<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/NCT03247179</url>
  </required_header>
  <id_info>
    <org_study_id>PRO16010595</org_study_id>
    <nct_id>NCT03247179</nct_id>
  </id_info>
  <brief_title>The Mobile PTSD Coach App in Acute Injury Survivors</brief_title>
  <official_title>Secondary Prevention With the Mobile PTSD Coach App to Improve Health Outcomes and the Continuity of Care Following Traumatic Physical Injury: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Palo Alto Veterans Institute for Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This project is a preliminary randomized controlled trial testing the potential impact of the&#xD;
      PTSD Coach mobile application at reducing posttraumatic stress and pain symptoms among&#xD;
      acutely injured trauma patients. Immediately following the injury, patients will be randomly&#xD;
      assigned to use the PTSD Coach app, or to the treatment as usual condition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Traumatic injury is the leading cause of mortality in the U.S. for young people, and a source&#xD;
      of long-term morbidity in all ages. A majority of trauma patients report chronic pain (CP)&#xD;
      and disability at 4-months (30%- 79%) and 12-months (63%) post-injury. Maladaptive&#xD;
      psychological processes have a stronger association with the transition to CP than does&#xD;
      injury severity. Posttraumatic stress disorder (PTSD) symptoms (e.g., intrusions, avoidance&#xD;
      and hyperarousal) occur in up to 22% of post-injury patients and herald the transition from&#xD;
      acute to CP. Although psychological interventions can modify PTSD symptoms, and reduce CP, it&#xD;
      is unknown if early intervention to prevent PTSD symptoms can prevent post-injury CP&#xD;
      altogether. &quot;PTSD Coach&quot; is a publicly available, free, mobile app that provides scalable and&#xD;
      psychosocial support modeled on principles of cognitive-behavioral therapy. PTSD Coach has&#xD;
      helped Veterans and civilians to manage PTSD.&#xD;
&#xD;
      This project will test whether PTSD Coach can reduce post-injury maladaptive psychological&#xD;
      processes and thereby prevent post-injury CP. The preventive intervention will be targeted&#xD;
      towards those at the highest-risk of developing PTSD.&#xD;
&#xD;
      The investigators propose to test the efficacy of the PTSD Coach app vs. treatment as usual&#xD;
      (TAU) among a sample of acute physical injury patients, to: 1) Determine engagement with PTSD&#xD;
      Coach, by measuring frequency of use over 4-weeks and assessing ratings of usefulness and&#xD;
      qualitative feedback: it is expected that &gt;80% of PTSD Coach users will use the app at least&#xD;
      once a week, and will rate it as at least somewhat helpful; 2) Estimate effect on CP symptoms&#xD;
      by measuring PTSD and pain intensity at 1- and 3-months. The effect of the intervention on&#xD;
      pain interference, disability, and coping self-efficacy will also be explored.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 19, 2017</start_date>
  <completion_date type="Actual">February 15, 2019</completion_date>
  <primary_completion_date type="Actual">December 20, 2018</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>Participants will be randomly assigned to either the experimental condition (PTSD Coach app usage), or the treatment as usual condition.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PTSD Checklist for DSM 5 (Diagnostic and Statistical Manual for Mental Disorders-5)</measure>
    <time_frame>past 30-days</time_frame>
    <description>PTSD symptoms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Short Form of the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale</measure>
    <time_frame>7-days</time_frame>
    <description>8-items assessing pain interference</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form of the PROMIS Pain Intensity Scale</measure>
    <time_frame>7-days</time_frame>
    <description>3-items assessing pain intensity</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Chronic Pain</condition>
  <condition>Acute Pain Due to Trauma</condition>
  <condition>Posttraumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>PTSD Coach Condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PTSD Coach App</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as Usual Condition</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Treatment as Usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PTSD Coach mobile application</intervention_name>
    <description>The PTSD Coach app is publicly available for free, and draws on cognitive behavioral therapy components to help participants learn, manage, and cope with their PTSD symptoms in real time.</description>
    <arm_group_label>PTSD Coach Condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English-speaking adults seeking treatment in the ED&#xD;
&#xD;
          -  Adults between the ages of 18-65&#xD;
&#xD;
          -  Sustained a musculoskeletal injury (e.g., fractures, sprains or strains, contusions,&#xD;
             dislocations, crushing injuries and open wounds; and other chief complains involving&#xD;
             the neck, back, or extremities)&#xD;
&#xD;
          -  Injury resulting from a motor vehicle crash (MVC) or motorcycle crash (MCC) that&#xD;
             occurred within the past 24 hours&#xD;
&#xD;
          -  Eligible patients must own a mobile phone with short-message service (SMS) features&#xD;
             (e.g., the ability to send and respond to text messages) and the ability to download&#xD;
             apps&#xD;
&#xD;
          -  Participants must self-report that they experienced a potential traumatic event&#xD;
             reflected by Criterion A of the DSM-5 PTSD diagnosis (endorse actual or perceived life&#xD;
             threat and/or serious injury141,142)&#xD;
&#xD;
          -  Participants must self-report that they experienced a painful injury reflected by a&#xD;
             pain score ≥4 using the verbal numerical score (0-10) in response to the question: &quot;On&#xD;
             a scale of 0-10, how severe is your pain?&quot;&#xD;
&#xD;
          -  Patients with a past history of PTSD, but not currently receiving treatment (e.g.,&#xD;
             benzodiazepines or mental/behavioral therapy), are eligible for participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presenting to the ED for a non-MVC/MCC (i.e., fall, assault)&#xD;
&#xD;
          -  Participants who do not own a mobile phone with SMS features&#xD;
&#xD;
          -  Participants with a pain score &lt; 4 or do not endorse Criterion A of the DSM-5 PTSD&#xD;
             diagnosis&#xD;
&#xD;
          -  Spinal injuries&#xD;
&#xD;
          -  Major lacerations resulting in significant damage to subcutaneous tissue (e.g.,&#xD;
             degloving) and specific nerve injury (these injuries could lead to a distinct&#xD;
             neuropathic pain syndrome)&#xD;
&#xD;
          -  Traumatic brain injury; Evidence of moderate to severe cognitive impairment secondary&#xD;
             to trauma-related head injury (GCS&lt;13)&#xD;
&#xD;
          -  Self-inflicted injury&#xD;
&#xD;
          -  Time since trauma &gt; 24 hours&#xD;
&#xD;
          -  Non-English speaking; younger than 18 or older than 65&#xD;
&#xD;
          -  Not medically stable or alert and oriented&#xD;
&#xD;
          -  Initiation of benzodiazepines and other psychotropic medications at time of ED visit&#xD;
&#xD;
          -  Initiation of mental or behavioral health therapy at time of ED visit&#xD;
&#xD;
          -  Currently enrolled in treatment (medication or mental/behavioral health therapy) for&#xD;
             PTSD&#xD;
&#xD;
          -  Prisoners&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria L Pacella, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UPMC Presbyterian Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Mercy Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>March 1, 2019</last_update_submitted>
  <last_update_submitted_qc>March 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Maria Pacella</investigator_full_name>
    <investigator_title>Research Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Acute Pain</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>There is no plan in place yet because it is undecided whether the research team will need to share the data with investigators/researchers not listed on the protocol.</ipd_description>
  </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/NCT03247179
org study id: PRO16010595
nct id: NCT03247179
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This project is a preliminary randomized controlled trial testing the potential impact of the
      PTSD Coach mobile application at reducing posttraumatic stress and pain symptoms among
      acutely injured trauma patients. Immediately following the injury, patients will be randomly
      assigned to use the PTSD Coach app, or to the treatment as usual condition.
Traumatic injury is the leading cause of mortality in the U.S. for young people, and a source
      of long-term morbidity in all ages. A majority of trauma patients report chronic pain (CP)
      and disability at 4-months (30%- 79%) and 12-months (63%) post-injury. Maladaptive
      psychological processes have a stronger association with the transition to CP than does
      injury severity. Posttraumatic stress disorder (PTSD) symptoms (e.g., intrusions, avoidance
      and hyperarousal) occur in up to 22% of post-injury patients and herald the transition from
      acute to CP. Although psychological interventions can modify PTSD symptoms, and reduce CP, it
      is unknown if early intervention to prevent PTSD symptoms can prevent post-injury CP
      altogether. "PTSD Coach" is a publicly available, free, mobile app that provides scalable and
      psychosocial support modeled on principles of cognitive-behavioral therapy. PTSD Coach has
      helped Veterans and civilians to manage PTSD.

      This project will test whether PTSD Coach can reduce post-injury maladaptive psychological
      processes and thereby prevent post-injury CP. The preventive intervention will be targeted
      towards those at the highest-risk of developing PTSD.

      The investigators propose to test the efficacy of the PTSD Coach app vs. treatment as usual
      (TAU) among a sample of acute physical injury patients, to: 1) Determine engagement with PTSD
      Coach, by measuring frequency of use over 4-weeks and assessing ratings of usefulness and
      qualitative feedback: it is expected that >80% of PTSD Coach users will use the app at least
      once a week, and will rate it as at least somewhat helpful; 2) Estimate effect on CP symptoms
      by measuring PTSD and pain intensity at 1- and 3-months. The effect of the intervention on
      pain interference, disability, and coping self-efficacy will also be explored.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomly assigned to either the experimental condition (PTSD Coach app usage), or the treatment as usual condition.
primary purpose: Prevention
masking: None (Open Label)
measure: PTSD Checklist for DSM 5 (Diagnostic and Statistical Manual for Mental Disorders-5)
time frame: past 30-days
description: PTSD symptoms
measure: Short Form of the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale
time frame: 7-days
description: 8-items assessing pain interference
measure: Short Form of the PROMIS Pain Intensity Scale
time frame: 7-days
description: 3-items assessing pain intensity
arm group label: PTSD Coach Condition
arm group type: Experimental
description: PTSD Coach App
arm group label: Treatment as Usual Condition
arm group type: No Intervention
description: Treatment as Usual
intervention type: Other
intervention name: PTSD Coach mobile application
description: The PTSD Coach app is publicly available for free, and draws on cognitive behavioral therapy components to help participants learn, manage, and cope with their PTSD symptoms in real time.
arm group label: PTSD Coach Condition
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Maria L Pacella, PhD
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Maria Pacella
investigator title: Research Assistant Professor
mesh term: Chronic Pain
mesh term: Acute Pain
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: Undecided
ipd description: There is no plan in place yet because it is undecided whether the research team will need to share the data with investigators/researchers not listed on the protocol.