<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/NCT04426981</url>
  </required_header>
  <id_info>
    <org_study_id>D20133</org_study_id>
    <nct_id>NCT04426981</nct_id>
  </id_info>
  <brief_title>Behavioral Activation in Orthopaedic Trauma Patients: A Pilot Study</brief_title>
  <official_title>Behavioral Activation in Orthopaedic Trauma Patients: A Pilot Study</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>
      This is a prospective observational pilot study designed to evaluate feasibility and&#xD;
      acceptability as well as preliminary efficacy of a behavioral activation intervention among&#xD;
      orthopaedic trauma patients after discharge home following their injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective observational pilot study designed to evaluate feasibility and&#xD;
      acceptability as well as preliminary efficacy of a behavioral activation intervention among&#xD;
      orthopaedic trauma patients after discharge home following their injury. Behavioral&#xD;
      activation is a behavioral treatment that focuses on helping participants engage in more&#xD;
      rewarding and enjoyable activities. In the first session, participants will begin to identify&#xD;
      domains of their life which are important to them. In the second session, participants will&#xD;
      be assisted in creating an action plan to engage in more activities in one or more domains of&#xD;
      importance. In session 3-8, participants will be assisted in problem solving any challenges&#xD;
      they encountered in implementing their previous action plan and will develop a new action&#xD;
      plan. The intervention will continue until participants achieved three action plans or reach&#xD;
      the eight-session limit, whichever comes first.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 9, 2020</start_date>
  <completion_date type="Actual">September 3, 2021</completion_date>
  <primary_completion_date type="Actual">September 3, 2021</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>Percentage of patients who agree to enroll</measure>
    <time_frame>6 months</time_frame>
    <description>Feasibility will be assessed based on percentage of patients who agree to enroll sessions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Score on Modified Treatment Evaluation Inventory Short Form</measure>
    <time_frame>6 months</time_frame>
    <description>Acceptability will be measured qualitatively and using the Modified Treatment Evaluation Inventory Short Form</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients who complete 5 out of 8 possible Behavioral Activation sessions</measure>
    <time_frame>6 months</time_frame>
    <description>Feasibility will be assessed based on patients who complete 5 out of 8 possible Behavioral Activation Sessions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Score on PROMIS general health survey (Response range is 0 to 100 where 100 indicates better function)</measure>
    <time_frame>6 months</time_frame>
    <description>Preliminary efficacy on functional outcome will be assessed using patient reported functional outcome using PROMIS general health survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score on VAS pain score (Response range is from 0 to 10 where 10 indicates greater pain)</measure>
    <time_frame>6 months</time_frame>
    <description>Pain-related preliminary efficacy will be assessed using patient reported VAS pain score will be assessed</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Fractures, Bone</condition>
  <arm_group>
    <arm_group_label>Intervention arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Consenting patients will be enrolled into a Behavioral Activation treatment arm. Behavioral activation is a behavioral treatment that focuses on helping participants engage in more rewarding and enjoyable activities.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral Activation</intervention_name>
    <description>Behavioral activation is a behavioral treatment that focuses on helping participants engage in more rewarding and enjoyable activities. In the first session, participants will begin to identify domains of their life which are important to them. In the second session, participants will be assisted in creating an action plan to engage in more activities in one or more domains of importance. In session 3-8, participants will be assisted in problem solving any challenges they encountered in implementing their previous action plan and will develop a new action plan. The intervention will continue until participants achieved three action plans or reach the eight-session limit, whichever comes first.</description>
    <arm_group_label>Intervention arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 18 years or older&#xD;
&#xD;
          -  Presenting at initial (approximately 2-week) postoperative follow-up&#xD;
&#xD;
          -  Prior management of isolated fracture or multi-trauma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Incarceration&#xD;
&#xD;
          -  Problems, in the judgement of study personnel, with maintaining follow-up&#xD;
&#xD;
          -  Cognitive disability (either acute or chronic)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dartmouth Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03766</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>January 26, 2022</last_update_submitted>
  <last_update_submitted_qc>January 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2022</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>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</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/NCT04426981
org study id: D20133
nct id: NCT04426981
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective observational pilot study designed to evaluate feasibility and
      acceptability as well as preliminary efficacy of a behavioral activation intervention among
      orthopaedic trauma patients after discharge home following their injury.
This is a prospective observational pilot study designed to evaluate feasibility and
      acceptability as well as preliminary efficacy of a behavioral activation intervention among
      orthopaedic trauma patients after discharge home following their injury. Behavioral
      activation is a behavioral treatment that focuses on helping participants engage in more
      rewarding and enjoyable activities. In the first session, participants will begin to identify
      domains of their life which are important to them. In the second session, participants will
      be assisted in creating an action plan to engage in more activities in one or more domains of
      importance. In session 3-8, participants will be assisted in problem solving any challenges
      they encountered in implementing their previous action plan and will develop a new action
      plan. The intervention will continue until participants achieved three action plans or reach
      the eight-session limit, whichever comes first.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of patients who agree to enroll
time frame: 6 months
description: Feasibility will be assessed based on percentage of patients who agree to enroll sessions
measure: Score on Modified Treatment Evaluation Inventory Short Form
time frame: 6 months
description: Acceptability will be measured qualitatively and using the Modified Treatment Evaluation Inventory Short Form
measure: Percentage of patients who complete 5 out of 8 possible Behavioral Activation sessions
time frame: 6 months
description: Feasibility will be assessed based on patients who complete 5 out of 8 possible Behavioral Activation Sessions
measure: Score on PROMIS general health survey (Response range is 0 to 100 where 100 indicates better function)
time frame: 6 months
description: Preliminary efficacy on functional outcome will be assessed using patient reported functional outcome using PROMIS general health survey
measure: Score on VAS pain score (Response range is from 0 to 10 where 10 indicates greater pain)
time frame: 6 months
description: Pain-related preliminary efficacy will be assessed using patient reported VAS pain score will be assessed
arm group label: Intervention arm
arm group type: Experimental
description: Consenting patients will be enrolled into a Behavioral Activation treatment arm. Behavioral activation is a behavioral treatment that focuses on helping participants engage in more rewarding and enjoyable activities.
intervention type: Behavioral
intervention name: Behavioral Activation
description: Behavioral activation is a behavioral treatment that focuses on helping participants engage in more rewarding and enjoyable activities. In the first session, participants will begin to identify domains of their life which are important to them. In the second session, participants will be assisted in creating an action plan to engage in more activities in one or more domains of importance. In session 3-8, participants will be assisted in problem solving any challenges they encountered in implementing their previous action plan and will develop a new action plan. The intervention will continue until participants achieved three action plans or reach the eight-session limit, whichever comes first.
arm group label: Intervention arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dartmouth-Hitchcock Medical Center
investigator full name: Ida Leah Gitajn
investigator title: Assistant Professor
mesh term: Fractures, Bone
sharing ipd: No