Interpersonal Therapy for Veterans With PTSD
Phase: NA
Conditions: Posttraumatic Stress Disorder
Sponsor: VA Office of Research and Development

 
 
 
Comparative Effectiveness of Two Treatments for Veterans 
With PTSD 
 
NCT02586064 
 
Protocol Version Date 09/18/18 

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Principal Investigator: Tracie Shea, Ph.D. 
 
Department: Mental Health and Behavioral Sciences Service (MHBSS) 
 
Study Title: Comparative Effectiveness of Two Treatments for Veterans with PTSD 
Full Protocol Version Date: 9/18/2018 
Key Personnel: 
 
Tracie Shea, Ph.D. 
Staff Psychologist VAMC 
 
 
Bonnie Green, Ph.D. 
Professor 
Georgetown University 
 
 
Janice Krupnick, Ph.D. 
Director of Trauma and Loss Program 
Research Prof, Georgetown University 
 
 
 
 
 
 
 
 
 
 
 
Location of Study: 
All assessment and intervention sessions will be conducted at the Veterans Affairs Medical Center in 
Providence, Rhode Island. 
Time Required to Complete the Research: 
The project start date is 07/01/2015 and the study will continue until 2019 
Department of Veterans Affairs Internal Review 
Board Research Protocol 
Content Requirements for Full Committee Review 

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The study described herein is a multisite study that will take place at the Providence VA 
Medical Center as well as the Southeast Louisiana Healthcare System in New Orleans, LA. 
Dr. Sautter is the Director of the Family Mental Health Program and Site-PI in New Orleans. 
The PVAMC IRB will only oversee activities conducted on site in Providence, RI and the 
New Orleans site will receive their own IRB approval and oversite. The goal of enrollment 
is 88 participants at each site. 
Purpose 
The strong association between posttraumatic stress disorder (PTSD) and interpersonal 
problems, such as relationship discord (Allen et al., 2010) and social isolation (Lemaire & 
Graham, 2011), is well documented.  Exhibiting behaviors that drive supportive family and 
friends away while retreating into social isolation,  Veterans with PTSD lose opportunities 
for social processing that could reduce their PTSD symptoms. Consequently, trauma-related 
isolation often leads to erosion of social and family support, increased PTSD  symptoms, and 
self-destructive behaviors such as suicidality. Indeed, a large-scale Air Force suicide 
prevention effort implemented from 1990-2002 targeted the reduction of risk factors while 
increasing protective  factors, such as social support and social network, and reported a  
33% reduction in suicide risk and decline in  suicide rate (Knox et al., 2003; 2010).  This 
shows the potential benefit of systematically targeting protective  interpersonal behaviors. 
The primary interventions for PTSD at VA facilities, i.e., Prolonged Exposure (PE), Cognitive 
Processing Therapy (CPT), and trauma-focused CBT, do not directly target the 
interpersonal problems that prevent Veterans from seeking the relationship experiences 
that can increase emotional resilience, or focus on  increasing emotional engagement and 
reducing avoidance and isolation (Jakupcak, et al, 2010), so critical for withdrawn, 
emotionally numb Veterans. Further, relationship problems often prevent Veterans with 
PTSD from benefitting from more trauma-focused interventions (Price, et al., 2013; Tarrier 
& Summerfield, 1999), suggesting that treatments targeting interpersonal problems might 
potentiate the efficacy of these empirically based psychotherapies EBPs. Only a  small 
minority of OIF/OEF Veterans with PTSD referred for trauma-focused psychotherapy 
actually engage in those treatments (DeViva, 2013; Harpaz-Rotem & Rosenheck, 2011; 
Maguen et al., 2012; Seal et al., 2010).  A more useful strategy might be to allow Veterans to 
select treatments that target the PTSD problems that they  identify during treatment 
planning (DeViva, 2013). Alternative approaches that provide immediate social 
reinforcement, like Interpersonal Therapy (IPT), may reduce PTSD symptoms while 
improving the interpersonal environment that is critical to trauma recovery. In summary, 
IPT could serve as a useful new tool  in the VA PTSD treatment armamentarium. 
The association between PTSD and relationship problems led to the development of couple- 
based PTSD  interventions within the VA (e.g., Monson et al., 2012; Sautter et al., 2013), but 
only a limited number of  Veterans with PTSD are appropriate for couple interventions. 
Logistics may interfere with attendance for both partners, and 30%-40% of returning 
Veterans are unmarried (Street, et al., 2009), putting these less-connected veterans at risk 
for social isolation and decreased support. In addition to relationship conflicts, IPT targets 
social isolation and other types of relationship problems, thus providing the potential to 
increase social support and relationship satisfaction among a broader range of Veterans 

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with PTSD. 
IPT was recently “rolled out” in VAMCs as a treatment for depression, a frequently comorbid 
diagnosis with  PTSD. Several studies suggest that IPT may also be effective for PTSD 
(Krupnick et al., 2008; Krupnick, 2010,  Bleiberg & Markowitz, 2005; Markowitz et al., in 
press; Meffert et al., 2014). The aim of the proposed study is to compare IPT for PTSD, a 
relationship-focused individual treatment, with PE, an evidence-based treatment for PTSD 
that has been “rolled out” nationally in the VA system.  The specific hypotheses to be tested 
are as follows: 
Primary Outcomes: 
1) IPT-PTSD will be statistically equivalent to PE in reducing the severity of PTSD 
symptoms. 
2) IPT-PTSD will be superior to PE in improving Interpersonal functioning. 
 
Secondary Outcomes: 
3) IPT-PTSD will be significantly more effective than PE in improving social 
adjustment. 
4) IPT-PTSD will be significantly more effective than PE in improving quality of life. 
5) (Exploratory) IPT-PTSD will be significantly more effective than PE in reducing 
suicidal ideation. 
 
Mechanisms of Change (Exploratory): 
6) Improvements in interpersonal functioning and perceived social support will 
mediate improvements in  PTSD symptom severity in IPT-PTSD. 
 
1. Background, Significance, and Rationale 
PTSD and Interpersonal Functioning 
A substantial literature links PTSD and intimate relationship distress and aggression in 
Veterans (Taft, et al., 2011). Reviewing the psychological sequelae of combat violence, 
Galovski & Lyons (2004) found the strong association between PTSD and family 
relationship problems evident across different countries and eras. These studies 
consistently reveal that Veterans diagnosed with chronic PTSD, versus those exposed to 
military-related trauma but not diagnosed with PTSD, and their romantic partners report 
more numerous and severe relationship problems and generally poorer family adjustment 
(Monson et al., 2009). Several studies indicate that Veterans with PTSD have more marital 
problems and higher divorce rates than their trauma-exposed counterparts without PTSD 
(e.g., Jordan et al., 1992). Male Veterans with PTSD, versus those without the disorder, 
have greater anxiety with regard to intimacy (Riggs et al., 1998), and they are less self- 
disclosing and emotionally expressive with their partners (Carroll et al., 1985). Further, 
PTSD has been associated with poorer parenting satisfaction, and there is evidence of 
greater behavior problems in the children of parents with PTSD (Gewirtz et al., 2010). 
Findings across settings and study methodologies document that male Veterans with PTSD 
are more likely to perpetrate psychological and physical aggression against their partners 
and children than Veterans who do not have PTSD (Carroll et al, 1985; Taft et al., 2011). 

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Moreover, findings from the National Vietnam Veterans Readjustment Study (Kulka et al., 
1990) found that one-third of male Veterans with PTSD exhibited violence, according to 
their female partners. Taft et al. (2009) found a similar rate of violence among Veterans 
with PTSD who were seen at a Veterans Administration medical center from 2003- 2008. 
In a study of Navy recruits (Merrill et al., 2004), PTSD was identified as a risk factor for 
violence, with an odds ratio of 2.05, compared with recruits without PTSD. Byrne & Riggs 
(1996) found rates as high as 63% for certain acts of aggression within the past year 
among Veterans with PTSD. 
Studies show links between clusters of PTSD symptoms and specific types of relationship 
problems. For example, PTSD symptoms of arousal and feeling a lack of control were the 
most robust predictors of self-reported aggression (Taft et al., 2009). In the only study on 
spousal abuse specifically in OIF and OEF service members, experiential avoidance was 
associated with physical aggression perpetration in 49 male National Guard members who 
returned from deployment to Iraq (Reddy et al., 2011).  Numbing and avoidance symptoms 
have been related to difficulties with intimacy, including sharing and receiving 
communication about emotions, as well as poorer general relationship satisfaction (Riggs  
et al., 1998), and with less satisfaction with parenting (Berz et al., 2008). Numbing and 
avoidance symptoms were also found to be strong predictors of poorer overall 
interpersonal and social functioning in returning OIF Veterans (Shea et al., 2010). Ruscio et 
al. (2002) suggest that the inability of Veterans with PTSD to experience and express 
emotions, and to engage with others, takes a toll on all family relationships. 
While the studies cited above provide ample evidence of the association between PTSD and 
relationship conflicts, far less research has been conducted on the impact of PTSD in other 
areas of relationship dysfunction, like isolation. These are areas that can be addressed in 
Interpersonal Psychotherapy (IPT) for PTSD, a relational approach to be tested in the 
current proposal. In particular, there have been no studies (to our knowledge) aimed at 
increasing social interaction and social support among Veterans with PTSD, even though 
feelings of detachment and estrangement are symptoms of PTSD, and social withdrawal and 
isolation are serious problems among Veterans with this disorder (Milliken et al.,           
2007; Tanielian & Jaycox, 2008). The Interpersonal Theory of Suicide (Van Orden et al., 
2010), notes that the most dangerous form of suicidal desire is caused by the simultaneous 
presence of two interpersonal constructs, one of which is thwarted belongingness. In a 
study of 185 Veterans (96 women) entering inpatient psychiatric treatment, feeling 
burdensome to others, interacting with a sense of thwarted belongingness, significantly 
predicted current suicidal ideation (Monteith et al., 2013). 
There is ample evidence of the importance of social connection and social support in 
preventing or moderating PTSD, however. Social support is associated with a reduced risk 
for the development of PTSD and other negative mental health outcomes after trauma 
exposure (Brewin et al., 2000). Social support in the acute aftermath of trauma predicts  
less PTSD symptomatology, yet has also been documented to diminish over time in the 
presence of chronic PTSD (e.g., Kaniasty & Norris, 2008; King et al., 2006). There is an 
especially strong association between support from friends and family and reduced risk for 
PTSD (Pietrzak et al., 2009). Carter et al. (2011) found that service members had lower 
levels of PTSD symptoms following deployment when they had communicated more 

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frequently with their spouses during deployment (if marital satisfaction was high and 
when delayed forms of communication, e.g., letters, emails, and care packages, were used). 
In a study of pre, during, and post-deployment risk factors for PTSD following deployment 
to Iraq, family stress during deployment (negative) and social support following return 
from deployment (positive) were the strongest independently predictive variables, aside 
from combat exposure (Shea et al., 2013). Other studies have documented that social 
support and interpersonal and family functioning affect individual PTSD treatment 
outcomes in Veterans (Evans et al., 2009; Price et al, 2013; Tarrier et al., 1999). 
Erbes (2011) and Monson et al. (2009) note several reasons why relationships, or their 
absence, may affect the occurrence of and prognosis for PTSD and other outcomes, 
including biological indices of health. With social support being negatively related to PTSD 
symptoms (Monson et al., 2009), relationship patterns among intimate partners may 
prolong or reduce avoidant behavior, or support or discourage emotional expression, each 
of which can affect the course of PTSD.  Research conducted with civilians (Cacioppo & 
Patrick, 2008) has linked loneliness with an increase in blood pressure over time. In a  
study of 200 breast cancer survivors, Jaremka et al. (2013) found that lonelier women 
experienced more pain, depression, and fatigue than those who had stronger connections  
to friends and family. Those who were more disconnected also had elevated levels of a 
particular antibody associated with the herpes virus- a sign of a weakened immune system. 
Thus, social disconnection can be not only emotionally, but also biologically, toxic. 
Treatment of PTSD 
The vast majority of treatment studies addressing PTSD, both in civilian and military 
populations, have focused on cognitive behavioral interventions, for both individual and 
conjoint treatments. Treatments with the greatest evidence base are Prolonged Exposure 
(PE) and Cognitive Processing Therapy (CPT), both of which have been rolled out across 
Veterans Administration hospitals and clinics nation-wide. A randomized controlled trial 
comparing PE to present-centered therapy in 277 female Veterans found that PE was an 
effective treatment for PTSD (Schnurr et al., 2007). Female Veterans who received PE 
experienced significantly greater reduction of PTSD symptoms than women who received 
present-centered therapy. The focus of PE and CPT is on confronting and integrating the 
trauma; and although they may result in improvement in functioning, they do not directly 
address the role of interpersonal relationships as a contributing factor to or consequence of 
PTSD. 
We have chosen PE as the treatment with which to compare IPT for PTSD for two reasons: 
1) it has the greatest research evidence to support its efficacy as a PTSD treatment (IOM, 
2008); it is considered the “gold standard” in addressing PTSD, and 2) its theoretical model 
presents a sharp contrast to that of IPT. Where PE emphasizes exposure as the mechanism 
of change, and focuses on fear responses, IPT focuses on the important role of social 
support and improvement in relationships as a means of overcoming PTSD symptoms. 
As Monson et al. (2012) point out, there is increasing recognition that intimate 
relationships play a potent role in recovery from PTSD and its comorbid symptoms, 
suggesting that treating relationships, and not just the Veteran’s PTSD, may be particularly 
effective. Indeed, as a result of their randomized controlled trial that demonstrated the 
effectiveness of cognitive-behavioral couple therapy for PTSD (CBCT; Monson et al., 2012), 

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this intervention is now being rolled out in the VA system. In their study, 40 couples, in 
which one partner met criteria for PTSD, were randomly assigned to CBCT or a wait-list 
condition. The results showed that PTSD symptom severity was significantly more 
improved in the couple therapy condition than in the wait-list condition. Also, patients’ 
intimate relationship satisfaction was significantly more improved in couple therapy than 
in the wait-list condition. These findings demonstrate that treatment focused on 
interpersonal issues can benefit both PTSD symptoms and relationships. 
Other studies of behavioral conjoint therapies (BCT) also show evidence for this approach. 
For example, in Glynn and colleagues’ (1999) study of 42 Vietnam Veterans, randomly 
assigned to directed therapeutic exposure (DTE: Carroll & Foy, 1992), DTE followed by 
BCT, or wait-list, both treatment conditions were associated with more improvement than 
the wait-list on “positive PTSD symptoms,” i.e., reexperiencing and hyperarousal, although 
neither was effective in reducing the “negative” symptoms of avoidance and numbing. 
Sautter et al. (2009) developed Structured Approach Therapy (SAT), a couple-based PTSD 
treatment targeting the avoidance/numbing symptoms of PTSD. Data from an open trial 
conducted with six Vietnam Veterans and their spouses showed significant reductions in 
self-rated, partner-rated, and clinician-rated overall PTSD severity, in addition to  
reductions in avoidance and numbing.  The investigators modified the intervention for 
OEF/OIF Veterans and their partners and reported significant improvements in returning 
Veterans’ PTSD and relationship satisfaction and decreases in their partners’ depression 
(Sautter et al., in press). Data from a recently completed randomized clinical trial have 
replicated these findings with 57 OEF/OIF Veterans with combat-related PTSD (Sautter et 
al., 2013). Returning Veterans and their partners receiving SAT showed significant 
reductions in attachment-related avoidance and anxiety, suggesting that improved 
relationship functioning is associated with decreased PTSD. As Monson et al. (2009) 
observe, however, in discussing “future directions” with regard to PTSD, “a significant 
proportion of Veterans is not in a longer-term romantic relationship” and that “parents, 
siblings, close friends, and/or fellow Veterans may be the Veteran’s family” (p. 712). Thus, 
interventions that are based on couple relationships only may not be appropriate for many 
Veterans with PTSD. Existing relationship-focused treatments for PTSD also do not address 
other relationship difficulties that may be associated with PTSD, such as loss of a relationship 
through death of a significant other, or the absence of relationships among Veterans with 
PTSD who are socially isolated or who have interpersonal deficits that preclude having 
sustained relationships. 
Research on Interpersonal Therapy for the Treatment of PTSD 
While IPT has been recognized as a “first-line” treatment for depression and is being rolled 
out across VA hospitals and clinics for the treatment of that disorder, far less attention has 
been paid to its potential role as a treatment for PTSD. Nevertheless, findings from recent 
studies suggest its potential as an effective treatment for PTSD and the relationship 
problems that may accompany it. 
Krupnick and colleagues (Krupnick, Green, Stockton, et al., 2008) first adapted IPT as a 
group modality for low-income women with PTSD. In this study, 48 low-income, 
predominantly minority women with extensive interpersonal trauma histories were 
randomized to group IPT for PTSD or a wait-list. Research participants, recruited from 

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family planning and gynecology clinics, mostly had histories of sexual or physical abuse 
beginning in childhood. Results showed that IPT was significantly more effective than the 
wait- list in reducing PTSD and depression symptom severity. IPT participants also had 
significantly more improvement than wait- list subjects on four out of five subscales of the 
Inventory of Interpersonal Problems: Interpersonal Sensitivity, Need for Social Approval, 
Lack of Sociability, and Interpersonal Ambivalence. 
In another study of civilians, Bleiberg & Markowitz (2005) used individual IPT for PTSD in 
an open trial of 14 men and women with PTSD following a variety of traumas that sought 
treatment at a university-based psychiatric clinic. Their findings showed that 12 of the 14 
no longer met criteria for PTSD at treatment termination; 69% had a PTSD score 
decrement of at least 50%. They followed this study with an NIMH-funded randomized 
trial comparing IPT for PTSD with PE and a supportive therapy control condition. Their 
findings show that IPT for PTSD achieved results that were comparable to those obtained 
for PE in a civilian population (J. Markowitz et al., in press). 
A recently published study (Meffert et al., 2014) examined the impact of IPT on Sudanese 
refugees living in Cairo, Egypt who had symptoms of PTSD. A randomized controlled trial 
with 22 Sudanese refugees, assigned to IPT or a wait-list condition, tested 6 sessions of IPT 
delivered by Sudanese community therapists. IPT showed a significant decrease in 
symptoms of PTSD, state anger, and depression using a conservative intent-to-treat 
analysis. The authors observed that this preliminary success has positive implications for 
developing effective mental health interventions for traumatized populations. 
In the only study of IPT for PTSD in a military population, Krupnick (2010) adapted IPT for 
PTSD in women Veterans. This was an open trial/pilot of IPT for PTSD in women Veterans 
who had experienced trauma during military service. Of the 15 women who started 
treatment, 10 completed the intervention. There was a significant decrease in PTSD 
symptoms among those completing treatment, as well as significant improvement in 
relationship functioning across patients. 
To summarize, there is abundant evidence that PTSD is associated with serious disruptions 
and impairments in multiple aspects of interpersonal relationships and functioning. 
Despite the notable advance in effective treatments for PTSD such as PE and CPT, 
interpersonal difficulties are not the focus of these treatments and there are no data to 
suggest that, beyond the Veteran’s intimate relationship satisfaction, the broad range of 
interpersonal problems associated with PTSD are addressed by these treatments. Although 
there is evolving empirical support for couples therapy (Monson et al., 2012; Sautter et al., 
2013), a large proportion of Veterans are not involved in intimate relationships. 
Furthermore, these treatments do not target interpersonal functioning outside of the 
Veteran’s relationship with his/her partner or spouse. There are many aspects of 
interpersonal functioning that have been shown to be impaired because of PTSD that 
extend far beyond their primary intimate relationship. These problems affect the Veterans’ 
relationships with everyone with whom they interact, including friends, children, 
coworkers, employers, and even health care providers. Veterans also have difficulties that 
keep them socially isolated. Thus, there is a clear need for effective treatments for 
interpersonal problems in Veterans. Support from previous studies of IPT in treating PTSD, 
along with evidence of the serious interpersonal difficulties that accompany PTSD in 

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Veterans, makes a compelling argument for the further study of IPT in treating PTSD in this 
population. 
2. Research Design and Methods 
A. Overview 
IPT-PTSD or Prolonged Exposure (PE) will be provided on an individual basis to patients 
randomized to one or the other treatment conditions. There will be 4 therapists. 
B. Participants 
The sample will consist of male and female Veterans over age 18 who meet current criteria 
for PTSD. Participants will be recruited at the Providence VA. 88 participants will be 
randomly assigned to one of the two conditions. 
 
Inclusion/exclusion criteria 
The inclusion and exclusion criteria are based on an attempt to be as unrestrictive as 
possible, while ensuring the safety of participants and maintaining the internal validity of 
the study. 
 
In order to be included, participants must: 
• Be male or female Veterans over the age of 18 
• Have experienced trauma (combat or noncombat) while deployed to a war zone 
• Meet current DSM-5 (APA, 2013) criteria for PTSD 
• Have at least one area of relationship dysfunction 
• Consent to be randomized 
 
Potential participants will be excluded for any of the following reasons: 
• Current severe substance use disorder 
• Current psychotic symptoms 
• Current Mania or un-medicated Bipolar Disorder 
• Current suicidal or homicidal ideation suggesting an imminent threat 
• Victim or perpetrator of severe domestic violence in the past 12 months 
• Currently receiving Cognitive Behavioral Treatment for PTSD (Patients currently in 
CBT may be enrolled when they have completed the treatment if they remain 
interested and continue to have PTSD) 
• Psychotropic medication start or dosage change within the prior 4 weeks - Those 
with a recent medication or dosage change may be considered after they have been 
on a stable dose with no medication changes in the prior 4 weeks. 
Participants with cognitive impairment will be excluded if they would be unable to readily 
understand the concepts of therapy or assessments. If such impairment is suspected, the 
MoCA will be administered (see below). Veterans with mild traumatic brain injury (mTBI) 
will not be excluded, since the typical level of cognitive impairment associated with mTBI is 
not sufficiently severe to interfere with treatment implementation. 
 
C. Recruitment procedures 
Participants will be recruited from a range of sources. The primary recruitment source will 
be the Providence Veterans Affairs Medical Center, including the OEF/OIF specialty 

9 
 
 
primary care clinic, the Returning Veterans Outreach Program (REVOC), and the PTSD 
Clinic. Dr. Shea is a member of the PTSD clinic staff and Director of PTSD Research at the 
PVAMC. She will coordinate efforts with the appropriate mental health staff to refer 
patients to the study. PVAMC staff will be told about the study and how to refer patients, 
and given a brochure to use for this purpose. A flyer with study information will also be 
posted as a screen saver on computer monitors in the facility. The current PTSD clinic 
caseload includes close to 1800 Veterans with PTSD, with an average of 7 - 8 referrals per 
week. Thus, the PVAMC has a very large pool of potential participants for recruitment. 
Study participants will also be recruited through outreach efforts to local Vet Centers and 
CBOC’s, military family organizations, community-based troop support organizations, and 
Veteran organizations. Additional outreach efforts will include making presentations at 
military reintegration events, such as Yellow Ribbon post-mobilization weekend retreats, 
posting fliers in the community, as well as making presentations to interested community 
groups. Recruitment will take place over 27 months with an average of 3.2 participants 
per month. 
D. Screening and Informed Consent Procedures 
Patients currently in treatment will be informed of the study by their clinician or by flyers.   
If interested, potential participants will have the option of signing a form giving permission 
to the investigators to contact them, or they can contact the investigators directly. The 
project coordinator/clinical evaluator (PC/CE) will contact them by phone to gather 
demographic information and provide information that will enable them to decide whether 
they want to be considered for the study (i.e., purpose of the study, the two intervention 
conditions, use of random assignment, time commitment, and payments). The medical 
record will be examined to determine whether diagnostic exclusion criteria (e.g. current 
severe substance use disorder, mania or psychotic symptoms) are present. Interested and 
eligible individuals will obtain an appointment with the PC/CE. During this next stage of 
screening, interviewers will review the Informed Consent forms to explain the study in 
greater detail. The participant will be fully informed of the nature and extent of study 
participation, the objectives of the study, and the two interventions to  which they may be 
randomly assigned. Participants will also be informed about the follow-up assessments they 
will complete. PC/CEs will be trained to ensure that participants comprehend the study and 
the consent form and willingness to adhere to study conditions. Potential participants will 
sign the consent and receive a copy to take home. 
 
After reviewing the consent form, the interviewer will ask if the participant is interested in 
proceeding with the next phase of screening to determine if s/he meets all study 
inclusion/exclusion criteria. If s/he is willing to proceed s/he will also be asked to sign a 
HIPAA authorization form. In the final stage of screening, interviewers will complete 
interviews to establish inclusion  and exclusion criteria, as described below. 
 
E. Assessment 
E1. Screening, Diagnostic, and Sample Characterization Measures 
After informed consent is obtained, participants will be evaluated using the diagnostic and 
screening measures to determine eligibility. 
 
Clinician Administered PTSD Scale (CAPS-5; Weathers et al., 2013) will be administered 
to assess diagnostic criteria for PTSD. Participants must meet criteria on this measure, 

10 
 
 
considered the “gold standard” for PTSD diagnosis, to be eligible for the study. Participants 
must also have a total score of 23 or greater, which constitutes at least a moderate (or 
clinically significant) level of symptom severity. The follow-up version will be used at post- 
treatment and at follow-ups as a primary measure of outcome. This measure, recently 
updated to conform to the DSM-5, has excellent reliability and validity for DSM-IV (Blake et 
al., 1995) and is widely used in PTSD treatment research. 
Structured Clinical Interview for DSM-5 (SCID; First et al., 1996), patient version: The 
DSM-5 version of the SCID will be administered to assess for the presence of current (past 
three months), severe substance use disorder (SUD) and alcohol use disorder (AUD), 
current psychosis, and current unmedicated bipolar disorder, which are exclusion criteria 
for study participation. In addition, in order to better describe the nature of the study 
population, lifetime (12 month period of heaviest use throughout life) SUD and AUD will be 
assessed. 
Conflicts Tactics Scale – Short Form (CTS2; Straus & Douglas 2004): This 20-item self- 
report measure will be used to rule out participants involved in current intimate partner 
violence. Respondents rate each item on an 8-point scale based on the number of times a 
particular behavior occurred during the past year in the relationship. Respondents 
reporting the commission of damaging physical violence in their intimate relationship as 
either the perpetrator or the victim will be excluded from the study and referred for other 
services. 
Inventory of Interpersonal Problems (IIP-32; Barkham, Hardy, & Startup, 1996): The IIP 
is a self-report instrument that identifies a person’s most salient interpersonal difficulties, 
e.g., assertive, supportive, involved, etc., and will serve as a primary measure of outcome. 
The 32-item measure, scored by summing scores of 0 (“not at all) – 4 (“extremely”) on each 
item, is similar to the original 117-item version in terms of its psychometric properties. 
Study inclusion will require a score of at least 2 (“moderately”) on one or more areas of 
relationship dysfunction. 
VA screen for suicidal and homicidal ideation and behavior: Standard screens for VA 
mental health patients will be used. Participants deemed at imminent risk will be walked to 
VA urgent care for further assessment. 
Montreal Cognitive Assessment (MoCA: Nasreddine et al., 2005) is a one-page test to 
assess cognitive impairment in multiple domains, short-term memory, executive function, 
attention, language, etc. We will use this measure when needed to assess cognitive capacity 
to participate in treatment and assessments. 
E2. Primary Outcome Measures 
Primary outcome domains include PTSD symptoms and interpersonal functioning. 
The CAPS-5 (past month ratings) will be used to assess change in PTSD symptoms, and the 
Inventory of Interpersonal Functioning (IIP-32) will be used to assess change in 
interpersonal functioning. 
E3. Secondary Outcome Measures 
PTSD Checklist-5 (PCL-5; Weathers et al., 2013) is a 20-item self-report measure that 
assesses DSM-5 symptoms of PTSD and PTSD symptom severity on a 5-point scale. The 

11 
 
 
wording reflects changes to existing symptoms and the addition of new symptoms in DSM- 
5. The self-report rating scale is 0-4 for each symptom, from "Not at all to "Extremely." We 
will use this measure to track PTSD symptoms throughout treatment. 
 
Patient Health Questionnaire (PHQ; Spitzer et al., 1999) The PHQ, a version of the 
PRIME-MD, contains the mood (PHQ-9) and anxiety modules in the original PRIME-MD. 
The GAD-7 assesses 7 common anxiety symptoms. These self-report measures will be used 
to track symptoms that are commonly comorbid with PTSD and expected to change along 
with PTSD. 
Work & Social Adjustment Scale (WSAS; Mundt et al., 2000) The WSAS is a self-report 
scale of functional impairment attributable to an identified problem in five different areas: 
ability to work, home management, social leisure, personal leisure, and maintaining close 
relationships. This five-item scale, with ratings of each of these areas of functioning from 0 
to 8, has been used to study the treatment of depression and anxiety. 
Multidimensional Scale of Perceived Social Support (MSPSS; Canty-Mitchell & Zimet, 
2000; Zimet et al., 1988) is a 12-item self-report measure of subjective social support. 
Three subscales address different sources of social support (family, friends, and significant 
other). It has good reliability and moderate construct validity, and is associated with lower 
levels of depression and anxiety. It is scored on a scale from 1 – 7, indicating agreement or 
disagreement with statements. 
WHO Short Form Quality of Life Measure (WHOQOL-BREF; WHOQOL Group, 1998), 
derived from data collected using the WHOQOL-100, produces scores for four domains 
related to quality of life: physical health, psychological, social relationships and 
environment. There is one item from each of the 24 facets of the WHOQOL-100, plus two 
questions on overall quality of life and general health. Item scores range from 1 – 5. 
Concise Health Risk Tracking Scale (CHRT; Trivedi et al., 2011) is a 12-item self-report 
measure of suicidal ideation, hopelessness, and interpersonal attachment/social support. 
All items are rated on a 5-point scale. Although the original measure uses the time frame of 
the past day, for the purposes of this study, we will be using the time frame of the past 
week. This longer time frame will expand coverage of recent health risk related thoughts, 
emotions and behaviors. 
E4. Additional Measures 
Deployment Risk and Resilience Inventory (DRRI): The DRRI-2 (Vogt et al., 2013) is a 
self-report measure developed to assess deployment-related experiences of military 
Veterans. Five scales will be used in the current study: pre-deployment life events, combat 
experiences, relationships during deployment, post-battle experiences, and post- 
deployment stressors. These scales will thus provide an initial index amount of life-time 
trauma exposure. 
Treatment Utilization: The Longitudinal Interval Follow-Up Assessment (LIFE) 
treatment section provides information about mental health and medical treatments 
(Keller et al., 1987), including number of hospitalizations, days spent in hospital, and 
number of outpatient visits for non-mental health medical treatments, mental health 
contacts, including inpatient and outpatient treatment, and psychiatric medications, 

12 
 
 
including dosages. A baseline version (LIFE-Base) assesses mental health treatment 
received prior to entering the study. We will adapt the LIFE-Base to assess whether prior 
treatment focused specifically on PTSD or relationship functioning. The LIFE treatment 
section will be administered at post-treatment and at the 3 and 6 month follow-up 
assessments to track any non-study treatment received. If other treatment received is 
unequal between conditions, we will use it as a covariate in analyses. 
Childhood Trauma Questionnaire (CTQ): The CTQ (Bernstein et al., 1994) is a self-report 
measure developed to retrospectively assess experiences of abuse and neglect in  
childhood, as well as aspects of the child-rearing environment. It consists of 53 items rated 
on a 5-point Likert scale, and has evidence of good internal consistency and test-retest 
reliability. 
E6. Assessment Schedule (see table below) 
Assessments will be conducted at baseline, before each session, after sessions 4 and 8, end 
of treatment, and 3 and 6 months after the end of treatment (see table for specific 
measures). For Veterans who do not complete treatment, we will make every effort to 
conduct assessments at the time of termination and at 12 to 14 weeks after randomization, 
and at the 3 and 6 months post-treatment follow-ups. 
 
Measure Construct 
Screen Base 
line 
All 
Sess 
Sess 
4 
Sess 
8 
End 
of 
Tx 
3- 
mo 
FU 
6- 
mo 
FU 
CAPS-5* 
PTSD Diagnosis 
XX 
XX 
XX 
XX 
SCID-5 
Psychosis, SUD, 
AUD, Bipolar 
XX 
CTS 
Domestic Violence 
XX 
IIP-32* 
Interpersonal 
Problems 
XX 
XX 
XX 
XX 
XX 
XX 
VA 
Screen 
Suicide or Homicide 
risk 
XX 
MoCA 
Cognitive 
Impairment 
XX 
PCL-5 
PTSD Sx 
XX 
XX 
XX 
XX 
XX 
PHQ 
Depression, GAD Sx 
XX 
XX 
XX 
XX 
XX 
XX 
CHRT 
Suicidal Ideation 
XX 
XX 
XX 
XX 
MSPSS 
Perceived Social 
sup. 
XX 
XX 
XX 
XX 
WSAS 
Social Adjustment 
XX 
XX 
XX 
XX 

13 
 
 
 
WHOQO 
L-BREF 
Quality of Life 
XX 
XX 
XX 
XX 
DRRI 
Trauma Exposure 
XX 
LIFE - Tx 
Treatment 
Utilization 
XX 
XX 
XX 
XX 
CTQ 
Childhood Trauma 
Questionnaire 
XX 
 
Measures and Times of Administration 
* CAPS-5 and IIP-32 (primary outcomes measures) obtained at screening will serve as the 
baseline measure 
 
Assessment Procedures: Every effort will be made to schedule in-person therapy sessions 
and follow-up assessments. Due to our inability to schedule in-person appointments due to 
health concerns (e.g., related to COVID-19), we will offer our last participant the opportunity 
to participate in the assessment phase via phone or by VA Video Connect (VVC) with trained 
study personnel. VVC enables Veterans to virtually meet with their VA healthcare providers, 
using encrypted video to ensure the session is secure and private. Veterans will have the 
option to complete the questionnaires over the phone or by VVC with a trained assessor.  
 
E7. Blinding of Assessments 
CEs will be blind to participants’ treatment condition. Prior to the outcome assessments, 
the CE will remind each participant not to reveal his/her treatment condition. At the post- 
treatment and follow-up assessments, CEs will complete questions including whether they 
think the blind was broken, and to which treatment condition they think the participant 
was assigned. 
E8. Standardization of Assessments 
PC/CE qualifications will include either masters or doctoral training in psychology or social 
work, with prior experience administering the SCID and CAPS in a Veteran sample. Dr. 
Krupnick will provide training on the SCID and CAPS. PC/CEs will conduct practice 
interviews and receive feedback from Dr. Krupnick until judged to be calibrated to an 
acceptable standard of administration. 
All of the CAPS and SCID interviews will be recorded. Ten percent of the interviews will be 
selected on an ongoing basis to monitor the reliability of the interviewer ratings. Dr. 
Krupnick will listen to the recorded interviews and provide feedback to interviewers in 
monthly meetings to maintain reliability. PC/CEs’ ratings will be compared with Dr. 
Krupnick’s ratings and any discrepancies in ratings will be discussed. 
E9. Procedures to Enhance Completion of Assessment Protocols 
A number of procedures will be used to minimize the likelihood that participants will fail to 
complete the schedule of assessments. Self-report measures will be completed at the time  
of the assessment and reviewed for completeness before the participant leaves. We will 
monitor carefully for fatigue and encourage breaks if needed. We will try to schedule 
assessments on the same day as treatment sessions. We will obtain the name and phone 
number of a close relative, friend, or other person who is likely to maintain contact with the 
participant, and to contact that person if attempts to contact the participant are 
unsuccessful. Post-treatment and follow-up assessments will be conducted in person. An 

14 
 
appointment for the 3-month post-treatment follow-up assessment will be made at 
termination of the study intervention. The participant will receive a letter or telephone call 
one week prior to the interview and a similar reminder a few days prior. Appointments for 
the 6-month interview will be made at the 3-month interview. Participants who do not   
have telephones will be contacted by mail and asked to call or email for an appointment. 

15 
 
 
Five contact attempts will be made before a participant is considered to be unreachable at 
that time point. Participants who fail to appear for a scheduled assessment will be 
contacted by phone, or mail or email when necessary, for rescheduling. If participants 
move away during their participation in the study or are otherwise unavailable for an in- 
person interview, we will perform follow-up assessments over the telephone to avoid 
missing data. Participants will be compensated $50 for the pre-treatment, post-treatment, 
and follow-up interviews. Those screening out on the SCID or CAPS will be paid $35 (for 
partial assessment). Mid-treatment assessments (after sessions 4 and 8) will be 
compensated at $25. 
F. Compensation 
Participants will be compensated for the time required to complete all assessments. They 
will be paid $50 for fully completing baseline, end of treatment, and follow-up assessments. 
Participants who screen out on the SCID or CAPS or who do not complete the full baseline 
assessment will be paid $35 (for partial assessment).  Mid treatment assessments (after 
sessions 4 and 8) will be compensated at $25. 
G. Treatment 
G1. Assignment 
Participants meeting study inclusion/exclusion criteria will be randomly assigned to IPT- 
PTSD or PE following completion of the initial assessment. To prevent unequal distribution 
of variables that might be related to outcome, we will use the urn randomization strategy 
described by Wei (1978) and Stout (Stout et al., 1994). Urn randomization is a stratified 
technique that assigns patients of a given subgroup to treatment conditions, but 
systematically biases the randomization in favor or balance among the treatment 
conditions of the stratification variables. The urn randomization procedure has been used 
in several previous treatment outcome studies, including the multi-site Project MATCH 
(Project MATCH research group, 1997). The urn randomization computer program also 
enables ongoing monitoring of the effectiveness of stratification and randomization 
procedures. Three dichotomous balancing factors will be used in randomization: gender 
(male vs female), War Era (OEF/OIF/OND, Vietnam, or other), and severity of PTSD. 
Severity will be dichotomized as the equivalent DSM-5 CAPS cut-off to <70 vs > 70 on the 
DSM-IV (when available from CAPS-5 developers). Study staff will implement the 
randomization. 
 
G2. IPT-PTSD 
IPT –PTSD is a relationally-focused intervention addressing PTSD symptoms and 
relationship dysfunctions that are conceptualized as resulting from and contributing to the 
perpetuation of these symptoms. It is based on the interpersonal and attachment theories 
of Harry Stack Sullivan (1953) and John Bowlby (1973) that place importance on the role of 
social support and interpersonal connection in preventing or ameliorating emotional 
problems. As the model below (Lipsitz & Markowitz, 2013) indicates, its focus on one or 
two particular problem areas, i.e., role disputes, role transitions, grief, and/or interpersonal 
deficits (called social isolation for this adaptation) leads to the resolution not only of 
interpersonal problems, but also a decrease in psychiatric problems. Interpersonal problem 
resolution involves increasing interpersonal skills as well as processing of emotions. 
Improving relationships enhances social support while decreasing interpersonal 

16 
 
 
stress. This, in turn, is theorized as helping with symptom reduction. 
Treatment consists of 12 individual weekly sessions of 45-50 minutes duration. The initial 
phase of treatment (sessions 1-3) involves learning about the Veteran’s military and other 
trauma history, completing a review of PTSD symptoms, presenting PTSD as an “injury” (to 
allow the Veteran some reduction of pressure while he/she is trying to recover), provision 
of psychoeducation about the links between PTSD and relationship problems, conducting 
an interpersonal inventory to determine which relationships (or lack thereof) contribute to 
the Veteran’s difficulties, and establishing an appropriate focus for the treatment. 
Learning about significant relationships that may have contributed to and/or affected by 
the Veteran’s PTSD symptoms/diagnosis helps the clinician to determine which problem 
area(s) would be the best fit for the individual. The intermediate phase (sessions 4-10) 
addresses the problem areas identified as the most salient for individual Veterans. This is 
achieved through such strategies as communication analysis, decision analysis, role play, 
etc. The termination phase (sessions 11 & 12) is focused on consolidating what has been 
learned, what issues still remain for the Veteran, expressing feelings about ending the 
therapy, and identifying the types of relationship triggers in the future that could reactivate 
PTSD symptoms (see Appendix B for IPT- PTSD manual). 
 
 
 
 
G3. Prolonged Exposure 
The aim of PE is to allow Veterans to re-experience the traumatic events they experienced 
during military service in a safe and supportive environment, and to re-engage in activities 
they had been avoiding because of the trauma. It consists of two types of exposure: 
imaginal exposure in which the Veteran is asked to confront memories of the trauma, 
including exposure to all sensory images of the trauma, and in vivo exposure, during which 
the Veteran is encouraged to visit places and engage in activities that he/she had been 

17 
 
 
avoiding. The goal is to reactivate the fear structure and then confront that which had been 
feared. 
 
PE will be delivered according to the standard manual used for the VA PE roll-out, which 
includes 10 90-minute weekly sessions delivered over 8 to 15 weeks. Although the manual 
includes 10 sessions, anywhere from 8 to 12 sessions are within the range of standard PE. 
IPT-PTSD consists of 12 individual weekly sessions, with each session of 45-50 minutes 
duration. In order to increase comparability in terms of number of sessions while also 
maintaining the flexibility of PE delivery, we propose a standard of 12 weekly sessions for 
each treatment, but will allow participants who improve more quickly to complete in 9 or 
10 sessions. 
 
After much consideration, we have decided to keep the session length for PE at the 
standard 90 minutes. The disadvantage of this choice is the difference in total time of each 
therapy. Literature on the dose-response relationship in psychotherapy has focused on 
number of sessions and not session length. One small study compared a shorter session 
length for PE of 60 minutes to the standard 90 minutes (van Minnen & Foa, 2006). Those in 
the shorter sessions showed less in-session habituation, but there were no differences in 
outcome. Although these findings were promising, due to limitations of sample size and 
design, they are not sufficiently strong to conclude that shorter sessions would be as 
effective as the standard 90 minutes sessions. Because we are examining the effectiveness 
of IPT-PTSD compared to PE as a “gold standard” comparison condition, we believe it is 
more important for it to be delivered as developed, previously tested, and currently 
practiced at the VA, than it is to equate session length. An alternative might be to lengthen 
IPT sessions to 90 minutes. However, we have concluded that it is also more important to 
adhere to the standard session length for IPT than to alter it to make it comparable to PE. 
So each treatment will be tested as typically practiced. 
Consistent with the standard manual used for PE (and used in the VA PE roll-out), 
treatment sessions are audio- recorded and patients are asked to listen to the recounting of 
the trauma daily. As this audio-recording is not analyzed data, but simply part of the usual 
and manualized PE treatment protocol, this audio-recording will not be behind VA firewall. 
Participants may use their own audio-recording device (e.g. cell phone), or if needed, they 
can borrow a cassette recorder from their PE therapist. 
 
 
G4. Therapist Selection, Training, and Supervision 
IPT-PTSD 
Therapists will be Ph.D. level psychologists or master’s level clinical social workers with 
prior experience treating PTSD patients. Initial training will be didactic, involving two days 
of instruction. Dr. Krupnick will conduct the didactic training for IPT-PTSD. Training will 
include disguised case examples derived from the pilot study of IPT-PTSD for women 
Veterans as well as role-plays of interventions. A recently developed DVD of IPT for 
depression with demonstrations by Kathleen Clougherty, LCSW and Gregory Hinrichsen, 
Ph.D. (conducted with depressed Veterans, some of whom also had comorbid PTSD) will be 
shown to demonstrate techniques of IPT with Veterans. This video was developed to 
demonstrate the core components of IPT for depression in a series of video vignettes and 

18 
 
 
will be relevant to training in IPT for PTSD. 
 
Following the IPT didactic training, each therapist will have one training case, with weekly 
supervision based on review of audiotaped sessions. The training case must be a minimum 
of 8 sessions to count. If the therapist is judged to be sufficiently competent, Dr. Krupnick 
will approve him/her to see study participants. Approval will be based on consistent  
ratings of adherence (75% of strategies implemented across sessions rated; see below). Dr. 
Krupnick will use an adapted version of the IPT Rating Scale (IPTRS), the measure that she 
has been using to assess the competence of VA clinicians who are learning IPT for 
depression, to assess the competence of IPT for PTSD therapists. All therapy sessions for 
study participants in both conditions will be recorded. For the first study case for IPT, 
every session will be reviewed and feedback will be provided weekly.  After therapists 
have been judged as competent in IPT, Dr. Krupnick will provide bi-weekly group 
supervision to all therapists providing this treatment. Dr. Krupnick will continue to review 
audio recordings if needed for difficult cases.  
 
Therapists for the PE condition will be Ph.D. level psychologists or master’s level clinical 
social workers who have been previously certified as PE therapists either through the VA 
roll-out or by Dr. Foa’s training program. Since the therapists will have already been 
trained and certified in PE, no additional PE training will be conducted with regard to the 
conduct of PE. However, since it is possible that the therapists may have “drifted” in their 
practice of this method, we will have a PE expert review early, middle, and late sessions 
from each of their first two cases to ensure that they are conducting PE according to 
manual specifications. Sonya Norman, Ph.D., who has been a PE trainer for the VHA, will 
review audiotapes to ensure PE competency and will provide consultation on PE methods, 
as needed. Dr. Norman will also provide bi-weekly group supervision to the PE therapists 
on their PE cases. 
G5. Adherence Monitoring 
Two Ph.D. level psychologists with experience treating Veterans with PTSD will complete 
adherence ratings for both treatments. The IPTRS (the rating scale that is used to assess  
IPT competence and adherence in IPT for depression) will be modified to be consistent  
with the IPT-PTSD manual (Appendix C). The adherence measure used in prior studies of 
PE (e.g. CSP-494; Schnurr et al., 2007) will be used to assess adherence for PE sessions 
(Appendix D). The purpose of the adherence measures is to confirm that therapists are 
conducting each of the treatments as prescribed and using none of the techniques that are 
proscribed for each method. Both adherence raters will rate early sessions (a minimum of 
20 sessions) to establish inter-rater reliability. Following establishment of acceptable 
reliability, approximately 20% of sessions will be randomly selected for adherence ratings. 
All session recordings will be digitized and encrypted and will be used only for the purpose 
of training, supervision, and adherence ratings. 
 
G6. Collaborative Procedures 
Proposed personnel for this study include Dr. Shea, the PI of the Providence site, Drs. 
Krupnick and Green at Georgetown University, and a statistician. Dr. Shea will have 
responsibility for administrative coordination of the study, including scheduling of 
meetings and conference calls, monitoring the progress of the study according to the 

19 
 
 
proposed time-line, and preparing interim and final progress reports. Dr. Shea will be 
responsible for hiring study staff, IRB submissions, and reporting of all adverse and serious 
adverse events. Drs. Shea, Krupnick, and Green will constitute the oversight committee, and 
will share responsibility for overseeing implementation of the protocol, ensuring 
consistency of procedures, and monitoring quality control of data. They will meet weekly 
via conference calls, with PC/CEs joining calls that involve study procedures. The study 
statistician will be responsible for data analyses, and Drs. Shea, Krupnick, Green, and the 
study statistician will participate in data interpretation and manuscript writing. The PIs  
and their staff will have weekly meetings to review progress and address any questions  
that arise regarding study procedures at their site. Local site issues will be resolved at the 
site, but issues affecting delivery of the overall protocol will be discussed with the larger 
group to ensure consistency of procedures. Dr. Krupnick will conduct training of PC/CEs, 
and will implement ongoing reliability studies of PC/CEs to ensure consistency of 
assessments. Dr. Krupnick will monitor appropriate delivery of the interventions for IPT 
and PE respectively. 
 
H. Data Management and Analysis 
H1. Data Management 
All data collected for this study will be used for research purposes only. Study data (all de- 
identified) will be managed using REDCap electronic data capture tools (www.project- 
redcap.org). REDCap (Research Electronic Data Capture) is a secure, web-based  
application for building and managing databases. It is specifically designed to support data 
capture for research studies. The REDCap application allows users to quickly and securely 
build and manage online databases and has features for tracking data manipulation and 
export to common statistical packages (Harris et al., 2009). Multiple users can access the 
database from different locations, and different levels of use and restriction can be 
specified. REDCap is approved for use in the VA, and is being used by many VA researchers. 
The PC/CE will oversee data management procedures. He/she will be responsible for 
initial editing and correction of forms before the research assistant enters them into 
REDCap. As forms are entered into the REDCap database, they will be checked against the 
participant-tracking file to ensure that all data that are gathered have been entered. 
Furthermore, (1) data sheets will be stored in locked offices of research study staff, building 
32 of the PVAMC) (2) data will be entered in coded form, (3) data will be stored on a secure 
server behind the VA firewall (\\vhaproappres01.v01.med.va.gov\research_protocols\Shea\IPT_PE-R), 
(4) data will be protected from unauthorized access by  passwords, (5) information that 
might potentially allow an individual participant to be identified will not be allowed in any 
publications or reports sent to individuals outside the  study, (6) all employees who are to 
handle data will be trained in confidentiality policies and procedures, and (7) all data- 
related incidents will be reported to the local ISO and PO per VA  policy. Study files will be 
maintained in accordance with the Department of Veterans Affairs Record Control Schedule 
10-1. De-identified data from the New Orleans site will be entered from that site into an 
integrated study data base. Only personnel involved in the study will have access to the 
REDCap data base. Subsets of de-identified data files may be downloaded onto personal 
computers for data-analysis, only by approved study personnel. 
 
H2. Power and Data Analyses 

20 
 
 
H2.1 Power Analysis. 
Our study is designed as a 2-arm randomized clinical trial comparing IPT-PTSD with PE 
using analysis of equivalency of the clinical outcomes between treatment groups. We 
hypothesize that the effectiveness of the IPT-PTSD intervention will be at least as good as 
the effectiveness of the well-established PE treatment in reducing symptoms of PTSD. By 
powering our study for an equivalence hypothesis based on two-sided significance testing 
at the 95% confidence level rather than a non-inferiority design based on one-sided testing 
or the usual 90% confidence level for equivalence, we allow for a rigorous comparison 
between the two treatments. We further expect that IPT-PTSD will be more effective than 
PE in improving interpersonal functioning. We will test this hypothesis as a superiority 
analysis to show that the change in the interpersonal functioning outcome in the IPT-PTSD 
group will be significantly superior to the change in the PE group. De-identified data from 
the Providence VAMC and New Orleans VA will be entered into separate REDCap  
databases, and then combined for analysis for an ideal total of 88 per site. Taking into 
account a dropout rate of 20% the goal is 70 participants in each treatment condition, 140 
in sum. 
The first primary outcome measure is the CAPS-5 total score measured at screening, post- 
treatment (12-weeks), and at 3-month and 6-month follow-up. Sample size calculations 
were conducted in PASS (Hintze, 2013) using the change in the CAPS total score from 
screening to post-treatment as the primary endpoint. Due to unavailability of CAPS-5 data 
at this time, our estimates for the expected changes were based on the DSM-IV CAPS. Using 
a two-sample t-test algorithm with equal variances in an equivalence test of means design, 
our study reaches 81% power to infer equivalence at 5% significance level (95% 
confidence level) with sample sizes of 70 in both groups (140 in total). The assumptions of 
the test are 1) the true difference between the mean change scores is zero (∆=0), 2) the 
within-group standard deviation for the change measure is 10 (corresponding to a 
minimum clinically effective decrease of 15), and 3) the equivalence limits are -5 to 5 units. 
Past studies report that a 10-unit difference between treatment methods in the post- 
treatment CAPS total score represents a minimum clinically meaningful difference. For this 
study, we consider a 5-point difference (∆=5) between the groups in the pre to post- 
treatment change scores in CAPS (for instance -15 vs -20) to be the smallest difference that 
would lead the methods to be declared equivalent (Hypothesis 1). The proposed sample 
size for this study will be 88 patients to be randomized to each group with a 1:1 ratio (176 
in total from both sites) and includes an assessment dropout rate of 20% (140 in total). 
Our study will reach 81% power with the same number of subjects to detect superiority of 
IPT in improving interpersonal functioning, measured post-treatment with the IIP-32 score 
using a one-sided, two-sample t-test at alpha=0.05 with a margin of superiority of -0.05 and 
assuming that the true difference between the means is -0.2, and within-group standard 
deviations are 0.35 (expected scores for post treatment IIP-32 mean for IPT=1.2, SD=0.35; 
for EP=1.4, SD=0.35). The estimates about IIP-32 scores were taken from past studies 
where the IIP-32 overall mean score was found to be 1.62 (SD=0.45) for patients who were 
about to start psychotherapy and 1.21 (SD=0.57) post-treatment, 0.98 (SD=0.50) for a non- 
clinical sample (Barkham et al., 1996), 1.69 (SD=0.58) for patients with anxiety and 
depression and 1.57 (SD=0.61) for patients with eating disorders (McEvoy et al., 2013). We 
could not find comparable data for Veteran populations. 

20 
 
 
H2.2 Data Analysis 
Basic statistical analysis: Initial statistical analysis will provide descriptive statistics on the 
demographic and clinical characteristics of the study participants using means, standard 
deviations, median and range for continuous variables and frequencies and percentages for 
categorical variables. To examine potential differences between the study groups at 
baseline, descriptive statistics will be obtained for each group and compared statistically 
using two-sample t-tests, nonparametric rank tests, chi-square and Fisher’s exact test as 
appropriate. All outcome variables will be summarized using similar methods for pre and 
post-treatment, 3 and 6-month follow-up. 
Outcome Assessment: The changes in the primary and secondary outcome measures from 
pre-to post-treatment will be compared by groups and tested via confidence intervals to 
examine the precision of equivalence (Hypothesis 1) and superiority (Hypothesis 2). 
Equivalency of the treatment groups in improving PTSD severity measured by CAPS (Ha: - 
5<∆<5) will be concluded if the two-sided 95% confidence interval for the difference 
between the change scores (∆) lies within the interval (-5,5). Superiority of the IPT in 
improving interpersonal functioning measured by IIP-32 (Ha: difference between the IIP-32 
mean post treatment [IIP for IPT-IIP for PE]<0) will be concluded if the upper bound of the 
two-sided 95% confidence interval for the difference is smaller than -0.05 (Rothman et al., 
2012) Changes in the secondary outcome measures for social adjustment, quality of life and 
suicidal ideation will be compared post-treatment and at follow-ups using traditional 
hypothesis testing where Ha: absolute change in the IPT score is larger than the change in 
the PE score at alpha=0.05 (Hypotheses 3-5). Due to increasing chance of evidence in favor 
of non-inferiority in intent-to-treat (ITT) trials, we will analyze both ITT and per protocol 
(treated) samples for the primary outcome measures. To handle missing data, we will 
employ multiple imputation models for the ITT analyses. We will also examine the 
difference between patients who complete the study and those who were lost to follow-up 
based on baseline demographic and clinical characteristics to evaluate type of missingness, 
adherence to therapy and limits to generalizability. 
Multivariate and Longitudinal Analyses: We will conduct secondary/advanced analyses by 
specifying multivariate and longitudinal regression models of the primary outcome 
measures, in order to estimate treatment differences adjusted by potential confounders, and 
to explore individual and group trajectories using available repeated measures data. 
Specifically, multiple linear regression analyses will be used to adjust the post-treatment 
change scores for baseline values of the outcome variable as well as age, gender, site and 
war era. These models will be estimated using cluster options (Intercooled Stata,   
command cluster) to account for the correlations between patients who were treated in the 
same hospital/site. Final analyses will include multi-level, mixed effect and/or linear 
growth curve models of the CAPS and the IIP-32 by combining the data across all time 
points to explore individual and group trajectories over time. The primary outcome 
measures will be regressed on a treatment group indicator and on covariates such as age, 
gender, war era, site and dummy variables for time points as fixed effects, along with 
random effects at hospital site and individual level. The statistical evaluation of the 
coefficient estimate for the treatment indicator (average difference between the groups 
across time points) will be based on both confidence interval and p-value approaches 
described earlier. 

21 
 
 
Exploratory Analyses: One of our goals is to better understand how IPT works towards the 
improvement of PTSD symptoms. Our study is not powered to detect the indirect effects of 
the IPT on decreasing PTSD severity through interpersonal functioning and social support 
scores. However, we propose exploratory analyses to test the mediating effect of the 
improved interpersonal functioning and social support on the relationship between the 
treatment methods and CAPS and Quality of Life Outcomes. We will employ commonly 
used linear regression models for mediation analysis to evaluate our hypothesis 
(Hypothesis 6) about the mechanisms of change (MacKinnon et al., 2007; Shrout & Bolger, 
2002; Sobel, 1982). 
H3. Time-Line 
 
Activity 
0-6 
Mo 
6-12 
Mo 
12-18 
Mo 
18-24 
Mo 
24-30 
Mo 
30-36 
Mo 
36-42 
Mo 
42-48 
Mo 
Hire, IRB, 
Train 
XX 
Recruitment 
XX 
XX 
XX 
XX 
XX 
Treatment 
XX 
XX 
XX 
XX 
XX 
XX 
Follow up 
XX 
XX 
XX 
XX 
XX 
XX 
Data entry 
XX 
XX 
XX 
XX 
XX 
XX 
XX 
Data analysis 
XX 
Manuscripts 
XX 
 
I. Dissemination and Future Plans 
The proposed study is a randomized clinical trial of the effectiveness of IPT-PTSD for the 
treatment of PTSD and relationship problems in Veterans. We will register with 
ClinicalTrials.gov, which contains over 100,000 trials sponsored by a variety of federal and 
private industry sources, and receives over 50 million page views per month and over 
65,000 visitors daily. Study findings will be submitted to a peer-reviewed journal and 
presented at professional conferences, such as the International Society for Traumatic 
Stress Studies, the APA, and appropriate VA and DoD conferences. If IPT-PTSD is found to 
be equivalent to PE in addressing PTSD (and superior in addressing interpersonal 
problems as hypothesized) we will consider multiple methods for further dissemination. 
We will create a fact sheet describing the intervention and findings to circulate to VA, 
National Guard, and other military officials, and relevant DOD programs, such as the 
Defense Centers of Excellence. The manual will be made available free of charge. After 
receiving permission, we will offer to begin dissemination by implementing the treatment 
at the Providence and New Orleans VAMCs. We would provide the manual and training to 
the mental health clinicians in the PTSD and Mental Health clinics, and encourage the use of 
relevant self-report outcome measures to provide an index of effectiveness in a naturalistic 
setting. 

22 
 
 
If there is interest in national VHA dissemination, the recent initiative to train mental 
health staff in Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) therapy 
and facilitate implementation of these treatments throughout the VHA provides an ideal 
model for dissemination (Karlin et al., 2010). CPT and/or PE training has been provided to 
thousands of mental health staff through the VHA. National training initiatives have also 
provided training in additional treatments, including Cognitive Behavioral Therapy for 
Depression, Behavioral Treatment for insomnia, and others. Thus, the infrastructure and 
methods for broad dissemination already exist, and could be applied to IPT for PTSD, if this 
were determined to be a priority. 
 
4. Human Subjects 
A. Risk to Subjects 
A1. Human Subjects Involvement, Characteristics, and Design 
The total sample to be collected in this study will consist of 88 adult (age 18 and over) male 
and female  Veterans with PTSD. 
 
A2. Inclusion/exclusion criteria. 
Inclusion criteria: Eligible participants will: (a) be at least 18 years of age, (b) meet current 
DSM-5 criteria for  PTSD as assessed by the CAPS-5, (c) have a total CAPS-5 score of at least 
23, (d) experience trauma during military service, and e) report impairment in  at least one 
area of interpersonal functioning. 
 
Exclusion criteria: Potential participants will be excluded if they: (a) have a DSM-5 diagnosis 
of current severe substance use disorder, (b) have current mania or unmedicated bipolar 
disorder, (c) have current psychotic  symptoms, (d) have current suicidality or homicidality 
requiring hospitalization, (e) are a victim or perpetrator of severe domestic violence within 
the prior 12 months, (f) are currently receiving Cognitive Behavioral Treatment for PTSD, 
(g) have had psychotropic medication start or dosage change within the prior 4 weeks, or 
(h) have cognitive impairment precluding the ability to understand the ability to 
understand the concepts of the therapy or assessments. 
 
A3. Sources of Materials 
Research materials to be used for research purposes include (a) questionnaires and 
interviews measuring demographic variables, PTSD symptom severity, psychosocial 
functioning, concurrent treatment, lifetime and current psychiatric disorders, and 
symptoms of anxiety and depression; and (b) digital recordings of diagnostic  interviews. 
 
A4. Potential Risks 
Potential risks include emotional distress due to discussing traumatic experiences, and 
breach of confidentiality. 
 
B. Adequacy of Protection against Risk 
B1. Protection against Risk 
Risk: Emotional distress due to discussing traumatic experiences. 
Minimization: Veterans will participate in assessments that may include discussion of 

23 
 
 
upsetting events that they experienced while deployed. Discussion of these experiences 
may make them feel uncomfortable. 
However, the assessments are unlikely to be more upsetting than standard clinical 
assessments, and since participants will be recruited from VA mental health clinics, they will 
be familiar with these types of  assessments. Veterans will be informed that they can refuse 
to answer any question they wish or stop the  interview at any time. Any participant 
verbalizing or showing signs of distress will be asked to remain in the  assessment or 
treatment setting until their distress is at a manageable and comfortable level. All study 
personnel who interact with study participants will have been professionally trained to 
respond to negative emotions if these should occur and to access emergency services if 
necessary. Dr. Shea or another licensed clinician will be available if needed during all 
assessments. 
Risks: Breach of confidentiality. 
Minimization: In terms of confidentiality, every effort will be taken to protect the 
confidentiality of the  participants in this study. All information about the Veteran that is 
gathered during the research (including  recordings) will be kept strictly confidential. 
However, Veterans will be informed that there is no guarantee that  the information 
gathered during the research cannot be obtained by legal process or court order. 
Furthermore, Veterans will be informed that complete confidentiality cannot be promised to 
subjects,  as federal and non-federal  monitoring agencies such as the Department of 
Veterans Affairs may also access the Veteran’s research records related to this study to 
monitor the security of the trial. All data will be received stripped of personal  identifiers. 
Measures will be identified with a study ID number not based on a personal identifier. A 
cross-index  of names and ID numbers will be stored in a restricted and password protected 
file on the Secure Research Server separate from all data files. Data entry and  management 
will take place in VA offices in Bldg. 32. Additional precautions include: (1) Data sheets will 
be  stored in locked offices, (2) data will be entered in coded form, (3) data will be stored in 
computer files on the  secure Research Server and protected from unauthorized access by 
passwords, (4) information that might potentially allow an individual participant to be 
identified will not be allowed in any publications or reports  sent to individuals outside the 
study, and (5) all employees who are to handle data will be trained in  confidentiality 
policies and procedures. Records will be maintained per Veterans Affairs Record Control 
Schedule 10-1. 
 
Regarding audio recordings used for treatment purposes (PE condition only), participants 
who borrow cassette recorders are advised to keep them in a secure, safe place when not in 
use. At each session, the audiotape content from the previous session is deleted. 
Participants, as outlined in the consent form, assume responsibility for the borrowed 
cassette recorders and information contained therein. 
 
Adverse Event Reporting 
In the case of an Adverse Effect (AE) or a Serious Adverse Effect (SAE), a written report of 
the AE or SAE will be prepared for the Chair of the IRB at the Providence VA Medical  Center. 
Any such AEs or SAEs will be presented to the full IRB committees. SAEs will be  reported 

24 
 
 
within 24 hours. Examples of serious adverse effects include death, life-  threatening 
adverse events, suicide attempts, and inpatient hospitalization. The report of  such AEs or 
SAEs will include whether they were expected or unexpected, a rating of  severity of the 
event, a brief narrative summary of the event, a determination of whether a  causal 
relationship existed between the study procedures and the event, whether the  informed 
consent should be changed as a result of the event, and whether all enrolled participants 
should be notified of the event. The annual progress reports to the IRB require summary 
information regarding all AEs and SAEs occurring during that year. 
Data Monitoring Committee 
Additionally, a Data Monitoring Committee(DMC) will be constituted and will be 
responsible for monitoring the safety of participants and the quality of the data, as well as 
providing recommendations on the appropriate termination of the study either when 
significant benefits or risks have been uncovered or when it appears that the clinical trial 
cannot be concluded successfully. Members of the DMC will not be involved with the 
proposed project and will include a medical expert, a clinical trials expert, biostatistics 
expert, and PTSD expert. The DMC will meet 2-4 times per year. A report, submitted to the 
DMC prior to each meeting, will include concerns about significant safety and data 
monitoring issues such as recruitment, retention, and quality of data collected. The specific 
content of the reports to the DSM include information about AEs and/or SAEs, treatment 
retention, recruitment, reasons for drop-out, and interim efficacy data. 
As they deem necessary, the members of the DSMB will evaluate whether the presence of 
early unanticipated therapeutic results or adverse consequences are significant enough to 
warrant amendment, suspension, or early termination of the study and will independently 
make recommendations to the PI to continue, to amend or to terminate the trial. 
Recommendations related to the study will be made in a written DSMB Report by the 
Board's Chairperson to the Principal Investigators and shared with the Providence IRB. 
Significant changes or amendments to the protocol, such as sample size or safety issues, 
will be reported to the IRBs should they occur. 
 
C. Potential Benefits of the Proposed Research to the Subjects and Others 
The risks to participants are judged to be acceptable relative to the anticipated benefits. The 
anticipated benefits of the study include advancement of knowledge about the potential 
efficacy of IPT-PTSD for Veterans  with PTSD. By participating in the study, participants may 
benefit from the intervention that they will receive. 
Given the level of risk(s) to the participants and the likelihood that some will benefit from 
the treatment (or from  the additional assessment contacts) and the even greater possibility 
of benefits to the larger population of  individuals with PTSD, the risk/benefits ratio seems 
favorable. 
D. Importance of the Knowledge to be Gained 
More research is necessary in developing treatments for PTSD that address the serious 
interpersonal  problems common among this population. Some Veterans refuse or are not 
comfortable with initiating trauma-  focused therapy, and alterative effective treatments are 
necessary to provide the range of treatment options to  meet the needs of this population. It 
is hoped that information gained from this study will improve treatment for  Veterans, even 

25 
 
 
if the Veterans themselves do not experience any improvement during their participation in 
the study. 
 
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