Treatment of Trauma-Related Anger in OEF/OIF/OND Veterans
Phase: NA
Conditions: Anger Problems
Sponsor: VA Office of Research and Development

 
 
 
 
 
 
 
 
 
 
 
 
 
Treatment of Trauma-Related Anger in OEF/OIF/OND Veterans 
 
 
NCT02157779 
 
 
Study Protocol 
 
 
Version 11/28/18  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

1 
 
 
 
 
 
 
Principal Investigator: Tracie Shea, Ph.D. 
 
Department: Mental Health and Behavioral Sciences Service (MHBSS) 
 
Study Title: Treatment of Trauma-Related Anger in OEF/OIF/OND Veterans 
Funding Source (Sponsor): VA RR&D 
Full Protocol Version Date: 11/28/18 
 
Key Personnel: 
 
Tracie Shea, Ph.D.  
Staff Psychologist VAMC 
Professor 
Department of Psychiatry and 
Human Behavior, Brown University 
Jennifer Lambert, 
Ph.D. PTSD Clinic 
Acting Chief VAMC 
Clinical Assistant Professor 
Department of Psychiatry and 
Human Behavior, Brown University 
 
 
 
 
 
 
 
 
 
 
 
Location of Study: 
All assessment and intervention sessions will be conducted at the Veterans Affairs Medical Center 
in Providence, Rhode Island. 
Time Required to Complete the Research: 
The project start date is 08/01/2014 and the study will continue until 07/31/2018. 
Department of Veterans Affairs Internal Review Board 
Research Protocol 
Content Requirements for Full Committee Review 

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1. Purpose 
Building on findings from our randomized pilot study, the specific aim of the current 
proposal is to conduct an adequately powered randomized clinical trial designed to test 
the effectiveness of a manualized cognitive behavioral intervention (CBI) for the 
treatment of anger problems in OEF/OIF/OND veterans, compared to a manualized 
supportive therapy intervention (SI) control condition. Our study will expand on 
preliminary evidence of the efficacy of this intervention in improving multiple measures 
of anger outcome including risk for impairment in family, social, and occupational 
functioning. The study will supplement current research on anger problems in combat-
exposed veterans, which has focused primarily on Vietnam Veteran samples and has 
been conducted decades after return from the war-zone. The longer term significance of 
this project lies in the potential for adapting the CBI anger intervention for use in VA 
hospitals nationwide. Future dissemination of this approach can result in high public 
health significance by decreasing adverse anger consequences for Veterans, including 
risk for divorce, domestic violence, job loss and instability. 
 
The overall objective is to conduct a randomized clinical trial with 120 Veterans who 
were exposed to one or more DSM-5 criterion A traumatic events during their 
deployment. We will address the following specific aims and hypotheses: 
 
(1) To investigate the efficacy of CBI on primary measures of anger 
treatment outcome. We hypothesize that: 
a) Compared to SI, CBI will be associated with significantly larger reductions 
in anger and aggressive behaviors at post-treatment and at 3 and 6 month 
follow-ups. 
 
(2) To investigate the efficacy of CBI on secondary measures of anger 
treatment outcome. We hypothesize that: 
a) Compared to SI, CBI will be associated with significantly more 
improvement in social functioning, occupational functioning, quality of 
life, and PTSD symptoms at post-treatment and at 3 and 6 month follow-
ups. 
 
(3) To examine mechanisms of action of CBI. We hypothesize that: 
a) Change in arousal, cognitive, and behavioral domains of anger will 
mediate outcome for anger and functioning in the CBI condition. 
 
(4) To examine the effectiveness of CBI for those with and without PTSD. 
We hypothesize that: 
a) CBI will be superior to SI on primary and secondary outcome measures 
(aims 1 and 2) for those with and without PTSD. 
 
2. Background, Significance, and Rationale 
Anger Problems in Military Personnel and Veterans: Poorly controlled anger is a common 

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problem with often devastating effects in veterans who have served in a warzone. As 
early as World War II, anger and aggression were identified as common responses to 
combat stress 1, 2, and the association between combat experience and symptoms of 
anger and hostility has repeatedly been demonstrated in empirical research 3, 4, 5. 
Findings from the National Vietnam Veterans Readjustment Survey4 showed that 
Vietnam veterans exposed to high levels of war stress expressed higher levels of hostility 
and committed more violent acts compared to Vietnam era (non theatre) veterans, 
civilians, and theatre veterans exposed to lower levels of war stress. Excessive anger and 
difficulty managing anger were also shown to increase risk for divorce, domestic 
violence, job loss and instability, and other serious impairments in family, social, and 
occupational functioning 4. 
 
Anger problems have also been documented in veterans who served in the first Gulf war, 
with up to 40% reporting moderate to extreme levels of irritability at a six-month follow- 
up 6. Most relevant to the proposed study, emerging evidence indicates that anger and 
aggression are likely to be problems for a significant proportion of veterans of Iraq 
(Operation Iraqi Freedom, OIF; Operation New Dawn, OND) and Afghanistan (Operation 
Enduring Freedom, OEF). Our data (described in preliminary studies) show that nearly 
half of National Guard and Reserve personnel reported anger or irritability of moderate 
or worse severity following return from deployment. A survey of reintegration problems 
among 754 OEF/OIF combat veterans receiving VA Medical care, showed that anger was 
the most commonly reported problem, with 57% reporting increased problems in 
controlling anger 7. In a sample comprised of 117 OEF and OIF combat veterans 
presenting to a VA Deployment Health Clinic, 39% reported at least one act of 
aggression such as destroying property (15%), threatening physical violence (21%) 
and/or physical fights (10%) within the past four months 8. 
 
Anger and aggression are strongly associated with PTSD 9, 10, and rates of anger problems 
tend to be higher in trauma-exposed veterans with PTSD compared to those without 4, 11. 
Nonetheless, serious anger problems are also elevated in trauma exposed veterans 
without a diagnosis of PTSD 4, 8, 12. Anger has also been shown to predict the 
development of PTSD13, 14, 15 across a variety of trauma populations, and among those 
with PTSD, anger is associated with poorer treatment outcome 16, 17. Finally, anger is a 
prominent concern for veterans seeking treatment 18, 19, and for their partners 18. 
 
Treatments for Anger Problems: There is a considerable amount of evidence supporting   
the effects of cognitive-behavioral treatment (CBT) of anger, and several meta-analyses 
summarizing this research 20, 21, 22, 23, 24. Beck & Fernandez21 completed a meta-analysis of 
studies that used cognitive-behavioral interventions. They reported a mean weighted 
effect size of .70 based on 50 studies incorporating 1640 participants. The studies 
included a   wide range of populations, with the majority including children or 
adolescents (50%), inmates (14%), and college students (14%). In addition to the 
heterogeneous samples, limitation of this meta-analysis is that effect sizes from studies 
using between-and within group designs were pooled. DiGiuseppe and Tafrate22 
conducted a meta-analysis of 57 studies of adult samples examining a range of 
intervention types for treating anger problems in adults. Although the types of sample 

4 
 
included were not described, the reference list suggests a high proportion of studies with 
cardiac or hypertensive samples, abusive parents, inmates, and college students. The 
majority of intervention types would be considered CBT approaches (e.g. stress 
inoculation training, cognitive restructuring, 
relaxation, systematic desensitization, behavioral skills training, and combined 
approaches). They reported an overall effect size of .71 averaged across a wide range of 
outcomes, with moderate to large improvements on anger self-report, aggressive 
behavior, positive non-angry behaviors, attitudes and cognitions, type- A behavior, and 
physiological measures. Average effect sizes were .71 for anger and 1.12 for aggression, 
and treatment gains were maintained at follow-up for the subset of studies including 
follow-up assessments. They also reported that the use of treatment manuals and 
integrity checks produced higher effect sizes, and that treatments provided on an 
individual basis were associated with higher average effect sizes (1.16) than those 
delivered on a group basis (.68). 
The most recent meta-analysis by Del Vecchio & O’Leary23 was more restrictive in study 
selection. They included studies of adults only, and required subjects to have a score in 
the clinical range on a standardized measure, random assignment, a control group 
(including no treatment, minimal treatment, wait-list, or other defined by the 
investigator), and at least 5 subjects in each cell. The average effect size for CBT (18 
studies) was .68, and for Cognitive Therapy (7 studies) was .82. Seventy-three percent of 
the studies in this review focused on college student samples, however, limiting 
generalizability to more typical clinical samples. Thus, the research on non-veteran 
samples is promising in terms of the potential of cognitive behavioral treatments for 
anger problems, but given the nature of the samples studied, generalizability to veteran 
samples is unknown. 
 
Research on Treatments for Anger in Military Personnel and Veterans: Much less is 
known about the efficacy of such treatments for anger problems in military personnel 
following exposure to war zone trauma. There is one published study to date involving 
the use of Novaco’s intervention with veterans25. Vietnam combat veterans with chronic 
PTSD and severe problems with anger and aggressive behavior received 12-sessions of 
treatment provided on an individual basis, in addition to routine care. Despite a small 
sample (total of 15 in anger treatment and control condition completing treatment), they 
found significant effects for the anger treatment (relative to a control group receiving 
routine care) for multiple self-report measures of anger reactions and anger control. The 
significant differences in anger control were maintained at an 18-month follow-up 25. 
These preliminary findings are promising, particularly given the chronic and severe 
nature of the symptoms in the individuals studied and the general treatment 
refractoriness in the population as a whole. 
 
Two studies examined cognitive behavioral treatments for veterans in open trials. One 
included four sessions delivered in a group format in a military/occupational setting to a 
sample of 91 participants including active duty military members (82%), civilian 
employees, and spouses of military members (9% of each) 26. The other study 27 included 

5 
 
a sample of 51 male veterans, most of whom (72%) served in the Vietnam war. Both 
studies showed statistically significant pre to post treatment decreases on state and trait 
anger scales, but in the absence of a control group, it is not possible to rule out other 
factors that may account for these findings. 
Most recently, Morland and colleagues 8 conducted a noninferiority trial to determine 
whether delivery of a 12 session group based cognitive behavioral anger management 
treatment by videoconferencing was as effective as an in-person group for male veterans 
with PTSD. The sample included primarily Vietnam Veterans (76%). Both groups were 
associated with significant and comparable reductions in anger symptoms, leading to the 
conclusion that video-conferencing is an effective and feasible way to deliver treatment 
for anger problems. As with the open trials, a limitation of this study in terms of 
establishing efficacy is that the absence of a control condition precludes conclusions 
regarding the specific effects of the cognitive behavioral interventions in both conditions, 
as distinct from the benefits of common factors such as group support, mobilization of 
hope, and contact with therapists. 
 
To summarize, problems with anger are common and have serious adverse consequences 
in military personnel and veterans who have served in warzones. Early indications are 
that the current cohort of OEF/OIF veterans is no exception. Although promising findings 
for cognitive behavioral treatments have been reported, to date there is not a single   
adequately powered randomized trial designed to test the efficacy of an anger treatment 
compared to an active control condition in veterans. Furthermore, research on anger 
treatment for veterans has relied on self-report measures, and there are no studies to 
date including the use of a blinded structured interview to assess outcome. The 
limitations of existing studies of anger treatment in veterans was highlighted in a recent 
review29 that was published as part of a series of articles commenting on the updated 
VA/DOD guidelines for management of PTSD: “Given the lack of rigorous research 
studies evaluating anger interventions with this [veterans with PTSD] population, 
additional research in this area is sorely needed. This research should involve the use of 
randomized controlled studies to evaluation anger management strategies and should 
include measures that assess both anger and aggression” (Taft et al., 2012, p. 783). 
 
Furthermore, research on anger treatment for veterans has relied on self-report 
measures, and there are no studies to date including the use of a blinded structured 
interview to assess outcome. The limitations of existing studies of anger treatment in 
veterans was highlighted in a recent review (Taft et al., 2012) that was published as part 
of a series of articles commenting on the updated VA/DOD guidelines for management 
of PTSD: “Given the lack of rigorous research studies evaluating anger interventions 
with this [veterans with PTSD] population, additional research in this area is sorely 
needed. This research should involve the use of randomized controlled studies to 
evaluation anger management strategies and should include measures that assess both 
anger and aggression” (Taft et al., 2012, p. 783). 
 
To determine whether there are current or completed studies of anger treatment in 
veterans, we searched lists of funded research on grants.gov. We also searched the 

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funded grants list for VA HSR&D, and for all VA funded MIRECs. We did not find any 
currently funded studies examining treatment for anger in veterans. Completed studies 
listed included the Morland study described above, and a pilot study of a cognitive 
behavioral group therapy for male veterans with a history of intimate partner violence. 
We have collaborated with the PI (Dr. Casey Taft) of the pilot study in a DoD funded 
clinical trial of the same treatment which is nearing completion. Recruitment for that 
study is open to veterans of all eras with IPV, and has drawn heavily from the court 
system. It is not restricted to OEF/OIF/OND veterans, and does not address anger 
problems outside of those that have already resulted in domestic violence. We also 
contacted the Office of Mental Health (Dr. Karlin) to inquire whether there are any 
clinical initiatives with a focus on anger treatment, and were informed that there are no 
current or planned initiatives on this topic at this time. 
 
Models of War Related Anger: Why are problems with anger so prominent in veterans 
who have served in war zones? One explanation is that higher levels of arousal and 
hypervigilance following repeated exposure to life threatening situations result in a lower 
threshold for anger reactions. Second, military training focuses on responding to threat 
with aggression, and response to threat with aggression is associated with the powerful 
reinforcement of survival in combat experiences. Novaco and Chemtob11 proposed a 
model for the relationship between anger and trauma that incorporates the adaptive 
value of anger and aggression in life threatening situations. Their model also builds 
upon Novaco’s earlier model that conceptualizes anger as the result of the cognitive 
processing of environmental circumstances, physiological arousal, and behavioral 
reactions, which interact with each other and with environmental circumstances 30. This 
three-domain framework was subsequently integrated with Chemtob et al.’s25 
information processing model of dysregulation. They describe a “survival mode” of 
functioning involving over- activation of cognitive structures that facilitate a response to 
life threatening situations. 
Once triggered, the “survival mode” preempts all other cognitive processing including a 
loss of self-monitoring. Additional characteristics associated with “survival mode” 
include specific cognitive biases such as a tendency to react more quickly by requiring 
less evidence of threat to engage action and decreasing capacity to regulate arousal level 
25. 
These processes explain the dysregulation, or inability to adaptively regulate behavioral 
responses to threat, and the persisting response of excessive anger and aggression in 
situations perceived as threatening, even in the absence of real threat. Thus, a response 
that is highly adaptive during combat becomes maladaptive with the loss of the ability to 
regulate the intensity and expression of anger appropriate to the current social and 
environmental conditions 11. Thus key elements of poorly controlled anger include 
cognitive processing characterized by overestimates of threat, high levels of arousal, and 
inability to regulate the intensity of emotion and behavioral response. 
 
Summary of Significance: Given the frequency, severity, and chronicity of anger problems 
in combat-exposed veterans, there is a critical need for further research to establish 
optimal interventions using larger samples and adequate control groups. Since cognitive 

7 
 
behavioral interventions require more intensive training and experience than supportive 
therapy approaches, it is important to determine whether such treatments exceed the 
effects of a positive therapeutic relationship, therapist support, and an opportunity to 
talk about problems. Furthermore, the research to date has focused primarily on 
Vietnam Veteran samples and has been conducted decades after return from the war-
zone. For these veterans, no treatment was available until many years after anger had 
negatively impacted relationships, jobs, and health. Potential advantages of earlier 
intervention, before the secondary consequences of anger problems are established, 
highlight the significance of testing interventions in military personnel and veterans 
earlier on after their deployments. The goal is to prevent anger-related problems 
following deployment from becoming entrenched and chronic, that is, before these 
problems take their toll on social and occupational functioning, quality of life, and 
physical health. 
 
Promising findings from our pilot work suggest that the adapted cognitive behavioral 
intervention has the potential to effectively treat anger problems in this new cohort of 
veterans. If shown to be effective in a fully powered clinical trial, with subsequent 
dissemination this intervention may result in a significant reduction in the negative 
consequences associated with ongoing anger-related problems and the extensive 
personal and societal costs of these consequences. 
 
3. Preliminary Studies 
Veteran PTSD Risk Factors Study: We recruited a sample of National Guard and Reserve 
Veterans following their return from deployment in Iraq or Afghanistan for a study of risk 
factors for and early longitudinal course of PTSD. Participants were recruited at post- 
deployment health screenings and re-screenings. The Clinician Administered PTSD Scale 
(CAPS) was used to assess PTSD symptoms. A portion of the initial sample of 238 
participants was re-assessed as funding allowed, including 215 at 6 months and 169 at 12 
months post-return. (The smaller sample at 12 months was due primarily to not having 
funds to continue the follow-up as opposed to attrition). Although only 10.5% met 
criteria for PTSD at the first month post-return, PTSD symptoms were common. 
Hyperarousal symptoms were the most frequent, with percent of individual symptoms 
ranging from 21% to 55% at the first month post return, in contrast to re-experiencing 
symptoms (range 9% to 17%) and numbing/avoidance symptoms (2% to 21%) (figure 
1). Among the hyperarousal symptoms (see figure 2), hypervigilance and anger were the 
two most common symptoms at all time points assessed. Even at 12 months post-return, 
38% of participants still met the CAPS anger symptom criteria. 
 
Examination of the associations between PTSD symptom cluster scores and measures of 
functioning and distress showed that while symptoms of numbing and avoidance were 
the strongest predictors of impairment in interpersonal and social functioning, 
hyperarousal symptoms were the strongest predictors of overall severity and distress 31. 
When individual symptoms were examined in relationship to measures of functional 
impairment, anger was the strongest predictor of impairment in overall adjustment 
(Global Assessment of Functioning Score) and social functioning 31. Thus, with the 

8 
 
exception of hypervigilance, anger was the most frequent symptom of PTSD at all three 
time points, and was the strongest predictor of impairment in social and overall 
functioning. 
 
Pilot study of CBI: We completed a treatment study designed to adapt the cognitive- 
behavioral intervention (CBI) for the treatment of anger to specific needs of military 
personnel returning from Iraq and Afghanistan, and to conduct a randomized pilot study 
to examine feasibility, acceptability, and preliminary evidence of efficacy of the adapted 
intervention in this population 32. The first phase involved adapting the manual, 
administering the adapted CBI to 12 participants, and piloting a supportive intervention 
(SI) to two participants. The SI manual was an adapted version of the Present Centered 
Therapy (PCT) that the Dr. Shea adapted as a control condition for a Cooperative Studies 
Program #494 “Treatment of PTSD in Women Veterans”. Our experience in Phase I led 
to further revisions of both manuals. The goal of the second phase was to conduct a 
randomized pilot study of male and female participants assigned to receive either CBI or 
SI. 
 
Table 3: Between groups differences at post-treatment adjusting for pre-
treatment scores (ANCOVA) and effect sizes 
 
Variable 
F 
P 
Effect Size 
STAXI-2 
Anger Expression Index 
Expression In 
Expression Out 
Control In 
Control Out 
7.6 
9.9 
24.0 
5.7 
6.0 
.019 
.004 
<.001 
.034 
.031 
1.12 
1.13 
0.98 
1.08 
1.22 
OAS-M 
Aggression 
Total 
4.28 
4.55 
.059 
.053 
0.78 
0.82 
Outcomes Questionnaire 
Interpersonal Relations 
Symptom Distress 
Social Role 
6.24 
1.40 
5.81 
.028 
.260 
.033 
1.24 
0.59 
1.20 
 
Despite the small sample size, CBI was statistically superior to SI in reducing anger 
problems on the primary outcome measures. CBI showed significantly more 
improvement than SI (p < .05) on the STAXI-2 expression and control scales and the 
anger expression index. The OAS-M was administered by trained interviewers who 
were blind to treatment condition. Differences on the aggression scale score and the 
total OAS-M score were close to significance (p < .06). On the self-report Outcomes 
Questionnaire, CBI improved significantly more than SI on two of the three scales. 
Between group effect sizes reflecting the greater improvement for CBI compared to SI 
were large, ranging from .78 to 1.24. 
 

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4. Research Design and Methods 
 
A. Overview 
The goal of this proposal is to investigate the effectiveness of CBI in treating anger 
problems in OEF/OIF/OND veterans. This is consistent with the goal of the RR&D 
Deployment Health Research (OEF/OIF) Funding Opportunity (RX-11-016) to increase 
research addressing the health care needs of Veterans returning from Afghanistan and 
Iraq, including studies that seek to increase participation in family and social 
activities, maintain employment, and improve overall quality of life. 
B. Participants 
The sample will consist of 120 OEF/OIF/OND male and female veterans who were 
exposed to one or more DSM-5 criterion A traumatic events during their deployment, 
and are experiencing excessive irritability and/or outbursts of anger and at least two 
additional hyperarousal symptoms of PTSD (i.e., difficulty falling or staying asleep, 
difficulty concentrating, hypervigilance, exaggerated startle response). 
 
Inclusion/exclusion criteria 
The inclusion and exclusion criteria are based on an attempt to be as unrestrictive as 
possible while ensuring the safety of participants and maintaining the internal validity of 
the study. In order to be included, participants must: 
 
• be male or female current or former members of the military (active duty, 
National Guard or Reserve) 
• have served in OEF, OIF, or OND 
• have experienced trauma during deployment 
• report clinically significant anger as measured by the CAPS-5 anger criterion 
(rating of 2 or higher on the item describing experiencing persistent negative 
mood states, with anger being one of the intense emotions experienced, and/or 
the item involving problematic expression of anger/irritability in behavior) report 
a minimum of two additional symptoms from the PTSD hyperarousal  symptom 
cluster 
• be interested in receiving treatment for anger 
• consent to be randomized 
• not receive other active PTSD or Cognitive-Behavioral treatment, or any 
individual or group treatment focused on problems with anger management 
during the intervention phase 
• not have had new psychotropic medication or dosage changes with the prior 
4 weeks. 
 
Potential participants will be excluded for any of the following reasons: 
• the presence of a severe substance or alcohol use disorder in the last 3 months  
• current psychotic symptoms (in the last 3 months) 
• current mania or manic episode within the last 3 months  
• current suicidal or homicidal ideation requiring hospitalization 

10 
 
• any severe cognitive impairment or history of Organic Mental Disorder 
 
Considerations in determining inclusion/exclusion criteria 
All of our listed exclusion criteria are designed to exclude those who would need 
alternative treatment or would be unlikely to benefit from the proposed treatment. In 
terms of inclusion criteria, several require further comment. First, although we originally 
proposed excluding women, we have taken the reviewers recommendation to reconsider 
this decision and will include both men and women. Although research has shown that 
females tend to have lower levels of physical aggression than males 33, reviews have 
suggested that sex differences for verbal aggression are generally much smaller 34. Given 
that there are increasing numbers of female veterans with exposure to warzone trauma 
(as well as military sexual assault), many of whom are likely to have problems with 
anger, it will be important to have effective treatments for both genders. We will balance 
randomization and examine possible differences in outcome by sex, and include sex as a 
covariate in analyses if needed. 
 
A second important consideration was whether to restrict the sample to those with a 
PTSD diagnosis. Many studies report more severe anger problems in veterans with PTSD 
than in those without, and it is possible that anger problems differ in other ways in those 
with and without PTSD. Further, two of the existing treatment studies of anger in 
veterans required PTSD diagnoses. On the other hand, significant anger problems are 
also common in combat exposed veterans without a PTSD diagnosis 12, 8, and not 
requiring a PTSD diagnosis will make the findings relevant to a larger proportion of 
returning veterans. We decided not to require a PTSD diagnosis for inclusion, but we will 
require exposure to trauma during deployment, and the presence of at least three 
hyperarousal symptoms (one being anger and irritability). This requirement is 
consistent with the conceptualization of anger as linked to hyperarousal in veterans 
exposed to war-zone life threat. We will include presence of a PTSD diagnosis as a 
balancing factor in urn randomization and will conduct exploratory analyses to examine 
whether treatment effects are the same for participants with and without a PTSD 
diagnosis. 
 
We will exclude participants with severe cognitive impairment who would be unable to 
readily understand the concepts. If such impairment is suspected, a mental status exam 
will be conducted. Veterans with mild traumatic brain injury (mTBI) will not be excluded 
as the typical level of cognitive impairment associated with mTBI is not sufficiently 
severe to interfere with treatment implementation. 
 
C. Recruitment procedures 
Participants will be recruited from a range of sources. The primary recruitment source 
will be the Providence Veterans Affairs Medical Center, including the OEF/OIF specialty 
primary care clinic, the Returning Veterans Outreach Program (REVOC), and the PTSD 
Clinic. In FY 2011, 1261 unique OEF/OIF/OND veterans were seen in these clinics, with 
10 to 15 new consults per week across the two programs. Dr. Shea is on the staff of the 
PTSD clinic, and Dr. Lambert is the director of the REVOC clinic and acting director of 
the PTSD clinic. 

11 
 
 
The Providence VAMC has established a new women’s specialty clinic in primary care, 
which is housed in a new building adjacent to our offices as well as the PTSD and 
Returning Veterans Clinics. We will draw upon these resources as well as the additional 
outreach methods described to recruit OEF/OIF/OND women veterans. 
 
Study participants will also be recruited through outreach efforts to military family 
organizations, community-based troop support organizations, veteran organizations, as 
well as to the active military community. Additional outreach efforts will include making 
presentations at military reintegration events, such as Yellow Ribbon post-mobilization 
weekend retreats, posting fliers at military bases and in the community, as well as 
making presentations to interested community groups. Potential participants will also 
be recruited with the assistance of our study recruiter, Paul Darcy, who will seek to 
engage Veterans in study treatment from the community, Veterans’ court, and other VA 
facilities (e.g., Vet Centers). Veterans who express interest in participating in the study 
will be asked to contact study staff directly or to sign a form giving permission for the 
study staff to contact them.  
 
Study advertisements will also be posted on the official PVAMC online posting sites (i.e. 
the PVAMC Twitter and PVAMC Facebook pages) according to the guidance of the 
PVAMC Public Affairs Officer. All advertisements will be reviewed and approved by the 
PVAMC IRB prior to release. 
Screening and Informed Consent Procedures 
Potential participants who are referred through one of the sources described above or 
who contact study personnel directly will enter the screening phase. Where possible, the 
medical record will be examined to determine if war era (i.e. OEF, OIF, OND) criterion is 
met, and whether diagnostic exclusion criteria (e.g. current severe substance use 
disorder, mania or psychotic symptoms) are present. 
 
Potential participants will have telephone contact with a study interviewer who will 
provide information that will enable potential participants to decide whether they want 
to be considered for the study (i.e., purpose of the study, the two intervention conditions, 
use of random assignment, time commitment required for both treatment and 
assessment, and schedule of payments). Those who are interested will obtain an 
appointment with the interviewer. 
 
During the next stage of screening, interviewers will review the Informed Consent forms 
to explain the study in greater detail. The participant will be fully informed of the nature 
and extent of study participation, the objectives of the study, and the two interventions 
to which they may be randomly assigned. Participants also will be informed of the fee 
payment structure that applies to the follow-up assessments they will complete 
following the treatment phase. Interviewers will be trained to ensure that all 
participants comprehend the nature of the study and the wording of the consent form, 
and will provide a copy of the forms for potential participants to take home. 
 

12 
 
After reviewing the consent form, the interviewer will ask if the participant is interested 
in proceeding with the next phase of screening to determine if s/he meets all study 
inclusion/exclusion criteria. If s/he is willing to proceed  s/he will also be asked to sign a 
HIPAA authorization form. We will ask participants if they are willing to have a 
significant other complete anger outcome measures for the purpose of providing an 
additional perspective on amount and types of change following treatment (as described 
below). If the participant agrees, s/he will be asked for permission to contact the 
nominated individual as part of the consent process. Although encouraged, identification 
of collaterals will not be required for inclusion in the study. 
 
In the final stage of screening, interviewers will complete interviews to establish inclusion 
and exclusion criteria. The Structured Clinical Interview for the DSM-V (SCID) will be 
administered to assess for the presence of current (in the last 3 months) psychosis, mania, 
or a substance use disorder. The Clinician-Administered PTSD Scale (CAPS) 37 will be used to 
establish recent exposure to a traumatic stressor. The CAPS includes a lifetime trauma 
checklist and questions about stressor exposure, which will be used to ensure that 
participants meet the DSM-5 criterion of stressor exposure that is required for diagnosis 
and for inclusion in the study. This checklist will be supplemented with additional questions 
inquiring about common stressors associated with current hazardous deployments. The 
trauma checklists will provide descriptive information about participants at study entry. 
After establishing that the potential participant has experienced at least one combat-related 
criterion A stressor, the interviewer will skip to section E (hyperarousal) to assess for the 
presence of trauma-related anger and arousal. Inclusion criteria for the study involve 
endorsement of at least two arousal symptoms, in addition to experiencing persistent 
negative mood states, with anger being one of the intense emotions experienced, and/or the 
item problematic expression of anger/irritability in behavior. If the participant does not rule 
out based on these measures, the interviewer will administer the remainder of the CAPS 
interview and SCID and the remaining questionnaires and interviews of the assessment 
battery. 
 
In addition to documenting that inclusion and exclusion are met, a screening form 
completed at this point records referral source, all prior deployments, and date of return 
from most recent deployment. 
 
D. Assessment 
D. 1. Screening, Diagnostic and Sample Characterization Measures 
Structured Clinical Interview for DSM-IV (SCID), patient version. The DSM-5 version of the 
SCID35 will be used during screening to establish exclusion diagnoses (substance use 
disorders, psychosis, and mania). It will also provide assessment of non-excluded Axis I 
disorders, which will be examined for possible effects on treatment outcome, and used as 
covariates in the outcome analyses as needed. 
 
Clinician Administered PTSD Scale (CAPS): The CAPS 36 (updated for DSM-5) will be 
administered at screening to assess the DSM-5 diagnostic criteria for PTSD. It will also be 
used at post-treatment and follow-up as a secondary measure of outcome. The CAPS has 
excellent reliability and validity36, 37 and is widely used in PTSD treatment research. Each 

13 
 
one of the DSM-5 PTSD symptoms is rated on a 0-4 (low to high) scale to determine 
symptom severity. The cutoff used to establish the presence of an individual symptom is a 
score of 2 or greater. In addition, overall PTSD severity is computed by summing the 
totals for all items. 
 
Hoge Combat Experiences Scale: This scale is included as a measure of trauma exposure in 
the warzone because it was developed specifically to assess trauma exposure in the Iraq 
and Afghanistan theatres 38. As such it includes items more specific to these wars (e.g. IEDs, 
searching homes). Items assess frequency of being in serious danger, number of firefights, 
injury including head injury, and frequency of exposure to 13 combat and other trauma 
events rated on a scale from 0 (never) to 4 (10 or more times). 
Childhood Trauma Questionnaire: The CTQ is a self-report measure developed to 
retrospectively assess experiences of abuse and neglect in childhood, as well as aspects of 
the child-rearing environment. It consists of 53 items rated on a 5-point Likert scale, and 
has evidence of good internal consistency and test-retest reliability 39. 
 
Brief Symptom Inventory: The Brief Symptom Inventory (BSI) is a 53-item version of the 
Symptom Checklist 90- Revised. It includes 9 symptom scales and global measures of 
symptom severity and psychological distress40. 
 
Schedule for Nonadaptive and Adaptive Personality-2 (SNAP-2): The Schedule for 
Nonadaptive and Adaptive Personality-2 (SNAP-2) is a 390-item self-report measure of 
personality. It includes 12 trait scales assessing maladaptive personality and three 
temperament scales of Negative Temperament, positive Temperament and Disinhibition 
assessing higher order personality domains. It has been shown to demonstrate good 
reliability and validity41, 42.  
 
Brief Addiction Monitor. The Use subscale of the Brief Addiction Monitor will be used to 
assess for frequency of alcohol and substance use within the past month at baseline and 
follow up assessments. This measure has been shown to be valid and reliable in prior 
research43.  
 
D. 2. Primary Outcome Measures: Anger and Aggression 
Two measures will serve as the primary outcome measures for anger: the Anger 
Expression Index (AXI) from the State-Trait Anger Inventory-244 and the Aggression 
Scale score from the Overt Aggression Scale-Modified45. 
 
STAXI-2: The STAXI-2 46 is a revision of Spielberger’s State-Trait Anger Expression 
Inventory (STAXI), expanded from 44 to 57 items on the basis of over a decade of 
research. It is a self-report questionnaire consisting of six scales and an Anger 
Expression Index (AX). Scales include State Anger, which measures the intensity of 
current angry feelings; Trait Anger, which measures the frequency of angry feelings over 
time; Anger Expression-Out, which measures how often angry feelings are expressed in 
verbally or physical aggressive behavior; Anger Expression-In, which measures how 
often angry feelings are experienced but not expressed; Anger Control-Out, which 

14 
 
measures how often a person controls the outward expression of angry feelings; and 
Anger Expression-In, which measures how often a person tries to control angry feelings 
by calming down. The Anger Expression Index is an overall measure of the expression 
and control of anger based on responses to the two anger expression and the two anger 
control subscales. The original STAXI and the STAXI-2 have been widely used in 
treatment studies, including veteran samples 25, 27, 28 and has substantial psychometric 
evidence, including convergent and discriminant validity, and sensitivity to change45. 
 
OAS-M: The OAS-M is a 25-item clinician-administered, semi-structured interview with   
nine subscales 45, 47. It was designed to evaluate various manifestations of aggressive 
behaviors in outpatients, including the severity, type, and frequency of aggressive 
behavior. The scale assesses three overall domains: Aggression (Verbal Aggression, 
Aggression Against Objects, Aggression Against Others, and Aggression Against Self), 
Irritability (Global Irritability and Subjective Irritability), and Suicidality (Suicidal 
Tendencies, Intent of Attempt, and Lethality of Attempt). Only the Aggression and 
Irritability subscales will be used in the current study. The two Irritability subscales are 
rated on Likert-type scales from 0 = none at all to 5 = extreme. The Aggression scale uses a 
different format in which each specific behavior is scored separately by frequency and 
then multiplied by assigned weights. For each Aggression subscale, seven specific 
behaviors are listed in order of severity and then weighted by their respective rank. The 
weighted frequencies are summed to form each subscale score. Subscale scores are then 
multiplied by their own assigned weight: Verbal Aggression by 1, Aggression Against 
Objects by 2, and Aggression Against Others and Self each by 3. Weighted subscales are 
added to obtain a final scale score for Aggression. Evidence for inter-rater and test-retest 
reliability has been documented for the OAS-M, with intraclass correlations (ICCs) of .91 
and greater for inter-rater, and ICCs of .46 to .54 for test-retest reliability, and the OAS-M 
has demonstrated sensitivity to pharmacotherapy-induced changes in aggression  47, 48. 
The time frame of the OAS-M is restricted to the past week. The OAS-M will be 
administered by interviewers blinded to treatment condition. 
 
Anger Consequences Scale (ACQ): The ACQ is a brief self-report measure developed to 
assess the frequency of negative anger-related behavioral consequences. Internal 
consistencies of .75 to .91 were reported on the original 42 item version; the revised 
version shortened the measure to 33 items based on factor analysis  49. This scale 
includes items not covered by the other anger measures, including for example, trouble 
with the law, driving recklessly, getting into an accident, damaging relationships, etc. 
 
Dimensions of Anger Response (DAR): The DAR, developed by Novaco50 is a 7-item self- 
report measure of anger reactions. A more recent report on the psychometrics of the DAR 
showed it to be unidimensional, reliable, and sensitive to change over time 50, 51. The DAR 
will be administered at each session. 
 
D. 3. Collateral Assessments 
Data from collaterals can provide an important additional perspective on treatment 
outcome. We will ask participants if they are willing to have a significant other complete 

15 
 
anger outcome measures for the purpose of providing an additional perspective on 
amount and types of change following treatment. For each participant who agrees, we 
will ask him or her to identify the person or persons with whom they spend the most 
time, and/or have sufficient interactions to be familiar with the participant’s typical 
behavior. A minimum of 5 hours of contact a week will be required to qualify as a 
collateral reporter. If there are multiple possible candidates, we will ask the participant to 
identify the one who they believe would be the best able to provide a valid assessment of 
their anger. Participants may take up to two days to consider the request and to discuss 
with the potential collateral. If the participant agrees, s/he will be asked for permission to 
contact the nominated individual as part of the consent process. Although encouraged, 
identification of collaterals will not be required for inclusion in the study. Collaterals will 
be fully informed of the study requirements and if they are willing to participate, will be 
asked to sign informed consent. Collaterals will also be provided with the Notice of VHA 
Privacy Practices. They will be asked to complete the STAXI-II (excluding the state anger 
scale), the Sheehan Disability Scale, and the Overt Aggression Scale interview at pre- and 
posttreatment. These measures will be adapted from first to third person for this 
purpose. We will record demographic information, the nature of the relationship (e.g. 
spouse, family member, friend) and the average number of hours of contact per week 
with the participant. At post-treatment, we will also administer a collateral version of to 
the Patient Satisfaction form. 
D. 4. Secondary Outcome Measures: Functioning and Quality of Life 
Longitudinal Interval Follow-Up Evaluation: Psychosocial functioning scales from the 
clinician administered Longitudinal Interval Follow-up Evaluation52 will provide 
assessment of functioning in areas of work (employment, household, or student), familial 
and nonfamilial interpersonal relationships, recreation, and global social adjustment on 
separate 6 to 8-point scales. Ratings will be based on the past month. The psychosocial 
functioning ratings have been found to be of generally high reliability 52, 53. 
 
Outcomes Questionnaire: Functioning will also be assessed by the self-report Outcomes 
Questionnaire (OQ) which was developed as a psychotherapy outcome measure 54. The 
OQ includes three subscales: symptom distress, interpersonal relations, and social role 
functioning. Test-retest coefficients in the mid .70s and .80s and internal consistency in 
the low .90s provide evidence for reliability. Concurrent validity has been demonstrated 
in relation to other measures, the OQ has been shown to be fairly stable in untreated 
individuals and sensitive to change in those individuals in treatment 55. 
 
World Health Organization Quality of Life (WHOQOL-BREF):  The World Health Organization 
Quality of Life (WHOQOL-BREF), is 26 item self-report measure used to assess quality of 
life in multiple domains (i.e., physical, psychological, social, and environment). 
Psychometric properties suggest that the measure is valid and reliable across cultures and 
nations56.  
 
 
D. 5. Mediators of Outcome 
Novaco Anger Scale (NAS): The three subscales of the NAS (cognitive, arousal, and 

16 
 
behavioral) will be examined as possible mediators of CBI treatment outcome. The revised 
version of these scales includes 48 items measuring impairment in the three components 
of Novaco’s model 57, 58. As described further below, the intervention in the current study, 
adapted from Novaco’s stress inoculation anger control treatment, includes strategies to 
address each of these components. The published manual for the NAS-PI57, 58 reports 
findings of high levels of internal consistency across a number of normal and psychiatric 
samples. Of particular relevance to the population to be addressed in this study is the 
data provided by Chemtob and colleagues on 114 Vietnam veterans which yielded alpha 
coefficients of 0.97 and 0.96 for the NAS and PI, respectively 25. 
D. 6. Additional measures 
Treatment Satisfaction: a brief 4 item measure adapted from the Treatment Satisfaction 
Form used in the NIMH Treatment of Depression Collaborative Research Program will be 
used to assess satisfaction with treatment. 
 
Treatment Utilization: The Longitudinal Interval Follow-Up Assessment (LIFE) treatment 
section provides continuous recording of mental health and medical treatments 52. For 
the latter, number of hospitalizations, days spent in hospital, and number of outpatient 
visits for non-mental health medical treatments are recorded for the time period 
covered. Types and amounts of all mental health contacts, including inpatient and 
outpatient treatment, are recorded on a monthly basis. All psychiatric medications, 
including dosages are recorded on a weekly basis (see Appendix 4 for list of 
medications). We will also assess all prescribed non-psychiatric medications, over the 
counter medications (including caffeine), and herbal and other supplements taken for 
any reason. 
 
A baseline version (LIFE-Base) assesses mental health treatment received prior to 
entering the study. We will adapt the LIFE-Base to indicate whether prior treatment 
occurred before, during, or after deployment, and also to assess whether prior treatment 
focused specifically on anger or PTSD. 
 
 
D. 7. Schedule of Assessments 
The schedule of assessments is shown in Table 1. The CAPS and the SCID will be 
administered during the screening process prior to randomization to ensure that only 
eligible participants are entered into the study. Only eligible participants will complete the 
full CAPS and SCID and other pre-treatment measures. Assessments will be conducted at 
pre-treatment, during treatment (after sessions 4 and 8), end of treatment (week 12), and 
at three and six months following completion of treatment. We estimate that completion 
of the SCID and the CAPS will take 2 hours on average, and that the remaining pre-
treatment measures will take about 2 ½ hours. The pre-treatment assessment will be 
conducted in 2 sessions. Mid-treatment assessments should take about 45 minutes. We 
estimate that post- treatment and follow-up assessments will take about 2 ½ hours on 
average. 
 
We will aim to complete the post-treatment and follow-up assessments in a single 

17 
 
session, providing breaks if needed. If necessary due to participant burden, we will 
schedule a second assessment session. We will prioritize the order of measures 
administered to ensure that in all cases the anger outcome measures (OAS-M, STAXI-2, 
and ACQ), and the Outcomes Questionnaire are completed. Telephone assessments will 
be used if participants are unable to come in for assessments. Every attempt will be 
made to perform post- treatment and follow-up assessments within one week of their 
scheduled date. 
 
 
Table 1. Schedule of Assessments 
 
Domain 
Screening 
Pre-Tx 
Sessions 
4 and 8 
Post-Tx 
Follow-up 
(3 and 6 
months) 
Inclusion/exclusion Criteria 
SCID 
CAPS 
X 
X 
X  
X  
Sample Characterization 
SNAP-2 
CTQ 
Combat Exposure 
BSI 
BAM (Use subscale) 
X 
X 
X 
X 
X 
X 
 
X 
 
X 
X 
Anger 
OAS-M* 
STAXI-2* 
ACQ* 
DAR (weekly) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Function/QOL 
LIFE psychosoc 
OQ 
Disability Scale 
WHOQOL-BREF 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Mediators 
NAS arousal 
NAS cognitive 
NAS behavioral 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Other Measures 
Tx Satisfaction 
LIFE Tx section 
X 
X 
X 
X 
Clinician administered interviews are in italics. ACQ = Anger Consequences Scale; BAM = Brief 
Addiction Monitor; BSI = Brief Symptom Inventory; CTQ = Childhood Trauma Questionnaire; DAR = 
Dimensions of Anger Scale; NAS = Novaco Anger Scale; OAS-M = Overt Aggression Scale Modified; OQ = 
Outcomes Questionnaire; SNAP-2 = Schedule for Nonadaptive and Adaptive Personality-2nd Edition; 
STAXI-2 = State Trait Anger Inventory-2; WHOQOL-BREF = The World Health Organization Quality of 
Life  
*Collateral assessments will be administered at pre- and post-treatment 
 

18 
 
D. 8. Blinding of Assessments 
All interviewers will be blind to participants’ treatment condition. Each of the outcome 
domains (anger, functioning/quality of life) includes one blinded interview. Prior to the 
outcome assessments, the interviewer will remind each participant not to reveal his 
treatment condition. At the post-treatment and follow-up assessments, interviewers 
will complete questions including whether they think the blind was broken, and to 
which treatment condition they think the participant was assigned. 
 
D. 9. Standardization of Assessments 
Interviewer qualifications will include masters or doctoral level training in psychology or 
social work, or bachelor’s level training combined with at least 2 years of prior 
experience using structured interviews. Research study staff will provide training on the 
SCID and the CAPS. This research study staff member has formal training and experience 
training others on these interviews. Dr. Shea will conduct training on the OAS-M. 
Interviewers will conduct practice interviews and receive feedback from Research Study 
staff and Shea until judged to be calibrated to an acceptable standard of administration. 
 
All of the clinical interviews (CAPS, SCID and OAS-M) will be recorded. Ten percent of 
each of the interviews will be randomly selected on an ongoing basis to monitor the 
reliability of the interview process. Research study staff will listen to the recorded 
interviews and provide feedback to interviewers in biweekly meetings to maintain 
reliability. Interviewer ratings will be compared with research study staff’s ratings and 
any discrepancies in ratings will be discussed. 
 
D. 10. Procedures to Enhance Completion of Assessment Protocols 
A number of procedures will be used to minimize the likelihood that participants will fail 
to complete the schedule of assessments. Self-report measures will be completed at the 
time of the assessment and reviewed for completeness before the participant leaves. We 
will monitor carefully for fatigue, and encourage breaks if needed. We will try to schedule 
assessments on the same day as treatment sessions. Participants will be compensated for 
all assessments. 
 
Permission will be requested at the time of informed consent to obtain the name and 
phone number of a close relative, friend, or other person who is likely to maintain contact 
with the participant, and to contact that person if attempts to contact the participant are 
unsuccessful. Post-treatment and follow-up assessments will be conducted in person at 
appointments scheduled for this purpose. An appointment for the three-month follow-up 
assessment will be made at termination of the study intervention, and for the six-month 
follow-up at the three-month interview. Participants will receive a letter one week prior to 
the interview and a reminder call a few days prior. Participants who do not have 
telephones will be contacted by mail and asked to call for an appointment. Five contact 
attempts will be made before a participant is considered to be unreachable at that time 
point. Participants who fail to appear for a scheduled assessment will be contacted by 
phone, or mail when necessary, for rescheduling. If participants move away during their 

19 
 
participation in the study, or are otherwise unavailable for an in-person interview, we will 
perform follow-up assessments over the telephone to avoid missing data. 
 
D. 11. Compensation 
Participants will be compensated for the time required to complete all assessments. They 
will be paid $100 for the pre-treatment baseline assessment and $60 for the subsequent 
post-treatment and follow-up assessment periods. 
Participants who screen out on the SCID or CAPS or who do not complete the full 
baseline assessment will be paid $40 (for partial assessment). Mid treatment 
assessments (after sessions 4 and 8) will be compensated at $25. Collaterals will be 
compensated $25 for the pre- and post-treatment assessments. Participants can receive 
their compensation in the form of an electronic funds transfer or gift card. Collaterals 
will be compensated with gift cards. 
E. Treatment 
E. 1. Assignment 
Participants meeting study inclusion/exclusion criteria will be randomly assigned to CBI 
or SI following completion of the initial assessment. To prevent unequal distribution of 
variables that might be related to outcome, we will use the urn randomization strategy 
described by Wei59 and Stout60 to help insure balance among treatment groups. Urn 
randomization is a stratified randomization technique, which randomly assigns patients 
of a given subgroup to treatment conditions, but systematically biases the 
randomization in favor of balance among the treatment conditions on the stratification 
variables. We have successfully used the urn randomization procedure in several 
previous treatment outcome studies, including the multi-site Project MATCH61 and have 
developed a computer program that conducts the randomization. This program also 
enables ongoing monitoring of the effectiveness of our stratification and randomization 
procedures. Three dichotomous balancing factors will be used in randomization: gender 
(male vs female), and presence of a PTSD diagnosis (yes vs no). 
 
E.2. Cognitive Behavioral Intervention 
CBI was adapted from a cognitive behavioral treatment developed by Raymond Novaco, 
targeted at reducing anger frequency, intensity, and duration, and at moderating the 
expression of anger 50, 57. It includes training in self-monitoring, cognitive reframing, 
arousal reduction, and behavioral coping. It also utilizes a “stress inoculation” approach, 
which involves therapist-guided, progressive imaginal exposure to provocations 
(including trauma triggers) in session and in vivo, in conjunction with modeling and 
rehearsal of coping skills. Adaptations of the original treatment for OEF/OIF veterans 
included 1) addition of psychoeducation using “Battlemind”, developed by researchers 
at Walter Reed (consistent with Battlemind principles, throughout the treatment, anger 
is conceptualized within the context of adaptive function in the warzone that becomes 
nonadaptive at home); 2) additional emphasis on arousal reduction through relaxation 
training; 3) including the option of a session involving a spouse or family member 
focused on psychoeducation; and revisions of the manual organization to facilitate 
therapist delivery. Key elements of CBI include: 

20 
 
 
• Psychoeducation about responses to trauma, particularly following deployment in 
a war-zone, trauma-related anger difficulties, stress, and aggression 
• Arousal reduction, including diaphragmatic breathing, and guided imagery training 
• Cognitive restructuring of anger schemas (identification and modification of 
beliefs and interpretations) 
• Behavioral coping strategies (training in communication, assertiveness, 
and strategic withdrawal) 
• Inoculation training (practicing the cognitive, arousal regulatory, and behavioral 
coping skills while visualizing progressively more intense anger-arousing scenes 
from personal hierarchies). 
E.3. Supportive Intervention Control 
The Supportive Intervention adapted for the pilot study included the same “Battlemind” 
psychoeducation as the CBI condition. Following the psychoeducation component, the 
rest of the intervention focuses on providing support and using problem solving 
strategies to help in managing behavior and feelings in current day-to-day life. 
Cognitive behavioral interventions are excluded. In addition to the exclusion of 
cognitive or behavioral strategies, SI is less structured; the patient has more input into 
the agenda of the sessions. 
 
E.4. Therapist Selection, Training and Supervision 
Therapists will be Ph.D. level psychologists or masters level clinical social workers with 
prior experience in cognitive behavioral therapy and prior experience treating PTSD 
patients. Therapists will receive training in both interventions. There are advantages and 
disadvantages to using the same or different therapists for study conditions. The primary 
concern with using the same therapists is the possible effect of a different level of 
enthusiasm and investment in the active treatment condition, which can bias results. 
However, bias can just as easily occur when therapists are assigned to deliver different 
treatment conditions. Our experience in the pilot study was that therapists appeared to be 
equally comfortable with both conditions, and ratings indicated adherence to the manual. 
Retention was slightly higher in the SI condition. An advantage of using the same therapist 
for both conditions is reduction of between treatment variance associated with therapist 
effects. Another advantage is the increased flexibility of assigning study participants to 
therapists to facilitate accommodation of study participants’ availability for appointments. 
 
Initial training will be didactic, involving two days of instruction for CBI, and one for SI. 
Drs. Shea and Lambert will conduct the didactic training for both conditions. Training 
will include disguised case examples derived from the pilot study sessions and role plays 
of interventions. Following the didactic training, each therapist will have one CBI training 
case, with weekly supervision based on review of audio recorded sessions. The training 
case must complete a minimum of 8 sessions to count. If the therapist is judged to be 
sufficiently competent, he or she will be approved to see study participants. This 
judgment will be based on mutual agreement by Drs. Shea and Lambert who will 
supervise therapists, and on consistent ratings of adherence (75% of strategies 

21 
 
implemented across sessions rated). All therapy sessions for study participants in both 
conditions will be recorded. For the first two study cases for each therapist, every 
session will be reviewed and feedback will be provided weekly. Supervision will become 
less frequent with subsequent cases, although a minimum of three sessions will be 
reviewed for each case and feedback provided as needed. 
 
E.5. Adherence Monitoring 
Current standards in psychosocial treatment research require monitoring of therapist 
behavior and interventions to ensure treatment fidelity (i.e., that therapists are 
delivering the interventions specified in the manual and not using interventions that 
are not part of the treatment). In the proposed study, the first objective is particularly 
important for the Cognitive Behavioral Intervention, and the second is particularly 
important for the Supportive Intervention. We have developed adherence scales for 
both conditions, and findings from our pilot work showed good adherence in both 
conditions. Adherence ratings for both conditions will be completed by research study 
staff, and will include three sessions (early, middle, and late session) for each study 
participant. Ten early sessions will also be rated by Dr. Shea to establish reliability with 
research study staff. 
 
F. Design Considerations 
F.1. Treatment Format 
The treatment we are studying is delivered in an individual format. An alternative choice 
would be to test the efficacy of a group format, which could be more cost-effective. We 
decided to use an individual format for several reasons. First, many patients with anger 
problems are unwilling to participate in group treatment. Second, the logistics of group 
interventions can be challenging, given the need to find a time that all potential group 
members can make. This may be particularly for OEF/OIF/OND veterans who often have 
time restrictions due to work and family. Further, in practice since groups are typically 
10 to 12 weeks long, new veterans often have to wait until another group is available. 
Third, the intervention in the proposed study includes an imaginal exposure component, 
which would be difficult to implement in a group format. Finally, it is possible that 
individual delivery of anger treatment may be more effective than group delivery given 
the greater amount of time and more intensive focus that is possible in individual 
treatment. If CBI is found to be effective compared to SI, the next step would be to 
compare individual and group delivery of CBI. 
 
 
F.2. Control Condition 
Selection of control groups for psychosocial treatments is complex. Unlike medication 
trials, it is not possible to derive true “placebo” conditions that control for all aspects of 
the treatment delivery except the active ingredient (drug). A variety of control conditions 
have been used in behavioral treatment research, but there is no consensus regarding an 
optimal or standard control condition. There is increasing recognition that the design and 
selection of an optimal control condition depends upon the particular intervention being 
studied and the research question being addressed. One important consideration is how 

22 
 
much is known about the treatment being studied. Rounsaville and Onken62 outline a 
three stage framework including an initial stage (feasibility, pilot studies), RCTs / efficacy 
trials, and effectiveness studies. The proposed study would be considered a stage 2 
efficacy trial according to this model; for such trials non-specific comparison designs have 
been recommended 63. In addition to controlling for passage of time, testing, statistical 
regression towards the mean (all of which may be controlled for by a wait-list control), a 
non-specific comparison condition controls for the aspects of therapy that characterize 
most forms of therapy and are distinct from the hypothesized active mechanisms of the 
treatment being studied. This type of control allows for inferences about the benefits of 
the specific treatment interventions, beyond the benefits of for example, meeting with a 
therapist, receiving attention and support, and expectations of improvement. The control 
condition proposed for the current study, which was adapted from the control condition 
used in the CSP clinical trial testing the efficacy of prolonged exposure 58, was designed to 
achieve this goal. 
 
A treatment as usual control condition in some settings might serve the same purpose, if 
the “usual treatment” is clearly defined and consistently used, and does not include the 
hypothesized active mechanisms of the treatment being studied In the setting for the 
proposed study, however, treatment as usual is not uniform, includes a range of 
providers, and could include a range of interventions, including medication only, group 
therapy, and/or individual therapy possibly including some aspects of cognitive or 
behavioral interventions. Because treatment as usual may vary in different settings, the 
findings could have limited generalizability. Even with careful assessment of type and 
dose of any additional treatment received in both conditions, we are concerned that the 
heterogeneity of treatment and the potential overlap of some cognitive behavioral 
interventions would make it more difficult to achieve the goal of allowing inferences 
about the efficacy of the specific cognitive behavioral interventions included in CBI. 
 
G. Data Management and Analysis 
G.1. Data Management 
Research study staff will oversee data management procedures. Study data will be 
collected and managed using REDCap electronic data capture tools hosted at the 
Department of Veterans Affairs. REDCap (Research Electronic Data Capture) is a secure, 
web-based application designed to support data capture for research studies. Through 
REDCap, participants are able to respond to survey items electronically and additionally 
research study staff can manually enter responses. All study software and licensing, such 
as SPSS IBM (which will be used for data analyses) will be managed by PVAMC IT and 
IRM. For data that is entered manually, the project coordinator will be responsible for 
initial editing and correction of forms before they are data entered by the research 
assistant. As forms are entered into the master database, they will be checked against the 
participant tracking file to assure that all data that are gathered have been data entered. 
The data will be verified after entry and verification status will be tracked by the 
software. Validity checks will also be done as the data are entered, and questions or 
problems will be resolved by discussion between research study staff and the Interviewer. 
All data will be received stripped of personal identifiers. Because of the sensitive nature 

23 
 
of some of the data gathered, a number of precautions will be taken to prevent disclosure 
of information to unauthorized parties: (1) data sheets will be stored in locked offices of 
Dr. Tracie Shea (PI), building 32 of the PVAMC) (2) data will be entered in coded form, (3) 
data will be stored on a secure server behind the VA firewall 
(\\vhaproapp12\Research_Protocols\Shea\Anger-R),  (4) data will be protected from 
unauthorized access by passwords, (5) information that might potentially allow an 
individual participant to be identified will not be allowed in any publications or reports 
sent to individuals outside the study, (6) all employees who are to handle data will be 
trained in confidentiality policies and procedures, and (7) all data-related incidents will 
be reported to the local ISO and PO per VA policy.  Study files will be maintained in 
accordance with the Department of Veterans Affairs Record Control Schedule 10-1. Data 
protection and precaution measures are further detailed in the Protocol Appendix – ISO 
(see page 31). 
 
G.2. Data Analysis 
All major variables will be screened for inconsistent or abnormal values, and continuous 
measures will be assessed for skewness and outliers. Transformations to improve 
normality may be applied to continuous variables. Missing data rates and patterns will be 
assessed; in particular, missing data rates by treatment group will be studied. Although 
urn randomization tends to produce well-balanced treatment samples 59 analyses will be 
carried out to determine any baseline differences between the treatment groups on 
demographic or other prognostic variables, using chi square analyses for discrete 
variables and ANOVA for continuous ones. If significant treatment group differences are 
found on potentially important baseline variables, these variables will be covaried in 
outcome analyses. Data from all randomized study participants will be used to compare 
the outcome of the two interventions on an intent-to-treat basis. Hypothesis tests will be 
two-tailed. 
Participants will be counted in the intervention group to which they were randomized, 
regardless of the number of sessions they completed. We will make every attempt to 
complete a post-treatment and 3 and 6 month follow-up assessments on any participants 
who do not complete treatment. We will also conduct supplementary analyses including 
only those cases completing the full 12 sessions. 
 
Aim 1: Investigate the effectiveness of CBI on primary measures of outcome 
Hypothesis: Compared to SI, CBI will be associated with significantly larger reductions in 
anger and aggressive behaviors at post-treatment and at 3 and 6 month follow-ups. 
 
Aim 2: Investigate the effectiveness of CBI on secondary measures of outcome 
Hypothesis: Compared to SI, CBI will be associated with significantly more 
improvement in social functioning, occupational functioning, quality of life, and PTSD 
symptoms at post- treatment and at 3and 6 month follow-ups. 
 
For aims 1 and 2, we will use hierarchical linear modeling (HLM) for repeated measures 
to test for differences due to treatment condition, covarying for the baseline score of the 
dependent variable65. The primary significance test will be the treatment group main 

24 
 
effect over time, though there will also be a test for the time by treatment interaction. 
Significant time by treatment interactions will be followed up by post hoc tests at specific 
assessment points by calculating simple intercepts, simple slopes, and regions of 
significance. Relevant covariates will be included to adjust for any imbalances across 
treatment conditions. 
Missing data will be dealt with as follows. HLM analyses can include cases with some time 
points missing. In the primary analysis, we will include all cases with at least 3 of the 5 
outcome time points (4 & 8 weeks, posttreatment, and 3 & 6 months) non-missing. Then, 
we will conduct a sensitivity analysis including all randomized participants, in which any 
missing outcome values will be filled in with baseline scores, which is an extreme 
assumption. Consistency of results from the two approaches will bolster the credibility of 
the primary analysis. 
 
The primary dependent variables for aim 1 are the STAXI-2 Anger Expression Index, and 
the OAS-M Aggression Scale score. Outcome on these measures is assessed at 4 and 8-
week points during treatment, at post-treatment, and at 3 and 6 months follow-up 
assessments. DVs for aim 2 include two LIFE scales (global social and work functioning), 
the Outcomes Questionnaire total score, the WHOQOL-BREF  total score, and the CAPS 
total score. Outcome on these measures is assessed at post-treatment and 3 and 6-month 
follow-up assessments. 
 
For aims 1 and 2 the alpha will be set at .025 to account for multiple dependent variables. 
 
Supplementary post-treatment outcome analyses will be conducted using collateral 
measures (including the STAXI-II, Anger Control Scale and Modified Overt Aggression 
Interview). We will calculate Pearson correlations of participant and collateral scales as 
an indication of agreement. If outcome analyses based on collateral measures are 
consistent with analyses of participant measures, this would bolster the validity of the 
participant outcome findings. Divergent findings could be due to multiple factors that 
could influence the validity of the participant and the collateral reports. In this case we 
will conduct analyses using integrated collateral and participant scores, calculated by 
averaging the participant and collateral responses to each item. 
 
Aim 3: (Exploratory) Examine hypothesized mechanisms of action of CBI 
Hypothesis: Change in arousal, cognitive, and behavioral domains of anger will 
mediate outcome for anger and functioning in the CBI condition. 
 
In order to examine the mediating role of arousal, cognition, and behavior (NAS 
scales), we will use arousal, cognition, and behavior at post-treatment as mediators of 
the effect of treatment in predicting later anger and functioning at months 3 and 6. 
Therefore, these mediation tests will be fully prospective, as recommended by Kazdin 
& Nock66, and as exemplified in prior mediational research done by Dr. Stout 67. These 
analyses will covary for the baseline scores of the mediators. Mediation of treatment 
effects through NAS scales will be tested using the Sobel test 69, 70. Simulation tests 
indicate that we will have more than 80% power to detect mediation when both paths 
have small to medium effect sizes 71. 

25 
 
 
Aim 4: (Exploratory) Examine the effectiveness of CBI for those with and without 
PTSD We will test for an interaction between CBI vs. SI and PTSD status by 
calculating simple slopes. Since we will not have 80% power to test this interaction, 
we will calculate treatment effect sizes separately for the PTSD and the no-PTSD 
cases. 
 
G.3. Power Analysis 
Power for our repeated-measures design was estimated using methods described by 
Faes et al.71. We obtained intervention effect sizes ranging from 0.78 to 1.12 in our pilot 
study, but given the small sample and the instability of effect sizes derived from pilot 
studies 72 we have conservatively based our statistical power analysis for detection of 
medium effects. 
We will use a two-sided alpha level of .025 in the primary and secondary outcome 
analyses to correct for the number of dependent variables; i.e., each DV will be tested 
individually with an alpha level of .025, keeping the study-wise alpha at .05. With this 
alpha level and an estimated 80% follow-up, a sample size of 120 will provide 90% 
power to detect a medium effect size of .60. 
 
H. Time-Line 
We anticipate the following time-line for the study:  
 
Months 
0-6 Hiring, Training, IRB approvals 
6-33 Recruitment 
6-36 Treatment 
9-39 Follow-Up (3 month) 
12-42 Follow-Up (6 month) 
6-43 Data Entry and Management 
43-48 Final Data Analyses and Manuscript 
Writing 
 
 
I. Dissemination and Future Plans 
The proposed study is a randomized clinical trial of the efficacy of a cognitive behavioral 
intervention (CBI) for the treatment of trauma related anger in OEF/OIF veterans. Prior 
to the start of the study, we will register with ClinicalTrials.gov. This website contains 
over 100,000 trials sponsored by a variety of federal and private industry sources, and 
receives over 50 million page views per month and over 65,000 visitors daily. 
Dissemination will include submission of the study findings to a peer-reviewed journal. 
The findings will also be presented at professional conferences, such as the International 
Society for the Study of Traumatic Stress, and appropriate VA and Department of 
Defense conferences. If CBI is found to be significantly superior to the supportive therapy 
control (SI), we will consider multiple methods for further dissemination. We will create 
a fact sheet describing the intervention and findings and circulate to VA, National Guard 
and other military officials, and relevant DOD programs such as the Defense Centers of 
Excellence. The manual will be made available free of charge. We could begin 
dissemination efforts by implementing the treatment at the Providence VAMC. We would 

26 
 
provide the manual and training to the mental health clinicians in the PTSD and 
Returning Veterans clinics, and encourage the use of relevant self-report outcome 
measures to provide an index of effectiveness in a naturalistic setting. A proposal of a 
multi-site study through the Cooperative Studies Program would be considered, to more 
formally test the effectiveness of the intervention across multiple VA settings. 
5. Privacy and Confidentiality 
Every effort will be taken to protect the confidentiality of the participants in this study. All 
information about the veteran that is gathered during the research (including recordings) 
will be kept strictly confidential. However, veterans will be informed that there is no 
guarantee that the information gathered during the research cannot be obtained by legal 
process or court order. Furthermore, veterans will be informed that complete 
confidentiality cannot be promised to subjects, particularly to subjects who are military 
personnel, because information bearing on their health may be required to be reported to 
appropriate medical or command authorities. Additionally, federal and non-federal 
monitoring agencies such as the Department of Veterans Affairs may also access the 
veteran’s research records related to this study to monitor the security of the trial. All 
data will be received stripped of personal identifiers. Measures will be identified with a 
study ID number not based on a personal identifier. A cross-index of names and ID 
numbers will be stored in a separate locked location from all data. Data entry and 
management will take place in VA offices in Bldg. 32. Additional precautions include: (1) 
Data sheets will be stored in locked offices, (2) data will be entered in coded form, (3) 
data will be stored in computer files on the secure Research Server in Bldg 32 and 
protected from unauthorized access by passwords, (4) information that might potentially 
allow an individual participant to be identified will not be allowed in any publications or 
reports sent to individuals outside the study, and (5) all employees who are to handle 
data will be trained in confidentiality policies and procedures. Records will be 
maintained per Veterans Affairs Record Control Schedule 10-1. 
 
Assessments and intervention sessions will occur at the Providence VAMC. The veterans 
will be informed that their VA medical records will note their enrollment in a research 
study with a copy of their consent form attached. In addition, their attendance at each AE 
or HEC session will be noted in their medical records. This will include, if applicable, any 
safety issues (e.g., suicidal or homicidal statements they made) and how these were 
addressed in session. The veteran will be informed that none of the other data from this 
study will be included in their medical records, except for attendance at intervention 
sessions. All study data, stripped of identifying information, will be locked in a file 
cabinet as described above. Records will be maintained per Veterans Affairs Record 
Control Schedule 10-1. 
6. Data Safety and Monitoring 
Monitoring of safety in the proposed study will be the responsibility of all personnel on 
the project, with primary responsibility and supervision by Dr. Shea. The Institutional 
Review Board at the Providence VA Medical Center will approve the protocol and the 

27 
 
Statement of Informed Consent for the study and will provide oversight of data and 
safety issues. 
Separate review of the protocol and consent form are made by the safety officer at the VA 
Medical Center. The study protocol will receive IRB approval prior to soliciting or 
requesting consent from any participants. Moreover, the study will be reviewed on an 
annual basis by the IRB committee with regard to recruitment and retention and annual 
reports will be made by the PI to the IRB chair of the Providence VA Medical Center 
regarding the progress of the proposed project, including any issues pertinent to 
recruitment, retention, confidentiality, and safety of human subjects. Any incidents that 
involve a breach of this plan or serious accident/injury will be reported to the IRB chair at 
the Providence VA Medical Center. As discussed, potential risks, albeit minimally likely, 
include distress or discomfort with questions regarding trauma history. 
Adverse Event Reporting 
In the case of an Adverse Effect (AE) or a Serious Adverse Effect (SAE), a written report of 
the AE or SAE will be prepared for the Chair of the IRB at the Providence VA Medical 
Center. Any such AEs or SAEs will be presented to the full IRB committees. SAEs will be 
reported within 24 hours. Examples of serious adverse effects include death, life- 
threatening adverse events, suicide attempts, and inpatient hospitalization. The report of 
such AEs or SAEs will include whether they were expected or unexpected, a rating of 
severity of the event, a brief narrative summary of the event, a determination of whether 
a causal relationship existed between the study procedures and the event, whether the 
informed consent should be changed as a result of the event, and whether all enrolled 
participants should be notified of the event. The annual progress reports to the IRB 
require summary information regarding all AEs and SAEs occurring during that year. We 
have appointed Thomas O’Toole, MD as our medical monitor. Dr. O’Toole  is a Providence 
VA Medical Center physician and researcher who works  independently from our research.  
He will be called upon to review all AEs and SAEs, and to provide input regarding the 
possible connection to the study protocol. 
7. Risks / Benefits Assessment 
A. Protection Against Risks 
Potential risks include distress associated with discussing traumatic or other disturbing 
events or emotions, and breach of confidentiality. 
Risk: Emotional distress associated with discussing traumatic or other upsetting events 
or emotions. 
Minimization: Study participants will participate in assessments and treatment sessions 
during which they may identify and discuss difficulties they are having with anger and 
with their adjustment home from a hazardous deployment. They also may discuss 
upsetting events that they experienced while deployed. Although the assessments are 

28 
 
unlikely to be more upsetting than standard clinical assessments, discussion of these 
experiences may make them feel uncomfortable. Should this happen, veterans will be 
informed that they can refuse to answer any question they wish or stop the interview at 
any time. Any participant verbalizing or showing signs of distress will be asked to remain 
in the assessment or treatment setting until their distress is at a manageable and 
comfortable level. No participant judged to be in danger of hurting him/herself or others 
will be allowed to leave the study setting unaccompanied. All study personnel who 
interact with study participants will have been professionally trained to respond to 
negative emotions if these should occur and to access emergency services if necessary. 
Collateral participants will also be informed that they may refuse to answer any question 
or stop the interview at any time. It is unlikely, but possible, that a collateral participant     
may show signs of distress. The same procedures will apply to these participants, i.e. if 
distressed they will remain in the assessment setting until their distress is at a 
manageable level. Dr. Shea will be available by phone or in person to study personnel 
during assessment and treatment sessions. She will be contacted immediately if there are 
any concerns about the participant’s emotional state, or upon any signs of suicidal or 
homicidal risk. All participants will be eligible for emergency services including referral 
to the Veterans Affairs Medical Center interim care during normal business hours or the 
emergency room after hours and on weekends and holidays, and inpatient 
hospitalization. 
 
Additionally, therapists will be doctoral level psychologists or masters level social 
workers, and trained to help veterans reduce and manage feelings of intense anger. 
Assessments will be conducted by trained staff with prior experience in conducting 
clinical interviews in psychiatric samples. Veterans will have the opportunity to discuss 
any uncomfortable feelings with the assessment interviewers and treatment providers. 
The veteran will also be informed that the therapist and assessment interviewer will 
always place the veteran’s well-being and safety over research considerations. 
Furthermore the veteran will be informed that should they experience any problems, they 
should report them to their therapist or to the principal investigator of this study. 
 
Risk: Breach of Confidentiality 
Minimization: All employees who handle data will be trained in confidentiality policies 
and procedures. All data and medical information obtained about the veteran, as an 
individual, will be considered privileged and held in confidence; the veteran will not be 
identified in any presentation of the results. Assessments and treatment sessions will 
occur at the Providence VAMC. Veterans will be informed that their VA medical records 
will note their enrollment in a research study with a copy of their consent form attached. 
In addition, their attendance at each therapy session will be noted in their medical 
records. This will include, if applicable, any safety issues (e.g., suicidal or homicidal 
statements they made) and how these were addressed in treatment. The veteran will be 
informed that none of the other data from this study will be included in their medical 
records, except for attendance at treatment sessions. All study data, stripped of 
identifying information, will be locked in a file cabinet. Study files will be maintained in 

29 
 
accordance with the Department of Veterans Affairs Record Control Schedule 10-1. 
 
All of the study data will be coded without the use of the veteran’s name and social 
security number and will be done in accordance with the law. Research information 
about the veteran will remain in Dr. Tracie Shea’s (PI) locked private research files and 
will be available only to staff connected with this study or individuals involved in human 
subjects protection. It will not be given to other medical care personnel at the veteran’s 
VA or the Department of Veterans Benefits without an additional written consent from 
the veteran. Any reports or publications of this study will not include information that 
could be used to identify the veteran. 
 
Measures will be identified with a study ID number not based on a personal identifier. A 
cross-index of names and ID numbers will be stored in a separate locked location from all 
data. Transfer of data will include only de-identified data, and will use encryption for any 
electronic transfer. Additional precautions include: (1) Data sheets will be will be stored 
in locked offices of Dr. Tracie Shea (PI), building 32 of the PVAMC, (2) data will be entered 
in coded form, (3) data will be stored in computer files protected from unauthorized 
access by passwords, (4) information that might potentially allow an individual 
participant to be identified will not be allowed in any publications or reports sent to 
individuals outside the study, and (5) all employees who are to handle data will be 
trained in confidentiality policies and procedures. 
 
Digital recordings will be made of all treatment and assessment sessions. These 
recordings will be reviewed by study personnel who are providing ongoing supervision 
to study therapists and interviewers, and by individuals conducting reviews of how well 
we followed study procedures (adherence ratings). These recordings will be coded 
without the use of the veteran’s name or social security number, or any other 
identifying information. 
Digital recordings may also be downloaded into a file transfer program (FTP) which is 
password protected. Research staff will be the only people to have access to the FTP.  
Study files will be maintained in accordance with the Department of Veterans Affairs 
Record Control Schedule 10-1. 
B. Potential Benefits of the Proposed Research to the Subjects and Others 
Poorly controlled anger is a common problem with often devastating effects in veterans 
who have been exposed to trauma while they served in a warzone. Additionally, 
individuals who have experienced trauma may continue to respond with excessive anger 
and aggression in situations that they perceive as threatening (even in the absence of life- 
threat) resulting in destruction of property, threats of physical violence and/or physical 
fights. Although this response may have been adaptive during trauma, it is maladaptive 
when individuals cannot regulate the intensity and expression of anger as appropriate 
with current socio-environmental conditions. There is empirical support for the use of 
Cognitive Behavioral Therapy (CBT) similar to what we propose in the treatment of 
other  populations with anger, and preliminary support for positive effects in veteran 

30 
 
samples. 
Through participation in this study, the veteran receives a comprehensive psychological 
assessment and treatment at no cost. Additionally, potential effects of the interventions 
could possibly lead to an improvement in the veterans’ ability to manage their anger and 
adjustment to being home following deployment. Furthermore, it is hoped that 
information gained from this study will improve treatment for veterans who have served 
in hazardous deployments, even if the veteran themselves do not experience any 
improvement during their participation in the study. Given the published reports and our 
own experience, the potential benefits outweigh the risks. 
C. Importance of the Knowledge to be Gained 
Problems with anger are common in veterans who have been deployed to a warzone, and 
can lead to devastating consequences in terms of family, social, and occupational 
functioning. Although promising findings for cognitive behavioral treatments have been 
reported, to date there is not a single adequately powered randomized trial designed to 
test the efficacy of an anger treatment compared to an active control condition in 
veterans. The goal of the proposed research is to determine if the Cognitive Behavioral 
Intervention to be tested can provide an effective treatment for anger problems in 
OEF/OIF veterans, and reduce the toll that these problems take on social and 
occupational functioning and quality of life. The potential of the research to ultimately 
benefit veterans with anger problems, and the provision of comprehensive assessment 
and treatment compares favorably when weighted against the potential risks of 
discomfort or distress, which are expected to be mild. 
 
 
 
 
 
 
 
 
 
 
 
 
 
PROTOCOL APPENDIX - ISO 
 
All VA sensitive information will be stored on the secure VA server located at: 
\\vhaproapp12\Research_Protocols\Shea\Anger-R 
 

31 
 
All data is collected using a study code that does not identify the patient. The cross-link 
matching the patient with the code is saved in a password-protected file, separate from the 
rest of the data files, on the same secure VA server that only the PI and research staff have 
access to. Paper versions of the assessment will be stored in locked filing cabinets in locked 
offices of Dr. Tracie Shea (PI), in building 32 of the PVAMC. Additionally, no VA sensitive 
data will be transmitted outside the VA.  Only VA non-sensitive data will be transmitted 
electronically via internet for discussion during study meetings.  Data collected from this 
study will be used for research purposes.  No patient identifiable information will be 
released or published without written permission unless required to do so by law.  Records 
will be maintained in accordance with the Department of Veterans Affairs Record Control 
Schedule 10-1.   
 
In the event that theft, loss of other unauthorized access of sensitive data or storage devices 
and non-compliance with security controls occur, study staff has been instructed to follow 
the Providence VA Medical Center’s standard operating procedure on incidence reporting.   
 
Transcription records will be maintained according to RSC 10-1. All digital recordings will 
be uploaded to the server for storage. Once the records are copied and verified from the 
recording device, the device will be turned into the ISO for final disposition.  
 
Original data files on portable storage media, i.e., CDs, USB Flash Drives, etc, will be 
uploaded to the server for storage. Once the files are copied and verified from the 
device/media, the device/media will be turned into the ISO for final disposition. 
  
Original data collected on non-digital storage media, such as audio tapes, will be 
maintained in accordance with VA RCS-10-01. 
 
We will use REDCap electronic data capture tools hosted at the Department of Veterans 
Affairs. REDCap (Research Electronic Data Capture) is a secure, web-based application 
designed to support data capture for research studies. Through REDCap, participants are 
able to respond to survey items electronically and additionally research study staff can 
manually enter responses. All study software and licensing, such as SPSS IBM (which will be 
used for data analyses) will be managed by PVAMC IT and IRM.   
 

32 
 
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