<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/NCT03776929</url>
  </required_header>
  <id_info>
    <org_study_id>D18154</org_study_id>
    <nct_id>NCT03776929</nct_id>
  </id_info>
  <brief_title>Dialectical Behavioral Therapy in High Risk OrthopaedicTrauma Patients</brief_title>
  <acronym>OI-DBT</acronym>
  <official_title>Dialectical Behavioral Therapy in High Risk OrthopaedicTrauma Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dartmouth-Hitchcock Medical Center</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>
      Psychological factors can affect the experience of pain and functional recovery from&#xD;
      orthopedic injury. The purpose of this study is to examine the effect of brief Dialectical&#xD;
      Behavior Therapy (DBT), a form of psychotherapy, on changing thoughts, feelings, and&#xD;
      behaviors that can cause problems in daily living and interfere with recovery from orthopedic&#xD;
      injury in patients who are at high risk for chronic pain and disability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Musculoskeletal injuries represent one of the leading causes of hospital admissions for&#xD;
      adults, and often results in long term pain, poor function, and permanent disability.&#xD;
      Patients afflicted with musculoskeletal injuries contribute to an enormous cost to society in&#xD;
      terms of direct health care spending, as well as indirect costs related to permanent&#xD;
      disability, loss of work, and chronic pain contributing to the rising opioid epidemic. This&#xD;
      is clearly a substantial and costly issue at Dartmouth-Hitchcock Medical Center (DHMC) as&#xD;
      well as the country at large. From 2011 to 2017, 54% of patients who were admitted for&#xD;
      fracture at DHMC had either a psychiatric diagnosis and/or a substance abuse diagnosis. It is&#xD;
      likely that this number vastly underestimates the true amount of emotional distress present&#xD;
      in this patient population because many patients with these issues do not carry formal&#xD;
      psychiatric diagnoses. Diagnosis of psychiatric illness or substance abuse was associated&#xD;
      with significantly higher resource utilization during hospital admission in terms of hospital&#xD;
      length of stay (LOS, mean difference 3 days), need for ICU stay, number of consulting&#xD;
      services, disposition to rehab, and rate of unplanned readmissions (21% versus 39%,&#xD;
      respectively). Furthermore, this patient population had significantly higher mean pain score&#xD;
      during admission and required 10-fold more opioids prescribed [measured in total morphine&#xD;
      equivalents (MME)] and number of separate prescriptions needed.&#xD;
&#xD;
      These data within the investigator's own patient population reinforce the well documented&#xD;
      reciprocal association between chronic pain and adverse mental health outcomes, such that&#xD;
      pain triggers depression for example, but depression may as well exacerbate experiences of&#xD;
      pain. In fact, catastrophic thinking about pain (tendency to assume the worst and believe&#xD;
      that one will be unable to cope with the outcome), pain anxiety, and symptoms of depression&#xD;
      are key factors that explain the magnitude of disability and pain intensity after&#xD;
      musculoskeletal trauma. Resilience, the capacity to adapt to or recover from adversity, has&#xD;
      been shown to attenuate the association between depression and pain. For this reason, the&#xD;
      investigators believe it is important for patients to learn effective coping skills in order&#xD;
      to effectively manage their pain and fear associated with recovering from a traumatic injury.&#xD;
&#xD;
      Dialectical Behavior Therapy (DBT) is a cognitive behavioral therapy that focuses on the&#xD;
      balance between change and acceptance. DBT skills include four modules: two that enforce&#xD;
      acceptance-oriented skills, mindfulness and distress tolerance, and two that promote&#xD;
      change-oriented skills, interpersonal effectiveness and emotional regulation. This&#xD;
      psychosocial treatment aims to reduce ineffective action tendencies associated with&#xD;
      dysregulated emotions. DBT has been studied extensively in adult samples, across a wide range&#xD;
      of settings. It has been shown to be effective in management of intense emotional states and&#xD;
      development of coping skills in the most challenging patient populations including patients&#xD;
      with Borderline Personality Disorder (BPD), eating disorders, and substance abuse.&#xD;
      Furthermore, DBT-based interventions have demonstrated preliminary effectiveness in managing&#xD;
      chronic pain and pain catastrophizing and anxiety. As such, patients with orthopedic trauma&#xD;
      at high risk for chronic pain and disability would benefit from an evidence-based treatment&#xD;
      approach that would teach them how to change thoughts, feelings, and behaviors that could&#xD;
      cause problems in daily living and interfere with recovery from injury.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study is temporarily suspended until resources are put in place for enrollment&#xD;
  </why_stopped>
  <start_date type="Anticipated">April 2020</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change over time in Pain Severity: VAS</measure>
    <time_frame>Baseline, 2 week follow-up, 6-8 week follow-up, 10-14 week follow-up</time_frame>
    <description>Visual Analogue Scale (VAS) Pain scores documented in the patient's medical record. Score Range 0-10. Higher score indicates greater pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Opioids Administered</measure>
    <time_frame>Hospital admission to hospital discharge, approximately 4-7 days</time_frame>
    <description>The opioids administered during hospitalization measured in total morphine equivalents</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change over time in General Health Status</measure>
    <time_frame>Baseline, 2 week follow-up, 6-8 week follow-up, 10-14 week follow-up</time_frame>
    <description>Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health: 10-item measure of physical and mental health. Scale range 0 to 100, mean 50, standard deviation 10. A higher score represents a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change over time in Psychological Functioning - Depression</measure>
    <time_frame>Baseline, 2 week follow-up, 6-8 week follow-up, 10-14 week follow-up</time_frame>
    <description>Patient Health Questionnaire-9 (PHQ-9): 9-item measure of major depression symptom severity on a 4-point Likert-type scale. Score range 0-27; Higher score indicates more severe depressive symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change over time in Psychological Functioning - PTSD</measure>
    <time_frame>Baseline, 2 week follow-up, 6-8 week follow-up, 10-14 week follow-up</time_frame>
    <description>PTSD Checklist for DSM-5 (PCL-5): 20-item measure of DSM-5 PTSD symptom severity on a 5-point Likert-type scale. Scale range 0-80. Higher score indicates more severe PTSD symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change over time in Pain Anxiety: PASS-20</measure>
    <time_frame>Baseline, 2 week follow-up, 6-8 week follow-up, 10-14 week follow-up</time_frame>
    <description>Pain Anxiety Symptoms Scale (PASS-20): 20-item measure of pain anxiety on a 6-point Likert-type scale. Scale range 0-100. Higher score indicates more pain-related anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change over time in Pain Interference: BPI-SF</measure>
    <time_frame>Baseline, 2 week follow-up, 6-8 week follow-up, 10-14 week follow-up</time_frame>
    <description>Brief Pain Inventory-Short Form (BPI-SF): 9-item measure of pain severity and impact of pain on daily functions. This is a 10-point scale with 0 being the best possible score, meaning &quot;no pain&quot;, and 10 being the worst possible score, meaning &quot;pain as bad as you can imagine&quot;.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Fracture</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention - Standard care only. Group of 32 subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dialectical Behavioral Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dialectical Behavioral Therapy in addition to standard care. Four hour and a half group sessions (or one-on-one sessions, if not enough for a group session) commencing after surgery while still inpatient. Each session is designed to stand-alone, allowing for enrolling patients on a rolling basis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dialectical Behavioral Therapy</intervention_name>
    <description>Dialectical Behavior Therapy (DBT) is a cognitive behavioral therapy that focuses on the balance between change and acceptance. DBT skills include four modules: two that enforce acceptance-oriented skills, mindfulness and distress tolerance, and two that promote change-oriented skills, interpersonal effectiveness and emotional regulation.</description>
    <arm_group_label>Dialectical Behavioral Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Admitted to Dartmouth-Hitchcock Medical Center with an operatively treated fracture.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Pain Catastrophizing Scale (PCS) score of &lt; 13&#xD;
&#xD;
          -  Anticipating hospital length of stay of less than 2 days&#xD;
&#xD;
          -  Are expected to have severe problems maintaining follow-up and treatment&#xD;
             recommendations&#xD;
&#xD;
          -  Have current or impending incarceration&#xD;
&#xD;
          -  Are actively psychotic or manic&#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>Ida L Gitajn, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dartmouth-Hitchcock Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>March 23, 2020</last_update_submitted>
  <last_update_submitted_qc>March 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dartmouth-Hitchcock Medical Center</investigator_affiliation>
    <investigator_full_name>Ida Leah Gitajn</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Dialectical Behavioral Therapy</keyword>
  <keyword>Orthopaedic</keyword>
  <keyword>Trauma</keyword>
  <keyword>Pain Catastrophizing Scale</keyword>
  <!-- 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/NCT03776929
org study id: D18154
nct id: NCT03776929
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Psychological factors can affect the experience of pain and functional recovery from
      orthopedic injury. The purpose of this study is to examine the effect of brief Dialectical
      Behavior Therapy (DBT), a form of psychotherapy, on changing thoughts, feelings, and
      behaviors that can cause problems in daily living and interfere with recovery from orthopedic
      injury in patients who are at high risk for chronic pain and disability.
Musculoskeletal injuries represent one of the leading causes of hospital admissions for
      adults, and often results in long term pain, poor function, and permanent disability.
      Patients afflicted with musculoskeletal injuries contribute to an enormous cost to society in
      terms of direct health care spending, as well as indirect costs related to permanent
      disability, loss of work, and chronic pain contributing to the rising opioid epidemic. This
      is clearly a substantial and costly issue at Dartmouth-Hitchcock Medical Center (DHMC) as
      well as the country at large. From 2011 to 2017, 54% of patients who were admitted for
      fracture at DHMC had either a psychiatric diagnosis and/or a substance abuse diagnosis. It is
      likely that this number vastly underestimates the true amount of emotional distress present
      in this patient population because many patients with these issues do not carry formal
      psychiatric diagnoses. Diagnosis of psychiatric illness or substance abuse was associated
      with significantly higher resource utilization during hospital admission in terms of hospital
      length of stay (LOS, mean difference 3 days), need for ICU stay, number of consulting
      services, disposition to rehab, and rate of unplanned readmissions (21% versus 39%,
      respectively). Furthermore, this patient population had significantly higher mean pain score
      during admission and required 10-fold more opioids prescribed [measured in total morphine
      equivalents (MME)] and number of separate prescriptions needed.

      These data within the investigator's own patient population reinforce the well documented
      reciprocal association between chronic pain and adverse mental health outcomes, such that
      pain triggers depression for example, but depression may as well exacerbate experiences of
      pain. In fact, catastrophic thinking about pain (tendency to assume the worst and believe
      that one will be unable to cope with the outcome), pain anxiety, and symptoms of depression
      are key factors that explain the magnitude of disability and pain intensity after
      musculoskeletal trauma. Resilience, the capacity to adapt to or recover from adversity, has
      been shown to attenuate the association between depression and pain. For this reason, the
      investigators believe it is important for patients to learn effective coping skills in order
      to effectively manage their pain and fear associated with recovering from a traumatic injury.

      Dialectical Behavior Therapy (DBT) is a cognitive behavioral therapy that focuses on the
      balance between change and acceptance. DBT skills include four modules: two that enforce
      acceptance-oriented skills, mindfulness and distress tolerance, and two that promote
      change-oriented skills, interpersonal effectiveness and emotional regulation. This
      psychosocial treatment aims to reduce ineffective action tendencies associated with
      dysregulated emotions. DBT has been studied extensively in adult samples, across a wide range
      of settings. It has been shown to be effective in management of intense emotional states and
      development of coping skills in the most challenging patient populations including patients
      with Borderline Personality Disorder (BPD), eating disorders, and substance abuse.
      Furthermore, DBT-based interventions have demonstrated preliminary effectiveness in managing
      chronic pain and pain catastrophizing and anxiety. As such, patients with orthopedic trauma
      at high risk for chronic pain and disability would benefit from an evidence-based treatment
      approach that would teach them how to change thoughts, feelings, and behaviors that could
      cause problems in daily living and interfere with recovery from injury.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change over time in Pain Severity: VAS
time frame: Baseline, 2 week follow-up, 6-8 week follow-up, 10-14 week follow-up
description: Visual Analogue Scale (VAS) Pain scores documented in the patient's medical record. Score Range 0-10. Higher score indicates greater pain.
measure: Number of Opioids Administered
time frame: Hospital admission to hospital discharge, approximately 4-7 days
description: The opioids administered during hospitalization measured in total morphine equivalents
measure: Change over time in General Health Status
time frame: Baseline, 2 week follow-up, 6-8 week follow-up, 10-14 week follow-up
description: Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health: 10-item measure of physical and mental health. Scale range 0 to 100, mean 50, standard deviation 10. A higher score represents a better outcome.
measure: Change over time in Psychological Functioning - Depression
time frame: Baseline, 2 week follow-up, 6-8 week follow-up, 10-14 week follow-up
description: Patient Health Questionnaire-9 (PHQ-9): 9-item measure of major depression symptom severity on a 4-point Likert-type scale. Score range 0-27; Higher score indicates more severe depressive symptoms.
measure: Change over time in Psychological Functioning - PTSD
time frame: Baseline, 2 week follow-up, 6-8 week follow-up, 10-14 week follow-up
description: PTSD Checklist for DSM-5 (PCL-5): 20-item measure of DSM-5 PTSD symptom severity on a 5-point Likert-type scale. Scale range 0-80. Higher score indicates more severe PTSD symptoms
measure: Change over time in Pain Anxiety: PASS-20
time frame: Baseline, 2 week follow-up, 6-8 week follow-up, 10-14 week follow-up
description: Pain Anxiety Symptoms Scale (PASS-20): 20-item measure of pain anxiety on a 6-point Likert-type scale. Scale range 0-100. Higher score indicates more pain-related anxiety
measure: Change over time in Pain Interference: BPI-SF
time frame: Baseline, 2 week follow-up, 6-8 week follow-up, 10-14 week follow-up
description: Brief Pain Inventory-Short Form (BPI-SF): 9-item measure of pain severity and impact of pain on daily functions. This is a 10-point scale with 0 being the best possible score, meaning "no pain", and 10 being the worst possible score, meaning "pain as bad as you can imagine".
arm group label: Standard Care
arm group type: No Intervention
description: No intervention - Standard care only. Group of 32 subjects
arm group label: Dialectical Behavioral Therapy
arm group type: Experimental
description: Dialectical Behavioral Therapy in addition to standard care. Four hour and a half group sessions (or one-on-one sessions, if not enough for a group session) commencing after surgery while still inpatient. Each session is designed to stand-alone, allowing for enrolling patients on a rolling basis.
intervention type: Behavioral
intervention name: Dialectical Behavioral Therapy
description: Dialectical Behavior Therapy (DBT) is a cognitive behavioral therapy that focuses on the balance between change and acceptance. DBT skills include four modules: two that enforce acceptance-oriented skills, mindfulness and distress tolerance, and two that promote change-oriented skills, interpersonal effectiveness and emotional regulation.
arm group label: Dialectical Behavioral Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ida L Gitajn, MD
role: Principal Investigator
affiliation: Dartmouth-Hitchcock Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dartmouth-Hitchcock Medical Center
investigator full name: Ida Leah Gitajn
investigator title: Principal Investigator