<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/NCT01714531</url>
  </required_header>
  <id_info>
    <org_study_id>111484</org_study_id>
    <secondary_id>H133G120052</secondary_id>
    <nct_id>NCT01714531</nct_id>
  </id_info>
  <brief_title>Improving Outcomes After Traumatic Injury: A Goal Management Approach</brief_title>
  <acronym>GMT</acronym>
  <official_title>Improving Trauma Outcomes: A Goal Management Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>U.S. Department of Education</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The majority of trauma survivors experience prolonged and profound physical and psychosocial&#xD;
      disability, with up to 50% unable to return to productive employment. The Centers for Disease&#xD;
      Control (CDC) estimates that more than 1 million of these individuals experience a mild&#xD;
      traumatic brain injury (TBI) and cost the United States nearly $17 billion each year.&#xD;
      Symptoms related to mild TBI result in cognitive, functional, and emotional impairments that&#xD;
      can lead to vocational and social disability. Long-term cognitive deficits include problems&#xD;
      with memory and attention, and most importantly executive functioning. Depressive and&#xD;
      post-traumatic stress disorder (PTSD) symptoms are extremely common in individuals with&#xD;
      cognitive impairment, occurring in up to 50% and 33% of individuals, respectively. The&#xD;
      investigators have found that 55% of trauma patients with mild TBI have profound cognitive&#xD;
      impairments in executive functioning at one-year survival. Executive functioning is defined&#xD;
      as &quot;a cognitive domain that controls the execution of complex activities of daily living&#xD;
      essential for purposeful, goal directed behaviors.&quot; Deficits in executive functioning are the&#xD;
      most disabling of all cognitive impairments and affect a person's ability to manage&#xD;
      effectively in one's personal and professional life. Current literature shows that deficits&#xD;
      in executive functioning contribute to reduced quality of life, difficulty in returning to&#xD;
      work, and persistent psychological distress in various medical and surgical populations.&#xD;
      Cognitive rehabilitation has proven effective for decreasing persistent cognitive impairment&#xD;
      and functional disability in patients with TBI. The overall goal of cognitive rehabilitation&#xD;
      is not only to improve a person's ability to process and interpret information but to&#xD;
      increase self-confidence and self-efficacy for coping with emotional distress. Despite&#xD;
      evidence supporting the use of cognitive rehabilitation, few studies have systematically&#xD;
      addressed cognitive treatment for individuals with mild TBI. Therefore, the investigators&#xD;
      propose to conduct a three-group randomized controlled trial to determine the efficacy of&#xD;
      Goal Management Training (GMT), a structured manual-based intervention targeting executive&#xD;
      functions that impact a person's ability to carry out daily tasks. The investigators&#xD;
      hypothesize that telephone-based GMT will improve cognitive functioning, functional status,&#xD;
      and psychological health in trauma survivors with mild TBI. Emerging research suggests that&#xD;
      telephone rehabilitation is a feasible and effective alternative (with much broader&#xD;
      applicability) to clinic-based interventions. Trauma survivors with mild TBI have limited&#xD;
      access to rehabilitation services due to financial constraints and mobility and geographic&#xD;
      restrictions that render clinic-based rehabilitation impractical. This clinical trial will&#xD;
      recruit 90 trauma survivors with mild TBI and cognitive deficits in executive functioning.&#xD;
      Eligible participants will be randomized to either 10-week (1) telephone-based GMT; (2)&#xD;
      telephone-based attention-control; or (3) usual care. Primary outcomes will include observed&#xD;
      and self-reported executive functioning and self-reported functional status as measured by a&#xD;
      battery of standardized and previously validated cognitive tests and instruments, including&#xD;
      the Delis-Kaplan Executive Function System Tower Test, the Dysexecutive Questionnaire, and&#xD;
      the Functional Activities Questionnaire. Secondary outcomes will consist of depressive and&#xD;
      PTSD symptoms, as measured by the Patient Health Questionnaire-9 and PTSD Checklist -&#xD;
      Civilian Version, respectively. Outcome data will be collected at baseline (6 weeks after&#xD;
      hospitalization) and at 4 month (treatment completion) and 7 month follow-up from hospital&#xD;
      discharge. Our cognitive rehabilitation intervention will serve to broadly disseminate&#xD;
      evidenced-based cognitive strategies to a trauma population that has difficulty returning to&#xD;
      productive life both inside and outside the home due to profound functional and psychological&#xD;
      disability. Findings from this study will support future research to improve the cognitive,&#xD;
      functional and psychological health of patients following major trauma through innovative&#xD;
      rehabilitation interventions and delivery methods.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>D-KEFs Tower Test</measure>
    <time_frame>7 months after hospital discharge</time_frame>
    <description>cognitive test for executive functioning</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trail Making Test B</measure>
    <time_frame>7 months after hospital discharge</time_frame>
    <description>Cognitive test for set shifting and cognitive flexibility</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sustained Attention to Response Test</measure>
    <time_frame>7 months after hospital discharge</time_frame>
    <description>Cognitive test for failures of sustained attention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FAS Verbal Fluency Test</measure>
    <time_frame>7 months after hospital discharge</time_frame>
    <description>Cognitive test for verbal fluency</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dysexecutive Questionnaire</measure>
    <time_frame>7 months after hospital discharge</time_frame>
    <description>Self-reported executive functioning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Activities Questionnaire</measure>
    <time_frame>7 months after hospital discharge</time_frame>
    <description>Self-reported functional status</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient Health Questionnaire-9</measure>
    <time_frame>7 months after hospital discharge</time_frame>
    <description>Self-reported measure of depressive symptoms</description>
  </other_outcome>
  <other_outcome>
    <measure>PTSD Checklist-Civilian Version (PCL-C)</measure>
    <time_frame>7 months after hospital discharge</time_frame>
    <description>Self-reported measure of PTSD symptoms</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">91</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Telephone-Based Goal Management Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The GMT intervention targets cognitive deficits in executive functioning that impact a person's ability to carry out daily tasks. Participants learn how to recognize and stop absentmindedness and automatic pilot and how to reduce daily errors and 'slips' through goal setting. The telephone-based GMT condition includes 7 sessions delivered over the phone for 10 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telephone-Based Attention-Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The attention group receives an educational intervention that is matched to the GMT intervention in terms of session length and contact with the study therapist. The telephone-based attention condition includes 7 sessions delivered over 10 weeks. Sessions address education on brain function and cognitive principles of memory, attention, language, perception, and motor skills. Education on stress reduction, sleep hygiene, energy management, exercise, communication, and nutrition are also provided</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the control group will receive usual care as determined by the treating surgeon. Usual care may include referral to a physical therapist, occupational therapist, psychiatrist, and/or psychologist and utilization of health services will be recorded during follow-up assessments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telephone-Based Goal Management Training</intervention_name>
    <arm_group_label>Telephone-Based Goal Management Training</arm_group_label>
    <other_name>GMT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telephone-Based Attention-Control</intervention_name>
    <arm_group_label>Telephone-Based Attention-Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Determination of mild TBI using American Congress of Rehabilitation Medicine&#xD;
             guidelines;&#xD;
&#xD;
          2. No history of schizophrenia, or other psychotic disorder or suicidal intent;&#xD;
&#xD;
          3. English speaking due to feasibility of employing study personnel to deliver and assess&#xD;
             the study intervention;&#xD;
&#xD;
          4. Age 21 years or older;&#xD;
&#xD;
          5. Able to provide a telephone number and a stable address; and&#xD;
&#xD;
          6. Presence of cognitive deficits in executive functioning (defined as 1 SD below the&#xD;
             norm referenced mean on any 2 of the following neuropsychological tests, the D-KEF&#xD;
             Tower Test, Trails B, and FAS)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Having a CT scan showing an intracranial hemorrhage;&#xD;
&#xD;
          2. Current alcohol or substance abuse dependence (within the last 6 months);&#xD;
&#xD;
          3. Persons with neurological history other than TBI (e.g., premorbid epilepsy, multiple&#xD;
             sclerosis, Alzheimer's disease);&#xD;
&#xD;
          4. Pre-existing cognitive impairment as determined by a validated surrogate or patient&#xD;
             questionnaire (defined as a score greater than 3.3 on the IQCODE instrument;&#xD;
&#xD;
          5. History of pre-morbid learning disability;and&#xD;
&#xD;
          6. Involvement in current litigation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristin Archer, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>April 21, 2017</last_update_submitted>
  <last_update_submitted_qc>April 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Kristin Archer</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Mild TBI</keyword>
  <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>
  </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/NCT01714531
org study id: 111484
secondary id: H133G120052
nct id: NCT01714531
lead sponsor: 
collaborator: 
has dmc: No
The majority of trauma survivors experience prolonged and profound physical and psychosocial
      disability, with up to 50% unable to return to productive employment. The Centers for Disease
      Control (CDC) estimates that more than 1 million of these individuals experience a mild
      traumatic brain injury (TBI) and cost the United States nearly $17 billion each year.
      Symptoms related to mild TBI result in cognitive, functional, and emotional impairments that
      can lead to vocational and social disability. Long-term cognitive deficits include problems
      with memory and attention, and most importantly executive functioning. Depressive and
      post-traumatic stress disorder (PTSD) symptoms are extremely common in individuals with
      cognitive impairment, occurring in up to 50% and 33% of individuals, respectively. The
      investigators have found that 55% of trauma patients with mild TBI have profound cognitive
      impairments in executive functioning at one-year survival. Executive functioning is defined
      as "a cognitive domain that controls the execution of complex activities of daily living
      essential for purposeful, goal directed behaviors." Deficits in executive functioning are the
      most disabling of all cognitive impairments and affect a person's ability to manage
      effectively in one's personal and professional life. Current literature shows that deficits
      in executive functioning contribute to reduced quality of life, difficulty in returning to
      work, and persistent psychological distress in various medical and surgical populations.
      Cognitive rehabilitation has proven effective for decreasing persistent cognitive impairment
      and functional disability in patients with TBI. The overall goal of cognitive rehabilitation
      is not only to improve a person's ability to process and interpret information but to
      increase self-confidence and self-efficacy for coping with emotional distress. Despite
      evidence supporting the use of cognitive rehabilitation, few studies have systematically
      addressed cognitive treatment for individuals with mild TBI. Therefore, the investigators
      propose to conduct a three-group randomized controlled trial to determine the efficacy of
      Goal Management Training (GMT), a structured manual-based intervention targeting executive
      functions that impact a person's ability to carry out daily tasks. The investigators
      hypothesize that telephone-based GMT will improve cognitive functioning, functional status,
      and psychological health in trauma survivors with mild TBI. Emerging research suggests that
      telephone rehabilitation is a feasible and effective alternative (with much broader
      applicability) to clinic-based interventions. Trauma survivors with mild TBI have limited
      access to rehabilitation services due to financial constraints and mobility and geographic
      restrictions that render clinic-based rehabilitation impractical. This clinical trial will
      recruit 90 trauma survivors with mild TBI and cognitive deficits in executive functioning.
      Eligible participants will be randomized to either 10-week (1) telephone-based GMT; (2)
      telephone-based attention-control; or (3) usual care. Primary outcomes will include observed
      and self-reported executive functioning and self-reported functional status as measured by a
      battery of standardized and previously validated cognitive tests and instruments, including
      the Delis-Kaplan Executive Function System Tower Test, the Dysexecutive Questionnaire, and
      the Functional Activities Questionnaire. Secondary outcomes will consist of depressive and
      PTSD symptoms, as measured by the Patient Health Questionnaire-9 and PTSD Checklist -
      Civilian Version, respectively. Outcome data will be collected at baseline (6 weeks after
      hospitalization) and at 4 month (treatment completion) and 7 month follow-up from hospital
      discharge. Our cognitive rehabilitation intervention will serve to broadly disseminate
      evidenced-based cognitive strategies to a trauma population that has difficulty returning to
      productive life both inside and outside the home due to profound functional and psychological
      disability. Findings from this study will support future research to improve the cognitive,
      functional and psychological health of patients following major trauma through innovative
      rehabilitation interventions and delivery methods.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: D-KEFs Tower Test
time frame: 7 months after hospital discharge
description: cognitive test for executive functioning
measure: Trail Making Test B
time frame: 7 months after hospital discharge
description: Cognitive test for set shifting and cognitive flexibility
measure: Sustained Attention to Response Test
time frame: 7 months after hospital discharge
description: Cognitive test for failures of sustained attention
measure: FAS Verbal Fluency Test
time frame: 7 months after hospital discharge
description: Cognitive test for verbal fluency
measure: Dysexecutive Questionnaire
time frame: 7 months after hospital discharge
description: Self-reported executive functioning
measure: Functional Activities Questionnaire
time frame: 7 months after hospital discharge
description: Self-reported functional status
measure: Patient Health Questionnaire-9
time frame: 7 months after hospital discharge
description: Self-reported measure of depressive symptoms
measure: PTSD Checklist-Civilian Version (PCL-C)
time frame: 7 months after hospital discharge
description: Self-reported measure of PTSD symptoms
arm group label: Telephone-Based Goal Management Training
arm group type: Experimental
description: The GMT intervention targets cognitive deficits in executive functioning that impact a person's ability to carry out daily tasks. Participants learn how to recognize and stop absentmindedness and automatic pilot and how to reduce daily errors and 'slips' through goal setting. The telephone-based GMT condition includes 7 sessions delivered over the phone for 10 weeks.
arm group label: Telephone-Based Attention-Control
arm group type: Active Comparator
description: The attention group receives an educational intervention that is matched to the GMT intervention in terms of session length and contact with the study therapist. The telephone-based attention condition includes 7 sessions delivered over 10 weeks. Sessions address education on brain function and cognitive principles of memory, attention, language, perception, and motor skills. Education on stress reduction, sleep hygiene, energy management, exercise, communication, and nutrition are also provided
arm group label: Usual Care Control
arm group type: No Intervention
description: Participants in the control group will receive usual care as determined by the treating surgeon. Usual care may include referral to a physical therapist, occupational therapist, psychiatrist, and/or psychologist and utilization of health services will be recorded during follow-up assessments.
intervention type: Behavioral
intervention name: Telephone-Based Goal Management Training
arm group label: Telephone-Based Goal Management Training
other name: GMT
intervention type: Behavioral
intervention name: Telephone-Based Attention-Control
arm group label: Telephone-Based Attention-Control
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: No
last name: Kristin Archer, PhD
role: Principal Investigator
affiliation: Vanderbilt School of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Kristin Archer
investigator title: Associate Professor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic