<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/NCT02215187</url>
  </required_header>
  <id_info>
    <org_study_id>#000435754</org_study_id>
    <secondary_id>H133G110275</secondary_id>
    <nct_id>NCT02215187</nct_id>
  </id_info>
  <brief_title>Telehealth-Education-Based Program for Military Caregivers of Injured Service Members With Head Injuries</brief_title>
  <official_title>Cognitive Behavioral Therapy (CBT) for Caregivers of Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) Service Members With Combat-Related Traumatic Brain Injuries (TBI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this research is to evaluate the impact of a telehealth-based,&#xD;
      cognitive behavioral therapy (CBT) intervention (problem-solving training: PST) for adult&#xD;
      informal military family/friend caregivers of OIF/OEF service members with a&#xD;
      deployment-related TBI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Traumatic brain injury (TBI) has gained increasing attention in American society as it is now&#xD;
      considered the &quot;signature injury&quot; of the Operation Iraqi Freedom/Operation Enduring Freedom&#xD;
      (OIF/OEF) campaigns. The chronic changes that often occur in the wake of TBI along with&#xD;
      possible physical injuries may run a chronic, unremitting course, imposing great strain and&#xD;
      distress upon family members who often assume a caregiver role with little preparation and no&#xD;
      formal training for these wounded service members as they reintegrate back into civilian life&#xD;
      post-deployment. Unfortunately, research has not adequately addressed the unique long-term&#xD;
      needs of informal military caregivers of deployed service members with TBI (i.e., family&#xD;
      members/close friends).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Health Questionnaire-9</measure>
    <time_frame>Change from baseline in PHQ-9 scores at post-program (3-months follow-up)</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Traumatic Brain Injuries</condition>
  <arm_group>
    <arm_group_label>Problem-Solving Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PST is a cognitive-behavioral intervention. Delivery of the PST + usual care condition will be administered to caregivers over the course of 6 one-hour per week, telephone calls/sessions that will entail education related to problem-solving skills/problem-solving model and application to caregiving and managing caregiver related problems.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Attention Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Attention/social contact control. Health education (non-skill focused).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Problem-Solving Training (PST)</intervention_name>
    <description>Training in problem-solving skills to be applied to military caregiver problems.</description>
    <arm_group_label>Problem-Solving Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Attention Control</intervention_name>
    <description>Social contact control (health education/no skill training)</description>
    <arm_group_label>Attention Control</arm_group_label>
    <other_name>Social contact control</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 19 years old&#xD;
&#xD;
          -  Meets study project definition of a military caregiver&#xD;
&#xD;
          -  Documentation or determination of an OIF/OEF deployment related TBI&#xD;
&#xD;
          -  Service member will have presented to a Veterans Administration Medical Center (VAMC)&#xD;
             or military medical center&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  Has access to a telephone for the administration of measures and/or intervention calls&#xD;
&#xD;
          -  Has no significant cognitive or communication problems that might significantly&#xD;
             interfere with adequately understanding information or talking on the telephone which&#xD;
             will be determined by the clinical judgment of the person consenting the participant.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a life-threatening or other serious disease that impacts the ability to&#xD;
             participate for the duration of the project&#xD;
&#xD;
          -  No determination or documentation of a deployment-related TBI related to OIF/OEF for&#xD;
             the injured service member&#xD;
&#xD;
          -  Has a severe hearing impairment that impedes communication and standardized&#xD;
             implementation of the intervention and telephone follow-up&#xD;
&#xD;
          -  Formal caregiver&#xD;
&#xD;
          -  Caregiver does not want to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura Dreer, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35243</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 24, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>February 10, 2023</last_update_submitted>
  <last_update_submitted_qc>February 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Laura E. Dreer, PhD</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>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT02215187
org study id: #000435754
secondary id: H133G110275
nct id: NCT02215187
lead sponsor: 
has dmc: Yes
The primary purpose of this research is to evaluate the impact of a telehealth-based,
      cognitive behavioral therapy (CBT) intervention (problem-solving training: PST) for adult
      informal military family/friend caregivers of OIF/OEF service members with a
      deployment-related TBI.
Traumatic brain injury (TBI) has gained increasing attention in American society as it is now
      considered the "signature injury" of the Operation Iraqi Freedom/Operation Enduring Freedom
      (OIF/OEF) campaigns. The chronic changes that often occur in the wake of TBI along with
      possible physical injuries may run a chronic, unremitting course, imposing great strain and
      distress upon family members who often assume a caregiver role with little preparation and no
      formal training for these wounded service members as they reintegrate back into civilian life
      post-deployment. Unfortunately, research has not adequately addressed the unique long-term
      needs of informal military caregivers of deployed service members with TBI (i.e., family
      members/close friends).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Patient Health Questionnaire-9
time frame: Change from baseline in PHQ-9 scores at post-program (3-months follow-up)
arm group label: Problem-Solving Training
arm group type: Experimental
description: PST is a cognitive-behavioral intervention. Delivery of the PST + usual care condition will be administered to caregivers over the course of 6 one-hour per week, telephone calls/sessions that will entail education related to problem-solving skills/problem-solving model and application to caregiving and managing caregiver related problems.
arm group label: Attention Control
arm group type: Sham Comparator
description: Attention/social contact control. Health education (non-skill focused).
intervention type: Behavioral
intervention name: Problem-Solving Training (PST)
description: Training in problem-solving skills to be applied to military caregiver problems.
arm group label: Problem-Solving Training
intervention type: Behavioral
intervention name: Attention Control
description: Social contact control (health education/no skill training)
arm group label: Attention Control
other name: Social contact control
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Laura Dreer, Ph.D.
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Laura E. Dreer, PhD
investigator title: Assistant Professor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Wounds and Injuries