<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/NCT03260127</url>
  </required_header>
  <id_info>
    <org_study_id>F2459-W</org_study_id>
    <secondary_id>IK2RX002459</secondary_id>
    <nct_id>NCT03260127</nct_id>
  </id_info>
  <brief_title>Enhancement of PTSD Treatment With Computerized Executive Function Training</brief_title>
  <official_title>Enhancement of PTSD Treatment With Computerized Executive Function Training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study focuses on helping Iraq and Afghanistan Veterans with posttraumatic stress&#xD;
      disorder (PTSD) benefit fully from therapy by first enhancing their thinking abilities. PTSD&#xD;
      has been associated with thinking problems, including difficulty planning/organizing,&#xD;
      thinking flexibly, and inhibiting distracting emotional information. There is some evidence&#xD;
      that computerized training programs are helpful for improving thinking. Therefore, this study&#xD;
      tests whether computerized cognitive training will in fact improve individuals' thinking&#xD;
      abilities and if this will in turn improve PTSD treatment outcomes and lead to more&#xD;
      individuals completing treatment and showing greater improvements in emotional symptoms and&#xD;
      quality of life than standard therapy (when paired with a word training condition).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PTSD affects approximately 14% of OEF/OIF Veterans and leads to considerable personal and&#xD;
      societal costs (e.g., increased morbidity, reduced work productivity, poorer relationships).&#xD;
      Although cognitive behavioral therapy (CBT) is one of the most effective treatments for PTSD,&#xD;
      a substantial portion (approximately 50%) of individuals drop out prematurely, do not respond&#xD;
      to treatment, or relapse.&#xD;
&#xD;
      Treatment engagement is worse for OEF/OIF Veterans, who attend fewer sessions and have higher&#xD;
      dropout rates than civilians and Veterans from other eras. One likely barrier to treatment&#xD;
      engagement and effectiveness is the executive functioning problems present in individuals&#xD;
      with PTSD. Executive functions (EFs) are the set of higher-level cognitive skills that&#xD;
      organize and integrate lower-level cognitive processes in order to perform complex,&#xD;
      goal-directed tasks. PTSD has been associated with EF deficits, including impairments in&#xD;
      inhibitory control, working memory, and cognitive flexibly, as well as dysfunction in a&#xD;
      network of brain regions that support EFs (e.g., prefrontal cortex [PFC], cingulate).&#xD;
&#xD;
      EFs are essential for CBT in order to engage the cognitive skills involved in treatment&#xD;
      (e.g., self-monitoring, inhibiting distorted thoughts, and flexibly generating/evaluating&#xD;
      alternative thoughts). This is particularly true for Cognitive Processing Therapy (CPT), a&#xD;
      frontline CBT treatment for PTSD, which involves identifying and challenging maladaptive&#xD;
      trauma-related thoughts to alter their impact on emotions and behavior. Thus, EF deficits may&#xD;
      lead to reduced CPT engagement and responsivity. In fact, worse EF at baseline has been&#xD;
      associated with poorer response to CBT in several disorders (e.g., generalized anxiety&#xD;
      disorder, obsessive compulsive disorder, and schizophrenia). Further, a study of brain&#xD;
      functioning during an EF task demonstrated that dysfunction in EF-related brain regions&#xD;
      including PFC and cingulate cortex at baseline predicted nonresponse to CBT for PTSD.&#xD;
      Directly targeting EF prior to CPT via cognitive training would strengthen executive networks&#xD;
      and likely boost treatment effectiveness, allowing Veterans to fully engage in and benefit&#xD;
      more from components of CPT (e.g., cognitive restructuring). Evidence suggests that&#xD;
      computerized cognitive training improves EF and functioning in EF-related brain regions,&#xD;
      increases mental health treatment completion rates, and goal of the proposed study is to&#xD;
      examine whether administering computerized EF training (CEFT) immediately prior to CPT will&#xD;
      improve executive functioning and enhance treatment adherence, completion rates, and&#xD;
      psychological and functional outcomes in OEF/OIF Veterans with PTSD.&#xD;
&#xD;
      Objective (neuropsychological) and subjective (self- report) measures of EF will be collected&#xD;
      to determine if CEFT enhances EF and if this in turn mediates the relationship between&#xD;
      treatment condition and PTSD symptom improvement. Functional neuroimaging during EF tasks&#xD;
      will also be collected at baseline to determine whether functioning within an EF network&#xD;
      predicts treatment response, above and beyond traditional paper-and-pencil measures of EF.&#xD;
      Veterans will be randomized to either 12 weeks of CEFT-CPT or a placebo word training&#xD;
      condition plus CPT.&#xD;
&#xD;
      Assessments will be administered at baseline, immediately after CEFT or word training (prior&#xD;
      to CPT), and after CPT completion. The proposed research aims to reduce barriers to treatment&#xD;
      engagement and has potential to significantly enhance current treatments for PTSD by&#xD;
      combining cognitive and psychotherapeutic approaches. Targeting EF directly and independently&#xD;
      represents a logical, innovative, and empirically-informed method for augmenting existing&#xD;
      treatments for PTSD in order to optimize outcomes. Findings from the proposed study will not&#xD;
      only directly inform clinical practice, but also have the potential to significantly improve&#xD;
      the quality of Veterans' lives, reduce societal costs and burden, improve access to care, and&#xD;
      reveal ways to better match individuals with treatments they are most likely to benefit from.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2, 2018</start_date>
  <completion_date type="Actual">October 31, 2022</completion_date>
  <primary_completion_date type="Actual">September 30, 2022</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Wisconsin Card Sorting Test (WCST)</measure>
    <time_frame>change from baseline to completion of computerized cognitive training (6 weeks)</time_frame>
    <description>WCST is a neuropsychological measure of executive functioning, will be examined separately as well as in a composite with the other neuropsychological measures of executive functioning</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Paced Auditory Serial Addition Test (PASAT)</measure>
    <time_frame>change from baseline to completion of computerized cognitive training (6 weeks)</time_frame>
    <description>PASAT is a neuropsychological measure of executive functioning, will be examined separately as well as in a composite with the other neuropsychological measures of executive functioning</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Delis Kaplan Executive Function System (D-KEFS)</measure>
    <time_frame>change from baseline to completion of computerized cognitive training (6 weeks)</time_frame>
    <description>D-KEFS is a neuropsychological measure of executive functioning, will be examined separately as well as in a composite with the other neuropsychological measures of executive functioning</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Behavior Rating Inventory of Executive Function (BRIEF)</measure>
    <time_frame>change in subjective executive functioning from baseline to completion of computerized cognitive training (6 weeks)</time_frame>
    <description>BRIEF is a self-report measure of executive functioning, items are summed to create a total score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>WAIS-IV Digit Span Sequencing subtest</measure>
    <time_frame>change from baseline to completion of computerized cognitive training (6 weeks)</time_frame>
    <description>WAIS-IV Digit Span Sequencing subtest is a neuropsychological measure of executive functioning, will be examined separately as well as in a composite with the other neuropsychological measures of executive functioning</description>
  </primary_outcome>
  <primary_outcome>
    <measure>N-Back Task Performance</measure>
    <time_frame>change from baseline to completion of computerized cognitive training (6 weeks)</time_frame>
    <description>N-Back is a task that tests executive functioning</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Go/No-Go Task Performance</measure>
    <time_frame>change from baseline to completion of computerized cognitive training (6 weeks)</time_frame>
    <description>Go/No-Go is a task that tests executive functioning</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinician-Administered PTSD Scale for DSM 5 (CAPS-5)</measure>
    <time_frame>change in PTSD symptoms from baseline to completion of Cognitive Processing Therapy (12 sessions completed after cognitive training), approximately 12 weeks after baseline assessment</time_frame>
    <description>CAPS-5 is a clinical interview assessing PTSD symptoms that will be administered at 3 time points: baseline, after completion of cognitive training, and after completion of Cognitive Processing Therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PTSD Checklist for DSM-5 (PCL-5)</measure>
    <time_frame>change in PTSD symptoms from baseline to completion of Cognitive Processing Therapy (12 sessions completed after cognitive training), approximately 12 weeks after baseline assessment</time_frame>
    <description>PCL-5 is a self-report questionnaire that will be administered at 15 time points: at baseline, after completion of cognitive training, at each of the 12 therapy sessions, and after completion of Cognitive Processing Therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>World Health Organization Quality of Life - BREF</measure>
    <time_frame>change in quality of life from baseline to completion of Cognitive Processing Therapy (12 sessions completed after cognitive training), approximately 12 weeks after baseline assessment</time_frame>
    <description>WHOQOL-BREF is a self-report questionnaire assessing quality of life that will be administered at 3 time points: baseline, after completion of cognitive training, and after completion of Cognitive Processing Therapy. Four subscales are computed (range 4-20): physical health, psychological, social relationships, and environment, higher scores indicate higher quality of life in each domain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time (in minutes) spent completing Cognitive Processing Therapy homework</measure>
    <time_frame>time (in minutes) spent completing homework from CPT session 1 to CPT session 12 (across approximately 6 weeks, weeks 7-12 after baseline)</time_frame>
    <description>At each of the CPT sessions, participants will report how much time they spent completing homework since the previous session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of CPT sessions completed</measure>
    <time_frame>CPT sessions completed (out of a possible 12) after completing the cognitive training (across approximately 6 weeks, weeks 7-12 after baseline)</time_frame>
    <description>Number of CPT sessions completed out of a possible total of 12 sessions</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Posttraumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>CEFT-CPT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Computerized executive function training plus Cognitive Processing Therapy for PTSD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>WT-CPT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Word game training plus Cognitive Processing Therapy for PTSD</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Computerized executive function training plus CPT (CEFT-CPT)</intervention_name>
    <description>Participants randomized to the CEFT-CPT arm will receive 6 weeks of computerized executive function training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)</description>
    <arm_group_label>CEFT-CPT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Word game training plus CPT (WT-CPT)</intervention_name>
    <description>Participants randomized to the WT-CPT arm will receive 6 weeks of computerized word game training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)</description>
    <arm_group_label>WT-CPT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans enrolled at&#xD;
             Veterans Affairs San Diego Healthcare System (VASDHS)&#xD;
&#xD;
          -  aged 18-55&#xD;
&#xD;
          -  current posttraumatic stress disorder (PTSD) diagnosis&#xD;
&#xD;
          -  endorsement of cognitive complaints&#xD;
&#xD;
          -  no pending medication changes&#xD;
&#xD;
          -  English-speaking.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  active substance use disorder in the last month&#xD;
&#xD;
          -  suicidal intent or attempt within the last month&#xD;
&#xD;
          -  schizophrenia, psychotic disorder and/or bipolar disorder&#xD;
&#xD;
          -  dementia&#xD;
&#xD;
          -  premorbid IQ &lt; 70&#xD;
&#xD;
          -  participation in other concurrent PTSD intervention studies&#xD;
&#xD;
          -  previous completion of more than 4 Cognitive Processing Therapy (CPT) sessions&#xD;
&#xD;
          -  history of a documented neurological disorder (e.g., Parkinson's disease, multiple&#xD;
             sclerosis, epilepsy)&#xD;
&#xD;
          -  moderate to severe traumatic brain injury (TBI) (i.e., loss of consciousness greater&#xD;
             than 30 minutes or post-traumatic amnesia greater than 24 hours).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura D. Crocker, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA San Diego Healthcare System, San Diego, CA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA San Diego Healthcare System, San Diego, CA</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92161</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>November 1, 2022</last_update_submitted>
  <last_update_submitted_qc>November 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PTSD</keyword>
  <keyword>treatment</keyword>
  <keyword>posttraumatic stress disorder</keyword>
  <keyword>therapy</keyword>
  <keyword>cognition</keyword>
  <keyword>thinking</keyword>
  <keyword>executive function</keyword>
  <keyword>computer</keyword>
  <keyword>training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>A de-identified, anonymized dataset will be created and shared. Requests for access must be made in writing signed by a requestor from the United States and include an email address for delivery and an assurance that the recipient will not attempt to identify or re-identify any individual. The request should reference the publication underlying the request. Requests may be made to the Principal Investigator/lead point-of-contact for the publication. If the investigator leaves the VA San Diego Healthcare System, the requests may be sent to the Associate Chief of Staff for Research.</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/NCT03260127
org study id: F2459-W
secondary id: IK2RX002459
nct id: NCT03260127
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study focuses on helping Iraq and Afghanistan Veterans with posttraumatic stress
      disorder (PTSD) benefit fully from therapy by first enhancing their thinking abilities. PTSD
      has been associated with thinking problems, including difficulty planning/organizing,
      thinking flexibly, and inhibiting distracting emotional information. There is some evidence
      that computerized training programs are helpful for improving thinking. Therefore, this study
      tests whether computerized cognitive training will in fact improve individuals' thinking
      abilities and if this will in turn improve PTSD treatment outcomes and lead to more
      individuals completing treatment and showing greater improvements in emotional symptoms and
      quality of life than standard therapy (when paired with a word training condition).
PTSD affects approximately 14% of OEF/OIF Veterans and leads to considerable personal and
      societal costs (e.g., increased morbidity, reduced work productivity, poorer relationships).
      Although cognitive behavioral therapy (CBT) is one of the most effective treatments for PTSD,
      a substantial portion (approximately 50%) of individuals drop out prematurely, do not respond
      to treatment, or relapse.

      Treatment engagement is worse for OEF/OIF Veterans, who attend fewer sessions and have higher
      dropout rates than civilians and Veterans from other eras. One likely barrier to treatment
      engagement and effectiveness is the executive functioning problems present in individuals
      with PTSD. Executive functions (EFs) are the set of higher-level cognitive skills that
      organize and integrate lower-level cognitive processes in order to perform complex,
      goal-directed tasks. PTSD has been associated with EF deficits, including impairments in
      inhibitory control, working memory, and cognitive flexibly, as well as dysfunction in a
      network of brain regions that support EFs (e.g., prefrontal cortex [PFC], cingulate).

      EFs are essential for CBT in order to engage the cognitive skills involved in treatment
      (e.g., self-monitoring, inhibiting distorted thoughts, and flexibly generating/evaluating
      alternative thoughts). This is particularly true for Cognitive Processing Therapy (CPT), a
      frontline CBT treatment for PTSD, which involves identifying and challenging maladaptive
      trauma-related thoughts to alter their impact on emotions and behavior. Thus, EF deficits may
      lead to reduced CPT engagement and responsivity. In fact, worse EF at baseline has been
      associated with poorer response to CBT in several disorders (e.g., generalized anxiety
      disorder, obsessive compulsive disorder, and schizophrenia). Further, a study of brain
      functioning during an EF task demonstrated that dysfunction in EF-related brain regions
      including PFC and cingulate cortex at baseline predicted nonresponse to CBT for PTSD.
      Directly targeting EF prior to CPT via cognitive training would strengthen executive networks
      and likely boost treatment effectiveness, allowing Veterans to fully engage in and benefit
      more from components of CPT (e.g., cognitive restructuring). Evidence suggests that
      computerized cognitive training improves EF and functioning in EF-related brain regions,
      increases mental health treatment completion rates, and goal of the proposed study is to
      examine whether administering computerized EF training (CEFT) immediately prior to CPT will
      improve executive functioning and enhance treatment adherence, completion rates, and
      psychological and functional outcomes in OEF/OIF Veterans with PTSD.

      Objective (neuropsychological) and subjective (self- report) measures of EF will be collected
      to determine if CEFT enhances EF and if this in turn mediates the relationship between
      treatment condition and PTSD symptom improvement. Functional neuroimaging during EF tasks
      will also be collected at baseline to determine whether functioning within an EF network
      predicts treatment response, above and beyond traditional paper-and-pencil measures of EF.
      Veterans will be randomized to either 12 weeks of CEFT-CPT or a placebo word training
      condition plus CPT.

      Assessments will be administered at baseline, immediately after CEFT or word training (prior
      to CPT), and after CPT completion. The proposed research aims to reduce barriers to treatment
      engagement and has potential to significantly enhance current treatments for PTSD by
      combining cognitive and psychotherapeutic approaches. Targeting EF directly and independently
      represents a logical, innovative, and empirically-informed method for augmenting existing
      treatments for PTSD in order to optimize outcomes. Findings from the proposed study will not
      only directly inform clinical practice, but also have the potential to significantly improve
      the quality of Veterans' lives, reduce societal costs and burden, improve access to care, and
      reveal ways to better match individuals with treatments they are most likely to benefit from.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Wisconsin Card Sorting Test (WCST)
time frame: change from baseline to completion of computerized cognitive training (6 weeks)
description: WCST is a neuropsychological measure of executive functioning, will be examined separately as well as in a composite with the other neuropsychological measures of executive functioning
measure: Paced Auditory Serial Addition Test (PASAT)
time frame: change from baseline to completion of computerized cognitive training (6 weeks)
description: PASAT is a neuropsychological measure of executive functioning, will be examined separately as well as in a composite with the other neuropsychological measures of executive functioning
measure: Delis Kaplan Executive Function System (D-KEFS)
time frame: change from baseline to completion of computerized cognitive training (6 weeks)
description: D-KEFS is a neuropsychological measure of executive functioning, will be examined separately as well as in a composite with the other neuropsychological measures of executive functioning
measure: Behavior Rating Inventory of Executive Function (BRIEF)
time frame: change in subjective executive functioning from baseline to completion of computerized cognitive training (6 weeks)
description: BRIEF is a self-report measure of executive functioning, items are summed to create a total score
measure: WAIS-IV Digit Span Sequencing subtest
time frame: change from baseline to completion of computerized cognitive training (6 weeks)
description: WAIS-IV Digit Span Sequencing subtest is a neuropsychological measure of executive functioning, will be examined separately as well as in a composite with the other neuropsychological measures of executive functioning
measure: N-Back Task Performance
time frame: change from baseline to completion of computerized cognitive training (6 weeks)
description: N-Back is a task that tests executive functioning
measure: Go/No-Go Task Performance
time frame: change from baseline to completion of computerized cognitive training (6 weeks)
description: Go/No-Go is a task that tests executive functioning
measure: Clinician-Administered PTSD Scale for DSM 5 (CAPS-5)
time frame: change in PTSD symptoms from baseline to completion of Cognitive Processing Therapy (12 sessions completed after cognitive training), approximately 12 weeks after baseline assessment
description: CAPS-5 is a clinical interview assessing PTSD symptoms that will be administered at 3 time points: baseline, after completion of cognitive training, and after completion of Cognitive Processing Therapy
measure: PTSD Checklist for DSM-5 (PCL-5)
time frame: change in PTSD symptoms from baseline to completion of Cognitive Processing Therapy (12 sessions completed after cognitive training), approximately 12 weeks after baseline assessment
description: PCL-5 is a self-report questionnaire that will be administered at 15 time points: at baseline, after completion of cognitive training, at each of the 12 therapy sessions, and after completion of Cognitive Processing Therapy
measure: World Health Organization Quality of Life - BREF
time frame: change in quality of life from baseline to completion of Cognitive Processing Therapy (12 sessions completed after cognitive training), approximately 12 weeks after baseline assessment
description: WHOQOL-BREF is a self-report questionnaire assessing quality of life that will be administered at 3 time points: baseline, after completion of cognitive training, and after completion of Cognitive Processing Therapy. Four subscales are computed (range 4-20): physical health, psychological, social relationships, and environment, higher scores indicate higher quality of life in each domain.
measure: Time (in minutes) spent completing Cognitive Processing Therapy homework
time frame: time (in minutes) spent completing homework from CPT session 1 to CPT session 12 (across approximately 6 weeks, weeks 7-12 after baseline)
description: At each of the CPT sessions, participants will report how much time they spent completing homework since the previous session
measure: Number of CPT sessions completed
time frame: CPT sessions completed (out of a possible 12) after completing the cognitive training (across approximately 6 weeks, weeks 7-12 after baseline)
description: Number of CPT sessions completed out of a possible total of 12 sessions
arm group label: CEFT-CPT
arm group type: Experimental
description: Computerized executive function training plus Cognitive Processing Therapy for PTSD
arm group label: WT-CPT
arm group type: Active Comparator
description: Word game training plus Cognitive Processing Therapy for PTSD
intervention type: Behavioral
intervention name: Computerized executive function training plus CPT (CEFT-CPT)
description: Participants randomized to the CEFT-CPT arm will receive 6 weeks of computerized executive function training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)
arm group label: CEFT-CPT
intervention type: Behavioral
intervention name: Word game training plus CPT (WT-CPT)
description: Participants randomized to the WT-CPT arm will receive 6 weeks of computerized word game training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)
arm group label: WT-CPT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Laura D. Crocker, PhD
role: Principal Investigator
affiliation: VA San Diego Healthcare System, San Diego, CA
facility: 
country: United States
responsible party type: Sponsor
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: Yes
ipd description: A de-identified, anonymized dataset will be created and shared. Requests for access must be made in writing signed by a requestor from the United States and include an email address for delivery and an assurance that the recipient will not attempt to identify or re-identify any individual. The request should reference the publication underlying the request. Requests may be made to the Principal Investigator/lead point-of-contact for the publication. If the investigator leaves the VA San Diego Healthcare System, the requests may be sent to the Associate Chief of Staff for Research.