<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/NCT03808727</url>
  </required_header>
  <id_info>
    <org_study_id>W81XWH-17-2-0067</org_study_id>
    <nct_id>NCT03808727</nct_id>
  </id_info>
  <brief_title>Massed Cognitive Processing Therapy for Combat-related PTSD</brief_title>
  <official_title>Massed Cognitive Processing Therapy for Combat-related PTSD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Boston Healthcare System</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fort Belvoir Community Hospital</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>The University of Texas Health Science Center at San Antonio</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>VA Boston Healthcare System</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>
      The purpose of this study is to determine if cognitive processing therapy (CPT) delivered in&#xD;
      a massed format (MCPT) is as effective as standard delivery of CPT. MCPT will be delivered in&#xD;
      an intensive outpatient setting (12 sessions in 5 days) composed of both group and individual&#xD;
      sessions. Standard delivery of CPT consists of 12 sessions over 6 weeks and involves only&#xD;
      individual sessions. Assessment of PTSD and related symptoms will be conducted at&#xD;
      pre-treatment and 1 month and 4 months following treatment in both conditions. Additionally,&#xD;
      in order to compare the treatment groups at the same point in actual time, each group will be&#xD;
      assessed at the one month posttreatment time point for the other condition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cognitive Processing Therapy (CPT) is identified as one of the most effective treatments for&#xD;
      posttraumatic stress disorder (PTSD) in a wide range of trauma populations, with a higher&#xD;
      effect size than any other evidence-based treatments for PTSD. However, CPT has been shown to&#xD;
      be somewhat less effective in active duty and veteran populations when compared to civilian&#xD;
      trauma victims. One reason may be that service members have difficulty committing to a&#xD;
      six-week course of therapy due to the demanding nature of active duty military operations&#xD;
      schedules. In addition, limited availability of clinical providers may reduce access to care.&#xD;
      One way to address these barriers may be to administer CPT in an intensive, 5-day format.&#xD;
      This format may increase rates of treatment completion and produce faster symptom improvement&#xD;
      than the standard administration of CPT. This study will test the efficacy of massed CPT&#xD;
      (MCPT) compared to standard CPT delivery. MCPT will be delivered in an intensive outpatient&#xD;
      setting (12 sessions in 5 days) composed of both group and individual sessions. Standard&#xD;
      delivery of CPT consists of 12 sessions over 6 weeks and involves only individual sessions.&#xD;
&#xD;
      The sample includes 140 active duty service members randomized to receive either MCPT or&#xD;
      standard CPT. Participants will be assessed 4 times during the course of the study. In order&#xD;
      to test the equivalence of the treatment conditions, outcomes will be compared at a&#xD;
      consistent number of weeks posttreatment for each condition (e.g., at baseline, and one month&#xD;
      and 4 months following the conclusion of the therapy). Additionally, in order to compare the&#xD;
      treatment groups at the same point in actual time, each group will be assessed at the one&#xD;
      month posttreatment time point for the other condition. The timing of these assessment&#xD;
      intervals allows for the comparison groups to be assessed similarly at each important&#xD;
      juncture of therapy (baseline and post-treatment) and also to be assessed for maintenance of&#xD;
      treatment gains following a similar passage of time (4 months post-treatment). Those who drop&#xD;
      out of treatment will be asked to return for the follow-up assessments based on their&#xD;
      projected end date for inclusion in the intent to treat analyses.&#xD;
&#xD;
      Aim 1: To evaluate the efficacy of massed CPT in a sample of active duty military in&#xD;
      reductions of clinician-rated and self-reported PTSD symptoms, as well as secondary outcomes&#xD;
      including depression, psychosocial functioning, and physical health after treatment&#xD;
      completion (assessed at one month and 4 months posttreatment for each condition). Rates of&#xD;
      treatment completion and speed of recovery will also be compared between conditions.&#xD;
&#xD;
      Aim 2: To examine predictors of symptom reduction in each treatment condition including&#xD;
      demographic characteristics, military factors, psychosocial variables, and comorbid mental&#xD;
      health symptoms.&#xD;
&#xD;
      Aim 3 (Exploratory): To evaluate the tolerability of massed versus standard administration of&#xD;
      CPT. Important nonspecific factors such as therapeutic alliance, patient preference,&#xD;
      treatment expectancy, perceived burden, and emotional factors such as anxiety and avoidance&#xD;
      will be examined with regard to treatment outcome.&#xD;
&#xD;
      To test the hypotheses regarding noninferiority of the MCPT treatment condition relative to&#xD;
      CPT, 95% conﬁdence interval (CI) on the difference in CAPS scores (and other measures)&#xD;
      between conditions will be constructed for each measurement period. MCPT will be deemed&#xD;
      noninferior to CPT, thus supporting hypotheses 1 and 2 if the upper limit of the CI is less&#xD;
      than 10 for CAPS - the a priori specified noninferiority margin.&#xD;
&#xD;
      To examine differences in treatment completion between conditions, frequencies (and&#xD;
      proportions) in a chi-square test of independence will be used. That is, if 70 participants&#xD;
      begin the study in each condition, the proportion that drops out prior to completion of&#xD;
      treatment is expected to be significantly less in the MCPT condition. To examine speed of&#xD;
      recovery, scores on outcomes at 5 weeks from baseline (one month post treatment for MCPT,&#xD;
      mid-treatment for CPT) will be compared via an a priori specified t-test.&#xD;
&#xD;
      In addition, a multilevel approach to analyzing longitudinal data 95 using the Linear and&#xD;
      Nonlinear Mixed Effects Models package from 96 will be utilized for further tests and&#xD;
      exploration of changes in measures of PTSD and secondary outcomes. Multilevel modeling is&#xD;
      ideal for studies which employ repeated measurements nested within individuals such as is the&#xD;
      case in this design. To examine individual predictors of symptom reduction (Aim 2), the four&#xD;
      measurement occasions will be leveraged to assess both group and individual differences in&#xD;
      trajectories for each of the study outcomes. Individual difference variables will be added to&#xD;
      the models as moderators of condition and time (i.e., to what extent do change patterns vary&#xD;
      by these individual variables?). For Aim 3, a similar strategy will be used but leveraging&#xD;
      the nonspecific factors as the outcomes and session as the time variable. Thus, the extent to&#xD;
      which nonspecific factors change as a function of treatment condition over the sessions will&#xD;
      be examined.&#xD;
&#xD;
      Lastly, an additional one-year follow-up assessment was added as an exploratory aim to&#xD;
      examine longer-term outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 5, 2019</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">May 13, 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5)</measure>
    <time_frame>Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition)</time_frame>
    <description>The CAPS is a semi-structured interview to assess presence and severity of PTSD symptoms. The total score on the CAPS will be used as the primary outcome measure in this study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)</measure>
    <time_frame>Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition) and weekly or daily during treatment</time_frame>
    <description>The PCL-5 is a 20-item self-report measure based upon the Diagnostic and Statistical Manual (DSM-5) criteria for PTSD</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)</measure>
    <time_frame>Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition) and weekly or daily during treatment</time_frame>
    <description>The PHQ-9 is a widely used and well-validated instrument for measuring the severity of depressive symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in suicidality as measured by the Depressive Symptom Index - Suicidality Subscale (DSI-SS)</measure>
    <time_frame>Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition) and weekly or daily during treatment</time_frame>
    <description>The DSI-SS is a 4-item self-report measure of suicidal ideation that focuses on ideation, plans, perceived control over ideation, and impulses for suicide.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in functioning as measured by the Well-Being Inventory (WBI)</measure>
    <time_frame>Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition)</time_frame>
    <description>The WBI provides a multidimensional assessment of status, functioning, and satisfaction in the four key life domains of vocation, finances, health, and social relationships.This study will only include the subscales measuring functioning and satisfaction in the domains of work, health, and social relationships.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in alcohol use as measured by the Alcohol Use Disorders Identification Test (AUDIT)</measure>
    <time_frame>Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition)</time_frame>
    <description>The AUDIT is a 10-item screening measure, developed by the World Health Organization (WHO), with three subscales (alcohol consumption, drinking behavior, and alcohol-related problems)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in anger as measured by the Dimensions of Anger Reactions-5 (DAR-5)</measure>
    <time_frame>Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition)</time_frame>
    <description>The DAR-5 63 is a short form version of the original Dimensions of Anger Reactions. 64 It addresses anger frequency, intensity, duration, aggression, and interference with social functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in health functioning as measured by the Veterans Rand 12-Item Health Survey (VR-12)</measure>
    <time_frame>Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition)</time_frame>
    <description>The Veterans VR-12 was developed from the Veterans VR-36 and adapted from the Short Form -36 (SF-36), and spans the range of health domains from physical to psychological health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in somatic symptoms as measured by the Patient Health Questionnaire - 15 (PHQ-15)</measure>
    <time_frame>Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition)</time_frame>
    <description>The PHQ-15 70 is an abbreviated version of the original PHQ that asks about somatic symptoms and symptom clusters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sleep disturbance as measured by the Insomnia Severity Index (ISI)</measure>
    <time_frame>Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition)</time_frame>
    <description>The ISI is a 7-item self-report measure that assesses perceived severity of insomnia.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>PTSD, Post Traumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>Massed Cognitive Processing Therapy (MCPT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitive Processing Therapy is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT is a 12-session manualized program that focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. MCPT will be delivered in an intensive outpatient setting (12 sessions in 5 days) composed of both group and individual sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Cognitive Processing Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cognitive Processing Therapy is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT is a 12-session manualized program that focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. Standard CPT will be delivered in 12 one-hour sessions over 6 weeks and involves only individual sessions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Processing Therapy</intervention_name>
    <description>Cognitive Processing Therapy is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT is a 12-session manualized program that focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world.</description>
    <arm_group_label>Massed Cognitive Processing Therapy (MCPT)</arm_group_label>
    <arm_group_label>Standard Cognitive Processing Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult male or female (age 18+) active duty military seeking treatment for PTSD&#xD;
&#xD;
          -  Diagnosis of PTSD determined by a clinician-administered Posttraumatic Stress Scale&#xD;
             (CAPS-5)&#xD;
&#xD;
          -  Speak and read English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current suicide or homicide risk meriting crisis intervention&#xD;
&#xD;
          -  Active psychosis&#xD;
&#xD;
          -  Moderate to severe brain damage (as determined by the inability to comprehend the&#xD;
             baseline screening questionnaires)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer Wachen, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Boston Healthcare System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fort Belvoir Community Hospital</name>
      <address>
        <city>Fort Belvoir</city>
        <state>Virginia</state>
        <zip>22060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>May 4, 2023</last_update_submitted>
  <last_update_submitted_qc>May 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>VA Boston Healthcare System</investigator_affiliation>
    <investigator_full_name>Jennifer Schuster Wachen, Ph.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>cognitive processing therapy</keyword>
  <keyword>CPT</keyword>
  <keyword>PTSD</keyword>
  <keyword>military</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>
  <!-- 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/NCT03808727
org study id: W81XWH-17-2-0067
nct id: NCT03808727
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine if cognitive processing therapy (CPT) delivered in
      a massed format (MCPT) is as effective as standard delivery of CPT. MCPT will be delivered in
      an intensive outpatient setting (12 sessions in 5 days) composed of both group and individual
      sessions. Standard delivery of CPT consists of 12 sessions over 6 weeks and involves only
      individual sessions. Assessment of PTSD and related symptoms will be conducted at
      pre-treatment and 1 month and 4 months following treatment in both conditions. Additionally,
      in order to compare the treatment groups at the same point in actual time, each group will be
      assessed at the one month posttreatment time point for the other condition.
Cognitive Processing Therapy (CPT) is identified as one of the most effective treatments for
      posttraumatic stress disorder (PTSD) in a wide range of trauma populations, with a higher
      effect size than any other evidence-based treatments for PTSD. However, CPT has been shown to
      be somewhat less effective in active duty and veteran populations when compared to civilian
      trauma victims. One reason may be that service members have difficulty committing to a
      six-week course of therapy due to the demanding nature of active duty military operations
      schedules. In addition, limited availability of clinical providers may reduce access to care.
      One way to address these barriers may be to administer CPT in an intensive, 5-day format.
      This format may increase rates of treatment completion and produce faster symptom improvement
      than the standard administration of CPT. This study will test the efficacy of massed CPT
      (MCPT) compared to standard CPT delivery. MCPT will be delivered in an intensive outpatient
      setting (12 sessions in 5 days) composed of both group and individual sessions. Standard
      delivery of CPT consists of 12 sessions over 6 weeks and involves only individual sessions.

      The sample includes 140 active duty service members randomized to receive either MCPT or
      standard CPT. Participants will be assessed 4 times during the course of the study. In order
      to test the equivalence of the treatment conditions, outcomes will be compared at a
      consistent number of weeks posttreatment for each condition (e.g., at baseline, and one month
      and 4 months following the conclusion of the therapy). Additionally, in order to compare the
      treatment groups at the same point in actual time, each group will be assessed at the one
      month posttreatment time point for the other condition. The timing of these assessment
      intervals allows for the comparison groups to be assessed similarly at each important
      juncture of therapy (baseline and post-treatment) and also to be assessed for maintenance of
      treatment gains following a similar passage of time (4 months post-treatment). Those who drop
      out of treatment will be asked to return for the follow-up assessments based on their
      projected end date for inclusion in the intent to treat analyses.

      Aim 1: To evaluate the efficacy of massed CPT in a sample of active duty military in
      reductions of clinician-rated and self-reported PTSD symptoms, as well as secondary outcomes
      including depression, psychosocial functioning, and physical health after treatment
      completion (assessed at one month and 4 months posttreatment for each condition). Rates of
      treatment completion and speed of recovery will also be compared between conditions.

      Aim 2: To examine predictors of symptom reduction in each treatment condition including
      demographic characteristics, military factors, psychosocial variables, and comorbid mental
      health symptoms.

      Aim 3 (Exploratory): To evaluate the tolerability of massed versus standard administration of
      CPT. Important nonspecific factors such as therapeutic alliance, patient preference,
      treatment expectancy, perceived burden, and emotional factors such as anxiety and avoidance
      will be examined with regard to treatment outcome.

      To test the hypotheses regarding noninferiority of the MCPT treatment condition relative to
      CPT, 95% conﬁdence interval (CI) on the difference in CAPS scores (and other measures)
      between conditions will be constructed for each measurement period. MCPT will be deemed
      noninferior to CPT, thus supporting hypotheses 1 and 2 if the upper limit of the CI is less
      than 10 for CAPS - the a priori specified noninferiority margin.

      To examine differences in treatment completion between conditions, frequencies (and
      proportions) in a chi-square test of independence will be used. That is, if 70 participants
      begin the study in each condition, the proportion that drops out prior to completion of
      treatment is expected to be significantly less in the MCPT condition. To examine speed of
      recovery, scores on outcomes at 5 weeks from baseline (one month post treatment for MCPT,
      mid-treatment for CPT) will be compared via an a priori specified t-test.

      In addition, a multilevel approach to analyzing longitudinal data 95 using the Linear and
      Nonlinear Mixed Effects Models package from 96 will be utilized for further tests and
      exploration of changes in measures of PTSD and secondary outcomes. Multilevel modeling is
      ideal for studies which employ repeated measurements nested within individuals such as is the
      case in this design. To examine individual predictors of symptom reduction (Aim 2), the four
      measurement occasions will be leveraged to assess both group and individual differences in
      trajectories for each of the study outcomes. Individual difference variables will be added to
      the models as moderators of condition and time (i.e., to what extent do change patterns vary
      by these individual variables?). For Aim 3, a similar strategy will be used but leveraging
      the nonspecific factors as the outcomes and session as the time variable. Thus, the extent to
      which nonspecific factors change as a function of treatment condition over the sessions will
      be examined.

      Lastly, an additional one-year follow-up assessment was added as an exploratory aim to
      examine longer-term outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5)
time frame: Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition)
description: The CAPS is a semi-structured interview to assess presence and severity of PTSD symptoms. The total score on the CAPS will be used as the primary outcome measure in this study.
measure: Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)
time frame: Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition) and weekly or daily during treatment
description: The PCL-5 is a 20-item self-report measure based upon the Diagnostic and Statistical Manual (DSM-5) criteria for PTSD
measure: Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
time frame: Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition) and weekly or daily during treatment
description: The PHQ-9 is a widely used and well-validated instrument for measuring the severity of depressive symptoms
measure: Change in suicidality as measured by the Depressive Symptom Index - Suicidality Subscale (DSI-SS)
time frame: Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition) and weekly or daily during treatment
description: The DSI-SS is a 4-item self-report measure of suicidal ideation that focuses on ideation, plans, perceived control over ideation, and impulses for suicide.
measure: Changes in functioning as measured by the Well-Being Inventory (WBI)
time frame: Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition)
description: The WBI provides a multidimensional assessment of status, functioning, and satisfaction in the four key life domains of vocation, finances, health, and social relationships.This study will only include the subscales measuring functioning and satisfaction in the domains of work, health, and social relationships.
measure: Changes in alcohol use as measured by the Alcohol Use Disorders Identification Test (AUDIT)
time frame: Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition)
description: The AUDIT is a 10-item screening measure, developed by the World Health Organization (WHO), with three subscales (alcohol consumption, drinking behavior, and alcohol-related problems)
measure: Changes in anger as measured by the Dimensions of Anger Reactions-5 (DAR-5)
time frame: Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition)
description: The DAR-5 63 is a short form version of the original Dimensions of Anger Reactions. 64 It addresses anger frequency, intensity, duration, aggression, and interference with social functioning.
measure: Changes in health functioning as measured by the Veterans Rand 12-Item Health Survey (VR-12)
time frame: Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition)
description: The Veterans VR-12 was developed from the Veterans VR-36 and adapted from the Short Form -36 (SF-36), and spans the range of health domains from physical to psychological health status.
measure: Change in somatic symptoms as measured by the Patient Health Questionnaire - 15 (PHQ-15)
time frame: Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition)
description: The PHQ-15 70 is an abbreviated version of the original PHQ that asks about somatic symptoms and symptom clusters
measure: Change in sleep disturbance as measured by the Insomnia Severity Index (ISI)
time frame: Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition)
description: The ISI is a 7-item self-report measure that assesses perceived severity of insomnia.
arm group label: Massed Cognitive Processing Therapy (MCPT)
arm group type: Experimental
description: Cognitive Processing Therapy is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT is a 12-session manualized program that focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. MCPT will be delivered in an intensive outpatient setting (12 sessions in 5 days) composed of both group and individual sessions.
arm group label: Standard Cognitive Processing Therapy
arm group type: Active Comparator
description: Cognitive Processing Therapy is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT is a 12-session manualized program that focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. Standard CPT will be delivered in 12 one-hour sessions over 6 weeks and involves only individual sessions.
intervention type: Behavioral
intervention name: Cognitive Processing Therapy
description: Cognitive Processing Therapy is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT is a 12-session manualized program that focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world.
arm group label: Massed Cognitive Processing Therapy (MCPT)
arm group label: Standard Cognitive Processing Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jennifer Wachen, Ph.D.
role: Principal Investigator
affiliation: VA Boston Healthcare System
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: VA Boston Healthcare System
investigator full name: Jennifer Schuster Wachen, Ph.D.
investigator title: Principal Investigator
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic