Guitars for Vets Intervention
description: This was an active intervention providing veterans with an acoustic guitar, guitar pick, tuning instruments, a music book, practice CDs, and individual and group sessions of music instruction during a 6-week intervention period. Six tailored 1-hour individual guitar instruction sessions were scheduled (1 session per week). In addition to the 6 tailored individual lessons, the intervention provided 3 group sessions. Veterans were given a guitar that they could keep upon completion of the program. The same instructor was assigned to a subject for the duration of the study, and group sessions were supervised by the Education Director of Guitars for Vets.
arm group label: Delayed Entry Group
arm group label: Immediate Entry Group
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Medical College of Wisconsin
investigator full name: Liliana Pezzin
investigator title: Professor of Medicine
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No