<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/NCT03764033</url>
  </required_header>
  <id_info>
    <org_study_id>D2946-R</org_study_id>
    <nct_id>NCT03764033</nct_id>
  </id_info>
  <brief_title>A Novel Posttraumatic Stress Disorder Treatment for Veterans With Moral Injury</brief_title>
  <acronym>IOK</acronym>
  <official_title>A Novel Posttraumatic Stress Disorder Treatment for Veterans With Moral Injury</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>No</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>
      The objective of this project is to test the efficacy of an individual treatment for&#xD;
      post-traumatic stress disorder (PTSD) stemming from moral injury called Impact of Killing&#xD;
      (IOK), compared to a present-centered therapy (PCT) control condition, and to determine the&#xD;
      rehabilitative utility of IOK for Veterans with PTSD. The first aim is to test whether IOK&#xD;
      can help improve psychosocial functioning for Veterans, as well as PTSD symptoms. The second&#xD;
      aim is to determine whether IOK gains made by Veterans in treatment are durable, as measured&#xD;
      by a six-month follow-up assessment. Veterans who kill in war are at increased risk for&#xD;
      functional difficulties, PTSD, alcohol abuse, and suicide. Even after current PTSD&#xD;
      psychotherapies, most Veterans continue to meet diagnostic criteria for PTSD, highlighting&#xD;
      the need for expanding treatments for PTSD and functioning. IOK is a treatment that can be&#xD;
      provided following existing PTSD treatments, filling a critical gap for Veterans with moral&#xD;
      injury who continue to suffer from mental health symptoms and functional difficulties.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Post-traumatic stress disorder (PTSD) is now the most common mental health diagnosis among&#xD;
      the youngest generation of Veterans receiving treatment from the Veterans Health&#xD;
      Administration (VHA), necessitating the need for diverse types of targeted care. Although&#xD;
      there are two evidence-based psychotherapies (EBP) for PTSD, the vast majority of combat&#xD;
      Veterans who receive these treatments still meet diagnostic criteria for PTSD and their&#xD;
      functioning continues to be impacted. Furthermore, Veterans that have experienced trauma&#xD;
      related to killing have high rates of suicide and more severe PTSD symptoms. Although there&#xD;
      have been few studies examining predictors of poor outcomes in EBPs, one area that has&#xD;
      recently begun to receive growing attention is moral injury. A recent study found that PTSD&#xD;
      and moral injury were distinct constructs with unique signs and symptoms, and preliminary&#xD;
      evidence indicates that the feelings of guilt and anger that characterize moral injury&#xD;
      associated with trauma such as killing in war may contribute to worsening symptoms over the&#xD;
      course of existing treatments. Although PTSD may be one manifestation of psychological trauma&#xD;
      related to killing, conceptualization of the impact of killing requires a broader framework.&#xD;
      The emerging concept of moral injury offers an alternative context to better understand the&#xD;
      many possible outcomes of exposure to killing. For these reasons, the development of targeted&#xD;
      moral injury interventions is critical. The investigators designed and received VA funding to&#xD;
      conduct a pilot randomized controlled trial (RCT) of the Impact of Killing (IOK) treatment,&#xD;
      which can be seamlessly added as a standalone treatment following existing EBPs for PTSD. IOK&#xD;
      focuses on key themes including physiology of killing responses, moral injury,&#xD;
      self-forgiveness, and improved post-deployment reintegration. The treatment was designed to&#xD;
      fit well into already existing systems of care and has been shown to improve functioning,&#xD;
      PTSD symptoms, and general psychiatric symptoms following EBP. Whereas the IOK RCT pilot was&#xD;
      initially conducted at the San Francisco VA Healthcare System, the investigators' goal is to&#xD;
      conduct a fully-powered, multi-site efficacy trial at two regionally-diverse sites with a&#xD;
      larger sample size and active control condition. Consequently, the objective of this project&#xD;
      is to test the efficacy of an individual treatment for PTSD stemming from moral injury called&#xD;
      IOK, compared to a present-centered therapy (PCT) control condition, and to determine the&#xD;
      rehabilitative utility of IOK for Veterans seeking treatment for PTSD. The primary outcome is&#xD;
      psychosocial functioning. The target population is Veterans who have initiated or completed&#xD;
      Cognitive Processing Therapy or Prolonged Exposure Therapy, two EBPs for PTSD, and continue&#xD;
      to have PTSD symptoms and moral injury related to killing. Veterans will be randomly assigned&#xD;
      to receive either: 1) IOK (10 individual therapy sessions lasting 60-90 minutes) or 2) PCT&#xD;
      (sessions of equal duration to IOK). The first aim is to test the efficacy of IOK through&#xD;
      measures of psychosocial functioning (primary outcome) and PTSD severity (secondary outcome).&#xD;
      The second aim is to determine whether IOK gains made by Veterans are durable. Given that&#xD;
      moral injury treatment is a new and burgeoning area, the investigators have two exploratory&#xD;
      aims that can help move the field forward. The first exploratory aim is to conduct&#xD;
      post-treatment evaluations with a subset of the IOK treatment group to better understand how&#xD;
      to support continued improvement in functioning among participants. The second exploratory&#xD;
      aim is to evaluate mediators of functional improvement, such as self-forgiveness, among&#xD;
      Veterans completing IOK. If the aims of this grant are achieved, the investigators will be&#xD;
      able to have a moral injury intervention following EBP that can be seamlessly integrated into&#xD;
      existing care for one of the most commonly occurring mental health problems in Veterans.&#xD;
      Furthermore, suicide is a national priority for VHA, and expanding treatment for PTSD and&#xD;
      moral injury has the potential to decrease suicide and improve functioning in Veterans.&#xD;
      Finally, IOK offers skills and ways of understanding warzone experiences that can be mastered&#xD;
      and can continue to be implemented by Veterans over time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 12, 2019</start_date>
  <completion_date type="Anticipated">March 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 29, 2024</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>
    <intervention_model_description>The investigators propose to conduct a multi-site, randomized, controlled trial to test the efficacy of an individual treatment for PTSD stemming from moral injury called IOK, compared to a present-centered therapy (PCT) control condition.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The clinical evaluators will be kept blind to treatment condition throughout the study period.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>World Health Organization Quality of Life-BREF</measure>
    <time_frame>Change from baseline (Week 1) and mid-treatment (Week 5)</time_frame>
    <description>A widely-validated, 26-item measure on a 5 point scale that assesses functioning in physical health, psychological health, social relationships, and environment, with higher scores indicating greater health in each domain. Each item is scored from 1-5, comprising 4 domains. The domain scores are not averages, they are the sum total score for each question within the domain. Scores range from 4-20 with lower scores representing lower quality of life.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>World Health Organization Quality of Life-BREF</measure>
    <time_frame>change from Mid-treatment (Week 5) to Post-treatment (Week 10)</time_frame>
    <description>A widely-validated, 26-item measure on a 5 point scale that assesses functioning in physical health, psychological health, social relationships, and environment, with higher scores indicating greater health in each domain. Each item is scored from 1-5, comprising 4 domains. The domain scores are not averages, they are the sum total score for each question within the domain. Scores range from 4-20 with lower scores representing lower quality of life.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>World Health Organization Quality of Life-BREF</measure>
    <time_frame>change from Post-treatment (Week 10) to 6 month follow-up</time_frame>
    <description>A widely-validated, 26-item measure on a 5 point scale that assesses functioning in physical health, psychological health, social relationships, and environment, with higher scores indicating greater health in each domain. Each item is scored from 1-5, comprising 4 domains. The domain scores are not averages, they are the sum total score for each question within the domain. Scores range from 4-20 with lower scores representing lower quality of life.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinician Administered PTSD Scale for DSM-5 (CAPS-5)</measure>
    <time_frame>Change from baseline (Week 1) and post-treatment (Week 10)</time_frame>
    <description>This measure is used to identify DSM-5 criteria for PTSD. CAPS-5 provides both a dimensional and categorical measure of current PTSD and the frequency and intensity of PTSD-related symptoms. Score range from 0-80 with lower score representing fewer PTSD symptoms.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Quality of Life Inventory (QOLI)</measure>
    <time_frame>Change from baseline (Week 1) and post-treatment (Week 5)</time_frame>
    <description>A 32-item measure that assesses well-being and satisfaction with life, using a 3-point rating scale for importance, and 6-point rating scale for satisfaction. The QOLI assesses an individual's quality of life through self-report of the importance they attach to each of 16 life domains (on a 3-point rating scale) as well as their current satisfaction with each domain (on a 6-point rating scale). Importance scores are multiplied by satisfaction scores for each domain, and then these scores are summed to determine an overall current quality of life for each individual. Higher scores indicate a higher overall quality of life.</description>
  </other_outcome>
  <other_outcome>
    <measure>Trauma-related Guilt Inventory (TRGI)</measure>
    <time_frame>Change from baseline (Week 1) and post-treatment (Week 5)</time_frame>
    <description>A 32-item measure, using a 5-point Likert scale, assessing the emotional and cognitive aspects of guilt associated with a specified traumatic event (e.g., combat experience, car accident, physical or sexual abuse, or sudden death of a loved one). The TRGI has a distress factor and three cognitive factors including Hindsight-Bias/Responsibility, Wrongdoing, and Lack of Justification.</description>
  </other_outcome>
  <other_outcome>
    <measure>Trauma-related Guilt Inventory (TRGI)</measure>
    <time_frame>change from Post-treatment (Week 10) to 6 month follow-up</time_frame>
    <description>A 32-item measure, using a 5-point Likert scale, assessing the emotional and cognitive aspects of guilt associated with a specified traumatic event (e.g., combat experience, car accident, physical or sexual abuse, or sudden death of a loved one). The TRGI has a distress factor and three cognitive factors including Hindsight-Bias/Responsibility, Wrongdoing, and Lack of Justification. Score Range is 1-160 with lower scores representing lower feelings of guilt.</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of Life Inventory (QOLI)</measure>
    <time_frame>change from Mid-treatment (Week 5) to Post-treatment (Week 10)</time_frame>
    <description>A 32-item measure that assesses well-being and satisfaction with life on 16 life domains (on a 3-point rating scale) as well as their current satisfaction with each domain (on a 6-point rating scale). Importance scores are multiplied by satisfaction scores for each domain, and then these scores are summed to determine an overall current quality of life for each individual. Higher scores indicate a higher overall quality of life</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of Life Inventory (QOLI)</measure>
    <time_frame>change from Post-treatment (Week 10) to 6 month follow-up</time_frame>
    <description>A 32-item measure that assesses well-being and satisfaction with life on 16 life domains (on a 3-point rating scale) as well as their current satisfaction with each domain (on a 6-point rating scale). Importance scores are multiplied by satisfaction scores for each domain, and then these scores are summed to determine an overall current quality of life for each individual. Higher scores indicate a higher overall quality of life.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">95</enrollment>
  <condition>Moral Injury</condition>
  <arm_group>
    <arm_group_label>Impact of Killing (IOK)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Present Centered Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Impact of Killing (IOK)</intervention_name>
    <description>Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .</description>
    <arm_group_label>Impact of Killing (IOK)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Present Centered Therapy</intervention_name>
    <description>Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)</description>
    <arm_group_label>Present Centered Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Veterans 18-82 years of age&#xD;
&#xD;
          -  Veterans who meet DSM-5 criteria for Post-traumatic Stress Disorder (PTSD) or score 23&#xD;
             or higher on the CAPS screening interview.&#xD;
&#xD;
          -  Veterans who endorsed killing or being responsible for the death of another in a war&#xD;
             zone and report continued distress regarding these events&#xD;
&#xD;
               -  Distress will be operationalized by a positive response to one or more of the&#xD;
                  nine self-directed moral injury items on the Expressions of Moral Injury&#xD;
                  Scale-Military Version (EMIS-M) or item #4 on the Moral Injury Events Scale&#xD;
                  (MIES)&#xD;
&#xD;
          -  Veterans who have initiated or completed an evidence-based treatment for PTSD, such as&#xD;
             Cogni-tive Processing Therapy (CPT) or Prolonged Exposure (PE)&#xD;
&#xD;
          -  If receiving CPT or PE, Veterans must complete treatment and wait two weeks prior to&#xD;
             screening&#xD;
&#xD;
          -  If receiving prescription medication for PTSD, Veterans must be one month stable on&#xD;
             medication and not make any changes to medication during the course of the active&#xD;
             treatment phase of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Veterans with current or lifetime diagnosis of a psychotic disorder or current&#xD;
             untreated/unmanaged mania.&#xD;
&#xD;
          -  Veterans with recent suicidal or homicidal behaviors (chronic suicidal ideation is not&#xD;
             exclusionary)&#xD;
&#xD;
          -  Veterans with recent psychiatric hospitalizations&#xD;
&#xD;
          -  Veterans with moderate or severe alcohol or drug dependence within the past three&#xD;
             months&#xD;
&#xD;
          -  Veterans receiving individual therapy for PTSD or those planning to start skills-based&#xD;
             or trauma-focused group psychotherapy will be excluded&#xD;
&#xD;
               -  However, these Veterans will be offered the opportunity to be screened again&#xD;
                  after completion of individual PTSD therapy or once they are three months stable&#xD;
                  in group treatment, with no plans to discontinue this treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>82 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shira Maguen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>San Francisco VA Medical Center, San Francisco, CA</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shira Maguen, PhD</last_name>
    <phone>(415) 221-4810</phone>
    <phone_ext>2511</phone_ext>
    <email>shira.maguen@va.gov</email>
  </overall_contact>
  <location>
    <facility>
      <name>San Francisco VA Medical Center, San Francisco, CA</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94121-1563</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>James J. Peters VA Medical Center, Bronx, NY</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10468</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amy Lehrner, PhD</last_name>
      <phone>718-584-9000</phone>
      <phone_ext>3205</phone_ext>
      <email>amy.lehrner@va.gov</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Durham VA Medical Center, Durham, NC</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean Beckham, PhD</last_name>
      <phone>919-286-0411</phone>
      <phone_ext>7973</phone_ext>
      <email>jean.beckham@va.gov</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>March 3, 2023</last_update_submitted>
  <last_update_submitted_qc>March 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stress Disorders, Post-Traumatic</keyword>
  <keyword>Moral Injury</keyword>
  <keyword>Treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03764033
org study id: D2946-R
nct id: NCT03764033
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The objective of this project is to test the efficacy of an individual treatment for
      post-traumatic stress disorder (PTSD) stemming from moral injury called Impact of Killing
      (IOK), compared to a present-centered therapy (PCT) control condition, and to determine the
      rehabilitative utility of IOK for Veterans with PTSD. The first aim is to test whether IOK
      can help improve psychosocial functioning for Veterans, as well as PTSD symptoms. The second
      aim is to determine whether IOK gains made by Veterans in treatment are durable, as measured
      by a six-month follow-up assessment. Veterans who kill in war are at increased risk for
      functional difficulties, PTSD, alcohol abuse, and suicide. Even after current PTSD
      psychotherapies, most Veterans continue to meet diagnostic criteria for PTSD, highlighting
      the need for expanding treatments for PTSD and functioning. IOK is a treatment that can be
      provided following existing PTSD treatments, filling a critical gap for Veterans with moral
      injury who continue to suffer from mental health symptoms and functional difficulties.
Post-traumatic stress disorder (PTSD) is now the most common mental health diagnosis among
      the youngest generation of Veterans receiving treatment from the Veterans Health
      Administration (VHA), necessitating the need for diverse types of targeted care. Although
      there are two evidence-based psychotherapies (EBP) for PTSD, the vast majority of combat
      Veterans who receive these treatments still meet diagnostic criteria for PTSD and their
      functioning continues to be impacted. Furthermore, Veterans that have experienced trauma
      related to killing have high rates of suicide and more severe PTSD symptoms. Although there
      have been few studies examining predictors of poor outcomes in EBPs, one area that has
      recently begun to receive growing attention is moral injury. A recent study found that PTSD
      and moral injury were distinct constructs with unique signs and symptoms, and preliminary
      evidence indicates that the feelings of guilt and anger that characterize moral injury
      associated with trauma such as killing in war may contribute to worsening symptoms over the
      course of existing treatments. Although PTSD may be one manifestation of psychological trauma
      related to killing, conceptualization of the impact of killing requires a broader framework.
      The emerging concept of moral injury offers an alternative context to better understand the
      many possible outcomes of exposure to killing. For these reasons, the development of targeted
      moral injury interventions is critical. The investigators designed and received VA funding to
      conduct a pilot randomized controlled trial (RCT) of the Impact of Killing (IOK) treatment,
      which can be seamlessly added as a standalone treatment following existing EBPs for PTSD. IOK
      focuses on key themes including physiology of killing responses, moral injury,
      self-forgiveness, and improved post-deployment reintegration. The treatment was designed to
      fit well into already existing systems of care and has been shown to improve functioning,
      PTSD symptoms, and general psychiatric symptoms following EBP. Whereas the IOK RCT pilot was
      initially conducted at the San Francisco VA Healthcare System, the investigators' goal is to
      conduct a fully-powered, multi-site efficacy trial at two regionally-diverse sites with a
      larger sample size and active control condition. Consequently, the objective of this project
      is to test the efficacy of an individual treatment for PTSD stemming from moral injury called
      IOK, compared to a present-centered therapy (PCT) control condition, and to determine the
      rehabilitative utility of IOK for Veterans seeking treatment for PTSD. The primary outcome is
      psychosocial functioning. The target population is Veterans who have initiated or completed
      Cognitive Processing Therapy or Prolonged Exposure Therapy, two EBPs for PTSD, and continue
      to have PTSD symptoms and moral injury related to killing. Veterans will be randomly assigned
      to receive either: 1) IOK (10 individual therapy sessions lasting 60-90 minutes) or 2) PCT
      (sessions of equal duration to IOK). The first aim is to test the efficacy of IOK through
      measures of psychosocial functioning (primary outcome) and PTSD severity (secondary outcome).
      The second aim is to determine whether IOK gains made by Veterans are durable. Given that
      moral injury treatment is a new and burgeoning area, the investigators have two exploratory
      aims that can help move the field forward. The first exploratory aim is to conduct
      post-treatment evaluations with a subset of the IOK treatment group to better understand how
      to support continued improvement in functioning among participants. The second exploratory
      aim is to evaluate mediators of functional improvement, such as self-forgiveness, among
      Veterans completing IOK. If the aims of this grant are achieved, the investigators will be
      able to have a moral injury intervention following EBP that can be seamlessly integrated into
      existing care for one of the most commonly occurring mental health problems in Veterans.
      Furthermore, suicide is a national priority for VHA, and expanding treatment for PTSD and
      moral injury has the potential to decrease suicide and improve functioning in Veterans.
      Finally, IOK offers skills and ways of understanding warzone experiences that can be mastered
      and can continue to be implemented by Veterans over time.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The investigators propose to conduct a multi-site, randomized, controlled trial to test the efficacy of an individual treatment for PTSD stemming from moral injury called IOK, compared to a present-centered therapy (PCT) control condition.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The clinical evaluators will be kept blind to treatment condition throughout the study period.
measure: World Health Organization Quality of Life-BREF
time frame: Change from baseline (Week 1) and mid-treatment (Week 5)
description: A widely-validated, 26-item measure on a 5 point scale that assesses functioning in physical health, psychological health, social relationships, and environment, with higher scores indicating greater health in each domain. Each item is scored from 1-5, comprising 4 domains. The domain scores are not averages, they are the sum total score for each question within the domain. Scores range from 4-20 with lower scores representing lower quality of life.
measure: World Health Organization Quality of Life-BREF
time frame: change from Mid-treatment (Week 5) to Post-treatment (Week 10)
description: A widely-validated, 26-item measure on a 5 point scale that assesses functioning in physical health, psychological health, social relationships, and environment, with higher scores indicating greater health in each domain. Each item is scored from 1-5, comprising 4 domains. The domain scores are not averages, they are the sum total score for each question within the domain. Scores range from 4-20 with lower scores representing lower quality of life.
measure: World Health Organization Quality of Life-BREF
time frame: change from Post-treatment (Week 10) to 6 month follow-up
description: A widely-validated, 26-item measure on a 5 point scale that assesses functioning in physical health, psychological health, social relationships, and environment, with higher scores indicating greater health in each domain. Each item is scored from 1-5, comprising 4 domains. The domain scores are not averages, they are the sum total score for each question within the domain. Scores range from 4-20 with lower scores representing lower quality of life.
measure: Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
time frame: Change from baseline (Week 1) and post-treatment (Week 10)
description: This measure is used to identify DSM-5 criteria for PTSD. CAPS-5 provides both a dimensional and categorical measure of current PTSD and the frequency and intensity of PTSD-related symptoms. Score range from 0-80 with lower score representing fewer PTSD symptoms.
measure: Quality of Life Inventory (QOLI)
time frame: Change from baseline (Week 1) and post-treatment (Week 5)
description: A 32-item measure that assesses well-being and satisfaction with life, using a 3-point rating scale for importance, and 6-point rating scale for satisfaction. The QOLI assesses an individual's quality of life through self-report of the importance they attach to each of 16 life domains (on a 3-point rating scale) as well as their current satisfaction with each domain (on a 6-point rating scale). Importance scores are multiplied by satisfaction scores for each domain, and then these scores are summed to determine an overall current quality of life for each individual. Higher scores indicate a higher overall quality of life.
measure: Trauma-related Guilt Inventory (TRGI)
time frame: Change from baseline (Week 1) and post-treatment (Week 5)
description: A 32-item measure, using a 5-point Likert scale, assessing the emotional and cognitive aspects of guilt associated with a specified traumatic event (e.g., combat experience, car accident, physical or sexual abuse, or sudden death of a loved one). The TRGI has a distress factor and three cognitive factors including Hindsight-Bias/Responsibility, Wrongdoing, and Lack of Justification.
measure: Trauma-related Guilt Inventory (TRGI)
time frame: change from Post-treatment (Week 10) to 6 month follow-up
description: A 32-item measure, using a 5-point Likert scale, assessing the emotional and cognitive aspects of guilt associated with a specified traumatic event (e.g., combat experience, car accident, physical or sexual abuse, or sudden death of a loved one). The TRGI has a distress factor and three cognitive factors including Hindsight-Bias/Responsibility, Wrongdoing, and Lack of Justification. Score Range is 1-160 with lower scores representing lower feelings of guilt.
measure: Quality of Life Inventory (QOLI)
time frame: change from Mid-treatment (Week 5) to Post-treatment (Week 10)
description: A 32-item measure that assesses well-being and satisfaction with life on 16 life domains (on a 3-point rating scale) as well as their current satisfaction with each domain (on a 6-point rating scale). Importance scores are multiplied by satisfaction scores for each domain, and then these scores are summed to determine an overall current quality of life for each individual. Higher scores indicate a higher overall quality of life
measure: Quality of Life Inventory (QOLI)
time frame: change from Post-treatment (Week 10) to 6 month follow-up
description: A 32-item measure that assesses well-being and satisfaction with life on 16 life domains (on a 3-point rating scale) as well as their current satisfaction with each domain (on a 6-point rating scale). Importance scores are multiplied by satisfaction scores for each domain, and then these scores are summed to determine an overall current quality of life for each individual. Higher scores indicate a higher overall quality of life.
arm group label: Impact of Killing (IOK)
arm group type: Experimental
description: Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
arm group label: Present Centered Therapy
arm group type: Active Comparator
description: Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)
intervention type: Behavioral
intervention name: Impact of Killing (IOK)
description: Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
arm group label: Impact of Killing (IOK)
intervention type: Behavioral
intervention name: Present Centered Therapy
description: Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)
arm group label: Present Centered Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 82 Years
healthy volunteers: No
last name: Shira Maguen, PhD
role: Principal Investigator
affiliation: San Francisco VA Medical Center, San Francisco, CA
last name: Shira Maguen, PhD
phone: (415) 221-4810
phone ext: 2511
email: shira.maguen@va.gov
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Wounds and Injuries
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No