<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/NCT04437095</url>
  </required_header>
  <id_info>
    <org_study_id>20-003735</org_study_id>
    <nct_id>NCT04437095</nct_id>
  </id_info>
  <brief_title>Positive Suggestions Via MP3 Messages</brief_title>
  <official_title>Delivering Positive Suggestions to the Critically Ill Patients Via Pre-recorded MP3 Messages to Improve Mental Health Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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 is to assess the use of an audio recording containing positive&#xD;
      suggestion as a means to provide needed psychological support to critically ill patients in a&#xD;
      feasible and reliable manner.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Following screening and consenting processes, patients will be randomized to enroll in&#xD;
      interventional or control groups. The interventional group will listen to an audio recording&#xD;
      of psychological support based on positive suggestion for about 30 min each day via&#xD;
      headphones. At the time of ICU discharge, patients will be administered validated&#xD;
      questionnaires to screen for symptoms of anxiety/depression (HADS), PTSD (IES-r), cognitive&#xD;
      dysfunction (MOCA-blind), as well as evaluation of health status (EQ-5D). Six months post ICU&#xD;
      discharge, patients will again be contacted and repeat the assessment with above&#xD;
      questionnaires. Scores on the questionnaires will be compared between the groups at the two&#xD;
      times points. Patient demographic data will also be obtained and assessed to contextualize&#xD;
      study findings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 17, 2020</start_date>
  <completion_date type="Anticipated">July 2025</completion_date>
  <primary_completion_date type="Anticipated">July 2025</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>Patients will be randomized 1:1 to intervention vs standard care. Using data from our prior observational study, mean (SD) HADS-Anxiety subscale was 7.3 (4.1) among these subjects (coefficient of variation = 4.1/7.3 = 0.56). A total 300 subjects will be enrolled and randomized until 100 subjects per arm recruitment target is reached to allow for mortality and dropout.&#xD;
The analysis will compare 6 month HADS-A by treatment arms using ANCOVA. The analysis will be conducted under a modified intention to treat principle, with subjects analyzed according to randomized arm, but excluding patients who die before follow up. Additional outcomes including HADS-D, MoCA-blind, and EQ-5D will be analyzed similarly using ANCOVA, and IES-R subscore&gt;1.6 will be analyzed by Chi-square test.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS) - Anxiety</measure>
    <time_frame>within 96 hours of ICU discharge</time_frame>
    <description>A self-reported questionnaire designed to identify anxiety and depression. Each item is rated on a 4-point scale from 0 &quot;absence&quot; to 3 &quot;extreme presence&quot;. Total score is 21 per subscale: 0 - 7: Normal levels of anxiety/depression; 8-10: Borderline abnormal; &gt; 11: Abnormal. Total questions: 14 Anxiety 7 Depression 7 A self-reported questionnaire designed to identify anxiety and depression. Each item is rated on a 4-point scale from 0 &quot;absence&quot; to 3 &quot;extreme presence&quot;. Total score is 21. Per subscale: 0 - 7: Normal levels of anxiety/depression; 8-10: Borderline abnormal; &gt; 11: Abnormal. TL questions: 14: Anxiety 7, Depression 7</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of Events Scale-Revised</measure>
    <time_frame>within 96 hours of ICU discharge</time_frame>
    <description>A self-reported questionnaire designed to measure distress caused by traumatic events. Items are rated on a 5-point scale ranging from 0 (&quot;not at all&quot;) to 4 (&quot;extremely&quot;). Total scores are summed with higher scores indicating greater distress with regards to a specific event. Total questions: 22: Intrusion 7, Avoidance 8, Hyperarousal 7</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Montreal Cognitive Assessment-Blind (MoCA-blind)</measure>
    <time_frame>within 96 hours of ICU discharge</time_frame>
    <description>A screening tool designed to detect mild cognitive dysfunction. Subscores for each of the 5 sections are calculated. The total score is summed from the subscores, with a maximum score of 22. A score equal &gt; 18 is considered normal cognition. Total questions:13: Memory 3, Attention 4, Language 3, Abstraction 2, Orientation 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D</measure>
    <time_frame>within 96 hours of ICU discharge</time_frame>
    <description>A self-report questionnaire of health status or health-related quality of life. Scoring information: 5L - 5 levels of severity: no problems, slight problems, moderate problems, severe problems, extreme problems. The visual analog scale ranges from 0 to 100 with higher scores reflecting better perceived current health-related quality of life state. Total questions: 6 Mobility: 1 Self-Care: 1 Usual Activities: 1 Pain/discomfort: 1 Anxiety/depression: 1 Health State - Visual Analog Scale: 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS) - Depression</measure>
    <time_frame>within 96 hours of ICU discharge</time_frame>
    <description>A self-reported questionnaire designed to identify anxiety and depression. Each item is rated on a 4-point scale from 0 &quot;absence&quot; to 3 &quot;extreme presence&quot;. Total score is 21. Per subscale: 0 - 7: Normal levels of anxiety/depression; 8-10: Borderline abnormal; &gt; 11: Abnormal. Total questions: 14: Anxiety 7, Depression 7</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS) - Depression</measure>
    <time_frame>6 months following ICU discharge</time_frame>
    <description>A self-reported questionnaire designed to identify anxiety and depression. Each item is rated on a 4-point scale from 0 &quot;absence&quot; to 3 &quot;extreme presence&quot;. Total score is 21. Per subscale: 0 - 7: Normal levels of anxiety/depression; 8-10: Borderline abnormal; &gt; 11: Abnormal. Total questions: 14: Anxiety 7, Depression 7</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS) - Anxiety</measure>
    <time_frame>6 months following ICU discharge</time_frame>
    <description>A self-reported questionnaire designed to identify anxiety and depression. Each item is rated on a 4-point scale from 0 &quot;absence&quot; to 3 &quot;extreme presence&quot;. Total score is 21. Per subscale: 0 - 7: Normal levels of anxiety/depression; 8-10: Borderline abnormal; &gt; 11: Abnormal. Total questions: 14: Anxiety 7, Depression 7</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of Events Scale-Revised</measure>
    <time_frame>6 months following ICU discharge</time_frame>
    <description>A self-reported questionnaire designed to measure distress caused by traumatic events. Items are rated on a 5-point scale ranging from 0 (&quot;not at all&quot;) to 4 (&quot;extremely&quot;). Total scores are summed with higher scores indicating greater distress with regards to a specific event. Total questions: 22: Intrusion 7, Avoidance 8, Hyperarousal 7</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Montreal Cognitive Assessment-Blind (MoCA-blind)</measure>
    <time_frame>6 months following ICU discharge</time_frame>
    <description>A screening tool designed to detect mild cognitive dysfunction. Subscores for each of the 5 sections are calculated. The total score is summed from the subscores, with a maximum score of 22. A score equal &gt; 18 is considered normal cognition. Total questions:13: Memory 3, Attention 4, Language 3, Abstraction 2, Orientation 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D</measure>
    <time_frame>6 months following ICU discharge</time_frame>
    <description>A self-report questionnaire of health status or health-related quality of life. Scoring information: 5L - 5 levels of severity: no problems, slight problems, moderate problems, severe problems, extreme problems. The visual analog scale ranges from 0 to 100 with higher scores reflecting better perceived current health-related quality of life state. Total questions: 6 Mobility: 1 Self-Care: 1 Usual Activities: 1 Pain/discomfort: 1 Anxiety/depression: 1 Health State - Visual Analog Scale: 1</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Post Intensive Care Unit Syndrome</condition>
  <condition>Psychological Trauma</condition>
  <condition>Anxiety</condition>
  <condition>Depression</condition>
  <condition>PTSD</condition>
  <arm_group>
    <arm_group_label>PSBPS Audiorecording</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thirty minute daily administration of audio recording containing messages of psychological support based on positive suggestion delivered via headphones</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Psychological Support Based on Positive Suggestion delivered via pre-recorded MP3 message</intervention_name>
    <description>Daily administration of audiorecording</description>
    <arm_group_label>PSBPS Audiorecording</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute respiratory failure and/or requiring vasopressors&#xD;
&#xD;
          -  Admitted to the ICU&#xD;
&#xD;
          -  Expected to stay &gt;48 hours in the ICU&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of dementia&#xD;
&#xD;
          -  History of mental retardation&#xD;
&#xD;
          -  History of suicide attempt&#xD;
&#xD;
          -  History of psychotic disorders such as schizophrenia&#xD;
&#xD;
          -  Acute alcohol/substance intoxication or withdrawal&#xD;
&#xD;
          -  Severe metabolic encephalopathy&#xD;
&#xD;
          -  Patients on comfort care&#xD;
&#xD;
          -  Patients not expected to survive the hospital stay&#xD;
&#xD;
          -  Those with hearing impairment&#xD;
&#xD;
          -  Non-English speaking.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lioudmila Karnatovskaia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lioudmila V Karnatovskaia, MD</last_name>
    <phone>507 284-2511</phone>
    <email>Karnatovskaia.Lioudmila@mayo.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kimberly R Johnson, MD</last_name>
    <phone>507 284-2511</phone>
    <email>johnson.kimberly5@mayo.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>February 27, 2023</last_update_submitted>
  <last_update_submitted_qc>February 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Lioudmila Karnatovskaia</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Post traumatic stress syndrome</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Depression</keyword>
  <keyword>PICS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Psychological Trauma</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/NCT04437095
org study id: 20-003735
nct id: NCT04437095
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the use of an audio recording containing positive
      suggestion as a means to provide needed psychological support to critically ill patients in a
      feasible and reliable manner.
Following screening and consenting processes, patients will be randomized to enroll in
      interventional or control groups. The interventional group will listen to an audio recording
      of psychological support based on positive suggestion for about 30 min each day via
      headphones. At the time of ICU discharge, patients will be administered validated
      questionnaires to screen for symptoms of anxiety/depression (HADS), PTSD (IES-r), cognitive
      dysfunction (MOCA-blind), as well as evaluation of health status (EQ-5D). Six months post ICU
      discharge, patients will again be contacted and repeat the assessment with above
      questionnaires. Scores on the questionnaires will be compared between the groups at the two
      times points. Patient demographic data will also be obtained and assessed to contextualize
      study findings.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be randomized 1:1 to intervention vs standard care. Using data from our prior observational study, mean (SD) HADS-Anxiety subscale was 7.3 (4.1) among these subjects (coefficient of variation = 4.1/7.3 = 0.56). A total 300 subjects will be enrolled and randomized until 100 subjects per arm recruitment target is reached to allow for mortality and dropout.
The analysis will compare 6 month HADS-A by treatment arms using ANCOVA. The analysis will be conducted under a modified intention to treat principle, with subjects analyzed according to randomized arm, but excluding patients who die before follow up. Additional outcomes including HADS-D, MoCA-blind, and EQ-5D will be analyzed similarly using ANCOVA, and IES-R subscore>1.6 will be analyzed by Chi-square test.
primary purpose: Prevention
masking: None (Open Label)
measure: Hospital Anxiety and Depression Scale (HADS) - Anxiety
time frame: within 96 hours of ICU discharge
description: A self-reported questionnaire designed to identify anxiety and depression. Each item is rated on a 4-point scale from 0 "absence" to 3 "extreme presence". Total score is 21 per subscale: 0 - 7: Normal levels of anxiety/depression; 8-10: Borderline abnormal; > 11: Abnormal. Total questions: 14 Anxiety 7 Depression 7 A self-reported questionnaire designed to identify anxiety and depression. Each item is rated on a 4-point scale from 0 "absence" to 3 "extreme presence". Total score is 21. Per subscale: 0 - 7: Normal levels of anxiety/depression; 8-10: Borderline abnormal; > 11: Abnormal. TL questions: 14: Anxiety 7, Depression 7
measure: Impact of Events Scale-Revised
time frame: within 96 hours of ICU discharge
description: A self-reported questionnaire designed to measure distress caused by traumatic events. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Total scores are summed with higher scores indicating greater distress with regards to a specific event. Total questions: 22: Intrusion 7, Avoidance 8, Hyperarousal 7
measure: Montreal Cognitive Assessment-Blind (MoCA-blind)
time frame: within 96 hours of ICU discharge
description: A screening tool designed to detect mild cognitive dysfunction. Subscores for each of the 5 sections are calculated. The total score is summed from the subscores, with a maximum score of 22. A score equal > 18 is considered normal cognition. Total questions:13: Memory 3, Attention 4, Language 3, Abstraction 2, Orientation 1
measure: EQ-5D
time frame: within 96 hours of ICU discharge
description: A self-report questionnaire of health status or health-related quality of life. Scoring information: 5L - 5 levels of severity: no problems, slight problems, moderate problems, severe problems, extreme problems. The visual analog scale ranges from 0 to 100 with higher scores reflecting better perceived current health-related quality of life state. Total questions: 6 Mobility: 1 Self-Care: 1 Usual Activities: 1 Pain/discomfort: 1 Anxiety/depression: 1 Health State - Visual Analog Scale: 1
measure: Hospital Anxiety and Depression Scale (HADS) - Depression
time frame: within 96 hours of ICU discharge
description: A self-reported questionnaire designed to identify anxiety and depression. Each item is rated on a 4-point scale from 0 "absence" to 3 "extreme presence". Total score is 21. Per subscale: 0 - 7: Normal levels of anxiety/depression; 8-10: Borderline abnormal; > 11: Abnormal. Total questions: 14: Anxiety 7, Depression 7
measure: Hospital Anxiety and Depression Scale (HADS) - Depression
time frame: 6 months following ICU discharge
description: A self-reported questionnaire designed to identify anxiety and depression. Each item is rated on a 4-point scale from 0 "absence" to 3 "extreme presence". Total score is 21. Per subscale: 0 - 7: Normal levels of anxiety/depression; 8-10: Borderline abnormal; > 11: Abnormal. Total questions: 14: Anxiety 7, Depression 7
measure: Hospital Anxiety and Depression Scale (HADS) - Anxiety
time frame: 6 months following ICU discharge
description: A self-reported questionnaire designed to identify anxiety and depression. Each item is rated on a 4-point scale from 0 "absence" to 3 "extreme presence". Total score is 21. Per subscale: 0 - 7: Normal levels of anxiety/depression; 8-10: Borderline abnormal; > 11: Abnormal. Total questions: 14: Anxiety 7, Depression 7
measure: Impact of Events Scale-Revised
time frame: 6 months following ICU discharge
description: A self-reported questionnaire designed to measure distress caused by traumatic events. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Total scores are summed with higher scores indicating greater distress with regards to a specific event. Total questions: 22: Intrusion 7, Avoidance 8, Hyperarousal 7
measure: Montreal Cognitive Assessment-Blind (MoCA-blind)
time frame: 6 months following ICU discharge
description: A screening tool designed to detect mild cognitive dysfunction. Subscores for each of the 5 sections are calculated. The total score is summed from the subscores, with a maximum score of 22. A score equal > 18 is considered normal cognition. Total questions:13: Memory 3, Attention 4, Language 3, Abstraction 2, Orientation 1
measure: EQ-5D
time frame: 6 months following ICU discharge
description: A self-report questionnaire of health status or health-related quality of life. Scoring information: 5L - 5 levels of severity: no problems, slight problems, moderate problems, severe problems, extreme problems. The visual analog scale ranges from 0 to 100 with higher scores reflecting better perceived current health-related quality of life state. Total questions: 6 Mobility: 1 Self-Care: 1 Usual Activities: 1 Pain/discomfort: 1 Anxiety/depression: 1 Health State - Visual Analog Scale: 1
arm group label: PSBPS Audiorecording
arm group type: Experimental
description: Thirty minute daily administration of audio recording containing messages of psychological support based on positive suggestion delivered via headphones
arm group label: Control
arm group type: No Intervention
description: Standard of care
intervention type: Other
intervention name: Psychological Support Based on Positive Suggestion delivered via pre-recorded MP3 message
description: Daily administration of audiorecording
arm group label: PSBPS Audiorecording
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lioudmila Karnatovskaia, MD
role: Principal Investigator
affiliation: Mayo Clinic
last name: Lioudmila V Karnatovskaia, MD
phone: 507 284-2511
email: Karnatovskaia.Lioudmila@mayo.edu
last name: Kimberly R Johnson, MD
phone: 507 284-2511
email: johnson.kimberly5@mayo.edu
facility: 
status: Recruiting
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Lioudmila Karnatovskaia
investigator title: Principal Investigator
mesh term: Depression
mesh term: Psychological Trauma
sharing ipd: No