Moral Injury
Conditions
Keywords
Stress Disorders, Post-Traumatic, Moral Injury, 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. 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.
Interventions
BEHAVIORALImpact of Killing (IOK)
Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
BEHAVIORALPresent 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)
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The clinical evaluators will be kept blind to treatment condition throughout the study period.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 82 Years
Healthy volunteers
No
Inclusion criteria
* Veterans 18-82 years of age * Veterans who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Post-traumatic Stress Disorder (PTSD) or score 23 or higher on the Clinician-Administered PTSD Scale for DSM-5 (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 Cognitive 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| World Health Organization Quality of Life-BREF | Change from baseline (Week 0) and post-treatment (Week 11) | 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, and a total raw score is calculated by summing all items (26-130). The total score is calculated by transforming the raw score to a 0-100 scale, with higher scores representing better quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Administered PTSD Scale for DSM-5 (CAPS-5) | Change from baseline (Week 0) and post-treatment (Week 11) | 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
| Measure | Time frame | Description |
|---|---|---|
| PTSD Checklist for DSM-5 (PCL-5) | Change from baseline (Week 0) and post-treatment (Week 11) | A 20-item measure that assesses PTSD symptom severity using a 5-point rating scale. The PCL-5 items correspond to the DSM-5 symptoms for PTSD. Total severity can range from 0 to 80. Higher scores indicate greater severity of PTSD symptoms. |
| Brief Symptom Inventory (BSI) | Change from baseline (Week 0) and post-treatment (Week 11) | A 53-item measure, using a 5-point Likert scale, in which participants rate the extent to which they have been bothered in the past week by various mental health symptoms (e.g., depression, anxiety, hostility, psychoticism, paranoid ideation, etc.). The BSI measures global psychological distress, with scores ranging from 0-53. Higher scores represent more severe psychiatric symptoms. |
| Trauma-related Guilt Inventory (TRGI) | Change from baseline (Week 0) and post-treatment (Week 11) | 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 main scales representing guilt, distress and guilt cognitions. Scores represent the average for items in the scale and range from 0-4, with higher scores representing greater guilt/distress. |
Countries
United States
Participant flow
Recruitment details
Veterans were recruited from 8/12/2019 to 11/30/2024 through direct mailings, advertisements, referrals from VA providers and other VA research studies. Screening procedures comprised a brief phone pre-screener, informed consent , and a diagnostic clinical interview. A total of 100 Veterans completed all screening procedures, were eligible for the study, completed a baseline self-report questionnaire of outcome measures, and were randomly assigned to a treatment condition.
Participants by arm
| Arm | Count |
|---|---|
| Impact of Killing (IOK) Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
Impact of Killing (IOK): Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK . | 49 |
| 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)
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) | 51 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Six Month Follow-Up | Lost to Follow-up | 0 | 5 |
| Treatment Phase | Withdrawal by Subject | 8 | 3 |
| Treatment Phase | Withdrawn by PI due to frequent no-shows and cancellations of study appointments. | 0 | 1 |
Baseline characteristics
| Characteristic | Present Centered Therapy | Total | Impact of Killing (IOK) |
|---|---|---|---|
| Age, Continuous | 46.8 years STANDARD_DEVIATION 12.9 | 48.4 years STANDARD_DEVIATION 13.7 | 50.0 years STANDARD_DEVIATION 14.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 19 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants | 81 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 25 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 34 Participants | 68 Participants | 34 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 50 Participants | 98 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 51 |
| other Total, other adverse events | 0 / 49 | 1 / 51 |
| serious Total, serious adverse events | 0 / 49 | 0 / 51 |
Outcome results
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, and a total raw score is calculated by summing all items (26-130). The total score is calculated by transforming the raw score to a 0-100 scale, with higher scores representing better quality of life.
Time frame: Change from post-treatment (Week 11) to 6 month follow-up (6 months after post-treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Impact of Killing (IOK) | World Health Organization Quality of Life-BREF | 50.86 score on a scale | Standard Error 2.03 |
| Present Centered Therapy | World Health Organization Quality of Life-BREF | 50.62 score on a scale | Standard Error 1.99 |
p-value: 0.97595% CI: [-4.46, 4.61]Mixed Models Analysis
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, and a total raw score is calculated by summing all items (26-130). The total score is calculated by transforming the raw score to a 0-100 scale, with higher scores representing better quality of life.
Time frame: Change from baseline (Week 0) and post-treatment (Week 11)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Impact of Killing (IOK) | World Health Organization Quality of Life-BREF | 53.35 score on a scale | Standard Error 2.03 |
| Present Centered Therapy | World Health Organization Quality of Life-BREF | 52.39 score on a scale | Standard Error 1.94 |
p-value: 0.72995% CI: [-3.66, 5.24]Mixed Models Analysis
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.
Time frame: Change from baseline (Week 0) and post-treatment (Week 11)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Impact of Killing (IOK) | Clinician Administered PTSD Scale for DSM-5 (CAPS-5) | 25.79 score on a scale | Standard Error 1.82 |
| Present Centered Therapy | Clinician Administered PTSD Scale for DSM-5 (CAPS-5) | 26.03 score on a scale | Standard Error 1.73 |
p-value: 0.83195% CI: [-5.27, 4.24]Mixed Models Analysis
Other Pre-specified
Brief Symptom Inventory (BSI)
A 53-item measure, using a 5-point Likert scale, in which participants rate the extent to which they have been bothered in the past week by various mental health symptoms (e.g., depression, anxiety, hostility, psychoticism, paranoid ideation, etc.). The BSI measures global psychological distress, with scores ranging from 0-53. Higher scores represent more severe psychiatric symptoms.
Time frame: Change from baseline (Week 0) and post-treatment (Week 11)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Impact of Killing (IOK) | Brief Symptom Inventory (BSI) | 1.11 score on a scale | Standard Error 0.11 |
| Present Centered Therapy | Brief Symptom Inventory (BSI) | 1.35 score on a scale | Standard Error 0.1 |
p-value: 0.06695% CI: [-0.37, 0.01]Mixed Models Analysis
Other Pre-specified
Brief Symptom Inventory (BSI)
A 53-item measure, using a 5-point Likert scale, in which participants rate the extent to which they have been bothered in the past week by various mental health symptoms (e.g., depression, anxiety, hostility, psychoticism, paranoid ideation, etc.). The BSI measures global psychological distress, with scores ranging from 0-53. Higher scores represent more severe psychiatric symptoms.
Time frame: Change from post-treatment (Week 11) to 6 month follow-up (6 months after post-treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Impact of Killing (IOK) | Brief Symptom Inventory (BSI) | 1.15 score on a scale | Standard Error 0.11 |
| Present Centered Therapy | Brief Symptom Inventory (BSI) | 1.45 score on a scale | Standard Error 0.1 |
p-value: 0.01695% CI: [-0.43, -0.04]Mixed Models Analysis
Other Pre-specified
PTSD Checklist for DSM-5 (PCL-5)
A 20-item measure that assesses PTSD symptom severity using a 5-point rating scale. The PCL-5 items correspond to the DSM-5 symptoms for PTSD. Total severity can range from 0 to 80. Higher scores indicate greater severity of PTSD symptoms.
Time frame: Change from baseline (Week 0) and post-treatment (Week 11)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Impact of Killing (IOK) | PTSD Checklist for DSM-5 (PCL-5) | 37.31 score on a scale | Standard Error 2.23 |
| Present Centered Therapy | PTSD Checklist for DSM-5 (PCL-5) | 42.9 score on a scale | Standard Error 2.14 |
p-value: 0.00695% CI: [-11.31, -1.87]Mixed Models Analysis
Other Pre-specified
PTSD Checklist for DSM-5 (PCL-5)
A 20-item measure that assesses PTSD symptom severity using a 5-point rating scale. The PCL-5 items correspond to the DSM-5 symptoms for PTSD. Total severity can range from 0 to 80. Higher scores indicate greater severity of PTSD symptoms.
Time frame: Change from post-treatment (Week 11) to 6 month follow-up (6 months after post-treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Impact of Killing (IOK) | PTSD Checklist for DSM-5 (PCL-5) | 36.77 score on a scale | Standard Error 2.23 |
| Present Centered Therapy | PTSD Checklist for DSM-5 (PCL-5) | 42.35 score on a scale | Standard Error 2.19 |
p-value: 0.00895% CI: [-11.34, -1.74]Mixed Models Analysis
Other Pre-specified
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 main scales representing guilt, distress and guilt cognitions. Scores represent the average for items in the scale and range from 0-4, with higher scores representing greater guilt/distress.
Time frame: Change from baseline (Week 0) and post-treatment (Week 11)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Impact of Killing (IOK) | Trauma-related Guilt Inventory (TRGI) | 2.01 score on a scale | Standard Error 0.15 |
| Present Centered Therapy | Trauma-related Guilt Inventory (TRGI) | 2.18 score on a scale | Standard Error 0.14 |
p-value: 0.04395% CI: [-0.69, -0.01]Mixed Models Analysis
Other Pre-specified
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 main scales representing guilt, distress and guilt cognitions. Scores represent the average for items in the scale and range from 0-4, with higher scores representing more guilt/distress.
Time frame: Change from post-treatment (Week 11) to 6 month follow-up (6 months after post-treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Impact of Killing (IOK) | Trauma-related Guilt Inventory (TRGI) | 1.79 score on a scale | Standard Error 0.15 |
| Present Centered Therapy | Trauma-related Guilt Inventory (TRGI) | 2.00 score on a scale | Standard Error 0.15 |
p-value: 0.02895% CI: [-0.74, -0.04]Mixed Models Analysis