Narrative Exposure Therapy for Justice-Involved Veterans (D1298-W)
Phase: NA
Conditions: Posttraumatic Stress Disorder
Sponsor: VA Office of Research and Development

Study Protocol 
Study Title: Narrative Exposure Therapy for Justice‐Involved Veterans 
NCT Number: NCT03777553  
Document Date: 4/21/2020 

Research Protocol: Narrative Exposure Therapy for Justice-Involved Veterans (VETNET)  
Principal Investigator: Elizabeth Van Voorhees, Ph.D. 
 
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Background, Significance, and Specific Aims 
Data from the National Vietnam Veterans Readjustment Study found that nearly half of 
all Vietnam combat Veterans with posttraumatic stress disorder (PTSD) had been arrested one or 
more times (Center, 2008), and several more recent studies have identified combat exposure, 
PTSD, and combat-related moral injury as predictors of criminal justice involvement and 
violence in Veterans of the wars in Iraq and Afghanistan  (Angkaw et al., 2013; Dennis et al., 
2017; Elbogen et al., 2012; Elbogen et al., 2014; Jakupcak et al., 2007; MacManus et al., 2015; 
Van Voorhees et al., 2016). Finally, childhood maltreatment has been identified as risk factor for 
violent crime in both Veterans and non-Veteran samples (Flanagan, Teer, Beylotte, Killeen, & 
Back, 2014; WIDOM, 1989), and research has found higher rates of childhood abuse and other 
adverse childhood experiences in Veterans compared to their civilian counterparts (Blosnich, 
Dichter, Cerulli, Batten, & Bossarte, 2014; Zinzow, Grubaugh, Monnier, Suffoletta-Maierle, & 
Frueh, 2007).  
 
A body of research has evolved outside of the U.S. for a type of trauma focused therapy, 
Narrative Exposure Therapy (NET), which was specifically developed for survivors of organized 
violence (Alghamdi, Hunt, & Thomas, 2015; Bichescu, Neuner, Schauer, & Elbert, 2007; 
Crombach & Elbert, 2015; Ertl et al., 2011; Hermenau et al., 2013; Orang et al.; Robjant & 
Fazel, 2010; Schauer, Nuener, & Elber, 2011). NET also has a specialized adaptation, Narrative 
Exposure Therapy for Forensic Offender Rehabilitation (FORNET), designed to address the 
treatment needs of those who have committed acts of violence and struggle with community 
reintegration after wartime and/or incarceration. FORNET, in particular, explicitly calls into 
question the victim/perpetrator duality in its approach to interrupting the cycle of violence in 
traumatized offenders (Hecker, Hermenau, Crombach, & Elbert, 2015). This approach has been 
found to be effective in reducing PTSD symptoms and aggression in several contexts (Crombach 
& Elbert, 2015; Ertl, Pfeiffer, Schauer, Elbert, & Neuner, 2011; Hecker et al., 2015; Hermenau, 
Hecker, Schaal, Maedl, & Elbert, 2013; Hinsberger et al., 2017).  The flexibility of having the 
option to use either NET or FORNET with U.S. military Veterans may be particularly powerful, 
given that this population is likely to have varying incidence of perpetration experiences. 
 
Rationale for the Therapeutic Approach 
Trauma focused therapy for PTSD: The fear network.  
The majority of therapies currently employed to treat PTSD are based upon the fear 
network model which holds that traumatic experiences create a unique form of memory. In a 
traumatic memory, trauma-related cues become powerfully associated with a fear network 
comprised of sensory (sight of blood, smell of perpetrator), cognitive (“I will die”, “I am 
helpless”), emotional (fear, anger), and physiological (heart racing, sweating) elements. Many of 
these elements of memory are stored pre-verbally, and trauma survivor’s efforts to avoid 
thinking about traumatic material keeps these memories walled off from verbal processing. 
PTSD develops when the trauma memory remains walled off and is not integrated into 
autobiographical memory. Because the trauma memory remains unintegrated and thus unmoored 
from time, place, and context, triggers related to one element of the trauma memory (i.e. a smell 
reminiscent of the perpetrator, feeling the heart racing) can activate the entire fear network, even 

Research Protocol: Narrative Exposure Therapy for Justice-Involved Veterans (VETNET)  
Principal Investigator: Elizabeth Van Voorhees, Ph.D. 
 
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in situations where there is no actual threat (Foa, Huppert, & Cahill, 2006; Schauer, Neuner, & 
Elbert, 2011).  
The existence of the fear network forms the theoretical basis for one of the therapies for 
PTSD treatment that has received the most support, Prolonged Exposure Therapy (PE).  PE seeks 
to recontextualize the trauma in time and place, with the therapeutic goal of reducing avoidance 
symptoms and preventing the maladaptive reactivation of the trauma-related fear network in the 
absence of threat (Foa et al., 2006; Schauer et al., 2011). 
Some forms of PTSD-related aggression can also be accommodated by the fear network 
model. Reactive aggression, for example, is a form of aggression that occurs in the context of 
perceived threat, and is typically associated with impulsive lashing out in response to fear and 
negative affect. Cognitive biases associated with perceiving threat in ambiguous or neutral 
situations have been associated with both PTSD and with aggression (Taft, Creech, & Murphy, 
2017; Taft et al., 2015), and in fact addressing these biases is a fundamental element of the 
Strength at Home Program for Veterans who have used violence in intimate relationships (Taft, 
Macdonald, Creech, Monson, & Murphy, 2016).   
 
Narrative Exposure Therapy (NET): The fear network and chronic trauma 
NET is an empirically supported therapy for PTSD that, like PE, is based upon the 
construct of the fear network as being fundamental to the development and maintenance of 
PTSD. NET differs from PE, however, in that it does not focus on a single index trauma, but 
rather takes a “lifeline” perspective that allows for the identification and processing of multiple 
traumatic events within a broader developmental context. This therapy was developed 
specifically to treat individuals with complex, cumulative trauma who live in low resource 
situations of ongoing instability or threat (Schauer et al., 2011). Several RCTs have demonstrated 
NET to be effective in treating PTSD and improving functioning in refugees, asylum seekers, 
former child soldiers, and demobilized combatants in war-torn areas, including those who have 
experienced high levels of cumulative trauma such as child maltreatment, war, genocide, and/or 
torture (Alghamdi, Hunt, & Thomas, 2015; Bichescu, Neuner, Schauer, & Elbert, 2007; 
Crombach & Elbert, 2015; Ertl et al., 2011; Hermenau et al., 2013; Orang et al.; Robjant & 
Fazel, 2010).  
 
Brief description of NET. NET begins with a session of psychoeducation that reviews 
the symptoms of PTSD and how they develop, and provides the rationale for the therapy. In the 
second session patients create a “lifeline” using a rope or string to symbolize the flow of their 
lives from birth to the present, placing flowers along the rope to symbolize positive events or 
people in their lives, and stones to symbolize losses or traumatic events. Over the following 6 to 
8 sessions, patients narrate the most important events of their lives as the therapist takes notes 
and asks questions to facilitate processing. When traumatic events are reached, the pace of 
narration is slowed, and the therapist encourages the patient to describe the event slowly and in 
great detail. The detailed narration of each trauma allows for processing of traumatic material so 
that it can be integrated into the broader life story, and so that it can be contextualized as an 
event that happened at a specific time and place in the past. In the context of social injustice or 
oppression, NET also offers the possibility of integrating other factors known to contribute to 
criminal behavior and/or violence into the broader personal narrative, including poverty 
(Markowitz, 2003), injustice (Beugré, 2005), and racial discrimination (Brody et al, 2006; 

Research Protocol: Narrative Exposure Therapy for Justice-Involved Veterans (VETNET)  
Principal Investigator: Elizabeth Van Voorhees, Ph.D. 
 
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McCord & Ensminger, 2003; Simons, Chen, Stewart, & Brody, 2003).  
As in other forms of exposure therapy, the session does not end until the patient’s 
emotional response has peaked in intensity and the level of distress has begun to diminish. 
During each session, the therapist takes notes on the narration and the account is read back to the 
patient at the beginning of the next session.  After corrections are made, the narration process 
continues until the entire lifeline is complete. The final session involves reconstruction of the 
lifeline, and discussion of hopes for the future. The patient is offered a copy of the written 
narration (Schauer et al., 2011).  
 
FORNET: Trauma and aggression in the context of organized violence 
FORNET was developed as an extension of NET for use with individuals who have both 
experienced and used violence. It is not uncommon for ex-combatants and traumatized violent 
offenders to report that their worst trauma involved harm to others (Hinsberger et al., 2017), and 
the commission of violent acts in war has been found to be associated with distress and 
impairment over and above the effects of PTSD (Dennis et al., 2017). Within the past decade the 
unique psychological sequelae that are associated with harming others in the context of war has 
begun to be studied under the construct of “moral injury” (Litz et al., 2009; Maguen et al., 2017). 
Pointing to the complexity of the relationship between trauma and aggression, there is evidence 
that combat Veterans can come to regard violence as appealing, even as they are traumatized by 
their own violent acts (Weierstall, Castellanos, Neuner, & Elbert, 2013).  
Developed for situations where the victim/perpetrator duality is not clear cut, FORNET 
integrates social learning theory with a theoretical foundation that proposes a hunting network 
that operates in parallel to the fear network (Hecker et al., 2015). Human history is replete with 
examples where hunting behaviors or aggression against other humans has resulted in social and 
evolutionary advantages, and this has resulted in the developed of a reward-driven network 
where violence cues can elicit an approach or attack response (Hecker et al., 2015; Weierstall & 
Elbert, 2011). While the hunting network can include many of these same elements as the fear 
network, the associated affective valence is positive and can be associated with feelings of 
power, control, and self-efficacy. For example, the sight of blood and the feeling of the heart 
racing can be paired with cognitions of “I defeated the enemy” and “I am strong”, and with 
emotions such as exhilaration, fascination, and excitement (Hecker et al., 2015; Weierstall & 
Elbert, 2011). Aggression associated with positive feelings is known in the literature as 
“appetitive aggression” (Weierstall & Elbert, 2011), an experience that in some military circles 
has been referred to as a “combat high” (Grossman, 1995).   
The overlap between the fear and hunting networks in violence-related PTSD can give 
rise to some of the confusion and enduring psychological distress experienced by combat 
Veterans who have used violence in the context of war. Failure to integrate both the fear and the 
hunting network into processing of traumatic events involving harm to others may contribute to 
the higher rate of non-responders to trauma-focused therapy for PTSD among traumatized 
individuals with a history of violence (Stenmark, Guzey, Elbert, & Holen, 2014).  
While over time the hunting network can become dominant as a mechanism of adapting 
to situations of ongoing violence, there appears to be a spectrum of appetitive violence even 
among those who have participated in situations of chronic violence and combat. Consistent with 
the construct of a “cycle of violence”, high levels of appetitive aggression are most common in 
situations of the most severe and unrelenting violence, where ceasing to feel distress at others’ 

Research Protocol: Narrative Exposure Therapy for Justice-Involved Veterans (VETNET)  
Principal Investigator: Elizabeth Van Voorhees, Ph.D. 
 
Protocol, 4/21/2020 
 
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suffering may be self-protective (Weierstall & Elbert, 2011). In many cases, however, tension is 
likely to remain between fear and hunting networks, and the cultural prohibitions against 
harming others are likely to continue to be a part of an individual’s identity.  In such cases, 
PTSD symptoms, moral injury, and other trauma sequelae may be particularly severe. For 
example, in our own research with U.S. Veterans who had been deployed to Iraq or Afghanistan, 
we found that 14% of participants endorsed the item, “I came to realize during the war that I 
enjoyed violence” at a level of “sometimes” or “often”, and that endorsement of this item was 
significantly positively associated with PTSD symptoms, moral injury, suicidality, aggression, 
depression, and trauma-related guilt.   
 
Brief description of FORNET.  
FORNET builds upon NET by nonjudgmentally acknowledging all emotions and 
experiences associated with experiencing and using violence, and by anchoring both the negative 
and positive aspects of these events firmly in the past. It seeks to “deconstruct” the hunting 
network by linking the positive elements of violence to a specific time and context, and by 
reinforcing the association of positive, appetitive emotions to more prosocial or socially 
acceptable activities in the present. FORNET also devotes specific attention to focusing on 
building an identity as a citizen, rather than a “criminal” or an “offender” (Hecker et al., 2015).  
 
Much of the process of FORNET is similar to NET. FORNET begins with 
psychoeducation and building the rationale for the therapy, and patients build a “lifeline” of the 
flow of their lives from birth to the present. In addition to flowers symbolizing positive events 
and stones symbolizing loss or trauma, patients have the option to use sticks to represent 
situations in which they harmed another person. Sticks can be combined with flowers or stones 
to reflect the complexity of these situations. During the narration of events, the therapist helps 
patients to identify their feelings at the time, and to juxtapose those with their current feelings, 
firmly anchoring the events and all associated cognitions and affect in the past. After narration of 
such an event, the therapist can help patients identify the meaning of the events from their 
current point of view (Hecker et al., 2015).  
 
In situations where someone has harmed another person more than once, the first event is 
often critical because it is most likely 1) to have required particular effort to overcome 
neurobiological and cultural aversion to harming others; and 2) to involve particularly salient 
awareness of personal vulnerability that contributed to the ability to overcome those inhibitions 
(Hecker et al., 2015; Weierstall & Elbert, 2011). Attention to these elements of the first event can 
be particularly important in helping individuals make meaning of this experience. At the end of 
each session, the patient and therapist focus on how their understanding of their history can 
inform what they want to make of their future (Hecker et al., 2015).  
The final session focuses specifically on developing perspectives for the future, 
strengthening self-efficacy for engaging in a positive, values-driven life, and identifying positive 
people in patients’ lives who care about their future. The final session also includes asking 
patients to recall a recent prosocial event where they experienced feelings of excitement, power, 
enjoyment, pride, or control, and to recount this in detail. Rather than continuing the story until 
the intensity of the emotion diminishes, however, the therapist stops the narration at the most 
exciting part. This experience is intended to prime the creation of a positive associative network 
with prosocial experiences, and to reinforce the sense that the patient can create positive 
experiences in the future that are aligned with an identity consistent with their values (Hecker et 

Research Protocol: Narrative Exposure Therapy for Justice-Involved Veterans (VETNET)  
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al., 2015).   
 
A New Approach to Trauma Treatment for U.S. Military Veterans: VETNET 
 
Though there is limited research on factors that moderate the success of NET or 
FORNET with traumatized individuals who have used violence against others, the studies that do 
exist suggest that increased political or social stability, and perceptions of personal role change 
from “offender” or “combatant” to a more positive, pro-social community identity, may reduce 
the risk of recidivism (Kobach, Schaal, Hecker, & Elbert, 2017). The idea of integrating 
reparations with self-forgiveness and fostering reconnection with the community is also part of 
treatments for moral injury (i.e. adaptive disclosure; Litz et al, 2009) and is consistent with the 
principles of restorative justice (Latimer, Dowden, & Muise, 2005; Morrison & Ahmed, 2006).  
 
Building upon the foundation of NET and FORNET, we propose to adapt these therapies 
for use with US military Veterans. Specifically, during the lifeline exercise the therapist will 
elicit discussion of what are often life-altering military-related events including military training, 
deployments, and separation from the military. Participants will be offered the option to use 
sticks to symbolize events where they harmed another person. If participants do not indicate that 
they have ever harmed another person, then the NET protocol will be used, though the possibility 
of using FORNET will be kept open if disclosure of harm is made later on in therapy. If 
participants do choose to use sticks in their lifeline, then the therapist will be alert to the 
possibility of needing to address moral injury or appetitive aggression by using adaptations 
specific to the FORNET protocol.   
For all Veterans, whether the NET or FORNET protocol is used, therapists will include in 
the final session a component that will be unique to VETNET and that draws upon elements of 
Acceptance and Commitment Therapy (Hayes, 2004) and Adaptive Disclosure Therapy (Litz et 
al, 2009).  This session will include an invitation to Veterans to consider how they will reconnect 
with their communities in ways that will build upon their strengths. The therapist will work with 
Veterans to identify their values, and how they would best act upon these values to contribute in 
meaningful ways to their communities. Examples could be working at an animal shelter, 
volunteering at a church, joining a Veterans’ service organization, or volunteering for a 
community garden, homeless shelter, or Habitat for Humanity. The therapist will help Veterans 
identify clear behavioral goals for following through on these ideas. The end of the final session 
will also include an evaluation and referral to services the Veteran is eligible for, either within 
the VA or in the community, such as housing assistance, educational assistance, or employment 
training, to continue to support successful reintegration.    
 
 

Research Protocol: Narrative Exposure Therapy for Justice-Involved Veterans (VETNET)  
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Specific Aims 
 
The overall objective of this application is to gather data on the feasibility and acceptability of 
Narrative Exposure Therapy (NET) in a pilot sample of Veterans with PTSD and history of 
anger and aggression. We are also interested in evaluating whether the intervention has the 
potential to have an effect on key clinical outcomes, including PTSD symptoms, suicidality, 
substance abuse, and aggression. 
 
The following Specific Aims have been developed for this project:  
 
Aim 1: Evaluate study feasibility and treatment delivery procedures of Narrative Exposure 
Therapy (NET) in Veterans  with PTSD and history of anger and aggression. Data gathered will 
include recruitment rates, drop-out rates, adverse event frequency and severity, participant 
engagement in treatment, and therapist fidelity.  
 
 
Aim 2: Collect data on appropriateness of assessment measures of key clinical constructs in the 
Veteran population. Clinical outcomes evaluated will include PTSD symptoms, suicidality, 
substance abuse, and aggression.   
 
Methods 
 
Overview of Study Visits 
This pilot feasibility trial will use a randomized controlled design to 1) evaluate and refine the 
treatment access and delivery procedures in a Veteran sample; 2) evaluate and develop 
procedures to ensure therapist fidelity; 3) evaluate the adequacy of outcome measures (i.e. 
distribution of scores, potential ceiling or floor effects); and 4) identify potential reasons for 
treatment adherence and treatment dropout. 
 
Participants will be screened over the phone to determine whether basic inclusion criteria are 
met, after which they will be invited to an in-person screening visit at the laboratory. At the 
laboratory screening and baseline visit, informed consent will be obtained. Veterans who meet 
inclusion criteria will be assigned to NET   
 
Study participation will include a baseline visit, participation in 10 weekly therapy sessions if 
randomized to NET a post-treatment follow-up visit, and completion of 3-month follow-up 
questionnaires by mail.  
 
Participants 
We expect that it will be necessary to complete a total of 29 in-person baseline assessments to 
enroll a final sample of 20 eligible participants. Based on Dr. Van Voorhees’ previous pilot RCT 
enrollment rates, we anticipate 70% of those screened to be eligible for participation. 
  
Table 2. Inclusion/Exclusion Criteria 
Participants must meet all inclusion criteria: 
Participants who meet any one of the 
exclusion criteria will be excluded:               

Research Protocol: Narrative Exposure Therapy for Justice-Involved Veterans (VETNET)  
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 Is a Veteran; 
 Has a history of physical aggression; 
 Meets current criteria for PTSD.  
  
 Currently incarcerated; 
 Current, active psychosis; 
 Is at imminent risk for suicide or 
homicide warranting immediate 
intervention; 
 Substance abuse that is severe enough to 
prevent full engagement in the study 
protocol; 
 Is unable to unwilling to complete study 
procedures. 
  Concurrent trauma-focused 
psychotherapy including Prolonged 
Exposure Therapy (PE), Cognitive 
Processing Therapy (CPT), or EMDR 
 
 
Recruitment 
Potential participants will be recruited through referrals by clinicians who work with Veterans 
with a history of aggressive behaviors, including Lucas Vrbsky, the Incarcerated Veterans 
Reentry Specialist for VISN 6; Courtney Ma’at, the Durham VAMC’s Health Care for Reentry 
Veterans Specialist & Veteran’s Justice Outreach Coordinator; Kathy Williams-Brown, the 
Interpersonal Violence Program Coordinator for the Durham VAMC; and Jeremy Brogden, the 
Veterans Justice Outreach Specialist for the Durham VAMC.  
 
Clinicians working with these Veterans will introduce the study to them, using the attached IRB-
approved clinician card as a guide. Similar to VA consults, a clinician can refer a participant 
directly to our clinic by adding the study PI or study coordinator as a co-signer to a note in CPRS 
in which the clinician has documented that the participant wishes to be contacted about 
participation. If Veterans are interested in participation, they will also be given a business card 
and brochure containing contact information for the study coordinator.  
 
We also plan to use several other recruitment strategies. First, we will use VA Data Access 
Request Tracker (DART) requests to identify Veterans with PTSD who have attended at least 
one appointment in the Veterans Justice Outreach clinic to be mailed invitational letters 
informing them of this study. Second, the Durham VAMC is the primary site for the VISN 6 
Mental Illness Research, Education, and Clinical Center (MIRECC), which focuses on Post-
Deployment Mental Health of OEF/OIF/OND-era Veterans. As of February 2013, over 2,500 
Afghanistan/Iraq era Veterans have participated in the VISN 6 MIRECC’s study, the Study of 
Post-Deployment Mental Health (IRB# 00933). A majority of those Veterans have agreed to be 
re-contacted regarding participation in future research studies regarding post-deployment issues 
as part of their enrollment in the Re-Contact Database of the VISN 6 MIRECC Post-Deployment 
Mental Health Data Repository (IRB# 01706). Application to recruit from the Re-Contact 
Database of the VISN 6 MIRECC Post-Deployment Mental Health Data Repository will be 
made to the VISN 6 MIRECC Director (Dr. John Fairbank) in accordance with IRB and R&D 
approved data repository procedures. Third, Peter Tillman, the Chief of the Health 

Research Protocol: Narrative Exposure Therapy for Justice-Involved Veterans (VETNET)  
Principal Investigator: Elizabeth Van Voorhees, Ph.D. 
 
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Administration Service the Durham VA Health Care System, has compiled a list of Veterans 
who were Other Than Honorably (OTH) discharged from service, and has agreed to share these 
lists with the study team. Veterans with OTH discharge status are at greater risk for suffering 
from psychiatric conditions, are at higher risk for suicide, and are more likely to have a history of 
incarceration than Veterans with honorable discharge status (Elbogen, et al, 2018; Reger et al, 
2015). Veterans identified as having an OTH discharge status are eligible for participation in this 
study. Fourth, we plan to recruit from the Traumatic Stress and Health Laboratory’s “Contact 
Database,” IRB #1080; this database contains information about previous lab study participants 
who have agreed to be contacted about other studies for which they may qualify.  
 
Any potential participant who is identified via a DART request, through the VISN 6 MIRECC 
Repository, via Mr. Tillman’s list, or through the Traumatic Stress and Health Laboratory’s 
“Contact Database” will be sent a recruitment letter that provides basic information about the 
study. The letter will inform Veterans that they will be contacted by phone in the coming days 
regarding their interest in participating in the study. In the letter, potential participants will be 
given an “opt-out” number to call in order to decline participation and/or further contact 
regarding participation. Seven business days after the mailing, Veterans who have not called the 
toll-free number to decline participation will be called by the study coordinator to request their 
participation in the research study.  
 
Study staff members will perform random spot-checks of names and addresses on all letters prior 
to mailing. This will capture any sorting error that may have occurred during the preparatory 
procedures. Any person who contacts the study coordinator for more information about the study 
(whether it be through brochures, word of mouth, etc.) will be informed about the study using the 
IRB-approved telephone screen script. 
 
Additionally, Jeremy Brogden, the Veterans Justice Outreach Specialist for the Durham VA 
Health Care System, receives notifications from the Durham and Pitt County jail staff and from 
mental health providers about Veterans who are in custody in these county jails. He also reviews 
weekly arrest records for Wake County and cross-references these with CPRS to identify 
Veterans in custody in Wake County. Mr. Brogden has agreed to share these lists with the study 
team. We note that VA policy prohibits recruitment of Veterans while they are incarcerated. Our 
study exclusion criteria also indicates that incarceration is an exclusion criterion. However, Mr. 
Brogden has noted that individuals in county custody are often quickly released, frequently 
within 24-hours of his becoming aware of their arrest.   
 
Upon receiving these lists each week from Mr. Brogden, the study coordinator will use the VINE 
system (a publicly available network providing information regarding custody status) to ensure 
Veterans from Mr. Brogden’s lists are no longer incarcerated prior to mailing IRB-approved 
recruitment letters to the Veterans’ home addresses to invite them to participate. Consistent with 
VA policy and with study inclusion/exclusion criteria, Veterans will only be eligible to 
participate after they have been released from custody.  
 
Seed recruitment is suitable for sampling “hidden populations” of participants who are best 
known by their own peers (Heckathorn, 1997).  It includes providing incentives to participants 

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for referral of other eligible participants. In our model, each participant, or seed, will receive 
three coupons to recruit other Veterans in his/her social networks. The recruitment coupons will 
provide a brief description of the survey and a phone number for contacting the study 
coordinator. The coupon will be marked with a unique identification number (not the study 
identification number) so that when the coupons are returned to us, the ID number can be used to 
provide a small payment ($15) to the participant who made the referral. The key connecting the 
participant’s study ID number with the seed ID number will be kept in a database separate from 
other PHI, creating two layers of separation between the seed ID and the already-participating 
Veterans’ identifying information. Any Veteran who does not wish to recruit in this manner will 
not be required to do so. 
 
Informed Consent, Screening and Baseline 
Participants will be pre-screened over the phone to determine whether basic inclusion criteria are 
met. If the participant passes the phone screen, an in-person assessment/baseline visit will be 
scheduled.  
 
At the in-person screening/baseline visit, informed consent with HIPAA authorization will be 
obtained prior to initiation of study procedures.  
 
Screening. 
The following measures will be used to determine eligibility criteria, and to gather baseline 
characteristics of the sample  
 
Demographics Questionnaire – A demographics questionnaire will collect demographic 
information including age, race, education, military history, and history of justice-involvement. 
 
The Traumatic Life Events Questionnaire [TLEQ; (E.S. Kubany et al., 2000)] is a brief self-
report inventory that asks about exposure to 21 kinds of potentially traumatic events from natural 
disasters to sexual abuse. The TLEQ provides a 7-point response format to indicate frequency of 
occurrence. This instrument allows for detailed assessment of trauma exposure prior to military 
service, during military service, and following military service. TLEQ results in trauma exposure 
summary categories of combat, childhood sexual assault, childhood violence, adult sexual 
assault, attack, illness and accident. This measure will be administered at baseline to provide an 
index of the range of trauma exposure in the sample.   
 
The Clinician-Administered PTSD Scale (CAPS) (F. W. Weathers et al., 2013) will be 
administered to evaluate for current PTSD at baseline and at follow-up. To minimize bias in 
outcomes evaluation, the clinician who conducts the therapy may administer the baseline CAPS, 
but will not administer the follow-up CAPS. The CAPS has been extensively used with Veterans, 
and its strong evidence of reliability and validity have established it as the “gold standard” for 
PTSD assessment. PTSD symptoms will be considered present based on the CAPS frequency 
≥1/intensity ≥2 rule (Weathers, Keane, & Davidson, 2001). For Veterans with multiple traumas, 
CAPS administration will be modified as recommended by the authors of Narrative Exposure 
Therapy (Schauer et al., 2011). Specifically, rather that requiring Veterans to choose from among 
multiple events which is the most traumatizing, we will ask Veterans to identify a “type” of 

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trauma (sexual assaults), or a life period during which they experienced multiple traumas (i.e. 
combat deployment), upon which to evaluate their experience of PTSD symptomatology. 
 
The Structured Clinical Interview for DSM-V Disorders Research Version (SCID; (First, 
Williams, Karg, & Spitzer, 2015)) (selected modules) will be administered to assess for active 
psychosis and severe substance abuse.  
 
Diagnostic raters will be trained using SCID and CAPS standardized training, which includes 
review of interview manuals, training videotapes, and co-rating training with an experienced 
rater. Interrater reliability based on videotapes of patient interviews for Axis I diagnoses across 
previous studies has been excellent (kappa = .96).   
 
Baseline measures. 
If a Veteran is determined to meet inclusion criteria and agrees to participate in the study, the 
following baseline assessments will be administered. These assessments will also be 
administered at post-treatment and both mailed follow-ups, unless otherwise indicated. 
 
The Appetitive Aggression Scale (AAS) (Weierstall & Elbert, 2011). This scale has two parts.  
Part 1 is a 17-item scale that asked participants to mark whether they have engaged in or witness 
specific violent acts. Fifteen of these items measure acts that could reflect appetitive aggression 
(e.g. “…made another person scream in pain”), and two are more clearly reactive (e.g. 
“...defended yourself in a fight”). If a participant endorses having engaged in any of the 15 
potentially appetitive aggressive behaviors, then Part 2 will be administered.  Part 2 is a 19-item 
scale that asks participants to rate their perceptions of aggression on a 5-point Likert scale 
ranging from 0 (disagree) to 4 (agree). Part 2 of the scale has been demonstrated to have 
acceptable reliability, and has been shown to measure a construct distinct from other 
conceptualizations of aggression (Weierstall & Elbert, 2011). This scale will only be 
administered at baseline and post-treatment. 
 
Killing Cognitions Scale (KCS) (Maguen et al., 2017) 
The KCS includes 55 items that evaluate several constructs identified as associated with distress 
in Veterans who have killed in the context of war.  It is currently under psychometric evaluation 
by the authors; we have obtained permission to use it for this study from the primary author, 
Shira Maguen. This scale will only be used with participants who endorse having killed in the 
context of war on Part 1 of the Appetitive Aggression Scale (AAS). 
 
PTSD Checklist for the DSM-5 (PCL-5) (Weathers et al., 2013). On the PCL-5, participants first 
report an autobiographical narrative of a trauma, and subsequently rate how bothered they were 
by each symptom (0 [not at all] – 4 [extremely]) for all DSM-V PTSD symptoms within the past 
week. Psychometric testing is currently underway on the newest version of the PCL; previous 
versions have been found to have high reliability and validity across trauma populations.  
 
The Moral Injury Events Scale (MIES) (Nash et al., 2013). The MIES is an 11-item scale that 
measures moral injury associated with experiences during military service.  Statements related to 
distress or feelings of betrayal related to potentially morally injurious events are rated on a 6 

Research Protocol: Narrative Exposure Therapy for Justice-Involved Veterans (VETNET)  
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point scale ranging from 1 (strongly agree) to 6 (strongly disagree). Three factors have been 
identified: Transgressions-Self, Transgressions-Other, and Betrayal. In two samples of Army and 
Air Force personnel, Cronbach’s alphas for the three scales ranged from .79 to .96, and results 
provided evidence of construct validity as well (Bryan et al., 2016).   
 
Revised Conflict Tactics Scales (CTS2) (Straus, Hamby, Boney-McCoy, & Sugarman, 1996). The 
CTS2 includes 78 items measuring the use of psychological and physical attacks by the 
participant, as well as the experience of such attacks. Participants answer how often these 
behaviors were perpetrated against them within a specified time period, as well as how often they 
have perpetrated these aggressive behaviors over that same period: 0 (never); 1 (once); 2 (twice); 
3 (3-5 times); 4 (6-10 times); 5 (11-20 times); 6 (more than 20 times). The original CTS2 
indexed a time period of one year, and was specific to aggression with an intimate partner. 
Consistent with previous studies on Veterans and violence (Beckham et al., 1997), the original 
CTS2 instructions will be modified in 2 ways to more appropriately reflect the goals of this 
study: 1) the target of the behavior will be expanded from “partner” to “anyone”; and 2) the time 
frame of the response will be reduced from one year to three months to detect potential changes 
associated with treatment. The CTS2 includes the following subscales: Negotiation, 
Psychological Aggression, Physical Assault, Sexual Coercion, and Injury. Coefficient alphas for 
the CTS2 subscales range from .07 to .95, with good evidence of construct validity (Straus et al., 
1996). 
 
Dimensions of Anger Reactions (DAR) (Novaco, Swanson, Gonzalez, Gahm, & Reger, 2012). 
The DAR is a 7-item scale measuring the frequency, duration, and behavioral response to anger, 
and anger-related functional impairment on social relationships, health, and work.  It was found 
to have concurrent and discriminant validity, and to correlate highly with measures of functional 
impairment, in a large sample of treatment-seeking soldiers who had served in Iraq or 
Afghanistan. The DAR will be administered at baseline, at each study visit, and at follow-up to 
provide information about the pattern of change in anger- and aggression-related cognitions over 
the course of the intervention. 
 
Trauma-Related Guilt Index (TRGI) (Edward S. Kubany et al., 1996). Guided by appraisal 
theories of emotion, the 32-item TRGI is an index of guilt associated with the experience of 
trauma. Participants rate statements on a 5-point scale ranging from extremely true/extremely 
guilty (4) to not at all true/not guilty at all (0). Factor analyses has revealed four scales: 
Hindsight-Bias/Responsibility, Distress, Violation of Personal Standards, and Lack of 
Justification. Evidence of internal consistency and validity has been found in several samples.      
 
Beck Depression Inventory (BDI-2) (Beck, Steer, & Brown, 1996). The BDI-2 is a 21-item scale 
that evaluates symptoms of depression. It is widely used both clinically and in research, and has 
been found to have high internal consistency (coefficient alpha = .91) with good evidence of 
convergent validity (Dozois, Dobson, & Ahnberg, 1998). 
 
Acquired Capability for Suicide Scale - Fearlessness About Death (ACSS-FAD) (Ribeiro et al., 
2014). The Interpersonal Theory of Suicide holds that the capacity to commit suicide requires a 
sense of fearlessness about death and an elevated pain tolerance, both of which can develop as a 

Research Protocol: Narrative Exposure Therapy for Justice-Involved Veterans (VETNET)  
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result of repeated exposure to horrifying experiences involving pain or death. Such experiences 
are not uncommon in soldiers, theoretically  increasing their risk for suicidal behavior. The 
ACSS-FAD is a 7-item scale that evaluates fearlessness about death. Participants rate each item 
on a scale of 0 (not at all like me) to 4 (very much like me). The scale has been found to have 
good reliability and validity (Ribeiro et al., 2014). 
 
Depressive Symptom Index: Suicidality Subscale (DSI-SS) (Joiner, Pfaff, & Acres, 2002). The 4-
item scale screens for suicidal ideation over the prior two weeks. Participants rate each item on a 
scale of 0 (e.g. “I do not have thoughts of killing myself”) to 3 (e.g. “I always have thoughts of 
killing myself”). Strong evidence of reliability and validity has been observed for this scale 
(Joiner et al., 2002).  
 
Interpersonal Needs Questionnaire (INQ) (Van Orden, Cukrowicz, Witte, & Joiner Jr, 2012). 
Based upon the Interpersonal Theory of Suicide (Joiner Jr et al., 2009), the INQ measures two 
proximal causes of the desire for suicide: Thwarted belongingness and perceived 
burdensomeness. Participants rate each of the 15 items on a scale of 1 (not at all true for me) to 7 
(very true for me). Support for the reliability and validity of these scales has been observed 
across ages and in samples with varying degrees of psychopathology (Van Orden et al., 2012).  
 
The Alcohol Use Disorder Identification Test (AUDIT) (Bradley, Bush, McDonell, Malone, & 
Fihn, 1998) contains 10 multiple choice questions about behavior and symptoms related to 
alcohol consumption. The Drug Abuse Screening Test (DAST) (Skinner, 1982) contains 20 
“yes/no” questions about behavior and symptoms pertaining to substance use.   Both the AUDIT 
and the DAST have shown excellent psychometric properties in studies of Veterans.  
 
Study Visits  
 
Three licensed clinical psychologists who have been trained by some of the original 
developers in Narrative Exposure Therapy will provide therapy in this study. As needed, 
consultation will be provided via telephone or video conferencing by national expert on NET, 
Liz Wieling, Ph.D., and/or by one of the developers of FORNET, Anselm Crombach, Ph.D.  
Participants will attend 10 weekly study visits of 90 minutes each. Session one will 
involve a psychoeducation session wherein the symptoms and etiology of PTSD are explained, 
and the rationale for treatment is provided. Session two will include development of the lifeline, 
during which the participant provides an overview of their life using a rope or string as symbol 
of the passage of time. The participant places flowers along the rope to symbolize positive events 
or relationships, and stones to symbolize negative events or traumas. A key element of VETNET 
is that the therapist will elicit discussion of what are often life-altering military-related events 
including military training, deployments, and separation from the military.  
While creating the lifeline, participants will be offered the option to use sticks to 
symbolize events where they harmed another person. If participants do not indicate that they 
have ever harmed another person, then the adapted NET protocol will be used, though the 
possibility of using FORNET adaptations will be kept open if disclosure of harm is made later on 
in therapy. If participants do choose to use sticks in their lifeline, then the therapist will be alert 
to the possibility of needing to address moral injury or appetitive aggression by using adaptations 
specific to the FORNET protocol.  In sessions three through nine participants will narrate key 

Research Protocol: Narrative Exposure Therapy for Justice-Involved Veterans (VETNET)  
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events in their lives, with specific focus on traumatic events as well as events when they harmed 
another person. During traumatic event narration, therapists will guide participants through 
slowly explaining the details of the event to allow for exposure and processing of previously 
avoided emotions, sensations, and thoughts. Therapists will encourage participants to stay in the 
trauma memory until anxiety, or other strong emotion, has peaked and has begun to subside. 
During narration of perpetration events, therapists will use a similar protocol, and will focus on 
contextualizing the perpetration event and contrasting the memory feelings (what was 
experienced at the time of the event) with the participant’s feelings in the here and now while 
recalling the event. After each session, the therapist will create the written version of the 
narrative, and this will be read to the participant at the beginning of the following session. After 
the participant has made corrections or additions to the narrative, the process will proceed to the 
next critical event. 
For all Veterans, whether the NET or FORNET protocol is used, therapists will include in 
the final session a component that will be unique to VETNET and that draws upon elements of 
Acceptance and Commitment Therapy (Hayes, 2004) and Adaptive Disclosure Therapy (Litz et 
al, 2009).  This session will include an invitation to Veterans to consider how they will reconnect 
with their communities in ways that will build upon their strengths. The therapist will work with 
Veterans to identify their values, and how they would best act upon these to contribute in 
meaningful ways to their communities. Examples could be working at an animal shelter, 
volunteering at a church, joining a Veterans’ service organization, or volunteering for a 
community garden, homeless shelter, or Habitat for Humanity. The therapist will help Veterans 
identify clear behavioral goals for following through on these ideas. The end of the final session 
will also include an evaluation and referral to services the Veteran is eligible for either within the 
VA or in the community such as housing assistance, educational assistance, or employment 
training, to continue to support successful reintegration.     
In the final session, the lifeline will also be recreated. The participant will be invited to 
reflect on the meaning that they attribute to the events, and to develop perspectives for the future. 
The final session also includes asking the patient to recall a recent prosocial event where they 
experienced feelings of excitement, power, enjoyment, pride, or control, and to recount this in 
detail. Rather than continuing the story until the intensity of the emotion diminishes, however, 
the therapist will stop the narration at the most exciting part. This experience is intended to prime 
the creation of a positive associative network with prosocial experiences, and to reinforce the 
sense that the patient can create positive experiences in the future that are aligned with an 
identity consistent with their values.   
To evaluate the change in PTSD symptoms over time, participants will be administered 
the PCL-5 and DAR at each session. 
Participants randomized to TAU will be contacted by phone once each week by the study 
coordinator for a brief check-in and to complete a PCL-5 and DAR. 
 
Post-treatment Follow-up Visits 
In-person follow-up interviews and assessments will be conducted with each Veteran 
participant. Follow-up will occur 1 to 2 weeks after the final therapy session (for completers) or 
11 to 12 weeks after baseline (for those who drop out) to assess changes in PTSD, perceptions of 
moral injury, anger, aggression, trauma-related guilt, depression, substance use, and suicide-
related constructs. For those randomized to TAU, follow-up will occur 11 to 12 weeks after 

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baseline. The CAPS and all baseline assessments will be re-administered. The CAPS will not be 
administered by any of the study therapists.  To assess the degree to which participants trusted 
and felt respected and understood by the therapist, the Helping Alliance Questionnaire (Luborsky 
et al., 1996) will also be administered at the follow-up visit. 
Qualitative interviews following an interview guide will be administered to all 
participants. For those completed treatment, questions will evaluate treatment acceptability, as 
well as participants’ impressions of whether and how the therapy was (or was not) helpful to 
them. For those who dropped out, reasons for dropout at each treatment phase will be explored. 
The qualitative portion of the post-treatment follow-up visit will be audio recorded using the 
Olympus DM-720 4GB Digital Voice Recorder or the Olympus DM-620, which are newer 
models of the approved-for-use Olympus DM-420. Recordings will be transcribed and analyzed 
using thematic analysis. 
 
Three-month Follow-up 
 
Three months after the final treatment session, packets of questionnaires including the 
baseline measures will be mailed along with a self-addressed, stamped return envelope, to 
participants regardless of drop-out status.  
 
 
 
 
Measure 
Screening 
Baseline 
Post-
treatment 
3 months 
Demographics Questionnaire 
X 
 
 
 
The Traumatic Life Events 
Questionnaire 
X 
 
 
 
The Clinician-Administered 
PTSD Scale 
X 
 
X 
 
The Structured Clinical 
Interview for DSM-V 
(Psychosis, Substance Misuse 
Modules)  
X 
 
 
 
The Appetitive Aggression 
Scale 
 
X 
X 
 
The Killing Cognitions Scale* 
 
X 
X 
 
PTSD Checklist for the DSM-5 
(PCL-5)**  
 
X 
X 
X 
The Moral Injury Events Scale 
 
X 
X 
X 
Revised Conflict Tactics Scales 
 
X 
X 
X 
Dimensions of Anger Reactions 
 
X 
X 
X 
Trauma-Related Guilt Index 
 
X 
X 
X 
Beck Depression Inventory 
 
X 
X 
X 

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Protocol, 4/21/2020 
 
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Acquired Capability for Suicide 
Scale - Fearlessness About 
Death 
 
X 
X 
X 
Depressive Symptom Index: 
Suicidality Subscale 
 
X 
X 
X 
Interpersonal Needs 
Questionnaire 
 
X 
X 
X 
The Alcohol Use Disorder 
Identification Test 
 
X 
X 
X 
The Drug Abuse Screening Test 
 
X 
X 
X 
The Helping Alliance 
Questionnaire 
 
 
X 
 
 
 
 
 
 
* The Killing Cognitions Scale will only be administered if participants endorse having killed in the 
context of war on Part 1 of the Appetitive Aggression Scale. 
** To evaluate the change in PTSD symptoms over time, participants will be administered the PCL-5 at 
each session. 
 
Evaluation of Specific Aims 
Specific Aim 1.  Evaluate study feasibility and treatment delivery procedures of Narrative 
Exposure Therapy (NET) in with a history of aggression and  PTSD. Data gathered will include 
recruitment rates, drop-out rates, adverse event frequency and severity, participant engagement 
in treatment, and therapist fidelity. 
 
To evaluate recruitment rates, we will track the number of Veterans who complete the in-
person screening.. To evaluate retention rates, we will consider retention rates > 80% to be 
successful.  Retention will be defined as completing at least 7 of 10 sessions, with the last 
sessions being a mutually-agreed upon final session. Retention strategies will include: 1) 
reminder calls, texts, and/or emails 24 hours prior to each study visit; 2) asking each participant 
at the end of each session about his or her intent to attend the next session; and 3) small 
appreciation gifts (e.g., pens, magnetized note pads, and thermoses). The second technique has 
been used successfully in previous clinical trials, and also provides information for assessing the 
assumption of ignorable attrition required for mixed effects analyses (Leon, Demirtas, & 
Hedeker, 2007).  The third technique has proven extremely helpful in recent longitudinal studies, 
resulting in high retention rates (Elliott et al., 2015; Cook et al., 2015; Kimbrel, Meyer et al., 
manuscript in preparation; Kimbrel, Flynn et al., 2015). For those participants who drop out of 
treatment, we will 1) attempt to contact them to offer compensation for participation in the 
qualitative interview regarding their reasons for withdrawal and in the post-treatment 
assessments; and 2) encourage them to complete subsequent study assessments. Qualitative 
interviews will be audio recorded, and analyses will help identify ways that the intervention can 
be further tailored to reduce dropout and to meet the needs of justice-involved Veterans. 
To facilitate therapist fidelity, consultation will be provided via telephone or video 
conferencing by national expert on NET, Liz Wieling, Ph.D, and/or by one of the developers of 
the NET adaptation for traumas involving harm to others, Anselm Crombach, Ph.D. Study 
therapists will evaluate treatment fidelity after every session using checklists specifically 

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developed for NET. This checklist will be adapted to maximize effectiveness in future trials over 
the course of this pilot. 
To evaluate participant retention through the 3 month assessment, we will consider the 
larger RCT feasible if 70% of Veterans complete the 3 month assessment. As recommended by 
Wisniewski and colleagues (Wisniewski, Leon, Otto, & Trivedi, 2006), we will maintain 
frequent participant contact throughout the evaluation period. For example, we will make 
intermittent phone calls to participants to check on their status, and send birthday and holiday 
cards to encourage a sense of community and ownership of the study.  
Adverse event monitoring is discussed in detail in the Human Subjects section of this 
proposal. Though we do not anticipate adverse events to be frequent or severe, if we observe a 
problem with adverse events we will build precautions into the structure of the treatment 
protocol and the study design. 
 
Specific Aim 2. Collect data on appropriateness of assessment measures for measuring key 
clinical constructs in Veterans with a history of aggression. Clinical outcomes evaluated will 
include PTSD symptoms, suicidality, substance abuse, and aggression.   
Change scores from baseline to 3 months post-baseline on the CAPS and on measures of 
PTSD symptom severity, perceptions of moral injury, anger, aggression, trauma-related guilt, 
depression, substance use, and suicide-related constructs will be calculated using the measures 
listed in the baseline section above. Measures will be evaluated for acceptable variability, and for 
absence of floor or ceiling effects in this sample. 
 
Participant Payment  
Veterans will receive $70 at screening baseline, $10 at each study visit for completion of 
assessment measure (PCL-5), and $80 at end-of-study follow-up. They will receive $35 for 
completing and returning 3-month follow-up questionnaires.  Total possible compensation for 
full study participation will be $330. 
 
For those study visits that occur in the research laboratory, participants in both arms may be 
provided with local bus passes in order to facilitate transportation. 
 
Risk/Benefit Analyses 
With regards to completing study measures, there is a risk of discomfort or distress in answering 
questions, especially questions related to traumatic experiences and PTSD symptomatology. 
There is also a risk of discomfort or distress during narration of traumatic experiences during 
therapy sessions. However, distress and discomfort related to questionnaire completion are 
usually temporary and well-tolerated. Distress associated with narrating traumatic events is not 
uncommon, but it is also usually temporary and well-tolerated, and the therapy protocol requires 
that the distress level be diminished before the end of each therapy session. There is a potential 
risk associated with the loss of confidentiality of study data.   
 
Protection Against Risk 
Participants are informed clearly during the initial informed consent process that the study is 
completely voluntary, and that they may refuse to answer any items that they do not wish to 
answer on the questionnaires and interviews. They are also informed that they are free to decline 

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participation in any procedure and can withdraw from the study at any time.  
 
Please see “Privacy, Confidentiality, and Information Security” section for more detailed 
information regarding protections related to storage of electronic and hard data. To ensure 
confidentiality, all records will be identified by the participant’s identification number, not by 
name. All raw hard copy data will be kept in a locked file cabinet in a locked room. Data files 
will be stored in a limited access folder on a secure server to which only study staff members 
have access.  
 
Protections Related to Undue Influence 
 With regards to participant payments, careful consideration has been given to the risk of undue 
financial influence. Veteran participants can earn up to $330 for full participation. We believe 
that the payments proposed are commensurate with the participant burden in this study. 
Screening, therapy visits, and follow-up procedures are lengthy, and given that the catchment 
area for our facility is quite large, it is not unlikely that any employed participants will need to 
take an entire day off in order to travel to the VA and complete the study procedures. It is 
necessary to provide financial incentive for them to participate because the study does not 
guarantee personal benefits from participation. We believe that the payments proposed are 
appropriate given the time and effort being asked of the participants.  
 
Data Safety and Monitoring Plan 
The individuals responsible for data safety and monitoring will be Elizabeth Van Voorhees (PI) 
and the study coordinator. Mechanisms for monitoring and reporting of data safety and adverse 
events (AEs) will include ongoing participant contact via study personnel, to include check-ins 
about any adverse events, and weekly meetings between the PI and study personnel.  
 
The PI will meet at least weekly with study personnel to discuss enrollment, participation, and 
any adverse events or unanticipated problems. Regular meetings between investigators, 
therapists and the project manager will allow for ongoing progress reports, including the number 
of participants currently involved in the study, attrition rates, and scheduled data collection from 
participants, as well as notification and review of any AEs. Safety monitoring for AEs will be 
conducted in real time by the PI and/or study coordinator. The following information about 
adverse events will be collected: 1) the onset and resolution of the AE, 2) an assessment of the 
severity or intensity (use existing grading scales whenever possible), 3) an assessment of the 
relationship of the event to the study (definitely, probably, possibly or not related), and 4) action 
taken (e.g., none, referral to physician, start or increase concomitant medication). The PI will 
determine the severity of the event, will assign attribution to the event, and will monitor the 
event until its resolution.  
 
Any adverse events will be reported to the IRB in accordance with local guidelines. We will 
follow established laboratory procedures for reviewing events to determine if they meet criteria 
for reporting as an AE or SAE. In particular, we will pay close attention to any reports from 
participants regarding suicidal or homicidal ideation, or increases in aggression or mood 
dysregulation. Any such reports will be reported as required by our local Human Research 
Protection Program’s research reporting Standards of Practice (SOP). 

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Based on the study team’s long-term clinical and research experience with patients with high risk 
psychiatric disorders such as PTSD, depression, and anxiety disorders, we have developed IRB-
approved standards of practice for psychiatric emergencies. These standards have been used for 
several years. It is not unexpected that participants will experience increased distress associated 
with the assessment procedures and diagnostic clinical interviews. Our extensive clinical and 
research experience suggest that there is no serious risk in these patients associated with 
assessment and interview procedures as proposed. Over the past several years, several hundred 
patients with psychiatric diagnoses have participated in our research team’s clinical trials at 
DVAMC, and there have been only rare occurrences of serious adverse events (i.e., 
hospitalization only) due to temporary psychiatric symptom increases. For more information 
regarding our standards of practice, please see section “Psychiatric Emergencies” below.  
 
Psychiatric Emergencies 
The Traumatic Stress and Health Research Lab has established IRB-approved standards of 
practice (SOP) for the evaluation of risk of suicide and homicide. All study staff members are 
trained in use of the psychiatric emergencies SOP by a Ph.D. or Masters’ level clinician with 
years of experience in working with persons with psychiatric disorders. The SOP includes a 
thorough risk assessment including evaluation of risk factors and protective factors associated 
with both suicide and homicide. Also included in the policy are differential recommendations for 
action based on determinations of low, moderate, or high risk. Any staff member conducting an 
interview in which moderate or high risk is determined will contact a senior staff person with 
clinical expertise in risk assessment (including the PI, co-investigator(s), and/or DVAMC’s 
Psychiatric Emergency Clinic or the Emergency Department).  
 
At several time points throughout the study, participants are reminded that they are asked to 
inform the study therapist, study coordinator, or study PI if they experience a psychiatric 
emergency such as homicidal or suicidal ideation. In addition, participants are provided the 
telephone number of study staff who they can call in the case of psychiatric emergencies, 
including an after-hours contact number.  
 
COVID-19 Temporary Study Procedures 
Participants who are ongoing at the time of the COVID-19 crisis will complete therapy and 
follow-up visits via phone and/or other approved telehealth platforms. Questionnaires will be 
completed by mail, orally, and/or MyHealthyVet. If enrollment continues during the COVID-19 
crisis, study procedures will be completed in the same manner. The consent process will take 
place by mail and phone.  
 
Safety Concerns. Study therapists will be informed that prior to beginning therapy by telephone 
or telehealth platform, participants will need to identify an emergency contact for the participant 
to be used only in true emergencies (e.g., medical crisis, high risk suicidal ideation). Second, 
therapists will be asked to confirm the participant’s location at the start of every appointment 
(the exact address is ideal) in case they need to contact local emergency personnel in the case of 
a psychiatric or medical emergency. If any participant expresses suicidal or homicidal ideation 
(SI and HI, respectively), study staff will respond using a standard of practice that has been used 

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successfully in our lab’s past telehealth-based trials. The study staff member responsible for the 
call will be instructed to gather more information from the participant, including information 
about plan, means, intent, intended victim (in the case of HI) and history of suicidal and 
homicidal behavior. Any participant who expressed SI will be provided with the suicide hotline 
number. The participant will be informed that the PI may contact him/her to talk more about 
his/her SI or HI. The study coordinator will obtain current contact information for the participant 
and inform the PI, who will contact the participant as necessary to ensure participant safety. In 
cases of imminent homicidality or suicidality, which are not anticipated, we will seek guidance 
from the Psychiatric Emergency Clinic on best strategies for follow-up, which could include, but 
is not limited to, self-presentation at the VA’s emergency room with the help of an emergency 
contact, calling 911, or calling local police for a wellness check.  
 
Post-Study Referrals for Participants 
At completion of the post-treatment assessment, the study therapist will discuss referrals for 
further treatment or services with the participant. TSHRL has developed patient educational 
materials regarding available resources, including portable resource cards for Veteran 
participants. Veteran resources include peer support, local Vet Centers, and information about 
treatments available at various clinics at the DVAMC and local VA community-based outpatient 
clinics, including the PTSD Clinic, Mental Health Clinic, Mental Health Access Clinic, 
Psychiatric Emergency Clinic, and Women’s Health Clinic. In addition, we provide information 
about non-Veteran specific resources such as local community mental health centers, local 
private mental health providers, and the treatment clinics at nearby Duke University Medical 
Clinic. Where applicable and convenient to the participant, direct referral will be made in 
addition to providing resource cards. 
 
 
Privacy, Confidentiality and Information Security 
 
1. Lists of Data Reviewed and/or Collected for Screening/Recruitment and Conduction of 
Study:  
The Personal Health Information that will be obtained, used, and/or shared for this study 
includes:   
Identifier(s) 
Source(s) of Health Information 
 Names 
 Medical history & physical exam 
information 
 All geographic subdivisions smaller than a 
State, including street address, city, county, 
precinct, and zip code.  Describe: For the 
purposes of recruitment, potential participants’ 
mailing address will be used to mail 
introductory letters. Participants’ address will 
be used to request payment from VA Financial 
Services.  
 Photographs, videotapes, audiotapes, or 
digital or other images 
 All elements of dates (except year) for dates 
directly related to an individual, including birth 
 Biologic specimens (e.g., blood, tissue, 
urine, saliva). Describe: 

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Identifier(s) 
Source(s) of Health Information 
date, admission date, discharge date, visit or 
treatment dates, etc.; and all ages over 89,  
Describe: Dates of study visits, dates of mental 
health treatment, & date of study consent will 
be obtained and stored. Date of study visits will 
be shared with VA Financial Services in order 
to pay participants for study participation.   
 Telephone numbers 
 Progress notes 
 Fax numbers 
 Diagnostic / Laboratory test results 
 Electronic mail addresses 
 Operative reports 
 Social Security Numbers 
 Imaging (x-ray, CT, MRI, etc.) 
 Medical record numbers 
 Discharge summaries 
 Health plan beneficiary numbers 
 Survey / Questionnaire responses 
 Account numbers 
 Billing records 
 Certificate and/or license numbers  
 HIV testing or infection records 
 Vehicle identifiers and serial numbers, 
including license plate numbers  
 Sickle cell anemia information 
 Device identifiers and serial numbers 
 Alcoholism or alcohol use information 
 Web Universal Resource Locators (URLs) 
 Drug abuse information 
 Internet Protocol (IP) address numbers 
 Mental health (not psychotherapy) notes 
 Biometric identifiers, including finger & 
voice prints 
 Psychological test results 
 Full-face photographic images and any 
comparable images 
 Genetic testing 
 Any other unique identifying number, 
linked study ID, characteristic, or code, 
describe:  Study ID numbers 
 Other, describe:        
 
2. Data and/or Specimen Acquisition:   
Data for this study will be collected through (check all that apply): 
 
  Prospective data and/or specimen collection obtained from participants.  Provide description 
of processes:  Data will be obtained through standardized interviews regarding psychiatric 
symptoms, self-report questionnaires, and through qualitative interviews. Data are acquired at 14 
time points (baseline, each treatment session (10 time points), post-treatment, 3 months, and 6 
months).  
 
  Retrospective data collection and/or specimens obtained from medical chart review/data 
access.  Describe how data will be obtained (e.g., fileman, CDW, etc.):  n/a. 
 
  Retrospective data collection and/or specimens obtained from an IRB-approved data and/or 
specimen repository.  Indicate the repository source including name, VA location, and IRB 
number:  n/a. 
 

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Note:  for data and/or specimens obtained from a VA approved data repository, a Data Use 
Agreement (DUA) must be executed prior to obtaining data and/or specimens.  See VHA 
Handbook 1200.12 for further information. 
 
3. Level of Data:   
The following level(s) of data will be acquired/maintained for this study (check all that apply): 
 
  Identified (e.g., names, addresses or other identifiers included)  
  Coded (direct and/or all identifiers removed, but study code/ID included)  
  De-Identified (all HIPAA 18 and study ID/code removed): 
  Verified Statistically  
 
OR 
  Verified by Absence or Removal of HIPAA 18 and study ID  
  Limited Data Set 
  Other: Describe:        
 
4. Location of Data and/or Specimens, and Data Retention Plan:   
Data and/or Specimen Location: Data will be stored electronically in 
\\v06.med.va.gov\dur\Research \Nicotine Research\Study Information\Study 
Logbooks\JIV_NET; \\v06.med.va.gov\dur\Research \Nicotine Research\Study 
Information\Study Databases\ JIV_NET; and \\v06.med.va.gov\dur\Research Nicotine 
Research\Study Information\Study Logbooks\JIV_NET\Qualitative Recordings. Data that will be 
stored electronically include name, address, phone number, social security number, amount of 
study payment earned, and dates of visits (in Study Logbooks location). The study logbook will 
contain the key connecting PHI and the study identification number. The qualitative recordings 
will include audio recordings of qualitative interviews with Veterans about their experience with 
the VETNET therapy. Questionnaire data and interview results will be coded and stored in the 
“Study Databases” location listed above.  Paper records of data include study consent form and 
HIPAA authorization (identified) and self-report questionnaires and interview results (coded).   
 
  Data will be also be placed at the VA Informatics and Computing Interface (VINCI; 
http://vaww.vinci.med.va.gov/vincicentral/VINCIWorkspace.aspx). The VA Informatics and 
Computing Infrastructure is a partnership between the VA Office of Information Technology and 
the Veterans’ Health Administration Office of Research and Development.  Researchers and 
operations staff can use VINCI to access data and statistical analysis tools in a virtual working 
environment through a certified VHA network computer using the VA Intranet or Virtual Private 
Network (VPN).  
 
B. Data Retention Plan 
 Research records will be maintained and destroyed according to the National Archives and 
Records Administration, Records Schedule Number:  DAA-0015-2015-0004.  Records 
destruction, when authorized, will be accomplished using the then current requirements for the 
secure disposal of paper and electronic records.  Currently, destruction of research records (see 
DAA-0015-2015-0004, section 7.6 “Research Investigator Files” for materials included in 
research records) is scheduled for 6 years after the cut-off (the cut-off is the completion of the 

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research project) and may be retained longer if required by other federal agencies.  Records will 
not be destroyed without pre-notification to the facility records manager.   
 
  Other data retention plan, describe:        
 
5. Data Access and Data Recipients:   
Only members of our DVAMC research team will have access to identifiers and coded data. In 
order for data analysis to occur using SAS software (see “Data Analyses” below), a coded 
dataset will be sent to VINCI for analysis using VA-owned data analysis software (SAS). In the 
event that appropriate SAS modules for analysis are not available through VINCI, coded data 
will be moved to Duke University Medical Center for analysis. Any data movement outside the 
protected VA environment will be accomplished using a VA-issued and owned FIPS-140-2 
encrypted thumb drive loaned to a VA study staff member or via FIPS-140-2 encrypted DVD. 
Data will be stored at Duke on a protected server to which only Dr. Van Voorhees and her study 
staff have access; data are encrypted at rest.  
 
All VA research personnel who have access to VHA records are instructed, in accordance with 
VA policy, on the requirements of Federal privacy and information laws and regulations, VA 
regulations and policies, and VHA policy. All study personnel who are VA employees working 
within the VA system have fulfilled all required HIPAA and other VA security and privacy 
policy training requirements and have agreed to follow guidelines pertaining to the protection of 
patient data. All research staff sign VA Rules of Behavior, and all study staff are up-to-date with 
VHA Privacy Policy Training and the VA Office of Cyber and Information Security Awareness 
Training Course. The data security and privacy procedures summarized in that course include 
logging off or locking the computer when walking away from it; no sharing of access codes, 
verify codes or passwords; not allowing anyone else to use the computer under one’s password; 
and disposing of sensitive information using VA-approved methods (e.g., shredder bins). Access 
to study data will be removed for all study personnel when they are no longer part of the research 
team.  
 
6. Data and/or Specimen Transportation and/or Transmission for all data and/or 
specimens involved in the study:   
I. 
   Data and/or specimens will not be transported or transmitted outside of Durham 
VAMC environment. n/a 
 
II. 
  Data and/or specimens will be transported BETWEEN sites that are under the 
auspices of the Durham VA Medical Center.  n/a 
 
 
III. 
   Data and/or specimens will be transmitted to other VA sites using the following 
method(s): n/a 
 
A. Data 
  Data are de-identified and thus will be sent via unencrypted e-mail or 
unencrypted disk (encryption is optional). 

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  Data are coded or contain identifiers and thus will be sent 
  Other, describe:  
      
 
B. Specimens 
  Specimens are de-identified and thus will be sent via standard carrier (tracking is 
optional). 
  Specimens are coded or contain identifiers and thus will be sent via VA-
authorized carrier with tracking.   
  Other, describe:        
 
IV. 
  Data and/or specimens will be transported to non-VA/VHA sites (e.g., academic 
affiliates, laboratories, etc.) using the following method(s): 
 
A. Data 
  Data are de-identified and thus will be sent via unencrypted e-mail or 
unencrypted CD. 
 Data are coded or contain identifiers and thus will be sent via a VA-issued and 
owned FIPS-140-2 encrypted flash drive loaned to a VA study staff member or via 
FIPS-140-2 encrypted DVD. If any carrier is used to transfer data, we will use a VA-
approved carrier with tracking.  
 
  Data are coded or identified and will be sent via the Safe Access File Exchange 
(SAFE) at https://safe.amrdec.army.mil/safe/.  SAFE is a secure method of 
exchanging files <2GB to and from individuals with a valid .gov, .mil, .com, or .edu 
email address. <insert information including collaborator name. 
  Data are coded or identified and will be uploaded to sponsor website using 
electronic case report form (eCRF)  
 Other, describe:       
 
B. Specimens  
  Specimens are de-identified and thus will be sent via standard carrier (tracking is 
optional) or will be hand-delivered by research study personnel.  Specify method of 
delivery:        
  Specimens are coded and thus will be sent via VA-approved carrier with tracking 
or will be hand-delivered by research study personnel.  Specify method of delivery:  
      
 
In accordance with the HIPAA and the Privacy Act, for any coded or identifiable data released 
from the Durham VAMC (with the exception of Limited Data Sets), an Accounting of 
Disclosure (AOD) will be maintained (e.g., in a database or spreadsheet) that includes the 
participant’s name, date of the disclosure, description of the nature of the Individually 
Identifiable Information (III) disclosed, purpose of each disclosure, and the name and address of 
the person/agency to whom the disclosure was made.  

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C.      
 Local DVAMC memorandum “Authorization to Use, Process, Store, or 
Transmit VA Sensitive Information Outside VA Owned or Managed Facilities” has been 
pre-filled out for each study team member who may transport the data and/or specimens 
off-site.  This (these) forms are included with the IRB materials.   
 
D. 
  Containers (e.g., briefcase, bin) are labeled with the following notice (label placed 
on the outside of container) in accordance with VHA Directive 6609: 
NOTICE!!! 
Access to these records is limited to: AUTHORIZED PERSONS ONLY. 
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. Anyone who 
discloses information in violation of the above provisions may subject to civil and 
criminal penalties. 
 
V. 
  We will communicate with Veterans enrolled as participants in this research study 
through MyHealtheVet.    
 
 
 
7. Risk Mitigation Strategies:   
  Data are fully de-identified (stripped of HIPAA 18 and study ID/code) before being shared 
outside of Durham VAMC. 
 
  Specimens are fully de-identified (stripped of HIPAA 18 and study ID/code before being 
shared outside of Durham VAMC. 
 
  Direct identifiers will be maintained separately from data and or specimens by using a code 
to “identify” subjects.  In a separate database (i.e., a “linking” or “cross-walk” database) this 
code will be linked to identifying subject information.  Persons responsible for overseeing the 
privacy and security of the study data are the PI, regulatory coordinator, study coordinator, and 
statistician. See “Protections Against Risk” herein for additional data protections.  
  Other, specify:        
 
8. Suspected Loss of VA Information: 
Should any incident such as theft or loss of data, unauthorized access of sensitive data or non-
compliance with security controls occur it will be immediately reported according to VA policy. 
All incidents regarding information security/privacy incidents will be reported to the ISO and PO 
within 1 hour of acknowledgement of issue and done so using the VHADUR Research Events 
Report e-mail group (VHADURResearchEventReport@va.gov). 
 

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9. Reporting of Results:   
   Reporting of results, such as in scientific papers and presentations, will never identify 
individual subjects.  Data will be presented in aggregate and individual-level data will not be 
published. 
 
  Other results reporting plan, describe:       
 
10. Future Use of Data: 
  Data will be retained for future use.  This is described elsewhere in the protocol and is noted 
in the HIPAA authorization. 
 
  Future Use of data is optional (i.e., not required by the research subject). 
  Future Use of data is required for participation in the study. 
 
  No future use of data is currently planned. 
 
11. Use of Mail Merge Technology 
   Mail merge programs will be used to generate letters and/or address labels for mailings to 
potential or already enrolled research subjects.  The study team is aware that to reduce risk of 
mail merge related privacy incidents, use of mail merge programs requires a 25% accuracy check 
to verify that (potential) research subject name and mailing address are properly “matched”.  If 
discrepancies are found, a 100% accuracy check is required before letters may be mailed.   
 
12. Use of Non-Standard Software 
 I do NOT intend to use any new specialized software (i.e. Software that’s not already 
approved OR installed) in this study. 
 
 I intend to use specialized software that has not already been installed and it has been 
approved for use by the VA Technical Reference Model (TRM) Group.  
(Note: All new software must be approved by TRM before it can be installed on VA systems.) 
 
 I intend to use previously installed software on my VA computer.  
 
13. Use of Cloud Computing Services 
 Cloud computing services will NOT be used in this study. 
 
 Cloud computing services WILL be used in this study as described below and have been 
approved nationally by the VA Chief Information Officer (CIO).  (Note: ONLY cloud computing 
services that have been approved nationally may be used.) 
 
 
 

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