Peer Social Support During In Vivo Exposure for PTSD: A Program to Address Dropout From Prolonged Exposure
Phase: NA
Conditions: Stress Disorders, Post-Traumatic, Anxiety Disorders, Mental Disorder, Traumatic Disorder
Sponsor: Medical University of South Carolina

Peer Social Support During In Vivo Exposure for PTSD: A Program to Address Dropout from Prolonged 
Exposure 
 
Clinical Trials Number: NCT03485391 
 
Study Protocol and Statistical Analysis Plan 
 
Date of protocol: 05/07/2020 
 
 

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Principal Investigator: 
 
Wendy A. Muzzy, MRA, MLIS 
Principal Investigator, MUSC 
Research Instructor 
 
 
Co-Principal Investigator: 
Ronald E. Acierno, Ph.D. 
Co-Principal Investigator, Ralph H. Johnson VA Medical Center 
Research Health Scientist, VAMC 
 
 
1.0. PROTOCOL TITLE 
 
Peer Social Support During In Vivo Exposure for PTSD: A Program to Address Dropout from Prolonged 
Exposure 
 
 
2.0. ABSTRACT 
 
Post-traumatic Stress Disorder (PTSD) is a significant problem for Veterans and Active Duty personnel. 
Although effective treatments for PTSD exist (e.g., Prolonged Exposure, PE; Cognitive Processing 
Therapy; CPT) and have, at great expense, been widely disseminated by VA and DoD, over of those 
30% who start treatment subsequently drop out prior to completion. In our first preliminary study we 
addressed published survey data from Veterans indicating that dropout was related to logistical barriers 
such as travel time, cost, and stigma associated with care from mental health settings, and so overcame 
these barriers by delivering treatment via home-based telehealth. However, dropout remained virtually 
unchanged. Veterans in our study who dropped out of treatment, including that delivered via home 
based telehealth, were interviewed and a majority responded that they would (a) consider returning to 
treatment and (b) would be more likely to complete treatment if a peer who had themselves successfully 
completed treatment were available to help them with exposure homework. In keeping with this 
feedback, our second preliminary study examined the feasibility of using peers to (a) encourage 
Veterans who had dropped out of PE to return to treatment and (b) offer support during in vivo (real 
world) exposure therapy homework assignments (e.g., as they would during ‘gym workouts’). 
Preliminary findings indicate that such an approach is feasible, and potentially effective, in that over 
50% of dropouts from PE agreed to return to treatment and 30% of these actually did so immediately. 
We will evaluate whether the opportunity to receive social support during in vivo exposure therapy 
homework from Veterans who themselves have successfully competed PE (i.e., the therapeutic 
equivalent of an exposure therapy ‘workout buddy’) is effective in reversing dropout and improving 
PTSD outcomes; and, secondarily, to determine whether this program is particularly helpful for those 
receiving PE via telemedicine. 
 
 
3.0. OBJECTIVES/SPECIFIC AIMS/RESEARCH QUESTIONS 
 

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This study seeks to address the problem of dropout from evidence-based treatment for PTSD. We will 
evaluate whether the opportunity to receive social support during in vivo exposure therapy assignments 
from Veterans who themselves have successfully competed PE (i.e., the therapeutic equivalent of an 
exposure therapy ‘workout buddy’) is effective in reversing dropout and improving PTSD outcomes. 
To achieve this objective, we will use a between group, randomized controlled repeated measures 
design comparing PE+Exposure Workout Buddy vs. PE+Peer General Support (i.e., the standard VA 
Peer Support program methods involving a peer who does NOT engage in any support during in vivo 
homework) to evaluate the ‘PE+Exposure Workout Buddy’ adjunctive therapy component in terms of 
its ability to increase likelihood that Veterans will (a) return to and complete treatment & (b) evince 
reduced PTSD symptomatology at post-treatment and 3- & 6-month follow-up. An exploratory objective 
is to determine whether the hypothesized differential advantage of the workout buddy program is more 
pronounced for Veterans who receive PE via telehealth vs. receiving PE in person, as data from 
Preliminary Study #1 indicate that this may be the case.  
 
Objective 1a. To determine relative differences in treatment dose obtained, measured in terms 
of the number of sessions completed upon return to treatment, in response to ‘PE+Exposure 
Workout Buddy’ vs. ‘PE+Peer General Support’ in individuals who have previously dropped out 
of evidence based treatment for PTSD. 
 
Hypothesis 1a. Treatment ‘dose’, measured in terms of number of sessions completed post 
randomization, will be greater for participants in the PE+Exposure Workout Buddy condition 
compared to PE+Peer General Support.  
 
Objective 1b. (Exploratory) To determine if differences are amplified or diminished with respect 
to prior identified risk factors such as age, race, gender, substance use, or social support. 
 
 
Hypothesis 1b. This enhanced dose/adherence will be observed for the PE+Exposure Workout 
Buddy condition within each risk factor previously associated with dropout (i.e., age, race, 
gender, and substance use). 
 
Objective 2a. To determine differential effectiveness, measured in terms of therapeutic gains 
over time on measures of PTSD symptomatology, of ‘PE+Exposure Workout Buddy’ vs. 
‘PE+Peer General Support’  with therapy dropouts in (i.e., ‘treatment outcome’). 
 
Hypothesis 2a. Treatment ‘outcome’, measured in terms of PTSD symptom reduction scores, 
will be significantly more improved for participants in the PE+Exposure Workout Buddy relative 
to PE+Peer General Support condition at each assessment point (post treatment, 3-month and 
6-month follow-up). 
 
Objective 2b. (Exploratory) To determine if differences are amplified or diminished with respect 
to race, gender, age, substance use, or social support. 
 
Hypothesis 2b. Relatively greater gains in the PE+Exposure Workout Buddy condition will be 
observed across race, gender, and age groups at post treatment, 3-month and 6-month follow-
up. Self reported levels of social support will mediate gains. 
 

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Objective 3. (Exploratory) To determine the presence of an initial signal of differential dose and 
effectiveness of ‘PE+Exposure Workout Buddy’ when delivered in traditional in person (face to 
face) vs. telehealth formats. (Note, the parameters by which this objective will be achieved are 
naturalistic insofar as this variable is not subject to randomization because participants who had 
received telehealth PE (about half of our clinic population) or in person PE prior to dropout (and thus 
prior to this study) will continue to receive treatment in the same modality upon randomization to either 
condition). 
 
 
4.0. MILITARY RELEVANCE 
 
Maintaining force strength is of paramount importance during times of conflict. Up to 24% of OEF/OIF 
Veterans meet criteria for PTSD and 35% report significant PTSD symptoms. These disorders manifest 
while these individuals are still DoD service members, and as such, current characteristics of combat, 
and subsequent shortcomings in current treatments for PTSD, particularly with respect to treatment 
retention, significantly affect force strength. Our best treatments can return personnel to nearly pre-
trauma performance at about 65-75% effectiveness. A large proportion of those who fail to respond to 
treatment do so not because treatment was ineffective, but because they were unable or unwilling to 
complete treatment. That is, they dropped out of treatment prior to completion. If the present 
intervention, which builds upon the teamwork and leadership skills implicit in military training, is effective 
in retaining individuals in treatment who otherwise would drop out, then we may well be able to 
dramatically cut the dropout rate from our most effective class of treatments, and thus significantly 
enhance our ability to sustain force strength.  
 
Moreover, from the perspective of future costs in terms of human suffering and mental health care, 
effective intervention is key. This is because PTSD does not seem to remit over time, and each year 
that effective intervention is delayed is characterized by functional impairment, depression, and 
increased health care costs to the Veteran, the DoD and the VA. These improvements to dropout 
prevention from evidence based therapy for PTSD, in addition to reducing effects of untreated PTSD, 
will contribute directly to the health and well being of service members, enhancing mission readiness 
and preventing unnecessary force depletion and care expenses. As such, military significance of this 
project is great, both in terms of directly enhancing force readiness, as well as reducing economic and 
human suffering costs borne by the DoD and its members. 
 
 
5.0. BACKGROUND AND SIGNIFICANCE 
 
We will evaluate whether the opportunity to receive social support during in vivo exposure therapy 
homework from Veterans who themselves have successfully competed Prolonged Exposure (PE) (i.e., 
the therapeutic equivalent of an exposure therapy ‘workout buddy’) is effective in (a) reversing PE 
dropout and (b) improving PTSD outcomes in a sample of Veterans who have previously dropped out 
of PE. This will be accomplished by comparing ‘PE+Exposure Workout Buddy’ to ‘PE+Peer General 
Support’ who does NOT engage in any support during in vivo homework, the treatment typically offered 
Veterans who drop out from evidence based PTSD care, in a Randomized Controlled Trial. 
 

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• Post-traumatic Stress Disorder (PTSD) is a significant problem for Veterans and Active Duty 
personnel. 
• Effective Treatments (e.g., Prolonged Exposure, PE; Cognitive Processing Therapy, CPT) exist and 
have, at great expense, been disseminated by the Departments of Veterans Affairs (VA) and 
Defense (DoD). 
• Despite treatment effectiveness, over 30% of those who are identified, referred, and successfully 
access evidence based psychotherapy for PTSD treatment drop out prematurely. 
• In a prior DoD study we addressed findings that dropout is related to logistical barriers such as travel 
time, cost, and stigma associated with care from clinic-based settings by delivering treatment via 
home telehealth. However, dropout remained virtually unchanged at 26%. 
• In Preliminary Study #1, Veterans who dropped out of treatment, including that delivered via home 
telehealth, were surveyed and half responded in the affirmative to a statement that they would have 
had a better likelihood of completing treatment if a peer who had completed treatment were available 
to help them with exposure homework. In Preliminary Study #2, 52% of a clinic sample of Veterans 
who dropped out of PE indicated that they “would be interested in trying exposure therapy for PTSD 
a second time if they could do so with the assistance of an exposure workout buddy.”  
• To serve these dropouts from PE therapy, we developed and began initial feasibility testing of the 
‘PE+Exposure Workout Buddy’ program in which Veterans who have recently completed PE and 
no longer meet criteria for the disorder meet patients at exposure sites in the community to offer 
support during exposure. 
• The present study is to use a randomized controlled repeated measures design to test the 
hypotheses that the in vivo ‘exposure workout buddy’ adjunctive component to PE will increase the 
likelihood that Veterans who have dropped out of PE will (a) return and complete treatment and (b) 
evince reduced PTSD symptomatology relative to a general support peer. 
 
Preliminary Studies: 
 
Preliminary Study #1: Dropout from Exposure 
Therapy for PTSD in Telehealth Vs. In Person 
Treatment (See Hernandez-Tejada et al., 2014 for 
a full description of Preliminary Study 1).  
 
All participants met DSM-IV criteria for PTSD. Of 
the 258 participants in our DoD study who were 
randomized to either telehealth or in person 
conditions and received at least one exposure 
therapy treatment session, 69 (26.5%) withdrew 
from treatment. All were male, 27.7% were 
Vietnam Veterans, 27.7% Persian Gulf Veterans, 
and 44.7% were OEF/OIF Veterans, with no 
significant differences in theatre in terms of 
treatment medium. Surprisingly, rate of dropout from telehealth (28.7%, n = 35) was not significantly 
different from that of in person treatment (25.0%, n = 34) (χ2=0.45, p = 0.30). Forty-seven of the 69 
(68.1%) treatment dropouts (27 telehealth; 20 in person) agreed to provide data regarding reasons for 
dropping out of treatment. Age ranged from 21-70 years, and there were no significant differences in 
terms of age, education, employment, marital status or baseline symptom severity between conditions. 
 

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Results: Considering travel logistics and their relationship to dropout, ANOVA indicated a significant 
(and entirely expected) difference between in person and telehealth participants, with in person 
participants reporting more problems with bad weather, parking, transportation, and work/family 
obligations (
 = 22.5) compared to telehealth (
 = 19.6) (F(1,45) = 5.20, p = 0.027). No other significant 
differences were noted for any other factor, including Treatment Demands (in person 
 = 16.2, vs. 
telehealth 
= 15.6; F(1,45) = 0.34, p = .560); Perceived Relevance of Treatment (in person 
 = 20.9, 
vs. telehealth 
 = 20.7; F(1,45) = 0.01, p = 0.906), or Relationship with Therapist (in person 
 = 9.1; 
telehealth 
 = 9.0; F(1,45) = 0.04, p = 0.847). However, when Veterans who dropped out of exposure 
based treatment were asked specifically about their experiences during imaginal and in vivo exposure 
homework, differences between in person and telehealth groups did emerge, and both groups reported 
significant difficulty, particularly with in vivo exposure trials. Specifically, while only 20% of in person 
and 31% of telehealth based treatment dropouts reported they “could not tolerate thinking about the 
trauma”, 40% of in person and 58% of telehealth treatment dropouts reported they “could not tolerate 
assignments to go out in public.” Moreover, 20% of in person but 41% of telehealth based Veterans 
reported that they “worried about losing control during exposures.” (See graphical illustration of these 
data.)  Overall, these preliminary data suggest that dropouts had problems with in vivo/situational 
exposure homework, and that participants in the telehealth condition who dropped out of treatment 
were having more difficulty with specific aspects of exposure therapy compared to those receiving 
exposure therapy in person. Along these lines, Hernandez-Tejada, et al (2014) noted that when treating 
PTSD in general, and particularly when offering exposure based treatments via telehealth, 
interpersonal support offered during exposure trials by other Veterans could be helpful. Actually, this 
“exposure homework workout buddy” idea was not so much our own as it was a direct and repeated 
approach suggested by the Veterans who had dropped out of treatment and who were interviewed 
regarding their reasons for doing so. Specifically, when we contacted aforementioned Veterans, 
approximately 50% indicated that they would have been likely to remain in treatment had they the 
support of another Veteran during in vivo exposure homework (see Preliminary Study #2). While novel 
in its application to PTSD treatment, peer assistance is a technique currently used successfully by other 
health and mental health specialties (e.g., cancer: see Meyer et al., 2015; serious mental illness: see 
Corrigan et al., 2014)). 
 
Preliminary Study #2: Offering Treatment Dropouts a Chance to Return to PE Treatment with an 
Exposure Therapy Workout Buddy: Feasibility of Recruitment of Patients and Peers 
 
The Veterans’ suggestion to combine the beneficial aspects of social support with the effectiveness of 
exposure based treatments for PTSD (e.g., one Veteran described it as ‘the best of supportive group 
counseling with the best of PTSD treatment’) represented no less than a “Eureka” moment for our 
research team, insofar as we recognized that combining peer support with exposure therapy might 
directly impact, in a cost effective manner, the treatment retention issue confronting patients of VA and 
DoD. Indeed, variations on this theme are evident in-group delivery of exposure therapy for PTSD (see 
Smith, Porter, Messina, Beyer, Defever, Foa, & Rauch, 2015). Our approach to leveraging peer support 
is directly in line with the recent VA/DoD implementation of “Peer Support Programs” (Money et al., 
2011) across the country. We predict that this support will help to address dropout associated with 
exposure therapy, particularly when delivered via telehealth, an increasingly prevalent modality in 
VA/DoD.  
 
Toward this end, we developed the ‘PE+Exposure Workout Buddy’ program, explained at length in the 
Treatments section below. It is important to note that Veterans serving as ‘workout buddies’ are not 
x
x
x
x
x
x
x
x

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replacing therapists or performing therapy; rather they are simply providing support and encouragement 
akin to that derived from others during group psychotherapy, such as during group delivered PE (Smith 
et al., 2015). PE Workout buddies are Veterans who have completed PE and no longer meet criteria 
for the disorder, and who have volunteered to meet Veterans engaged in PE (in this case, Veterans 
who have dropped out of PE, but returned at the offer of a PE workout buddy) at their situational 
exposure homework site to offer encouragement and support in addressing a previously discussed and 
agreed upon exposure hierarchy item. Our preliminary qualitative interviews with Veterans in this 
program indicate that this enhances PE treatment in two ways: first, Veterans appear more likely to 
attempt in vivo exercises if they know a fellow Veteran is waiting at the site of their exposure homework 
(i.e., when they ‘don’t feel like’ doing the exposure homework, they are nonetheless more likely to leave 
their house and drive to Wal-Mart for the exposure assignment if they know the Workout Buddy is there 
waiting). Second, they are more likely to complete the exposure homework item if they have the 
encouragement and support of another Veteran during the process.  
 
For this preliminary feasibility study, we re-contacted 82 Veterans who had dropped out of exposure 
based treatment for PTSD (either from two ongoing treatment outcome studies or from VA PTSD clinic 
services) and offered them the opportunity to attempt PE again, this time with the assistance of an 
‘exposure therapy workout buddy’. We also asked clinicians to contact individuals who had successfully 
completed treatment and no longer met criteria for PTSD who might be interested in serving as a PE 
Workout Buddy.  
 
Feasibility Results: Fully 52% (n=43) of the 82 dropouts indicated that they “would be interested in 
trying exposure therapy for PTSD a second time if they could do so with the assistance of an exposure 
workout buddy,” and 30% (13) of these immediately completed informed consent to re-initate treatment. 
Given the strong support from Veterans who had dropped out of treatment for the  peer support solution, 
we next attempted to identify peers who might be good candidates to serve in this capacity (e.g., offer 
to meet patients at in vivo homework locations to offer support and encouragement). Thirteen potential 
exposure therapy workout buddies were contacted, 85% (11) agreed to enroll in the program as a 
volunteer, and 8 have completed the brief training, indicating that recruitment of peers does not appear 
problematic. Note each peer agreed to accompany up to 4 different patients over a 6-month period, 
and the future dissemination potential of the program from the perspective of Veterans volunteering to 
help other Veterans appears strong. 
 
As noted above, 13 Veterans who dropped out of treatment agreed to return to PE with an exposure 
workout buddy and 12 have contributed baseline pilot study data. Two Veterans have already 
completed PE treatment with the social support assistance of a workout buddy and the remaining 11 
are in the process of treatment, engaging in standard PE with their therapist, and meeting peers in the 
community to complete in vivo exposure therapy assignments. We polled participants (both those who 
had completed the PE+Workout Buddy program, and those who were in the midst of treatment) as to 
their satisfaction and general experiences. 100% reported that they were either “very satisfied” or 
“extremely satisfied with the program. All participants reported that they would strongly recommend the 
program to a friend. 100% of participants agreed with the statement that “the peer was dependable,” 
and 100% indicated in the affirmative to the statement “the peer addressed important issues in their 
health care.” Zero adverse events were reported, by patients, peers, or therapists. Thus, the feasibility 
of the program, measured in terms of the successful resolution of the logistics of peer recruitment, peer 
training, peer and patient coordination with each other and with the therapist for in vivo exposure 
therapy homework assignment meetings, and most importantly, patient willingness to return to 
treatment (52%), overall appears very strongly supported. 

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6.0. RESEARCH DESIGN 
 
Using a 2-arm, randomized controlled trial with repeated 
measures at baseline, post treatment, and 3- & 6-month 
follow-up we will compare PE+Peer General Support to 
PE+Exposure Workout Buddy intervention, in which peers 
who have successfully completed PE PTSD treatment and 
no longer meet PTSD symptom criteria are paired with 
Veterans who have recently dropped out of treatment to 
help the latter complete exposure homework assignments 
to determine if this pairing affects the following 2 primary 
endpoints: (1) treatment dose/completion and (2) treatment 
outcome. Exploratory aims are to determine if the program 
results in (3) differential treatment completion and 
outcomes for telehealth vs. in person-delivered PE 
treatment, as preliminary data indicate that the exposure 
workout buddy adjunctive component may be more 
relevant to Veterans receiving PE via telehealth, a 
treatment delivery format of increasing prevalence in VA 
and DoD settings. See Logic Model Diagram for study 
design illustration. NOTE: (a) whereas telehealth delivered 
psychotherapy involves a therapist at one site and a patient at a second, all exposure workout buddies 
will be located near patients and workout buddy interactions with participants take place in person, in 
the community (b) Peers will NOT be conducting any therapy or substituting for the therapist, 
who will continue to deliver treatment. Rather, workout buddies will simply be meeting patients at 
community exposure assignment sites such as the parking lot of Wal-Mart, & accompanying them 
during exposure, which typically simply involves staying in a location until anxiety subsides. General 
support peers follow the VA standard Peer Support model and roles. General support peers make 
telephone contact with Veterans, and meet with them informally in person when Veterans arrive for 
their appointments.  They will remind and encourage participants to attend appointments, check up on 
them once per week via telephone and ask about current treatment progress, life stresses, 
opportunities, problems and successes, and offer general support and advice regarding VA programs. 
 
Veterans (participants and peers) with PTSD will be recruited from the Charleston VA Medical Center 
catchment area. Participants will have been assigned to exposure therapy for PTSD and either started 
treatment, or dropped out before treatment; peers will have successfully completed exposure therapy 
for PTSD. Note, Charleston VA Medical Center treatment providers for PTSD all offer both in person 
and telemedicine based treatment, and equal numbers of patients in both treatment modalities will be 
enrolled (approximately 10 and 10). Those eligible to participate will also include Veterans who are 
identified as “at-risk” of dropping out, Veterans who are uncomfortable completing in vivo exposure 
activities, and those who may have PTSD symptoms, but at the sub-threshold level. Participants will 
receive 8-12 weekly sessions of exposure therapy treatment with assistance of a PE Peer, who will 
meet them at least once per week for in vivo exposure therapy assignments, for 3-4 weeks at the 
beginning of treatment. All participants and peers will be consented. Participants will be assessed at 

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baseline, post-treatment, and 3- & 6-month follow-up. Participants who demonstrate clinically significant 
and adequate gains prior to the 8th session will be eligible for early termination if they achieve a 24-
point reduction from baseline PCL on two consecutive measurements. This criterion has been 
established in prior exposure therapy trials to guard against the potential of misclassifying early 
responders as treatment dropouts. 
 
Peer Selection. Therapists will be asked if they have any patients who have completed treatment and 
did very well, both overall and with in vivo exposure therapy components. Therapists are directed to 
contact these patients, inform them about the peer program, and ask them if they would like Dr. Acierno, 
a VA clinician and researcher, to discuss the program further, outline the nature of expectations, 
including confidentiality, and research characteristics, and schedule a 2 hour training. Thus, initial 
nominations for the program are based on therapist impressions of successful candidates AFTER they 
have completed treatment. As such, the therapists know candidates’ strengths. Peers, who undergo 
training and subsequently indicate their willingness to serve as a peer will have their names added to 
our database, which is housed on a secure VA server.  Note, peers will be trained that confidentiality 
is key, and we will explain confidentiality in the same way as is expected when individuals participate 
in supportive group therapy. That is, this is a supportive intervention of peers as is found in supportive 
group therapy, with which Veterans are very familiar, and that all discussions held during such 
interactions are confidential, as is all information, including identifying information, learned about 
another participant, through participating in this project.  
 
7.0. RESEARCH PLAN 
 
7.1. Selection of Subjects 
 
7.1.1. Subject Populations. Participants will be 100 Veterans of OEF, OIF, OND, Persian Gulf, or 
Vietnam conflicts with PTSD; peers will be 50 Veterans from the same conflicts. As the Charleston VA 
also serves Active Duty personnel, a small proportion of participants will be from this subgroup. 
Participants will be male or female, aged 18 years and above, who have dropped out of evidence based 
treatment for PTSD (PE) after completing 1-7 sessions and who still have PTSD (in the literature on 
PE, the first session is sometimes session 0, during which treatment components, including exposure, 
are explained. A significant proportion of dropout occurs at this point, and thus we intend to include 
these individuals as participants to maintain relevance of study findings). 
 
7.1.2. Source of Research Material. Self-report scales, session attendance data, and interviews will 
be used to evaluate clinical and process outcome at pre-treatment, immediate post-treatment, 3-month, 
and 6-month follow-up; with the exception of session attendance, process outcomes will be evaluated 
at post-treatment and 3- & 6-months. These timeframes have been selected because they correspond 
to assessment structures of prior studies of PTSD, and because they represent critical timing points for 
the diagnosis. In pilot testing of the assessment battery, 95 minutes was the average time of completion; 
however, all participants will nevertheless be informed that the assessment will require approximately 
2 hours and will be allowed to take a break from assessment at the approximate 30-minute point. All 
assessments will be audiotaped and study personnel will listen to a randomly selected 20% to ensure 
reliability over the course of the study. 
 

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In addition to these regular battery-based comprehensive assessments, the PCL-5 and Patient Health 
Questionnaire will be repeated every week, before the session begins, to allow a more in-depth 
evaluation of the longitudinal trajectory of PTSD symptom severity over the active treatment period. 
Moreover, in instances of premature study exit, participants will be asked to complete a PCL-5 and 
Patient Health Questionnaire at that point in time in order to obtain more valid exit point data. As in our 
prior studies, the more complete PCL-5 trajectory will be used to facilitate multiple imputation of missing 
data for treatment dropouts for related outcomes.  
 
Clinical Outcomes. The following interview and self-report measures have been widely used in the 
clinical evaluation of adults with PTSD, and will be used in the present study. They will be collected at 
baseline, post-treatment, and 3- & 6-month follow-ups. The PCL-5 and Patient Health Questionnaire 
are also collected every other week during treatment. 
 
1. Clinician Administered PTSD Scale-5 (CAPS-5; Weathers et al., 2013): PTSD diagnoses will be 
ascertained using the CAPS-5, considered the gold standard in PTSD assessment. The CAPS 
is a 30-item, structured interview that corresponds to the DSM-5 criteria for PTSD. For each 
diagnostic item, standardized questions and probes are provided. Questions focus on symptom 
presence, the onset and duration of symptoms, subjective distress, impact of symptoms on 
social and occupational functioning and improvement in symptoms.  
2. Mini International Neuropsychiatric Interview 7.0 (MINI 7.0): The MINI is a standardized 
structured interview used to assess psychiatric diagnoses according to the DSM-5. The MINI is 
similar in sensitivity, specificity, and inter-rater reliability to more lengthy diagnostic interviews, 
such as the SCID (Sheehan et al., 1998). Major Depression, Panic, and Substance Dependence 
diagnoses will be evaluated via this structured interview.  
3. PTSD Checklist-5 (PCL-5; Blevins, Weathers et al., 2015):  The PCL-5 is a new version of the 
PCL, among the most commonly used self report measures of PTSD symptoms and intensity. 
The PCL-5 is structured to correspond to the DSM-5 PTSD criteria. The 20-items are scored on 
a 0-4 Likert scale for each symptom corresponding to “Not at all” to “Extremely”. Total scores 
range from 0 to 80. Initial psychometric data are encouraging. With college student samples, 
Blevin et al found PCL-5 scores exhibited strong internal consistency (α = .94), test-retest 
reliability (r = .82), and convergent (rs = .74 to .85) and discriminant (rs = .31 to .60) validity. With 
Veteran samples, Bovin et al (2015) found that the PCL-5 had good internal consistency (α =.96) 
and test-retest reliability (r = .84). Moreover, signal detection analyses using CAPS-5 indicated 
a cutoff score of 31-33 on the PCL-5 optimally categorized PTSD diagnosis. 
4. Selected scales of the Deployment Risk and Resiliency Inventory (DRRI; King, King, & Vogt, 
2003). The DRRI is collection of self-report measures assessing 14 key deployment-related risk 
and resilience factors with demonstrated implications for Veterans' long-term health.  
5. Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001): The Patient Health 
Questionnaire -9 is widely used, well-validated measure of depression severity with high internal 
consistency (alpha .83 to .92; Cameron, Crawford, et al, 2008), and is correlated strongly with 
other depression measures (Kroenke et al., 2001). Its 9 items assess affective and somatic 
symptoms and correspond to diagnostic criteria for MDD. 
6. Veterans RAND 12-Item Health Survey (VR-12; Kazis, 2000, 2004).  The VR-12 is a valid and 
reliable instrument to measure quality of life and/or functional status in veterans. It will be used 
to track changes in general mental and physical health functioning (i.e., functional status or 
general health functioning). 

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7. Pittsburgh Sleep Quality Index (PSQI; Buysse, Reynolds, Monk, Berman & Kupfer, 1989): The 
PSQI assesses the quality and patterns of sleep. It differentiates “poor” from “good” sleep by 
measuring seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep 
efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last 
month. 
8. Brief Inventory of Psychosocial Functioning (B-IPF; Marx et al., 2013). The Brief Inventory of 
Psychosocial Functioning (Marx et al. 2013) is a 7-item self-report instrument measuring 
respondents’ level of functioning in seven life domains: romantic relationship, relationship with 
children, family relationships, friendships and socializing, work, training and education, and 
activities of daily living. Respondents indicate the degree to which they had trouble in the last 30 
days in each area on a 7-point scale ranging from “0 = Not at all” to “6 = Very much.” 
 
Additional Co-variables. In addition to demographic and baseline levels of the clinical outcome variables 
that will serve as adjustment co-variables and putative effect modification variables in proposed 
analyses, we will assess the level of combat exposure of participants at baseline using the Combat 
Exposure Scale (CES; Keane, Fairbank, Caddell, Zimering, Taylor, & Mora, 1989) because combat 
exposure intensity has been related to treatment response in past studies, including our own (see Price, 
Gros, Strachan, Ruggiero, & Acierno, 2013). The CES is a 7-item self-report measure that assesses 
wartime stressors experienced by combatants. Items are rated on a 5-point frequency (1 = no or never 
to 5 = more than 50 times), 5-point duration (1 = never to 5 = more than 6 months), 4-point frequency 
(1 = no to 4 = more than 12 times) or 4-point degree of loss (1 = no one to 4 = more than 50%) scale. 
Respondents are asked to respond based on their exposure to various combat situations, such as firing 
rounds at the enemy and being on dangerous duty. The total CES score (ranging from 0 to 41) is 
calculated by using a sum of weighted scores, which can be classified into 1 of 5 categories of combat 
exposure ranging from "light" to "heavy."  Futher, we will administer the Alcohol Use Disorders 
Identification Test (AUDIT; Saunders et al., 1993), a 10-item screening questionnaire with three 
questions on the amount and frequency of drinking, 3 questions about alcohol dependence, and 4 
questions about problems caused by alcohol.  The Drug Abuse Screening Test (DAST-10; Skinner, 
1982) will also be administered to all participants.  The instrument contains 10 items that serve as a 
brief clinical screening and treatment evaluation for substance use.  The DAST-10 items are structure 
in a “yes/no” format.  Staff will gather a prior treatment history at baseline via the “Previous PTSD 
Treatment Information” measure, an eleven-item questionnaire detailing previous treatment history in 
the VA. Finally, current treatment will be assessed using the “Existing Treatment” questionnaire, which 
queries about current participation in research studies, treatment received, and medication information.   
 
Process Outcomes. During data collection of clinical outcomes, we will also examine the following 
measures immediately post-treatment, and at 3- & 6-month follow-up (only treatment credibility will be 
assessed at mid-treatment, after treatment has been explained):   
 
1. Session Attendance, Session Frequency Limits, Definition of Treatment Completion, and Study 
Attrition This is, of course, a primary outcome variable related to AIM 1a and 1b of this study, 
and examines impact of the exposure workout buddy program on ‘treatment dose’ delivered, 
measured both in terms of total new treatment sessions attended and % completing treatment 
in each group. To this end, we will keep careful records of session attendance and study dropout. 
A treatment dropout will be defined as any patient who does not complete a total of at least 10 
new sessions of treatment OR who leaves treatment prior to a reduction of PCL-5 Scores below 

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the clinical cutoff posted by the VA National Center for PTSD of 33 obtained in two consecutive 
PCL-5 scores. A treatment completer will be defined as completing 10 or more sessions; or when 
no additional treatment is needed due to treatment gains, two consecutive PCL-5 scores below 
33 will reflect these gains. The overall limit to number of sessions in either group will be 15 (so 
as to prevent outliers in session frequency affecting ‘dose’ between group analyses). It is 
expected that most patients will occasionally miss a session or fail to complete their homework 
assignments. These will not be considered dropouts; patients will be allowed to make-up 
sessions as long as they re-enter treatment within a 4 week period. Patients who miss all 4-
treatment sessions during a 4-week period will be considered dropouts (i.e., if a patient, during 
treatment, does not attend the next session within 4 weeks of the last session completed, they 
will be considered a dropout). Note MEASUREMENT ISSUE: participants who completed a 
greater number of sessions prior to original dropout may be expected to achieve clinical outcome 
goals in fewer sessions than those completing one or two sessions prior to dropout. Hence, the 
‘dose’ variable of Aim 1a and b, measured in terms of overall number of new sessions, is 
confounded by ‘prior dose’, or the number of treatment sessions received prior to study initiation. 
Therefore, in addition to number of new sessions completed, we will also assess number of 
treatment completions, measured in terms of completing at least 10 sessions or achieving 
clinical gains on the PCL-5 reflected by scores below 33 on two consecutive PCL-5 
measurements as specified above. 
2. Treatment Credibility (Peers after 1st patient experience; Participants prior to session 2) To 
assess differences in outcome expectancy, treatment credibility scales developed by Borkovec 
and Nau (1972) will be used. Four of the questions will be used for this study, with 10-point Likert 
scales. These include questions regarding how logical treatment seems, how confident they are 
about treatment, and expectations of success.  
3. Treatment Adherence Treatments in both groups will require patients to carry out “homework 
assignments.” These forms will be collected and monitored each week during treatment. The 
percentage of returned, completed forms will be computed as an indicator of adherence to 
homework assignments.  
4. Modified Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA; Frueh et al., 2002):  
(Patient, following their last treatment session) Patient satisfaction is an important treatment 
outcome variable, closely associated with clinical outcomes (Druss et al., 1999). This measure 
also asks about specific components of the workout buddy program (e.g., the quality of 
communication, ease of use, willingness to use treatment) in order to allow in depth analysis of 
potential causes of differences in workout buddy effectiveness for in person vs. telehealth 
delivered PE (AIM 3). The CPOSS-VA is 16-item measure, with a Likert scale response format, 
based on a general measure of patient satisfaction (Pellegrin et al., 2001). In a sample of 
Veterans preliminary data showed excellent reliability (alpha = .96) and good convergent validity 
with anchors (Frueh et al., 2002). 
5. Barriers to Therapy Scale (Modified) Assesses logistic, interpersonal and anxiety based barriers. 
6. COVID-19 Research Therapy Impact Scale; Ten item questionnaire which assesses the impact 
of the COVID-19 pandemic on research participation and daily life. 
 
Preliminary Economic Outcomes. Workout-buddy Related Capital Costs: Incremental costs of the 
intervention relative to the comparator are the relevant costs for decision making, thus preliminary 
estimates for this new program will be obtained here. These costs primarily include workout buddy 
training time and materials, and extra therapist time required to coordinate exposure hierarchy logistics 

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for initial meetings, as well as therapist time to collect feedback regarding exposure trials from peers in 
between sessions. 
 
7.1.3. Inclusion and Exclusion Criteria. Participants will be 100 Veterans of OEF, OIF, OND, Persian 
Gulf, or Vietnam conflicts with PTSD; peers will be 50 Veterans from the same conflicts. Participants 
will be male or female, aged 18 years and above, who have dropped out of evidence based treatment 
for PTSD (PE) after completing 1-7 sessions and who still have PTSD (in the literature on PE, the first 
session is sometimes session 0, during which treatment components, including exposure, are 
explained. A significant proportion of dropout occurs at this point, and thus we intend to include these 
individuals as participants to maintain relevance of study findings).  Participants who are considered 
“at risk” of dropping out will also be included; this is defined as having failed to complete 3 sessions of 
exposure therapy within any 6-week period, verbally indicating major anxiety about exposure activities, 
and/or populations identified at higher risk of dropping out of exposure therapy. 
 
Actively psychotic or demented persons and individuals with both suicidal ideation and clear intent will 
be excluded; however, to maximize generalization of results, other forms of psychopathology will not 
be a basis for exclusion. All structured interviews will be audiotaped to calculate inter-rater reliability on 
a randomly selected 20%. Based on clinic data and data from our two prior DoD/VA PE treatment 
outcome studies, we will have satisfactory minority representation: 35-50% African American, 8-10% 
Hispanic, and 4-6% Asian American; 10% are expected to be women.  
 
Participant Eligibility Criteria. Study inclusion and exclusion criteria are as follows: 
 
Inclusion Criteria:  
1. Adult male or female over the age of 18 that has served, or is currently serving, in the 
military. 
2. Either diagnosis of PTSD as determined by a Clinician Administered PTSD Scale for 
DSM-5 (CAPS-5) clinical interview or CAPS-5 severity ≥ 25, and a PCL-5 score of ≥25. 
3. Attempted PE treatment in the past, but did not complete treatment (defined as dropping 
out from treatment or refusal to engage in in vivo exposure assignments) OR identified 
as “at-risk” of dropping out of current exposure therapy treatment (defined as failure to 
complete 3 sessions of therapy within any 6 week period, verbally indicating that they are 
not comfortable with the exposure activities, and/or populations identified at higher risk of 
dropping out of exposure therapy 
 
Exclusion Criteria:  
1. Active psychosis or dementia at screening. 
2. Suicidal ideation with clear intent. 
3. Concurrent enrollment in another clinical trial for PTSD or depression.  
 
Peer Eligibility Criteria. Study inclusion and exclusion criteria are as follows: 
 
Inclusion Criteria:  
1. Adult male or female over the age of 18 that has served, or is currently serving, in the 
military. 

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2. Successful competition of exposure therapy treatment in the past and willingness to act 
as peer in the program. 
3. PCL-5 score of 32 or lower. 
 
Exclusion Criteria: 
1. Active psychosis or dementia at screening. 
2. Suicidal ideation with clear intent.  
 
Medication Stabilization. Participants meeting inclusion criteria will be asked to maintain medications 
at current dosages when medically appropriate. Participants who have not initiated new prescription 
medications in the previous 4 weeks will complete the baseline assessment battery. However, potential 
participants who have recently begun trials of prescription medication will be required to wait 4 weeks 
prior to completing the baseline assessment battery to ensure medication stabilization, at which point 
the assessment battery will be administered (or re-administered if applicable). This re-administered 
battery will be used for pre-treatment data in analyses. 
 
7.1.4. Recruitment Process. The Ralph H. Johnson Veterans Affairs Medical Center (RHJ VAMC) 
catchment area is home to a very large number of PTSD treatment outcome studies, as well as to 
several studies on suicide, depression, and anxiety. Moreover, the nationally known PTSD Clinic 
conducts only evidence-based psychotherapy, with an emphasis on PE, and was the first to offer this 
treatment via telehealth and via home based telehealth. As such, all RHJ VAMC Mental Health Clinic 
staff are cross trained in research referral to study staff for all potential participants, and research staff 
are housed alongside clinic staff. More relevant to the present application, as there are a large number 
of providers conducting PE in both clinic and research treatment settings (19 current full time PE 
providers each providing both in person and home based telehealth PE), the number of PE dropouts 
meeting inclusion criteria and available for recruitment to this study is quite large (our current roster of 
dropouts just in the past 6 months is over 250, representing about 30% of cases).  
 
We have obtained (for our PE+Exposure Workout Buddy pilot study) and currently maintain Institutional 
Review Board (IRB) and Veterans Affairs Research and Development (VA RD) approval for clinical 
research staff to approach all Veterans who have dropped out of PE with an invitation to participate in 
the pilot feasibility workout buddy study. Each week, representatives from each of the 8 research teams 
attend a case staffing with all PTSD Clinical Team (PCT) clinicians to review new cases, their 
appropriateness for research participation, study cross referral, and to review dropouts from PE. Names 
will be obtained at these staffings for re-contact by research clinicians. As we are the only study 
including PE dropouts, recruitment via this pathway has been strong for the pilot study, and will continue 
to be significant for this project.  
 
Related to the question of whether or not participants meeting inclusion criteria are available, is whether 
those available participants will actually agree to return to treatment. Our pilot study data, described 
above, indicate that 52% of those who have dropped out of PE agree to return with the assistance of 
an exposure workout buddy, and 30% of these sign consents to do so immediately. The willingness of 
Veteran PE dropouts to consider returning to treatment upon hearing of the workout buddy program 
was extremely encouraging. 
 

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In addition to direct contact with recent dropouts from therapy provided by the 19 active clinicians, we 
will list this study among those listed in our consortium institution’s (Medical University of South 
Carolina) “active research projects” web page and weekly newspaper research recruitment sections. 
Third, primary care and mental health providers of Veterans for whom PTSD is suspected may also 
refer to the study. In the latter scenario, the Veteran will be informed that researchers at the VA are 
evaluating a treatment to help those who have dropped out of PE and the Veteran will be asked for 
permission to release contact information only to study personnel. If this verbal consent is given and a 
referral made, project staff will contact potential candidates. Participants who do not meet inclusion 
criteria will nonetheless be offered services through the RHJ VAMC Mental Health service. Our final 
recruitment strategy will be to run a series of advertisements in relevant local newspapers. 
 
Recruitment Steps: Potential participants will be contacted by study staff when recruitment derives from 
the weekly PTSD clinic staff meetings. Potential participants who respond to brochures, or who are 
referred by other providers will be directed to the study coordinator for face-to-face explanation of the 
study in a private treatment room at either the RHJ VAMC, CBOC, or MUSC leased space where they 
will review informed consent and have all questions answered.  If for any reason the study coordinator 
and patient cannot meet face-to-face, participants may be contacted via telephone to discuss study 
parameters.   After informed consent has been collected, the initial assessment interview will be 
scheduled within 7 days by our trained interviewers (who are NOT the therapists for the study). All 
potential participants will first complete the entire assessment interview either face-to-face, via 
telephone, or via Tandberg if the assessor and patient are located at two different CBOCs; immediately 
after the assessment interview, participants meeting inclusion and exclusion criteria will be randomized 
to condition by the study coordinator using the randomization protocol designed by the study statistician 
and informed of this outcome. Participants will be told to expect a telephone call from their counselor 
to start treatment within 7 days. Additionally, we will mail letters of invitation to patients from Dr. 
Acierno’s former research studies who dropped out of treatment, as well as Veterans who began 
treatment in the PCT clinic but did not finish.  
 
Recruitment and Enrollment Targets: See the chart on next page for the anticipated participant 
recruitment. 
 
Minority and Female Recruitment. Inclusion of minorities in PTSD research with Veterans is recognized 
as being of critical importance (Frueh et al., 1998). Based on our previous and ongoing RHJ VAMC 
studies (Acierno, 2015), we estimate that approximately 40% of the sample will be African Americans; 
8-10% Hispanic, and 4-6% Asian American; 10% are expected to be women.  
 

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7.1.5. Consent Process. Informed consent will be administered by approved individuals trained in 
human subjects regulations and informed consent procedures, with appropriate VAMC and University 
training certifications on file and up to date. These individuals will first be asked to read the treatment 
protocol, and will then attend a 1-day training for study personnel given by the PI and other team 
members on how to provide information about the study and obtain consent for participation in the study 
(i.e., informed consent), and will role play until the PI determines excellent competency in this area. 
This is so that each person collecting informed consent is familiar with all study aspects.  
 
Timing and Location of Informed Consent. Informed consent will be collected in research offices (VA 
and MUSC offices) where potential candidates (both Peers and patients, as both will provide data) will 
be invited to learn about the study and that they will have a 50-50 chance, like a coin toss, to be 
assigned to either PE+Exposure Workout Buddy or PE+Peer General Support conditions. Informed 
consent will be collected in a private, interruption free environment. Potential candidates will not be 
required to make a decision to participate at this initial contact, though that possibility will be available. 
If they wish to discuss participation with significant others, they will be encouraged to do so. If any 
potential volunteers are illiterate, the consent form will be verbally read and explained in the presence 
of a witness.  
 
To reduce the burden of participating in research we may use VA approved teleconsent methods.   
 
After discussing teleconsent procedures during screening, study staff will mail a paper consent form to 
the patient along with a self-addressed, stamped envelope and instructions on how to access the 
videoconference platform.  At the scheduled day and time of consent, staff will contact patients via 
videoconference from a VA device (computer, laptop, tablet or phone) and begin the teleconsent 
session.  During the teleconsent video session, project staff will explain the purpose of the research, 
the nature of the intervention, potential benefits and risks, the voluntary nature of participation, and the 
data collection procedures. The study staff and the consent form will make it clear that the individual’s 
eligibility for services will not be affected by the decision to participate in the study. They will be informed 
that they are being asked to participate in a research study. They will be told the nature of the 
procedures, informed of risks associated with their participation, asked to read the consent form, and 
encouraged to ask questions or discuss any pertinent issues.  If patients agree to consent, they will be 

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asked to sign applicable areas of the consent/HIPAA form.  Research staff will ask patients to hold up 
the signed forms to the camera so that the consenter may take a screen shot of the signature.  These 
images will be stored on the secure VA research network.  Participants will then be asked to mail back 
the completed, signed consent form in the return envelope provided. 
 
Per VA Directive 6609 instructions for mailing sensitive materials, study staff will attach a notice with 
the following language on on the front of any mailed consent paperwork, and instruct participants to 
attach it to the completed paperwork to be returned: 
 
NOTICE!!! 
 
1. 
Access to these records is limited to: AUTHORIZED PERSONS ONLY. 
2. 
Information may not be disclosed from this file unless permitted by all applicable legal authorities, 
which may include the Privacy Act; 38 U.S.C. §§ 5701, 5705, 7332; the Health Insurance Portability 
and Accountability Act; and regulations implementing those provisions, at 38 C.F.R. §§ 1.460 – 1.599 
and 45 C.F.R. Parts 160 and 164. 
3. 
Anyone who discloses information in violation of the above provisions may subject to civil and 
criminal penalties. 
 
To mitigate risk, study staff will instruct the participant to only sign those areas of the consent/HIPAA 
that must be in the participant’s handwriting.  Other areas of the forms (such as the name of the 
participant and date at the top of each page of the consent) will be completed by study staff once the 
paperwork is returned.  Note that study staff expects this form of consent to be rare, and will only be 
offered to participants with unavoidable barriers that prevent them or study staff from consenting in 
person.  Absolutely no study procedures will begin until study staff completes the consent process. 
 
 
7.1.6. Subject Screening Procedures. Following consent, a baseline assessment and screening will 
take place with an interviewer or study coordinator to determine the participant’s eligibility. The initial 
consent and screening will require 2-3 hours. For individuals that do not meet study inclusion criteria, 
the study staff will assist with coordinating appropriate care outside of the study. Individuals meeting 
the study inclusion and exclusion criteria will be randomized into one of the two treatment groups.  
 
7.1.7. Compensation for Participation. All participants will receive $30 for the baseline assessment, 
$30 for the post-treatment assessment, $35 for the 3-month follow-up assessment, and $45 for the 6-
month follow-up assessment for a combined total of $140. Compensation may also be available in the 
form of Wal-Mart gift cards for peers who complete exposure activities with Veterans. 
  
7.1.8. Treatment Procedures. Participants will be randomly assigned to one of the two study 
conditions: 1) Experimental Condition: PE+Exposure Workout Buddy (i.e., a peer who specifically offers 
social support during in vivo exposure homework) or 2) Control Condition: PE+Peer General Support 
(i.e., a peer who does NOT engage in any support during in vivo homework, but offers support 
according to standard VA peer support models).  
 
Participants will be randomly assigned (1:1) to one of the two study conditions. After determining 
eligibility, enrolled patients will be assigned to treatment groups by study staff using a web-based 

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computer generated randomization scheme through REDCap, an application designed to support data 
capture for research studies. Study personnel will be able to obtain randomization assignment by 
completing a REDCap survey verifying inclusion/exclusion criteria. Randomization will occur at the 
patient level. Once a patient is randomized, he or she will be entered into the study and included in the 
intent-to-treat analysis plan. The only members of the research team who will be aware of 
randomization assignment will be the project therapists, the research assistant, and the statistical 
analyst in charge of randomization. Moreover, will we will take the following steps to minimize 
contamination between the two arms of the study: 1) patients in the intervention and control arms will 
be instructed not to share intervention materials with friends or other clinic patients; 2) patients will be 
given instructions not to disclose their treatment assignment to any other healthcare providers; and 3) 
per standard practices for MUSC-VA research, providers will be informed of their patients’ participation, 
but will be blinded to condition. 
 
1. Experimental Condition: PE+Exposure Workout Buddy. The experimental treatment is a 
modified version of PE insofar as social support in the form of ‘workout buddies’ for in vivo 
exposure homework is added to the protocol. Specifically, PE is a manualized treatment (Foa et 
al., 2007) that includes the following components: (a) psychological education about the 
common reactions to traumatic events and presentation of the treatment rationale (sessions 1 
and 2), (b) repeated in vivo exposure to trauma-related stimuli such as people, places, things, 
or situations that trigger memories of the traumatic event but are realistically safe (in vivo 
exercises are assigned as homework during sessions 3 through 11), (c) repeated, prolonged, 
imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 
- 11; patients listen to session audiotapes for homework between sessions), and (d) relapse 
prevention strategies and further treatment planning (session 12).  
 
PE is based on emotional processing theory, which suggests that traumatic events are 
incompletely and inaccurately encoded in memory as “fear networks.” Gradual exposure to 
corrective information via the confrontation of (i.e., exposure to) conditioned trauma-related 
stimuli within a safe and therapeutic environment results in a competing and antithetical memory 
structure that inhibits the conditioned fear response. PE relies on two primary therapeutic tools: 
in vivo exposure and imaginal exposure. During in vivo exposure, the patient confronts feared, 
but safe, stimuli or cues that elicit trauma-related distress. During imaginal exposure, patients 
are guided by therapists and “revisit” the traumatic event, providing a detailed verbal account 
that includes sensory information, thoughts, feelings, and reactions experienced during the 
traumatic event.  
 
Consistent with the spirit of the new VA mandate to use peers in specialty clinics such as PTSD 
clinics, we will offer those individuals who indicate that they have decided to drop out / have 
dropped out of treatment (e.g., stopped attending sessions) the opportunity to have a peer (see 
description of peer and training below) who has been through treatment successfully, and no 
longer holds a PTSD diagnosis, help them to complete in vivo exposure trials as an ‘exposure 
workout buddy,’ by offering social support during exposure homework.  
 
Peer Selection. For the pilot feasibility study, a large number of peers volunteered and were 
trained. Most of these peers have indicated that they will be available for this study. We will use 
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pilot study. Specifically, therapists will be asked if they have any patients who have completed 
treatment and did very well, both overall and in particular with in vivo exposure therapy 
components. Therapists will then be asked to contact these patients, inform them about the 
exposure workout buddy program, and ask them if they would like Dr. Acierno, a VA clinician 
and researcher, to discuss the program further. Upon being contacted, Dr. Acierno will outline 
the nature of expectations and research characteristics, and schedule a training session. Thus, 
initial nominations for the program are based on therapist impressions of successful candidates 
AFTER they have completed treatment. Peers who are candidates for the workout buddy 
program will be consented, evaluated for presence of PTSD diagnosis via the CAPS 5, and only 
those who no longer have the PTSD diagnosis will be permitted to participate in this study. Peers 
will also serve in the capacity of general peer support for the comparison condition, but will be 
explicitly directed NOT to meet the Veteran during in vivo exposure assignments. In fact, the 
only meetings between general VA support peers and patients take place at the VA, as is 
standard with VA peer programs (further description of duties below) 
 
Peer Exposure Assignment ‘Workout Buddy’ Training. NOTE: Peers are not therapists or 
therapist replacements, and the major activities of the peers are to simply meet Veterans at in 
vivo exposure homework sites and offer encouragement and support. To illustrate, this is like a 
workout buddy agreeing to meet you at the gym. This person is not a physical therapist or trainer, 
rather, they are just a peer who agrees to go to the gym and offer verbal support during gym 
activities. This is exactly the role of the peer: to offer verbal support during in vivo exposure 
activities that have been agreed upon. Thus, logistics and limits of responsibility, not skills, are 
the primary focus of training. Much time is spent emphasizing appropriate rules of confidentiality, 
self-disclosure (which is instructed to be limited), boundaries and safety procedures. As 
mentioned, analogies have been very helpful: that of peer and participants as ‘workout buddies’ 
and that of peer and participant having the same relationship and responsibilities to one another 
as group therapy patients. These analogies are applied as described below. Each peer will 
attend a 2-hour training meeting with the PI Acierno and Co-I Hernandez-Tejada. During this 
meeting, the rationale for in vivo exposure will be reviewed, and the benefits of having a 
supportive partner, friend, or exposure workout buddy during in vivo exposure will be outlined. 
Training will explicitly include content wherein peers will be clearly informed that they 
are not engaging in the role of therapist or providing therapy; rather, their role is equivalent to 
that of a supportive group member in traditional group counseling (with which many Veterans 
are familiar), only this support is given in the context of exposure exercises. In such a situation, 
group members offer each other advice and support on how to achieve stated goals. In the 
present case, the stated and agreed upon goal will be the in vivo exposure therapy assignment. 
As with group counseling members, peers are trained in the importance of confidentiality, and 
are not paid or compensated for their time (they are reimbursed for fuel). This clarifies that they 
are not in the role of a compensated therapist while also speaking to the sustainability of the 
program, a position underscored by the fact that we have had such a high Peer volunteer rate 
(85% of those approached) (see Preliminary Study #2). Limits to personal responsibility will be 
clearly outlined, and peers will be well educated that neither the outcome of the treatment, nor 
the disposition of the patient is their responsibility. We will review potential negative outcomes, 
including patient suicide, and apply the limits of personal peer responsibility to each. Moreover, 
we will make it explicitly clear that exactly and only those roles and responsibilities found in group 

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counseling sessions, including support, respect, and confidentiality, are in place here, with the 
exception that meeting locations are offsite and without therapist direction.  
 
Workout Buddy Logistics & Supervision: Getting Started. Our pilot study experience allowed us 
to refine methods of initiating the exposure workout buddy program to the following steps: Once 
patients have agreed to re-initiate treatment, the available peer in closest proximity to the patient 
will be asked by the project coordinator to call in to the next therapy session. During the session, 
the therapist will make introductions and the peer will listen to the patient and therapist review 
the next item of the in vivo exposure hierarchy in depth. The location, timing, outline, description, 
and parameters of the in vivo exposure therapy assignment will be reviewed and will be clear to 
patient, peer, and therapist. Once this clarity has been achieved, peer and patient will finalize 
arrangements to meet at a set time and place to engage in this exposure trial and will be directed 
to arrange at least 1 such meeting per week for 3-4 weeks. The analogy of a workout buddy will 
be used, insofar as the role of the peer is to be present and encourage the Veteran during his 
or her exposure efforts. For patients who dropped out of treatment prior to developing and 
engaging in hierarchy item exposure, the workout buddy ‘session call in’ will be delayed until this 
hierarchy is established. Once established and reviewed, the peer will call into the next session 
and discuss logistics of meeting patient at the exposure hierarchy item location with patient and 
therapist.  
 
Note that with respect to peer behaviors, these are PRECISELY the procedures we encourage 
and have used when delivering exposure-based therapies in group settings (see Smith et al., 
2015) and to those with supportive family members. Specifically, we encourage group members 
to work together during in vivo exposure trials in between sessions to offer encouragement and 
praise for successful completion. In this instance, we are borrowing that effective aspect of group 
therapy and applying it in dyads to patients who have dropped out prematurely from exposure 
based treatment. 
 
As with the feasibility trial, peers will not be matched on gender or age, except in cases of Military 
Sexual Trauma, for which peers are matched on gender. Peers will be selected on the basis of 
geographic proximity to participants. After the participant, workout buddy peer, and therapist 
hold a conference call to review logistics of in vivo exposure trials, therapists will speak with only 
the participant to assure that he or she continues to want to participate with a peer exposure 
workout buddy. Over the following weeks, this ‘check-in’ with participants will be repeated and 
the therapist will ask the patient to comment on any problems or benefits associated with in vivo 
exposures that were accompanied by a peer workout buddy to obtain a progress report of how 
exposure trials are going, and to determine if there were any issues that should be discussed. 
Similarly, following the first scheduled in vivo session, the therapist will contact the peer to review 
how the exposure homework went. Subsequently, peers, patients, and therapists will hold five-
minute telephone check-ins during treatment sessions to assure that exposures are going well 
according to both patient and peer. In the event a peer is not available to call in during a treatment 
session, the therapist will contact them after the session. This investment of therapist time has 
not been a problem in the feasibility trial, and will be precisely measured. Finally, during the first 
therapist call with the peer, the therapist will ask if the peer would like to continue with the 
participant and if there are any issues or problems. If a peer indicates that they prefer to no 
longer work with a participant, a different workout buddy will be recruited. If two workout buddies 

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indicate for any one participant that they prefer not to work with that participant, the peer workout 
buddy program will be terminated for that participant, and therapists will include these 
interpersonal events as topics of therapeutic focus appended to subsequent PE sessions. This 
has not occurred in our previous feasibility trial. 
 
To ensure that participants are not currently experiencing significant PTSD symptoms when 
serving as peers, a PCL will be administered at the baseline assessment, of which peers must 
score below 32.  Of note, a score higher than 32 does not necessarily indicate only elevated 
PTSD symptoms because this measure contains questions related to depression; therefore, the 
PI may determine eligibility based on PTSD versus depression symptomology. In these 
instances, peers will be offered “booster” sessions by their previous therapists from which they 
received their initial exposure treatment.  Booster sessions will consist primarily of emotional 
processing and/or confronting current life stressors which may contribute to current elevated 
PTSD symptoms.  Peers will be administered frequent PCL measures to assure that scores 
remain lower than the threshold, and may be offered booster sessions at any time during their 
participation in the study.   
 
In Vivo Exercises with Peers. As detailed above, each peer workout buddy will undergo a 2-hour 
training to review expectations, responsibilities, and most importantly, limits of responsibilities. 
Specific discussion of engaging in only those activities the workout buddy feels comfortable 
performing is held. Specific review of excluded activities will also be held. All workout buddies 
engage only in hierarchy items jointly determined by the therapist and participant, with assent of 
the workout buddy. No new, or unscheduled exposure activities, initiated on the part of the 
workout buddy or the participant are permitted. Workout buddies are directed to communicate 
with participants if either party feels or seems to feel uncomfortable with the activity in question. 
The difference between discomfort arising from conditioned anxiety that is part of PTSD and 
discomfort arising from feelings that the situation is inappropriate are discussed as part of peer 
training.  
 
Only situational activities, in clearly safe places, will be included in the in vivo exposure 
participation events by workout buddies. This will be determined by review with therapist and 
workout buddy. If EITHER party feels there is more than minimal risk, the activity will not be 
included. Note: risk of anxiety on the part of the participant is not a justifiable reason to exclude 
an activity; indeed, producing and dealing with such anxiety in a supportive environment is the 
point of in vivo exercises. It is impossible to list every possible activity that should be avoided vs. 
included. However, several common activities, listed below, are excluded:   
• activities involving driving together on the part of either the exposure workout buddy or the 
peer as driver (public transportation, such as taking a bus together is permitted); 
• activities in or around private residences of the participant or exposure workout buddy; 
• activities involving weapons (e.g., shooting range); 
• new or previously unlisted or unscheduled activities; and 
• activities that are associated with risk or danger as defined per therapist and or peer workout 
buddy. 
 

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Workout buddies and participants are told that the workout buddy program is only in place for a 
given patient for 3-4 weeks, at least once per week, and is a means by which to allow participants 
to progress to their own, independently conducted in vivo exposure trials. Thus, ‘phase out’ of 
the program is built in from the beginning. Workout buddies will focus on helping participants 
engage in those exposure exercises that typically are social in nature. Again, any exposure trials, 
such as driving, that require the participant to engage alone, or from which workout buddies are 
specifically prohibited will not be the target of this program.  
 
2. Control Condition: PE+Peer General Peer Support. Participants in this condition will receive PE 
(see above) and be assigned a peer support volunteer who will NOT engage in any support 
during the in vivo homework. The primary purpose of the peer in this condition is to emulate 
standard VA PTSD peer support procedures. Therefore, in this conditions peers provide general 
support, such as reminding and encouraging participants to attend appointments, meeting with 
them at the VA 2-4 times per month to assess general progress,  checking up on them once per 
week via telephone and asking about current treatment progress, life stresses, opportunities, 
problems and successes, and offering general support with VA programs. The PE component 
of this treatment will be matched to experimental condition in terms of session number and 
duration (12 sessions); treatment completion will be defined as for the experimental condition 
(minimum 10 sessions or pre-specified reductions in PCL score at two consecutive sessions; 
see above). Counselors will deliver treatment according to the same schedule as the 
experimental condition, once weekly for 75-90 minutes.  
 
Treatment Providers Training, and Supervision. Treatment providers for both conditions will be master’s 
level counselors with at least 2 years of experience providing evidence based counseling to adults. All 
providers will perform both treatments in equal measure to control for non-specific therapist effects, as 
with our prior three PE treatment outcome studies. All project therapists have already engaged in 
training through the prior PE studies and workout buddy pilot study. However, for new therapists, 
providers will undergo a 4-day PE workshop and a 4 hour PE+Exposure Workout Buddy Training with 
Drs. Hernandez-Tejada and Acierno. During the project, therapists will follow the treatment manual and 
will undergo regular peer supervision directed by Dr. Birks. 
 
Treatment Integrity and Adherence. The present study will obtain a quantitative measure of protocol 
adherence through a checklist of specific procedures scheduled in the treatments outlined above. In 
order to ensure that treatments are competently administered in accord with protocols as written, all 
sessions will be audiotaped, and 20% of these will be randomly selected and rated for competence and 
adherence by co-investigators. This will also allow us to study any differences between conditions on 
specific and non-specific factors, such as length of therapy, therapist empathy and rapport. Raters, 
blind to treatment condition, will rate the tapes independently to allow for the computation of inter-rater 
reliability. To evaluate adherence, rating forms were developed based upon the treatment manual to 
determine if the therapist appropriately covered the content of each session (i.e., demonstrated the 
particular behavior described in each item). To evaluate competence, rating forms were developed to 
assess how well the therapists accomplished a range of relevant tasks for each. These rating forms 
use 7-point Likert scale response formats, and are modeled after the therapist rating forms used in 
other studies of cognitive-behavioral treatments, including our own treatment outcome studies. 
 

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Treatment integrity can also be challenged by the introduction of non-study treatments. That is, 
participants may seek additional treatment on their own during follow-up data collection periods. This 
is particularly a problem if one treatment does not “work” and participants naturally look elsewhere for 
help. Individuals cannot ethically be prevented from seeking treatment. Therefore, we will assess, at 
post treatment and during follow-up periods, whether participants have obtained additional mental 
health treatment. Participants who do receive additional treatment will be compared to others within 
their treatment conditions that do not receive such additional intervention. Any differences noted will 
result in relevant adjustments to data analytic procedures (e.g., reporting data summaries of individuals 
receiving other treatment). 
 
Attrition and Retention. As study participants may have already dropped out of PE treatment once and 
may arguably be more likely to do so again in the future, this study has been powered to offset a 
projected 35% dropout rate during treatment, and a 10-15% loss to follow-up during the 6-month follow-
up period. Patients who attend at least 10 sessions or evince two consecutive weeks with PTSD Clinical 
Checklist-Military Version (PCL-5) scores below 20 (note, the National Center for PTSD suggested 
cutoff is 33 (Weathers et al., 2013)) will be considered completers. Participants will be allowed to make-
up sessions when appropriate or necessary within a 4-week window. Make-up sessions for subjects in 
both conditions will be handled in the same manner: when feasible, these sessions will be scheduled 
for later the same week. We will minimize drop out from the study by providing monetary compensation 
for completing baseline, post treatment, and 3, 6-month follow-up assessments (but not treatment 
sessions). Additionally, following the informed consent process, we will request additional contact 
information (two family members and/or friends) who would know how to get in touch with the participant 
if we are unable to do so with his/her primary contact number. We will also specifically ask for e-mail 
and cell phone contact information. This information will be updated at each assessment time point. 
We also will employ the following strategies to maintain study participation: 1) We will stress the 
importance of attendance during the first session and educate patients regarding the treatment process, 
treatment participation, and (for the experimental group) partnering with a workout buddy for exposure 
trials; 2) Study personnel will send letters ahead of telephone and/or e-mail scheduling contacts and 
make reminder telephone calls to participants on the day or evening prior to each session; 3) Study 
personnel will coordinate care, as needed, with participant’s case managers, psychiatrists, social 
workers, and other care providers who have acted as referral agents for the study; 4) Study personnel 
will be flexible in accommodating participant schedules for treatment sessions; and 5) Project staff will 
meet weekly to review scheduling activities and problem solve regarding strategies and approaches 
that may increase successful follow-up and retention.  
 
7.2. Drugs, Dietary Supplements, Biologics, or Devices. N/A 
 
7.3. Study Procedures. The following study procedures will be followed: 
• A member of the research team will explain the purpose of the study to potential participants. 
Potential participants will be asked to read and sign the consent.  
• If the participant has been referred from another study and already undergone baseline testing, the 
participant will be asked as part of the consent process to use these assessments rather than 
repeating the assessment battery. 
• If the participant is newly referred to this study or declines use of previously completed assessments, 
he or she will meet with an evaluator and complete the assessment questionnaires.  

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• The results of these screening procedures will be reviewed to determine whether it is appropriate 
for the participant to continue in the study. If it would not be appropriate for the person to continue 
in the study, a member of the research team will discuss the reasons why and, if needed, coordinate 
appropriate follow-up outside of this study. 
• Once all the baseline testing is completed and eligibility is determined, the participant will be 
randomized to either condition. 
 
All therapy and evaluation sessions will be audio recorded. Therapy sessions will be audio recorded 
for the patient to be able to complete homework during sessions. Assessments will be recorded to 
ensure that study staff is correctly following the study procedures; a randomly selected subset of these 
tapes will be reviewed by research experts who are part of the research team. Participants will have 
the option to accept or deny the use of video/audio recording during evaluations and therapy at informed 
consent. Agreeability to recording will have no bearing on participant eligibility. 
 
7.3.1. Collection of Human Biological Specimens. N/A 
 
7.3.1.1. Laboratory Evaluations and Special Precautions. N/A 
 
7.3.1.2. Specimen Storage. N/A 
 
7.3.2. Data Collection. All data will be in the form of self-report questionnaires for psychological 
outcomes included with this document. Demographic data will be collected, but no uniquely identifying 
participant data will reside with, or be linked to actual responses to questionnaires.  
 
The study assessments will be administered online through the Charleston VA’s academic affiliate, 
Medical University of South Carolina (MUSC) REDCap™ (Research Electronic Data Capture) software. 
REDCap™ is a software toolset and workflow methodology for electronic collection and management 
of research clinical trial data.  It provides secure, web-based flexible applications, including real time 
validation rules with automated data type and range checks at the time of entry.  The underlying 
database is hosted in a secure data center at MUSC, a secure environment for data systems and 
servers on campus, and includes redundancy, failover capability, backups and extensive security 
checks.  The system has several layers of protection including user/group account management, “Data 
Access Groups” which allow data to be entered by multiple groups in one database with segmented 
user rights for entered data, audit trails for all changes, queries and reports, and Secure Sockets Layer 
(SSL) encryption. The administration of study assessments will be conducted and monitored by the 
study staff through a password-protected REDCap account. Only research team members will have 
access to the data. Data will remain on REDCap and will be uploaded to the VA secure network until it 
is verified as de-identified per HIPAA regulation. All paper forms will be held in a locked filing cabinet 
in the recruiting Site PI’s locked research offices. Study data will be collected by study ID only via 
REDCap. REDCap data will regularly be backed up and exported to the VA secure server. At the study’s 
conclusion, the electronic crosswalk file linking study IDs with patient identifiers will be destroyed per 
MUSC and VA policy.  
 
 

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7.3.2.1. Instrumentation. See the table at Section 7.1.2 above for a summary of the assessments and 
timing of administration. All measures are being administered for research purposes. Assessments will 
be administered in person whenever possible. However, in order to accommodate participant 
schedules and/or instances in which a participant may have left the local area at the time of a follow up 
assessment, we may collect full or partial assessments in person or via phone or electronic data capture 
using a secure link to the HIPAA-compliant REDCap database. Assessments completed via phone or 
remote electronic data capture will not include psychophysiological measures. Reasonable efforts will 
be made to collect all data as described in this protocol, but we expect some participants may not be 
able to complete part or all of any given follow-up assessment. 
 
7.3.2.2. Data Storage and Access. 
 
Participant Identification. A file of research identification numbers and associated social security 
numbers will be stored separately on paper and on computer, for purposes of audit by the VA/MUSC 
IRB, if necessary.  
 
Protection of Patient Confidentiality/Disposition of Data. Protection of participant confidentiality is an 
important component of subject protection. The main potential risk to subjects is violation of their 
confidentiality. We will take careful precautions to maintain confidentiality for all subjects, using 
procedures we have used with similar previous studies: The investigators and the research team will 
sign a confidentiality agreement with the Charleston VAMC that no identifying information of specific 
individuals will appear in any internal reports prepared for the VA or external documents (e.g., peer-
reviewed publications, presentations). All study data related to psychological outcomes (i.e., the 
participant responses to questionnaires) and demographics will not have any unique identifying data 
commingled or attached in any way. There will be no linkage between a volunteer’s identity and their 
responses. The master list of participants (again, not linked to any participant responses) will remain 
on the VA secure network in an encrypted folder, and the document itself will be encrypted with a 
password for an added measure of protection. All data will be stored in locked files or on encrypted 
computers in the PI’s research offices.  
 
When study results are published or presented, only aggregate reports of the results will be used and 
subjects’ identity will not be revealed. All analyses will be conducted on de-identified data only. All paper 
documents will be securely stored in locked filing cabinets. Access to research records (paper and 
computerized) will be restricted to the project staff. Specifically, access to de-identified study data will 
be limited to named project investigators, the project coordinator, VAMC audit personnel, and MUSC 
IRB audit personnel. The list of participant names will be kept separate from all data, and will be 
available only to project staff.  
 
Data will be maintained per VA protocols, and not less than two years prior to permanent storage. We 
will seek guidance regarding VA policies for maintenance terms of psychological data to determine the 
exact period of time that will elapse upon completion of which all study records will be stored 
permanently. 
 
Data regarding sensitive information such as HIV status or illegal residency will not be collected. Rather, 
only demographic and psychological outcome data will be collected. However, State and Local 

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authorities do require reporting of potentially suicidal or homicidal behavior. These exceptions to 
confidentiality will be clearly explained to volunteers during the informed consent process. 
 
All investigators and project personnel have completed a certified program of instruction in the 
protection of human subjects in research, such as the VA website tutorial, NIH website tutorial or the 
University of Miami CITI course.  
 
7.3.3. Human Biological Specimen (Biomarker) Processing. Not applicable. This study will neither 
be collecting specimens nor conducting laboratory evaluations of biomarkers. 
 
7.4. Statistical Consideration  
 
7.4.1. Sample Size Estimation. For the continuous longitudinal clinical, functional, and process 
outcomes for Primary Aims, with 50 subjects randomized to each intervention group, we will have 89% 
power to detect at least a 0.3 standardized (sd units) effect size between the two intervention groups 
assuming 4 time points (baseline, post-treatment, and 3- & 6-month follow-ups), and; intra-class 
correlation no greater than 0.5; level of significance <=0.05, two-tailed. A standardized effect size of 
0.35 sd (Cohen’s d, “small” effect) is equivalent to a raw effect size of 2.8 raw scale units for PCL-5 
(assuming pooled sd for post treatment PCL-5 scores is 8.1, from preliminary data). For the 
dichotomous process outcome completer/dropout, with 50 subjects per group, the study will have 85% 
power to detect a relative improvement in retention for the experimental condition of 20%. Power will 
be 89% for the continuous ‘dose’ received measure of number of sessions attended, assuming an effect 
size of 0.3 for the experimental condition. We make these conservative effect size predictions based 
on the fact that we intend to use Intent to Treat (ITT) analyses for primary outcomes for which group 
average treatment effects are lower compared to completer analyses.  
 
To account for dilution effect of ITT analyses, "administrative" dropout, i.e., those who drop out 
immediately upon randomization (do not receive a treatment or return for a post baseline visit), and the 
need to impute missing data, we will ‘over recruit’ by 15% to achieve a final ITT sample size of 58 
participants randomized to each treatment group (i.e., ITT N = 116, Completer N = 100).  
 
7.4.3. Data Analysis.  
 
Preliminary Descriptive Analyses. Satisfaction and process measures will be summarized for patients 
and peers. Baseline values for demographic, war theatre, clinical, and other putative prognostic 
variables will be compared for imbalance across the two randomized treatment conditions and across 
the non-randomized, exploratory conditions (in person vs. telehealth delivered PE+Exposure Workout 
Buddy vs. PE+Peer General Support). These analyses will identify potential confounding variables to 
be used as covariates in subsequent analyses and will include race/ethnicity, age, psychiatric 
comorbidity, and initial disease severity. To investigate potential limits on generalizability, we will 
compare characteristics of participants who prematurely exit and/or are protocol non-adherent (i.e., 
they dropped out again) against those who were completers/protocol adherent. Characteristics of 
patients who do not complete the study or do not adhere to treatment will be compared for both 
conditions. 
 

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Objective 1a: To determine the differential impact on treatment dose received of ‘PE+Exposure 
Workout Buddy’ vs. ‘PE+Peer General Support’ in individuals who have dropped out of evidence based 
treatment for PTSD in terms of the number of sessions completed following randomization to either 
treatment. Objective 1b. To determine if this differential dose received is amplified or diminished with 
respect to prior identified risk factors such as age, race, gender, or substance use. 
 
Analysis Issues for Objective 1: As mentioned in the Measures section, ‘dose’, or number of new 
sessions received is likely confounded by ‘prior dose’, or number of pre-dropout sessions 
received prior to initiation of this study. Nonetheless, the basic question of treatment dose as 
measured by number of new sessions completed after receiving the experimental treatment is 
important and will be obtained. However, to deal with this potential confound, (a) number of 
sessions completed prior to dropout will serve as a covariate in subsequent analyses & (b) ‘dose’ 
will also be examined dichotomously, in terms of between group proportions of treatment 
completers (defined as completing 10 or more new sessions OR 2 subsequent PCL5 scores 
below 33).  
 
Analysis Plan for Objective 1: We will adopt a relatively direct analytic approach for this first 
objective. Specifically, if preliminary descriptive analyses reveal baseline differences in 
psychopathology or other potentially confounding variables, including number of sessions 
completed prior to dropout (i.e., prior to entry into this study) these will serve as covariates in 
ANCOVA, which will be used to compare average dose received in terms of number of treatment 
sessions in each group. These ANCOVAs will be repeated with race and gender as between 
group factors to determine if any interaction is present between treatment condition and these 
demographic characteristics. A similarly direct approach will be taken for the dichotomous 
variable of treatment completion, for which we will initially use chi square analyses for bivariate 
examination of treatment completion in terms of each demographic variable and each treatment 
condition, followed by logistic regression in which those variables producing significant chi 
square relationships to this outcome will be included in regression models. We will use 95% 
confidence intervals (CI) for single proportions to estimate the proportion of participants who 
complete treatment within each intervention group. We will also estimate the difference in 
completer proportions between groups using 95% CI for difference in proportions. In addition, 
frequency distributions describing participants' reasons for discontinuation of study participation 
will be developed. In this way, the effect of each treatment condition on ‘dose’, measured in 
terms of overall number of sessions completed, and in terms of proportion of participants 
completing at least 10 sessions / achieving clinical cutoff will be described.  
 
Objective 2a. To determine differential effectiveness of ‘PE+Exposure Workout Buddy’ vs. ‘PE+Peer 
General Support’ who does NOT engage in any support during in vivo homework with therapy dropouts 
in terms of therapeutic gains over time on measures of PTSD symptomatology (i.e., ‘treatment 
outcome’). Objective 2b. To determine if differential effectiveness is amplified or diminished with respect 
to race, gender, age or substance use. 
 
Analysis Issues for Objective 2. The primary analyses for this objective will use the ITT sample, 
which will consist of all participants who are randomized to either PE+Exposure Workout Buddy 
or PE+Peer General Support. Patients will not be discontinued from the study assessments 
because of non-adherence and all patients will remain in the study assessment protocol unless 

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consent is withdrawn or there are concerns regarding patient safety. We will adopt several 
approaches to dealing with missing data for the intent-to-treat analysis set:  for continuous 
outcomes, we will employ mixed effects models (GLMM, MEM) which allow for measurement of 
subjects at different time points and missing data (Hedeker & Gibbons, 2006); for single endpoint 
imputation, we will use the multiple imputation methods of Little and Rubin (1987). We will model 
the dichotomous outcome, missing/not missing post treatment score, using logistic regression 
to determine if missingness is related to treatment condition. In a secondary analysis, the results 
of analyses using treatment completers (completer analyses) will be compared with results using 
the full set of all randomized participants (ITT analyses) to test sensitivity of study conclusions 
to dropouts.  
 
To address possible Type I errors due to the number of analyses: (1) for the primary analyses, 
we specify a priori the primary measures corresponding to the stated a priori hypotheses (with 
other measures being considered secondary/exploratory) and maintain the significance level 
(alpha) at 0.05 for analyses involving the primary study variables; and (2) for secondary analyses 
using additional outcome variables and combat exposure measures, we will adjust p-values 
using a Bonferroni-type correction for multiple outcomes and will report both unadjusted and 
adjusted p-values. Secondary outcomes and exploratory analyses will be evaluated qualitatively 
in terms of consistency with primary results and cautiously in terms of statistical significance of 
results. The sensitivity of the study results to adjustment for multiplicity of outcomes will be 
evaluated. 
 
Analysis Plan for Objective 2. Our primary outcome is the PCL5 continuous score for PTSD. 
Clinical (CAPS, PCL-5, Patient Health Questionnaire), functional (SF-36), and process 
(treatment credibility scales, patient satisfaction, session rating scale, service delivery 
perceptions, retention in treatment) outcomes will be compared using the generalized linear 
mixed models (GLMM) approach. In addition to accommodating a wide range of distributional 
assumptions 
[continuous 
(e.g., 
PCL-5, 
CAPS, 
Patient 
Health 
Questionnaire), 
dichotomous/categorical (e.g., binomial), ordinal (e.g. patient ratings), count (e.g., number of 
missed homework assignments (Poisson), the approach accommodates multilevel data 
(clustering) such as repeated measurements of subjects, missing data, time-varying covariates, 
and possible cluster effects within sites or clinics through inclusion of random effects in the model 
(Hedeker & Gibbons, 2006). For the continuous outcomes, for example PCL5, GLMM is 
equivalent to a linear mixed effect model (MEM) approach. MEM analyses estimate individual 
change in outcome for each subject in addition to estimating average change in outcome within 
each intervention arm. Covariates, such as initial severity as measured by the PCL-5, age, race, 
and comorbid illnesses will be added to the model to adjust for putative confounding variables. 
Unadjusted and covariate-adjusted least squares means for continuous outcomes will be 
compared at relevant time points (e.g., immediate post end-of-active-intervention and 6-month 
end-of-study time points) using appropriate model contrasts and the Tukey-Kramer adjustment 
for multiple comparisons. We will first assess trends in the outcome profiles over the full study 
period (active + follow-up). In these analyses, we will allow slopes to differ depending upon 
whether it is active or follow-up phase. In secondary analyses, we will also assess separately 
the active phase and the follow-up phase (3- & 6-months) trajectories to remove from the active 
phase results the complicating issue of intervening events in the follow-up phase. Intervention 
specific patient satisfaction items will be described separately within each intervention group 

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using standard descriptive analyses (e.g., means, proportions along with corresponding 
confidence intervals). Global satisfaction level (e.g., overall satisfaction level) will be compared 
between intervention groups using the GLMM process described above. Mediation effects of 
perceived level of social support on outcome will also be examined. 
 
Estimation of effect sizes. The magnitude of treatment group differences (effect sizes) for 
outcome variables will be estimated using 95% confidence intervals (CI). Effect sizes will be 
used to evaluate clinical significance of treatment group comparisons. 
 
Exploratory Objective 3. To determine the presence of initial signals of differential dose and 
effectiveness of  ‘PE+Exposure Workout Buddy’ when delivered in traditional in person (face to face) 
vs. telehealth formats. (Note, the parameters by which this objective will be achieved are naturalistic 
insofar as this variable is not subject to randomization because participants who had received telehealth 
or in person PE prior to dropout and thus prior to this study will continue to receive treatment in the 
same modality upon randomization to either PE+Exposure Workout Buddy or PE+Peer General 
Support). 
  
Analysis Plan for Exploratory Objective 3 The analytic requirements of the exploratory objective 
to detect initial signal of differential effect of the PE+Exposure Workout Buddy program for those 
receiving treatment via telehealth vs. in person mirror those of Objective 1 with respect to ‘dose’ 
and ‘% completing treatment’, and Objective 2 with respect to clinical outcomes. As such, the 
logistic regression analyses conducted for Objective 1 will be repeated, this time including 
treatment delivery medium (in person vs. telehealth) as an independent predictor variable. 
Likewise, the analytic plan for Objective 2 will also be repeated, including treatment delivery 
medium as an independent variable for continuous clinical outcome analyses. In this way, the 
hypothesized advantage of the PE+Exposure Workout Buddy program for telehealth will receive 
initial study. 
 
As is typical in most treatment outcome studies, we will also supplement exploratory analyses 
by examining the possible mediating effect of the process variables on clinical outcomes. These 
analyses address the question of whether process outcomes such as satisfaction with the 
intervention, treatment credibility, and session attendance explain the relationship between the 
outcome variable (PTSD severity) and intervention group (primary independent variable). For 
example, these analyses will explore whether a more positive outcome in one group may be 
explained by greater session attendance and higher satisfaction ratings in that group, or as 
hypothesized here, social support. Specifically, in mediator analyses, it is posited that variation 
in the primary independent variable (intervention group) accounts for variation in the mediators 
(e.g., social support, session attendance), and variations in the mediators account for variations 
in outcome (PTSD severity). For these analyses, we will use the GLMM modeling approach 
described above coupled with the method of Baron and Kenney (1986) and Holmbeck (1997) 
for evaluating putative mediators. 
 
7.7. Confidentiality. Some in-person therapy sessions and interview assessments will be delivered in 
private offices located at the Ralph H Johnson VAMC 109 Bee Street, Charleston, SC 29401 or an 
associated Community Outpatient Clinics (CBOCs). Those addresses are: Beaufort VA Outpatient 
Clinic 1 Pinckney Road Beaufort, SC 29902; Goose Creek Clinic 2418 NNPTC Circle Goose Creek, 

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SC 29445; Hinesville VA Outpatient Clinic 500 East Oglethorpe Highway Hinesville, GA 31313; Myrtle 
Beach VA Outpatient Clinic 3381 Phillis Boulevard Myrtle Beach, SC 29577; Savannah VA Outpatient 
Clinic 1170 Shawnee Street Savannah, GA 31419; Trident VA Outpatient Clinic 9237 University 
Boulevard North Charleston, SC 29406.  Some in-person therapy sessions and interview assessments 
will be delivered at MUSC leased space at 740 East General Stewart Way, Suite 202 Office E, 
Hinesville, GA 31313. Secure offices may be rented in the community to ensure there is private space 
to see participants. The location of these rented facilities will be determined pending final agreements. 
Digital audio recordings of assessments and video recordings of treatment sessions will be labeled with 
the participant’s study id number and saved on a secure password protected server. Those recordings 
are to be reviewed for fidelity to ensure that the treatment is being delivered in accordance with the 
treatment manual will be viewed on a secure password protected server. Every member of the research 
team will be trained and monitored about how to handle and protect both medical and research records. 
Only authorized study staff will have access to either the raw data or electronic study data. 
 
7.7.1. Certificate of Confidentiality. We are not seeking a Certificate of Confidentiality.  
 
7.7.2. Data Protection. Data will be coded using an assigned number. Data collected on paper during 
treatment will be placed into locked cabinets at the respective clinics where the data is collected. 
Electronically captured data as well as audio/video recordings will be uploaded to a secure database. 
Every member of the research team will be trained and monitored about how to handle and protect 
both medical and research records. Furthermore, the research team strictly controls access to study 
data. These audio files will only be used for the purpose of fidelity to ensure the treatment is being 
delivered in accordance with the treatment manual for this study only. Upon study termination, and 
once the data has been analyzed to the fullest extent by the researchers, the audio and video files will 
be deleted from the secure server if in accordance with VA and MUSC policy.  
 
 
8.0 RISKS/BENEFITS ASSESSMENT 
 
8.1. Foreseeable Risks. Potential psychological risk of the treatment includes exacerbations of 
distress during the assessment or treatment sessions. Measures to avoid this include constructing an 
intervention that has as one of its primary aims, reduction of distress and depression through increased 
activity. Additional measures include informing participants that they are free to terminate treatment 
sessions at any time. Risks associated with follow-up assessment include the possibility that 
participants might be upset by questions pertaining to their emotional functioning. Again, all participants 
will be informed at the outset that they may terminate participation at any point. Our past research 
suggests that data collection using many of these measures can be conducted without undue 
psychological distress or exacerbation of symptoms among adult participants. This experience includes 
substantial research with younger and older adults, rape victims, victims of other forms of violence, and 
work on large-scale studies asking questions about similar topics with general population samples. 
Alternative treatments generally include group treatment, treatment by antidepressant medication, or 
by relatively invalidated psychotherapeutic techniques. 
 
Another, albeit unlikely risk is to peer support specialists if patients have some negative outcome and 
the peer blames themselves for this outcome. For example, if a patient is very distressed during an 
exposure therapy assignment and subsequently drinks alcohol and drives and is arrested or has a 

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crash, the peer may blame him or herself for this negative outcome. To address this, the PI stresses in 
his training of peers that their responsibility is limited to themselves with respect to showing up at 
exposure assignments as a workout buddy, and that any negative behaviors on the part of the peer 
would very likely have occurred, and occurred with greater severity had they not been involved and 
helping. 
 
Social risks are present if another person or parties observe participants attending treatment clinics or 
learn by other means of participants receiving treatment. Participants will not be overtly identified as 
research candidates or candidates for psychological intervention. Participants in mental health research 
at the VAMC are NOT required to ‘check in’ at the mental health front desk, and instead report directly 
to treatment areas in order to reduce any potential for stigma. 
 
Legal risks arise if individuals are homicidal or suicidal and make these intentions known to project 
staff, which are then required to notify authorities and the target of homicidal intent. These risks are 
outlined in the informed consent documents. 
 
Risk Management and Emergency Response. In the event respondents experience extreme 
psychological distress secondary to participation, they will be encouraged to telephone the Principal 
Investigator (PI) or the Co-Investigators. In addition, they will have access to the VA’s urgent care 
services. Any adverse effects noted by any project personnel in response, or in potential response to 
any project intervention, assessment protocol, or study involvement will be immediately reported to the 
PI and Project Co-Is, who will then report these serious adverse effects in writing to the University/VA 
IRB within 24 hours of the initial report. The research team is comprised of licensed clinical 
psychologists with extensive experience working with adults who have experienced significant life 
stressors. Participants will be requested at the beginning and the end of the initial interview session to 
write down the PI’s name and telephone number. Moreover, if assessors or project staff believe that a 
participant is significantly distressed by participation, the PI will be notified and will contact the 
participant to assess distress and assure participant safety. If called by participants, the PI will attempt 
to address all subject concerns and set up an alternate referral for counseling for those who desire it 
from outside the project. 
 
In any study of mental health problems or symptoms, risk of suicide is amplified relative to most other 
medical disorders. Therefore, specific precautions will be taken to prevent harm to participants and 
potential participants. All assessors will be specifically trained to assess suicide risk (e.g., suicide 
verbalizations, extreme sadness, etc.) associated with major depressive disorder, and the structured 
clinical interview will specifically query for both suicidal ideation and intent. In initial screening 
procedures, participants identified by clinical interview with both suicidal ideation and acute intent will 
be excluded from the study, but will be offered emergency psychiatric care immediately. This care is 
available 24 hours per day at the Charleston VAMC emergency room. In any instance where ideation 
or intent is identified, a Project Investigator will be immediately notified and will contact the participant 
for further evaluation. If both ideation and intent are present, the aforementioned hospital intervention 
will be provided. 
 
Thus, all assessment points represent suicide risk identification, assessment, and intervention 
opportunities. In addition, all project therapists will be specifically trained regarding the increased risk 

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of suicide in depressed persons and will receive specific instruction of suicide risk assessment by 
Project Investigators.  
 
In any instance (either during assessments or during treatment sessions) where suicide risk is 
identified: (1) a Project Investigator will immediately contact the participant and determine suicide risk. 
(a) If suicidal ideation, but not intent is present, the individual will be retained in the study and assessed 
for suicide risk by one of the Investigators in one week. (b) In cases of acute suicidal intent, state law 
requires immediate hospitalization and we will follow these guidelines. Note, as mentioned, suicidal 
ideation is not grounds for study exclusion or mandatory hospitalization, whereas clear intent to commit 
suicide requires hospitalization.  
 
Potential Benefits. The benefit to the volunteer is a potential reduction in aversive psychological 
symptoms of anxiety and depression, as well as the cognitive realization that, through their volunteer 
efforts, they are helping to advance the state of knowledge as it applies to positive mental health for 
Veterans. The benefit is (1) reducing attrition from the military due to mental health causes and (2) 
reducing eventual mental health costs for the VAMC system, thereby benefiting individuals and the VA. 
Another benefit is to the peer support specialist, who may be particularly happy to ‘give back’ to other 
Veterans. 
 
8.2. Alternatives. Mental health treatment is available, including various forms of psychotherapy and 
drug treatments. Military personnel may be eligible for care at one of the Veterans Healthcare System 
facilities or clinics. If not, they will be instructed that they can request treatment for PTSD through Army 
One-Source. Not participating in the study is also an alternative. 
 
 
9.0. ADVERSE EVENTS, UNANTICIPATED PROBLEMS, AND DEVIATIONS 
 
9.1. Adverse Events. All adverse events will be assessed and monitored according to the established 
SOP and the IRB of record’s policies and procedures. 
 
9.2.  Reporting Adverse Events, Unanticipated Problems Involving Risks to Subjects or Others 
(UPIRSOs), and Deviations to the Office of the IRB. All adverse events, unanticipated problems 
involving risk to participants or others, and deviations will be reported to the Institutional Review Board 
(IRB) in accordance with current IRB policy. UPIRSOs and recurrent non-compliance with study 
procedures will be reported promptly to the IRB. All adverse events that do not meet the UPIRSO 
criteria and deviations that are not non-compliance will be summarized at Continuing Review per the 
IRB of record’s policy.  
 
9.3. Research Monitor. Tataina Davidson, Ph.D. 
 
Responsibilities of the Research Monitor. The research monitor is required to review all 
unanticipated problems involving risk to volunteers or others, serious adverse events and all volunteer 
deaths associated with the protocol and provide an unbiased written report of the event to the 
USAMRMC Office of Research Protections (ORP) Human Research Protection Office (HRPO). At a 
minimum the research monitor should comment on the outcomes of the event or problem and in the 
case of a serious adverse event or death comment on the relationship to participation in the study. The 

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medical monitor should also indicate whether he/she concurs with the details of the report provided by 
the study investigator. Reports for events determined by either the investigator or medical monitor to 
be possibly or definitely related to participation and reports of events resulting in death should be 
promptly forwarded to the HRPO. Additional responsibilities include:  
 
• observe recruitment and enrollment procedures and the consent process for individuals, groups 
or units; 
• oversee study interventions and interactions; 
• may discuss the research protocol with the investigators, interview human subjects, and consult 
with others outside of the study about the research;  
• reviewing monitoring plans and UPIRTSO reports;  
• overseeing data matching, data collection, and analysis 
• shall have authority to stop a research protocol in progress, remove individual human subjects 
from a research protocol, and take whatever steps are necessary to protect the safety and well-
being of human subjects until the IRB can assess the monitor’s report; 
• shall have the responsibility to promptly report their observations and findings to the IRB or other 
designated official and the HRPO. 
 
 
10.0. WITHDRAWAL FROM STUDY PARTICIPATION   
 
Participation in the study may be discontinued by the principal investigator if continued participation is 
considered a danger to a participant’s welfare. Reasons for discontinuation can include: 1) serious 
adverse event; 2) clinical worsening for any reason that is deemed to necessitate non-study 
psychological or psychiatric treatment; 3) exacerbation of PTSD, anxiety, or depressive symptoms that 
the participant cannot tolerate; or 4) discontinuation would be in the participant's best interest. 
Participants deemed candidates for discontinuation will be discussed with the therapist and the 
supervisor and will be brought to the attention of the PI for final decision.  
 
Participants who are discontinued from the study for any reason will be scheduled for a final evaluation 
within one week and given appropriate treatment referrals. If participants are discontinued due to a 
serious adverse event, they will continue to be followed clinically by the therapist and/or member of the 
research staff until the adverse event is resolved or becomes stable. If participants are discontinued for 
a medical or psychiatric reason, they will be given the opportunity to either complete the balance of 
their PE sessions or to receive a full course of PE after the condition has resolved or stabilized and the 
endpoint assessment has been completed. The reason the participants are discontinued from the study 
and any referrals made will be documented. Participants will be told they will be contacted for post-
treatment assessments whether or not they complete the trial. 
 
 
11.0. USAMRMC VOLUNTEER REGISTRY DATABASE 
 

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We do not anticipate that this will be a greater than minimal risk study necessitating the use of the 
Volunteer Registry Database will be necessary.  
 
 
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