A Novel Posttraumatic Stress Disorder Treatment for Veterans With Moral Injury



Status:Not yet recruiting
Conditions:Hospital, Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology, Other
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:July 1, 2019
End Date:April 30, 2023
Contact:Shira Maguen, PhD
Email:shira.maguen@va.gov
Phone:(415) 221-4810

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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.

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
We found this trial at
3
sites
Durham, North Carolina 27705
Phone: 919-286-0411
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Bronx, New York 10468
Phone: 718-584-9000
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Bronx, NY
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San Francisco, California 94121
Principal Investigator: Shira Maguen, PhD
Phone: 415-221-4810
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San Francisco, CA
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