A Novel Posttraumatic Stress Disorder Treatment for Veterans With Moral Injury

Moral Injury Clinical Trial

— IOK  

Official title:

A Novel Posttraumatic Stress Disorder Treatment for Veterans With Moral Injury

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03764033
• Other study ID #: D2946-R
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 12, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 101
• Est. completion date: December 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 82 Years

Eligibility

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

Related Conditions & MeSH terms

• Moral Injury
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Wounds and Injuries

Intervention

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 .
• 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)

Locations

Country	Name	City	State
United States	James J. Peters VA Medical Center, Bronx, NY	Bronx	New York
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina
United States	San Francisco VA Medical Center, San Francisco, CA	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life Inventory (QOLI)	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.	Change from baseline (Week 1) and post-treatment (Week 5)
Other	Trauma-related Guilt Inventory (TRGI)	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.	Change from baseline (Week 1) and post-treatment (Week 5)
Other	Trauma-related Guilt Inventory (TRGI)	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.	change from Post-treatment (Week 10) to 6 month follow-up
Other	Quality of Life Inventory (QOLI)	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	change from Mid-treatment (Week 5) to Post-treatment (Week 10)
Other	Quality of Life Inventory (QOLI)	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.	change from Post-treatment (Week 10) to 6 month follow-up
Primary	World Health Organization Quality of Life-BREF	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.	Change from baseline (Week 1) and mid-treatment (Week 5)
Primary	World Health Organization Quality of Life-BREF	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.	change from Mid-treatment (Week 5) to Post-treatment (Week 10)
Primary	World Health Organization Quality of Life-BREF	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.	change from Post-treatment (Week 10) to 6 month follow-up
Secondary	Clinician Administered PTSD Scale for DSM-5 (CAPS-5)	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.	Change from baseline (Week 1) and post-treatment (Week 10)