Enhancement of PTSD Treatment With Computerized Executive Function Training
Phase: NA
Conditions: Posttraumatic Stress Disorder
Sponsor: VA Office of Research and Development

 
 
 
Enhancement of PTSD Treatment With Computerized Executive Function Training 
 
 
NCT #: NCT03260127 
 
Date of IRB protocol: July 2022 
 
 

Human Protocol (Version 1.41)
General Information
*Please enter the full title of your study::
Enhancement of PTSD Treatment with Computerized Executive Function Training
 
 
*Please enter the Study Number you would like to use to reference the study:
CPT plus EF Training
* This field allows you to enter an abbreviated version of the Study Title to quickly identify this 
study.
 
 
Add departments
and Specify Research Location:
Is 
Primary? Department Name
VASDHS - VASDHS
 
Assign key study personnel(KSP) access to the study
*Please add a Principal Investigator for the study:
 
Crocker, Laura D., PhD
 
3.1 If applicable, please select the Research Staff personnel
 
A) Additional Investigators
Bomyea, Jessica A., PhD 
 Co-Investigator
Colvonen, Peter J., PhD 
 Co-Investigator
Jak, Amy J., PhD 
 Co-Investigator
Merritt, Victoria C., PhD 
 Co-Investigator
Norman, Sonya B., PhD 
 Co-Investigator
B) Research Support Staff
Davey, Delaney K. 
 Study Coordinator
Golshan, Shahrokh, PhD 

 Biostatistician
Higdon, Alexandra O., PsyD 
 Clinical Research Associate
Hoffman, Samantha N. 
 Clinical Research Associate
Jurick Lefler, Sarah, PhD 
 Post-Doc
Keller, Amber Victoria 
 Clinical Research Associate
Marvin, Morgan E., BA 
 Research Associate
Ory, Jillian Leigh, BA 
 Research Associate
Schierbeek, Jackson 
 Research Associate
Witten, Cody 
 Research Associate
*Please add a Study Contact
 
Crocker, Laura D., PhD 
The Study Contact(s) will receive all important system notifications along with the Principal 
Investigator. (e.g. The project contact(s) are typically either the Study Coordinator or the Principal 
Investigator themselves).
 
VASDHS IRB
Human Subjects Protocol
v20190121
Section 1 - Preliminaries
Principal Investigator:
Laura D. Crocker, PhD
Protocol Title:
Enhancement of PTSD Treatment with Computerized Executive Function Training
IRB Protocol Number:
H170017
Protocol Nickname:
CPT plus EF Training
Form Template Version:
v20150115
Date Prepared:
07/26/2022
Please be advised that this protocol application form has changed as a result of the 2018 Common 
Rule.  There are new questions and sections, and you may be required to provide additional information to 
previous sections.
1a) Is this study considered human research?
Yes 

No 
I don't know 
1b) Please select:
This is an application for a NEW human subject research protocol 
This is a revision of an existing protocol 
Was this study initially approved prior to January 21, 2019?
 Yes  
 No
Were you instructed to convert to the 2018 Common Rule Requirements?
  Yes  
  No
 Section 2 - Research Subjects
 
2a) What is the total planned number of VA-consented subjects?
Include the total number of subjects who will prospectively agree to participate in the study (e.g., documented 
consent, oral consent, or other).
200
 
2b) What is the total number of VA subjects who WILL NOT be consented?
Include the total number of subjects that will be included without consent (e.g., chart review).  Note: Data about 
people are still considered “human subjects” by the IRB, so even if you do not intend to contact the patients 
whose charts you will review, you still should enter the number of charts as your “planned subjects."
0
 Section 2.1 Consented Subject Groups
2.1) For each of the subject categories listed below, indicate whether or not these subject groups will 
participate in the study: 
2.1a) Children under the age of 18
Note:   If neonates or children will be involved in this study, certification by the Medical Center Director will be 
required. Only minimal risk research may be performed with children.  Only non-invasive monitoring and/or 
prospective observational and retrospective record review studies that are minimal risk can be conducted in VA 
involving neonates.
  Yes  
  No
2.1b) Pregnant women
  Yes  
  No
2.1c) Individuals with cognitive/decisional impairment
  Yes  
  No
2.1d) Non-English-speaking individuals
  Yes  
  No
2.1e) Prisoners of War (explicitly targeting this group)
  Yes  
  No
2.1f) Non-Veterans (Note: Justification for inclusion of non-Veterans will be required)

  Yes  
  No
2.1g) Incarcerated individuals (Note: VA CRADO approval will be required)
  Yes  
  No
2.1h) VA employees - including VA paid, IPA, or WOC (Note: Union review and authorization may be 
required)
 Yes  
 No
2.1i) Students of the institution (e.g., resident trainees) or of the investigator
 Yes  
 No
2.1j) Patients with cancer (or high cancer risk) [explicitly targeting this group]
  Yes  
  No
 Section 3 - Study Features   (these items default to "No" for convenience)
  
3) This section consists of several Yes/No questions addressing protocol characteristics.     Click on Save and 
.
Continue
 Section 3.1 Protocol Basics
Select all that apply
3.1a) The research 
 the participant.
intends to change
 Yes  
 No
3.1b) 
 with living participants to collect data or specimens with no intent to change them.
Interactions
  Yes  
  No
3.1c) This is a study that 
 has any 
 
never
subject contact and does not collect subject identifiers
  Yes  
  No
3.1d) This is a 
study involving retrospective or prospective medical records.
chart review 
  Yes  
  No
3.1e) This is a 
study occurring in-part or in-full at other locations.
multi-site 
  Yes  
  No
3.1f) There is an 
 component to this research. 
international
International research includes sending or receiving 
human derived data or specimens (identifiable, limited data set, coded, or deidentified) to or from an 
international source.  International research does not include studies in which VA is only one of multiple 
participating sites where the overall study-wide PI is not a VA investigator.
  Yes  
  No
3.1g) This study includes 
 (not including VA-leased space or CBOC clinics) conducted 
off-station activity
under VASDHS IRB approval.  Note: this does not include research conducted by a collaborator at their home 
institution under their institutional approval.
 Yes  
 No
3.1h) VA subjects will 
 in part or in full 
 (not including VA-leased space or 
participate
at other locations
clinics) under VASDHS IRB approval. Note: if this study involves remote participation of subjects, please 
indicate "no" and describe their remote participation in section 9 of the application.  This question is intended 
to understand whether participants must physically go to a non-VA location to participate in this VA research 
study. 

 Yes  
 No
 Section 3.2 Specimen Use and Data Repository
Indicate whether or not each of the following applies to this protocol
3.2a) Involves specimens that are left over from pathological or diagnostic testing (
)
non-research specimens
  Yes  
  No
3.2b) Involves 
 purposes 
specimens collected for research
only
  Yes  
  No
3.2c) This study includes 
 (specimens are retained for use outside of the purposes of this 
specimen banking
protocol)
  Yes  
  No
3.2d) The study involves 
genotyping or other 
DNA 
genetic analysis
  Yes  
  No
3.2e) Biological
will be sent outside of the VA.
 specimens/material 
  Yes  
  No
3.2f) A 
 is maintained (data are retained after completion of the protocol for other uses, 
data repository
 see  before checking "yes")
IMPORTANT:
?
  Yes  
  No
3.2g)  
of the VA (identifiable, coded, limited data set, or deidentified)
Data will be shared outside 
 Yes  
 No
 Section 3.3 Treatment and Clinical Trials
Indicate whether or not each of the following applies to this protocol
3.3a) Includes a 
 component (a research treatment)
treatment
 Yes  
 No
3.3b) Study is a 
  
clinical trial. Note:  A clinical trial is a research study in which one or more human subjects 
are 
 (which may include placebo or other control) to 
prospectively assigned to one or more interventions
evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
 Yes  
 No
3.3c) Has a data safety monitoring board (
or data safety monitoring committee.
DSMB) 
  Yes  
  No
3.3d) Has a 
 (but not a DSMB) (this is not the data security plan, it is a safety plan).
data safety monitoring plan
 Yes  
 No
 Section 3.4 Drugs and Devices
Indicate whether or not each of the following applies to this protocol

3.4a) 
 that require 
 action such as an Investigational New Drug (IND) approval or exemption or 510
Drugs
FDA
(k) approval.
  Yes  
  No
3.4b) Other drugs, supplement, etc. that
action for inclusion in the study.
 do not require FDA 
  Yes  
  No
3.4c) Medical 
 IDE approval or waiver
devices requiring FDA
  Yes  
  No
3.4d)
 medical 
 Other
devices
  Yes  
  No
 Section 3.5 Risk and Hazards
Indicate whether or not each of the following applies to this protocol
3.5a) Study places subjects at 
(do not include risks that are due to standard care)
greater than minimal risk 
 Yes  
 No
3.5b) Human subjects are exposed to 
 (do not include standard care).
radioisotopes
  Yes  
  No
3.5c) Subjects have other 
 (e.g., x-rays) (do not include standard clinical use).
radiation exposure
  Yes  
  No
3.5d) Target population has psychiatric diagnosis or behavioral complaint.
 Yes  
 No
 Section 3.6 Clinical Facilities and Standard Care
Indicate whether or not each of the following applies to this protocol
3.6a) Study 
 (e.g., adds required tests run in the VA lab for study purposes; research 
uses VA clinical services
procedures concurrent with clinical care)
  Yes  
  No
3.6b) Includes procedures or drugs that will be considered part of standard care.
 Yes  
 No
3.6c) Involves 
purposes.
lab tests done for research 
  Yes  
  No
 Section 3.7 Subject Expenses and Compensation
Indicate whether or not each of the following applies to this protocol
3.7a) There may be expense or added 
or the subject's insurance.
costs to the subject 
  Yes  
  No
3.7b) This is a 
 and subjects may be billed for study drugs or procedures.
qualifying cancer treatment trial

  Yes  
  No
3.7c) This is a cancer treatment trial but 
 for study drugs or procedures.
subjects will not be billed
  Yes  
  No
3.7d) Subjects will be
(either in cash or other means such as a gift certificate).
 compensated 
 Yes  
 No
 Section 3.8 Subject Activities
Indicate whether or not each of the following applies to this protocol
3.8a) Involves 
 completed by subjects
surveys or questionnaires
 Yes  
 No
3.8b) Includes the use of 
 such as flyers, advertisements, or letters
recruitment materials
 Yes  
 No
3.8c) Involves facial 
 or audio or video 
of 
photographs
recordings 
patients
 Yes  
 No
 Section 3.9 Sponsors and Collaboration
Indicate whether or not each of the following applies to this protocol
3.9a) This research is a funded research project (commercial (industry) sponsor, NIH, VA, other).
  Yes  
  No
3.9b) Other 
is provided (e.g., drugs or supplies).
commercial (industry) non-financial support 
  Yes  
  No
3.9d) The protocol has 
 involvement (e.g., subjects or funding).
Department of Defense
  Yes  
  No
3.9c) The PI or other study staff member has a financial interest or other
related to 
 real or potential conflict 
this study.
  Yes  
  No
3.9e) This study involves 
research activities (research conducted at other institutions under the 
c llaborative 
o
authorities or approvals of the other institution/s). Note: this may include other VA and/or non-VA institutions, 
but does not include off-site VA research.
  Yes  
  No
 Section 4 - Estimated Duration
4) What is the estimated duration of the entire study?  (From IRB approval to IRB closure)
6 years
 Section 5 - Lay Language Summary
5) Provide a summary or synopsis of the proposed study using non-technical language (not more than 1 

paragraph)
This study focuses on helping Iraq and Afghanistan Veterans with posttraumatic stress disorder 
(PTSD) benefit fully from treatment. Although some people are able to successfully complete 
therapy and see significant improvements in symptoms, many others drop out of therapy early 
and/or do not notice improvements in symptoms. In addition to emotional symptoms, PTSD has 
been associated with thinking problems, including difficulty planning/organizing, thinking flexibly, 
and inhibiting distracting emotional information. One of the most effective treatments for PTSD - 
Cognitive Processing Therapy (CPT) - relies heavily on these types of thinking abilities to learn 
and use the skills that aid in recovery, thus having problems thinking likely contributes to high 
rates of dropout from treatment and/or problems fully engaging in treatment in order to get the 
most benefit from it. There is some evidence that computerized training programs are helpful for 
improving thinking, including planning/organizing, thinking flexibly, and inhibiting distracting 
information. Thus, it is possible that Iraq and Afghanistan Veterans may be better able to benefit 
from PTSD treatment if they first engage in computerized cognitive training to enhance their 
thinking abilities. Therefore, this study tests whether computerized cognitive training will in fact 
improve individuals’ abilities to plan/organize, think flexibly, and inhibit distracting information 
and if this will in turn improve PTSD treatment outcomes and lead to more individuals completing 
treatment and showing greater improvements in emotional symptoms than CPT (when paired 
with a placebo word training condition).
 Section 6 - Specific Aims
6) Provide a statement of specific aims and 
 that serve as the basis for this protocol.  Emphasize 
hypotheses
those aspects that justify the use of human subjects.
Aim 1: Investigate whether Computerized Executive Function Training (CEFT) leads to objective 
and subjective improvements in executive functioning and whether this in turn mediates PTSD 
symptom improvement. 
Hypothesis 1a: CEFT will be associated with improvements in both objective and subjective 
executive functioning. 
Hypothesis 1b: Enhanced executive functioning will mediate the relationship between treatment 
group and PTSD symptom improvement.
Aim 2: Investigate the efficacy of administering CEFT prior to Cognitive Processing Therapy (CEF-
CPT) in improving treatment adherence, completion rates, and outcomes in OEF/OIF Veterans 
with PTSD.
Hypothesis 2a: Individuals in the CEFT-CPT condition will have greater improvements in PTSD 
symptoms and quality of life than the control condition (placebo word training plus CPT). 
Hypothesis 2b: Individuals in the CEFT-CPT condition will have higher rates of treatment 
engagement (i.e., completing more hours of homework and attending a greater number of 
sessions) and higher rates of treatment completion than those in the control condition.
Aim 3: Investigate whether functioning of brain regions in an EF network at baseline predicts 
treatment response.
Hypothesis 3: Dysfunction in a network of brain regions supporting EF will predict poorer 
response to treatment. Specifically, those who do not complete treatment and who demonstrate 
a poorer response will exhibit decreased connectivity between dorsolateral PFC and other 
regions, including anterior cingulate cortex and parietal cortex, compared to completers and 
better responders.
 Section 7 - Background and Significance
7) Provide a succinct discussion of relevant background information to justify performing the proposed study.
PTSD affects approximately 14% of OEF/OIF Veterans and leads to considerable personal and 
societal costs (e.g., increased morbidity, reduced work productivity, poorer relationships). Cognitive behavioral 
therapy (CBT) has been shown to be one of the most effective treatments for PTSD. The Institute of Medicine 

and VA/DoD Clinical Practice Guidelines for PTSD recommended two types of trauma-focused CBTs in 
particular as frontline psychotherapies for PTSD: cognitive processing therapy (CPT) and prolonged exposure 
(PE). These evidence-based CBTs can improve PTSD symptoms, enhance quality of life, and save billions of 
dollars by improving occupational, social, and physical health functioning. Despite significant efforts by the VA to 
make evidence-based treatments readily available to Veterans with PTSD, a substantial portion (approximately 
50%) of individuals drop out of treatment prematurely, do not respond to treatment, or relapse after treatment 
completion. Treatment engagement is worse for OEF/OIF Veterans, who are less likely to begin evidence-based 
treatment, attend fewer sessions, have higher dropout rates, and are less likely to complete treatment than 
civilians and Veterans from other eras.
One likely barrier to treatment engagement and effectiveness is the executive functioning problems 
present in individuals with PTSD. Executive functions (EFs) are the set of higher-level cognitive skills (e.g., 
problem solving, set-shifting, cognitive flexibility) that organize and integrate lower-level cognitive processes in 
order to perform complex, goal-directed tasks. PTSD has been associated with EF deficits, including 
impairments in inhibitory control, working memory, and cognitive flexibly, as well as dysfunction in a network of 
brain regions that support EFs (e.g., prefrontal cortex [PFC], cingulate). PTSD not only disrupts the functioning 
of PFC during EF tasks but also its functional communication with other regions, preventing the downregulation 
of limbic regions by PFC when faced with perceived threats and preventing PFC from effectively modulating 
parietal cortex to ignore emotional distraction and maintain task goals.
EFs are essential for CBT in order to engage the cognitive skills involved in treatment (e.g., self-
monitoring, inhibiting distorted thoughts, flexibly generating/evaluating alternative thoughts). This is particularly 
true for CBT approaches that are primarily cognitive in nature such as CPT, which involves identifying and 
challenging maladaptive trauma-related thoughts to alter their impact on emotions and behavior. Thus, EF 
deficits may lead to reduced CPT engagement and responsivity. In fact, worse EF at baseline has been 
associated with poorer response to CBT in several disorders (e.g., generalized anxiety disorder, obsessive 
compulsive disorder, schizophrenia). Further, a study of brain functioning during an EF task demonstrated that 
dysfunction in EF-related brain regions including PFC and cingulate cortex at baseline predicted nonresponse to 
CBT for PTSD.
Many researchers have argued that using methods that more directly target the dysfunctional cognitive 
processes present in various psychological disorders will improve current treatment approaches. Therefore, 
directly targeting EF prior to CPT via cognitive training would strengthen executive networks and likely boost 
treatment effectiveness, allowing Veterans to fully engage in and benefit more from components of CPT (e.g., 
cognitive restructuring). Research indicates that cognitive training can improve EF and enhance functioning in 
EF-related regions including PFC and parietal cortex. Cognitive training has been implemented as an 
intervention for various psychiatric conditions, including schizophrenia, ADHD, anxiety, depression, and 
substance abuse with evidence that it improves cognitive processes, clinical symptoms, quality of life, and 
adaptive functioning. Importantly, studies of PTSD that used computerized training to enhance attentional
/cognitive control found that it reduced PTSD symptoms. In addition, computerized attention bias modification 
(ABM) training has been used in individuals with PTSD to facilitate disengagement of attention from negative
/threatening information. Although ABM training was not designed to target EF per se, research indicates that 
ABM improves PFC functioning and its communication with other brain regions, suggesting it enhances top-
down attentional control. Two studies that used ABM to augment CBT indicated that this combination was 
associated with a greater reduction in PTSD and anxiety symptoms after treatment compared to a control 
condition. Additional evidence that EF training is likely a useful adjunct to trauma-focused therapy for PTSD 
comes from research showing that it can increase mental health treatment completion rates and enhance 
response to CBT in other psychiatric conditions.
Thus, the main goal of the proposed study is to examine whether administering computerized EF 
training (CEFT) immediately prior to CPT will improve executive functioning and enhance treatment adherence, 
completion rates, and psychological and functional outcomes in OEF/OIF Veterans with PTSD. Objective 
(neuropsychological) and subjective (self-report) measures of EF will be collected to determine if CEFT 
enhances EF and if this in turn mediates the relationship between treatment condition and PTSD symptom 
improvement. Functional neuroimaging during EF tasks will also be collected at baseline to determine whether 
functioning within an EF network predicts treatment response, above and beyond traditional paper-and-pencil 
measures of EF.
The proposed research aims to reduce barriers to treatment engagement and has potential to 
significantly enhance current treatments for PTSD by combining cognitive and psychotherapeutic approaches. T
argeting EF directly and independently represents a logical, innovative, and empirically-informed method for 
augmenting existing treatments for PTSD in order to optimize outcomes. Findings from the study will not only 
directly inform clinical practice, but also have the potential to significantly reduce societal costs and burden, 
improve access to care, and reveal ways to better match individuals with treatments they are most likely to 
benefit from. Successful treatment of PTSD also reduces comorbidities including depression, substance use, 
and suicidality and improves the quality of Veterans’ lives, including enhancing physical health, employment 
rates/work productivity, and interpersonal functioning. 
 Section 9 - Design and Methods
9) Describe the research design and the procedures to be used to accomplish the specific aims of the 
project.  Provide a precise description of the planned data collection (include what systems or databases will 
be used/accessed to gather data), analysis and interpretation.  For chart review studies, include the timeframe 

of collection.  Address sample size, inclusion of women and minorities.  Define in clear terms exactly what will 
 
be done to the human subjects.
Overview: The study is a randomized controlled trial (RCT) that will compare computerized EF training 
administered prior to CPT (CEFT-CPT) to a placebo word game training prior to CPT (WT-CPT). Goals of the 
research include 1) examining whether CEFT improves EF in OEF/OIF Veterans with PTSD and whether this in 
turn mediates PTSD symptom improvements, 2) investigating the efficacy of CEFT-CPT in improving treatment 
adherence, completion rates, and psychological and functional outcomes, and 3) determining whether baseline 
measures of EF predict treatment response. Veterans will be enrolled from the VASDHS system of PTSD 
clinics, spanning the main and 3 satellite facilities, and general outpatient mental health clinics. Assessments will 
be administered at baseline, immediately after CEFT or word training (prior to CPT), and after CPT completion. 
 
Participants:
 
Inclusion criteria: 1) OEF/OIF Veterans enrolled at VASDHS, 2) aged 18-55 3) current PTSD diagnosis, 4) 
endorsement of cognitive complaints, 5) no pending medication changes, 6) English-speaking. Given the 
potential impact on outcome variables of interest, we will track current medication use in enrolled Veterans to 
ensure no recent or pending changes.
 
Exclusion criteria: 1) active substance use disorder in the last month, 2) suicidal intent or attempt within the 
last month, 3) schizophrenia, psychotic disorder and/or bipolar disorder, 4) dementia, 5) premorbid IQ < 70, 6) 
participation in other concurrent PTSD intervention studies, 7) previous completion of more than 4 CPT 
sessions, 8) history of a documented neurological disorder (e.g., Parkinson’s disease, multiple sclerosis, 
epilepsy) 9) moderate to severe TBI (loss of consciousness greater than 30 minutes or post-traumatic amnesia 
greater than 24 hours).
 
Further exclusion criteria details: A history of mild TBI is highly comorbid in OEF/OIF but the majority of the 
literature supports a mental health etiology to persistent symptoms following mTBI; the current study will account 
statistically for mTBI history but it is not exclusionary.
 
Since the primary aim of the present research proposal is centered around the intervention component, 
Veterans will still be enrolled in the study if they have contraindications for MRI, since that will not prevent them 
from engaging in and completing PTSD treatment in real-world settings. In addition, the rate of exclusion for MRI-
contraindications is very low. Contraindications for MRI include: pregnancy, cardiac pacemaker, metal fragments 
in eyes/body, participants who have been a metal worker/welder, aortic aneurysm clips, prosthesis, by-pass 
surgery/coronary artery clips, hearing aid, heart valve replacement, IUD, a shunt (ventricular or spinal), 
electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (TENS unit), vision problems uncorrectable 
with lenses, claustrophobia, inability to lie still on one’s back for approximately 60 minutes, prior neurosurgery, 
older tattoos with metal dyes, unwillingness to remove nose, ear or face jewelry, braces or permanent dental 
retainers.
 
Subject recruitment: Veterans with PTSD will be recruited at VASDHS. We will utilize the VASDHS system of 
PTSD clinics, spanning the main and 3 satellite facilities, and general outpatient mental health clinics. An effort 
will be made to recruit women and minorities into the study. Staff in each clinic will provide a 
descriptive study flyer to patients newly accepted and enrolled into the outpatient PTSD program with a 
diagnosis of PTSD (based on information collected through intake). Individuals reporting interest in the study will 
be asked for verbal consent to be contacted by the research coordinator. In addition, informational flyers will be 
posted throughout the clinics with telephone number listed for interested participants to call. Research 
databases of Veterans who have previously consented to be contacted about additional study opportunities can 
also serve as a recruitment tool. The research coordinator will contact prospective participants to provide an 
explanation of study procedures and to complete a phone-based screening. A lab-based baseline assessment 
visit will be scheduled if the individual meets basic eligibility requirements.
 
During recruitment, we will initially screen Veterans by phone. Those that are eligible for the 
study based on the phone screen will be brought to the lab for consenting, intake, and 
baseline assessments (approximately 200 Veterans). However, we assume a portion of 
those individuals will not qualify for the study. That will leave us with approximately 150 
Veterans (75 per condition) to randomize to treatment. For recruitment, we will utilize 
the VASDHS system of PTSD clinics, spanning the main and 3 satellite facilities, and 
general outpatient mental health clinics. VA employees are not the target population, 
however they will not be excluded if they meet the inclusion criteria.
 
Financial Incentives: Participants will be compensated for their time after each completed assessment. 
Veterans will receive $50 for the baseline assessment ($30 for completion of the questionnaires and 

neuropsychological assessment, $20 for the fMRI assessment), $30 as a bonus for completing at least 80% of 
the cognitive training (or placebo word games), $50 for the post-computerized training assessment, and $70 for 
the post-therapy assessment (Total possible = $200).
 
Procedures:
 
Design and methods: Veterans will be randomized to either 12 weeks of CEFT-CPT or placebo word training 
plus CPT. Assessments will be administered three times: at baseline, immediately after CEFT or word training 
(prior to CPT), and after CPT completion. Assessment of PTSD diagnosis, symptom severity, quality of life, and 
subjective and objective measures of cognition will be administered at baseline (prior to computerized training 
onset), immediately after completing the cognitive training portion of the study (i.e., 6 weeks after baseline, just 
prior to starting CPT), and after completion of CPT treatment (approximately 6 weeks later, a total of 12 weeks 
after study initiation). Treatment satisfaction will be assessed after CEFT and CPT completion. Symptom 
severity will also be assessed at the midway point for the cognitive training and weekly during the CPT 
intervention component. Functional neuroimaging during rest and during two well-validated EF tasks will be 
collected at baseline, a Go-No Go Task that taps inhibition and an N-Back Task that taps working memory.
 
Pre-study screening (15-30 minutes): Initial screening for interest and eligibility will take place in person or via 
telephone. Veterans will be given an overview of the study and, after providing verbal consent, will be screened 
with a questionnaire covering the major inclusion/exclusion criteria. Veterans who are not excluded based on the 
phone screening and who express interest in participating in the study will be invited to come to the VASDHS for 
continued evaluation of eligibility for participation in the study.
 
Baseline Assessment (4 hours): During the baseline appointment, Veterans will first provide written informed 
consent and HIPAA consent and then complete a structured clinical interview, the Clinician-Administered PTSD 
Scale for DSM-5 (CAPS-5) to determine PTSD diagnosis. Veterans will be then be assessed on a battery of self-
report questionnaires to measure psychiatric symptoms and functioning including PTSD, depression, quality of 
life, and subjective EF in daily life (see measures section below). Objective cognitive functioning will be 
measured with standard neuropsychological tests in the domains of EF, verbal memory, attention/processing 
speed, and premorbid intellectual functioning. Multiple measures of EF will be administered that include tests of 
inhibition, working memory, and cognitive flexibility. The other cognitive domains assessed have also been 
associated with PTSD and may contribute to poorer EF (e.g., processing speed). Objective measures of effort 
will also be administered to assess validity of neuropsychological testing, in order to accurately interpret test 
scores/performances. All assessments will be administered by a trained research assistant.
 
Veterans who meet MRI safety criteria will also attend a separate 1-hour MRI appointment to collect functional 
neuroimaging data during two well-validated EF tasks. During this appointment, structural imaging data will also 
be collected for registration to the functional data. If Veterans do not meet MRI safety criteria, they will perform 
the two EF tasks during the baseline assessment appointment, as data from the behavioral tasks will still be 
analyzed even if the fMRI data is not available.
 
Treatment Randomization: Following baseline assessment, participants will be randomized to the 
experimental (CEFT-CPT) or control condition (WT-CPT). A computer-generated randomization sequence will 
be provided by our statistical expert Dr. Shahrokh Golshan (consultant). Randomization will be stratified by 
gender to ensure a balanced number of males and females are in each treatment group. Participants, the study 
assessor, and therapists will be blinded to the experimental treatment condition.
 
Post-Intervention Assessments (3-4 hours): The full battery of self-report questionnaires measuring 
psychiatric symptoms, quality of life, and subjective cognitive functioning, objective measures of 
neuropsychological functioning, and structured clinical interview for PTSD diagnosis will be re-administered 
twice, once after cognitive training completion and again after CPT completion. For the neuropsychological 
tests, alternate forms will be used where available and the RCT design will distribute any practice effects equally 
across the two groups. Participants will also complete the two EF tasks again that were administered at baseline 
during neuroimaging (though fMRI will not be collected again) or during the baseline assessment if they did not 
undergo fMRI for safety reasons.
 
Assessment Measures:
 
Symptom Measures:
PTSD: 
 (CAPS-5; Weathers et al., 2013) is the gold-
The Clinician-Administered PTSD Scale DSM 5
standard, semi-structured interview that corresponds to DSM-5 criteria for PTSD. The CAPS-5 shows 
strong reliability and validity.
PTSD Checklist for DSM-5 (PCL-5; Weathers, Litz, Keane, Palmieri, Marx, & Schnurr, 2013) will be used 
to regularly assess PTSD symptomatology at several points throughout the study. The PCL-5 is a 20-item 
self-report measure of PTSD symptoms with good psychometric properties. The PCL-5 maps directly onto 
DSM-5 diagnostic criteria.

Depression: 
 (BDI-II; Beck, Steer, & Brown, 1996) is a 21-question 
Beck Depression Inventory-II
multiple-choice self-report inventory, one of the most widely used instruments for measuring depressive 
symptoms.
Subjective day-to-day executive functioning: 
 
Behavior Rating Inventory of Executive Function
(BRIEF; Guy et al., 2004) is an ecologically sensitive 75-item self-report questionnaire that measures 
several aspects of EF in an individual’s everyday life in the last month, including inhibition, shifting, 
working memory, planning/organizing, emotional control, etc.
Optional measure: If there is any ambiguity in terms of psychiatric diagnoses based on the phone 
screen and a review of patient records (CPRS) that would disqualify the participant (i.e., schizophre
nia, psychotic disorder, bipolar disorder, substance use disorder), the relevant portions of the MINI International 
Neuropsychiatric Interview (MINI; Sheehan, 2014) will be administered during the baseline assessment to clarify 
eligibility.
 
Objective neuropsychological testing: .
Tests of executive functioning: Measures of inhibition, shifting/cognitive flexibility, and working 
memory include the Wisconsin Card Sorting Test (WCST; Heaton, 1981), Delis Kaplan Executive 
Function System (D-KEFS) Color-Word Interference Test and Trail Making Test (Delis, Kaplan, & 
Kramer, 2001), Paced Auditory Serial Addition Test (PASAT; Gronwall, 1977)
Verbal memory: California Verbal Learning Test-II (CVLT-II; Delis, Kramer, Kaplan, & Ober, 2000)
Tests of attention and processing speed: Wechsler Adult Intelligence Scale – IV (WAIS-IV) Digit 
Span, Digit Symbol, and Symbol Search subtests (Wechsler, 2008)
Premorbid intellectual functioning: Wide Range Achievement Test, Fifth Edition 
(WRAT5) Reading subtest (Wilkinson & Robertson, 2017) [administered only at the baseline visit]
Tests of neuropsychological performance validity: Test of Memory Malingering (Tombaugh, 1996) 
and an embedded measure within the CVLT-II (i.e., Forced Choice)
 
Other measures:
Quality of Life: World Health Organization Quality of Life-BREF (WHOQOL-BREF; the 
WHOQOL Group, 1998) comprises 26 items, which measure the following broad domains: 
physical health, psychological health, social relationships, and environment. 
Functional Impairment/Disability: Inventory of Psychosocial Functioning (IPF; Rodriguez et 
al., 2012) is a self-report measure that assesses PTSD-related functional impairment 
across several domains, including relationships, work, education, self-care, etc.
TBI History: 
 (OSU TBI-ID; Corrigan & 
Ohio State University TBI Identificanion Method - Interview Form
Bogner, 2007) is a short, structured interview that assesses TBI history and details about injury 
including cause, presence/minutes of loss of consciousness and post-traumatic amnesia, number of 
TBIs, etc. [administered only at the baseline visit]
Client Satisfaction with Treatment: Client Satisfaction Questionnaire (CSQ; Attkisson & Zwick, 1982) i
s an 8-item self-report scale measuring satisfaction with treatment. It has excellent internal consistency 
and correlates with therapists’ estimates of client satisfaction. This instrument will be used to measure 
participants’ satisfaction with the interventions.
Homework Compliance: Homework Compliance Scale (HCS; Primakoff et al., 1986) is a single item 
questionnaire in which participants rate their degree of homework compliance on a scale from 0 
(homework was not assigned) to 6 (I did more of the assigned homework than requested). An estimate 
of the number of minutes spent completing homework since the previous session and number of 
completed worksheets and assignments will also be recorded at each CPT session.
Alcohol Screening Tool: The Alcohol Use Disorders Identification Test-C (Audit-C; Saunder 
et al., 1993) is a 3-item screening measure used to screen for alcohol use disorder, which 
is an exclusion criteria for the study.
Neuroimaging: Collected only at baseline
 
Experimental fMRI Tasks: 
 
N-Back Working Memory Task: In this task, pseudo-words are presented on each trial and the 
participant must determine whether the current stimulus matches the one n-back. There are 3 
types of n-backs in the task: 1-back, 2-back, and 3-back. Participants respond via a keystroke 
whenever they see a pseudo-word repeated either one, two, or three pseudo-words back. Each 
participant will receive a practice block before going into the scanner and two blocks while in the 
scanner, with each block containing all 3 N-back conditions in an alternating order. Reaction time 
and accuracy on each trial are recorded during scanning.
 
Go-No Go Inhibition Task: In this task, shapes are presented on screen. Participants are instructed to make a 
button press to every shape except when a circle or square appears on screen. Each participant will receive 
a practice block before going into the scanner and two blocks while in the scanner. Reaction time 
and accuracy on each trial are recorded during scanning.

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Acquisition of images: All scans 
3T General Electric (GE) Discovery 
will be collected on a research-dedicated 
MR750 whole body system using a 32-channel receiver coil (Nova Medical Inc, Wilmington MA). An initial 
localizer scan will be acquired to assure proper positioning in the scanner and to allow for slice prescription. An 
anatomical scan will be collected for registration of functional data to standard space. Blood oxygenation level 
dependent (BOLD) signal will be measured using gradient echo planar imaging during the functional tasks. In 
addition, two field maps will be collected to assist with distortion correction of the BOLD images. 
 
Resting state: Resting state data will be acquired for 8 minutes via T2-weighted functional images 
using a gradient-echo multiband echoplanar imaging method. Participants will be instructed to 
remain still, stay awake, keep their eyes open, and focus on a fixation point.
 
Computerized EF Training: CEFT will consist of 6 weeks of online training 30 minutes a day for 5 days a week 
on a home computer followed by the standard protocol of the cognitive-only version of CPT (CPT-C) for 6 weeks 
(2 sessions per week). CEFT will be administered via BrainHQ by Posit Science and will consist of six cognitive 
training modules that target executive processes of inhibition, shifting, and updating of working memory. All 
tasks become more challenging with practice. Veterans will receive a brief introduction to the program on site at 
the VA (log-in, which modules to complete, and how long to spend each day on the training). These instructions 
will be provided in a written format to be used once participants are on their home computer. If participants do 
not have a home computer/internet access, they can complete the modules at another location such as a public 
library or at the VA, but training will still be self-directed. BrainHQ offers a secure portal that allows for 
monitoring of usage and progress of participants. Researchers will be in weekly phone contact with participants 
to check on their progress with the cognitive training and answer any questions. This check-in will also serve the 
purpose of keeping them engaged and motivated.
 
 
BrainHQ Modules:
Mind Bender: cognitive flexibility/set shifting exercise, participants switch between two different rules in 
order to make correct responses
Auditory Ace: auditory working memory exercise, essentially an N back task where auditory information 
is retained and manipulated to determine if the current card matches a card N steps back in the 
sequence
Card Shark: visuospatial working memory exercise, similar to the Auditory Ace, except the information 
used to determine matches is presented visually
Juggle Factory: visuospatial working memory exercise, participants reconstruct a sequence of numbers 
in moving circles in the correct order, at more difficult levels participants must inhibit the influence of 
distracters
Mixed Signals: inhibition exercise, participants respond if what they hear and see matches in a particular 
way (while ignoring irrelevant information), otherwise they withhold their response
Divided Attention: inhibition exercise, participants indicate whether two objects match on a particular 
aspect (e.g., shape, color, fill) while ignoring irrelevant/competing aspects
Placebo word games: Participants in the active control group will be assigned to complete 
computerized placebo game training at the same frequency as CEFT. Games and puzzles will be 
This placebo condition 
accessed online via BrainHQ in a similar manner to the CEFT condition. 
controls for the effects of computer exposure, contact with research staff, and monetary 
payments. In addition, it controls for nonspecific engagement and motivation through the 
reinforcement of graphics-based computer games but does not provide the constrained, intensive, 
adaptive training of specific executive functions that the active condition provides. Participants 
will rotate through a series of games (e.g., 
) for the same 
sudoku, crossword, connect four
number of hours as the EF training condition. After 6 weeks of game training, they will also 
receive CPT-C as detailed below.
 
Cognitive Processing Therapy: CPT is an evidence-based, trauma-focused therapy for PTSD endorsed by the 
VA/DoD Practice Guidelines and is widely available within VASDHS. Patients will receive a well-validated 
version of CPT, CPT-Cognitive only (CPT-C), which is a standard PTSD treatment provided at the VA that 
differs from the original version of CPT in that it does not include written trauma accounts. It entails 12 visits to 
the VA, each lasting 50 minutes.
 
More specifically, CPT-C is a form of CBT targeting PTSD and other corollary symptoms following traumatic 
events that has been used successfully with patients exposed to a range of other traumatic events, including 
combat trauma. Based on a social cognitive theory of PTSD and trauma, CPT focuses on the content of trauma-
related thoughts, whether these thoughts are consistent or inconsistent with the patient's prior beliefs about the 
world, and the impact these thoughts have on emotions and behaviors. In the first session patients are educated 
about PTSD symptoms, cognitive theory, and treatment goals. The patient is given a practice assignment to 
write a one-page ‘Impact Statement’ focusing on how the identified traumatic experience has influenced 
thoughts and beliefs about the self, others, and the world. In the next two sessions the Impact Statement is used 
to identify distorted thoughts about the trauma ("stuck points") and the patient is taught to identify the 

relationship between thoughts and feelings. Sessions 4 and 5 focus on helping the patient identify and challenge 
distorted cognitions. Sessions 6–12 focus on teaching and reinforcing cognitive behavioral therapy skills, with a 
specific emphasis on the themes of trust, safety, power, control, self-esteem, and intimacy. 
 
Veterans who meet the screening requirements who prefer to be seen at the Mission Valley 
Clinic will be given the opportunity to complete therapist meetings at that facility. Study staff 
will meet with the patient and conduct study procedures in the same manner in which they are 
conducted in the San Diego VA. 
Therapy appointments will be offered via VA Video Connect if participants are unable to attend an 
appointment in person. Questionnaires given at psychotherapy sessions (PCL-5 and HCS) can be 
delivered via telehealth with providers working remotely.
Data Analysis: Data management and analysis will be supervised by Dr. Golshan (Biostatistician and 
consultant). Data will be analyzed from all randomized subjects on whom we have a baseline assessment and 
at least one post-baseline evaluation. Every attempt will be made to obtain at least one follow up assessment on 
any individuals who drop out of treatment. Data will be screened for outliers, missing values, and violation of 
statistical assumptions. Preliminary analyses will be used to examine the descriptive statistics of the study 
sample and assess for the influence of outliers and non-normally distributed variables for possible exclusion or 
transformation. Gender, age, medications, depression, and TBI-related variables will be examined for 
differences between groups at baseline; they will be added as covariates if differences are significant.
 
Missing Data: Missing data values will be minimized by intensive training of the staff in techniques of clarifying 
answers and checking questionnaires while Veterans are on-site. When missing values are identified, several 
approaches to acquire the necessary data will be employed including 1) contacting the Veterans to obtain the 
missing data and/or 2) examining the missing data to assess randomness. We expect missing data to be 
randomly distributed. Missing data (i.e., loss to follow up) will be tested to determine if it is informative, and the 
methods developed by Diggle (1989) and Ridout (1991) to test for completely random dropouts will be applied. 
We will test whether the drop-outs are random or systematic by comparing the drop-outs with the study 
completers on the baseline data. An absence of significant differences would support the random nature of drop-
outs. If the extent of missing data is small and the data appear to be consistent with a missing-at-random model 
(MAR), then the maximum-likelihood analysis using all randomized cases and the observed data is an 
appropriate method for handling the missing data.
 
Analyses will be conducted using multilevel modeling (MLM; also known as hierarchical linear 
modeling and linear mixed effects modeling). MLM has several advantages over more traditional 
analytic approaches such as change scores or repeated measures ANOVAs, as it allows for the 
inclusion of participants who have missing data and who dropped out of the study prematurely 
without using data imputation or biased procedures that often reduce power, such as casewise 
deletion. MLM also accounts for the fact that repeated observations across time are not 
independent but are nested within individuals. This method can provide an estimate of the 
individual variability around the population trend, the variability of the individual intercepts 
(baseline symptom levels) and slopes (change in symptoms across time), and the correlation 
between them. Initial model testing will be conducted to determine whether including individual-
level random effects of intercept and slope (to model variability in initial symptom level and 
variability in response to treatment) will improve model fit. In addition to including the significant 
random effects, the model will include the fixed effects of treatment group, time, and group-by-
time interaction. Data will be analyzed from all randomized subjects (full intent-to-treat sample) 
using all available data collected at the different assessment points.
 
Image processing: All functional image processing will be done with the Analysis of Functional Neuroimages 
(AFNI) software package. AFNI will be used to first preprocess the data (motion corrected, fieldmap corrected, 
slice-time corrected, temporally filtered, spatially smoothed). For examination of regional activation for each 
task, a general linear model that includes a baseline and linear trend plus regressors for each trial type and 
parameters to account for any residual motion will be calculated.  A map of the fit coefficient for the contrasts of 
interest for each task (i.e., the contrast between 2-back and 1-back conditions in the n-back task, the contrast 
 Functional connectivity 
between no go and go trials in the go-no go task), will be created for each subject. 
analysis will be performed within AFNI via Context-Dependent Correlation Analysis (McLaren et al., 2012). This 
analysis enables account for the effect of a specific task contrast on the connectivity model in the analysis, and 
the interaction between this psychological effect (task contrast) and the neuronal response (physiological effect) 
at the seed region (dorsolateral prefrontal cortex, anterior cingulate cortex, and other regions activated by the 
specific task derived from main effects analysis). In other words, the integration process at multiple levels in the 
brain is dependent on the context of task conditions. Other than the seed time course, such a context-dependent 
correlation analysis, aka psychophysiological interaction (PPI), requires the insertion of one specific regressor in 
the model, a second-order regressor of the interaction. Additionally, the individual raw signal datasets will be 
band-pass filtered (0.009< ƒ< 0.08) to reduce physiological noise. Individual timecourses in these processed 
raw signal datasets will be extracted for seed regions of interest (ROIs). After censoring for data points >2 

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standard deviations from the average signal, hemodynamic delay from the seed voxel timecourse will be 
extracted. The resultant signal will then multiplied by the contrasts of interest thereby creating an interaction 
timecourse to be convolved with a gamma-variate hemodynamic function. The interaction timecourses will be 
used as regressors of interest together with nuisance regressors and AFNI’s REML function will be applied. The 
resulting correlation coefficient for the timecourse in the regions of interest will be calculated for each voxel. 
Correlation maps for the timecourse in the regions of interest and the timecourse from all other brain voxels will 
be created to demonstrate. The Fisher Z transforms of these correlation maps will be warped to conform to the 
Talairach atlas and a Gaussian blur with a maximum of 6.0 mm full width at half maximum (FWHM) will be 
applied. Resting state data will be analyzed using well established methods in the field that Dr. Eyler has 
experience implementing, including regressing out sources of variance (e.g., motion, physiological noise, whole-
brain global signal, cerebrospinal fluid and white matter signal; see methods of Dev et al., 2016; Nguyen et al., 
2016). Network seeds will include task-positive regions involved in top-down attentional control (e.g., DLPFC, 
inferior parietal lobule [IPL]) and task-negative regions part of the default mode network (e.g., medial prefrontal 
cortex [mPFC] and posterior parietal cortex [PCC]; Fox et al., 2005). Freesurfer will be used to extract volumetric 
and cortical thickness data in ROIs (e.g., DLPFC, ACC) to be used in exploratory analyses of the structural data 
to complement the fMRI results.
 
COVID-19 Emergency Procedures: In order to ensure patient safety during the COVID-19 public 
health emergency, the temporary procedures detailed below allow for participation while 
maintaining social distancing. The protocol remains as approved with the following exceptions:
If a Veteran is potentially interested in participation after the initial contact and screens 
eligible via the telephone screen, we will send an encrypted email (using VA Azure RMS), a 
message through MyHealtheVet, documents by US mail, or a DocuSign envelope (see 
below for procedure) containing (1) the approved ICF, (2) the approved HIPAA document, 
and (3) the CA Experimental Subjects Bill of Rights, and arrange a telehealth visit through 
a VA-approved secure telehealth communication software to complete the informed 
consent process, explain the HIPAA Authorization, and CA Experimental Subjects Bill of 
Rights. The staff member will witness the signing of the ICF and HIPAA Authorization and 
will instruct the potential participant to provide documentation of written informed consent 
by either returning images of the documents or the full signed PDF through MyHealtheVet, 
by allowing a screenshot of the signed documents (approval date and signature must be 
clearly visible), or downloading the signed forms through DocuSign. These electronic 
documents will be stored electronically separate from study data on the R: drive and the 
participant will retain their copies.
If secure telehealth communication is not possible or available, consenting and HIPPA 
authorization will be conducted via phone after the participant receives the documents 
through the mail. The participant will be instructed to mail back the signed consent form. 
Paper documents will be stored securely according to VA requirements.
Once documentation of written consent is received, the staff member will begin the 
baseline eligibility assessment. Interview-based measures for assessments will be 
completed using a VA-approved secure telehealth communication software or phone in 
which a staff member will transcribe the responses into an electronic form behind the VA 
firewall or record the answers on paper forms that will be stored and locked in participant 
data files per usual protocol. 
The participant may complete assessment questionnaires in the following ways: (1) 
complete the forms (on paper and scan or using a fillable pdf) and return them via 
MyHealtheVet, (2) complete the forms using a password-protected pdf sent to them via 
encrypted email (using VA Azure RMS) and returned via email to a staff VA email account, 
or (3) read responses to the items to a staff member who will record the responses into an 
electronic form behind the VA firewall on the R drive. If electronic methods prove difficult 
for a particular participant, paper packets will be returned to the VA by U.S. post or they 
may return them during their in-person abbreviated assessment and this decision will be 
documented. Questionnaire forms will not contain PIV and are identifiable only by 
participant ID. 
Neuropsychological assessments will be completed using VA-approved secure telehealth 
communication software to the extent possible. If the software is not available due to 
technology issues, verbal neuropsychological measures will be delivered via phone. 
Shortened in-person visits will be scheduled in order to complete neuropsychological tests 
that are unable to be administered using telehealth communication software or phone. 
These visits will be abbreviated to minimize contact between staff and Veteran 
participants. Safety guidelines for these visits will be detailed in the RAMP plan and will be 
consistent with VA guidelines for the resumption of in-person human research. 
If possible, MRI sessions will be scheduled immediately following the participant’s in-
person baseline visit to minimize the number of VA visits the Veteran participant will be 
required to make. Imaging appointments will follow all UCSD safety guidelines in addition 
to VA guidelines for the resumption of in-person human research. 

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To assess the impact of COVID-19 on participants, the CAIR Pandemic Impact 
Questionnaire (C-PIQ) will be administered during assessments using the methods 
described above.
Assessments (including telehealth/phone appointments, questionnaires, and the 
abbreviated in-person neuropsychological testing) will be administered at baseline, again 
after the cognitive training portion of the study, and post treatment. 
All psychotherapy sessions will be delivered via telehealth using VA Video Connect. If VA 
Video Connect is not available due to technology issues, therapy will be delivered via other 
secure telehealth communication software or phone.
The study is currently recruiting and newly enrolling, according to guidelines set forth in 
the VA Interim Policy on Human Subject Research During the COVID-19 Pandemic and our 
IRB-approved RAMP plan.                           
The additional protocol for remotely consenting veterans using DocuSign is as follows:
At the time of remote consenting, the study team member/consenter will send a DocuSign 
envelope (email containing links to the study documents) to the potential subject. 
At the scheduled time, the study team member (referred to as “consenter”) will contact 
the potential subject via VA-approved secure telehealth communication software or phone. 
The consenter will guide the potential subject to open the DocuSign envelope (email) and 
the linked study documents therein. The consenter will open a copy of the study 
documents on their own computer as a reference. The consenter will review the study 
documents with the potential subject, ask questions to gauge comprehension, and answer 
any questions and concerns. If the potential subject agrees to participate in the study, the 
consenter will guide them to fill in the fields in the study documents (e.g., “Last, First, 
Middle Initial” name field, Last 4 SSN field, etc.) and to sign the documents. When the 
subject has signed the documents, they will click “FINISH” to finalize the documents.
While still on the telehealth communication software or phone with the subject, the 
consenter will receive an email notification to log into DocuSign. The consenter will verify 
that all fields are completed accurately and subsequently sign the document(s) (e.g., ICF). 
The consenter will guide the subject on how to download a copy(ies) of the signed 
document(s) to the subject’s personal computer for their record. 
The consenter will download a copy(ies) of the signed document(s) to a study folder in VA 
network drive (i.e., R:\Crocker) as study record.
 Section 9.1 Clinical Procedures
9.1) Differentiate research procedures (or any procedures done for research purposes only) from clinical 
procedures (procedures that are done as part of standard care).
(Note: this differentiation should be clear in the consent form as well)
Research and usual care procedures: All procedures are done for research purposes. All study 
participants will receive Cognitive Processing Therapy (CPT) which is the standard of care for 
PTSD but will be delivered by study psychologist in the context of this research study. 
Audio recordings of the therapy sessions that are conducted at the Mission Valley Clinic will be 
uploaded to the protected VA server for potential review by supervisors while onsite and deleted 
from the approved recorder so that no potentially identifying information is lost in transport. 
In addition to the therapy conducted within this research study, Veterans will undergo an 
assessment battery that will be administered three times during the study – these assessments 
are also for research and not clinical purposes though the tests included in the assessment are 
standard clinical tools.
 Section 9.8 Questionnaires & Surveys
9.8) Provide the name and a reference for questionnaires/surveys that are standard or identify them here and 
attach a copy of the questionnaire/survey.  Questionnaires or surveys that are not clinical standard references 
must be uploaded.  Reference the help link for additional information related to surveys administered to VA 
 
personnel and approved platforms for web-based surveys.
1. Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Weathers et al., 2013)
2. PTSD Checklist for DSM-5 (PCL-5; Weathers, Litz, Keane, Palmieri, Marx, & Schnurr, 2013) 

3. Beck Depression Inventory-II (BDI-II; Beck, Steer, &Brown, 1996)
4. Behavior Rating Inventory of Executive Function (BRIEF; Guy et al., 2004)
5. Wisconsin Card Sorting Test (Heaton, 1981)
6. Delis Kaplan Executive Function System, Color-Word Interference Test and Trail Making Test 
(Delis, Kaplan, & Kramer, 2001)
7. Paced Auditory Serial Addition Test (Gronwall, 1977)
8. California Verbal Learning Test-II (CVLT-II; Delis, Kramer, Kaplan, & Ober, 2000)
9. Wechsler Adult Intelligence Scale – IV (WAIS-IV) Digit Span, Digit Symbol, and Symbol 
Search subtests (Wechsler, 2008)
10. Wide Range Achievement Test, Fifth Edition (WRAT5; Wilkinson & Robertson, 2017)
11. Test of Memory Malingering (TOMM; Tombaugh, 1996)
12. World Health Organization Quality of Life-BREF (WHOQOL-BREF; the WHOQOL Group, 1998) 
13. Inventory of Psychosocial Functioning (IPF; Rodriguez et al., 2012) 
14. Ohio State University TBI Identification Method - Interview Form (OSU TBI-ID; Corrigan & 
Bogner, 2007)
15. Client Satisfaction Questionnaire (CSQ-8; Attkisson & Zwick, 1982)
16. Homework Compliance Scale (HCS; Primakoff et al., 1986)
17. MINI International Neuropsychiatric Interview (MINI; Sheehan, 2014)
18. The Alcohol Use Disorders Identification Test-C (Audit-C; Saunder et al., 1993)
19. CAIR Pandemic Impact Questionnaire (C-PIQ)
 Section 9.9 Data Safety Monitoring Board or Plan
9.9) Provide a Data Safety Monitoring Plan (DSMP) or the details of a Data Safety Monitoring Board; if a 
written plan is available, attach a copy of the plan to the submission form.
Data will be de-identified and labeled with a code number that is unique to each patient in the 
study. All hard copy data will be stored in locked file cabinets in locked rooms in VASDHS 
Building 13, while all electronic data
will be stored in password-protected files in a limited access folder on the secure VA network 
drive. A key code that links participants with their coded identifier will be maintained by Dr. 
Crocker. This key code will be stored
separately from all other study data and available only to Dr. Crocker and her research 
coordinator. Any materials with protected health information (e.g., informed consents) will be 
stored in separate locked file
cabinets from de-identified, coded materials to ensure the security of patient privacy. All 
computerized cognitive testing data will also be de-identified and coded with only an ID number 
and thus will contain no
Protected Health Information (PHI). The coded computerized cognitive data will be stored on a 
FIPS 140 compliant server that is accessible to the research team and then transferred to a 
secure VA network for statistical analysis. All statistical transfer routines are inherently secure 
via their operating platform and they contain no patient names or personal data. Participant 
confidentiality will be protected to the extent provided by law. Sensitive information that might 
be disclosed in this study and would be subject to mandatory reporting includes information 
regarding child or elder abuse. Evidence of suicidality or homicidality may also be disclosed to 
appropriate mental health personnel or others to ensure the safety of all parties. Raw and 
electronic data will be stored in the VASDHS in accordance with current VA research guidelines.
In addition, the institution’s IRB requires regular updates on the status of research projects, 
including the number of participants enrolled, adverse events or unanticipated problems, number 
of withdrawals from the project, complaints about the research, and any protocol changes. Any 
adverse events or unexpected study-related side effects will be reported immediately to the IRB.
Regarding the cognitive training that will be administered via BrainHQ, data transport and 
storage systems are HIPAA and FIPS-140 compliant. No personally identifiable information is 
mandatory to use the BrainHQ program. User names will be coded as anonymized, de-identified 
study numbers or otherwise de-identified. The only information created, transmitted, and stored 
by the program pertains to usage (e.g., how much training has been done) and progress (e.g., 
how much improvement has been calculated) that a user makes. IP addresses are not recorded 
to be in HIPAA compliance. Also, data will be downloaded from BrainHQ on a regular basis.
There is the possibility of an abnormal finding on the MRI scan. However, the MRI scans are not 
being done for clinical purposes, and the MRI scan procedure is not sufficient for the clinical 
diagnosis of a possible brain disorder. The purpose of this scan is not to diagnose abnormalities, 
but on rare occasions a finding is observed that might be clinically important. Should there be 
cause for concern, with the permission of the participant, this information will be forwarded to 
the primary care physician for follow-up.

 Section 9.11 Pictures and Audio/Video Recordings of Patients
9.11) Describe the purpose of photographs (facial), or audio, or video recordings of patients.  Describe 
whether the recordings will contain, or potentially contain, identifiers.  Note: use of photographs or recordings 
must be covered in the informed consent process and documented consent documents (e.g., consent form, 
information sheets, telephone screen scripts).
Audiorecordings are used to ensure the fidelity of the psychotherapy delivered by study 
therapists. Recordings will be made with a digital audio recording device.
 Section 9.12 Off Station Activities
9.12) Describe each off-station activity including where it occurs, subject involvement, and any additional 
required protections.  Note:  if the off-station activity is being conducted under the approval authority of another 
institution, this is not VA offsite research and should be described as collaborative research effort.  Please contact 
the HRPP office if you have any questions
Computerized cognitive training will be completed on Veterans' home computers. If they do not 
have a home computer, they will be able to complete it at another location, such as a local 
library. As discussed previously, data transport and storage systems are HIPAA and FIPS-140 
compliant. No personally identifiable information is mandatory to use the BrainHQ program. User 
names will be coded as anonymized, de-identified study numbers or otherwise de-identified. The 
only information created, transmitted, and stored by the program pertains to usage (e.g., how 
much training has been done) and progress (e.g., how much improvement has been calculated) 
that a user makes. IP addresses are not recorded to be in HIPAA compliance. Also, data will be 
downloaded from BrainHQ on a regular basis.
MRI scanning sessions will be completed at the University of California, San Diego UCSD Center 
for Functional MRI (UCSD CFMRI). Before entering the scanning room, subjects will be screened 
for scan safety and will be inspected with a metal detector wand for potential metal on their body.
Off-station activity will only occur as part of COVID-19 emergency procedures to eliminate the 
need for participants to travel to the San Diego VA hospital for study treatment and assessment 
delivery. This will involve video teleconference into a participant's home. The clinician and 
assessor will be located at a VASDHS space at the time of the appointment unless staff are 
approved to telework or quarantined, in which case they will deliver the telehealth session 
through remote access or a VA-issued laptop. If VA-approved secure telehealth communication 
software is not working, the phone will be used. No additional protections are needed. Assessors 
and therapists will use telemental health services, or telephone, to contact and coordinate 
patient care and participant interest.
 Section 10 - Human Subjects
10) Describe the characteristics of the proposed subject population. Include age, gender, ethnicity, and health 
status as appropriate.  Note: Data about people are still considered “human subjects” by the IRB, so even if you 
do not intend to contact the patients whose charts you will review, you still describe the characteristics related to 
   
the subjects whose charts you will review.
Provide inclusion and exclusion criteria as appropriate.  Provide a statement how non pregnancy is 
confirmed if pregnancy is an exclusion criteria.
For multisite studies, provide the total number of subjects from all sites and include description of the 
local site's role as a coordinating center if applicable.
Indicate the number of VA participants to be studied.
Indicate the estimated number of 
 subjects that will fail the screening process, if any.
consented
Participants: The study specifically targets Veterans with PTSD and cognitive complaints. During 
recruitment, we will initially screen Veterans by phone. Those that are eligible for the study 
based on the phone screen will be brought to the lab for consenting, intake, and baseline 
assessments (approximately 200 Veterans). However, we assume a portion of those individuals 
will not qualify for the study. That will leave us with approximately 150 Veterans (75 per 

condition) to randomize to treatment. For recruitment, we will utilize the VASDHS system of 
PTSD clinics, spanning the main and 3 satellite facilities, and general outpatient mental health 
clinics. The TBI Polytrauma Clinic and TBI Cognitive Rehabilitation Clinic will also be used as a 
source of recruitment since the majority of Veterans presenting to these clinics have comorbid 
PTSD. VA employees are not the target population, however they will not be excluded if they 
meet the inclusion criteria.
2. Inclusion/Exclusion Criteria:
Inclusion criteria are: 1) OEF/OIF Veterans enrolled at VASDHS, 2) aged 18-55 3) current PTSD 
diagnosis, 4) endorsement of cognitive complaints, 5) no pending medication changes, 6) 
English-speaking.
Exclusion criteria include: 1) active substance use disorder in the last month, 2) suicidal intent or 
attempt within the last month, 3) schizophrenia, psychotic disorder and/or bipolar disorder, 4) 
dementia, 5) premorbid IQ < 70, 6) participation in other concurrent PTSD intervention studies, 
7) previous completion of more than 4 CPT sessions, 8) history of a documented neurological 
disorder (e.g., Parkinson’s disease, multiple sclerosis, epilepsy) 9) moderate to severe TBI (loss 
of consciousness greater than 30 minutes or post-traumatic amnesia greater than 24 hours).
The exclusion criteria involving specific DSM-5 (Diagnostic and Statistical Manual-5) disorders, 
including substance use disorder, schizophrenia, psychotic disorder, bipolar disorder, and 
dementia (criteria 1, 3, 4) will be determined based on a CPRS chart review for clinical 
assessments that determine diagnosis based on DSM-5 criteria. We will also ask them during the 
phone screen about diagnoses. If there is any ambiguity in terms of psychiatric diagnoses based 
on the phone screen and a review of patient records (CPRS) that would disqualify the participant, 
the relevant portions of the MINI International Neuropsychiatric Interview (MINI; Sheehan, 
2014) will be administered during the baseline assessment to clarify eligibility, as noted in the 
methods section. CPRS will also be reviewed for evidence of suicide intent or attempt within the 
last month (criteria 2), including a review of their Comprehensive Suicide Risk Assessment 
(CSRA) documented in CPRS. We will also ask them during the baseline assessment, including 
during the completion of the Beck Depression Inventory-II (BDI-II) that has a question about 
suicidal intent. An endorsement of a 1 or higher on this item will prompt further assessment for 
intent as described in the suicidality form. Premorbid IQ below our cutoff (criteria 5) will be 
determined either by a chart review if the participant received a previous clinical 
neuropsychological assessment documented in CPRS or by administering the WRAT5 during the 
baseline assessment (see methods section). Criteria 6, 7, 8, 9 will be determined by a CPRS 
chart review and also based on participant answers to the relevant questions on the phone 
screen. If the severity of any TBIs experienced (criteria 9) is ambiguous, eligibility will be 
determined by the Ohio State University TBI Interview administered at the baseline assessment 
(see methods section). 
Veterans will not be excluded for current psychotropic medication usage or past mental health 
treatment that was not CPT ,but given the potential impact on outcome variables of interest, we 
will track duration and type of past mental health therapies as well as current medication use in 
enrolled Veterans.
Since the primary aim of the present research is centered around the intervention component, 
Veterans will still be enrolled in the study if they have contraindications for MRI, since that will 
not prevent them from engaging in and completing PTSD treatment in real-world settings; they 
will just not participate in the MRI portion of the study at baseline. In addition, the rate of 
exclusion for MRI-contraindications is very low. Contraindications for MRI include: pregnancy, 
cardiac pacemaker, metal fragments in eyes/body, participants who have been a metal worker
/welder, aortic aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, 
heart valve replacement, IUD, a shunt (ventricular or spinal), electrodes, metal plates/pins
/screws/wires, or neuro/bio-stimulators (TENS unit), vision problems uncorrectable with lenses, 
claustrophobia, inability to lie still on one’s back for approximately 60 minutes, prior 
neurosurgery, older tattoos with metal dyes, unwillingness to remove nose, ear or face jewelry, 
braces or permanent dental retainers.
No exclusions will be made based on gender, race or ethnic background. Gender and ethnic 
composition of the samples will reflect that of the population of eligible patients presenting from 
the recruitment sources.
 Section 10.6 Avoiding coercion of students or employees
10.6) Indicate how coercion of students and/or employees will be avoided:

Although VA employees are not the target population, if they meet the inclusion criteria for the 
study they may be enrolled in this study. All study procedures with VA employees enrolled in this 
study will be done by staff who does not have a direct professional relationship or personal 
relationship with that employee.
 Section 11 - Recruitment
11) Describe, step-by-step, the plans for recruitment of subjects (or selection of subjects as in record review). 
This description must include how, when, and where potential subjects are approached as well as procedures 
for identifying potential participants (through medical records, physician referral, third-party 
sources, etc.).  Include how selection is equitable.  Indicate if vulnerability to coercion may be present and if so 
plans to ensure voluntary participation.
The system of PTSD clinics within VA San Diego (spanning the main and 3 satellite facilities) and 
general outpatient mental health clinics will serve as primary recruitment clinics. The TBI 
Polytrauma Clinic and TBI Cognitive Rehabilitation Clinic will also be used as a source of 
recruitment since the majority of Veterans presenting to these clinics have comorbid PTSD. 
Research databases of Veterans who have previously consented to be contacted about additional 
study opportunities can also serve as a recruitment tool. We will provide informational, IRB 
stamped study brochures to Veteran Resource Centers and any psychological services centers at 
local higher education institutions. Additionally, we will use VA web, electronic board, and TV 
advertisements.
Additionally, to better target veterans who meet inclusion criteria for our study, research staff 
will search CPRS and pre-screen VASDHS patients who have previously received information 
about the current study from the Mission Valley or La Jolla VA PTSD Clinic Orientation Meeting for 
inclusionary criteria. Once patients who meet criteria are identified, research staff will send a 
recruitment letter via mail to these veterans prior to contacting them by phone. Those who are 
interested in participating will then undergo the standard phone screen and, if still determined 
eligible, will be scheduled for consenting.
We will also receive referrals from other VA studies. These studies will provide referrals of 
veterans have consented to be contacted for additional studies. Studies we will recruit from 
include protocol numbers
H150015, H130148, H150113, H130296, H170084, H180029, & H150106. Subjects from these 
studies who appear to be eligible for participation in this study and who have consented to be 
contacted about future research opportunities will be sent a recruitment letter via mail prior to 
contact by phone unless they have specifically consented to phone contact. 
Additionally, we plan to contact veterans who have enrolled in the VA IRB approved registry, 
VASDHS TBI/PTSD Registry - H170023, allowing themselves to be contacted by future VA IRB 
studies. In section 12.10, we ask for a waiver of partial HIPAA so we can contact the Veteran via 
their preferred method of contact. If at any time, the Veteran enrolled in the VASDHS TBI/PTSD 
Registry lets this study know that they want to withdraw from the registry and no longer want to 
be contacted, we will contact H170023's study coordinator as soon as possible.
IRB-approved recruitment flyers will be posted in each targeted clinic with study telephone 
numbers listed and VA treatment providers will also share flyers and information about the 
study. Providers will request verbal consent from the Veteran to be contacted by study personnel 
if they report interest in participating in the study. Interested Veteran's can fill out our Research 
Interest Form or clinicians can refer via CPRS note to the PI, Dr. Crocker. Potentially eligible 
Veterans will be identified by study staff by phone contact from Veterans responding to flyers, 
interest form, or clinician referral. Study staff will provide detailed information about the study 
and its procedures via phone. For those Veterans who remain interested, they will undergo 
preliminary screening on the phone to determine that they meet basic inclusion criteria (e.g., 
demographics, diagnoses, cognitive complaints). If the phone screening suggests they meet 
basic criteria, they will be invited to undergo consenting and initial assessments that will confirm 
their study eligibility.
Only veterans who are currently receiving health care from the VASDHS will be enrolled. Study 
staff will provide detailed information about the study and its procedures to interested 
individuals. For those who agree to participate, study staff will arrange for consent and initial 
screening. Participants will take part in the study at the VA San Diego. All participants will be 
able to continue with any standard clinical care that they have been participating in or may be 
recommended by their doctor during the course of their participation in the study. Participants 
will enter the study on a consecutive admissions basis. We intend to recruit 200 Veterans in 
order to enroll 150 Veterans who qualify for study inclusion. Every reasonable effort will be made 

to provide the informational brochure, “Volunteering in Research – Here Are Some Things You 
Need To Know” to potential research subjects.
 Section 11.1 Recruitment Materials
11.1) Identify all recruitment materials (flyers, advertisements, letters, etc.) that will be used; include the web 
address for any web-based advertisements. The text of all communications with prospective participants must 
be reviewed and approved by the IRB before it can be used.  You will be reminded to attach copies of 
recruitment materials to the initial submission packet.  Note:  Posting of flyers with pull tabs is not permitted 
within VASDHS (including the VMRF building).  However, you may request to advertise on the e-boards (located 
 
at the elevators and throughout the facility) or on the VASDHS Research Opportunities web-page.
We will be using an approved brochure and flyer that are provided to clinics at the VA in La Jolla, 
Mission Valley, Oceanside, and South County/Chula Vista and to Veterans Resource Centers and 
psychological services centers at local higher education institutions. We will also use an approved 
recruitment letter that will be sent to potential Veteran participants for those who previously 
agreed to be contacted for research purposes but did not explicitly agree to be contacted by 
phone. In addition to brochures, we use VA web, electronic boards, and advertisements posted 
on boards in the hospital and Veterans Medical Research Foundation.
 Section 12 - Informed Consent
12) Indicate whether or not each category of consent is involved in this study:
12a) Will the study team obtain information or biospecimens for the purpose of screening, recruiting, or 
determining the eligibility of prospective subjects without (or prior to) obtaining informed consent of the 
prospective subject or the prospective subject’s LAR?
 Yes  
 No
Check one or both of the below boxes if they apply to this study:
Information will be obtained through oral or written communication with the prospective subject or the subject’s 
Legally Authorized Representative (LAR) and this is not a FDA regulated study.
 Yes  
 No
Identifiable information or biospecimens will be obtained by accessing records or stored identifiable 
biospecimens and this is not an FDA regulated study.
 Yes  
 No
If either or both of the above boxes is checked "yes", an informed consent waiver does not have to be requested 
 if the protocol is initially approved after 01/01/2019 or if it has been converted to the 
for this activity
2018 Common Rule requirements. However, a request for a HIPAA waiver will still need to be requested and 
informed consent obtained for any research interventions after eligibility is established.  Otherwise, waivers of 
consent and authorization must be requested for this activity.  Waivers of consent and authorization are 
required for screening purposes for FDA regulated research. 
12b) 
 informed consent
Signed
 Yes  
 No
12c) Waiver of documented consent (e.g., 
consent) for all or part of the study.
oral 
  Yes  
  No
12d) Request for a 
 of consent for all or some study activities.
waiver
 Yes  
 No
12e) Alteration of 
 of consent.
other required elements
  Yes  
  No

12f) 
assent to participate (Director approval will be required)
Child 
  Yes  
  No
12g) Will any language 
 be used by those obtaining consent and understood by the 
other than English
prospective participant or the legally authorized representative?
  Yes  
  No
12h) 
 to determine if participants have the capacity to consent for themselves.
Decisional Capacity Assessment
 Yes  
 No
12i) 
 consent (legally authorized representative)
Surrogate
  Yes  
  No
 Section 12.1 Informed Consent Process
12.1a) Will consent be obtained before any study procedures are performed (including screening procedures 
 
except screening procedures with Consent and/or HIPAA waiver when required)?
 Yes  
 No
12.1b) Will the information being communicated to the participant or legally authorized representative 
during the consent process include exculpatory language through which the participant or legally authorized 
representative is made to waive or appear to waive any of the participant’s legal rights or release or appear to 
release the Researcher, Sponsor, the VA or its agents from liability for negligence.
  Yes  
  No
12.1c) A master list of all VA subjects consented (written or not) under this protocol will be maintained.
 Agree
 Disagree
12.1d) Identify the circumstances under which consent will be obtained including where the process will take 
place; any waiting period between describing the research and obtaining consent including sufficient time for 
the prospective participant to consider participation, and any steps taken to minimize the possibility of 
coercion or undue influence.
Participants will first hear details about the study during the phone screen process, at which time 
if eligible, they will be scheduled for consenting and an initial assessment. At the time of 
consenting (prior to the initial assessment), the study coordinator or the RA will explain the 
study to the participant and answer any questions the participant may have. After providing 
information about the study sufficient for the individual to make an informed decision about 
participating in the study, those who decide to participate will undergo the informed consent 
process by the study staff, who will be appropriately trained to obtain informed consent from the 
participants. Study staff will make sure the veteran has sufficient understanding of all aspects of 
the study, including time commitment, risks and benefits of participating, and the ability to 
withdraw from the study at any time with no impact on any clinical care they may receive or are 
receiving from the VASDHS, before obtaining written consent. Individuals will have as much time 
as is needed to make their decision about participating in the research. Furthermore, volunteers 
may discuss the study with a family member or other individual prior to consenting; informed 
consent will not be obtained until they have conferred with any and all individuals they feel 
necessary to make a fully informed decision to participate in research. All consent will be 
obtained in English; non-English speaking individuals will not be enrolled in this study. This 
consent process will be completed prior to undergoing any assessment or intervention/treatment 
related to the study. Informed consent will be obtained in person and within private office space 
within building 13. Participants will complete a decisional capacity quiz verifying that they 
understood the main components of the proposed research, their rights, and expectations during 

the study. Though unlikely, if individuals cannot successfully complete this decisional capacity 
assessment and provide fully informed consent, they will not be enrolled in the current study. A 
Master List of all VA subjects consenting to this protocol will be maintained in a secured location.
 Section 12.4 Waiver of Informed Consent
12.4a) Is it practicable to conduct the research without the waiver or alteration of consent?
  Yes  
  No
12.4b) Does the research examine public benefit or service programs and is subject to state or local 
government approval?
  Yes  
  No
12.4c) Will the research involve greater than minimal risk?
  Yes  
  No
12.4d) Will waiving or altering informed consent adversely affect the subjects’ rights and welfare?
  Yes  
  No
12.4e) Is it appropriate to provide pertinent information to subjects later BUT this information will NOT be 
provided?
  Yes  
  No
12.4f) Identify to what aspects of the study you are requesting a waiver of consent (i.e., full study or specific 
aspects). Describe the waiver or alteration needed and why it can be granted (include why the research is not 
practical without the waiver or alteration and how the waiver enables conducting the study).
Waiver of informed consent or alteration of consent elements may be allowed if the IRB documents these 
findings and approves waiver or alteration.
Many research subjects are interested in other research and during the consenting process of the 
study, they participated in elect to be contacted for future research. These participants who 
previously participated in other research and have consented to be contacted for future research 
will be referred to us. In order to minimize inquiries to patients who do not qualify for this study 
by not meeting inclusion criteria or meeting exclusion criteria that is recorded in their CPRS file, 
a HIPAA waiver is needed for the study staff to be able to access the patient's CPRS file as a 
screening procedure to check eligibility for this study. This will allow us to not unnecessarily 
contact patients who clearly do not qualify to participate in this study. Information to be used to 
look up a patient in CPRS is the patient's name and the last four digits of the social security 
number.
Information to look at for eligibility includes diagnosis of PTSD, other mental health diagnoses 
including bipolar disorder, a psychotic disorder, or current substance use disorder, neurological 
disorder, history of participating in Cognitive Processing Therapy (CPT), history of moderate to 
severe traumatic brain injury, age, and OEF/OIF/OND status. 
Additionally, a waiver is required for study staff to access VASDHS patient medical records in 
order to identify eligible patients who have received information about the current study from the 
Mission Valley or the La Jolla VA PTSD Clinic Orientation Meeting and to collect names, last four 
digits of the social security number, mental health information, addresses, and phone numbers 
for recruitment purposes. Patients identified as meeting criteria will be sent information about 
our study via mail prior to being contacted by study staff via phone.

Additionally, referrals from study H170023, the VA IRB approved VASDHS TBI/PTSD Registry, 
have given their documented oral consent to be contacted by future studies. We request a HIPAA 
waiver so we can contact the Veteran via his or her preferred method of contact.
 Section 12.6 Decisional Capacity Assessment
12.6a) Describe the method(s) for determination of decisional capacity: (see  for guidance)  
?
Please note that 
 
documentation of the assessement is required.
The study staff who is informing the potential participant, after consenting will administer a short 
decisional capacity quiz to ensure sufficient decision making capacity of the participant. All 
answers should be answered correctly for the participant to pass the quiz. If a participant has a 
hard time with a questions, the study staff may give a more thorough explanation of the 
questions and give the participant another chance at answering the question.
12.6b) If subjects with limited decisional capacity will be enrolled, describe methods for obtaining subject 
assent or why they are not indicated:
Subjects with limited capacity will not be enrolled.
12.6c) If subjects with limited decisional capacity will be enrolled, describe procedures for respecting subject 
dissent and any additional safeguards or why these features are not needed:
Subjects with limited capacity will not be enrolled.
12.6d) If subjects with limited decisional capacity will be enrolled, describe the risk and, if greater than 
minimal, the relation to potential benefits:
Subjects with limited capacity will not be enrolled.
12.6e) If subjects with limited decisional capacity will be enrolled, describe the justification for the inclusion of 
any incompetent persons or persons with impaired decision-making capacity:
Subjects with limited capacity will not be enrolled.
 Section 12.9 HIPAA Authorization
For each category below, indicate whether or not this study involves the indicated process:
12.9a) 
 HIPAA Authorization.  
Signed
**New Template is available in the ?  Help section**
 Yes  
 No
12.9b) HIPAA waiver to cover the entire study
  Yes  
  No
12.9c) HIPAA waiver for recruitment, screening, and/or for a portion of the study.
 Yes  
 No
12.9d) HIPAA Authorization or waiver is 
 for some or all of the study subjects (e.g. no health data).
not required
  Yes  
  No
 Section 12.10 HIPAA Waivers and Alterations

12.10a) Describe the purpose/nature of the HIPAA waiver or alteration and list specifically, what identifiers 
and health information are being requested under the waiver/alteration and identify whether the waiver is 
for access, use, and/or collection of this information.
Many research subjects are interested in other research and during the consenting process of the 
study, they participated in elect to be contacted for future research. These participants who 
previously participated in other research and have consented to be contacted for future research 
will be referred to us. In order to minimize inquiries to patients who do not qualify for this study 
by not meeting inclusion criteria or meeting exclusion criteria that is recorded in their CPRS file, 
this HIPAA waiver is needed for the study staff to be able to access the patient's CPRS file as a 
screening procedure to check eligibility for this study. This will allow us to not unnecessarily 
contact patients who clearly do not qualify to participate in this study. Information to be used to 
look up a patient in CPRS is patient's name and the last four digits of the social security number.
Information to look at for eligibility includes diagnosis of PTSD, other mental health diagnoses 
including bipolar disorder, a psychotic disorder, or current substance use disorder, neurological 
disorder, history of participating in Cognitive Processing Therapy (CPT), history of moderate to 
severe traumatic brain injury, age, and OEF/OIF/OND status. 
Additionally, a waiver is required for study staff to access VASDHS patient medical records in 
order to identify eligible patients who have received information about the current study from the 
Mission Valley or the La Jolla VA PTSD Clinic Orientation Meeting and to collect names, last four 
digits of the social security number, mental health information, addresses, and phone numbers 
for recruitment purposes. Patients identified as meeting criteria will be sent information about 
our study via mail prior to being contacted by study staff via phone.
Additionally, referrals from study H170023, the VA IRB approved VASDHS TBI/PTSD Registry, 
have given their documented oral consent to be contacted by future studies. We request a HIPAA 
waiver so we can contact the Veteran via his or her preferred method of contact.
12.10b) The proposed access, use, and/or disclosure of PHI involves no more than a minimal risk to the 
privacy of individuals.
 Agree
 Disagree
12.10c) The plan to protect the identifiers from improper use and disclosure is adequate.
 Agree
 Disagree
Describe the plan
The identifiers will not be released to any other research study and the only hard copy will 
remain in a locked file cabinet in VMRF Building 13, room 312H. Only this study staff has access 
to the identifiers.
12.10d) An adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the 
research, unless there is a health or research justification for retaining the identifiers or such retention is 
otherwise required by law.
 Agree
 Disagree
12.10d2) Describe the plan:
Data will only be destroyed according to RCS-10 under Records Control Manager guidance.
12.10e) By signing this protocol for submission, the PI is providing written assurance that the PHI will not be 
reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the 
research project, or for other research for which the use or disclosure of protected health information would 
 
be permitted by the Privacy Rule.
:  If the waiver of HIPAA authorization is for 
38 U.S.C. 7332 Information
the use of 38 USC 7332 information (applicable to drug abuse, alcohol abuse, HIV infection, and sickle cell 
anemia records), by signing this protocol for submission the PI is providing written assurance that the 
purpose of the data is to conduct scientific research and that no personnel involved may 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. (Ref:  38 U.S.C. 7332(b)(2)(B))
 Agree
 Disagree
12.10f) The research could not practicably be conducted without the waiver or alteration.
 Agree
 Disagree
12.10f2) Describe how the waiver/alteration enables the research to be conducted
The waiver will enable us to screen the patients who previously consented to be contacted for 
other research by accessing their CPRS file to check their eligibility for participation in this study 
by confirming diagnoses and therapy history. Then, a phone call will be made to those who meet 
the eligibility criteria. The waiver will also enable us to conduct a phone screen to prevent 
scheduling veterans who are ineligible to participate.
12.10g) The research could not practicably be conducted without access to and use of the PHI.
 Agree
 Disagree
12.10g2) Describe why it would be impracticable to conduct this research without the PHI described 12.10a. (v3
/8/18)
Once we obtain a waiver, the study staff will be able to use patient's name and last four digits of 
the social security number to access the patient's CPRS record. Study staff will then screen 
patients with inclusion/exclusion criteria information in their CPRS file before making a phone call.
 Section 13 - Alternatives to Participation
13) Describe the alternatives to participation in this research study (see  for guidance)
?
If an individual chooses to not participate or withdraw from participation in this study, they will 
be offered the option to be referred to standard clinical CPT or other mental health treatment 
done with no research component. There may be risks associated with standard treatments for 
PTSD that they can review with their health care provider.
 Section 14 - Potential Risks
14) Describe any potential or known risks or discomforts and assess their likelihood and seriousness (see  for 
?
guidance)
The first safety issue for this study is related to MRI scanning. MRI is a noninvasive procedure 
and overall, risks for MRI scanning are minimal given appropriate screening, which is done via an 
initial phone interview and again immediately prior to scanning. There are no known adverse 
effects from exposure to magnetic fields. To ensure the safety and comfort of all subjects, we will 
exclude those with a history of claustrophobia, difficulty lying flat for long periods, or anyone 
with any metal or a pacemaker in the body. Potential risks include discomfort while lying still in a 
confined space during imaging; claustrophobia; and fatigue from the approximately 1 hour of 
total time for the MRI scan procedure. In addition, there are risks of bodily harm associated with 
MRI imaging if the subject has metal in his or her body, or wears a pacemaker.
There is the possibility of an abnormal finding on the MRI scan. However, the MRI scans are not 
being done for clinical purposes, and the MRI scan procedure is not sufficient for the clinical 
diagnosis of a possible brain disorder. The purpose of this scan is not to diagnose abnormalities, 
but on rare occasions a finding is observed that might be clinically important. Should there be 
cause for concern, with permission of the participant, this information will be forwarded to his
/her primary care physician for follow-up.
Another risk of participating in the study include emotional discomfort as participants are being 
asked to discuss difficult personal topics. Participation in this study may involve some added 
risks or discomforts associated with anxiety and reactions to trauma which can lead to temporary 

increases in discomfort. Emotional discomfort and associated anxiety typically subside as the 
skills taught in treatment are learned. Participants can decline to answer questions that make 
them uncomfortable. Study staff are also trained to handle any distress that arises and 
participants will be provided with information on who to contact during and after standard 
business hours in the event of any distress or concern. Study staff or emergency/crisis personnel 
will be available 24 hours a day to offer additional intervention, treatment, or make emergency 
referrals if necessary. If participants choose to withdraw early from the study or study staff feels 
it is in a patient’s best interest, they will be offered the option to enter standard clinical 
treatment with no research component. Should any participant present a danger to self or others 
related to suicidal intent, homicidality, or other acute psychiatric issue, standard clinical 
interventions to ensure safety and stabilization will be implemented and the participant will be 
withdrawn from the study if necessary. 
Another risk of participation in this study is fatigue and/or boredom during the assessments. 
Frequent rest intervals will be available during the testing periods to reduce fatigue. 
All data will be collected specifically for research purposes and treated in a confidential manner. 
Loss of confidentiality is a risk of participating in research; as a result of participation in this 
project, there is a very small risk that sensitive information (e.g., diagnostic information) could 
become known outside the research setting. Significant efforts relating to data security keep this 
risk exceptionally low.
Finally, since this is an investigational study, it may involve risks that are currently 
unforeseeable. This is explained to the participant and if new risks become known in the future, 
participants will be informed of them. Similarly, participants will be told if any important new 
information is found during the course of this study that may affect wanting to continue as a 
participant.
 Section 15 - Risk Management
15) Describe the procedures for protecting against or minimizing any potential risks/discomforts, and the 
adequacy of resources for conducting the study and resources participants may need as a consequence of the 
research.  When applicable, include detail of the following safety measures:   
(a) The type of safety 
information to be collected, including AEs; 
(b) Frequency of safety data collection; 
(c) 
Frequency or periodicity of review of cumulative safety data; 
(d) Statistical tests for analyzing the 
safety data to determine if harm is occurring; and 
(e) Conditions that trigger an immediate suspension 
of the research.  See  for further requirements.
?
MRI: Overall, risks for MRI scanning are minimal given appropriate screening, which is done via 
an initial phone interview and again immediately prior to scanning. We will use a standard MRI 
screening form currently in use by the Keck Center for fMRI, which frequently performs research 
MRI studies. This instrument has been used successfully in past protocols to exclude patients 
with suspected or known risk factors. If the screening form elicits any suspected risk factors, the 
form will be supplemented by review of medical records with the subject’s permission. Finally, 
subjects will be asked the screening questions one more time by the MRI technician before being 
placed in the magnet and will be apprised of the risks as part of signing the consent form.
Exposure to a high magnetic field. Subjects will be screened for implanted materials and devices 
during the initial screening assessment. Moreover, all subjects will be re-screened before they 
will be allowed to enter the MRI facilities. Any non-removable magnetic or electrical material will 
automatically exclude subjects. A trained MR technician will scan the participants. The MR 
scanner at the UCSD Center for Functional MRI has a field strength of 3.0 Tesla. Imaging at this 
field strength is not considered a significant risk according to FDA guidelines. Because the pulse 
sequences to be used are commonly used research sequences, we do not expect any hazard 
associated with power deposition.
Peripheral nerve stimulation from rapidly switched magnetic fields. Participants will be informed 
about the possibility of stimulation effects during the informed consent process. We will monitor 
the subject‘s status during the scan about their comfort level and unexpected sensorimotor 
experiences. If a subject reports stimulation effects, we will remove the subject from the scanner 
and terminate the subject‘s participation in the study.
Claustrophobia. Usually this is manifested in the first couple of minutes after the person is placed 
in the magnet. We inquire about comfort and if the subject complains of discomfort or anxiety, 
we will immediately remove them from the magnet. Often our prompt response allays their 
concern and they chose to continue. If the participant decides they are too uncomfortable to 
continue, we end their participation in the fMRI scan.

Physical discomfort and fatigue. These risks usually develop slowly over the course of the scans. 
Discomfort can be minimized by careful placement of neck, head, and leg supports when a 
participant is placed in the magnet. Fatigue can be reduced by appropriate pacing of the study 
scans. The scan operator will ask about a participant‘s comfort every 5 to 10 minutes. If a 
subject becomes too uncomfortable to continue, she/he will be removed from the scanner but 
removed from the study only if they request to end their participation.
Acoustic noise. Subjects will be instructed to wear earplugs or headsets that reduce the noise by 
about 20-40 dB. They will also be instructed to indicate if the noise is a source of physical or 
psychological discomfort. If discomfort occurs the fMRI scan will be terminated.
Pregnancy. At this time it is unknown whether or not there are potential risks to a fetus from 
exposure to magnetic fields (MRI). For studies that involve MRI, fMRI, and similar scans, women 
of childbearing potential must be excluded from this part of the study if a pregnancy test is 
positive or if the subject thinks that she might be pregnant.
Other potential MR risks. The subject will be informed during the consent process that the scans 
are not optimal for diagnosing a brain disorder. Yet some abnormalities might be observed on 
the scans. Should there be cause for concern, with permission of the participant, any clinically 
important observations will be forwarded to his/her primary care physician for follow-up. 
Although it is possible to reconstruct a form of the facial features from the MRI data, the 
likelihood that this information could be used to identify a person with the reliability of a 
photograph has not been confirmed by research to date, making these reconstructions not 
comparable to photographic images. It is preferable to maintain the facial features in the MR 
images for purposes of later data analysis and skull reconstruction. As part of the authorization 
and informed consent process, subjects will be informed of the slight risk of potential 
identification based on reconstruction of MR images and will give authorization to disclose this 
information to study investigators.
The process of being asked about the presence of a mental health diagnosis during the telephone 
screen may cause temporary discomfort and Veterans can be reminded of immediately 
accessible clinical services available to them (e.g., VA Psychiatric Emergency Clinic) in the event 
of any significant discomfort.
Risk of emotional discomfort that can arise during Cognitive Processing Therapy will be 
addressed in that all Veterans will see their study therapist biweekly to weekly for the therapy 
component of the study. Dr. Crocker will review the assessment and progress of each subject 
and consult with Dr. Jak during weekly meetings. The clinical experience and skill level of 
personnel will enable study staff to implement protocol procedures with a minimum of 
psychological discomfort for study participants. All patients will be monitored on a weekly basis, 
and study personnel will be available during regular business hours to respond to patients’ 
concerns and participants will have emergency contact information for after-hours concerns.
There is always a risk associated with the management of patients with mood and anxiety 
disorders that they will develop suicidality. This risk will be carefully mitigated by the systematic 
and careful assessment of suicidality and homicidality throughout the protocol via weekly in-
session assessments made by the therapists. Subjects who develop suicidality will be evaluated 
by therapist, Dr. Crocker, and Dr. Jak to determine whether continued participation in the study 
is safe and clinically warranted. If the study personnel and participant feel that discontinuation 
would best suit the participant, the participant will be discontinued from the study, and the 
participant will be reviewed for appropriate treatment. All mental health staff are trained in and 
required by the VA to regularly assess suicidality and/or homicidally. If a patient endorses 
suicidal ideation or homicidal ideation, standard safety procedures are implemented via a 
licensed psychologist. These depend on the level of threat presented by the patient and may 
range from making a safety plan with the patient to implementing 5150 procedure for an 
inpatient hold. Homicidal ideation additionally involves assessment of whether to invoke the 
Tarasoff law.
For participants who wish to terminate prematurely, we will request a final meeting to assess 
clinical status and safety and to review reasons for withdrawal (if the participant is willing to 
share them). Referrals for alternative mental health services, including those in our clinics 
outside this protocol, will also be provided. Participants enrolled in the study may withdraw at 
any time without penalty or loss of any benefits or treatment options available to them. 
Investigators may also withdraw a participant from the study for treatment non-compliance or a 
newly developed psychiatric or medical problem if, in the opinion of the investigators, these 
factors interfere with the participant’s ability to participate fully in the study. If a participant 
discontinues the study for any reason, he/she will be offered and allowed access to any care in 
our clinics that any other patient not associated with the study would receive.

The risk of fatigue and boredom possibly related to neuropsychological testing will be mitigated 
by examiners making the tests as interesting to the participants as possible and offering 
numerous breaks over the course of the assessment period. Veterans do not need to answer any 
question or complete any test that makes them uncomfortable. To minimize undue influence and 
risks, research participants/VA employees that are directly supervised by the PI will be consented 
by a different member of the research team, and any research personnel that may have a 
personal affiliation with the research participants/VA employee will not be involved in consenting 
nor perform the research procedures; and where applicable, any research personnel that may 
have a personal affiliation with the research participant/VA employee will not have access to 
code keys of the coded data, medical records/CPRS notes, and employee records.
The subjects' confidentiality will be strictly maintained. Consent and other forms containing 
identifying data will be kept separate from other research data. All personal identifying 
information that includes diagnosis and/or medical status will be kept in a locked cabinet where 
access can be strictly controlled. Other research records will be numerically coded to remove any 
identifying information. Computer and other data records will be coded so the subjects' identity 
cannot be directly ascertained. All computerized cognitive testing data will also be de-identified 
and coded with only an ID number and thus will contain no Protected Health Information (PHI). 
One key document connecting the names with the codes will be maintained and kept by the 
researcher. All data will be kept locked in the offices of the researcher or other appropriately 
trained research staff. Research records will be kept completely confidential to the extent 
provided by law, and the participant’s identity will not be disclosed without their written consent 
unless required by law. Only the study staff in this project will have access to these records.
COVID-19 Modification Safety Measures: While COVID-19 remains a public health risk all face-to-
face appointments will be minimized to ensure safety. The majority of assessment measures 
originally completed during in-person visits and all therapy sessions will be completed via 
teleconference and phone. For all practical purposes, the provision of mental health services by 
telemedicine is considered routine clinical care within the VHA. We will follow the Standard 
Operating Procedures Manual developed by Peter Shore for Home-Bases Telemental Health in 
VISN 20. All COVID-19 guidelines established by the VA San Diego Healthcare System and 
Research Service will be closely followed to ensure participant safety during the abbreviated in-
person visits.
 Section 17 - Potential Benefits
17) Discuss benefits that may be gained by the subject as well as potential benefits to society in general  (see  ?
for guidance)
Participants may or may not experience benefits from participation in this study. Participants 
may experience reduction in symptoms related to PTSD over the course of the study, including 
reduction of emotional distress and improvement in quality of life and cognitive abilities. In 
addition, the knowledge derived from this study may be of considerable benefit in terms of 
improving treatment for PTSD for future Veterans.
 Section 18 - Risk/Benefit Analysis
18) Discuss why the risks to subjects are reasonable in relation to the anticipated benefits to subjects and in 
relation to the importance of the knowledge that may reasonably be expected to result.
The risks involved with neuroimaging, clinical assessment, cognitive training, and psychotherapy 
appear justified by the potential benefits to the subject of the provision of treatment by a skilled 
therapist, potential improvements in PTSD cognitive and emotional symptoms and thus quality of 
life. There is also potential gain from finding ways to improve treatment for all Veterans with 
PTSD. As compared to these potential benefits, the risks to subjects appear reasonable and 
justified.
 Section 20 - Compensation for Participation
20) Provide all details and justifications of the compensation plan.  See  for detailed requirements.
?
Participants will be compensated for their time after each completed assessment. Veterans will 
receive $50 for the baseline assessment ($30 for completion of the questionnaires and 

neuropsychological assessment, $20 for the fMRI assessment), $30 as a bonus for completing at 
least 80% of the cognitive training (or placebo word games), $50 for the post-computerized 
training assessment, and $70 for the post-therapy assessment (Total possible = $200). If 
participants attend a given assessment, they will be paid the entire amount per assessment 
regardless of whether they complete the entire assessment.
 Section 21 - Responsibilities and Qualifications
Here are the identified study staff members
Laura D. Crocker, PhD
Amy J. Jak, PhD, Jessica A. Bomyea, PhD, Peter J. Colvonen, PhD, Sonya B. Norman, PhD, 
Victoria C. Merritt, PhD, Alexandra O. Higdon, PsyD, Amber Victoria Keller, Samantha N. Hoffman, 
Delaney K. Davey, Shahrokh Golshan, PhD, Cody Witten, Jackson Schierbeek, Jillian Leigh Ory, 
BA, Morgan E. Marvin, BA, Sarah Jurick Lefler, PhD
21) For each staff member listed above, describe their role and qualifications.  Also indicate which of the 
study staff are authorized to obtain consent, when applicable to the study. 
Dr. Crocker (PI) and Dr. Jak (Co-PI) will oversee the overall direction of the project, including the 
development, coordination, implementation, and monitoring of program activities. Drs. Crocker 
and Jak will carry the major responsibility for supervising all aspects of project activities. 
Specifically, they will be responsible for general study oversight, supervision and assurance of 
regulatory approvals, and training and supervision of staff related to subject recruitment, phone 
screening, consenting, CPT, MRI data collection, and neuropsychological assessments. They will 
also coordinate data analysis and manuscript preparation. Dr. Crocker will be the study therapist 
and will deliver therapy to participants, as well as enter visit notes in CPRS.
Both PIs will be authorized to obtain consent and test participants will guide the protocol through 
the IRB, VA research and development committee, HRPO, and other regulatory approval 
processes, recruit and consent volunteers, maintain study records, enter data into a computer 
database.
Samantha Hoffman (Research Associate): Authorized to assist with recruitment and screening of 
participants, obtain informed consent, test participants, collect MRI data, administer and score 
assessments, perform data entry, maintain study records. She will work closely with and assist 
PIs.
Amber Keller (Research Associate): Authorized to assist with recruitment and screening of 
participants, obtain informed consent, test participants, collect MRI data, administer and score 
assessments, perform data entry, maintain study records. She will work closely with and assist 
PIs.
Sonya Norman, Ph.D. (Co-PI): Will be responsible for the oversight and supervision of study staff 
related to data collection and clinical intervention, as well as CPRS clinical notes. She will work 
closely with PIs.
Peter Colvonen, Ph.D. (Co-PI): Will be responsible for the oversight and supervision of study 
staff related to data collection and clinical intervention, as well as CPRS clinical notes. He will 
work closely with PIs.
Shahrokh Golshan, Ph.D. (Biostatistician): Will be responsible for participant study randomization 
and statistical analyses.
Sarah Jurick Lefler, Ph.D. (Post-Doc): Authorized to obtain consent and test participants, 
maintain study records, enter data into a computer database. This person will work closely with 
project participants, investigators, and staff. Also will administer and score assessments as 
described in section 9 and will conduct image acquisition and post-processing. She will work 
closely with the PI and will also assist with data analysis and manuscript preparation.
Cody Witten (Student Volunteer): Authorized to obtain consent and test participants, recruit and 
consent volunteers, maintain study records, enter data into a computer database. This person 
will work closely with project participants, investigators, and staff. Also will administer and score 
assessments as described in section 9 and will conduct image acquisition and post-processing. 
He will work closely with the PI and will also assist with data analysis and manuscript preparation.

Delaney Davey (Study Coordinator): Authorized to guide the protocol
through the IRB, VA research and development committee, HRPO, and other regulatory approval 
processes recruit and screen participants, obtain informed consent, test participants, collect MRI 
data and post-processing, administer and score assessments, perform data entry, maintain study 
records, as well as enter visit notes into CPRS. She will work closely with and assist PIs.
Alexandra Higdon, Psy.D. (Research Psychologist): Authorized to assist with recruitment and 
screening of participants, obtain informed consent, test participants, administer and score 
assessments, perform data entry, maintain study records. She will work closely with and assist 
PIs. Dr. Higdon will be a study therapist and will deliver therapy to participants, as well as enter 
visit notes in CPRS. 
Victoria Merritt, Ph.D. (Co-PI): Will be responsible for the oversight and supervision of study staff 
related to data collection and clinical assessments. She will work closely with PIs.
Jillian Ory (Research Associate): Authorized to assist with recruitment and screening of 
participants, obtain informed consent, test participants, collect MRI data, administer and score 
assessments, perform data entry, maintain study records. She will work closely with and assist 
PIs.
Jackson Schierbeek (Research Associate): Authorized to assist with recruitment and screening of 
participants, obtain informed consent, test participants, collect MRI data, administer and score 
assessments, perform data entry, maintain study records. He will work closely with and assist 
PIs.
Jessica Bomyea, Ph.D. (Co-PI): Authorized to obtain consent and test participants, maintain 
study records, enter data into a computer database. She will work with project participants and 
will oversee and supervise staff related to data collection and assessments. Also will conduct 
image post-processing and data analysis. She will work closely with the PIs and will assist with 
manuscript preparation.
Morgan Marvin (Research Associate): Authorized to assist with recruitment and screening of 
participants, obtain informed consent, test participants, collect MRI data, administer and score 
assessments, perform data entry, maintain study records. She will work closely with and assist 
PIs.
 Section 22 - Bibliography
22) List relevant articles that the IRB can use to provide necessary background for the protocol. Do not 
include an extensive NIH-grant-style bibliography.  (Up to 5 recommended, but use more if needed to support 
the protocol or citations above.)
1. Aupperle, R. L., Melrose, A. J., Stein, M. B., & Paulus, M. P. (2012). Executive function and 
PTSD: Disengaging from trauma. Neuropharmacology, 62(2), 686–694. 
2. Badura-Brack, A. S., Naim, R., Ryan, T. J., Levy, O., Abend, R., Khanna, M. M., … Bar-Haim, 
Y. (2015). Effect of attention training on attention bias variability and PTSD symptoms: 
Randomized controlled trials in Israeli and U.S. Combat Veterans. American Journal of 
Psychiatry, 172(12), 1233–1241. 
3. Bradley, R., Greene, J., Russ, E., Dutra, L., & Westen, D. (2005). A multidimensional meta-
analysis of psychotherapy for PTSD. American Journal of Psychiatry. 162, 214–227. 
4. Chard, K. M., Schumm, J. A., Owens, G. P., & Cottingham, S. M. (2010). A comparison of OEF 
and OIF veterans and Vietnam veterans receiving cognitive processing therapy. Journal of 
Traumatic Stress, 23(1), 25–32. 
5. Crocker, L. D., Heller, W., Warren, S. L., O’Hare, A. J., Infantolino, Z. P., & Miller, G. a. 
(2013). Relationships among cognition, emotion, and motivation: implications for intervention 
and neuroplasticity in psychopathology. Frontiers in Human Neuroscience, 7, 261. 
6. Erbes, C. R., Curry, K. T., & Leskela, J. (2009). Treatment presentation and adherence of Iraq
/Afghanistan era veterans in outpatient care for posttraumatic stress disorder. Psychological 
Services, 6(3), 175–183. 
7. Falconer, E., Allen, A., Felmingham, K. L., Williams, L. M., & Bryant, R. A. (2013). Inhibitory 
neural activity predicts response to cognitive-behavioral therapy for posttraumatic stress 
disorder. The Journal of Clinical Psychiatry, 74(9), 895–901. 
8. Garfinkel, S. N., & Liberzon, I. (2009). Neurobiology of PTSD: A review of neuroimaging 
findings. Psychiatric Annals, 39(6), 370–381.
9. Hayes, J. P., Hayes, S. M., & Mikedis, A. M. (2012). Quantitative meta-analysis of neural 
activity in posttraumatic stress disorder. Biology of Mood & Anxiety Disorders, 2(1), 9. 

10. Kehle-Forbes, S. M., Meis, L. A., Spoont, M., & Polusny, M. A. (2015). Treatment initiation 
and dropout from prolonged exposure and cognitive processing therapy in a VA outpatient clinic. 
Psychological Trauma: Theory, Research, Practice, and Policy, 8, 107–114. 
11. Keshavan, M. S., Vinogradov, S., Rumsey, J., Sherrill, J., & Wagner, A. (2014). Cognitive 
training in mental disorders: Update and future directions. American Journal of Psychiatry, 171, 
510-522. 
12. Klingberg, T. (2010). Training and plasticity of working memory. Trends in Cognitive 
Sciences, 14(7), 317-324. 
13. Kuckertz, J. M., Amir, N., Boffa, J. W., Warren, C. K., Rindt, S. E. M., Norman, S., … McLay, 
R. (2014). The effectiveness of an attention bias modification program as an adjunctive 
treatment for post-traumatic stress disorder. Behaviour Research and Therapy, 63, 25-35. 
14. Li, H., Li, J., Li, N., Li, B., Wang, P., & Zhou, T. (2011). Cognitive intervention for persons 
with mild cognitive impairment: A meta-analysis. Ageing Research Reviews, 10, 285-296. 
15. Merzenich, M. M., Van Vleet, T. M., & Nahum, M. (2014). Brain plasticity-based therapeutics. 
Frontiers in Human Neuroscience, 8, 385. 
16. Mohlman, J., & Gorman, J. M. (2005). The role of executive functioning in CBT: A pilot study 
with anxious older adults. Behaviour Research and Therapy, 43(4), 447–465. 
17. Monson, C. M., Schnurr, P. P., Resick, P. A., Friedman, M. J., Young-Xu, Y., & Stevens, S. P. 
(2006). Cognitive processing therapy for veterans with military-related posttraumatic stress 
disorder. Journal of Consulting and Clinical Psychology, 74, 898-907.
18. Morey, R., Petty, C., & Cooper, D. (2008). Neural systems for executive and emotional 
processing are modulated by symptoms of posttraumatic stress disorder in Iraq War veterans. 
Psychiatry Research, 162, 59-72. 
19. Mott, J. M., Mondragon, S., Hundt, N. E., Beason-Smith, M., Grady, R. H., & Teng, E. J. 
(2014). Characteristics of U.S. Veterans who begin and complete prolonged exposure and 
cognitive processing therapy for PTSD. Journal of Traumatic Stress, 27(3), 265–273. 
20. Patel, R., Spreng, R. N., Shin, L. M., & Girard, T. a. (2012). Neurocircuitry models of 
posttraumatic stress disorder and beyond: A meta-analysis of functional neuroimaging studies. 
Neuroscience & Biobehavioral Reviews, 36(9), 2130–2142. 
21. Polak, A. R., Witteveen, A. B., Reitsma, J. B., & Olff, M. (2012). The role of executive 
function in posttraumatic stress disorder: A systematic review. Journal of Affective Disorders, 141
(1), 11–21. 
22. Riemann, B. C., Kuckertz, J. M., Rozenman, M., Weersing, V. R., & Amir, N. (2013). 
Augmentation of youth cognitive behavioral and pharmacological interventions with attention 
modification: A preliminary investigation. Depression and Anxiety, 30(9), 822–828. 
23. Schottenbauer, M. a, Glass, C. R., Arnkoff, D. B., Tendick, V., & Gray, S. H. (2008). 
Nonresponse and dropout rates in outcome studies on PTSD: Review and methodological 
considerations. Psychiatry, 71(2), 134–168. 
24. Vinogradov, S., Fisher, M., & de Villers-Sidani, E. (2012). Cognitive training for impaired 
neural systems in neuropsychiatric illness. Neuropsychopharmacology, 37(1), 43–76.
 Section 27 - Privacy, Confidentiality, and Information Security
27a) Provide a brief description of how participant privacy and confidentiality will be protected in this study. 
Describe the circumstance under which it may be possible for a research team member to identify subjects 
and any related protections or assurances to prohibit or avoid identification. Describe how the number of 
people with access to identifiers for research purposes is limited in order to protect a participant’s privacy.
Research records will be kept confidential to the extent provided by law. All personal identifying 
information that includes diagnosis and/or medical status will be kept on the VA’s secure 
computer system or in a locked cabinet where access can be strictly controlled. Research records 
will be numerically coded with a unique identifier to remove any personally identifying 
information. Because
names must appear on the consent form, it will be stored in a file separate from the other hard 
copy data. All hard copies of data collection sheets will be kept in locked file cabinets inside of 
locked offices in the VA belonging to the research staff (Bldg 13, room 306H or 312H). The 
participant name-to-code
conversion sheet will be stored in a locked file cabinet, inside of a locked office, accessible only 
to the researchers and to those project staff with a need for this information. The participant 
name-to-code conversion sheet will be secured separately from the research data. Participants 
will not be identified in
any reports or publications. Access to these records will be limited to the researchers and project 
staff who have a need to access the information to carry out the research. Appropriate parties 
other than the research staff may be granted access to the study data as required (e.g., VASDHS 
Research and Development Personnel; VA IRB personnel; and/or medical monitors); these 

individuals will be bound by
the same rules of confidentiality as the investigative team. Data will be destroyed according to 
RCS10 guidelines after the completion of the study and will be destroyed by approved methods 
at that time.
Social security numbers will be collected for access to the Veteran’s CPRS medical record as well 
for payment to the Veteran for participation in the study. These social security numbers will be 
stored securely on the VA’s secure computer system or for hard copy payment records, they will 
be stored in a locked file cabinet in a locked office in Building 13, room 306H or 312H. Refer to 
the VA Privacy and Data
Security Plan for further detail.
27.b) Entry of a CPRS 
is required when subjects will be 
 
Research Informed Consent Note
admitted as 
for research 
the study 
inpatients or treated as an outpatients 
 
and
involves research medical care or may affect 
medical care.
If a Research consent Note is required, then a 
 should also be entered for each 
Research Progress Note
procedure or intervention.
Scanning the Consent and HIPAA Authorization into CPRS is 
.  Linking the Consent to the 
not required
Research Informed Consent Note may be permitted and can be useful for trials involving the Research 
Pharmacy or when research will be performed in conjunction with clinical procedures.
For Non-Veterans, if Research Informed Consent Notes are entered, then the 
 
NOPP Acknowledgment
must be scanned into the record.  Otherwise a copy of the signed NOPP must be retained with the 
Investigator's research records and a copy sent to the Privacy Officer; see the   Help for more information.
 ?
27.b1) Is entry of CPRS notes required based on the above criteria?
CPRS notes are needed for ALL subjects 
CPRS notes are needed for SOME subjects 
CPRS notes are NOT needed for any subjects 
27c) Select the VA Sensitive Information (VASI) use category
This study does not collect or use any VASI 
This study uses but does not save, collect, copy, or record VASI 
This study does collect or record VASI 
 Section 27.1  VA Sensitive Information (VASI)
27.1a) For each type of VASI, indicate all that apply:
Indicate which of the following will be collected/recorded:
Protected Health Information (PHI)
Names
Device identifiers and serial numbers
E-mail addresses
Medical record numbers
URLs (Universal Resource Locator)
All elements of dates (except year) or any age over 89
Health plan beneficiary numbers
IP Addresses (Internet Protocol)
Telephone numbers
Account numbers
Biometric Identifiers including finger and voice print
Fax numbers

Certificate or license numbers
Full face photographic images and comparable images
All geographic subdivisions smaller than a state
Vehicle ID and serial numbers including license plate numbers
Social security numbers or scrambled SSNs (describe below)
Other unique identifying number, characteristic, or code (describe below)
27.1a1)  Describe why SSN are needed for this study
Social security numbers will be collected for access to the Veteran’s CPRS medical record as well 
for payment to the Veteran for participation in the study.
27.1b) Consent Forms and/or HIPAA Authorization
 Yes  
 No
27.1c) Images with personal identifiers are used for this study (x-rays, MRI images with patient names, record 
numbers, dates, etc.)?
  Yes  
  No
27.1d) Photos with faces or audio video recordings are used for this study.
  Yes  
  No
27.1e) Biological specimens with identifiers are used for this study.
  Yes  
  No
 Section 27.2  Data Collection, Tools, and Resources
27.2a)  Will any specially obtained software be used?
  Yes  
  No
27.2b) Will any mobile devices (laptop, tablet, portable hard-drive, etc.) be used in support of this study?
 Yes  
 No
27.2b1) Provide details of the device/s.  Indicate whether the device is FIPS 140-2 encryption validated and 
confirm that the device is listed in the VA EIL.  Provide details regarding the nature of the data that will be 
stored or transmitted on the device and confirm whether a copy of all data will be stored on the VA network. 
VMRF laptop computer will be used to collect non-VASI behavioral data (664 EE111331). A copy 
of all behavioral data will be transported to the R drive using VA-issued encrypted thumb drive 

and stored permanently on R:\Crocker.
If study staff are sent home to telework as part of the COVID-19 emergency response then staff 
will deliver psychotherapy and assessments using secure video conferencing on either a VA 
laptop or personal laptop via VA remote access. No data from the secure video conference will be 
stored on personal devices.
27.2c) Does the study require use of an electronic data capture system? 
  Yes  
  No
27.2d) Will any other web-based applications be used (e.g., for recruitment, completing online questionnaires, 
or processing data)?
 Yes  
 No
27.2d1) Provide the web address, details regarding their security features, the nature of the data involved, and 
the research purpose.  Also include a description of how VA retains a copy of the data generated using these 
tools.
Regarding the cognitive training that will be administered via BrainHQ (https://research.brainhq.
com), data transport and storage systems are HIPAA and FIPS-140 compliant. No personally 
identifiable information is mandatory to use the BrainHQ program. User names will be coded as 
anonymized, de-identified study numbers or
otherwise de-identified. The only information created, transmitted, and stored by the program 
pertains to usage (e.g., how much training has been done) and progress (e.g., how much 
improvement has been calculated) that a user makes. IP addresses are not recorded to be in 
HIPAA compliance. Also, data will be downloaded from BrainHQ on a regular basis and stored on 
the secure VA network drive.
REDCap is a free, secure Web application (only accessible on a VA computer) that facilitates the 
collection and entry of research data. This study will use REDCap for entry of research data only 
(not for completing online questionnaires). Only authorized study staff will be able to access the 
REDCap database. This tool helps VA researchers enter, store, and manage their project data in 
a systematic manner. Guidance on accessing and using VA REDCap is available to researchers 
with VA network access by copying and pasting the following URL into the browser: http://vaww.
virec.research.va.gov/REDCap/Overview.htm.
Data from REDCap will be occasionally exported to an excel or SPSS file and stored on the R-
drive behind the VA firewall.
27.2e)  Will coded data that excludes personal identifiers be used?   Coded data excludes 
HIPAA identifiers 
all 
(per VHA Handbook 1605.1 Appendix B), including dates
 Yes  
 No
27.2e1) Identify where the code key is stored and in what format (electronic, paper).
A key code that links participants with their coded identifier will be maintained by Dr. Crocker. 
This key code will be stored in hard copy format in locked file cabinets in locked rooms in 
VASDHS Building 13 and will be stored separately from all other study data and available only to 
Dr. Crocker and her research coordinator. The key code will also be stored electronically in a 
password-protected file in a limited access folder on the secure VA network drive.

 Section 27.3  Data Sharing and Transportation
27.3a) Does this study involve collecting, sharing or transporting any type of data outside of the local VA?
  Yes  
  No
 
Section 27.4  Research Record Storage and Retention
For each type of record, indicate whether it is collected for this study
27.4a) Hardcopy records/data (includes paper, pictures, film, etc.)
 Yes  
 No
27.4a1) Identify precisely where hardcopy data will be stored to include physical site, building, and room 
number, etc.  For each location identify whether VASI or non-sensitive information is stored at that 
location.  For VASI, identify how the data is secured. 
All hard copies of VASI information will be kept in locked file cabinets inside of locked offices in 
the VA belonging to the research staff (Bldg 13, room 312H). VASI information will be accessible 
only to the researchers and to those project staff with a need for this information. The 
participant name-to-code
conversion sheet will be secured separately from the research data.
All non-sensitive information hard copies of data collection sheets will be kept in locked file 
cabinets inside of locked offices in the VA belonging to the research staff (Bldg 13, room 306H or 
312H).
27.4a2) Are all of the above locations at VA?
 Yes  
 No
27.4b) Electronic study records (includes computer files, removable disk files, digital files, etc.).
 Yes  
 No
27.4b1) Identify precisely where 
electronic records/data will be stored to include the full map 
 
non-sensitive
drive, network location/server name, etc., and a brief description of what data/information is stored at each 
location.
Electronic non-sensitive files will be stored in the Jak drive on the SAN network on the VMRF 
server designated for Dr. Jak (Jak server). 
De-identified data will be stored through the VA REDCap system, which is only accessible on a 
VA computer network with a VA login. Non-sensitive data will also be encrypted and stored on 
the R drive (R01SDCHSM02.R01.Med.Va.gov\Crocker). Only essential study personnel will have 
access to these records/data.
A copy of de-identified fMRI images, with no participant names, dates in date fields, or other 

VASI, will be kept on a VASDHS contracted (initial contract #: 36C26218C0160) computer server 
in the west datacenter of San Diego Supercomputer Center (SDSC UC San Diego MC 0505, 9500 
Gilman Drive, La Jolla, CA 92093-0505). This storage solution complies with all VA directives 
developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control 
requirements for Federal information systems. This includes standards for the protection of 
electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security 
categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation 
of all baseline security controls commensurate with the FIPS 199 system security categorization 
(reference Appendix D of VA Handbook 6500, VA Information Security Program).
VMRF laptop computer will be used to collect non-sensitive behavioral data (664 EE111331). A 
copy of all behavioral data will be transported to the R drive using VA-issued encrypted thumb 
drive and stored permanently on R:\Crocker.
27.4b2) Identify precisely where 
electronic records/data will be stored to include the full map drive, 
 
VASI
network location/server name, etc., and a brief description of what data/information is stored at each location.
If no VASI is collected or recorded for this study, simply indicate that the “Study does not collect or record 
VASI”.
An additional storage location will be the R drive on the secure VA network, specifically folder R:
\Crocker for VASI electronic data.
VASI data, coded with a participant ID number, will be stored through the VA REDCap system, 
which is only accessible on a VA computer network with a VA login. Data exported from REDCap 
will be encrypted and stored on the R drive. Only essential study personnel will have access to 
these records/data. Once data collection is complete, the data will be exported from REDCap one 
last time and then the REDCap database will be deleted.
27.4b3) Are any of the locations described in 27.4b outside of the VA Secure Network? Note: this includes 
storage on a computer local hard drive.
  Yes  
  No
27.4c)  Record Retention - VHA requires compliance with Records Control Schedule (RCS-10) for retention 
of electronic and hard copy records.  Following study closure, these temporary records must be retained 
for six years and then destroyed.  Longer retention may be permitted if requred by other Federal regulations 
or requirements.  Will RCS-10 requirements be followed (i.e., 6-year retention)?
I will adhere to VHA Records Control Schedule-10 requirements 
I request an exception to RCS-10 requirements 
 Section 27.5  Additional Privacy or Information Security Details
Provide any other privacy or information security details here.
A portion of the treatment sessions will be audio recorded to be reviewed by VA study staff to 
ensure treatment fidelity. The digital audio recordings will be uploaded to the "R:\Crocker" folder 
and deleted from the digital recorder immediately after upload. The digital recorder will be stored 
in a locked cabinet in building 13, room 312H when not in use. Audio recording will only take 
place if study participants have agreed to audio recording and have signed the VA consent form. 
Recordings will be destroyed following RCS 10 guidelines. 
For the cognitive training portion of the study, data transport and storage systems are HIPAA 
and FIPS-140 compliant. No personally identifiable information is mandatory to use the BrainHQ 
program. User names may be coded as anonymized study identification numbers or otherwise de-
identified. The only information created, transmitted, and stored by the program pertains to 
usage (e.g., how much training has been done) and progress (e.g., how much improvement has 
been calculated) that a user makes. IP addresses are not recorded to be in HIPAA compliance.

 Section 27.6  Attestations
In the event of real or suspected breach of security, the Information Security Officer, Privacy Officer, VA 
Police (if appropriate), and the individual’s supervisor will be notified within one hour of learning of the event.
 Agree
 Disagree
Study staff will be up to date on any required VHA Privacy Policy and Information Security training or they 
will not be allowed access to VA Sensitive Information.
 Agree
 Disagree
Access to research sensitive information, if any, will be removed when study personnel are no longer part of 
the research team.
 Agree
 Disagree
At least one copy of all study records (whether sensitive or non-sensitive) will be retained under VA control 
and only destroyed in compliance with the approved Records Control Schedule
 Agree
 Disagree
The VA retains ownership of the research data.  Should the investigator leave the VA, custody of the research 
records will be assigned to another investigator and the Research Service notified in writing, or custody of the 
research records will be transferred to the Research Service.
 Agree
 Disagree
 Section 28 - Protocol Association to New or Existing Project
  
28) Is this a new R&D Project?  Before you go on to complete the 
 (which is 
Initial Review Submission Form
used for attachments), please address the association of this Protocol to an R&D Committee Project.  This 
Protocol may represent a new R&D Project, or it may be an additional Protocol under an existing R&D 
  
Project (such as when a single grant supports multiple Protocols).  Will this Protocol be submitted to the 
R&D Committee as a new Project?
 Yes  
 No
 The Protocol Application is now complete for a Protocol that will also be a new R&D Committee 
Project.
 
Next you will go on to the Initial Review Submission Form which is used to package up the Protocol 
Application and any needed attachments and submit them to the IRB.
Click on Save and Continue