Clinical trial NCT03764033: A Novel Posttraumatic Stress Disorder Treatment for Veterans With Moral Injury
Official title: A Novel Posttraumatic Stress Disorder Treatment for Veterans With Moral Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Moral Injury
Keywords: Stress Disorders, Post-Traumatic
Moral Injury
Treatment
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-12-04
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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.

Eligibility criteria: Inclusion Criteria:

* Veterans 18-82 years of age
* Veterans who meet DSM-5 criteria for Post-traumatic Stress Disorder (PTSD) or score 23 or higher on the CAPS screening interview.
* 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) or item #4 on the Moral Injury Events Scale (MIES)
* 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 or current untreated/unmanaged mania.
* 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

Primary outcomes:
measure: World Health Organization Quality of Life-BREF
timeFrame: Change from baseline (Week 1) and Post-treatment (Week 10)
measure: World Health Organization Quality of Life-BREF
timeFrame: Change from Post-treatment (Week 10) to 6 month follow-up
Secondary outcomes:
measure: Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: Change from baseline (Week 1) and post-treatment (Week 10)
Other outcomes:
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Change from baseline (Week 1) and Post-treatment (Week 10)
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Change from Post-treatment (Week 10) to 6 month follow-up
measure: Brief Symptom Inventory (BSI)
timeFrame: Change from baseline (Week 1) and Post-treatment (Week 10)
measure: Trauma-related Guilt Inventory (TRGI)
timeFrame: Change from baseline (Week 1) and Post-treatment (Week 10)
measure: Brief Symptom Inventory (BSI)
timeFrame: Change from Post-treatment (Week 10) to 6 month follow-up
measure: Trauma-related Guilt Inventory (TRGI)
timeFrame: Change from Post-treatment (Week 10) to 6 month follow-up
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center, San Francisco, CA
state: California
city: Bronx
country: United States
facility: James J. Peters VA Medical Center, Bronx, NY
state: New York
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: San Francisco VA Medical Center, San Francisco, CA
name: Shira Maguen, PhD
role: PRINCIPAL_INVESTIGATOR
References: