An Efficient, Exposure-based Treatment for PTSD Compared to Prolonged Exposure: A Non-inferiority Randomized Trial
Phase: NA
Conditions: PTSD
Sponsor: VA Office of Research and Development

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An efficient, exposure-based treatment for PTSD compared to Prolonged Exposure: A non-inferiority 
randomized trial 
Principal Investigator: Denise Sloan, Ph.D. 
 
Phone: 857-364-6333 
 
E-mail: denise.sloan@va.gov 
 
Protocol Version Number: 10 
Protocol Version Date: N/A  
 
Funding Mechanism:  VA, CSR&D  
ClinicalTrials.gov number: NCT03962504 
 
 
 
 
 

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TABLE OF CONTENTS 
 
1. Protocol Summary/Abstract   (Limit to approximately 500 words) ................................. 3 
2. Background Information ........................................................................................................ 3 
3. Rationale and Purpose .......................................................................................................... 4 
4. Objectives ................................................................................. Error! Bookmark not defined. 
5. Relevance to Veterans Health ............................................................................................. 4 
6. Study Design ........................................................................................................................... 5 
7. Study Subject Selection ........................................................................................................ 8 
a. 
Subject Inclusion Criteria ............................................................................................. 8 
b. 
Subject Exclusion Criteria ........................................................................................... 8 
c. 
Recruitment ................................................................................................................... 9 
8. Data Collection/ Study Measures ...................................................................................... 10 
9. Planned Statistical Analyses .............................................................................................. 16 
10. Ethical Issues ........................................................................................................................ 18 
a. 
Risks ............................................................................................................................. 18 
b. 
Potential Benefits ........................................................................................................ 19 
c. 
Analysis of Risks in Relation to Benefits ................................................................. 20 
d. 
Stopping Rules .......................................................................................................... 221 
11. Safety Monitoring Plan ...................................................................................................... 221 
12. Adverse Event/Unanticipated Problems Reporting Plans ............................................. 24 

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1.  Protocol Summary/Abstract   
 
Objectives: 
The goal of this study is to investigate whether written exposure 
therapy (WET) is non-inferior compared to Prolonged Exposure (PE) 
in the treatment of PTSD in a sample of veterans diagnosed with 
PTSD. Treatment dropout rates and moderators of treatment 
outcome will also be examined. 
Research Design: 
The study is a randomized, non-inferiority design. 
Methodology 
Men and women veterans diagnosed with PTSD will be randomly 
assigned to either WET (n = 90) or PE (n = 90). There will be three 
VA recruitment sites; Boston, Charleston, SC and Madison, WI. PTSD 
symptom severity will serve as the primary outcome. Assessments 
will be conducted by independent evaluators at baseline, 10-, 20-, 
and 30-week post first treatment session.   
Clinical Implications: 
If WET is found to be non-inferior to the more time intensive PE 
treatment then the VA will have evidence to support the use of a 
brief PTSD treatment, which will assist in addressing the high 
demand for PTSD clinical services. 
 
 
 
 
2. Aims/Objectives 
 
The proposed study will examine the extent to which WET is non-inferior in reducing PTSD symptom 
severity among veterans with PTSD relative to the widely used but more time intensive, PE.  
We propose the following aims and hypotheses: 
Aim 1: Determine if WET is non-inferior relative to PE in terms of PTSD symptom severity. 
Hypothesis 1a. WET will be non-inferior to PE at both 10- and 20-weeks after initiating 
treatment. PTSD symptom severity will be assessed using the Clinician Administered PTSD Scale 
for DSM-5. 
Hypothesis 1b. Non-inferiority will be maintained 30 weeks after initiating treatment.  
Aim 2. Determine if WET has better treatment retention than PE.  
Hypothesis 2a. WET will have significant fewer treatment dropouts compared with the first 5 
sessions of PE. 
Aim 3: We will explore potential moderators of treatment effects for both WET and PE. Given that prior 
studies of PTSD treatment moderators have shown mixed results, this aim is exploratory. Our 
exploratory analyses will include variables that have been tested in other studies (e.g., age, sex, combat 
era, pre-treatment depression, social support, and estimated IQ). 
Aim 4:  Functioning will be examined as a secondary outcome.  

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Hypothesis: We expect that participants assigned to both PE and WET will display significant 
improvements in functioning as measures by the WHOQOL-BREF, however, we do not expect to 
find between condition differences. 
 
 
3. Background Information 
 
PTSD is a highly prevalent condition for which veterans frequently seek treatment in the VA 
healthcare system (Fulton et al., 2015). Several evidence-based psychotherapies are available, 
with Prolonged Exposure (PE; Foa et al., 2007) and Cognitive Processing Therapy (CPT; Resick et 
al., 2007) having the strongest evidence (Cusack et al., 2016).  VA has devoted considerable 
resources to ensure that its mental healthcare providers are trained in these two gold standard 
PTSD treatments (Karlin et al., 2010). Unfortunately, implementation data indicate that trained 
VA providers are not consistently using these treatments, citing high clinic demands in 
combination with limited staff resources as a barrier (Finley et al., 2015; Watts et al., 2014). 
Moreover, many veterans are either unwilling or unable to engage in these treatments, with 
attrition as high as 50% in some clinics and studies (Kehle-Forbes et al., 2016; Steenkamp et al., 
2015). These circumstances suggest that there is a critical need to identify alternative evidence-
based PTSD treatments that are brief, well-tolerated, and do not place heavy burdens upon 
clinicians and veteran patients alike.  
 
 
4. Rationale and Purpose  
 
Written Exposure Therapy (WET) is a promising alternative that fulfills these requirements. WET is 
brief (i.e., 5 sessions with no between session assignments) and is the result of careful, systematic 
research on the components necessary for successful PTSD treatment. Prior studies on WET have 
demonstrated its efficacy in reducing PTSD symptoms, with extremely low attrition among those 
who received the treatment (e.g., less than 10%). Although the accumulated evidence for WET is 
sufficiently strong that it is now included as a recommended PTSD treatment in the VA/DoD 
Clinical Practice Guidelines for managing PTSD (2017), there have been no randomized clinical 
trials (RCTs) of WET focusing solely on veterans.  Such a study is crucial as PE and CPT are not as 
effective with veterans as they are with non-veteran trauma survivors and dropout rates tend to 
be higher with veterans as well (Steenkamp et al., 2015). Before WET is used throughout the VA 
to treat veterans with PTSD, it is necessary to conduct a rigorous RCT on WET with a veteran 
sample to demonstrate the efficacy of WET with veterans. We are directly comparing WET with 
Prolonged Exposure, to investigate if WET is just as effective as a greater time and resource 
intensive, exposure-based approach. 
 
 
5. Relevance to Veterans Health 
 
PTSD is a prevalent condition for which veterans frequently seek treatment in the VA healthcare 
system.  There are a number of first-line PTSD treatment approaches available, such as Prolonged 
Exposure and Cognitive Processing Therapy. However, the efficacy rates of these treatments is 
not as high as what has been observed with civilian populations (e.g., Hoge, 2016; Steenkamp et 

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al., 2015) and approximately 36% of individuals drop out of these treatments prematurely (Imel et 
al., 2013). In addition to these efficacy and treatment dropout concerns, implementation barriers 
have been noted among VA mental health providers (e.g., Finley et al., 2015), with clinical care 
demands in combination with limited staff resources cited as a barrier to implementation. Taken 
together, these issues underscore the need to identify alternative treatment approaches that 
address the barriers cited by both patients and providers. Written Exposure Therapy (WET) is one 
potential alternative treatment approach that addresses these barriers. WET is a five session 
treatment that has demonstrated efficacy and is associated with low treatment dropout rates 
(e.g., 5-10%). If WET is found to be non-inferior relative to the more time intensive Prolonged 
Exposure in the treatment of veterans with PTSD, then VA would be able to recommend its use 
for the veteran population. 
 
 
6.  Study Design 
The proposed study will use a non-inferiority design to examine whether WET is non-inferior to 
Prolonged Exposure (PE), a first-line treatment for PTSD that is frequently used by VA treatment 
providers and is more time intensive.    
The study will take place at three sites: VA Boston Healthcare System (VABHS), which has two 
PTSD clinic (PTC) clinics (Jamaica Plain and Brockton campuses), Ralph H Johnson (RHJ) VAMC PTC 
clinic, in Charleston, South Carolina, and William S. Middleton Memorial Veterans Hospital, 
Madison, WI. Veterans will be randomly assigned to either WET (n = 90) or PE (n = 90). 
Assessments will be conducted at baseline, and 10-, 20-, and 30- weeks post first treatment 
session.  PTSD symptom severity, acquired through the use of a clinician-administered structured 
interview, will serve as the primary outcome variable.  
Randomization and Blinding 
After eligibility is determined, the project statistician, who is not involved in evaluations, will 
randomize participants using a computerized block (gender) randomization procedure with a 1:1 
allocation ratio for WET and PE conditions. The project coordinator, who will be responsible for 
final determination of study eligibility, will be blinded to the randomization sequence. Participants 
will be unaware of study hypotheses and will be instructed not to reveal their randomization 
status to the IEs prior to each assessment. To further protect blinding, IEs will be located 
separately from the therapists, and a new rater will be assigned in the event of an unintentional 
unblinding.  
 
Treatment Conditions and Delivery  
WET and PE will be delivered using structured treatment manuals to ensure treatment fidelity. 
Each treatment session will be recorded to permit close supervision and assessment of treatment 
fidelity and integrity by an independent rater. Therapists will be licensed mental health providers 
from the two recruitment sites. We anticipate selecting 4-6 study therapists at each recruitment 
site.  
 
When conducting a RCT that compares two treatments, one must carefully consider therapist 
effects. Investigators must choose between nesting therapists within a specific form of therapy 

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(e.g., a given therapist always conducts PE) or counterbalancing therapists across both forms of 
treatment (e.g., a given therapist runs both WET and PE).  Although counterbalancing can remove 
therapist effects by equating them across conditions, one runs the risk of diluting both treatment 
conditions if therapists become confused and mix elements across treatments. On the other 
hand, nesting therapists within condition allows them to specialize in one treatment.  If therapists 
differ widely with respect to skill and/or enthusiasm for one particular treatment, this choice can 
confound therapists with condition.  
In this proposed study, we elected to counterbalance therapists within condition for two reasons.  
First, we have no reason to suspect that study therapists will have particular enthusiasm for either 
treatment, as they have not been involved in the development of this project and therapists at 
both sites have been using both PE and WET in the clinics. Second, therapists will be equivalent 
with respect to skill level, experience with veterans, and other factors that potentially could be 
confounds.  
We will conduct guided interviews with approximately 8 of the therapists who delivered PE and 
written exposure therapy to veteran participants in the study. The interviews will be conducted to 
better understand their perception of written exposure therapy and how it compares with more 
time intensive evidence-based PTSD treatment, Prolonged Exposure, that is routinely used in the 
VA system.  This information will be helpful in understanding facilitators and barriers to using 
written exposure therapy, as well as factors that may affect when providers would use the 
treatment over other available treatments.  
Qualitative interviews with key stakeholders are an ideal method to collect nuanced, comprehensive 
information about PTSD treatment from a relatively small sample. Qualitative data from providers with 
firsthand knowledge about the use of given treatments at their facility, as well as the potential fit of 
more versus less intensive treatment approaches, provide an ideal source for meeting the proposed 
goals of identifying facilitators and barriers for scale-up of WET. 
All study activities will be conducted at VABHS, but the sample of therapists will be drawn from our 
study recruitment sites at the Charleston and Madison VA medical centers. Clinicians at these VA sites 
will be interviewed via MicroSoft Teams using audio only by VABHS study staff. No names will be used in 
the interviews. 
 
This is a retrospective study using exclusively qualitative methods. We will ask providers to take 
part in a one-time interview lasting up to 45 minutes. No interventions will be implemented, nor will 
providers be randomized in any way. We anticipate enrolling up to 8 clinicians across both sites. 
 
Process: 
1. Study staff will send up to three recruitment emails to the clinicians who provided 
treatment for the study. The email will describe the interview opportunity and offer 
recipients a chance to opt-out of receiving follow-up emails or phone calls. 
2. After 3 emails, if the provider has neither opted-out of recruitment or responded to 
indicate their interest, no further contact will be made. 
3. If the provider indicates interest, the study will be described. If the provider agrees to take 
part, a time for the interview will be arranged at their convenience. 

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4. The prospective agreement will be emailed to the participant in advance of the scheduled 
interview. (see attached prospective agreement). 
 
Interviews: Interviews will be scheduled to accommodate the providers schedule and, when possible, 
scheduled during a clinical cancelation to reduce burden. All interviews will be guided by a semi-
structured interview guide (see attached). The questions are intended to elicit information from the 
stakeholders’ own experiences. All interviews will be conducted by Dr. Thompson-Hollands or another 
trained and qualified study team member. Interviews will be audiotaped and transcribed verbatim. 
Interviews will last up to 45 minutes, and there will be no further follow up with providers after that 
time. Providers will not be paid for their participation, as they are all VA employees. 
 
Audio recordings will be stored on the PI’s dedicated research drive. Transcription will be 
conducted by the VA Centralized Transcription Services Program (CTSP). CTSP is a VA-based service that 
employs professional transcriptionists (VA employees) for use across various research projects. 
Transcriptionists will be given electronic access to one specific folder on the PI’s research drive by IRM 
(the folder containing the audio recordings). They will not have access to other folders within the 
research drive. The PI will coordinate with IRM to remove the transcriptionists’ access following the end 
of transcription. 
 
Statistical Analysis Plan 
 
Power analyses are not relevant for qualitative studies, as the goal is to conduct a sufficient 
number of interviews to reach thematic saturation. We expect to reach saturation with the proposed 
sample size, but we will recruit more interviewees if our analyses do not yield thematic saturation. 
 
We have elected to use a rapid content analysis approach (Hamilton, 2020) to identify key 
findings that address barriers and facilitators to the use of WET and PE. Rapid content analysis allows 
data analysis to occur simultaneously with data collection, providing a streamlined pathway for data 
reduction. Rapid content analysis will be conducted by coders (Dr. Thompson-Hollands and other 
trained study staff). The coders will use transcript summary templates and matrices to organize and 
distill key themes. Matrices allow for the identification of systematic similarities and differences across 
interviews, facilitating the efficient synthesis of findings. Separate matrices will be developed for each 
site, to facilitate comparisons. As additional interviews are conducted and analyzed, cross-cutting 
themes are identified. Our analytic approach will incorporate both inductive and deductive elements, 
ensuring that we evaluate initial constructs of interest and assumptions while also allowing for the 
emergence of new and unexpected themes.  
 
Ethical Issues 
 
a. Risks 
There is a potential risk of loss of confidentiality for providers. While we will not be asking about 
sensitive personal information, providers may nevertheless describe opinions that could be 
perceived as critical regarding a given treatment. All data will be coded with a study ID number 
rather than the providers name, and transcripts will have identifying information removed (e.g., any 
proper names used by the provider will be replaced with a label indicating the role of that person, 

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such as [the veteran] or [my coworker]; the name of the facility/clinic will likewise be replaced by a 
label such as [this facility] or [this clinic]).  
 
b. Potential Benefits 
No anticipated direct benefits to providers.  
1.  
c. Analysis of Risks in Relation to Benefits 
The risk of loss of confidentiality is low, and is balanced by the potential value of the information to 
be gathered. Any individual provider may choose not to share opinions or experiences that they feel 
are too sensitive to disclose, and they will be permitted to decline to answer any question at their 
own discretion.  
 
d. Stopping Rules 
A provider may always withdraw their participation at any time..  
 
 
7. Study Subject Selection 
 
a. Sample Description 
Men and women veterans presenting to VA for mental health treatment services. 
2.  
b. Subject Inclusion Criteria 
a current DSM-5 diagnosis of PTSD (assessed with the Clinician Administered PTSD Scale for DSM-5; 
CAPS-5),  
veteran status 
if taking psychotropic medication, on a stable dose for at least 30 days prior to study entry 
 
c.  Subject Exclusion Criteria 
current engagement psychosocial treatment for PTSD,  
current diagnosis of severe substance use disorder (mild to moderate severity will not be excluded; 
determined with SCID),  
current psychosis or unstable bipolar disorder diagnosis (determined with MINI clinician-
administered interview),  
high suicidal risk (i.e., intent with a plan; assessed with the SITBI),  
significant cognitive impairment (assessed with clinical judgement).  
d.  Recruitment 
 
The primary recruitment strategy will be referrals by mental health providers in the PTC. In 
addition, we will notify additional mental health clinics about our study and seek referrals from 
these clinics as well (e.g., General Mental Health, Substance use clinics, Center for Returning 
Veterans, Behavioral Medicine). Given the study is now being conducted fully remotely due to 

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COVID-19 pandemic, we will broaden our recruitment to all VA’s within the state of MA. For 
instance, we will recruit from CBOCS in the state (e.g., Lowell, Worcester) and reach out to other 
VA medical centers in the state for referrals (e.g., Bedford VA, Northampton VA). In addition to 
referrals from providers within VA medical system, we will post flyers throughout the VA medical 
centers that will describe the study and direct interested veterans to contact study staff for 
additional information. We will also announce the study on various social media pages, such as 
“Massachusetts Women Veterans” and “New England Center and Home for Veterans”. The study 
will track the source of recruitment for each participant in order to continue to evaluate and 
maximize recruitment strategies throughout the study. 
 
Initial Enrollment and Screening Appointment. Consent and screening will occur during the initial 
appointment. The study will be explained and the potential participant will read the informed 
consent document (ICD). Risks and benefits will be discussed and an opportunity to ask questions 
will be provided. The advising staff member will ensure the participant understands the research 
prior to signing the ICD, and the participant will be provided with a copy so that they have it as a 
record and can to discuss the research with family and friends, if they wish. In some cases, 
informed consent will be conducted remotely rather than face to face appointment. In those 
situations, the informed consent will be mailed to the participant along with an addressed 
stamped envelope. A videoconference (VVC) session will be scheduled with the participant during 
which the study team member reviews the ICF with the participant. If the participant agrees to 
sign the ICF, they will hold up the signed ICF page to the computer camera so the study team 
member can take a screen shot of the signed ICF. The screen shot will be printed and saved as 
documentation of the signed ICF. The participant will be asked to mail the signed ICF back to the 
study team. If the original signed ICF is received, it will be saved along with the printed screen 
shot picture of the signed ICF.  
After informed consent, eligibility screening will be conducted by an independent evaluator (IE) 
using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and Mini International 
Neuropsychiatric Interview (MINI) to be administered via a phone interview. We will utilize a 
centralized telephone assessment using IEs housed at VABHS and supervised by Dr. Brian Marx. 
IEs, all masters or doctoral-level in clinical psychology or a related field, will be hired to conduct 
interviews. The training of IEs in administering the CAPS-5 and MINI will be standardized 
according to assessment training procedure established by Dr. Marx (e.g., Sloan et al., 2016; 
Schnurr et al., 2015). Specifically, IEs engage in four stages of training, including relevant readings, 
didactic instruction with experts, mock interviews, and co-rating exercises with previously taped 
assessments. Following training, IEs engage in bi-monthly calibration exercises. The IE will be 
informed of any drift in scoring (i.e., failure to match diagnoses or a discrepancy in total score 
with the trainers) so as to correct this going forward. All interviews will be digitally recorded. The 
telephone assessments will facilitate completeness by enhancing the convenience for 
participants, who will not have to travel for assessment sessions. Dr. Marx has successfully used 
this procedure in several other studies, including VA Cooperative Study 591 in which assessments 
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(Schnurr et al., 2015). The psychometric quality and acceptability to research participants of 
psychiatric phone interviews are now well-established in both Veteran (Aziz & Kenford, 2004; 
Magruder et al., 2005; Schnurr et al., 2002) and non-Veteran (e.g., Rohde et al., 1997; Sartor et 
al., 2012; Shalev et al., 2012) samples. Magruder et al. (2005), using the CAPS with a sample of 
Veterans seeking VA primary care, found 100% agreement across in-person and telephone 
interviews.  In fact, all of these studies except Rhode et al. specifically focused on PTSD and used 
the CAPS; Rohde et al. (1997) found that the inter-rater reliability of phone interviews was 
excellent (kappa = .96 for major depressive disorder and .87 for anxiety disorders).  In summary, 
the phone interviews will provide a valid method of assessing PTSD yet be considerably more 
cost-effective and more convenient for participants than in-person interviews. 
Assessment Schedule. Participants will be assessed by an IE at baseline, 10-, 20- and 30-weeks 
post first treatment session.  This study has a challenge of two treatments that possess 
substantially different number of sessions (e.g., 5 vs 8 to 15). The use of post-treatment 
assessment would be problematic given that participants in the two treatment conditions would 
be completing treatment at substantially different time from baseline assessment, with time to 
post-treatment being significantly greater in the PE condition than the WET condition. This is 
problematic as differences in outcome could be attributable to time since baseline assessment 
rather than treatment differences. Thus, in order to assure that time does not serve as a 
confound, assessments in this study will occur at equal intervals from baseline for both treatment 
conditions. Although we would expect that the majority of PE participants would complete 
treatment by the 10 week assessment period, it is well-documented that for CPT and PE the time 
to complete treatment varies substantially across participants, even when the treatment protocol 
is to attend twice weekly sessions (Gutner et al., 2016). In our prior study we requested 
participants attend twice weekly sessions for CPT but even with this system in place only 65% of 
the CPT participants completed treatment in 12 weeks and only one participant out of 63 
completed treatment in 6 weeks (see Sloan, Marx, & Lee, 2018 for a discussion of this issue).  
Participants in both treatment conditions will be considered a “treatment drop out” if they do not 
attend all treatment sessions. Consistent with the intent-to-treat approach, any participant who 
drops out will be asked to complete all assessments and all participants who are randomized will 
be included in data analyses for Study Aims 1 and 3. Treatment expectancy, credibility and 
satisfaction will be assessed to ensure that acceptability and feasibility of WET continues to be 
high with the veteran sample 
 
8.  Data Collection/ Study Measures 
 
Assessment Measures  
Assessors: Assessors will be masked to treatment assignment of participants. Assessors are 
located at the JP campus of VA Boston.  Participants will have the option of conducting 
assessment sessions in person at the JP campus or via telephone. For participants opting to 
conduct assessments via telephone, self-report measures will be mailed to them in advance of the 
clinician-administered assessment, and participants will be asked to return completed self-report 

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measures within two weeks in a self-addressed stamped envelope that will be provided to them. 
Assessments conducted for the other recruitment sites in the study (e.g., Madison, WI and 
Charleston, SC) will all be conducted via telephone with self-report measures collected at the 
recruitment sites.  
 
Structured Clinical Interview for DSM-5 (SCID-5; First et al., 2015): The SCID-5 includes questions 
assessing each of the DSM-5 adult disorders (Spitzer, et al., 1994). Each disorder is coded as 
present, not present, or probable, based on structured questions that map onto the DSM-IV 
criteria. Additionally, each diagnosis will be given a Clinical Severity Rating (CSR) of 0 to 8, where a 
rating of 4 or higher represents clinical levels of interference or distress. Individuals receiving a 
CSR of 4 or higher for substance dependence disorders or bipolar disorder or reporting any 
psychotic symptoms will be excluded. 
 
Structured Clinical Interview for DSM-5 Personality Disorders, Borderline module only (SCID-5-
PD; First, Williams, Benjamin, & Spitzer, 2016). The SCID-5-PD is a semi-structured diagnostic 
interview assessing DSM-5 personality disorders using the same coding strategy as described 
above for the SCID-5. Clinicians will only administer the Borderline Personality Disorder (BPD) 
section of the SCID-5-PD at each assessment occasion to measure the presence of BPD diagnoses 
or traits at baseline assessment.  
 
Frequency and quantity of alcohol and substance use will be assessed using clinician-administered 
measures adapted from the PhenX Toolkit (version June 4, 2019, Ver 26.0). These measures were 
derived from reliable and valid measures of alcohol and substance use and selected based on 
scientific community consensus (Hamilton et al., 2011). Specifically, the Alcohol – 30-Day 
Quantity and Frequency is a 2-item measure that assesses the quantity and frequency of alcohol 
consumption during the past 30 days. The Substance Use Frequency measures assess the use of 
ten categories of substances (including prescription drug misuse) over the past 30 days. This scale 
also includes an item assessing average quantity of cannabis use episodes per day in the past 30 
days. All three of these measures will be administered by clinicians at each assessment occasion 
in order to examine changes in alcohol and substance use during treatment. 
 
The Clinician Administered PTSD Scale for DSM-5 (CAPS-5; Weathers et al., 2013a). The CAPS-5 is 
a structured diagnostic interview and the gold standard for assessing the DSM-5 symptoms of 
PTSD (American Psychiatric Association, 2013). The scale also assesses social and occupational 
functioning, dissociation symptoms, and the validity of symptom reports. The CAPS-5 uses a single 
5-point ordinal rating scale to measure symptom severity. Symptom severity ratings combine 
information about symptom frequency and intensity obtained by the interviewer. Psychometric 
properties indicate high criterion and construct validity and high agreement with a self-report 
measure of PTSD (Weathers et al., 2018). The CAPS-5 requires approximately 40 minutes to 
administer. Participants’ total CAPS-5 severity scores will serve as the primary outcome of 
interest. 
 
Life Events Checklist-5 (LEC-5). The LEC-5 (Weathers, Blake, Schnurr, Kaloupek, Marx, & Keane, 
2013) will be used to determine the presence of a traumatic life event(s). The LEC-5 includes the 
same list of 16 different potentially traumatic events (PTE) from the original LEC and is designed 
to facilitate PTSD diagnosis (Weathers et al., 2013). For each PTE, respondents rate their 

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experience of that event on a 6-point nominal scale. There are no published data on the 
psychometric properties of the LEC-5, but is nearly identical to the original LEC, which has high 
internal consistency and test-retest reliability (Weathers et al., 2013).  The worst traumatic event 
identified at the initial assessment is recorded and used for all subsequent administrations of the 
CAPS-5. The LEC-5 requires approximately 15 minutes to complete.  
 
The World Health Organization Quality of Life BREF (WHOQOL-BREF; WHO, 1998) instrument 
comprises 26 items, which measure the following broad domains: physical health, psychological 
health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the 
original instrument that is more convenient for use in large research studies or clinical trials. This 
measure requires 5-10 minutes to complete. It is included in this study to examine quality of life 
improvement as a secondary outcome measure. 
 
The Personality Inventory for DSM-5 – Brief Form (PID-5-BF; American Psychological Association, 
2013) is a 25-item self-report measure that assesses five personality trait domains associated with 
personality dysfunction: negative affect, detachment, antagonism, disinhibition, and 
psychoticism. The PID-5-BF will be administered at each assessment occasion to measure changes 
in maladaptive personality dimensions as a result of treatment. 
 
Multidimensional Scale of Perceived Social Support (MSPPS; Zimet, Dahlem, Zimet & Farley, 
1988) is a 12 item self-report measure of social support.  Social support has been found to 
moderate outcome following a traumatic event. This measure will be included at baseline 
assessment to examine if social support moderates treatment outcome. In addition, the MSPPS 
will be administered at each assessment occasion to measure changes in perceived social support 
during treatment. 
 
Test of Premorbid Functioning (TOPF) is a premorbid estimate of intelligence that takes 5-10 
minutes to administer and requires participants to read a list of up to 70 words. This measure will 
be administered at baseline. In our prior non-inferiority study we found estimated IQ served as a 
moderator for CPT treatment outcome (with higher IQ predicting better outcome) but estimated 
IQ did not serve as a moderator for WET (Marx et al., 2017). 
Peritraumatic Dissociative Experiences Questionnaire (PDEQ; Mamar et al., 1994) is a 10 item 
self-report measure of dissociative experiences during and immediately following a traumatic 
event. We will examine whether PDEQ moderates treatment outcome.  This measure will be 
completed at each assessment occasion. 
Posttraumatic Cognitions Inventory (PTCI-9; Wells et al., 2017) is a 9-item self report measure 
indexing cognitions following a traumatic event, such as self-blame and negative world cognitions. 
This measure will be completed at each asssessment occasion to examine changes in 
posttraumatic cognitions as a result of treatment. 
 
The Openness to Sharing Questionnaire (OSQ) is a 5-item self-report measure to assess the 
amount, depth, extent, detail, and difficulty of past disclosure related to a traumatic event. The 
first two items assess the respondent’s amount and depth of disclosure (e.g., “How many times 
have you talked about this event?”) and require a numerical response. The last three items (e.g., 

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“When you talk about this event, how much detail do you include?) are rated on a standardized 7-
point Likert scale. The measure is administered at baseline and all subsequent assessment 
timepoints; however, the questions at subsequent timepoints have been modified to explicitly 
assess disclosure outside of therapy or assessment sessions. The measure was developed by 
Bedard-Gilligan and colleagues (2012); however, psychometric properties are not published. This 
measure will be administered at each assessment occasion. 
 
The Family Involvement Questionnaire (FIQ) is a self-report measure designed to assess 
preferences for and beliefs about interpersonal involvement in mental health treatment. The 
baseline version of the questionnaire includes six items, and the version for subsequent 
assessment points includes three items. Questions regarding openness/willingness for family 
involvement are rated on a 10-point Likert scale ranging from 1 (Completely closed/unwilling) to 
10 (Completely open/willing). In a “check all that apply” format, participants are also asked to 
indicate who they would include in treatment, goals for interpersonal involvement, and 
concerns about interpersonal involvement. This measure will be administered at each 
assessment occasion. 
 
The Insomnia Severity Index (ISI) is a brief (7 item) instrument that was designed to assess the 
severity of both nighttime and daytime components of insomnia. It is increasingly used as a 
metric of treatment response in clinical research and will be used in the current study to assess 
changes in insomnia symptoms as a function of treatment. This measure will be administered at 
each assessment occasion. 
 
Safety Monitoring Measures 
The PTSD Checklist for DSM-5 (PCL-5; Weathers, Litz, et al., 2013) will be administered at each 
assessment occasion, including baseline, and the beginning of every treatment session to monitor 
for symptom worsening, defined as an increase from the initial assessment of at least 10 points 
that is sustained for at least three consecutive treatment sessions (Foa, Zoellner, Feeny, Hembree, 
& Alvarez-Conrad, 2002). The PCL-5 is completed in reference to the identified criterion A event 
established at the baseline assessment. This is a psychometrically strong measure that is sensitive 
to change (Weathers et al., 2013; Bovin et al., 2016) and requires no more than 5-10 minutes to 
complete. 
 
The Beck Depression Inventory-II (BDI-II; Beck et al., 1996) is a 21-item self-report measure 
assessing current depressive symptoms and has well-established reliability and validity (Dozois et 
al., 1998). The BDI-II will be administered at each assessment occasion, including baseline, and the 
beginning of every treatment session to monitor exacerbation of depression symptoms associated 
with treatment, as well as to assess any changes in suicidal ideation. This measure requires no 
more than 5-10 minutes to complete. 
 
The Self-Injurious Thoughts and Behaviors Interview (SITBI; Nock et al., 2007) is a structured 
clinical interview that assesses the presence, frequency, and characteristics of a wide range of 
self-injurious thoughts and behaviors, including suicidal ideation, suicide plans, suicide gestures, 

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suicide attempts, and nonsuicidal self-injury. The SITBI has demonstrated excellent psychometric 
properties in multiple samples, including strong interrater reliability, and test–retest reliability 
over a 6-month period. Moreover, concurrent validity was demonstrated via strong 
correspondence between the SITBI and other measures of suicidal ideation, suicide attempt, and 
nonsuicidal self-injury. This interview takes approximately 20 minutes to administer. 
 
Therapy Process Measures 
The Treatment Expectancy Questionnaire (TEQ) is a widely-used measure of treatment credibility 
(Borkovec & Nau, 1972). This measure is administered at the conclusion of the first treatment 
session (after the treatment rationale and specific procedures are explained). The TEQ asks the 
individual to rate on a 10-point scale how logical the treatment seems, the participant’s 
confidence in undergoing the treatment and recommending it to others, and their expectations 
for the treatment’s success. We anticipate treatment expectancy to be high for both treatments, 
with no significant between condition effects. The measure requires approximately 5 minutes to 
complete. 
 
The Client Satisfaction Questionnaire (CSQ; Larsen, Attkisson, Hargreaves, & Nguyen, 1979), a 
measure of participant satisfaction with treatment, is administered at the last treatment session. 
This 8-item measure assesses satisfaction with treatment and has demonstrated concurrent 
validity. We expect client satisfaction ratings to be high for both conditions. The measure requires 
approximately 5 minutes to complete. 
 
The therapeutic alliance will be assessed using the 12-item therapist and client versions of the 
Working Alliance Inventory (WAI; Horvath & Greenberg, 1989; Tracey & Kokotovic, 1989). In 
addition to the total score, the WAI has three subscales: Goals, which reflects the agreement 
between therapist and patient on overall goals of treatment; Tasks, which reflects the agreement 
on the appropriate tasks on which to focus (to achieve goals); and Bond, the quality of the 
affective relationship between the therapist and the patient.  The WIA will be included to examine 
therapeutic alliance as a potential moderator of treatment outcome, as well as to examine 
potential treatment condition differences. The WAI therapist version will be completed by the 
study therapists for each participant they treat, and the client version will be completed by each 
participant enrolled in the RCT at the end of treatment. 
 
In the PE condition, clinicians will complete Homework Review Forms (HRFs) specific to PE session 
content to assess homework compliance. There is no homework in the WET condition. 
 
 
 
 
 
 
 
 
 

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Table of Assessment Schedule 
Measure 
Baseline 
First Tx 
Session 
Weekly 
During Tx 
Last Tx 
Session 
10-week 
20-week 
30-week 
LEC-5 
X 
 
 
 
 
 
 
TOPF 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SCID-5 
X 
 
 
 
 
 
 
SCID-5-PD 
BPD only 
X 
 
 
 
 
 
 
CAPS-5 
X 
 
 
 
X 
X 
X 
SITBI 
X 
 
if needed 
 
X 
X 
X 
Alcohol 30-
day 
X 
 
 
 
X 
X 
X 
Substance Use 
Frequency 
X 
 
 
 
X 
X 
X 
PID-5-BF 
X 
 
 
 
X 
X 
X 
MSPPS 
X 
 
 
 
X 
X 
X 
WHOQOL-
BREF 
X 
 
 
 
X 
X 
X 
PDEQ 
X 
 
 
 
X 
X 
X 
OSQ 
X 
 
 
 
X 
X 
X 
FIQ 
X 
 
 
 
X 
X 
X 
ISI 
X 
 
 
 
X 
X 
X 
TEQ 
 
X 
 
 
 
 
 
PCL-5 
X 
 
X 
 
X 
X 
X 
BDI 
X 
 
X 
 
X 
X 
X 
PTCI-9 
X 
 
X 
 
X 
X 
X 
CSQ 
 
 
 
X 
 
 
 
WAI 
 
 
 
X 
 
 
 
 
INTERVENTIONS 
Written Exposure Therapy (WET). The WET condition consists of 5 weekly treatment sessions, 
with the first session lasting 1 hour and each subsequent session lasting approximately 40 
minutes. The first session consists of education about common trauma reactions and the WET 
rationale. The participant is then given general instructions for completing the trauma narratives 
and specific instructions for completing the first 30-minute narrative writing session. All WET 
sessions begin with the therapist reading the specific writing instructions, clarifying any questions 
the person has, and leaving the instructions with the participant during the 30-minute writing 
session. Writing instructions begin with a focus on the details of the trauma and then shift to the 
meaning of the trauma event. After 30 minutes of writing, the therapist stops the writing and 
conducts a 5-10 minute check-in regarding how the writing session went for the participant. In 

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response to VA clinician feedback indicating that veterans sometimes avoid writing about 
traumatic event in the first and sometimes second writing session, we will permit up to an 
additional two sessions to course correct in such situations.  Specifically, if the veteran does not 
follow writing instructions in the first and/or second session, these sessions should be repeated to 
allow for necessary level of exposure to the traumatic event. However, additional sessions will not 
be provided even if patients continue to partially or fully avoid (i.e. do not follow writing 
instructions).   
Prolonged Exposure (PE).  PE is designed to be delivered in weekly 90 minute sessions over 8-15 
sessions. The sessions are flexible according to the response of the patient. Stopping before 15 
sessions should occur because (1) the patient has a stable score (i.e., at least two consecutive 
sessions) below the probable PTSD diagnosis cut score of 33 (Bovin et al., 2016) and (2) the 
clinician and patient agree that substantial clinical gain has occurred and no additional sessions 
are needed. Up to 15 sessions are provided if the score remains above the probable PTSD cut 
score. Treatment response is determined based on PCL-5 measure administered at each 
treatment session. The conceptual foundation of PE is based upon emotional processing theory 
(Foa & Kozak, 1986). The PE model proposes that chronic PTSD develops when there is a failure to 
process the traumatic memory because of extensive avoidance of trauma reminders. PE mimics 
the natural fear modification process. During PE, patients are encouraged to confront (or expose 
themselves) to safe but anxiety-eliciting situations, in both imagination and in vivo, with the goal 
of overcoming excessive fear and anxiety.  Thus, PE includes the following core components: (a) 
psychoeducation about the common reactions to traumatic events and presentation of the 
rationale for PE, (b) repeated in vivo exposure to situations or objects being avoided due to 
distress and anxiety, and (c) repeated, prolonged imaginal exposure to memories of the event(s). 
The focus of treatment initially lies in educating the patient about the PTSD diagnosis, gathering 
of detailed information about the traumatic event, and providing a sound rationale for PE. 
Patients’ understanding of the rationale for PE is important because recognition of the 
importance of breaking their patterns of avoidance is a key goal. Patients, together with their 
therapist develop a hierarchy of feared but safe trauma related situations and objects and are 
instructed to gradually approach these situations between sessions (in vivo exposure exercises). 
The structure of gradual exposure is fairly consistent with traditional exposure-based 
interventions such that anxiety-provoking stimuli (e.g., physical or verbal cues) are presented 
gradually. The 3rd component of treatment is imaginal exposure. During this phase, therapists 
assist patients in repeatedly recounting their traumatic event in detail, including their thoughts, 
feelings, and reactions that occurred during the event(s). Imaginal exposure is conducted during 
sessions and is audiotaped for patients to listen to at home between sessions.  
 
9.  Statistical Analysis Plan 
 
Data will be analyzed in SPSS and MPlus software, which licenses are obtained by the Behavioral 
Science Division of the National Center for PTSD at VA Boston. The software is stored on a 
password protected server that is behind the VA firewall. 
 
The equivalence of the treatment conditions will first be assessed according to key baseline 
variables (demographics and outcome variables) using t-tests, nonparametric equivalence, or Chi-
square tests, depending on the type (continuous or dichotomous) and distribution (normal or 

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non-normal) of the data. Any variables that differ among groups will be used as covariates in the 
final analyses.   
We anticipate some participant attrition during the trial. If a subject drops out of the 
study for any reason, we will vigorously pursue follow-up to minimize missing data. Yet, some 
data will inevitably be missing. Missing data will be handled in all analyses using direct maximum 
likelihood or multiple imputation techniques within MPlus 8.0 (Muthen & Muthen, 2018) under a 
missing at random (MAR) assumption. Modern missing data techniques such as direct ML increase 
statistical power and provide more accurate estimates of model parameters and standard errors, 
and are the recommended intent-to-treat approach for clinical trials (Enders, 2010). The primary 
analyses in this study will be performed on the intent-to-treat population that includes all patients 
randomized to a condition. Supplementary analyses will also be conducted examining outcomes 
in the subset of participants who complete a full course of treatment in each condition. In order 
to better understand the potential reproducibility of our findings, our conclusions from all 
analyses will be based on both the statistical significance of parameters and the magnitude of 
associated effect sizes. 
Aim 1. Our primary hypothesis that WET will be non-inferior to PE will be evaluated using similar 
analytic procedures conducted in our previous non-inferiority trial of WET (Sloan et al., 2018). 
Specifically, the non-inferiority margin of 10 will be used for comparing the two conditions on the 
primary PTSD outcome of CAPS-5 scores at the 10 week, 20 week, and 30 week assessments. The 
mean difference score between conditions will be calculated at each follow-up and the hypothesis 
of non-inferiority will be evaluated based on whether the entire 95% confidence interval of the 
mean difference is less than the margin of 10 points. We will then supplement this analysis by 
calculating additional effect sizes to characterize between condition differences in PTSD 
outcomes. Specifically, we will calculate Cohen’s d (with 95% CI) for the mean difference in CAPS-
5 scores at each time point and will calculate odds ratios (with 95% CI) for the proportion of 
participants who no longer meet diagnostic criteria for PTSD based on the CAPS-5 at each 
assessment period. 
 
Aim 2. The comparison of treatment dropout in WET vs PE will be examined by calculating odds 
ratio effect sizes (with 95% confidence interval) for the proportion of participants who do not 
complete a full course of treatment (5 sessions) in WET and those who drop out of PE by session 
5. The statistical significance of the between-group differences in dropout rates will then be 
evaluated using a chi-square difference test. 
  
Aim 3. The exploratory analyses of moderators of WET and PE will be conducted using latent 
growth curve modeling conducted within Mplus. As the focus is not primarily on the nature of the 
growth trajectory, the intercept of the LGM will be centered on the baseline CAPS-5 assessment 
(i.e., first slope loading fixed to 0), the slope loading for the final time point will be fixed at 1.0, 
and loadings for all intermediate assessments will be freely estimated. The mean and variance of 
the slope factor in this model will reflect the total change in and individual differences in change 

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in PTSD symptoms across the full assessment period. The hypothesized moderators (age, sex, 
combat era, social support, time since index trauma event, and estimated IQ) will then be 
specified as predictors of the slope factor in separate models. These LGM will be conducted for 
the full sample first, and will then be conducted separately within each treatment condition to 
examine whether moderators of treatment outcome are consistent across WET and PE. To aid in 
the interpretation of clinical significance, results from LGM analyses will be converted to effect 
size metrics within 95% confidence intervals following established procedures (Feingold, 2015). 
Evaluation of model fit in the LGM models will be examined using fit diagnostics (i.e., standardized 
residuals) and common fit statistics (i.e., root mean square error of approximation) following the 
associated cutoff criteria recommended by Hu & Bentler (1999). 
 
We will conduct additional exploratory analyses to evaluate characteristics of patients who 
require additional WET sessions, as well as characteristics of patients who require more than 12 
PE sessions. These analyses will be conducted using logistic regression with dependent variable 
being more than 12 sessions of PE or more than 5 sessions of WET (conducted separately for each 
treatment condition). We will include characteristics such as age, time since trauma event, 
combat era, baseline PTSD symptom severity, baseline depression, baseline social support, 
baseline estimated IQ. 
 
Aim 4: Follow standard practice for examining secondary outcome measures in a non-inferiority 
trial (e.g., Thompson-Hollands et al., 2018), we will use hierarchical linear modeling (HLM; 
Raudenbush & Bryk, 2002) to determine impact of treatment on functional impairment as 
measured by the WHOQOL-BREF. Analyses will be conducted using an autoregressive covariance 
matrix at level 1 (within person) and a scaled identity matrix at level 2 (between persons). A 
between-treatments variable will be included in the analysis, as functional impairment is a 
secondary outcome and therefore not subject to the same noninferiority analyses. Guidelines 
from Cohen (1988) will be used to interpret the within- and between-condition effect sizes (d). 
 
10. Ethical Issues 
 
e. Risks 
Treatment: Some risks are associated with the administration of psychosocial treatment. The 
primary risk is the evocation of uncomfortable levels of anxiety or other emotions during the 
treatment sessions. Some participants may find sessions stressful and react to them with anxiety.  
  
Recording: Some participants may feel uncomfortable about the assessment and treatment 
sessions being recorded. However, this will be a required procedure. The purpose of the recording 
will be explained, confidentiality will be respected, and both informed consent and authorization 
for recording will be obtained as per requirements put forth by the Healthcare Information 
Portability and Accountability Act (HIPAA). Recordings will be marked only by subject 
identification codes and stored in password protected computer server accessible only to staff 
directly involved with the project.  

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Self-Report Measures and Assessor Ratings:  No risks are seen associated with these assessment 
procedures other than discomfort associated with the audio-recording. These will be handled as 
described above for recording of assessment and therapy sessions. 
 
2. ADEQUACY OF PROTECTION AGAINST RISKS 
a. Recruitment and Consent Procedures 
Following the recruitment procedures used in our past clinical treatment studies for PTSD with 
veterans, we used a variety of recruitment strategies (e.g., posting fliers throughout the medical 
center, clinic referrals). We will also create a study brochure for clinicians to provide to potential 
veteran participants. Based on past experiences, we anticipate clinic referrals to be the most 
effective recruitment strategy.  The study announcements and brochure will state that the 
treatment is part of a research study that is available to qualified veterans. Interested veterans 
will be instructed to call for further information.  
 
In accordance with HIPAA regulations, written informed consent will be obtained from each 
veteran after a thorough explanation of procedures by a project staff person and the opportunity 
for the veteran to ask and receive answers to questions. Veteran participants will be informed of 
the nature of the investigation, the types of assessments and treatments involved, alternative 
treatments, and the potential risks involved in participation and will be asked to sign an informed 
consent statement prior to participating in the proposed study. In addition, the participant will 
receive an explanation of how information related to their case will be handled including all 
parties involved, data management, and plans to publish data in group format without identifying 
information.  
  
Veteran participants will also be informed that confidentiality may be broken under the following 
circumstances: disclosure of suicidal or homicidal intentions, disclosure of child abuse, disclosure 
of elder abuse.  Confidentiality may be broken in such instances in order for protective measures 
to be taken. 
  b. Protection against risk  
1. We will carefully screen to identify individuals whose risk for potential adverse outcomes is 
elevated were they to participate in the proposed research. Such individuals will be excluded from 
the study. As an example, a person deemed high suicidal risk would be excluded from study 
participation. These individuals will be followed by study personnel (if they give consent to be 
followed). 
 
2. Clinical staff will be trained to cope with any anxiety/distress experienced by participants during 
the assessments and treatment. 
 
3. Careful monitoring of participants during the initial assessment and throughout the study will be 
conducted by the project staff. Participants will complete the PCL-5 at each assessment and 
treatment session in order to monitor symptoms (and potential symptom increases). Each 
participant will see the same clinician for each of their treatment visits and the same assessor for 
each assessment occasion. Following the clinical trial policy of the VA Boston Healthcare System 

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(VABHS) all participants will be given an emergency number to call after business hours in case of 
an emergency. This number will be the psychiatry on call system of the respective VA site.  
 
4. Participants will be instructed to contact study personnel at any time (including during the follow-
up period) in the event of worsening of symptoms or relapse. Participants whose clinical condition 
has substantially deteriorated will be removed from study treatment and appropriate clinical 
referrals will be made. These veterans will also be followed by study personnel, if they give 
permission to be followed.  
 
5. Participants failing to benefit from the study treatments will be provided with appropriate clinical 
referrals. Participants who begin treatment and experience adverse outcomes related to the 
treatment being received will also be provided with appropriate clinical referrals. The appropriate 
clinical referrals will be determined by the judgment of clinicians and supervising staff familiar 
with the specific participant and may include cognitive-behavioral treatment, other 
psychotherapy, or referral for medication treatment. 
 
6. As in any type of treatment or clinical research program, participants’ confidentiality must be 
carefully guarded and respected. All data with identifying information will be stored in locked files 
or password-protected computer server. Data being analyzed will be identified by subject codes, 
and identifying information will be removed. The identity of participants will not be revealed in 
the presentation or publication of any results from the project. All personnel working on the 
project will be educated about the importance of strictly respecting participants’ rights to 
confidentiality and will have completed several training courses including proper practice in 
accordance with HIPAA regulations, protection of human subjects, and computer security.  
 
7. If new information emerges for one or both of the treatments in the study that indicates the 
treatment is associated with detrimental effects, we will alert participants of this new information 
and consult with IRB regarding whether or not the study should be stopped given the new 
information. 
 
f. Potential Benefits 
The direct benefit to veterans who enter this study will be to obtain relief from anxiety symptoms, 
decreased avoidance, decreased disability, and increased quality of life. For many individuals with 
PTSD the disorder has greatly impeded their social, vocational, and academic functioning among 
those veterans who are enrolled in college courses. The treatments offered in the study are 
recommended treatment approaches according to the VA/DoD clinical practice guidelines (2017). 
Thus, the treatments have strong evidence to support their effectiveness. 
More broadly, establishing cost-effective, brief and readily deliverable alternatives to traditional 
(time intensive) psychotherapy options for veterans with PTSD has broad health and policy 
implications for the Department of Veteran Affairs given the high prevalence of this debilitating 
disorder in the veteran population.  
3.  
g. Analysis of Risks in Relation to Benefits 
The risks in the study are low given that the treatments included are first line, recommended 
PTSD treatments, as outline in the VA/DoD Clinical Practice Guidelines. Moreover, veterans will be 
receiving high quality PTSD treatment with close supervision monitoring of the therapists, in 

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combination with greater attention (e.g., calling between sessions or when a session is missed) 
that is typically possible in routine clinical care. The study anticipates that veterans will reap 
treatment gain for both treatment conditions in the study. Thus, the potential benefit to the 
veteran is significant reduction of PTSD symptoms and improvement in quality of life. Overall, the 
risks to benefit ratio is very favorable. 
 
h.  Stopping Rules 
A participant may always withdraw their participation at any time.   
• 
A participant will be withdrawn from the study if: 
o They report a substantial increase in PTSD symptoms that is stable for 3 weeks and 
the participant indicates the increase is the result or likely the result of treatment 
they are receiving in the study. 
o The participant becomes high risk for suicide and is hospitalized. 
o The participant requires treatment (detox or residential) due to the substance use. 
o The participant becomes verbally or physically aggressive towards research staff. 
4.  
 
11.  Safety Monitoring Plan   
Data and safety monitoring for this study will be provided by the Clinical Science Research & 
Development (CSR&D) centralized Data Monitoring Committee (DMC).  The DMC is provided by 
CSR&D to ensure independent oversight of the safety and integrity of the project. The DMC is an 
independent multidisciplinary group, whose members have collectively – through research, 
education, training, experience, and expertise – the requisite knowledge pertinent to the subject 
areas to be reviewed. Membership details are available on the CSRD website.  The DMC will 
provide an ongoing independent evaluation of this study focused on safety and feasibility, 
including participant accrual and retention, adverse events monitoring, and data 
analyses.  Meetings will be held three times per year at which recommendations will be made to 
the Director of CSR&D for endorsement. These recommendations will range from approval to 
continue (unconditionally or with conditions to be addressed) to probation or possibly 
termination, if there are problems with enrollment or safety concerns. 
 
The PI will be responsible for providing these quarterly summaries to the local IRB and CSR&D as 
part of the annual review process.  In addition, the PI will be responsible for executing any 
recommended changes to DMC and complying with the reporting requirements.  
 
Protocol for Monitoring Adverse Events 
Because of the psychiatric nature of the sample to be studied, there is a potential for adverse 
events to occur.  These adverse events include suicidal ideation, homicidal ideation, and an 
increase in PTSD and depression symptom severity.  Although the likelihood of these adverse 
events occurring in response to PTSD treatment is low (e.g., Foa et al., 2002; Sloan et al., 2018), 
these adverse events will be closely monitored throughout the study. Apart from these potential 
adverse events, we do not anticipate the occurrence of any other adverse events related to the 
treatments to be examined. 

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There are two reasons suicidal risk will be assessed in the proposed study.  The first reason is to 
determine participant eligibility and the second reason is to ensure the safety and well-being of 
participants throughout the study.  We will assess suicidal risk using the Mini International 
Neuropsychiatric Interview (MINI) suicide module at each assessment occasion.  The MINI suicide 
module is a clinician administered interview that consists of 9 questions related to suicidal 
ideation and behaviors, with possible scores ranging from 0 to 53.  Low suicide risk is defined as 0-
8 points, moderate suicide risk is defined as 9-16 points, and high suicide risk is defined as scoring 
17 or greater.  We have decided to use this measure because the MINI suicide module is clinician-
administered, includes clear guidelines for determining suicide risk, and requires approximately 
10 minutes to administer.  The MINI demonstrates excellent inter-rater reliability, with kappa 
values exceeding 0.75 (Lecrubier et al., 1997; Sheehan et al., 1998); and generally good test-retest 
reliability, with kappa values typically exceeding 0.65 (Lecrubier et al., 1997; Sheehan et al., 1998).  
Individuals will be excluded from enrolling in our proposed randomized controlled trial if they 
score 17 or higher (high risk) on the MINI suicide module at the initial assessment.  Individuals 
who are excluded from participating in the clinical trial will be provided with appropriate clinical 
referrals.  The PI will follow up with each of these individuals within one week to make sure they 
have connected with appropriate clinical care. 
 
To monitor suicide risk throughout the treatment phase, we will administer the BDI-II at each 
treatment session.  If a participant endorses suicidal ideation at any level in response to question 
#9 (suicidal thoughts or wishes), a licensed psychologist will administer the MINI suicidal module.  
Participants deemed to be a high risk for suicide on the MINI (i.e., score of 17 or higher) will be 
removed from the study treatment and appropriate actions will be taken. These actions are 
described below in the data monitoring section.  In addition, if the participant is willing, they will 
continue to be followed by the PI. 
 
Homicidal risk will be assessed using approach recommended by VA/DOD Clinical Practice 
Guideline for Major Depressive Disorder (2009).  At the initial assessment and at the beginning of 
each treatment session, participants will be directly asked whether they have thoughts of harming 
anyone.  If the participant indicates they do have thoughts of harming someone, then the clinician 
will ask whether the participant has an active plan or method to harm someone (e.g., weapon in 
their home) and whom the participant wishes to harm.  Further assessment will take place for 
participants who indicate that they have an active plan or method. Specifically, they will be asked 
whether they have ever lost control and acted violently and, if so, the severity of reported past 
violent behavior will be assessed.  If a participant indicates that they have thoughts of harming 
someone and they have an active plan, the participant will be considered potentially high risk and 
further assessment will be conducted, as described in the section on managing adverse events. 
 
We will monitor for a substantial increase in PTSD symptom severity during the treatment phase 
using the Posttraumatic Check List for DSM-5 (PCL-5).  The PCL-5 is a 20 item self-report measure 

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of PTSD symptom severity.  This measure will be completed at each assessment session and each 
treatment session.  A substantial increase in symptoms is defined as at least 10-point increase in 
PTSD from the initial assessment and has been sustained for a three-week period (e.g., Foa et al., 
2002).   
 
Protocol for Managing Adverse Events 
In the event a participant is deemed high suicide and/or homicidal risk, staff will immediately 
locate the PI or site PI, both of whom are licensed psychologists. The PI or site PI will intervene by 
a) following up with direct questions about suicidal/homicidal behaviors, b) assess mental status 
by asking about psychotic symptoms, mood symptoms and drug and alcohol use, c) schedule 
extra contacts if necessary, emphasizing problem solving, d) help the participant generate short-
term objectives, and e) negotiate an action plan. The action plan will be collaboratively generated 
by the investigator and the participant. The plan will address what actions need to be taken in the 
succeeding days to solve the problems that precipitated suicidal/homicidal behavior. The plan will 
also address the use of voluntary and involuntary hospitalization, if necessary. Lastly, in the case 
of homicidal ideation with explicit intent to harm a named individual, the PI will report the intent 
to the local police as required legally required to protect the named individual.  This procedure 
will be the same for SI/HI that is uncovered during the course of telephone assessments. That is, 
the assessor will alert the PI or site PI who will then reach out to the veteran via telephone and 
take appropriate clinical action. 
 
In addition to these formal assessments, all participants will be given the number of the on-call 
psychiatry service at the respective VA site and informed that they should call this number after 
business hours in the event that they are feeling suicidal and/or distressed, or homicidal. This is 
the local IRB policy for clinical trials conducted at the two VA recruitment sites.  During business 
hours the participants will be instructed to contact the contact the PI (VABHS) or site PI (RHJVA).  
Should a participant call to indicate suicidal/homicidal risk, then the previously described 
intervention plan will be followed. Participants will also be informed during the informed consent 
process that if suicidal and/or homicidal intentions are disclosed confidentiality may be broken in 
order for protective measures to be taken.  The suicidal risk management plan has empirical 
support for its efficacy (Chiles & Strosahl, 2005) and is the plan that is recommended for use by 
the American Psychiatric Association.  Moreover, the homicidal risk assessment and management 
plan is recommended by VA/DoD Clinical Practice Guidelines (2009). 
 
In the event that a participant experiences an increase in PTSD symptom severity but without 
suicidal/homicidal risk, the PI or site PI will intervene by asking direct questions about the nature 
and causes of the distress, conduct a PTSD assessment, and schedule extra contacts (assessments) 
if deemed necessary. Such individuals will be withdrawn from study treatment from the protocol 
if they report a substantial increase in the PTSD symptom severity (i.e. at least 10 points higher 
than their baseline PTSD symptom severity score) that is sustained over a three-week period and 
the cause of the increase is determined to be related to the study treatment. We have selected 

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the 10-point increase and 3-week time frame based on Foa, Zoellner et al. (2002) in which they 
emphasize the importance of using a reliable index score when considering increases (and 
decreases) in PTSD symptoms. Importantly, Foa and colleagues (2002) have reported that only a 
minority of participants showed an acute substantial increase in PTSD symptom severity during 
Prolonged Exposure treatment, and that this acute increase was not associated with an increased 
risk for dropout or poor treatment outcome.  Nevertheless, to protect against risk, we will 
monitor participants for undue distress reactions and will use a 10-point increase from baseline 
assessment of PTSD symptom severity that is sustained for 3 weeks as a guide for potentially 
withdrawing a participant from the study treatment.  If a participant is withdrawn from the study 
treatment, they will be followed by study personnel, if they agree to be followed, to ensure that 
they have received adequate clinical care.  In addition, if they agree, the study will continue to 
conduct assessments with the participant. In addition, participants who are deemed ineligible to 
enroll in the trial will be referred to the appropriate VA mental health clinic.  The PI or site PI will 
subsequently contact (within one week) these veterans to make sure that they have not 
experience any barriers in following through with clinical referrals.   
 
12.   Adverse Event/Unanticipated Problems Reporting Plans 
 
Protocol for Reporting Adverse Events 
Any study-related unanticipated problem and any type of AE or SAE, will be reported immediately 
to the PI, who will then report the event to the local IRB per VABHS standard operating 
procedures.  In addition, for SAE’s, the PI will submit a SAE form to the local IRB and the DMC 
within 48 business hours of becoming aware of SAE. Staff will keep a copy of this SAE form on file 
at the study site. The information to be reported will include the subject number, a description of 
the event, date of onset, current status, whether or not the treatment was discontinued, the 
reason why the event is classified as serious, and the PI assessment of the association between 
the event and the study treatment.  Dr. Sloan will provide any significant new information 
regarding ongoing SAEs promptly (i.e., within 48 business of becoming aware of event) to the 
DMC.  Adverse events not designated as serious will be reported to DMC on a quarterly basis and 
annually to the respective local IRB.  
The other two recruitment sites will follow the same procedures for reporting of adverse events 
and unanticipated problems, with the addition of also notifying the study PI at VA Boston.  
 
 
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