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A Novel Posttraumatic Stress Disorder Treatment for Veterans With Moral Injury (IOK)

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ClinicalTrials.gov Identifier: NCT03764033
Recruitment Status : Not yet recruiting
First Posted : December 4, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Moral Injury Behavioral: Impact of Killing (IOK) Behavioral: Present Centered Therapy Phase 2 Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 95 participants
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.
Masking: Single (Outcomes Assessor)
Masking Description: The clinical evaluators will be kept blind to treatment condition throughout the study period.
Primary Purpose: Treatment
Official Title: A Novel Posttraumatic Stress Disorder Treatment for Veterans With Moral Injury
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 21, 2022
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Impact of Killing (IOK)
Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
Behavioral: Impact of Killing (IOK)
Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .

Active Comparator: Present Centered Therapy
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)
Behavioral: Present Centered Therapy
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)




Primary Outcome Measures :
  1. World Health Organization Quality of Life-BREF [ Time Frame: Change from baseline (Week 1) and mid-treatment (Week 5) ]
    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.

  2. World Health Organization Quality of Life-BREF [ Time Frame: change from Mid-treatment (Week 5) to Post-treatment (Week 10) ]
    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.

  3. World Health Organization Quality of Life-BREF [ Time Frame: change from Post-treatment (Week 10) to 6 month follow-up ]
    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.


Secondary Outcome Measures :
  1. Clinician Administered PTSD Scale for DSM-5 (CAPS-5) [ Time Frame: Change from baseline (Week 1) and post-treatment (Week 10) ]
    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.


Other Outcome Measures:
  1. Quality of Life Inventory (QOLI) [ Time Frame: Change from baseline (Week 1) and mid-treatment (Week 5) ]
    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.

  2. Trauma-related Guilt Inventory (TRGI) [ Time Frame: Change from baseline (Week 1) and mid-treatment (Week 5) ]
    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.

  3. Trauma-related Guilt Inventory (TRGI) [ Time Frame: change from Mid-treatment (Week 5) to Post-treatment (Week 10) ]
    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.

  4. Trauma-related Guilt Inventory (TRGI) [ Time Frame: change from Post-treatment (Week 10) to 6 month follow-up ]
    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.

  5. Quality of Life Inventory (QOLI) [ Time Frame: change from Mid-treatment (Week 5) to Post-treatment (Week 10) ]
    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. Scores range from

  6. Quality of Life Inventory (QOLI) [ Time Frame: change from Post-treatment (Week 10) to 6 month follow-up ]
    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. Scores range from



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veterans
  • Veterans who meet DSM-5 criteria for Post-traumatic Stress Disorder (PTSD)
  • Veterans who endorsed killing or being responsible for the death of another in a war zone and report continued distress regarding these events

    • Distress will be operationalized by a positive response to one or more of the nine self-directed moral injury items on the Expressions of Moral Injury Scale-Military Version (EMIS-M; see Appendix 5 EMIS)
  • Veterans who have initiated or completed an evidence-based treatment for PTSD, such as Cogni-tive Processing Therapy (CPT) or Prolonged Exposure (PE)
  • If receiving CPT or PE, Veterans must complete treatment and wait two weeks prior to screening
  • If receiving prescription medication for PTSD, Veterans must be one month stable on medication and not make any changes to medication during the course of the active treatment phase of the study

Exclusion Criteria:

  • Veterans with current or lifetime diagnosis of a psychotic disorder
  • Veterans with recent suicidal or homicidal behaviors (chronic suicidal ideation is not exclusionary)
  • Veterans with recent psychiatric hospitalizations
  • Veterans with moderate or severe alcohol or drug dependence within the past three months
  • Veterans receiving individual therapy for PTSD or those planning to start skills-based or trauma-focused group psychotherapy will be excluded

    • However, these Veterans will be offered the opportunity to be screened again after completion of individual PTSD therapy or once they are three months stable in group treatment, with no plans to discontinue this treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03764033


Contacts
Contact: Shira Maguen, PhD (415) 221-4810 ext 2511 shira.maguen@va.gov
Contact: Rebecca Gloria, PhD (415) 221-4810 ext 23978 Rebecca.Gloria2@va.gov

Locations
United States, California
San Francisco VA Medical Center, San Francisco, CA Not yet recruiting
San Francisco, California, United States, 94121
Contact: Shira Maguen, PhD    415-221-4810 ext 2511    shira.maguen@va.gov   
Contact: Rebecca Gloria, PhD    (415) 221-4810 ext 23978    Rebecca.Gloria2@va.gov   
Principal Investigator: Shira Maguen, PhD         
United States, New York
James J. Peters VA Medical Center, Bronx, NY Not yet recruiting
Bronx, New York, United States, 10468
Contact: Amy Lehrner, PhD    718-584-9000 ext 3205    amy.lehrner@va.gov   
United States, North Carolina
Durham VA Medical Center, Durham, NC Not yet recruiting
Durham, North Carolina, United States, 27705
Contact: Jean Beckham, PhD    919-286-0411 ext 7973    jean.beckham@va.gov   
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Shira Maguen, PhD San Francisco VA Medical Center, San Francisco, CA

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03764033     History of Changes
Other Study ID Numbers: D2946-R
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Stress Disorders, Post-Traumatic
Moral Injury
Treatment

Additional relevant MeSH terms:
Wounds and Injuries
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders