Psychosocial Rehabilitation After Moral Injury and Loss With Adaptive Disclosure

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.

B: Mental health change hypotheses:

B.3. Veterans randomized to AD-MIL will have greater reductions in PTSD symptom severity and
a smaller percentage of PTSD cases B.4. Veterans randomized to AD-MIL will have greater
reductions in depressive symptoms B.5. Veteran randomized to AD-MIL will have greater
reductions in shame and guilt

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 The investigators plan to conduct a multi-site randomized controlled trial of AD-MIL,
comparing it to PCT. The trial will follow the consensus recommendations for clinical trials
in the VA (VA-ORD, 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 Participants will comprise a sample of 186 Veterans (including women and members
of diverse ethnic and racial groups) with PTSD as a result of the Iraq or Afghanistan Wars.

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.

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 therapy