Psychosocial Rehabilitation After Moral Injury and Loss With Adaptive Disclosure

Post-traumatic Stress Disorder Clinical Trial

Official title:

Psychosocial Rehabilitation After Moral Injury and Loss With Adaptive Disclosure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03056157
• Other study ID #: D2135-I
• Secondary ID: RX-15-005
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: February 28, 2022

Study information

• Verified date: March 2022
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is 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 in several large-scale PTSD trials. The primary end-point is psychosocial functioning (improvements in social, educational and occupational functions and improvements in quality of life). Secondary end-points include PTSD, depression, and shame and guilt. The investigators will also explore the impact of AD-MIL on anger and aggressive behaviors, suicidal ideation, and alcohol abuse.

Description:

The overarching goal of this study is to conduct a multi-site randomized control trial comparing Adaptive Disclosure-Moral Injury and Loss (AD-MIL), a new combat-specific psychotherapy for war-related PTSD stemming from Moral Injury (MI) and traumatic loss (TL), to Present Centered Therapy (PCT; Frost et al., 2014), in terms of its impact on psychosocial functioning. The investigators have five hypotheses, grouped into (A) functional change and (B) mental health change.

A: Functional and behavioral change hypotheses:

A.1. Immediately post-treatment, 3-, and 6-months post-treatment, Iraq and Afghanistan Veterans with PTSD randomized to AD-MIL will have greater reductions in social, educational, and occupational disability A.2. Immediately post-treatment, 3-, and 6-months post-treatment, Iraq and Afghanistan Veterans with PTSD randomized to AD-MIL will have greater improvements in quality of life.

A.3 COVID-19 aim. In the extended time period for the trial, at the post-treatment and 3-months post-treatment intervals, Veterans with PTSD randomized to AD-E will have greater reductions in social, educational and occupational disability

B: Mental health change hypotheses:

B.4. Veterans randomized to AD-MIL will have greater reductions in PTSD symptom severity and a smaller percentage of PTSD cases B.5. Veterans randomized to AD-MIL will have greater reductions in depressive symptoms B.6. Veteran randomized to AD-MIL will have greater reductions in shame and guilt B.7. Veterans randomized to AD-E will have greater reductions in psychological distress

The investigators will also explore the impact of treatment on anger and aggressive behaviors, suicidal ideation, and alcohol abuse.

BACKGROUND Posttraumatic stress disorder (PTSD) is a highly prevalent and disabling condition among war Veterans, posing a significant public health burden. Depending on the degree and type of exposure to warzone stressors, approximately 20% of the 2.5 million service members who served in Iraq and Afghanistan have or will develop clinically significant PTSD. PTSD causes private suffering and has a uniquely damaging ripple effect on family members, friends, co-workers, productivity, and healthcare costs. Veterans with PTSD suffer from a variety of co-morbid mental and physical health conditions and are heavy service-utilizers. They also have extensive functional impairments, such as occupational problems, family and relationship difficulties, aggressive and risky behaviors, and reduced quality of life. Unfortunately, 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 ethos and the unique harms of war trauma, namely, moral injury (MI) and traumatic loss (TL). In addition, VA treatments have failed to demonstrate an impact on functioning and quality of life, problems that are no less impacted by the warzone trauma being targeted in treatment. Instead, symptom change is typically the sole metric of success, and functional deficits are rarely taken into account. 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. Consequently, the overarching goal of this proposed study is to fill a substantial 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 have modified and extended Adaptive Disclosure to treat MI and TL (AD-MIL) by building in skills training and behavioral contracting to improve functioning, and targeting MI- and TL-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles. 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 CTVHCS is part of a multi-site randomized controlled trial of AD-E, comparing it to PCT (Frost et al., 2014). The VA sites are Boston, Minneapolis, San Francisco and San Diego, and Central Texas. The coordinating/lead site is VA Boston Healthcare System led by the study PI, Brett Litz, PhD. The trial will follow the consensus recommendations for clinical trials in the VA (VAORD, 2008): (1) clearly defined target symptoms: Functional and clinical outcomes will be operationalized; (2) reliable and valid measures: Assessment tools are selected for their content relevance and psychometric properties; (3) use of blind evaluators of outcome: The evaluator will be independent and blind to treatment condition. This assessor will remind participants to help maintain their blind; (4) assessor training: The independent evaluator (IE) will be carefully trained to criteria and monitored on an ongoing basis; (5) manualized, replicable, specific treatment programs; (6) unbiased assignment to treatment arms and (7) treatment adherence: Sessions will be recorded, and a random percentage will be used to assess treatment integrity. Adherence to the therapy manuals will be monitored by senior supervisors. The investigators will follow the CONSORT guidelines for randomization and participant tracking.

Participants For the trial, participants will comprise a sample of 148 veterans (including women and members of diverse ethnic and racial groups) with PTSD as a result of military trauma.

The investigators plan to recruit 50 CTVHCS Veterans total. 25 CTVHCS Veterans will be enrolled at the CTVHCS site; thus, the local intent to treat sample is 25 CTVHCS Veterans. A secondary aim of this proposal is to support recruitment in the trial, and to this end approximately 25 CTVHCS Veterans will be enrolled in the San Francisco site and will be seen by a San Francisco VA study therapist. The investigators will review 400 charts and expect to recruit and enroll approximately 16% of reviewed Veterans, based on experiences at other study sites.

Recruitment Veterans will be recruited and treated at VA sites in Minneapolis, MN, San Diego, CA (Oceanside CBOC), and San Francisco, CA. Co-Investigators (Co-Is) at these study sites have successfully resolved operational obstacles and challenges to implementing clinical trials in their respective settings. Referrals for clinical studies have been nurtured through each Co-I's role as a clinician and PTSD expert. Co-Is will (a) provide 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) attend clinical staff meetings; (c) give talks to describe various treatments in staff grand rounds and other contexts (e.g., to trainees); and (d) provide feedback to staff about referred patients.

Assessor Training and Adherence

A co-investigator, Dr. Matt Gray (University of Wyoming) will train the assessors prior to beginning enrollment. Training will include reading and viewing training materials, observation of CAPS administration, and supervised administration of at least three CAPS. Dr. Gray has expertise in the conduct of CAPS assessment and has past experience performing training and fidelity monitoring for use of CAPS assessment in clinical trials. Each assessor will be considered trained on CAPS when he or she "matches" Dr. Gray on three interviews. To establish matching, Dr. Gray will co-rate an interview conducted by the assessor. A match occurs when the assessor and Dr. Gray agree on the diagnosis and are within 2 points of severity on all of the symptom clusters (PTSD criteria B, C, D, and E). If the assessor does not match on three interviews after five attempts, Dr. Gray will determine whether additional training is necessary or if the assessor needs to be replaced.

All assessments will be audiotaped to ensure that a standardized approach is being used across patients (provided that the participant consents). Dr. Gray will review audio recordings of 10% of the assessments, selected randomly. Dr. Gray can at his discretion increase the proportion reviewed for difficult patients or assessors needing additional monitoring. Assessors will be provided with feedback about their performance. All recordings will be stored on a restricted-access directory (i.e., only lab personnel with personal usernames expressly granted access may access the directory containing the folder of recordings, and they must log in with their personal username and password to do so) in a locked office maintained at the Boston VA Healthcare System, Jamaica Plain campus. Selected sessions (recordings and interviewer-scored assessments sheets) will be transported to Dr. Gray via Federal Express or another carrier that allows for tracking.

Random Assignment Veterans will be randomly assigned to PCT or AD-MIL. The Boston site will generate a randomized permuted block scheme to randomly assign patients to blocks by gender and minority status. Block size for gender and minority status will be based on the distribution of these variables at each site. Blocking by gender and minority status will ensure appropriate accrual rates for participants with lower base-rate characteristics. The Boston site will use constrained randomization (i.e., biased coin design) if unexpected imbalance arises in gender and minority distribution across treatment groups.

Treatment Fidelity Monitoring

Two half-time therapists with Ph.D.'s in clinical or counseling psychology and VA internship experiences treating Veterans with PTSD will be trained to deliver AD-MIL or PCT (not both). Training will involve a review of the respective manuals and supporting materials, intensive supervision of two trial cases, weekly group phone supervision (Dr. Litz for AD-MIL; Dr. Bolton for PCT), and weekly one-on-one supervision with Dr. Amidon (for AD-MIL) or Dr. Bolton (for PCT). Dr. Amidon was trained by Dr. Litz to administer AD for the Marine Corps trial and was recently trained to conduct AD-MIL. Dr. Bolton has provided training, supervision, and fidelity monitoring on numerous other treatment outcome studies, including two large randomized trials for Veterans in which PCT was compared to a trauma-focused intervention. Drs. Amidon and Bolton will review recordings of the first 2 trial cases to shape fidelity. All sessions will be audiotaped. Two random session recordings from a random 20% of the cases will be rated to ensure fidelity to each treatment approach. Selected sessions will be transported to Dr. Amidon and Bolton via Federal Express or another carrier that allows for tracking.

ANALYSES Inferential analyses. The longitudinal and clustered nature of the design produces a multilevel or nested data structure. In this study, Veterans and therapists are nested (clustered) within performance sites. The lower level (level-1) data consists 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., treatment arm and study site). In SAS Proc Mixed the two levels merge into one model with random intercept and slopes (aka "growth curve" model) using compound symmetry for variance within site and auto-correlated AR1 structure for the repeated measures. The investigators will conduct a mixed model analysis with random slopes/random intercepts from this multilevel regression framework to estimate initial status and formally compare 3-month changes over time in outcome (i.e., a linear contrast, with the level-1 or the within-subjects component of the analyses). Also, as an exploratory analysis, the investigators will test how coefficients vary as a function of level-2 components, including the longer term 6-month follow-up data. The analyses include continuous and categorical time varying and invariant predictors and covariates, use all the data, and produce more accurate parameter estimates.

Aim I: Randomized controlled trial of AD-MIL, comparing it to PCT:

Hypotheses 1 and 2: Veterans in the AD-MIL arm will have a steeper downward and upward slope in SDS (primary endpoint) and QOLI scores, respectively. Schematically, the following model will be tested:

Level 1: Yij = 0j + 1jdumpost + 2jdum3mosfu + 3jdum6mosfu + rij, Level 2: 0j = 00 + 01T + ui; 1j = 10 + 11T, 2j = 20 + 21T, 3j = 30 + 31T where Yij is the SDS score for subject j at assessment point i. In this model, time is represented by dummy-coded variables. Initially, dummy-coded variables representing the post-treatment (dumpost) and three- (dum3mosfu) and six- (dum6mosfu) month follow-up intervals will be entered into the level-1 component of the model. With this coding scheme, the pre-treatment time point is the reference time point; therefore, 0j = an individual's pre-treatment SDS score, while 1j, 2j, and 3j index the change from pre-treatment to post-treatment, three-month follow-up, and six-month follow-up, respectively. rij represents the level-1 (within-subjects) residual term. At level-2, there is a regression equation for each of the level-1 coefficients, and T is the indicator for treatment condition (AD-MIL or PCT), while uj represents the level-2 residual term. With Time (T) entered as a dummy-coded variable, in each level-2 equation, 0. represents the value of the particular level-1 regression coefficient for the treatment condition coded as 0 (i.e., the reference group), while 1. represents the difference between the two treatment conditions. The primary hypothesis will be evaluated by the level-2 coefficient 11, which represents differences between the two treatment groups from pre- to post-treatment. The investigators hypothesize that the AD-MIL group will show larger treatment gains: H0: 11 = 0 vs. H1: 11 0. The level-2 coefficients 21 and 31 can be evaluated to determine whether the treatment differences remain at follow-up assessments. Different coding schemes can be employed for the time component of the analyses. For example, orthogonal polynomial contrast codes can be used to evaluate linear and quadratic change in SDS scores from pre-treatment to the six-month follow-up assessment point. Identical calculations will be performed with the B-IPF and DRRI-2 Post-Deployment Social Support measure.

Hypotheses 3-5: Veterans in AD-MIL will have: (3) steeper downward PTSD symptom severity slopes (CAPS-5 and PCL-5) and lower incidence of PTSD cases (tested with Chi-square); (4) steeper slopes in depressive symptoms (PHQ-9); and (5) steeper slopes in shame and guilt (PANAS and TRGI). Separate models will be tested for each outcome. These models will be structured the same as the model used to test Hypotheses 1 and 2, with the above continuous measure scores designated as the outcome variables (Yij) in separate analyses. Once again, the level-2 coefficient 11 representing differences between the two treatment groups from pre- to post-treatment will be of primary interest, with the level-2 coefficients 21 and 31 evaluated to determine whether treatment differences remain at follow-up assessments.

Exploratory analyses: Will AD-MIL be associated with steeper downward slopes in anger and aggressive behaviors (STAXI-II, CTS2), suicidal ideation (DSI-SS), and alcohol abuse (QDS) as compared to PCT? The models used to evaluate these questions will be structured the same as the models above. The investigators will be especially circumspect about statistically significant findings for these variables.

Clinical significance: Clinical significance will be calculated by the Jacobson-Truax (1991) method. This method suggests a two-step criterion. First, a reasonable cutoff between the dysfunctional and functional populations is established. Because normative data for Veterans on the SDS and QOLI do not yet exist, Jacobson and Truax's (1991) suggested cutoff A, defined as the point 2 SDs beyond the range of the pre-therapy mean (cutoff A = Mclinical - 2 SDclinical for SDS and + 2 SDclinical for the QOLI) will be used. Next, a reliable change index (RC) for each participant will be calculated to ensure that changes are not due to an artifact of measurement error. The RC is computed according to the following: RC = (x2 - x1)/Sdiff where x1 represents the participant's pre-treatment SDS or QOLI 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 will be calculated from the internal consistency of the measure at each time point. An RC larger than 1.96 reflects real change. Based on the two-step criterion, individuals will be classified as recovered (passed both cutoff A and RC criteria), improved (pass RC criterion but not cutoff A), unchanged (passed neither criteria), or deteriorated (passed RC criterion but symptom scores increased) for each follow-up interval. Chi-square analyses will be used to compare proportions per arm at each follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: February 28, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• deployed to the Afghanistan and/or Iraq Wars

• meet the DSM-5 diagnostic criteria for PTSD

Exclusion Criteria:

• bipolar or psychotic disorders

• current drug or alcohol dependence (other than caffeine or tobacco dependence)

• evidence of traumatic brain injury severe enough to influence the ability to understand and respond to study procedures

• suicidal or homicidal ideation severe enough to warrant immediate attention

• concurrent enrollment in any cognitive-behavioral treatment or any other treatment that involves systematic disclosure of troubling deployment-related memories

• participants may continue current pharmacological treatment if stable on medication for at least 6 weeks, marital counseling, or any supportive therapy6.

• Lack of or inconsistent access to a useable phone

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Adaptive Disclosure for Moral Injury and Loss
Ad-MIL is a 12-session treatment designed to address shame and guilt and to develop compassion for the self and the other. At the outset of AD-MIL, the investigators ask Veterans to enlist a family member or friend to provide support and to reinforce their plan for adaptive, purposeful functioning moving forward. The sessions that follow homework assignments involve a discussion to reinforce positive steps taken and identifying obstacles to completion (e.g., self-defeating beliefs). There is a special emphasis on discussing self-handicapping, namely feeling unworthy of getting better or living a good life. The goal is not only for Veterans to develop a sense of mastery in accomplishing tasks and to experience the benefits of the activities, but also to work on overcoming feelings of unworthiness.
• Present Centered Therapy
Participants randomized to the PCT arm will receive 12 sessions of therapy focused on problems occurring in the present (with no focus on trauma or re-visiting past experiences).

Locations

Country	Name	City	State
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts
United States	Minneapolis VA Health Care System, Minneapolis, MN	Minneapolis	Minnesota
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California
United States	San Francisco VA Medical Center, San Francisco, CA	San Francisco	California
United States	Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX	Waco	Texas

Sponsors (5)

Lead Sponsor	Collaborator
VA Office of Research and Development	Central Texas Veterans Health Care System, Minneapolis Veterans Affairs Medical Center, San Diego Veterans Healthcare System, San Francisco Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (55)

Adler AB, Litz BT, Castro CA, Suvak M, Thomas JL, Burrell L, McGurk D, Wright KM, Bliese PD. A group randomized trial of critical incident stress debriefing provided to U.S. peacekeepers. J Trauma Stress. 2008 Jun;21(3):253-63. doi: 10.1002/jts.20342. — View Citation

Batterham PJ, Ftanou M, Pirkis J, Brewer JL, Mackinnon AJ, Beautrais A, Fairweather-Schmidt AK, Christensen H. A systematic review and evaluation of measures for suicidal ideation and behaviors in population-based research. Psychol Assess. 2015 Jun;27(2):501-512. doi: 10.1037/pas0000053. Epub 2014 Dec 15. Review. — View Citation

Bryan CJ, Morrow CE, Etienne N, Ray-Sannerud B. Guilt, shame, and suicidal ideation in a military outpatient clinical sample. Depress Anxiety. 2013 Jan;30(1):55-60. doi: 10.1002/da.22002. Epub 2012 Oct 17. — View Citation

Cameron IM, Crawford JR, Lawton K, Reid IC. Psychometric comparison of PHQ-9 and HADS for measuring depression severity in primary care. Br J Gen Pract. 2008 Jan;58(546):32-6. doi: 10.3399/bjgp08X263794. — View Citation

Eftekhari A, Ruzek JI, Crowley JJ, Rosen CS, Greenbaum MA, Karlin BE. Effectiveness of national implementation of prolonged exposure therapy in Veterans Affairs care. JAMA Psychiatry. 2013 Sep;70(9):949-55. doi: 10.1001/jamapsychiatry.2013.36. — View Citation

Fontana A, Rosenheck R, Brett E. War zone traumas and posttraumatic stress disorder symptomatology. J Nerv Ment Dis. 1992 Dec;180(12):748-55. — View Citation

Friedman MJ. Posttraumatic stress disorder among military returnees from Afghanistan and Iraq. Am J Psychiatry. 2006 Apr;163(4):586-93. — View Citation

Frost ND, Laska KM, Wampold BE. The evidence for present-centered therapy as a treatment for posttraumatic stress disorder. J Trauma Stress. 2014 Feb;27(1):1-8. doi: 10.1002/jts.21881. Review. — View Citation

Gerger H, Munder T, Barth J. Specific and nonspecific psychological interventions for PTSD symptoms: a meta-analysis with problem complexity as a moderator. J Clin Psychol. 2014 Jul;70(7):601-15. doi: 10.1002/jclp.22059. Epub 2013 Dec 18. — View Citation

Germer CK, Neff KD. Self-compassion in clinical practice. J Clin Psychol. 2013 Aug;69(8):856-67. doi: 10.1002/jclp.22021. Epub 2013 Jun 17. — View Citation

Gray MJ, Schorr Y, Nash W, Lebowitz L, Amidon A, Lansing A, Maglione M, Lang AJ, Litz BT. Adaptive disclosure: an open trial of a novel exposure-based intervention for service members with combat-related psychological stress injuries. Behav Ther. 2012 Jun;43(2):407-15. doi: 10.1016/j.beth.2011.09.001. Epub 2011 Oct 1. — View Citation

Green BL, Goodman LA, Krupnick JL, Corcoran CB, Petty RM, Stockton P, Stern NM. Outcomes of single versus multiple trauma exposure in a screening sample. J Trauma Stress. 2000 Apr;13(2):271-86. — View Citation

Hofmann SG, Grossman P, Hinton DE. Loving-kindness and compassion meditation: potential for psychological interventions. Clin Psychol Rev. 2011 Nov;31(7):1126-32. doi: 10.1016/j.cpr.2011.07.003. Epub 2011 Jul 26. Review. — View Citation

Hoge CW, Auchterlonie JL, Milliken CS. Mental health problems, use of mental health services, and attrition from military service after returning from deployment to Iraq or Afghanistan. JAMA. 2006 Mar 1;295(9):1023-32. — View Citation

Hoge CW, Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL. Combat duty in Iraq and Afghanistan, mental health problems and barriers to care. US Army Med Dep J. 2008 Jul-Sep:7-17. — View Citation

Hoge CW, Grossman SH, Auchterlonie JL, Riviere LA, Milliken CS, Wilk JE. PTSD treatment for soldiers after combat deployment: low utilization of mental health care and reasons for dropout. Psychiatr Serv. 2014 Aug 1;65(8):997-1004. doi: 10.1176/appi.ps.201300307. — View Citation

Jordan BK, Marmar CR, Fairbank JA, Schlenger WE, Kulka RA, Hough RL, Weiss DS. Problems in families of male Vietnam veterans with posttraumatic stress disorder. J Consult Clin Psychol. 1992 Dec;60(6):916-26. — View Citation

Kaloupek DG, Chard KM, Freed MC, Peterson AL, Riggs DS, Stein MB, Tuma F. Common data elements for posttraumatic stress disorder research. Arch Phys Med Rehabil. 2010 Nov;91(11):1684-91. doi: 10.1016/j.apmr.2010.06.032. Review. — View Citation

Kearney DJ, Malte CA, McManus C, Martinez ME, Felleman B, Simpson TL. Loving-kindness meditation for posttraumatic stress disorder: a pilot study. J Trauma Stress. 2013 Aug;26(4):426-34. doi: 10.1002/jts.21832. Epub 2013 Jul 25. — View Citation

Kok BE, Coffey KA, Cohn MA, Catalino LI, Vacharkulksemsuk T, Algoe SB, Brantley M, Fredrickson BL. How positive emotions build physical health: perceived positive social connections account for the upward spiral between positive emotions and vagal tone. Psychol Sci. 2013 Jul 1;24(7):1123-32. doi: 10.1177/0956797612470827. Epub 2013 May 6. Erratum in: Psychol Sci. 2016 Jun;27(6):931. — View Citation

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. — View Citation

Lang AJ, Schnurr PP, Jain S, He F, Walser RD, Bolton E, Benedek DM, Norman SB, Sylvers P, Flashman L, Strauss J, Raman R, Chard KM. Randomized controlled trial of acceptance and commitment therapy for distress and impairment in OEF/OIF/OND veterans. Psychol Trauma. 2017 Aug;9(Suppl 1):74-84. doi: 10.1037/tra0000127. Epub 2016 Jun 20. — View Citation

Litz BT, Engel CC, Bryant RA, Papa A. A randomized, controlled proof-of-concept trial of an Internet-based, therapist-assisted self-management treatment for posttraumatic stress disorder. Am J Psychiatry. 2007 Nov;164(11):1676-83. — View Citation

Litz BT, Stein N, Delaney E, Lebowitz L, Nash WP, Silva C, Maguen S. Moral injury and moral repair in war veterans: a preliminary model and intervention strategy. Clin Psychol Rev. 2009 Dec;29(8):695-706. doi: 10.1016/j.cpr.2009.07.003. Epub 2009 Jul 29. Review. — View Citation

Magruder KM, Frueh BC, Knapp RG, Johnson MR, Vaughan JA 3rd, Carson TC, Powell DA, Hebert R. PTSD symptoms, demographic characteristics, and functional status among veterans treated in VA primary care clinics. J Trauma Stress. 2004 Aug;17(4):293-301. — View Citation

Maguen S, Luxton DD, Skopp NA, Gahm GA, Reger MA, Metzler TJ, Marmar CR. Killing in combat, mental health symptoms, and suicidal ideation in Iraq war veterans. J Anxiety Disord. 2011 May;25(4):563-7. doi: 10.1016/j.janxdis.2011.01.003. Epub 2011 Jan 22. — View Citation

Maguen S, Madden E, Bosch J, Galatzer-Levy I, Knight SJ, Litz BT, Marmar CR, McCaslin SE. Killing and latent classes of PTSD symptoms in Iraq and Afghanistan veterans. J Affect Disord. 2013 Mar 5;145(3):344-8. doi: 10.1016/j.jad.2012.08.021. Epub 2012 Sep 7. — View Citation

Maguen S, Metzler TJ, Bosch J, Marmar CR, Knight SJ, Neylan TC. Killing in combat may be independently associated with suicidal ideation. Depress Anxiety. 2012 Nov;29(11):918-23. doi: 10.1002/da.21954. Epub 2012 Apr 13. — View Citation

McDonald SD, Calhoun PS. The diagnostic accuracy of the PTSD checklist: a critical review. Clin Psychol Rev. 2010 Dec;30(8):976-87. doi: 10.1016/j.cpr.2010.06.012. Epub 2010 Jul 6. Review. — View Citation

McFall M, Fontana A, Raskind M, Rosenheck R. Analysis of violent behavior in Vietnam combat veteran psychiatric inpatients with posttraumatic stress disorder. J Trauma Stress. 1999 Jul;12(3):501-17. — View Citation

Moher D, Schulz KF, Altman DG; CONSORT Group. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Clin Oral Investig. 2003 Mar;7(1):2-7. Epub 2003 Jan 31. — View Citation

Nash WP, Litz BT. Moral injury: a mechanism for war-related psychological trauma in military family members. Clin Child Fam Psychol Rev. 2013 Dec;16(4):365-75. doi: 10.1007/s10567-013-0146-y. Review. — View Citation

Nash WP, Marino Carper TL, Mills MA, Au T, Goldsmith A, Litz BT. Psychometric evaluation of the Moral Injury Events Scale. Mil Med. 2013 Jun;178(6):646-52. doi: 10.7205/MILMED-D-13-00017. — View Citation

Neria Y, Litz BT. BEREAVEMENT BY TRAUMATIC MEANS: THE COMPLEX SYNERGY OF TRAUMA AND GRIEF. J Loss Trauma. 2004 Jan 1;9(1):73-87. — View Citation

Pace TW, Negi LT, Adame DD, Cole SP, Sivilli TI, Brown TD, Issa MJ, Raison CL. Effect of compassion meditation on neuroendocrine, innate immune and behavioral responses to psychosocial stress. Psychoneuroendocrinology. 2009 Jan;34(1):87-98. doi: 10.1016/j.psyneuen.2008.08.011. Epub 2008 Oct 4. — View Citation

Pivar IL, Field NP. Unresolved grief in combat veterans with PTSD. J Anxiety Disord. 2004;18(6):745-55. — View Citation

Popiel A, Zawadzki B. Trauma Related Guilt Inventory - psychometric properties of the Polish adaptation (TRGI-PL). Psychiatr Pol. 2015;49(5):1089-99. doi: 10.12740/PP/36754. English, Polish. — View Citation

Rodriguez P, Holowka DW, Marx BP. Assessment of posttraumatic stress disorder-related functional impairment: a review. J Rehabil Res Dev. 2012;49(5):649-65. Review. — View Citation

Samper RE, Taft CT, King DW, King LA. Posttraumatic stress disorder symptoms and parenting satisfaction among a national sample of male vietnam veterans. J Trauma Stress. 2004 Aug;17(4):311-5. — View Citation

Santiago PN, Ursano RJ, Gray CL, Pynoos RS, Spiegel D, Lewis-Fernandez R, Friedman MJ, Fullerton CS. A systematic review of PTSD prevalence and trajectories in DSM-5 defined trauma exposed populations: intentional and non-intentional traumatic events. PLoS One. 2013 Apr 11;8(4):e59236. doi: 10.1371/journal.pone.0059236. Print 2013. Review. — View Citation

Savarese VW, Suvak MK, King LA, King DW. Relationships among alcohol use, hyperarousal, and marital abuse and violence in Vietnam veterans. J Trauma Stress. 2001 Oct;14(4):717-32. — View Citation

Schnurr PP, Friedman MJ, Engel CC, Foa EB, Shea MT, Chow BK, Resick PA, Thurston V, Orsillo SM, Haug R, Turner C, Bernardy N. Cognitive behavioral therapy for posttraumatic stress disorder in women: a randomized controlled trial. JAMA. 2007 Feb 28;297(8):820-30. — View Citation

Schnurr PP, Hayes AF, Lunney CA, McFall M, Uddo M. Longitudinal analysis of the relationship between symptoms and quality of life in veterans treated for posttraumatic stress disorder. J Consult Clin Psychol. 2006 Aug;74(4):707-13. — View Citation

Schnurr PP, Lunney CA. Exploration of gender differences in how quality of life relates to posttraumatic stress disorder in male and female veterans. J Rehabil Res Dev. 2008;45(3):383-93. — View Citation

Shea MT, Vujanovic AA, Mansfield AK, Sevin E, Liu F. Posttraumatic stress disorder symptoms and functional impairment among OEF and OIF National Guard and Reserve veterans. J Trauma Stress. 2010 Feb;23(1):100-7. doi: 10.1002/jts.20497. — View Citation

Sheehan KH, Sheehan DV. Assessing treatment effects in clinical trials with the discan metric of the Sheehan Disability Scale. Int Clin Psychopharmacol. 2008 Mar;23(2):70-83. doi: 10.1097/YIC.0b013e3282f2b4d6. Review. — View Citation

Steenkamp MM, Litz BT. Psychotherapy for military-related posttraumatic stress disorder: review of the evidence. Clin Psychol Rev. 2013 Feb;33(1):45-53. doi: 10.1016/j.cpr.2012.10.002. Epub 2012 Oct 13. Review. — View Citation

Stein NR, Mills MA, Arditte K, Mendoza C, Borah AM, Resick PA, Litz BT; STRONG STAR Consortium. A scheme for categorizing traumatic military events. Behav Modif. 2012 Nov;36(6):787-807. doi: 10.1177/0145445512446945. Epub 2012 Jun 7. — View Citation

Straus MA, Douglas EM. A short form of the Revised Conflict Tactics Scales, and typologies for severity and mutuality. Violence Vict. 2004 Oct;19(5):507-20. — View Citation

Taft CT, Street AE, Marshall AD, Dowdall DJ, Riggs DS. Posttraumatic stress disorder, anger, and partner abuse among Vietnam combat veterans. J Fam Psychol. 2007 Jun;21(2):270-7. — View Citation

Teten AL, Miller LA, Bailey SD, Dunn NJ, Kent TA. Empathic deficits and alexithymia in trauma-related impulsive aggression. Behav Sci Law. 2008;26(6):823-32. doi: 10.1002/bsl.843. — View Citation

Toblin RL, Riviere LA, Thomas JL, Adler AB, Kok BC, Hoge CW. Grief and physical health outcomes in U.S. soldiers returning from combat. J Affect Disord. 2012 Feb;136(3):469-75. doi: 10.1016/j.jad.2011.10.048. Epub 2011 Dec 9. — View Citation

Vogt D, Smith BN, King LA, King DW, Knight J, Vasterling JJ. Deployment risk and resilience inventory-2 (DRRI-2): an updated tool for assessing psychosocial risk and resilience factors among service members and veterans. J Trauma Stress. 2013 Dec;26(6):710-7. — View Citation

Vogt DS, Proctor SP, King DW, King LA, Vasterling JJ. Validation of scales from the Deployment Risk and Resilience Inventory in a sample of Operation Iraqi Freedom veterans. Assessment. 2008 Dec;15(4):391-403. doi: 10.1177/1073191108316030. Epub 2008 Apr 24. — View Citation

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. Review. — View Citation

* Note: There are 55 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of change in functional impairment from baseline through 6-month follow-up	The Sheehan Disability Scale (SDS) will be the investigators' primary functional outcome measure. Respondents indicate 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," and list the number of lost and unproductive work or school days. For this study, the investigators will have participants' index impairment caused by PTSD symptoms in the last month.	Assessments will occur at baseline and approximately 3, 6, and 9 months after the first treatment session, or, if no treatment sessions were attended or a participant terminated therapy early, approximately 3, 6, and 9 months after baseline
Primary	Rate of change in psychosocial functional gains made from baseline through 6-month follow-up	The Brief Inventory of Psychosocial Functioning (BIPF) will be used to confirm and expand upon the description of the functional gains made from AD-MIL, and allow comparisons with veteran norms or other published trial results. 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.	Assessments will occur at baseline and approximately 3, 6, and 9 months after the first treatment session, or, if no treatment sessions were attended or a participant terminated therapy early, approximately 3, 6, and 9 months after baseline
Primary	Rate of change in PTSD symptom severity and diagnosis from baseline through 6-month follow-up	The Clinician Administered PTSD Scale for DSM-5 (CAPS-5) will be used to diagnose PTSD and index PTSD symptom severity.	Assessments will occur at baseline and approximately 3, 6, and 9 months after the first treatment session, or, if no treatment sessions were attended or a participant terminated therapy early, approximately 3, 6, and 9 months after baseline
Primary	Rate of change in state anger from baseline through 6-month follow-up	The investigators will measure anger with the State-Trait Anger Expression Inventory-2 (STAXI-2) State Anger subscale, which is a 15-item self-report measure of current intensity of anger.	Assessments will occur at baseline and approximately 3, 6, and 9 months after the first treatment session, or, if no treatment sessions were attended or a participant terminated therapy early, approximately 3, 6, and 9 months after baseline
Primary	Rate of change in use of aggressive behavior from baseline through 6-month follow-up	We will measure aggressive behaviors using the physical assault and psychological aggression subscales of the Revised Conflict Tactics Scale (CTS2).	Assessments will occur at baseline and approximately 3, 6, and 9 months after the first treatment session, or, if no treatment sessions were attended or a participant terminated therapy early, approximately 3, 6, and 9 months after baseline
Primary	Rate of change in alcohol use from baseline through 6-month follow-up	Alcohol abuse will be evaluated with the Quick Drinking Screen (QDS), 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).	Assessments will occur at baseline and approximately 3, 6, and 9 months after the first treatment session, or, if no treatment sessions were attended or a participant terminated therapy early, approximately 3, 6, and 9 months after baseline
Secondary	Moral Injury Events Scale	The MIES is an 11-item scale that evaluates various military-related potential moral transgressions by self or others.	Baseline
Secondary	Rate of change in quality of life from baseline through 6-month follow-up	The Quality of Live Inventory will be used to generate an overall score on scores and subscales of achievement, self-expression, relationships, and surroundings calculated based on satisfaction scores weighted by endorsed importance.	Assessments will occur at baseline and approximately 3, 6, and 9 months after the first treatment session, or, if no treatment sessions were attended or a participant terminated therapy early, approximately 3, 6, and 9 months after baseline
Secondary	Rate of change in social support resources from baseline through 6-month follow-up	The Post-Deployment Social Support subscale of Deployment Risk and Resiliency Inventory-2 scale will be used to assess social support resources.	Assessments will occur at baseline and approximately 3, 6, and 9 months after the first treatment session, or, if no treatment sessions were attended or a participant terminated therapy early, approximately 3, 6, and 9 months after baseline
Secondary	Rate of change in PTSD symptom burden across course of psychotherapy	The PTSD Checklist for DSM-5 will be used to examine PTSD symptom burden at baseline and prior to each of the 12 weekly treatment session.	Baseline and weekly prior to each of the 12 weekly treatment sessions
Secondary	Rate of change in shame and guilt from baseline through 6-month follow-up	The investigators will use the Positive and Negative Affectivity Schedule (PANAS) to measure shame and guilt, indexed to the last month.	Assessments will occur at baseline and approximately 3, 6, and 9 months after the first treatment session, or, if no treatment sessions were attended or a participant terminated therapy early, approximately 3, 6, and 9 months after baseline
Secondary	Rate of change in guilt feelings and attitudes about a specific warzone event from baseline through 6-month follow-up	The Trauma-Related Guilt Inventory (TRGI) will be used to assess guilty feelings and attitudes about a specific warzone event (Kubany et al., 1996). It is scored into three scales (Global Guilt, Distress Scale, and Guilt Cognitions) and 3 subscales (Hindsight-Bias/Responsibility, Wrongdoing, and Lack of Justification).	Assessments will occur at baseline and approximately 3, 6, and 9 months after the first treatment session, or, if no treatment sessions were attended or a participant terminated therapy early, approximately 3, 6, and 9 months after baseline
Secondary	Rate of change in suicidality across course of psychotherapy	The Depressive Symptoms Index - Suicidality Subscale (DSI-SS) is a 4-item scale that focuses on ideation, plans, perceived control over ideation, and impulses for suicide. It is being used as a core measure in the Military Suicide Research Consortium. 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).	Baseline and weekly prior to each of the 12 weekly treatment sessions
Secondary	The DRRI-2 Combat Experiences and Aftermath of Battle	The DRRI-2 measures combat exposure to potentially traumatic events.	Baseline