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/NCT05989230</url>
    </required_header>
    <id_info>
      <org_study_id>IRB00277255</org_study_id>
      <nct_id>NCT05989230</nct_id>
    </id_info>
    <brief_title>Emotional Awareness and Expression Therapy for People With Persistent Pain Following Orthopedic Trauma</brief_title>
    <official_title>Emotional Awareness and Expression Therapy for People With Persistent Pain Following Orthopedic Trauma: A Pilot Feasibility Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Johns Hopkins University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Johns Hopkins University</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 single-arm trial is to determine the feasibility of emotional awareness&#xD;
        and expression therapy (EAET) for individuals with persistent pain following orthopedic&#xD;
        trauma. As part of this study, participants will be asked to attend weekly EAET treatment&#xD;
        sessions and complete assessments (including pre-treatment, post-treatment, and follow-up)&#xD;
        consisting of questionnaires and sensory testing procedures.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Orthopedic trauma, resulting in severe injuries such as multiple fractures or amputation,&#xD;
        occurs in approximately 3 million people annually in the United States; about half of these&#xD;
        people experience persistent pain and psychological distress (depression, anxiety,&#xD;
        posttraumatic stress disorder [PTSD] symptoms) 6 to 12 months post injury. Pain and distress&#xD;
        exacerbate one another, are likely to persist, and relate to disability: half of patients&#xD;
        report substantial disability 7 years post trauma. Medical interventions such as surgery&#xD;
        promote survival; however, there is an urgent need to develop targeted psychological&#xD;
        interventions to treat these disabling symptoms.&#xD;
  &#xD;
        Few psychological interventions are available to treat pain and distress following orthopedic&#xD;
        trauma. Emotional Awareness and Expression Therapy (EAET) is an 8-week psychological&#xD;
        intervention recently developed for chronic pain conditions characterized by central&#xD;
        sensitization. EAET is unique in treating pain and mood by targeting emotion regulation&#xD;
        processes related to traumatic life events. Such events are ubiquitous following orthopedic&#xD;
        trauma and recent findings show that EAET results in improvements in pain and mood; thus, it&#xD;
        may be uniquely effective to address the needs of orthopedic trauma survivors. However, there&#xD;
        are documented barriers to implementing psychological interventions in this population, so&#xD;
        the feasibility of EAET is unknown. The purpose of this study is to test the feasibility of&#xD;
        delivery and assessment of EAET for orthopedic trauma survivors with persistent pain in a&#xD;
        single-arm trial. As part of this study, participants will be asked to do the following&#xD;
        things:&#xD;
  &#xD;
          -  Attend EAET treatment with a mental health provider. Session will last around 60 minutes&#xD;
             each.&#xD;
  &#xD;
          -  Complete baseline, post-treatment, and follow-up assessments. These assessments will ask&#xD;
             patients to complete questionnaires related to physical and emotional health, as well as&#xD;
             receive sensory testing in order to examine pain processing. The questionnaires will&#xD;
             take 20-25 minutes. The sensory testing procedures will take about 20 minutes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2024</start_date>
    <completion_date type="Anticipated">December 2026</completion_date>
    <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility of Enrollment</measure>
      <time_frame>24 months</time_frame>
      <description>Feasibility of enrollment will be measured by percentage of eligible patients who enroll in the study.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility of Retention</measure>
      <time_frame>24 months</time_frame>
      <description>Feasibility of retention will be measured by percentage of participants who are retained over the duration of the study.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility of Recruitment</measure>
      <time_frame>24 months</time_frame>
      <description>Feasibility of Recruitment will be measured by the enrollment of a full sample within two years of the start of the enrollment period.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of patient session attendance</measure>
      <time_frame>8 weeks</time_frame>
      <description>Percentage of patients who complete 6 of 8 total EAET sessions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Therapist Fidelity (Questionnaire developed by study team)</measure>
      <time_frame>8 Weeks</time_frame>
      <description>Percentage of treatment fidelity across all treatment sessions (study therapist self-report using questionnaire developed by study team).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of patients who indicate patient satisfaction and acceptability</measure>
      <time_frame>8 Weeks</time_frame>
      <description>Percentage of patients who indicate treatment acceptability on the Treatment Evaluation Inventory-Short Form. This is a 9-item measure and participants respond using a 1-5 point likert scale for a possible total range of 9-45. Higher scores indicate greater satisfaction and acceptability.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility of Study Assessment</measure>
      <time_frame>1 Week</time_frame>
      <description>Measured by percent of pre-treatment assessments completed by participants.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility of Study Assessment</measure>
      <time_frame>8 Weeks</time_frame>
      <description>Measured by percent of post-treatment assessments completed by participants.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility of Study Assessment</measure>
      <time_frame>12 months</time_frame>
      <description>Measured by percent of follow-up assessments completed by participants.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Orthopaedic Trauma</condition>
    <condition>Chronic Pain</condition>
    <condition>Musculoskeletal Injury</condition>
    <arm_group>
      <arm_group_label>Emotional Awareness and Expression Therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Emotional Awareness and Expression Therapy (EAET) is a non-pharmacological intervention designed to address persistent pain.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Emotional Awareness and Expression Therapy</intervention_name>
      <description>The goal of EAET is to increase awareness of uncomfortable emotions that are often linked to stressful past experiences (e.g., anger, sadness, fear) and learn adaptive ways to experience and express those emotions, in a safe and controlled environment. Core treatment components include pain education, drawing associations between the experience of pain and emotion, and experiencing and expressing emotions via imaginary, in vivo, and real life exposures. EAET will be delivered via 8, 60-minute, weekly psychotherapy visits.</description>
      <arm_group_label>Emotional Awareness and Expression Therapy</arm_group_label>
      <other_name>EAET</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  One or more acute orthopedic injuries&#xD;
  &#xD;
            -  The patient sustained an orthopedic injury including, but not limited to:&#xD;
  &#xD;
                 -  Pelvic or acetabulum fracture&#xD;
  &#xD;
                 -  Open/displaced comminuted fracture of long bones&#xD;
  &#xD;
                 -  Upper extremity injuries with a major nerve involvement&#xD;
  &#xD;
                 -  Injuries with significant injuries to major blood vessels&#xD;
  &#xD;
                 -  Traumatic amputation of big toe, thumb, or proximal to the wrist or ankle.&#xD;
  &#xD;
            -  Initial admission to the trauma or orthopedic center/service of the participating&#xD;
               hospital OR all necessary screening and patient characteristic data available in&#xD;
               medical record (determination based on information available at time of enrollment)&#xD;
  &#xD;
            -  18 years old or older&#xD;
  &#xD;
            -  Received operative fixation for at least one acute orthopaedic injury at a&#xD;
               participating hospital. Patients should be recruited at the time of primary injury,&#xD;
               not revision or complication surgery&#xD;
  &#xD;
            -  Average Brief Pain Inventory Score &gt; 3/10&#xD;
  &#xD;
            -  Presence of pain most days (&gt; 3 days/week) for past three months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  peri-prosthetic fractures of the femur (regardless of etiology)&#xD;
  &#xD;
            -  non-ambulatory due to an associated spinal cord injury&#xD;
  &#xD;
            -  non-ambulatory pre-injury&#xD;
  &#xD;
            -  currently pregnant&#xD;
  &#xD;
            -  moderate or severe traumatic brain injury (TBI), as evidenced by intracranial&#xD;
               hemorrhage present on admission CT&#xD;
  &#xD;
            -  major amputation(s) of the upper or lower extremities&#xD;
  &#xD;
            -  non-English speaking&#xD;
  &#xD;
            -  Likely to have severe problems with maintaining follow-up for any of the following&#xD;
               reasons:&#xD;
  &#xD;
                 -  The patient has been diagnosed with a severe psychiatric conditions&#xD;
  &#xD;
                 -  The patient has current alcohol and/or drug addiction based on medical record or&#xD;
                    patient self-report.&#xD;
  &#xD;
                 -  The patient is intellectually challenged without adequate family support&#xD;
  &#xD;
                 -  The patient lives outside the hospital's catchment area&#xD;
  &#xD;
                 -  The patient follow-up is planned at another medical center&#xD;
  &#xD;
                 -  The patient is a prisoner&#xD;
  &#xD;
                 -  The patient is homeless&#xD;
  &#xD;
                 -  Other&#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>Rachel Aaron, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Johns Hopkins University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Rachel Aaron, PhD</last_name>
      <phone>410-502-2428</phone>
      <email>raaron4@jhmi.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Stephen Wegener, PhD</last_name>
      <email>swegener@jhmi.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</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>Chronic Pain</mesh_term>
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_browse>
    <!-- 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/NCT05989230
  org study id: IRB00277255
  nct id: NCT05989230
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this single-arm trial is to determine the feasibility of emotional awareness
        and expression therapy (EAET) for individuals with persistent pain following orthopedic
        trauma. As part of this study, participants will be asked to attend weekly EAET treatment
        sessions and complete assessments (including pre-treatment, post-treatment, and follow-up)
        consisting of questionnaires and sensory testing procedures.
  Orthopedic trauma, resulting in severe injuries such as multiple fractures or amputation,
        occurs in approximately 3 million people annually in the United States; about half of these
        people experience persistent pain and psychological distress (depression, anxiety,
        posttraumatic stress disorder [PTSD] symptoms) 6 to 12 months post injury. Pain and distress
        exacerbate one another, are likely to persist, and relate to disability: half of patients
        report substantial disability 7 years post trauma. Medical interventions such as surgery
        promote survival; however, there is an urgent need to develop targeted psychological
        interventions to treat these disabling symptoms.
  
        Few psychological interventions are available to treat pain and distress following orthopedic
        trauma. Emotional Awareness and Expression Therapy (EAET) is an 8-week psychological
        intervention recently developed for chronic pain conditions characterized by central
        sensitization. EAET is unique in treating pain and mood by targeting emotion regulation
        processes related to traumatic life events. Such events are ubiquitous following orthopedic
        trauma and recent findings show that EAET results in improvements in pain and mood; thus, it
        may be uniquely effective to address the needs of orthopedic trauma survivors. However, there
        are documented barriers to implementing psychological interventions in this population, so
        the feasibility of EAET is unknown. The purpose of this study is to test the feasibility of
        delivery and assessment of EAET for orthopedic trauma survivors with persistent pain in a
        single-arm trial. As part of this study, participants will be asked to do the following
        things:
  
          -  Attend EAET treatment with a mental health provider. Session will last around 60 minutes
             each.
  
          -  Complete baseline, post-treatment, and follow-up assessments. These assessments will ask
             patients to complete questionnaires related to physical and emotional health, as well as
             receive sensory testing in order to examine pain processing. The questionnaires will
             take 20-25 minutes. The sensory testing procedures will take about 20 minutes.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Feasibility of Enrollment
  time frame: 24 months
  description: Feasibility of enrollment will be measured by percentage of eligible patients who enroll in the study.
  measure: Feasibility of Retention
  time frame: 24 months
  description: Feasibility of retention will be measured by percentage of participants who are retained over the duration of the study.
  measure: Feasibility of Recruitment
  time frame: 24 months
  description: Feasibility of Recruitment will be measured by the enrollment of a full sample within two years of the start of the enrollment period.
  measure: Percentage of patient session attendance
  time frame: 8 weeks
  description: Percentage of patients who complete 6 of 8 total EAET sessions.
  measure: Therapist Fidelity (Questionnaire developed by study team)
  time frame: 8 Weeks
  description: Percentage of treatment fidelity across all treatment sessions (study therapist self-report using questionnaire developed by study team).
  measure: Percentage of patients who indicate patient satisfaction and acceptability
  time frame: 8 Weeks
  description: Percentage of patients who indicate treatment acceptability on the Treatment Evaluation Inventory-Short Form. This is a 9-item measure and participants respond using a 1-5 point likert scale for a possible total range of 9-45. Higher scores indicate greater satisfaction and acceptability.
  measure: Feasibility of Study Assessment
  time frame: 1 Week
  description: Measured by percent of pre-treatment assessments completed by participants.
  measure: Feasibility of Study Assessment
  time frame: 8 Weeks
  description: Measured by percent of post-treatment assessments completed by participants.
  measure: Feasibility of Study Assessment
  time frame: 12 months
  description: Measured by percent of follow-up assessments completed by participants.
  arm group label: Emotional Awareness and Expression Therapy
  arm group type: Experimental
  description: Emotional Awareness and Expression Therapy (EAET) is a non-pharmacological intervention designed to address persistent pain.
  intervention type: Behavioral
  intervention name: Emotional Awareness and Expression Therapy
  description: The goal of EAET is to increase awareness of uncomfortable emotions that are often linked to stressful past experiences (e.g., anger, sadness, fear) and learn adaptive ways to experience and express those emotions, in a safe and controlled environment. Core treatment components include pain education, drawing associations between the experience of pain and emotion, and experiencing and expressing emotions via imaginary, in vivo, and real life exposures. EAET will be delivered via 8, 60-minute, weekly psychotherapy visits.
  arm group label: Emotional Awareness and Expression Therapy
  other name: EAET
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Rachel Aaron, PhD
  role: Principal Investigator
  affiliation: Johns Hopkins University
  last name: Rachel Aaron, PhD
  phone: 410-502-2428
  email: raaron4@jhmi.edu
  last name: Stephen Wegener, PhD
  email: swegener@jhmi.edu
  responsible party type: Sponsor
  mesh term: Chronic Pain
  mesh term: Wounds and Injuries