CAP - Using Emotion Regulation to Decrease Aggression in Veterans With PTSD
Phase: NA
Conditions: Chronic Post-Traumatic Stress Disorder
Sponsor: VA Office of Research and Development

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Using Emotion Regulation to Decrease Aggression in Veterans With PTSD 
Short Name: Manage Emotions to Reduce Aggression (MERA) 
Protocol v.4  Dated 1/08/2018 
IRB ID: Pro00023884 
PI: Shannon Miles, PhD 
AUDIT 
…….. Alcohol Use Disorders Identification Test 
CAP 
…….. Consortium to Alleviate PTSD 
CAPS 
…….. Clinician-Administered PTSD Scale 
CPT 
…….. Cognitive Processing Therapy 
DERS  
…….. Difficulties in Emotion Regulation Scale 
DSM 
…….. Diagnostic and Statistical Manual of Mental Disorders 
DUDIT 
…….. Drug Use Disorder Test 
EBP 
…….. Evidence-Based Psychotherapy 
ERQ 
…….. Emotion Regulation Questionnaire 
ERQ-cog 
…….. Emotion Regulation Questionnaire - cognitive reappraisal subscale 
ERQ-es 
…….. Emotion Regulation Questionnaire - expressive suppression subscale 
IPAS 
…….. Impulsive Premeditated Aggression Scale 
MERA 
…….. Manage Emotions to Reduce Aggression  
JAHVA 
…….. James A. Haley Veterans Hospital  
OEF 
…….. Operation Enduring Freedom 
OIF 
…….. Operation Iraqi Freedom 
OND 
…….. Operation New Dawn 
OAS 
…….. Overt Aggression Scale 
PCL 
…….. Posttraumatic Stress Disorder Checklist 
PC-PTSD 
…….. Primary Care PTSD Screen 
PCT 
…….. PTSD Clinical Team 
PE  
…….. Prolonged Exposure 
PTSD 
…….. Posttraumatic Stress Disorder 
VA 
…….. Veterans Affairs 
 
Funding Source:  
 
    
Organization:  Department of Veteran 
Affairs:  Consortium to Alleviate PTSD 
(CAP) 
Institutions where work will be performed: 
James A Haley Veterans Affairs Hospital  
1. Rationale:  Veterans with posttraumatic stress disorder (PTSD) have higher rates of impulsive aggression, 
aggression that is emotionally charged, reactive, and uncontrolled, than Veterans without PTSD. Emotion 

2 
 
regulation difficulties mediated the relationship between PTSD symptoms and impulsive aggression. 
Additionally, Veterans who feared their emotions at pretreatment were less likely to complete PTSD evidence-
based psychotherapy, such as cognitive processing therapy (CPT) or prolonged exposure (PE). These results 
indicate a potential treatment avenue to reduce impulsive aggression and improve evidence-based 
psychotherapy outcomes, namely, to increase emotion regulation skills. This pilot project will test the feasibility 
of implementing a 3-session emotion regulation training and generate pilot data on its effectiveness at reducing 
impulsive aggression and increasing PTSD treatment initiation, engagement, and completion.  
 
2. Background: Aggression in returning Veterans. Aggression is common among Veterans with PTSD.1 Forty-
eight percent of returning Veterans with PTSD reported engaging in physical aggression, and 20% reported 
engaging in severe violence in the first year after deployment.2  Veterans with PTSD have more anger, hostility3 
and certain forms of violence, such as intimate partner aggression,3,4 than civilians. The association between 
PTSD and aggression is concerning, considering 7-20% of Afghanistan and Iraq War Veterans have PTSD.5,6 
Aggression can have devastating interpersonal and societal consequences for victims and perpetrators, 
including incarceration,7,8 family violence, and disruption of treatment-facilitating factors, such as social 
support.9,10  
Aggression research has identified two primary aggression subtypes—impulsive and premeditated11—and 
each has been associated with different clinical correlates12 and treatment outcomes.11,13 Impulsive aggression 
has been characterized as emotionally charged, reactive, and uncontrolled. Episodes of impulsive aggression 
frequently result in regret for the act. Premeditated aggression is considered deliberate, instrumental, and 
planned.11 Seventy percent of Veterans presenting to a Veterans’ Affairs (VA) hospital with PTSD and aggression 
primarily engaged in the impulsive type of aggression.18 The preponderance of impulsive aggression in this 
population indicates a potential opportunity for intervention, and we are therefore focusing our efforts on this 
subtype.  
 
Emotion dysregulation mediates the relationship between PTSD and impulsive aggression. One factor related 
to impulsive aggression is emotion regulation.16 Lacking or underdeveloped skills in emotion awareness, 
emotion acceptance, behavioral control, and/or content-appropriate regulation strategies is considered 
emotion dysregulation.17 A diminished capacity for emotion regulation is evident in PTSD samples,25  in both 
cross-sectional25-26 and longitudinal studies.27 Importantly emotion dysregulation fully mediated the relationship 
between PTSD severity and impulsive aggression in a Veteran PTSD sample.16 Emotion dysregulation as the 
mediator, or underlying mechanism, of the relationship between PTSD and impulsive aggression allows for the 
potential of addressing impulsive aggression through building emotion regulation skills. In civilian samples, 
emotion regulation treatments have already augmented PTSD treatments and led to better emotion regulation 
abilities and reductions in PTSD symptoms.34-36 While emotion regulation treatments are commonly provided in 
the VA, only 1 published study tested an emotion regulation treatment in conjunction with cognitive-behavioral 
skills training for trauma-exposed Veterans.37 This study found that reductions in fear of losing control of one’s 
affect (an aspect of emotion regulation) predicted reductions in PTSD symptoms (β = .56). The proposed study 
addresses the need for research on how emotion regulation training can augment PTSD treatments in Veteran 
samples, and to determine whether emotion regulation can be taught in a condensed time frame, to better 
accommodate busy Veterans’ schedules.  
 
Condensing the duration of emotion regulation treatments for Returning Veterans. Often, efficacious 
treatments need to be adapted to be successfully implemented within existing clinics and cultures.43 For 
example, current emotion regulation treatments improve emotion regulation abilities; yet their format may 
need to be altered to fit the needs of busy Operation Enduring Freedom (OEF) / Operation Iraqi Freedom (OIF) 
and / Operation New Dawn (OND) Veterans. Emotion regulation treatments in previous studies were delivered 

3 
 
in residential/inpatient settings37 or in outpatient settings over 8 to 12 weeks.34-36 This duration of treatment, 
particularly when offered in combination with CPT or PE, is an unfeasible time commitment for OEF/OIF/OND 
Veterans, who are already difficult to engage in mental health care due to family and work obligations.44 
Additionally, the majority of drop outs from PTSD evidence-based psychotherapies occur prior to session 3,45 
thus, the initial therapy sessions with these Veterans are a critical time for skill development and treatment 
“buy in.” A provider may only have up to 3 sessions to assist Veterans with impulsive aggression.  
 
A secondary consequence of teaching Veterans how to manage their emotions may be increasing evidence-
based psychotherapy initiation, engagement, and completion. PTSD severity is a predictor of dropout from 
evidence-based psychotherapy.46-48 Providing initial relief of negative affect through better emotion regulation 
skills may help Veterans manage their everyday distress and be able to focus on PTSD evidence-based 
psychotherapies.  
 
In summary, the primary goal of this pilot project is to test the feasibility and preliminary outcomes of a brief 
course of emotion regulation training in Veterans with PTSD and impulsive aggression. An exploratory goal is 
to gather information on the subsequent PTSD evidence-based psychotherapy initiation, engagement, and 
completion rates. 
3. Research Questions 
 
    
Research objectives. This is a 2-year pilot study designed to test the feasibility and preliminary 
effectiveness of Manage Emotions to Reduce Aggression (MERA), delivered in three (3) 90-minute 
sessions.  
Research Aims 
Aim 1: To examine the feasibility and acceptability of MERA training in a sample of 20 OEF/OIF/OND 
male Veterans who have not initiated a PTSD evidence-based psychotherapy.  
Aim 2: To gather data on the effectiveness of MERA by measuring pre- to posttraining changes in 
impulsive aggression and emotion regulation skills. 
Exploratory aim: To obtain data on whether MERA increases PTSD evidence-based psychotherapy 
initiation, engagement, and completion. 
 
4.  Design/Procedure 
Select one category that most adequately describes your research:  
Pilot study that will be an open trial without a control group. There will be no 
random assignment; all subjects will get the active treatment. 
 
  
  
Recruitment. Veterans will be identified in 3 ways: 1.) At JAHVH, Veterans who are diagnosed with
PTSD are offered evidence-based psychotherapy; providers who give a Veteran a PTSD diagnosis will 
offer MERA to Veterans who endorse aggression. If the Veteran agrees, providers can co-sign the 
research staff on the Veteran’s note in the electronic medical records or call the study staff. 2.) 
Research staff will examine up to 1000 new referrals for PTSD evidence-based psychotherapy and 
with the Waivers of HIPPA Authorization and Informed Consent examine their electronic medical 

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records to see if they may be eligible for the study. If veterans appear to meet study criteria, study 
staff will send the Veteran a letter and if no opt-out call is received within two weeks, call Veteran and 
explain the study. 3.) Veterans can self-refer if they see study flyers or hear about the study from 
other Veterans.  
Research staff will conduct a phone screen to estimate if the Veteran will meet inclusion criteria, and 
if the Veteran appears appropriate for the study, a full assessment will be conducted.   
Screening Procedures. Research staff will call referred Veterans two weeks after the initial study letter 
is sent to Veterans (or after a provider refers them to the study), explain the study, and receive verbal 
consent to continue the telephone call. Research staff will then conduct a phone screen to assess for 
PTSD (PC PTSD-5), aggression frequency in the past month (self-reported number of aggressive acts); 
active suicidal intent; active homicidal intent; history of PE/CPT initiation; and, if the Veteran has an 
independent aggression rater, s/he will allow the study staff to contact in order to verify aggressive 
acts. No screening data will be used as study data. For their convenience, Veterans may be seen in 
person for the screening. Veterans who meet study criteria will be invited to schedule a time to learn 
about the study and review informed consent forms. Veterans must then meet eligibility criteria 
based on the pre-training assessment, before being included in the study.  
Measures and assessment schedule. All assessments are routinely used within the VA and DoD. 
Veterans will be assessed on the following areas: 
1) Demographics and Military Service Characteristics Form - The form measures standard 
demographics (race, gender, age) and military service information (e.g., rank). Veteran will be 
asked to list all medications they are taking.  
2) Alcohol Use Disorders Identification Test (AUDIT) self-report version. The AUDIT59 will be used to 
identify people with hazardous or harmful patterns of alcohol consumption, which is an exclusion 
criterion. Items are scored on a 4-point scale for a highest possible total score of 40. The AUDIT 
has good internal consistency (α = .80-.93) as well as sensitivity and specificity.60 The first three 
items identify current alcohol use. Only the first three items will be scored. Veterans with scores 
of 5 or above will be excluded from the study.  
3) Drug Use Disorder Identification test (DUDIT) self-report version.86 DUDIT will be used to identify 
people with hazardous patterns of substance use (all drugs besides alcohol). Items are scored on a 
4-point scale for a total of 44 points. A scores of 25 suggests a person is highly dependent on 
drugs and any Veteran with this score will be excluded from the study.  
4) Mini International Neuropsychiatric Interview (MINI 7.0): The MINI 7.0 is a short, structured 
clinical diagnostic interview designed to cover the major psychiatric disorders in DSM-5 and ICD-
10. It is widely used in epidemiological studies and multi-site clinical trials. Responses to the 
interviewer’s questions are rated as either “yes” or “no.” The MINI cannot be used to index the 
severity of a given psychiatric problem, only caseness. When there are many skip-outs, the MINI 
takes ~15 minutes to administer. The MINI will be used to assess for bipolar and psychotic 
disorders, which are exclusion criteria.  
5) PTSD Criteria 
a) Primary Care PTSD Screen (PC-PTSD-561,62). The PC-PTSD-5 contains 5 items (PC PTSD-5) that 
are scored dichotomously as either 0 (no) or 1 (yes). Items map onto re-experiencing, 

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emotional numbness, avoidance, hyperarousal, and changes in cognition/affect symptoms 
experienced in the past month. A score of 3 or more is considered a positive screen. The PC-
PTSD-5 will be given during a screening phone call to assess whether the Veteran will likely 
meet the eligibility requirement of having a current PTSD diagnosis.  
b) Life Events Checklist for DSM-5 (LEC-5): The LEC-5 (Weathers, Blake, Schnurr, Kaloupek, Marx, 
& Keane, 2013) includes the same list of 16 different potentially traumatic life events from 
the original LEC that are commonly associated with PTSD symptoms and designed to facilitate 
PTSD diagnosis (Gray, Litz, Hsu, & Lombardo, 2004). There is also a blank for specifying an 
additional stressful event not encompassed in the 16 events. For each potentially traumatic 
life event, respondents rate their experience of that event on a 6-point nominal scale (1 = 
happened to me, 2 = witnessed it, 3 = learned about it, 4 = part of my job, 5 = not sure, and 6 
= doesn’t apply). The primary addition to the LEC-5 is a category involving occupational 
exposure (“for example, paramedic, police, military, or other first responder”). There has not 
been a publication on the psychometric properties of the LEC-5, but the measure is nearly 
identical to the original LEC. In a group of 108 undergraduate psychology students the LEC 
demonstrated good convergence with the Traumatic Life Events Questionnaire (average 
kappa = 0.55) and correlated with the Posttraumatic Stress Disorder Checklist – Civilian 
version (reliability coefficients 0.34 to 0.48). The LEC demonstrated good test-retest reliability 
over 7 days.  In 131 combat veterans the LEC was related in the predicted directions with 
other measures of psychopathology known to be associated with potentially traumatic life 
events as assessed by the Posttraumatic Stress Disorder Checklist – Military version, Clinician-
Administered PTSD Scale, and the Mississippi Scale for Combat-Related PTSD. 
c) Deployment Risk and Resiliency Inventory-2 (DRRI-2):  The DRRI-2 (Vogt, et al., 2013) is a suite 
of 17 individual scales that assess key deployment-related risk and resilience factors with 
demonstrated implications for veterans’ long-term health.  Only the Combat Experiences and 
Postbattle Experiences subscales will be used to assess stressful deployment experiences. 
d) Clinician-Administered PTSD Scale (CAPS) is a structured diagnostic interview for assessing 
PTSD. It has excellent psychometric properties and diagnostic efficiency.63 The CAPS-5 uses a 
single 5-point ordinal rating scale to measure symptom severity. CAPS-5 scores range from 0 
to 80, with higher scores indicating greater PTSD severity. The CAPS-5 will be administered by 
the study staff. To meet PTSD diagnostic criteria and be included in the study, a Veteran must 
endorse a score of 2 or higher on at least 1 Criterion B, 1 Criterion C, 2 Criterion D, and 2 
Criterion E symptoms. The Veteran must have the symptoms for at least 1 month with 
clinically significant distress and/or functional impairment. The dimensional CAPS-5 score will 
be used to assess symptom change pre- to posttraining (exploratory outcome). To identify the 
index trauma(the worst and most currently distressing event), participants will first complete 
the DRRI-2 Combat Experiences Scale, the DRRI-2 Postbattle Experiences Scale, and the Life 
Events Checklist for DSM-5 (described above).  
e) PTSD Checklist-564 (PCL-5) is similar in form to the PTSD Checklist (PCL) based on the DSM-
IV.65,66 The PCL-5 is a 20-item self-report measure, selected for its dimensional sensitivity, with
higher scores reflecting greater PTSD severity. Scoring is based on how much the patient has 
been bothered by the symptoms in the past month on a scale from 0 (not at all) to 4 
(extremely). A cutoff of 38 represents a likely PTSD diagnosis. + 
6) Emotion regulation.   
a) The Difficulties in Emotion Regulation Scale (DERS)17 is a 36- item self-report measure with 6 
different emotion-dysregulation factors: nonacceptance of emotional responses, difficulties 
engaging in goal-directed behaviors, impulse-control difficulties, lack of emotional awareness, 

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limited access to emotion regulation strategies, and lack of emotional clarity. The factor 
structure has been replicated in college-student samples17 and psychiatric inpatients with 
good psychometric properties.67 Scoring is based on how well the item describes the 
individual, from 1 (almost never) to 5 (almost always); higher scores represent more emotion 
dysregulation. The total score will be used in this study.   
b) The Emotion Regulation Questionnaire23 (ERQ) is a 10-item self-report measure with 2 factors 
that assess specific emotion regulation strategies: cognitive reappraisal (changing the way 
one thinks about a situation) and expressive suppression (not expressing the emotion 
outwardly but feeling it internally). More effective emotion regulation is indicated by higher 
cognitive reappraisal scores and lower expressive suppression scores. Internal-consistency 
estimates (alpha) were .80 for the reappraisal factor and .73 for the suppression factor in a 
college-student sample,23 and both were greater than .75 in a Veteran sample.69 Scoring is 
based on how well the items describe the individual in the past week, from 1 (strongly 
disagree) to 7 (strongly agree).   
7) Aggression.  
a) The Impulsive Premeditated Aggression Scale50  (IPAS) is a 30-item self-report measure that 
assesses impulsive and premeditated aggression. In psychiatric outpatients, Cronbach’s 
alphas were .82 and .77 for premeditated aggression and impulsive aggression, respectively. 
Scoring is based on how well each item describes an individual’s aggressive acts, from 1 
(strongly disagree) to 5 (strongly agree). To determine eligibility for the study, the measure 
will be scored in a categorical method by calculating the total percentage of positive items 
(“strongly agree” or “agree”) for each aggression subscale and classifying the Veteran as 
either a primarily impulsive or premeditated aggressor, based on which subscale has the 
highest percentage of positive items. The summed dimensional score for the impulsive 
aggression subscale will be used to examine pre to posttraining differences in impulsive 
aggression.  
b) The Overt Aggression Scale (OAS58) is a 17-item self-report measure that assesses frequency 
of different aggression acts, including verbal and physical aggression against self, other, and 
objects. Intraclass correlation coefficients of reliability ranged from .89-.99 in 2 adult 
psychiatric samples.58 The measure will be adapted for the current study to indicate 
frequency of each aggressive act over the past week. Aggressive acts will be summed to 
create a total score.  
c) Independent verification of aggressive acts – all Veterans will have an adult (18 years or older) 
live-in partner, family member, or roommate with whom he has in-person contact most days 
of the week verify aggression by independently answering the OAS, based on the Veteran’s 
behavior. Independent verification of aggressive acts is an important feature of high quality 
aggression research,70,71  improving the quality of data without, in our experience, hindering 
recruitment. Impulsive aggressors may have impaired memory of the aggressive acts because 
of the intensity of rage, and they often confuse anger with aggression. Veterans may not think
they are improving if they still experience anger, even if they are not acting aggressively.13,70,71 
However, it is the decrease of aggression, not the elimination of anger, that is the goal of the 
training. The independent aggression rater will complete the OAS before and after their 
Veteran participants in MERA via a phone call with the study staff.   
d) The Pre Index Event Aggression survey is an 8-item self report of aggressive acts prior to the 
PTSD index event.  Currently, there is no available instrument to briefly and retrospectively 
gauge aggression in Veterans across the life span. this This is a new instrument that is being 
piloted with this study. This is not an outcome measure.  

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8) Veterans’ acceptability of the training will be measured by an exit interview during the post-
training assessment. The 25-item exit interview has 6 open-ended questions that asks about the 
most and least useful parts of MERA and suggestions for improvement. The 8 skills taught in the 
training are listed, and Veterans answer whether they learned the skill, are using it, and if it is 
helpful. The remaining items are either yes/no or Likert-scale questions that ask about therapist 
characteristics and the overall program experience. 
 
Pretraining assessment procedures. Veterans who are eligible based on the phone screen will be 
scheduled for an in-person, pretraining assessment. Prior to the assessment, research staff will 
explain the study to the Veteran and answer any questions. After providing informed consent, the 
Veteran will complete study measures (described above in Measures and Assessment Schedule).  
The CAPS-5 will be administered by a master’s level independent evaluator. The assessment session 
will be audio taped; to estimate interrater agreement, a random 3% of tapes will be evaluated by the 
study staff. After the pre-training assessment, study staff will review the Veteran’s answers to the 
self-report questionnaires and the structured interviews. If the Veteran meets inclusion criteria and 
does not meet exclusions criteria, then study staff will call the Veteran within 7 days to notify him that
the study appears to be an appropriate fit and alert him of when the next treatment session will be. If 
the Veteran does not meet criteria, study staff will call the Veteran (within 7 days) and explain that 
the study does not appear to be a good fit for the Veteran. All Veterans will already be established 
within the VA and will be reminded of their next mental health appointments. If the Veteran desires 
additional resources, the PI will complete appropriate requests via the electronic medical records.  
If Veterans are found to be eligible they will obtain a baseline level of aggression (and reduce 
retrospective bias), by completing an aggression tracking forms (OAS) during the approximate 2 
weeks between the pretraining assessment and the treatment sessions. Because Veterans may 
inaccurately report aggressive acts, an inclusion criterion is an independent aggression rater who is 
willing to verify aggressive acts. This is clearly stated in the informed consent and will be explained to 
the Veteran. Study staff will contact the independent aggression rater by phone and read the OAS to 
him/her (See Independent Aggression Rater Script). This should take less than 10 minutes. Aggression 
frequency reported by the independent aggression rater and Veteran will be compared to determine 
whether the Veteran’s report is accurate. This information will be helpful in determining recruitment 
procedures for the subsequent studies/grant. 
Veterans who do not meet the inclusion criteria or meet exclusion criteria will be referred back to the 
appropriate clinic, either General Mental Health Clinic or PTSD Clinical Team, depending on the 
Veteran’s needs. If a Veteran needs immediate treatment (e.g., suicidal intent, active psychotic 
symptoms), s/he will be referred for immediate evaluation following standard VA emergency 
protocols. Veterans will be able to engage in usual care during the study.  
Assessment schedule  

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Measure  
No. 
items 
Screen 
Pre-
training 
(2 wk. 
before 
MERA) 
1st 
MERA 
session 
2nd 
MERA 
session 
3rd 
MERA 
session  
Post-
training 
(1 mo. 
post 
MERA) 
Chart  
review  
(6 mo. 
post 
MERA) 
Inclusion criteria/Sample Description 
PC-PTSD 
4 
X 
 
 
 
 
 
 
Demo- 
graphics 
18 
 
X 
 
 
 
 
 
MINI- 
Psychotic 
Disorders 
14 
 
X 
 
 
 
 
 
MINI-Bipolar 
Disorders  
8 
 
X 
 
 
 
 
 
LEC-5 
17 
 
X 
 
 
 
 
 
DRRI-
Combat 
experience  
18 
 
X 
 
 
 
 
 
DRRI-
postbattle 
experiences 
15 
 
X 
 
 
 
 
 
AUDIT 
10 
 
X 
 
 
 
 
 
DUDIT 
11 
 
X 
 
 
 
 
 
CAPS-5 
30 
 
X 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
ERQ 
10 
 
X 
X 
X 
X 
X 
 
Independent 
OAS 
17 
 
X 
 
 
 
X 
 
IPAS 
30 
 
X 
 
 
 
X 
 
PIEA 
5 
 
X 
 
 
 
 
 
Primary outcomes 
 
 
 
 
 
DERS 
36 
 
X 
 
 
 
X 
 
OAS 
17 
 
X 
X 
X 
X 
X 
 
Exit 
interview 
25 
 
 
 
 
 
X 
 
EBP  
initiation 
0 
X 
 
 
 
 
 
X 
EBP 
engagement 
0 
 
 
 
 
 
 
X 

9 
 
EBP 
completion 
0 
X 
 
 
 
 
 
X 
Note: EBP = evidence-based psychotherapies.  
Training. Approximately 2-3 weeks after the pretraining assessment, Veterans will participate in 
MERA, delivered in 3 90-minute sessions over the course of 3 weeks at the Tampa VA PTSD Clinic.  
The PI will lead and audio record all treatment sessions. Treatment fidelity of each treatment session 
will be rated by a psychologist (TBN). Veterans will receive a training manual that contains session 
content along with tracking forms to monitor progress between sessions. The training begins with 
education about the adaptive nature of emotions, how childhood and military experiences can 
influence emotion regulation, and how combat requires different emotion regulation strategies than 
most civilian environments. It uses modeling and practice with feedback to teach cognitive-behavioral 
therapy and acceptance-based emotion regulation skills, such as diaphragmatic breathing, cognitive 
restructuring, and mindfulness. A goal of this training is to teach a variety of skills that can be used in 
different situations and for basic emotions (generally adaptive responses triggered by the 
environment that fade with time) and manufactured emotions (triggered by one’s inaccurate 
interpretations of an event that do not fade with time if thoughts continue). Finally, information is 
provided about PTSD, PTSD evidence-based psychotherapies,74 and what the Veteran can expect in 
terms of emotional experiences during evidence-based psychotherapy.  
Content of Manage Emotions to Reduce Aggression (MERA) Training  
Module 
Content/description  
Session 1 – 
Introduction to 
emotions (anger, 
sadness, and joy). 
Emotion regulation 
skills training.  
• Training rationale.  
• Discussion of Veterans’ current emotion regulation difficulties.  
• Psychoeducation about 3 basic emotions (anger, sadness, joy). 
• Identify: Triggers, accompanying thoughts, and physiological reactions 
for anger, sadness, and joy. 
• Demonstrate and practice 2 skills: Progressive muscle relaxation and 
grounding.  
Session 2 – Life’s 
influence on 
emotions. Education 
on remaining 
emotions (disgust 
and fear). Emotion 
regulation skills 
training.  
• Discussion of how childhood and military influenced emotion regulation 
strategies.  
• Psychoeducation about remaining basic emotions (disgust and fear).  
• Identify: Triggers, accompanying thoughts, and physiological reactions 
for disgust and fear.  
• Demonstrate and practice at least 2 skills: Remembering values, 
diaphragmatic breathing, and cognitive restructuring.  
Session 3 – Using 
emotion regulation 
• Brief introduction to PTSD treatments.  
• Psychoeducation as to what emotional experiences to expect and how 
to manage them during PTSD treatment.  

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during PTSD 
treatment. 
• Demonstrate and practice 3 skills:  Ride the wave (mindfulness), 
increase positive emotions, and visualization.  
• Writing an action plan for next treatment step. 
Posttraining assessment. One month after the third MERA session, Veterans will be reassessed by the 
master’s level independent evaluator who conducted the pretraining assessment with a similar 
assessment battery (see Assessment Schedule for exact measures) to detect any changes in PTSD, 
emotion regulation, and aggression (Aim 2). Veteran will also complete an exit interview that they can 
express their opinion of the training and any suggestions for improvement. Veterans’ independent 
aggression raters will be asked to complete the OAS again via a phone call.  
Chart monitoring. Research staff will examine each Veteran’s chart at 6 months posttraining to see 
whether he initiated, engaged, and completed CPT or PE (Exploratory Aim 3), in addition to any other 
psychotherapy, during or after MERA (potential confounding variable for Aim 2). 
Study Duration/Study Timeline. The study should take approximately 2 years to complete.  
Data Analysis/Statistics 
This pilot study is largely descriptive to determine the feasibility and preliminary effectiveness of 
MERA. Due to the small sample size, all alpha levels will be set at 0.1 with the goal of maximizing the 
chance of detecting statistical differences.  
Aim 1: Veteran verbal feedback, collected at the end of the third MERA session, will be examined 
to improve the acceptability of the training. Frequencies will be calculated on the number of Veterans 
who were referred, completed the screen, completed the pretraining assessment, met eligibility 
criteria, and attended all 3 emotion regulation training sessions.  
Aim 2. Our second aim was to explore changes in aggression and emotion dysregulation from pre- 
to post-treatment among patients who completed MERA. Given study attrition and our desire to use 
as much data as possible, the statistical design for the primary analyses was an intent-to-treat, mixed 
effects regression model examining the main effect of time as the effect of substantive interest. 
Analyses were conducted using the generalized linear mixed models module in SPSS Version 24 using 
data from all sessions. Data transformations using appropriate link functions given the nature of the 
data (e.g., log transformation due to significant skewness in the OAS across all time points), where 
necessary, were conducted. Results were back translated into the original metric for ease of 
interpretation. Where appropriate, pairwise comparisons between time points were examined to 
determine which time points differed from one another. Effect sizes are reported to provide context 
for statistically significant results. Finally, percentages were provided for the frequency of veterans’ 
engagement in an EBP after MERA (Exploratory Aim). 
Exploratory Aim. Frequencies will be used to examine the number of PTSD evidence-based 
psychotherapy sessions to determine initiation, engagement, and completion rates following MERA.  

11 
 
ADVERTISEMENT:  Bulletin Board 
Exact language of Advertisement: 
 
    
Male Veterans Who Served in Afghanistan or Iraq  
Manage Emotions to Reduce Aggression 
Do you have PTSD and struggle to manage aggression? We are researching a 3-session emotion-
regulation training that is designed to help Veterans manage emotions and decrease aggression.  
Study Involves: 
• 
3 treatment training sessions                 •2 assessment sessions  
If interested in learning how to decrease your aggression and also want to help other Veterans by 
evaluating the treatment, please call  
Dr. Shannon Miles at 813-972-2000 x6728, Principal Investigator  
Offered by James A. Haley  
Veterans Affairs Hospital.  
Funded by the Department  
of Veteran Affairs’  
Consortium to Alleviate PTSD.  
IRB# 23884 
Payment: 
Veterans will not be paid for taking part in the 3-session training. However, they will be compensated for the 
pre and post-training assessments. After completing the pre-training assessment, each Veteran will receive a 
$30.00 by direct deposit to his bank account. If he is eligible for the study based on screening questions and 
complete the training, he will complete a post-treatment assessment and receive a $30.00 by direct deposit 
after the assessment. If you do not have a bank account, you can be paid by check. That is a maximum of $60.00 
if both assessments are completed.  
 
Veterans will receive a Form 1099 from the VA, which is required to process their payments. This form requires 
that study staff to use whole social security number instead of just the last 4 digits.   
 
Costs: There are no costs associated with the study over and above the costs that would be incurred from 
standard care or services. For VA patients, there may be co-payment costs for some of the non-research 
procedures for which the VA may not pay even if these occur while you are participating in this research.  Some 
veterans are required to pay co-payments for medical care and services provided by the VA.  These co-payment 
requirements will continue to apply to medical care and services provided by the VA that are not part of this 
study and that you would receive as part of your regular medical care. 
5. Sample size: We request to consent up to 60 participants to account for potential dropouts. We aim for a 
sample of 30 Veterans. The final goal is to have complete pre- and post-treatment data for 20 participants. Up 
to 25 participants may need to complete the post-treatment assessment in order not to slow recruitment at the 
end of the study.   

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6. Study Population with Inclusion/Exclusion Criteria: Veterans enrolled at the Tampa VA and who meet the 
following criteria will be recruited to the study:  
Inclusion criteria: 1.) Male Veteran who served in OEF/OIF/OND. 2.) Currently meets criteria for a PTSD 
diagnosis, determined by the Clinician-Administered PTSD Scale-5.57 3.) Engaged in at least 3 self-reported 
impulsive aggression acts (e.g., yelling, throwing objects, hitting objects/people) in the last month, measured by 
the Overt Aggression Scale.58 4.) Impulsive aggression is his/her primary form of aggression, determined by 
having a higher Impulsive Aggression subscore than a Premeditated Aggression subscore on the Impulsive 
Premeditated Aggression Scale.50 5.) Because aggressors are poor historians when reporting their aggression 
frequency,14-15 each Veteran must agree to allow an independent aggression rater (a person with whom the 
Veteran has a long-standing, close personal relationship and has in-person interaction most of the days of the 
week; ) verify the number of aggressive acts, using the Overt Aggression Scale. 6.) No psychotropic medication 
change for six weeks prior to the assessment and agreement not to ask for a medication change for the 
duration of the study.  
Exclusion criteria: Veterans who meet the following criteria will be excluded: 1.) Previously began PE or CPT. 2.) 
Is currently suicidal with intent of self-harm in the last week. 3.) Is currently homicidal with plans to hurt a 
specific person. 4.) Is unable to complete self-report measures. 5.) Does not have an independent aggression 
rater. 6.) Has severe alcohol consumption patterns (Alcohol Use Disorders Identification Test59), severe drug use 
consumption patterns (Drug Use Disorders Identification Test), active psychosis, or mania (MINI). 7.) Had a 
psychotropic medication change within 6 weeks prior to the pretraining assessment. Veterans receiving general 
mental health services or non- PE or CPT psychotherapy will be allowed to participate in this study.   
7. Expected Results (Publication and Presentation Plans): The PI plans to publish a manuscript describing the 
results of the pilot project after the final data are collected in 2019. Data will be presented in aggregate form, or 
if case studies are written, all information will be disguised with no identifying information.   
  
8. Name of PI: 
PI: Shannon R. Miles, Ph.D. 
 
9: Potential Risk:  
Category 1: Research not involving greater than minimum risk.  
Potential risks include the 1.) loss of confidentiality including having to report child or elder abuse and 
2.) temporary increase in anxiety or worry. 1.) The risk of losing confidentiality is minimal and will be 
managed by storing personally identifying information in a locked cabinet, using random subject 
numbers to identify the patient data in paper and electronic form, and not including personally 
identifiable information in databases. Limitations to confidentiality include situations wherein the 
patient poses a serious danger to self or others, a medical emergency occurs, or there is cause to 
believe that a child, older person, or disabled person is being abused, neglected, or exploited. These 
exceptions to confidentiality are listed on the consent form. The risk will be made explicit to the 

13 
 
patients prior to completing the questionnaires. Additionally, this is consistent with routine clinical 
practice and state laws. Often Veterans bring in their partners to PTSD treatment sessions and the same 
reporting laws apply in clinical practice and research.  
 
2.) Veterans will be asked about how they are currently coping with emotional experiences. The 
assessments and training are already used as routine clinical practice within the VA system, with a 
difference being the training is delivered in a condensed format rather than the tradition 8-12 sessions. 
With all psychological treatments and assessments, the procedures may cause a temporary mild 
increase in worry, anxiety, or other emotions. The goal of the treatment  is to teach participants more 
adaptive ways of coping, and any such increases in emotions are expected to be temporary. All patients 
will have the opportunity to terminate the assessment or therapy at any time. Further treatment 
resources will be made available, including the 24-hour Emergency Room, treatment through mental 
health, and the Veteran suicide hotline number. No physical risk is foreseen. 
10. Any experimental procedures: Research has shown that emotion regulation skills can help people manage 
their emotions and daily stress and these skills may also help you manage your aggression. Emotion regulation 
treatments are already provided in the VA system and are not experimental. However, the condensed 
treatment format (3 sessions instead of 8-12) has not been tested before and is not currently part of standard 
VA practice. 
11: Potential Benefits:   
Potential benefits to the Veteran.  
Emotion dysregulation related to PTSD can lead to aggression and is a huge barrier for 
OIF/OEF/OND Veterans adjusting back to civilian life. The legal, interpersonal, social, and 
psychological consequences of emotion dysregulation and aggression are far-reaching and are a 
constant strain on individuals, families, and society. The intervention teaches Veterans how to 
better manage emotions and his aggression. The Veteran may feel better in his daily life after 
learning these skills. Additionally, a goal of the study is to decrease aggression, which has 
interpersonal, legal, and financial consequences. If the study assists Veterans in being able to 
control aggression, improved psychosocial functioning may be the result. However, the participant 
may obtain no benefit from participating. 
Potential benefits to society of the planned work.  
    
Expanding the understanding of what treatments work to reduce aggression is imperative and this 
condensed treatment may offer Veterans some relief from their emotion dysregulation and 
impulsive aggression in a shorter time frame than traditional anger management treatments. 
Decreases in aggression not only benefit the Veteran, but also the Veteran’s family and community. 
The treatment may also benefit the VA because of the decrease in provider time required to deliver 
the training. The VA system is already taxed with serving the increasing number of returning Veterans 
and this may help reduce that challenge.  
Risk-to-benefit ratio. 
    This proposed work has a favorable risk-to-benefit ratio because there are many potential benefits to 
the participants and society which include better emotion regulation skills, reducing aggression, and 

14 
 
increasing knowledge about what helps Veterans reduce aggression. Additionally, Veterans may 
experience improvements in emotion regulation skills after 3 sessions, as compared to traditional 
emotion regulation treatments, which are 8-12 sessions. The VA may also benefit from the 
condensed format of the training. The possible risks are minimal and typically transient and are no 
more than experienced during routine clinical practice.  
12. Human Subjects considerations:  
Four forms are being requested as part of this study: A waiver of informed consent, a waiver of HIPPA 
authorization (for screening), an informed consent, and a HIPPA authorization. In order to screen participants, 
waivers of informed consent and HIPPA authorization are requested to allow the research staff to open the 
medical records of veterans who have been referred to the PTSD clinic. This will allow the research staff to see 
if the Veteran appears appropriate for the study before contacting the Veteran. If the Veteran likely meets 
study criteria, research staff will send a letter describing the study to the Veteran which will provide a number 
the Veteran can call for more information or to opt-out of the study. The letter will explain that the research 
staff will call the Veteran in two weeks if they do not receive an opt-out call. After two weeks, study staff will 
call the Veteran, explain the study, and receive verbal consent to continue the telephone call. Research staff 
will then conduct the phone screen.  
 
Veterans who are eligible based on the phone screen will be scheduled for an in-person, pretraining informed 
consent session which will take place in a private office. Research staff will explain the study to the Veteran 
including the risks and benefits, that participant is voluntary and will in no way affect his/her treatment, and 
that s/he can withdraw from the study at any time without explaining why. The research staff will answer all 
questions. If the Veteran would like to take home the informed consent form and further consider if he would 
like to participate, another session will be scheduled for the pre-training assessment session. 
 
Data Security.  
PHI to be collected and used for this study include name, address (including street, city, and zip code), 
telephone contact numbers, and date of birth. Real Social Security Numbers (SSN) will be collected in 
order to compensate Veterans for their time (Form 1099). Past and current diagnoses of alcohol and 
drug use disorders be gathered from the participant’s medical chart. These data are part of Title 38 
U.S.C. 7332 protected information (drug abuse, alcohol abuse, HIV infection, and/or sickle cell anemia 
medical records). The purpose of collecting drug and alcohol abuse (38USC7332) data is to conduct 
scientific research. No personnel involved, in this study, will identify, directly or indirectly, any individual 
patient or subject in any report of such research or otherwise disclose patient or subject identities in any 
manner. Any information about patients obtained from this research will be kept strictly confidential.  
The study will generate both paper and electronic data. Access to information obtained for the purposes 
of this study will be restricted to authorized research personnel who have completed all required 
research trainings, although just like other hospital records they are subject to subpoena by court order. 
Paper data will be stored in a locked filing cabinet in the PTSD Clinic, in the PI’s locked research space. 
Consent forms will be stored separately in the locked storage space, apart from all coded study data. 
Study results will be published without any identifying information reported, and patients’ identities will 
be disguised.  
Data flow: Data will be collected from the participants, identified with only a code number, stored in a 
locked filing cabinet in the PI’s research office space, and then coded data will be entered into a 
database on the R drive. Study personnel will work only with de-identified data. The cross-reference file 

15 
 
that links study IDs and PHI will be stored in a separate, secure folder on the James A. Haley VA R drive 
server with access limited to the study staff. It is understood by the PI and study staff that data will not 
be used or shared with others outside the scope of the research study as documented in the protocol 
approved by the IRB and JAHVAMC R&D Committee. Data and research related information will be 
maintained and destroyed in accordance with VA policy. Access to research study data will be removed 
from study staff when they are no longer rated to team.  
Every member of the research team will be trained and monitored about how to handle and protect 
both medical and research records.  Furthermore, the research team strictly controls access to study 
data.   
Serious Adverse Events and Unanticipated Problems 
This study does not involve a drug intervention, device intervention, or highly invasive data collection 
procedure. However, recognizing that unanticipated events can occur in the course of any study, even a 
minimal risk study, the following reporting protocols will apply:  
Unauthorized use, disclosure, transmission, removal, theft, loss, or destruction of VA research-
related PHI, individually identifiable private information, or confidential information, as defined by 
the HIPAA Privacy Rule, the Common Rule, the Privacy Act, or 38 U.S.C. §§5701, 5705, and 7332; 
• 
Report within 1 hour to ACOS for Research, the facility ISO/ PO. 
Unanticipated serious adverse events (SAEs) that the Site PI considers to be related, possibly related, 
or probably related to study participation;  
• 
Site will report within 24 hours of site’s awareness to the site IRB and facility ISO/PO. 
Serious Adverse Events include deaths, life-threatening physical parameters (laboratory values, blood 
pressure), hospitalization, disability or permanent damage, congenital anomalies or birth defects, an 
event that requires intervention to prevent permanent impairment, other serious medical events 
(bronchospasm, seizures).  
For all events, the site PI will assess the event to evaluate whether it is unanticipated, related to the 
study, or if it places the participant or others at an increased risk for harm in order to determine whether 
it should be reported to the local and sponsor IRBs. 
• As covered in section participants expressing suicidal ideation either in person or on the phone will be 
managed according to local VAMC protocols, which includes: Stay with the Veteran until s/he can be 
‘handed off’ to appropriate medical staff, including the Emergency Room for evaluation.  
• All study personnel who work directly with research participants will be given the names and phone 
numbers of the patient’s medical care team.  After the Veteran has been ‘handed off’ to the 
appropriate staff, the PI will be alerted. 
An Accounting of Disclosure (AOD) will be created and maintained for any disclosure of individually 
identifiable information (III) outside the VA. The electronic spreadsheet will include the participant’s 
name, date of the disclosure, nature or description of the III disclosed, purpose of each disclosure and 
the name and address of person or agency to which the disclosure was made.  
Who, besides the PI, the study staff, the IRB and the sponsor, will have access to identifiable research 
data? 

16 
 
    
Access to identifiable research data from JAMVAH will be restricted to JAHVAH research staff and 
IRB. People who ensure quality from the institutions where the research is being done, federal and 
other regulatory agencies will have access to all of the research data. It is understood by the PI that 
data will not be used or shared with others outside the scope of the research study as documented in 
the protocol approved by the IRB and R&D Committee. Removal of access to research study data will 
be accomplished for all study personnel when they are no longer part of the research team. 
  
13. Data safety monitoring plan:  
The study is minimal risk. 
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