<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/NCT04482348</url>
  </required_header>
  <id_info>
    <org_study_id>2019-01-0084</org_study_id>
    <nct_id>NCT04482348</nct_id>
  </id_info>
  <brief_title>Reaction to Mind-Body Connection</brief_title>
  <official_title>Patient Reactions to Explanations of the Mind-Body Connection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas at Austin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas at Austin</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>
      New and return patients seeing an orthopedic specialist were randomized to evaluate one of 7&#xD;
      brief explanations of the mind-body connection with variations in cognitive, emotional, or&#xD;
      physiology-based explanations. Reactions were measured as resonance (Likert scale) and&#xD;
      Self-Assessment Manikins (SAM) for happiness, excitement, and control. Patients also&#xD;
      completed demographic and mental and emotional health surveys. Overall 304 patients were&#xD;
      included (mean age 49 -17, range 18 to 87; 51% men). Multilevel multivariable linear&#xD;
      regression models were constructed to assess factors associated with resonance, happiness,&#xD;
      excitement, and control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design the investigators obtained institutional review board approval and prospectively&#xD;
      enrolled 308 patients in this cross-sectional study over a 4-month period. All patients were&#xD;
      seen at one of four participating orthopaedic offices in a large urban area. the&#xD;
      investigators included all new or return orthopaedic patients aged 18 to 89 years old. After&#xD;
      the visit with the surgeon, a research assistant not involved in patient care explained the&#xD;
      study to the patient and asked them to participate. the investigators obtained a waiver for&#xD;
      written consent; completing the questionnaires represented consent.&#xD;
&#xD;
      Outcomes measures Each patient read one of 7 randomly selected explanations for more pain&#xD;
      than expected on a tablet. There were 2 cognitively-framed explanations (&quot;the mind is a great&#xD;
      story teller&quot;; one positively- and one negatively framed), 2 emotionally-framed explanation&#xD;
      (&quot;stressed or down&quot;; one positively- and one negatively framed), one mixed emotion and&#xD;
      cognition (&quot;mind and body work together&quot;), and two physically based explanations&#xD;
      (&quot;over-excited state&quot;, &quot;overstimulated&quot;)&#xD;
&#xD;
      Subjects completed the following questionnaires: (1) a demographic survey including the&#xD;
      following variables: age, sex, race/ethnicity, marital status, work status, insurance status,&#xD;
      level of education, number of i) people living in the household, ii) children living in the&#xD;
      household, iii) adults living in the household, iv) adults who generate income; (2) the&#xD;
      Generalized Anxiety Disorder 2-item version (GAD-2); (3) the Patient Health Questionnaire&#xD;
      2-item version (PHQ-2); (4) the Pain Self-Efficacy Questionnaire 2-item version (PSEQ-2); and&#xD;
      (5) the Pain Catastrophizing Scale 4-item version (PCS-4).&#xD;
&#xD;
      Patients rated resonance with the explanation of more pain than expected on a 5-point Likert&#xD;
      scale as follows from 1 to 5: &quot;nope I don't buy it&quot;, &quot;this doesn't make sense&quot;, &quot;I'm not sure&#xD;
      how I feel about this&quot;, &quot;this makes sense&quot;, and &quot;absolutely, that makes perfect sense&quot;.&#xD;
&#xD;
      Self-Assessment Manikins (SAM; a picture-oriented instrument) were used to measure 3&#xD;
      affective dimensions, happiness, excitement and control in response to the explanation.&#xD;
&#xD;
      The happiness dimension ranges from a smiling happy to a frowning unhappy SAM figure. The&#xD;
      excitement dimension ranges from an excited wide-eyed to a relaxed sleepy SAM figure. The&#xD;
      control dimension is represented with a changing size of the SAM figure and ranges from a&#xD;
      small to a large SAM figure; the largest represents the most control in the situation.&#xD;
&#xD;
      The GAD-2 is a 2-item questionnaire (0=not at all to 3=nearly every day) that measures&#xD;
      symptoms of anxiety in the last two weeks. Total score ranges from 0 to 6, with higher scores&#xD;
      indicating more symptoms of anxiety.&#xD;
&#xD;
      The PCS-4 measures less adaptive thoughts in response to nociception on a 4-item scale (0=not&#xD;
      at all to 4=all the time). The scale contains two items on magnification, one item on&#xD;
      rumination, and one item on helplessness. Total score ranges from 0 to 16, higher scores&#xD;
      indicate more catastrophic thoughts.&#xD;
&#xD;
      The PSEQ-2 measures two beliefs: that one can engage in activities and enjoy life in spite of&#xD;
      pain. The total score ranges from 0 (not at all confident) to 12 (completely confident).&#xD;
&#xD;
      The PHQ-2 is a 2-item questionnaire that measures symptoms of depression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Actual">January 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 2019</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>New and return patients seeing an orthopedic specialist were randomized to evaluate one of 7 brief explanations of the mind-body connection with variations in cognitive, emotional, or physiology-based explanations.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>resonance with the explanation of more pain than expected</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>5-point Likert scale as follows from 1 to 5: &quot;nope I don't buy it&quot;, &quot;this doesn't make sense&quot;, &quot;I'm not sure how I feel about this&quot;, &quot;this makes sense&quot;, and &quot;absolutely, that makes perfect sense&quot;.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-Assessment Manikins(SAM)</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>to measure 3 affective dimensions, happiness, excitement and control in response to the explanation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>demographic survey</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>age, sex, race/ethnicity, marital status, work status, insurance status, level of education, number of i) people living in the household, ii) children living in the household, iii) adults living in the household, iv) adults who generate income</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GAD-2</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>a 2-item questionnaire (0=not at all to 3=nearly every day) that measures symptoms of anxiety in the last two weeks. Total score ranges from 0 to 6, with higher scores indicating more symptoms of anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PCS-4</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>measures less adaptive thoughts in response to nociception on a 4-item scale (0=not at all to 4=all the time). The scale contains two items on magnification, one item on rumination, and one item on helplessness. Total score ranges from 0 to 16, higher scores indicate more catastrophic thoughts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PSEQ-2</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>measures two beliefs: that one can engage in activities and enjoy life in spite of pain. The total score ranges from 0 (not at all confident) to 12 (completely confident)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PHQ-2</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>a 2-item questionnaire (0=not at all to 3=nearly every day) that measures symptoms of depression in the last two weeks. Total score ranges from 0 to 6, with higher scores indicating more symptoms of depression</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">308</enrollment>
  <condition>Mental Health Wellness 1</condition>
  <arm_group>
    <arm_group_label>the mind is a great story teller-positively framed</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>explanations for more pain than expected</description>
  </arm_group>
  <arm_group>
    <arm_group_label>the mind is a great story teller-negatively framed</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>explanations for more pain than expected</description>
  </arm_group>
  <arm_group>
    <arm_group_label>emotionally-framed explanation-stressed or down-positive frame</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>explanations for more pain than expected</description>
  </arm_group>
  <arm_group>
    <arm_group_label>emotionally-framed explanation-stressed or down-negative frame</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>explanations for more pain than expected</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mixed emotion and cognition (&quot;mind and body work together&quot;)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>explanations for more pain than expected</description>
  </arm_group>
  <arm_group>
    <arm_group_label>physically based explanations &quot;over-excited state&quot;</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>explanations for more pain than expected</description>
  </arm_group>
  <arm_group>
    <arm_group_label>physically based explanations &quot;overstimulated&quot;</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>explanations for more pain than expected</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Explanation</intervention_name>
    <description>Explanation provided to patients for more pain than expected</description>
    <arm_group_label>emotionally-framed explanation-stressed or down-negative frame</arm_group_label>
    <arm_group_label>emotionally-framed explanation-stressed or down-positive frame</arm_group_label>
    <arm_group_label>mixed emotion and cognition (&quot;mind and body work together&quot;)</arm_group_label>
    <arm_group_label>physically based explanations &quot;over-excited state&quot;</arm_group_label>
    <arm_group_label>physically based explanations &quot;overstimulated&quot;</arm_group_label>
    <arm_group_label>the mind is a great story teller-negatively framed</arm_group_label>
    <arm_group_label>the mind is a great story teller-positively framed</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all new or return orthopaedic patients aged 18 to 89 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Illiteracy&#xD;
&#xD;
          -  Cognitive problems which patient was not able to fill surveys&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Ring, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas at Austin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dell Medical School, University of Texas at Austin</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 17, 2020</last_update_submitted>
  <last_update_submitted_qc>July 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas at Austin</investigator_affiliation>
    <investigator_full_name>David Ring</investigator_full_name>
    <investigator_title>Professor of surgery and perioperative care</investigator_title>
  </responsible_party>
  <keyword>cognitive health</keyword>
  <keyword>social health</keyword>
  <keyword>emotional health</keyword>
  <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/NCT04482348
org study id: 2019-01-0084
nct id: NCT04482348
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
New and return patients seeing an orthopedic specialist were randomized to evaluate one of 7
      brief explanations of the mind-body connection with variations in cognitive, emotional, or
      physiology-based explanations. Reactions were measured as resonance (Likert scale) and
      Self-Assessment Manikins (SAM) for happiness, excitement, and control. Patients also
      completed demographic and mental and emotional health surveys. Overall 304 patients were
      included (mean age 49 -17, range 18 to 87; 51% men). Multilevel multivariable linear
      regression models were constructed to assess factors associated with resonance, happiness,
      excitement, and control.
Study design the investigators obtained institutional review board approval and prospectively
      enrolled 308 patients in this cross-sectional study over a 4-month period. All patients were
      seen at one of four participating orthopaedic offices in a large urban area. the
      investigators included all new or return orthopaedic patients aged 18 to 89 years old. After
      the visit with the surgeon, a research assistant not involved in patient care explained the
      study to the patient and asked them to participate. the investigators obtained a waiver for
      written consent; completing the questionnaires represented consent.

      Outcomes measures Each patient read one of 7 randomly selected explanations for more pain
      than expected on a tablet. There were 2 cognitively-framed explanations ("the mind is a great
      story teller"; one positively- and one negatively framed), 2 emotionally-framed explanation
      ("stressed or down"; one positively- and one negatively framed), one mixed emotion and
      cognition ("mind and body work together"), and two physically based explanations
      ("over-excited state", "overstimulated")

      Subjects completed the following questionnaires: (1) a demographic survey including the
      following variables: age, sex, race/ethnicity, marital status, work status, insurance status,
      level of education, number of i) people living in the household, ii) children living in the
      household, iii) adults living in the household, iv) adults who generate income; (2) the
      Generalized Anxiety Disorder 2-item version (GAD-2); (3) the Patient Health Questionnaire
      2-item version (PHQ-2); (4) the Pain Self-Efficacy Questionnaire 2-item version (PSEQ-2); and
      (5) the Pain Catastrophizing Scale 4-item version (PCS-4).

      Patients rated resonance with the explanation of more pain than expected on a 5-point Likert
      scale as follows from 1 to 5: "nope I don't buy it", "this doesn't make sense", "I'm not sure
      how I feel about this", "this makes sense", and "absolutely, that makes perfect sense".

      Self-Assessment Manikins (SAM; a picture-oriented instrument) were used to measure 3
      affective dimensions, happiness, excitement and control in response to the explanation.

      The happiness dimension ranges from a smiling happy to a frowning unhappy SAM figure. The
      excitement dimension ranges from an excited wide-eyed to a relaxed sleepy SAM figure. The
      control dimension is represented with a changing size of the SAM figure and ranges from a
      small to a large SAM figure; the largest represents the most control in the situation.

      The GAD-2 is a 2-item questionnaire (0=not at all to 3=nearly every day) that measures
      symptoms of anxiety in the last two weeks. Total score ranges from 0 to 6, with higher scores
      indicating more symptoms of anxiety.

      The PCS-4 measures less adaptive thoughts in response to nociception on a 4-item scale (0=not
      at all to 4=all the time). The scale contains two items on magnification, one item on
      rumination, and one item on helplessness. Total score ranges from 0 to 16, higher scores
      indicate more catastrophic thoughts.

      The PSEQ-2 measures two beliefs: that one can engage in activities and enjoy life in spite of
      pain. The total score ranges from 0 (not at all confident) to 12 (completely confident).

      The PHQ-2 is a 2-item questionnaire that measures symptoms of depression.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: New and return patients seeing an orthopedic specialist were randomized to evaluate one of 7 brief explanations of the mind-body connection with variations in cognitive, emotional, or physiology-based explanations.
primary purpose: Diagnostic
masking: Single (Participant)
measure: resonance with the explanation of more pain than expected
time frame: up to 24 weeks
description: 5-point Likert scale as follows from 1 to 5: "nope I don't buy it", "this doesn't make sense", "I'm not sure how I feel about this", "this makes sense", and "absolutely, that makes perfect sense".
measure: Self-Assessment Manikins(SAM)
time frame: up to 24 weeks
description: to measure 3 affective dimensions, happiness, excitement and control in response to the explanation
measure: demographic survey
time frame: up to 24 weeks
description: age, sex, race/ethnicity, marital status, work status, insurance status, level of education, number of i) people living in the household, ii) children living in the household, iii) adults living in the household, iv) adults who generate income
measure: GAD-2
time frame: up to 24 weeks
description: a 2-item questionnaire (0=not at all to 3=nearly every day) that measures symptoms of anxiety in the last two weeks. Total score ranges from 0 to 6, with higher scores indicating more symptoms of anxiety
measure: PCS-4
time frame: up to 24 weeks
description: measures less adaptive thoughts in response to nociception on a 4-item scale (0=not at all to 4=all the time). The scale contains two items on magnification, one item on rumination, and one item on helplessness. Total score ranges from 0 to 16, higher scores indicate more catastrophic thoughts
measure: PSEQ-2
time frame: up to 24 weeks
description: measures two beliefs: that one can engage in activities and enjoy life in spite of pain. The total score ranges from 0 (not at all confident) to 12 (completely confident)
measure: PHQ-2
time frame: up to 24 weeks
description: a 2-item questionnaire (0=not at all to 3=nearly every day) that measures symptoms of depression in the last two weeks. Total score ranges from 0 to 6, with higher scores indicating more symptoms of depression
arm group label: the mind is a great story teller-positively framed
arm group type: Active Comparator
description: explanations for more pain than expected
arm group label: the mind is a great story teller-negatively framed
arm group type: Active Comparator
description: explanations for more pain than expected
arm group label: emotionally-framed explanation-stressed or down-positive frame
arm group type: Active Comparator
description: explanations for more pain than expected
arm group label: emotionally-framed explanation-stressed or down-negative frame
arm group type: Active Comparator
description: explanations for more pain than expected
arm group label: mixed emotion and cognition ("mind and body work together")
arm group type: Active Comparator
description: explanations for more pain than expected
arm group label: physically based explanations "over-excited state"
arm group type: Active Comparator
description: explanations for more pain than expected
arm group label: physically based explanations "overstimulated"
arm group type: Active Comparator
description: explanations for more pain than expected
intervention type: Other
intervention name: Explanation
description: Explanation provided to patients for more pain than expected
arm group label: emotionally-framed explanation-stressed or down-negative frame
arm group label: emotionally-framed explanation-stressed or down-positive frame
arm group label: mixed emotion and cognition ("mind and body work together")
arm group label: physically based explanations "over-excited state"
arm group label: physically based explanations "overstimulated"
arm group label: the mind is a great story teller-negatively framed
arm group label: the mind is a great story teller-positively framed
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
last name: David Ring, MD, PhD
role: Principal Investigator
affiliation: University of Texas at Austin
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas at Austin
investigator full name: David Ring
investigator title: Professor of surgery and perioperative care
sharing ipd: No