Psychosocial Rehabilitation After Moral Injury and Loss With Adaptive Disclosure

The aim of this study was to determine the efficacy of Adaptive Disclosure for Moral Injury and Loss (AD-MIL), a combat-specific psychotherapy for war-related PTSD stemming from Moral Injury (MI) and traumatic loss (TL) with Iraq and Afghanistan War Veterans with PTSD. AD-MIL will be compared to Present Centered Therapy (PCT). AD-MIL is a modified version of Adaptive Disclosure (AD), which has been modified and extended to solely treat MI and TL by targeting psychological and behavioral obstacles to occupational, relationship, and family functioning, as well as quality of life. PCT is a manualized evidenced-based PTSD treatment used to address functioning problems in several large-scale PTSD trials. The primary end-point was psychosocial functioning (improvements in social, educational and occupational functions). Secondary end-points included PTSD, depression, moral emotions (anger, shame, and guilt), alcohol use, self-compassion, and mindful/valued living.

Study Overview

• Status: Completed
• Conditions: Post-traumatic Stress Disorder; Moral Injury; Traumatic Loss
• Intervention / Treatment: Behavioral: Adaptive Disclosure for Moral Injury and Loss; Behavioral: Present Centered Therapy

Detailed Description

The investigators conducted a multi-site randomized trial comparing Adaptive Disclosure for Moral Injury and Loss (AD-MIL; an expanded version of Adaptive Disclosure) for war-related PTSD stemming from Moral Injury (MI) and traumatic loss (TL) to Present Centered Therapy (PCT; Frost et al., 2014). The primary endpoint was psychosocial functioning. The investigators had six hypotheses:

A: Functional and behavioral changes:

A.1. Immediately post-treatment, and 3- and 6-months post-treatment, Veterans with PTSD randomized to AD-MIL will have greater reductions in social, educational, and occupational disability.

A.2. COVID-19 aim. In the extended time period for the trial, at the post-treatment, or post-treatment and 3-months post-treatment intervals (depending on when the participant was randomized), Veterans with PTSD randomized to AD-MIL will have greater reductions in social, educational and occupational disability (the investigators also explored whether there would be greater PTSD and depression symptom reduction in this interval).

B: Mental health changes:

B.3. AD-MIL will lead to greater reductions in PTSD symptom severity and a smaller percentage of PTSD cases.

B.4. AD-MIL will lead to greater reductions in depressive symptoms. B.5. AD-MIL will lead to greater reductions in shame and guilt B.6. AD-MIL will lead to greater reductions in psychological distress.

Exploratory hypotheses: AD-MIL will lead to greater reductions in aggressive behaviors, suicidal ideation, and alcohol use, and greater increases in compassion for the self and others and social connectedness.

BACKGROUND PTSD is a functionally disabling condition among war Veterans. Approximately 20% of Veterans of post-9-11 operations have clinically significant PTSD and suffer from a variety of co-morbid mental and physical health conditions. They also have extensive functional impairments, aggressive and risky behaviors, and reduced quality of life. Although considerable gains have been made in the VA's dissemination of PTSD treatments that are highly effective with civilian trauma, these therapies have been shown to work considerably less well for war trauma. The investigators have argued that this is partly due to a lack of attention to the military culture and warrior ethos and the unique harms of war trauma, namely, moral injury (MI) and traumatic loss (TL). In addition, PTSD treatments have failed to demonstrate an impact on functioning and quality of life, problems that are no less impacted by the warzone trauma. Instead, symptom change is typically the sole metric of success, and functional deficits are rarely considered. The investigators argue that PTSD symptoms should be conceptualized and targeted as part of the fabric of the whole Veteran and his or her context. The investigators aimed to fill a care-gap in the VA by creating an evidence-based treatment for war-related PTSD stemming from MI and TL, focusing on improving psychosocial functioning. The investigators extended Adaptive Disclosure to treat MI and TL (AD-MIL) by: (1) facilitating emotional-processing of TL and MIs and a healing and action plan by letter writing tasks to the lost person or, depending on the nature of the MI, the person or persons harmed by transgressive acts (MI stemming from personal actions or the failure to act) or the person or persons who were the transgressors (MI stemming from being the victim of others' transgressions or bearing witness to grave transgressive acts); (2) skills training and behavioral contracting to improve functioning and targeting MI- and TL-related psychological and behavioral obstacles to habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. If found to be effective, AD-MIL will fill a care-gap in the VA, reduce PTSD patients' suffering, and help Veterans reclaim or establish positive relationships, work roles, and self-care routines.

METHOD Overview: The VA sites were Boston, Minneapolis, San Francisco, San Diego, and Central Texas. The coordinating/lead site was VA Boston led by the study PI, Brett Litz, PhD. The trial followed the consensus recommendations for clinical trials in the VA (VA ORD, 2008): (1) clearly defined target symptoms: functional and clinical outcomes were operationalized; (2) reliable and valid measures: assessment tools were selected for their content relevance and psychometric properties; (3) use of blind evaluators of outcome: the evaluator was independent and blind to treatment condition. This assessor reminded participants to help maintain their blind; (4) assessor training: the independent evaluator was carefully trained to criteria and monitored on an ongoing basis; (5) manualized, replicable, specific treatment programs; (6) there was unbiased assignment to treatment arms and (7) treatment adherence: sessions were be recorded, and a random percentage was used to assess treatment integrity. Adherence to the therapy manuals was monitored by senior supervisors. The investigators followed the CONSORT guidelines for randomization and participant tracking.

Participants: The trial required 148 Veterans (including women and members of diverse ethnic and racial groups) with PTSD as a result of military trauma.

Recruitment: Veterans were recruited and treated at the Minneapolis, San Diego, San Francisco, and Waco VAs. Co-Investigators (Co-Is): (a) provided materials describing the nature of the study and the target populations sought, distributing said materials via formal (e.g., staff meetings) and informal (e.g., bulletin boards) channels; (b) attended clinical staff meetings; (c) gave talks to describe various treatments in staff grand rounds and other contexts (e.g., to trainees); and (d) provided feedback to staff about referred patients.

Assessor Training and Adherence: A co-investigator, Dr. Matt Gray (University of Wyoming) trained the assessors prior to beginning enrollment. Training included reading and viewing training materials, observation of CAPS-5 administration, and supervised administration of at least three CAPS-5s. Dr. Gray has expertise in CAPS-5 training and fidelity monitoring. The assessor was considered trained on CAPS-5 when they matched Dr. Gray on three interviews. To establish matching, Dr. Gray co-rated interviews conducted by the assessor. A match occurred when the assessor and Dr. Gray agreed on the diagnosis and were within 2 severity points on all of the symptom clusters (PTSD criteria B, C, D, and E).

All assessments were audiotaped to ensure that a standardized approach was used across patients (provided that the participant consents). Dr. Gray reviewed a random 10% of the assessments. All recordings were stored on a restricted-access encrypted drive. Selected recordings were transported to Dr. Gray via Federal Express that allows tracking.

Random Assignment: Veterans were assigned to PCT or AD-MIL based on a randomized permuted block scheme, blocked by gender and minority status. Block size for gender and minority status was based on the distribution of these variables at each site. The Boston site used constrained randomization (i.e., biased coin design) if unexpected imbalance arose in gender and minority distribution across treatment groups.

Treatment Fidelity Monitoring: Half-time therapists with Ph.Ds. in clinical or counseling psychology and VA internship experiences treating Veterans with PTSD were trained to deliver AD-MIL and PCT. Training involved a review of the respective manuals and supporting materials, intensive one-on-one training and supervision, and weekly and ad hoc supervision (Dr. Litz for AD-MIL; Dr. Harris for PCT). All sessions were audiotaped. Two random session recordings from a random 20% of the cases were rated to ensure fidelity to each treatment approach.

ANALYSES Data Analysis: The longitudinal and clustered nature of the design produced a multilevel or nested data structure (Raudenbush & Bryk, 2002), with a likelihood of between-subject variability in treatment trajectory over time (e.g., random slopes). In this study, Veterans and therapists were nested (clustered) within performance sites. The lower level (level-1) data consisted of the repeated measures for each individual at each assessment. Level-1 data is nested within upper level (level-2) person-level variables (e.g., study site).

Using SAS 9.4 and R/R Studio, the investigators explored the change trajectory of endpoints over the course of pre-treatment, during-treatment, and post-treatment time intervals. Specifically, the investigators used the linear mixed model regression framework to assess the differential treatment effects of endpoint symptom burden over time. The investigators examined observed measurement scores and specified linear mixed models that best fit the time-change trends (e.g., linear, piecewise). The investigators tested for the presence of random variation, such as between-site cluster effects and between-subject random slopes of treatment effect. The investigators determined the best fit linear mixed effects model as a combination of most appropriate representation of time and empirically-evidenced random and fixed effects.

The linear mixed effects models incorporated clinically relevant time-invariant and time-varying predictors and used Maximum Likelihood Estimation to produce estimates that were unbiased in the presence of random missingness and dropout. These provided an Intent-To-Treat (ITT) analysis that incorporated all available data. Per-protocol and "completer" subset analyses were performed under the same paradigm. Additionally, a subset of subjects who began therapy during the COVID-19 pandemic were identified and analyzed separately; they comprised subjects which began therapy following December 31st, 2020. The tenability of the "At-Random" missingness assumption was assessed and a sensitivity analysis of the results was conducted to determine robustness of the inferences.

Clinical significance: The investigators used a variation of the two-stage Jacobson & Truax (J&T; 1991) method to establish a reasonable cutoff between dysfunctional and functional scores. The investigators first established the cutoff A, defined as the point 2 SDs beyond the range of the pre-therapy mean (cutoff A = M(baseline) - 2 SD(baseline)). Next, the investigators generated a reliable change index (RCI) for each participant to ensure that changes were not due to artifact of measurement error ([x2 - x1]/Sdiff where x1 represents the participant's pre-treatment total score, x2 represents the participant's post-treatment or follow-up total score, and Sdiff is the standard error of difference between the two test scores. Sdiff was calculated from the test-retest reliability of measures. An RCI larger than 1.96 reflects real change. Individuals were classified as recovered (passed both cutoff A and RC criteria), improved (passed RC criterion but not cutoff A), unchanged (passed neither criterion), or deteriorated (passed RC criterion but symptom scores increased) for each follow-up interval. Chi-square analyses were used to compare proportions per arm at each follow-up.

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92161
      • VA San Diego Healthcare System, San Diego, CA
    • San Francisco, California, United States, 94121
      • San Francisco VA Medical Center, San Francisco, CA
  • Massachusetts
    • Boston, Massachusetts, United States, 02130
      • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Minneapolis VA Health Care System, Minneapolis, MN
  • Texas
    • Waco, Texas, United States, 76711
      • Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Served in an active-duty role within the military since September 2001 (Veterans may be eligible whether or not they were deployed to a warzone)
2. Met the DSM-5 diagnostic criteria for PTSD as a result of military trauma (per Clinician Administered PTSD Scale for DSM-5 [CAPS-5]) and reported non-negligible levels of associated functional impairment (Sheehan Disability Scale [SDS] score = 10)
3. Prospective enrollees must have been willing to commit to 12 consecutive weekly therapy sessions lasting up to 90 minutes in duration and to complete assessment materials.

Exclusion Criteria:

1. Bipolar or psychotic disorders.
2. Current drug or alcohol dependence (other than caffeine or tobacco dependence). Prospective enrollees who had maintained sobriety for at least 6 weeks immediately prior to the time of enrollment may have been eligible.
3. Evidence of traumatic brain injury severe enough to influence the ability to understand and respond to study procedures
4. Suicidal or homicidal ideation severe enough to warrant immediate attention
5. Concurrent enrollment in any treatment that involves: (1) systematic disclosure of troubling trauma-related memories or (2) present-focused psychosocial skills training for PTSD or (3) supportive therapy/case management on a > monthly basis or (4) any individual therapy or (5) newly (< 6 weeks) prescribed pharmacological treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adaptive Disclosure for Moral Injury and Loss; AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).	Behavioral: Adaptive Disclosure for Moral Injury and Loss; AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).; Other Names: AD-MIL
Active Comparator: Present Centered Therapy; PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving day-to-day functioning. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive functional responses to these stressors with a problem-focused and problem-solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.	Behavioral: Present Centered Therapy; Participants randomized to the PCT arm will receive 12 sessions of therapy focused on day-to-day functional problems with no focus on trauma or re-visiting past experiences; Other Names: PCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS)	The Sheehan Disability Scale (SDS; Sheehan, 1983; Sheehan et al., 1996) is a composite of three self-rated items regarding the degree to which symptoms disrupted work/school, social life, and family life/responsibilities on an 11-point scale ranging from "Not at all" to "Extremely," with an option for "Not applicable". The possible range of scores is 0 to 30. Higher scores indicate greater disability.	Assessments occurred at baseline, every treatment session, post treatment, and approximately 3 and 6 months after post treatment.
Pre-to-Post-Treatment Clinically Significant Change (CSC) in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS)	The investigators used the Jacobson and Truax methodology to index individual participant clinically significant change in functional impairment, assessed through the Sheehan Disability Scale (SDS). Individuals were classified as experiencing probable recovery if they passed the Criterion Cutoff and the RCI criteria; improved if they passed the RCI criterion, but their post-treatment or follow-up score did not pass the Criterion Cutoff; unchanged if they failed to pass the RCI; or deteriorated if they passed the RCI criterion but symptom scores increased.	Baseline and post-treatment.
Change in Psychosocial Functioning Assessed Through the Brief Inventory of Psychosocial Functioning (B-IPF)	The Brief Inventory of Psychosocial Functioning (B-IPF; Marx, 2013) was used to assess functional gains. It is a 7-item scale indexing overall level of functioning in seven life domains: romantic relationship, relationship with children, family relationships, friendships and socializing, work, training and education, and activities of daily living. The investigators used a prorated total percentage for the dimensional ratings, such that Veterans who were not in romantic relationships, had no children, or were not in employed or in school did not have those domains included in their percentage. Possible scores on the B-IPF range from 0% to 100%, with higher scores indicating more issues in psychosocial functioning.	Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.
Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS) for the COVID-19 Cohort	The Sheehan Disability Scale (SDS; Sheehan, 1983; Sheehan et al., 1996) is a composite of three self-rated items regarding the degree to which symptoms disrupted work/school, social life, and family life/responsibilities on an 11-point scale ranging from "Not at all" to "Extremely," with an option for "Not applicable". The investigators used a prorated total mean score for the dimensional ratings such that only social and family ratings will be included for Veterans who were not employed or attending school at the time. The possible range of scores is 0 to 30. Higher scores indicate greater disability.	Assessments occurred at baseline, every treatment session, and approximately 3 and 6 months after post treatment.
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5) for the COVID-19 Cohort	The PTSD Checklist for DSM-5 (PCL-5; Weathers et al., 2013) is a 20-item self-report checklist based on the 20 DSM-5 symptoms post-traumatic stress disorder (PTSD). The PCL-5 has been validated as a means of monitoring symptom change during treatment. The 20 items are scored are scored in the past month on a scale from 0 ("not at all") to 4 ("extremely"), generating a total symptom severity score between 0 and 80, with higher scores indicating greater PTSD symptom severity.	Assessments occurred at baseline, every treatment session, and approximately 3 and 6 months after post treatment.
Change in PTSD Symptom Severity and Diagnosis Assessed Through the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) for the COVID-19 Cohort	The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Weathers et al., 2013) is closely modeled on the CAPS-IV, a structured diagnostic interview and gold standard for assessing PTSD. It has excellent psychometric properties and diagnostic efficiency (Weathers et al., 2001). The CAPS-5 uses a single 4-point ordinal rating scale to measure symptom severity. These ratings combine information about symptom frequency and intensity obtained by the interviewer. CAPS-5 scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.	Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9) for the COVID-19 Cohort	The Patient Health Questionnaire (PHQ-9) is widely used and well-validated measure of symptoms of depression (Kroenke et al., 2001). It scores each of the nine DSM criteria for depression on a scale of 0 ("not at all") to 3 ("nearly every day"). The range of possible scores is 0 to 27. A higher score indicates more frequent depression symptoms.	Assessments occurred at baseline, every treatment session, and approximately 3 and 6 months after post treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PTSD Symptom Severity and Diagnosis Assessed Through the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)	The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Weathers et al., 2013) is closely modeled on the CAPS-IV, a structured diagnostic interview and gold standard for assessing PTSD. It has excellent psychometric properties and diagnostic efficiency (Weathers et al., 2001). The CAPS-5 uses a single 4-point ordinal rating scale to measure symptom severity. These ratings combine information about symptom frequency and intensity obtained by the interviewer. CAPS-5 scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.	Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.
Pre- to Post-Treatment Clinically Significant Change (CSC) in PTSD Symptom Severity and Diagnosis Assessed Through the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)	The investigators used the Jacobson and Truax methodology to index individual participant clinically significant change in PTSD symptom severity and diagnosis, which the investigators assessed through the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Individuals were classified as experiencing probable recovery if they passed the Criterion Cutoff and the RCI criteria; improved if they passed the RCI criterion, but their post-treatment or follow-up score did not pass the Criterion Cutoff; unchanged if they failed to pass the RCI; or deteriorated if they passed the RCI criterion but symptom scores increased.	Baseline and post treatment.
Change in PTSD Caseness Assessed Through PTSD Diagnoses Using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)	The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Weathers et al., 2013) is closely modeled on the CAPS-IV, a structured diagnostic interview and gold standard for assessing PTSD. It has excellent psychometric properties and diagnostic efficiency (Weathers et al., 2001). The CAPS-5 uses a single 4-point ordinal rating scale to measure symptom severity. These ratings combine information about symptom frequency and intensity obtained by the interviewer. A patient is determined to have met the DSM-5 criteria for PTSD if they have endorsed at least one symptom from the B cluster, at least one symptom from the C Cluster, and at least two symptoms from the E cluster, along with experiencing the symptoms for at least one month and reporting clinically significant distress or functional impairment.	Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.
Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5)	The PTSD Checklist for DSM-5 (PCL-5; Weathers et al., 2013) is a 20-item self-report checklist based on the 20 DSM-5 symptoms post-traumatic stress disorder (PTSD). The PCL-5 has been validated as a means of monitoring symptom change during treatment. The 20 items are scored are scored in the past month on a scale from 0 ("not at all") to 4 ("extremely"), generating a total symptom severity score between 0 and 80, with higher scores indicating greater PTSD symptom severity.	Assessments occurred at baseline, every treatment session, and approximately 3 and 6 months after post treatment.
Pre- to Post-Treatment Clinically Significant Change (CSC) in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5)	The investigators used the Jacobson and Truax methodology to index individual participant clinically significant change in PTSD symptom burden, which the investigators assessed through the PTSD Checklist for DSM-5 (PCL-5). Individuals were classified as experiencing probable recovery if they passed the Criterion Cutoff and the RCI criteria; improved if they passed the RCI criterion, but their post-treatment or follow-up score did not pass the Criterion Cutoff; unchanged if they failed to pass the RCI; or deteriorated if they passed the RCI criterion but symptom scores increased.	Baseline and post treatment.
Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9)	The Patient Health Questionnaire (PHQ-9) is widely used and well-validated measure of symptoms of depression (Kroenke et al., 2001). It scores each of the nine DSM criteria for depression on a scale of 0 ("not at all") to 3 ("nearly every day"). The range of possible scores is 0 to 27. A higher score indicates more frequent depression symptoms.	Assessments occurred at baseline, every treatment session, and approximately 3 and 6 months after post treatment.
Change in Guilt Cognitions About a Specific Warzone Event Assessed Through the (Lack of) Justification Subscale of the Brief Trauma Related Guilt Inventory (TRGI-Brief)	The (lack of) Justification subscale of the Brief Trauma Related Guilt Inventory (TRGI-Brief; Kubany et al., 1996) is a 4-item measure that assesses guilty thoughts about the justification of one's actions related to a specific traumatic event. Possible scores range from 0 to 4, with higher scores indicating increased guilt.	Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.
Change in Guilt Cognitions About a Specific Warzone Event Assessed Through the Hindsight-Bias Subscale of the Brief Trauma Related Guilt Inventory (TRGI-Brief)	The Hindsight-Bias subscale of the Brief Trauma Related Guilt Inventory (TRGI-Brief; Kubany et al., 1996) is a 7-item measure that assesses guilty thoughts about the preventability and responsibility of a traumatic event. Possible scores range from 0 to 4, with higher scores indicating increased guilt.	Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.
Change in Guilt Cognitions About a Specific Warzone Event Assessed Through the Wrongdoing Subscale of the Brief Trauma Related Guilt Inventory (TRGI-Brief)	The Wrongdoing subscale of the Brief Trauma Related Guilt Inventory (TRGI-Brief; Kubany et al., 1996) is a 5-item measure that assesses guilty thoughts about wrongdoing tied to a specific traumatic event. Possible scores range from 0 to 4, with higher scores indicating increased guilt.	Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.
Change in Shame Tied to a Specific Warzone Event Assessed Through the Internal Shame Subscale of the Trauma-Related Shame Inventory (TRSI)	The Internal Shame Subscale of the Trauma-Related Shame Inventory (TRSI; Øktedalen et al., 2014) is a 12-item self-report instrument designed to assess individuals' negative self-evaluations in the context of their traumatic experiences. Possible scores range from 0 to 36, with higher scores indicating more negative self-evaluations. The measure has demonstrated good construct validity (Øktedalen et al., 2014).	Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.
Change in Psychological Health and Distress Assessed Through the Schwartz Outcome Scale-10 (SOS-10)	The Schwartz Outcome Scale-10 (SOS-10; Blais et al., 1999) is a 10-item general mental health outcome measure meant to capture psychological health and distress. Possible scores range from 0 to 60 with higher scores indicating better psychological health and lower distress. The SOS-10 has demonstrated good psychometric properties (Blais et al., 1999).	Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Overall Self-Compassion Assessed Through the Self Compassion Scale (SCS)	The Self Compassion Scale (SCS; Neff, 2003) is a 26-item measure that includes 6 subscales (including Self-Kindness, Self-Judgment, Common Humanity, Isolation, Mindfulness, and Over-Identification) and measures overall self-compassion. The possible range of scores is 1 to 5, with higher scores indicating higher self-compassion. The SCS has shown good internal consistency reliability as well as good test-retest reliability (Neff, 2003).	Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.
Change in State Anger Assessed Through the Dimensions of Anger Reactions (DAR)	The Dimensions of Anger Reactions (DAR; Forbes et al., 2004) is a widely used measure of state anger. The measure consists of a 7-item inventory intended to capture anger disposition. Possible scores range from 0 to 56, with higher scores indicating higher state anger.	Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.
Change in Use of Psychologically Aggressive Behavior Assessed Through the Psychological Aggression Subscale of the Revised Conflict Tactics Scale (CTS2)	The Psychological Aggression subscale of the Revised Conflict Tactics Scale (CTS2; Straus et al., 1996) was used to measure psychologically aggressive behavior. The subscales consists of 8 items, rated on a scale from 0 ("never") to 6 ("more than 20 times"), with higher scores indicating greater use of aggressive behaviors in the past month. To calculate the annual frequency score, values of 3 though 6 were transformed as follows: 3 = 4, 4 = 8, 5 = 15, 6 = 25. These values were then summed, with higher scores indicating greater frequency.	Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.
Change in Use of Physically Aggressive Behavior Assessed Through the Physical Assault Subscale on the Revised Conflict Tactics Scale (CTS2)	The Physical Assault subscale of the Revised Conflict Tactics Scale (CTS2; Straus & Douglas, 2004; Straus et al., 1996) was used to measure occurrence of physically aggressive behavior. The subscale consists of 12 items, rated on a scale from 0 ("never") to 6 ("more than 20 times"), with higher scores indicating greater use of aggressive behaviors in the past month. To calculate the annual frequency score, values of 3 through 6 were transformed as follows: 3 = 4, 4 = 8, 5 = 15, 6 = 25. These values were then summed, with higher scores indicating greater frequency.	Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.
Change in Suicidality Across Assessed Through the Depressive Symptoms Index - Suicidality Subscale (DSI-SS)	The Depressive Symptoms Index - Suicidality Subscale (DSI-SS; Metalsky & Joiner, 1997) is a 4-item scale that focuses on ideation, plans, perceived control over ideation, and impulses for suicide. A review of measures of suicidal ideation and behaviors found that the DSI-SS had excellent internal consistency and concurrent validity (Batterham et al., 2014). Possible scores range from 0 to 12, with higher scores indicating greater severity of suicidal ideation.	Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after posttreatment.
Change in Alcohol Consumption Assessed Through the Quick Drinking Screen (QDS)	Alcohol abuse was evaluated with the Quick Drinking Screen (QDS; Sobell et al., 2003), a 4-item probe of frequency and quantity of alcohol consumption in the last month. The QDS has very good psychometric characteristics (Sobell et al., 2003). The outcome for this measure used in this study was average drinks per week, calculated by using items 1 and 2 from the screen.	Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.
Change in Social Connectedness Assessed Through the Social Connectedness Scale (SCS)	The Social Connectedness Scale (SCS; Lee and Robbins, 1995) was used to assess interpersonal closeness. The SCS is an 8-item scale that focuses on individual experiences in a social world (i.e., with peers, friends, and society) and the degree of difficulty in maintaining a sense of closeness. Possible scores range from 8 to 42, with higher scores indicating more social connection.	Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.
Change in Compassion for Humanity Assessed Through The Santa Clara Brief Compassion Scale (SCBSC)	The Santa Clara Brief Compassion Scale (SCBSC; Hwang, et al., 2008) is a 5-item short form of the Compassionate Love Scale for Humanity (CLS). Possible scores range from 1 to 7, with higher scores indicating more compassion for humanity.	Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Minneapolis Veterans Affairs Medical Center; San Francisco Veterans Affairs Medical Center; San Diego Veterans Healthcare System; Central Texas Veterans Health Care System
• Investigators: Principal Investigator: Brett T. Litz, PhD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Publications and helpful links

General Publications

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
• Weathers FW, Keane TM, Davidson JR. Clinician-administered PTSD scale: a review of the first ten years of research. Depress Anxiety. 2001;13(3):132-56. doi: 10.1002/da.1029.
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• Weathers FW, Bovin MJ, Lee DJ, Sloan DM, Schnurr PP, Kaloupek DG, Keane TM, Marx BP. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Development and initial psychometric evaluation in military veterans. Psychol Assess. 2018 Mar;30(3):383-395. doi: 10.1037/pas0000486. Epub 2017 May 11.
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Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2018
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: January 31, 2017
• First Submitted That Met QC Criteria: February 16, 2017
• First Posted (Actual): February 17, 2017

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Veterans; Post-traumatic Stress Disorder; Moral Injury; Traumatic Loss; Adaptive Disclosure
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Wounds and Injuries
• Other Study ID Numbers: D2135-I; RX-15-005 (Other Grant/Funding Number: Office of Research and Development)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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