Cognitively Augmented Behavioral Activation for Veterans With Comorbid TBI/PTSD
Phase: NA
Conditions: Traumatic Brain Injury, Posttraumatic Stress Disorder
Sponsor: VA Office of Research and Development

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Cognitively Augmented Behavioral Activation for Veterans with Comorbid mTBI/PTSD 
Protocol #: [Version 14, 8/12/2020] 
Funding Agency: RR&D Merit Review 
 
Principal Investigator/Study Chair: Daniel Storzbach, Ph.D and Amy Wagner, Ph.D 

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Abstract 
Veterans returning from the current conflicts in Iraq and Afghanistan exhibit high rates of comorbid  mTBI/PTSD. Given the 
comorbidity and neuropsychiatric symptom overlap of these disorders, it can be difficult to determine whether problems 
and disruptions in functioning are due to mTBI, PTSD, or both. Hence, it is challenging for providers to know how to 
prioritize these patients’ clinical issues and how to effectively treat them. Currently, there are no evidence-based treatments 
for comorbid mTBI/PTSD. Further, it is unclear to what extent existing treatments for each disorder can be           
adherently and effectively implemented for the other. As such, most current treatment recommendations suggest a holistic  
or integrated approach to treatment for comorbid mTBI/PTSD targeting symptoms and functionality rather than underlying 
etiology. We are proposing a treatment for comorbid mTBI and PTSD that directly targets daily functioning and quality of 
life. The primary objective of this study is to evaluate the efficacy of Cognitively Augmented Behavioral Activation (CABA), a   
new hybrid treatment for veterans diagnosed with comorbid mild Traumatic Brain Injury (mTBI) and posttraumatic        
stress disorder (PTSD). The study’s specific goals are to determine whether: 1) CABA reduces PTSD symptoms in  
veterans with mTBI/PTSD, 2) CABA reduces cognitive-related functional impairment in veterans with mTBI/PTSD, 3) CABA 
results in improvements in depression symptoms, cognitive functioning, and quality of life in veterans with 
mTBI/PTSD; and 4) CABA is an acceptable treatment for veterans with mTBI/PTSD. The overall goal is to develop an 
evidence-based manualized treatment for comorbid mTBI/PTSD that can be readily implemented in Veterans Health 
Administration (VHA) treatment settings. The study design makes use of the convergent availability of resources at the two 
participating Veterans Administration Medical Centers (VAMCs) in Portland, Oregon, and Seattle, Washington to conduct a 
Randomized Controlled Trial (RCT) of CABA. The study will recruit a total of 192 veterans ≤ 55 years of age, 96 participants at 
each site, enrolled at participating VAMCs who are diagnosed with both mTBI and PTSD. Inclusion criteria will be 1) 
Veterans ≤ 55 years of age enrolled at one of the participating VA sites who are able to provide informed consent, 2) Diagnosis 
of PTSD based on the Clinician Administered PTSD Scale (Blake et al., 1990), 3) Positive screen on the Structured Interview 
for Collecting Head Trauma Event Characteristics as outlined by the VA/DoD Clinical Practice Guideline for        
Management of Concussion/mTBI and positively endorsed any of the Neurobehavioral Symptom Inventory (NSI) cognitive 
symptoms items (items 13-17), 4) English speaking, able to attend treatment (if in CABA condition) and assessment 
sessions, and willing to refrain from additional mental health treatment during the first 3 1/2 months of the active phase of 
treatment if they are assigned to the CABA condition, and 5) Willingness to participate in audio- recorded sessions. 
Exclusion criteria will be 1) Current diagnosis of moderate or severe substance (alcohol) use disorder using DSM-5 criteria 
within the past 30 days, 2) Current Bipolar or psychotic disorder (requirement to refrain from additional treatments might be 
harmful), 3) Veterans with a history indicated by medical record review of a diagnosis of moderate, severe, or penetrating 
TBI, or self- reported history on the Structured Interview for Collecting Head Trauma Event Characteristics of TBI with PTA 
greater than 24 hours or LOC greater than 30 minutes, 4) Active suicidal intent indicating significant clinical risk, which 
would suggest that a treatment specifically targeting this intent was indicated clients who report suicidal ideation without  
imminent risk will be admitted into the study, 5) Initiated psychotropic medication, including Prazosin, within 4 weeks or 
changed dosage within 2 weeks prior to the first assessment, as this would make it difficult to determine which treatment 
contributed to change in the CABA condition; additionally, started or changed dosage of sleep medication or low dosages 
of tricyclic antidepressant or trazodone for pain or sleep within 1 week prior to the first assessment. Participants could be 
re-considered for eligibility after stability on medication was achieved. Enrollees will be asked, but not prohibited, to hold the 
doses of the current medications stable over the course of enrollment (though changes in medications after enrollment will 
not exclude them from on-going participation), 6) Auditory or visual impairments that would compromise ability to participate 
cognitive rehabilitation group or benefit from compensatory strategies. Eligible participants will be randomly assigned to 
either the CABA or Treatment as Usual (TAU) group. Participants in the CABA group will receive the CABA intervention via 
telehealth (video or telephone) during the first 14 weeks of their participation in the  study, whereas TAU participants will continue 
to receive TAU (usual care in a PTSD specialty treatment clinic, but no CABA) during their participation in the study. Both 
groups will undergo evaluations at baseline, 7 weeks (mid-treatment), and 14 weeks (post-treatment). During their study 
participation, all participants will continue to receive their usual medical care. 

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List of Abbreviations 
 
AIC 
Akaikes Information Criterion 
ANOVA 
Analysis of Variance 
BA 
Behavioral Activation 
BDI-II 
Beck Depression Inventory, Second Edition 
CABA 
Cognitively Augmented Behavioral Activation 
CAPS-IV 
Clinician Administered PTSD Scale 
CCT 
Compensatory Cognitive Training 
CD 
Compact Disc 
CIQ 
Community Integration Questionnaire 
CSQ 
Client Satisfaction Questionnaire 
CogSMART 
Cognitive Symptom Management and Rehabilitation Therapy 
Co-PIs 
Co-Principal Investigators 
COWAT 
Controlled Oral Word Association Test 
CPT 
Cognitive Processing Therapy 
CSRD 
Clinical Sciences Research Development 
CST 
Cognitive Strategies Training 
CVLT-II 
California Verbal Learning Test-2nd Edition 
df 
degrees of freedom 
D-KEFS 
Delis-Kaplan Executive Function System 
DoD 
Department of Defense 
DSMB 
Data and Safety Monitoring Board 
DVA 
Department of Veterans Affairs 
GW 
Gulf War 
HCS 
Health Care System 
HIPAA 
Health Insurance Portability and Accountability Act 
HLM 
Hierarchical Models 
HVLT-R 
Hopkins Verbal Learning Test – Revised 
IADL 
Independent Activities of Daily Living 
ICC 
Intra-class Correlation Coefficient 
ICD 
International Classification of Disease 
IRB 
Institutional Review Board 
IQ 
Intelligence Quotient 
IOM 
Institute of Medicine 
MCI 
Mild Cognitive Impairment 
MCQ 
Memory Compensation Questionnaire 
MS 
Multiple Sclerosis 
MSNQ 
Multiple Sclerosis Neuropsychological Screening Questionnaire 
MINI 
Mini International Neuropsychiatric Interview 
mTBI 
Mild Traumatic Brain Injury 
NP 
Neuropsychological 
Neuro-QOL 
Quality of Life in Neurological Disorders 
NIMH 
National Institute of Mental Health 
NINDS 
National Institute of Neurological Disorders and Stroke 
NOS 
Not Otherwise Specified 
NSI 
Neurobehavioral Symptom Inventory 
OEF 
Operation Enduring Freedom 
OIF 
Operation Iraqi Freedom 
OND 
Operation New Dawn 

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PCCS 
Portland Cognitive Strategies Scale 
PCL-C 
PTSD Checklist – Civilian Version 
PCL-M 
PTSD Checklist – Military Version 
PDA 
Personal Digital Assistant 
PE 
Prolonged Exposure 
PI 
Principal Investigator 
PRMQ 
Prospective-Retrospective Memory Questionnaire 
PTSD 
Post Traumatic Stress Disorder 
PEHRC 
Portland Environmental Hazards Research Center 
RBANS 
Repeatable Battery for Assessment of Neuropsychological Status 
RMASS 
Research Management and Study Skills 
RR&D 
Rehabilitation Research and Development 
RRM 
Random Regression Model 
SAS 
Statistical Analysis Software 
SD 
standard deviation 
SDS 
Severity Dependence Scale 
ShDS 
Sheehan Disability Scale 
SLS 
Satisfaction with Life Scale 
SS 
Error Sum of Squares 
TBI 
Traumatic Brain Injury 
TAU 
Treatment as Usual 
TMT 
Trail Making Test 
TRAC 
Trigger Response, Alternative Coping 
TRAP 
Trigger Response, Avoidance Pattern 
UC 
Usual Care 
VAMC 
Veterans Affairs Medical Center 
VAPORHCS 
Veterans Affairs Portland Health Care System 
VAPSHCS 
Veterans Affairs Puget Sound Health Care System 
VASDHS 
Veterans Affairs San Diego Healthcare System 
VHA 
Veterans Healthcare Administration 
VISNS 
Veterans Integrated Service Networks 
VVC 
VA Video Connect 
WAIS-III 
Wechsler Adult Intelligence Scale-3rd Edition 
WAIS_IV 
Wechsler Adult Intelligence Scale-4th Edition 
WRAT-4 
Wide Range Achievement Test-4th Edition 
WMS-4 
Wechsler Memory Scale-4th Edition 

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Contents 
Protocol Title .............................................................................................................................. 7 
1.0 
Study Personnel ......................................................................................................................... 7 
2.0 
Introduction ................................................................................................................................. 8 
3.0 
Objectives ................................................................................................................................. 15 
4.0 
Resources and Personnel ....................................................................................................... 16 
5.1 
Study Procedures .................................................................................................................... 17 
5.2 Study Design ............................................................................................................................. 17 
5.3 Recruitment Methods ................................................................................................................ 23 
5.4 Informed Consent Procedures .................................................................................................. 25 
5.5 Inclusion/Exclusion Criteria ....................................................................................................... 26 
5.6 Study Evaluations ..................................................................................................................... 27 
5.7 Data Analysis ............................................................................................................................ 31 
5.8 Withdrawal of Subjects. ........................................................................................................ 36 
6.0 
Reporting .................................................................................................................................. 37 
7.0 
Privacy and Confidentiality ....................................................................................................... 37 
8.0 
Communication Plan ........................................................................................................... 38 
9.0 
References ............................................................................................................................... 39 

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Protocol Title: Cognitively Augmented Behavioral Activation for 
Veterans with Comorbid mTBI/PTSD 
 
1.1 
Study Personnel 
 
Principal Investigator/Study Chair (and Portland Site PI): Daniel 
Storzbach, Ph.D, VAPORHCSVAPORHCS 503-220-8262 
x56497; Daniel.storzbach@va.gov 
Co-PI/Study Chair: 
Amy Wagner, Ph.D, VAPORHCSVAPORHCS 
503-220-8262 x33365; Amy.wagner@va.gov 
Seattle Site PI: 
Kathleen Pagulayan, Ph.D, VAPSHCS 
206-768-5321; Kathleen.pagulayan@va.gov  
Co-Investigators: 
• 
Megan Callahan, Psy.D, VAPORHCS: Interventionist, Multisite Study Coordinator  
503-220-8262 x50525; Megan.Callahan@va.gov 
• 
Marilyn Huckans, Ph.D, VAPORHCS 
503-220-8262 x54689; marilyn.huckans@va.gov 
• 
Matthew Jakupcak, Ph.D, VAPSHCS 
206-277-1853; matthew.jakupcak@va.gov 
• 
Mai Roost, Ph.D VAPORHCS; Interventionist  
503-220-8262 x58308; mai.roost@va.gov 
• 
Maya O’Neil, Ph.D, VAPORHCS: Multisite Data Manager  
503-220-8262 x54522; maya.oneil@va.gov 
• 
Halina Kowalski, MA, MFT, NCC, LPCI, VAPORHCS; Interventionist  
503-220-8262 x53013 Halina.kowalski@va.gov 
Consultants/Contractors: 
• 
Jennifer Vasterling, Ph.D, Boston VAMC 
Consultant 
857-364-6522; jennifer.vasterling@va.gov 
• 
Jesse Fann, Ph.D, University of Washington Department of Psychiatry 
Consultant 
206-685-4280; fann@u.washington.edu 
• 
Shah Golshan, Ph.D UCSD 
Contracted Study Statistician 
858-822-7737; sgolshan@ucsd.edu 

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2.0 
Introduction 
 
mTBI and PTSD are highly prevalent and frequently comorbid among Veterans. Studies estimate that 15- 
23% of those who have served in Iraq and Afghanistan have experienced TBIs1, the majority of which are 
defined as mild traumatic brain injuries (mTBI).  Many of these individuals sustain more than one mTBI over  
the course of their deployments2, often with little recovery time between exposures due to the demands of a 
combat zone. Both of these factors (multiple concussions and insufficient recovery time) increase the risk for 
persisting cognitive difficulties frequently seen in this population3. Posttraumatic stress disorder (PTSD) is one 
of the most common mental health disorders among Veterans of wartime service, affecting approximately 15% 
of Veterans across eras4. In their comprehensive review, Carlson et al.5 report an overall prevalence of 
comorbid TBI and PTSD among OIF/OEF Veterans at 5-7%. Significantly, individuals with TBI are at increased 
risk for developing PTSD6. Among Veterans with histories of TBI, rates of PTSD range from 33-65%5,7, with 
rates highest among those seeking clinical care. Both mTBI and PTSD are associated with significant  
functional disability and high personal, social, and health care costs8, with accumulating evidence that their 
comorbidity exacts an even greater impact on functionality than either disorder alone9. 
 
The reasons for comorbidity between PTSD and mTBI are complex, likely related to both causal factors 
and neuropsychiatric symptom overlap between disorders (Vasterling, Bryant, & Keane, 2012). First, 
many events (e.g., motor vehicle accidents, combat explosions) that increase the risk of TBI can also be 
psychologically traumatic. Modern warfare involving multiple deployments and high rates of blast exposure has 
greatly increased Service Members’ risk of TBI and PTSD10. There is evidence for similar neuroanatomical 
underpinnings for TBI and PTSD. Neuroimaging studies suggest the same brain regions are affected in both 
TBI and PTSD (including prefrontal cortex, hippocampus, and amygdala)10,11. Neurobiological processes 
believed most affected by TBI have been linked to the development and course of PTSD, such as problems 
with executive control, affect regulation12,13 and memory encoding and integration14. The overlap between  
mTBI and PTSD may be accounted for at least in part by overlap in symptoms, regardless of etiology. Core 
symptoms of PTSD and postconcussive syndrome include problems with concentration/attention, memory, 
sleep disturbance, and irritability15,16. Moreover, cognitive complaints and objective neurocognitive deficits are 
common among individuals with PTSD, even in the absence of TBI history11,17. 
 
Comorbidity and neuropsychiatric symptom overlap pose challenges for the treatment of individuals 
with both mTBI and PTSD. There are no established evidence-based treatments or treatment guidelines for 
individuals with comorbid mTBI and PTSD10,18 due in large part to the complexity of this population and 
uncertainty about specific causal or maintaining factors. For example, given the comorbidity and symptom 
overlap, it can be difficult to determine whether problems and disruptions in functioning are due to mTBI, 
PTSD, or both10,19, and hence, how to prioritize treatment (e.g., what to treat first). Further, it is unclear to what 
extent existing treatments for each disorder can be adherently and effectively implemented for the other. For 
instance, the two evidence-based treatments for PTSD that are widely disseminated throughout the VA are 
Cognitive Processing Therapy20 and Prolonged Exposure21. Both are considered "trauma processing" 

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therapies and require a moderate degree of cognitive resources and assume normative learning and emotion 
regulation abilities. It is possible that cognitive deficits that occur with mTBI could interfere with these 
treatments22,23, though this is not well-studied. Preliminary studies provide some evidence that individuals with 
mTBI can engage in and benefit from PE and CPT24,25, yet controlled trials have not been conducted and the 
impact of these treatments on cognitive symptoms remains unknown. 
 
Likewise, it is conceivable that treatment of cognitive problems related to mTBI could be impeded by 
symptoms specific to PTSD, such as avoidance and emotion dysregulation26, though no study has evaluated 
treatment for mTBI-related problems among individuals with comorbid mTBI/PTSD. There are few studies 
evaluating treatment for mTBI-related cognitive impairment alone, due in large part to controversies regarding 
definition and measurement of mTBI and etiology of cognitive difficulties27. Investigators from our research 
group28 conducted a non-randomized pilot study examining the efficacy of cognitive strategy training in 
OEF/OIF Veterans with mTBI for whom PTSD symptom severity was also evaluated (by the PTSD Checklist). 
Average pre-treatment levels of PTSD were above clinical cut-off for syndromal PTSD. At post-test, Veterans 
reported significant improvement of cognitive symptom severity, depression, and quality of life; however, no 
changes were evident in PTSD severity. 
 
Further complicating treatment decisions, current theories suggest the symptoms of mTBI and PTSD are 
interrelated by two-way relationships, creating multiple “vicious cycle” feedback loops such that mTBI and 
PTSD have the potential to become mutually self-sustaining27,28,29. For instance, comorbid PTSD and mTBI- 
initiated cognitive problems could result in maladaptive behaviors that reduce postdeployment occupational  
and social functioning, leading to increased stress that exacerbates PTSD and cognitive problems; increased 
stress and cognitive problems then result in further vocational decline (or unemployment) and relationship 
problems, and so on. Also implicated in these theories are the impacts of additional common comorbidities with 
mTBI, and PTSD, including chronic pain, depression, and functional impairment due to physical injuries30. As 
such, most current treatment recommendations suggest a holistic or integrated treatment approach for 
comorbid mTBI/PTSD targeting symptoms and functionality rather than etiology10,31. 
 
Veterans with mTBI and PTSD may benefit from alternative, present-centered approaches that 
emphasize first improving daily functioning, quality of life, and related patient-centered outcomes. 
Based on population complexities and heterogeneity, difficulties in isolating causal and maintaining factors,  
and recommendations in the field, we are proposing a treatment for comorbid mTBI and PTSD that directly 
targets daily functioning and quality of life. There are additional reasons to consider alternative, present- 
centered approaches. In the treatment of PTSD, there exist numerous barriers to the provision of evidence- 
based, trauma-processing therapies32. Among Veterans, commonly reported barriers include stigma about 
seeking mental health care, difficulties accessing care, and competing life circumstances (e.g., childcare33). Of 
those who do seek care there is substantial drop-out from trauma-focused treatments (upwards of 50%34) with 
an overall recovery rate for such treatments estimated at 40% when non-completers are considered35. Further, 
there is evidence that many Veterans are disinclined to talk about past traumatic experiences36 and instead 
have a preference for present-focused, skills-based interventions37. Present-centered treatments have been 
found to be efficacious in the treatment of PTSD with less treatment drop-out and comparable long-term 
outcomes relative to trauma focused treatments38,39. Additional provider- and systems-level barriers to the 
provision of trauma-focused treatments include insufficient training/confidence and time. Even in the VA where 

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most clinicians in PTSD specialty clinics have been trained in CPT or PE, a recent national survey found that 
fewer than 30% of patients were receiving these treatments40. Hoge35 has estimated that, due to issues of 
tolerability, evidence-based trauma-focused PTSD treatments will only reach about 20% of all Veterans in 
need. Though not yet studied, barriers to care may be even greater among those with comorbid mTBI and 
PTSD due to their increased functional disabilities. To increase the reach of mental healthcare services, 
additional treatments are needed that are more accessible to the large numbers of Veterans with PTSD and 
comorbid mTBI/PTSD not currently accessing or benefitting from care. 
 
Our proposed treatment for comorbid mTBI/PTSD, Cognitively-Augmented Behavioral Activation 
(CABA) combines and builds on our previously independent treatment development efforts. Next we 
describe our independent research followed by our collaborative work and the focus of this proposal. 
Cognitive Interventions for mTBI. Dr. Huckans and colleagues initially developed an 8-week manualized 
treatment (Cognitive Strategies Training, CST) for cognitive symptoms associated with mTBI, consisting of 
group interactive didactics, in-class discussions, and activities which introduce participants to a variety of 
internal strategies and external aids designed to help them manage problems with memory, attention, 
planning, and organization. CST aims to increase overall functionality among individuals with mTBI by 
encouraging participants to apply their new skills to areas in their lives that are most adversely impacted by 
cognitive problems. Based on this initial work, CST was revised and renamed Compensatory Cognitive 
Training (CCT). Outcome data for both the open trial of the initial treatment28 and the subsequent randomized 
controlled trial of CCT (VA funded through RR&D Merit Review, Storzbach, PI) are strong. CCT participants 
are demonstrating significant reductions in cognitive symptoms and depression. Importantly, participants have 
not shown significant reduction in symptoms of PTSD, suggesting the need for PTSD-specific treatment 
components. For further details see the Preliminary Studies section. 
 
Behavioral Activation for PTSD. Wagner and Jakupcak have developed an adaptation of Behavioral 
Activation therapy (BA) for PTSD for the large number of Veterans who decline, drop out of, or do not have 
access to trauma-focused treatments. BA is a well-established treatment for depression41,42,43,44 that targets 
patterns of avoidance and involves the identification and enactment of activities that are reinforcing to the 
individual and consistent with his/her long-term goals45. As such, case formulations and treatment planning are 
ideographic and patient-centered, based on empirically-supported principles of change. The rationale for the 
application of BA to PTSD is based on the central role of avoidance in the development and maintenance of 
PTSD46, and is consistent with contemporary views of mental disorders which identify unifying constructs, 
including avoidance, across a range of disorders47. Similar to in vivo exposure typical of CBT treatment for 
PTSD, engaging in goal-directed activity may allow for re-learning to conditioned trauma-related cues. BA 
differs from in vivo exposure in that the focus is specific to activities that are consistent with Veterans' goals, as 
opposed to those that are avoided because they elicit fear or anxiety. 
 
Initial studies from our research group showed BA significantly reduced PTSD symptoms among both 
civilians48 and military Veterans49,50,51. Importantly, researchers outside of our group have also found beneficial 
effects of BA for the treatment of PTSD52,53,54. Our most recent version of BA builds on previous work and was 
recently evaluated in a dual-site, randomized controlled trial of BA for PTSD compared to Treatment as Usual 
(PTSD specialty care) (Wagner & Jakupcak, CSR&D VA Merit Review). Results showed that BA significantly 
reduced PTSD symptoms with strong effect sizes and demonstrated some superiority over specialty PTSD 

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treatment (see Preliminary Studies for details). Moreover, findings also indicate that Veterans who screened 
positive for mTBI demonstrated an attenuated response to BA, underscoring the importance of augmenting this 
treatment with additional strategies to address the unique needs of those with mTBI/PTSD. 
 
Pilot Data on Our Combined Intervention (Cognitively-Augmented Behavioral Activation, CABA) are 
Promising. CABA is an integration of CCT for mTBI-related problems and BA for PTSD. Our rationale for 
combining CCT and BA is based on compatibilities in their structures and approach and the unifying focus on 
increasing functionality. Further, although not the focus of the current study, previous research on BA suggests 
this integration could address additional comorbities of the mTBI/PTSD population, including depression42 and 
pain-related problems55. CABA is a 10-session treatment delivered in weekly 90 minute individual therapy 
sessions. At its core, CABA involves using Behavioral Activation to identify meaningful goals and activities 
while simultaneously learning cognitive strategies to aid in working towards those goals. The initial phase of 
CABA is devoted to psychoeducation about mTBI and PTSD, the rationale for BA, and lifestyle strategies that 
can improve cognitive functioning and mood. Cognitive compensatory skills are taught in each subsequent 
week that include internal and external strategies to help manage problems with memory, attention, and 
executive functions. The participant and provider spend portions of each session applying the cognitive skills to 
managing real life situations and increasing behavioral activation in the service of personal goals. Pilot data on 
5 Veterans indicate that CABA significantly reduces PTSD, depression, and cognitive symptoms. Treatment 
details and pilot data are provided below. 
 
Relevance of the proposed work to the VA Patient Care Mission 
 
Demonstrating that an intervention specifically designed for the treatment of comorbid mTBI/PTSD is 
effective for both PTSD and cognitively-related functional impairment would be a significant innovation 
addressing a large gap in currently available treatments for Veterans. If found to be efficacious, the CABA 
treatment could be quickly disseminated to all VHA facilities. The CABA intervention would not only be useful   
in PTSD specialty care clinics, but could also be implemented in rehabilitation settings such as Polytrauma or 
Neuropsychology Clinics, specifically targeting Veterans with mTBI/PTSD who may not seek out traditional 
mental health treatment. The program’s portability and ready availability make it immediately possible to deliver 
evidence-based treatment specifically designed for Veterans with comorbid mTBI/PTSD. Future studies will 
compare CABA to alternative treatments toward further identifying the most effective treatments for 
mTBI/PTSD. Our proposed study is consistent with one of the explicitly stated missions of RR&D which 
is to ensure that Veterans achieve maximal recovery from combat-related neurotrauma by addressing 
co-occurring conditions or "polytrauma." 
 
PRELIMINARY STUDIES AND CURRENT STATUS OF THE FIELD 
 
The proposed study is a continuation of multiple collaborative efforts at VA Portland HCS and Puget 
Sound HCS. A series of studies investigating treatments for traumatic psychological effects of battlefield 
deployment has culminated in the piloting of a new intervention, Cognitively Augmented Behavioral Activation 
(CABA), specifically designed for treatment of Veterans with comorbid mTBI/PTSD. Wagner and Jakupcak 
have been pursuing modifications of Behavioral Activation therapy to target PTSD as well as comorbid PTSD 
and depression among both civilian and Veteran populations. They recently completed a VA-funded (CSR&D, 
Merit Review) for a dual-site (Portland and Seattle VAs) randomized controlled trial of BA for the treatment of 

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PTSD among OIF/OEF Veterans. Concurrent with Wagner and Jakupcak’s research on BA for PTSD, 
Storzbach and Huckans have been conducting research on cognitive rehabilitation for Veterans with mTBI. In 
2007, Dr. Huckans developed and initiated the CST pilot study at VAPORHCS. Subsequently, Dr. Storzbach’s 
currently ongoing 3-year 4-site (VA Portland HCS, VA Puget Sound HCS, VA San Diego HCS, and Boise 
VAMC) randomized controlled trial of CCT was funded through a VA Merit Review award. The study evaluates 
the efficacy of a manualized, 10-week, CCT group intervention for OEF/OIF Veterans with cognitive disorder 
resulting from mTBI. 
 
Behavioral Activation for Veterans with PTSD49. Feasibility and effectiveness of BA for PTSD was  
examined in a sample of 11 Veterans from a VA outpatient PTSD clinic in this pre-post open trial pilot study. 
The sample was primarily male, Vietnam era Veterans all meeting diagnostic criteria for PTSD. Given the 
chronic nature of PTSD in this sample, BA was delivered in its comprehensive (i.e, 16-session) format. There 
was a statistically significant reduction in PTSD symptom severity, with five Veterans demonstrating reliable 
symptom reductions on the Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV)56 that ranged from 12 to 
44 points (M = 21.6). Six of ten Veterans demonstrated symptom reduction on the PTSD Checklist57 and one 
demonstrated an increase in symptom severity. The decrease in PTSD scores was consistent with small to 
medium effect sizes. These results provide initial support for the application of BA for the treatment of PTSD 
among Veterans. Change was evident among Veterans with chronic symptoms of PTSD and complex 
psychiatric profiles, suggesting stronger results would be likely among less chronic and severe populations. 
 
Behavioral Activation as an early intervention for PTSD among recently injured trauma survivors48. This 
study is an initial examination of BA for the treatment of PTSD among civilian survivors of traumatic injury. The 
intent was to provide BA as an early intervention in an ecologically valid (real-world) manner. Participants were 
8 patients recruited from the surgical ward of a Level 1 trauma center, who met diagnostic criteria for PTSD  
one month post-trauma, randomly assigned to either BA or treatment as usual (TAU). This was an ethnically 
diverse sample of men and women, ages 18-65. In consultation with the lead author of the behavioral  
activation manual (Dr. Christopher Martell), the components of comprehensive BA were modified to be 
delivered in 4-6, 90 minute sessions. In addition, the psychoeducational materials were modified to include 
descriptions of PTSD symptoms and to emphasize the role of avoidance in PTSD. The BA group demonstrated 
significantly greater reductions in PTSD (as measured by the PCL) than the control group (t = 2.07; one-tailed  
p < .05; unbiased Hedges’s g = 1.27) and there was a trend for the BA group to score better than the control 
group on a measure of physical functioning (t = 1.89; one-tailed p = .05; unbiased Hedges’s g = 1.16). These 
preliminary data added to the promise of BA as an effective alternative for the early intervention of PTSD. 
 
Behavioral Activation as a primary-care based treatment for PTSD and depression among OIF/OEF 
Veterans50. This preliminary study examined treatment-satisfaction and potential therapeutic benefits of BA as a 
primary care-based treatment for PTSD and depression among OIF/OEF Veterans. Eight Veterans were 
enrolled, 6 completed at least four sessions, and 5 Veterans completed post-treatment and 3-month follow-up 
assessments after receiving 5-8 weekly sessions of Behavioral Activation delivered in a specialty post- 
deployment primary care clinic. The BA manual was similar to that used by Wagner and colleagues48, with the 
provision of additional sessions (up to 8) in an effort to strengthen treatment effects. Participants demonstrated 
a significant reduction in PTSD over time as assessed by both the Clinician Administered PTSD Scale56 (F(2,3) 
= 10.66, p < .05, d = 1.44, with an average drop in CAPS scores of 23.2 points) and PTSD Checklist57 (F(2,3) = 

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24.97, p < .05, d = 1.87). Effect sizes for change in depression and quality of life were strong (d = 1.28 and .62, 
respectively) though not statistically significant. Importantly, treatment satisfaction ratings were high. 
 
Behavioral Activation as an alternative treatment for PTSD among OIF/OEF Veterans (Wagner & 
Jakupcak, in preparation). This VA-funded Merit study (CSR&D) examined our 8-session (individual therapy) 
adaptation of Behavioral Activation (BA) for PTSD among returning OIF/OEF Veterans. Utilizing a randomized 
controlled design and two sites (Portland and Seattle VAs), BA was compared to Treatment as Usual (TAU), 
defined as referral to PTSD Specialty Clinics (TAU treatment was not controlled to allow for maximum flexibility 
in treatment planning and to reflect actual practice in PTSD specialty clinics; all TAU providers were trained in 
either Prolonged Exposure (PE), Cognitive Processing Therapy (CPT), or both, and Veterans were offered a 
minimum of 8 individual therapy appointments). Our primary aim was to determine whether BA is effective in 
reducing PTSD and depression symptoms and therefore is an effective alternative treatment for veterans with 
PTSD (e.g., for Veterans who do not want or cannot access trauma processing treatments). Therefore, we 
examined within-group as well as between-group effects. Participants were evaluated for PTSD, depression, 
and treatment satisfaction at pre- and post-treatment as well as 3-month follow-up. 
 
Eighty Veterans (40 in each group) were enrolled in the study. Repeated measures analyses showed strong 
treatment effects over time for PTSD across groups as measured by both the CAPS and PCL (see Table 1), 
indicating that both BA and treatment within PTSD specialty clinics are effective in the treatment of PTSD.  
Effect sizes for time (eta2) were moderate (CAPS=.42; PCL=.43). Time effects were also evident for  
depression as measured by the BDI (eta2=.19). There was a significant group by time interaction for the PCL 
(eta2=.08), such that Veterans receiving BA reported greater reductions in PTSD on this measure 
compared to those in TAU. Relevant to the current proposal, exploratory analyses were performed by adding 
history of mTBI to the above model. There was not a significant three-way interaction. However, two-way 
interactions of mTBI by time (F=3.3, p=.041, eta2=.07) and treatment by time (F=3.47, p=.036, eta2= .08) 
suggest that across groups, individuals without a history of mTBI did significantly better, though did not  
maintain treatment gains over time to the same extent as those with a history of mTBI. Treatment satisfaction 
ratings were high for both groups and comparable. These data strongly support the effectiveness of BA as an 
alternative treatment for PTSD among returning Veterans (i.e., that it is at least as effective and acceptable as 
specialty PTSD treatment that includes PE or CPT), and further support the rationale for our combined 
intervention for individuals with both PTSD and TBI. 
 
Table 1. Pre- and Post-Treatment and 3-month follow-up Scores (means, standard deviations) 
 
BA 
TAU 
Time x 
Pre 
Post 
3-mo 
Pre 
Post 
3-mo 
Time F 
Group F 
CAPS 
72.7 (14.5) 
54.7 (24.1) 
57.7 (26.0) 
79.4 (16.0) 
62.6 (27.5) 
56.5 (26.5) 
31.0** 
ns 
PCL 
58.6 (7.7) 
43.3 (12.8) 
48.8 (14.4) 
58.1 (8.6) 
49.8 (13.1) 
47.3 (13.4) 
32.24** 
3.8* 
BDI-II 
24.2 (7.0) 
18.7 (11.7) 
21.0 (12.0) 
24.4 (8.2) 
20.3 (9.4) 
18.3 (10.4) 
10.1** 
ns 
CAPS = Clinician Administered PTSD Scale; PCL = PTSD Checklist; BDI-II = Beck Depression Inventory; 
**p<.01; *p<.05 
 
Cognitive Strategies Training CST (CST) Pilot Study28: Please see published study in Appendix 4 for 
details. Study findings demonstrated beneficial effects of CST has on self-reported cognitive functioning, 

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increased use of compensatory strategies and aids, and reduction of psychiatric symptoms. This study was 
used to support the proposal for the multi-site VA Merit Review study that is currently ongoing (see below). 
Current CCT multi-site Merit Review study: The study aims to evaluate the efficacy of a manualized, 10- 
week, group intervention (Compensatory Cognitive Training, CCT) for OEF/OIF Veterans with cognitive 
disorder resulting from mTBI. A modification of CST, CCT consists of weekly 120-minute group sessions over 
10 weeks. The CCT curriculum is an expansion of CST that includes non-overlapping elements of a similar 
manual developed by Elizabeth Twamley and her colleagues at the San Diego VA59 in particular: skills to 
manage sleep problems, fatigue, headaches, anxiety/mood difficulties, improve active listening, and promote 
relaxation and mindfulness. CCT also added the use of behavioral analyses (as in BA) to individualize the 
treatment and interventions and therefore improve outcomes. Study design is a randomized controlled trial, 
comparing CCT to usual care (UC). The study is expected to conclude in 2013. Participants in the CCT group 
receive the CCT intervention during the first ten weeks of their participation in the study, whereas UC 
participants continue to receive usual care (which can include medical, pharmacological, and 
psychotherapeutic care, but no CCT intervention) during study participation. Both groups undergo evaluations 
at baseline, 5 weeks (midway through CCT), 10 weeks (immediately after CCT completion), and 15 weeks (5 
weeks after CCT completion). Interim pre- and post-treatment cognitive results are shown in Table 2. 
 
Table 2. Early interim results of CCT study from participants receiving CCT (n = 20) 
 
Pre-Tx score 
Post-Tx score 
df 
t 
p-value 
Cohen’s d 
HVLT-R 
44.58 ± 12.38 
54.89 ± 6.39 
19 
-4.06 
.001 
1.05 
Digit Span 
8.50 ± 2.67 
10.80 ± 2.71 
19 
-4.20 
<.001 
.85 
Letter Fluency 
9.90 ± 3.29 
12.05 ± 2.30 
19 
-5.48 
<.001 
.96 
Category Fluency 
10.60 ± 3.19 
12.15 ± 3.00 
19 
-2.87 
.01 
.50 
Note: Data expressed as mean total score ± standard deviation unless otherwise noted. 
 
Cognitively-Augmented Behavioral Activation (CABA) clinical pilot study: CABA was developed by 
members of our research team (Dr. Roost, with feedback by Drs. Storzbach and Wagner) and combines central 
components of both BA for PTSD and CCT (see "Experimental Intervention" below for a detailed description of 
CABA; see Appendix 2 for a draft of CABA). CABA is a 10-week manualized treatment for comorbid  
TBI/PTSD, delivered in 90 minute individual sessions. A clinical pilot study, which began in 2011, is being 
conducted in order to evaluate the effectiveness of this novel approach for individuals with comorbid 
TBI/PTSD. To date, 5 participants have completed the treatment. All participants were OEF/OIF male Veterans 
with PTSD and cognitive complaints with mean age of 37. All Veterans completed the 10-week treatment; 
however, one participant did not complete the post-assessment due to the birth of his baby. The high 
adherence rate noted during the clinical pilot study is reflective of CABA's acceptability and tolerability. Pre-  
and post-assessment measures (one week prior to and one week following treatment) included the BDI-II; 
PCL-M; NSI; MSNQ; PRMQ; MCQ; WAIS IV Matrix Reasoning; TMT A and B; and RBANS List Learning, Story 
Memory, Digit Span, List Recall, Story Recall, and Figure Recall. Analyses revealed a significant reduction in 
depression (BDI-II; t=3.978; p<0.05), PTSD (PCL-M; t=3.015; p<0.05), cognitive complaints (NSI; t=7.816; 
p<0.01), and attention/organization problems (MSNQ; t=3/757; p<0.05) after the CABA intervention. All effect 
sizes (Cohen's d) were large: 0.86 for the BDI-II, 0.94 for the PCL-M, 1.61 for the NSI, and 1.26 for the MSNQ. 

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There was a trend for better performance on most objective neuropsychological measures (RBANS; TMT A & 
B; WAIS-IV Matrix Reasoning) after the CABA intervention; however, none reached statistical significance. 
 
OIF/OEF/OND Veterans are targeted for this project due to the fact that Veterans returning from the current 
conflicts in Iraq and Afghanistan exhibit high rates of comorbid mTBI/PTSD for which evidence-based 
treatments do not currently exist. The study targets outpatients in that treatment for both mTBI and PTSD 
outside of this study occur regularly within the VA clinical setting via outpatient appointments. Veterans must be 
adults to serve and thus the Veterans we recruit will all be 18 years or older. Seniors over 65 with cognitive 
complaints will be excluded due to increased risk of age related mild cognitive impairments as opposed to  
mTBI which would confound our results. There will be no other restrictions on age, ethnicity, or race, and both 
men and women will be included. Recruitment fliers will specifically include the statement, “women and 
members of minority groups are encouraged to participate.” Of the OEF/OIF/OND veterans with mTBI, 95% of 
veterans are reported to be male. Seventy-percent of these veterans reported their race to be white, while 19% 
reported as non-white. The race of 11% of these veterans was categorized as unknown. This breakdown of 
gender and race is similar to populations seen in studies of OEF/OIF veterans with mTBI conducted by this 
research group. Thus, we would expect to recruit a similar population that would be representative of OEF/OIF 
veterans with mTBI. 
 
 
3.0 
Objectives 
 
The primary objective of this study is to evaluate the efficacy of CABA for Veterans with comorbid mTBI/PTSD. 
The overall goal is to develop an evidence-based manualized treatment that can be readily implemented in 
VHA treatment settings. The study will use a randomized controlled design to address the following specific 
aims and hypotheses: 
 
Specific Aim 1: To determine if CABA reduces PTSD symptoms. 
Specific Aim 2: To determine if CABA reduces cognitive-related functional impairment. 
Specific Aim 3: To determine if CABA is associated with additional positive clinical effects in patient-centered 
outcomes, including improved mood, adaptive cognitive function, and quality of life. 
Specific Aim 4: To evaluate the overall acceptability of this treatment. 
 
Primary hypotheses: 
1a) CABA treated comorbid mTBI/PTSD-diagnosed Veterans will demonstrate significantly decreased PTSD 
symptom severity compared to those receiving Treatment as Usual (TAU), defined as standard PTSD specialty 
care. 
1b) CABA treated comorbid mTBI/PTSD-diagnosed Veterans will display significantly decreased cognitive- 
related functional impairment compared to those in the TAU group. 
 
Secondary hypotheses: 
2a) CABA treated comorbid mTBI/PTSD-diagnosed Veterans will demonstrate additional significant 
improvements in patient-centered outcomes including depression symptom severity, cognitive symptoms, 
usage of cognitive strategies, and quality of life compared to a TAU group. 

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2b) Those receiving CABA will report significantly higher treatment satisfaction than those receiving TAU. 
 
Exploratory Investigation to Provide Guidance for Future Research Directions: Exploratory 
analyses will examine possible mediator and moderator variables and secondary outcome variables, 
including measures of neuropsychological test performance and general functioning. We will also 
investigate whether CABA- associated treatment gains are maintained over a 6 month follow-up period 
(the 6 month follow-up is discontinued when the assessments/interventions are completed over 
telehealth). 
 
 
4.0 
Resources and Personnel 
 
The study design makes use of the convergent availability of resources at the VA Portland 
Health Care System (VAPORHCS) and VA Puget Sound Healthcare System (VAPSHCS) in 
Seattle, WA where the research will be conducted. The treatment intervention will be conducted 
at both sites. A private room will be available at each site to ensure the confidentiality of 
participants. Office space is available at both medical centers for the safe and confidential 
storage of materials. 
 
The following table includes a list of personnel who will work on the study including their roles, 
affiliations, and responsibilities. 
 
Name 
Affiliation 
Role 
Access to PHI? Duties 
Daniel Storzbach,Ph.D 
VAPORHCS 
Principal 
Investigator/Study 
Chair AND 
Portland Local Site 
YES 
Overall multisite study 
oversight; Portland 
Local site study 
oversight 
Amy Wagner, Ph.D 
VAPORHCS 
Co-Principal 
Investigator/Stud 
y Chair 
YES 
Overall multisite 
study oversight 
Kathleen Pagulayan, Ph.D VAPSHCS 
Seattle Local 
Site PI 
YES 
Seattle local site 
study oversight 

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Megan Callahan, Psy.D 
VAPORHCS 
Co-Investigator / 
Multisite Study 
Coordinator 
YES 
Overall multisite 
study management, 
provide the study 
intervention, recruit 
subjects, obtain ICF, 
administer 
surveys/interviews 
Provide the study 
intervention, recruit 
subjects, obtain ICF, 
administer 
surveys/interviews 
Marilyn Huckans, Ph.D 
VAPORHCS 
Co-Investigator 
/ Interventionist 
YES 
Provide the study 
intervention and 
assist multisite PI’s. 
Jennifer Vasterling, Ph.D 
Boston VA 
Co-Investigator 
/ Consultant 
NO 
Consult on the 
study 
Jesse Fann, Ph.D 
University of WA Co-Investigator 
/ Consultant 
NO 
Consult on the 
study 
Matthew Jakupcak, Ph.D 
VAPSHCS 
Co-Investigator 
/ Interventionist 
YES 
Provide the study 
intervention and assist 
the Seattle Site PI. 
Mai Roost, Ph.D 
VAPORHCS 
Co-Investigator 
/ Interventionist 
YES 
Provide the study 
intervention and assist 
the Portland Site PI 
Maya O’Neil, Ph.D 
VAPORHCS 
Co-Investigator 
/ Multisite Data 
Manager 
YES 
Will provide data 
analysis support locally 
(VAPORHCS) 
Shah Golshan, Ph.D 
UCSD 
Co-Investigator 
/ Statistician 
NO 
Will conduct 
randomization and 
overall interim and final 
data analyses 
Halina Kowalski, MA 
VAPORHCS 
Co-Investigator 
 
YES 
Provide the study 
intervention and recruit 
subjects, obtain ICF, 
administer 
surveys/interviews 
 

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Randomization procedures as well as overall multisite study interim and final data analyses will 
be conducted by our contracted statistician, Shah Golshan, Ph.D who is affiliated with 
University of California, San Diego. Dr. Golshan will receive a “limited data set” copied in 
encrypted format sent via secure email. The “limited data set” is defined as such for inclusion 
of patient assessment dates and otherwise would be considered de-identified. A Data Use 
Agreement will be pursued between the VAPORHCS and Dr. Golshan recognizing the 
agreement of the terms for use of this data which shall be transmitted and accessed strictly for 
data analysis purposes pursuant to the goals of this study. 
 
5.0 
Study Procedures 
5.1 Study Design 
 
Overall design: 
 
We propose a dual-site randomized controlled trial comparing Cognitively Augmented Behavioral Activation 
(CABA) with a treatment as usual control group (TAU). The study design makes use of the convergent 
availability of resources at the participating VAs (Portland and VA Puget Sound). VA Puget Sound has two 
divisions, Seattle and American Lake, and all study activities may take place at either division. Participants will 
be Veterans ≤ 55 years of age (both male and female) with comorbid mTBI/PTSD enrolled for outpatient 
medical services at these VAs. A total of 192 participants will be recruited, 96 at each site. As described in the 
“Overall Clinical Trial Plan" section, participants in CABA will receive the CABA intervention via telehealth 
during the first 14 weeks of study participation, whereas TAU participants will receive usual care (no CABA 
intervention) during study participation (but will be offered CABA at no cost after the end of the study). In order 
to adhere to a national VA performance measure that requires 8 sessions to be delivered over a 14-week 
period, participants will be contacted by phone by a blinded assessor for the mid-treatment assessment 7 
weeks after the onset of treatment. Allowing 14 weeks to complete a 10-session treatment protocol accounts 
for cancellations and missed sessions. Participants will then be seen for a follow-up assessment 14 weeks 
after initiating treatment. During their study participation, all participants will continue to receive their usual 
medical care. Due to the COVID-19 pandemic and hospital restrictions for in-person visits, all study operations 
will be conducted remotely. A detailed description of this plan is described in the following section.  
 
Overall Clinical Trial Plan: 
 
Experimental intervention: Cognitively Augmented Behavioral Activation (CABA). CABA combines key 
elements of BA for PTSD and CCT. In its comprehensive form as a treatment for depression45, BA includes 
several key features, including orientation to the rationale and components of treatment, careful tracking of the 
patient’s mood and relationship between activities and mood through behavioral analyses, identification of 
reinforcing goals and activities, identification of patterns of avoidance that block attainment of these goals and 
activities, and strategies for engaging the individual in alternative coping that increases behaviors that are 
reinforcing. This treatment was originally developed to be delivered in 16-24 weekly sessions. When 
proposing a study to examine the efficacy of BA for PTSD, Dr. Amy Wagner, a PI on this study, consulted 

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with the lead author of the behavioral activation manual, Dr. Martell. As a result of this consultation, the 
components of comprehensive BA were modified to be delivered in 8 60-minute sessions. The decision to 
condense the treatment was based in part on the early intervention focus of this work. The aim was to 
develop a treatment that was easier to complete for Veterans and easier to deliver in primary care settings, 
thus increasing the potential for future dissemination. Support for the effectiveness of BA delivered in a 
condensed format is supported48,50,64. In BA for PTSD, the psychoeducational materials were modified to 
include descriptions of PTSD symptoms and to emphasize the role of avoidance in PTSD. Activity 
scheduling was maintained as the central organizing tool, with emphasis placed on increasing activities 
consistent with the individual’s short- and long-term goals and values. Since the presence of physical injury 
(which can be a result of trauma) can lead to new restrictions in activities (short term, long term, or 
permanent), greater attention was spent on goal identification and development. During behavioral analyses, 
attention was given to the full range of factors that may contribute to avoidance in those with trauma 
histories, including fear, pain, physical limitations, secondary emotions (e.g., shame), threat- and danger-
related cognitions. To the extent that a patient’s substance use can similarly be conceptualized as avoidant 
behavior 65, it can be targeted in this intervention as well. 
Cognitive rehabilitation therapy used in CABA is taken from the Compensatory Cognitive Training (CCT) 
manual, which is a group intervention currently being used in Dr. Storzbach's Merit Review Study aimed at 
treating mTBI in Veterans. The CCT treatment manual is an integration of two previous treatment manuals: 
COGSMART at San Diego VAMC and CST at VAPORHCS. The CCT intervention is designed to be practical, 
portable, low-tech, and engaging to clients. The goal is to help participants develop new habits that will help 
them with real-world situations relevant to cognitive functioning. The 10-week CCT intervention is comprised of 
weekly two-hour sessions including interactive didactics, in-class discussions, and activities which introduce 
participants to a variety of lifestyle strategies, internal and external/environmental cognitive strategies, and 
external aids designed to help them manage problems with memory, attention, and executive functions. 
Participants are required to use a memory prosthetic of their choosing, either a paper day planner or an 
electronic calendar. Participants are given class handouts and weekly home exercises so they can practice 
and implement skills in their daily life. Participants are encouraged to practice the new skills during activities 
that relate to their most important life goals. Home exercises are discussed at subsequent sessions so that 
participants can receive feedback and troubleshoot application of new skills to their specific real life goals and 
problems. Participants receive extensive training in and practice with their day planners, with a particular focus 
on how the day planner can facilitate their use of other compensatory strategies taught in group (e.g., writing 
down important information for later reference, breaking tasks down into smaller steps, prioritizing healthy 
habits and other important life goals, using worksheets to aid with goal planning and problem solving). 
 
CABA is designed as a 10-session treatment, to be delivered in 90" individual sessions (see Appendix 2 for a 
draft of the CABA manual). Due to the COVID-19 pandemic, these sessions will be provided via 
telehealth, including VA Video Connect (VVC, or alternative VA-approved video-based platform) or 
telephone.. CABA is shorter in duration than CCT because it is delivered individually. It is longer than the BA 
for PTSD manual because of the added CCT elements. The overlap between elements of CCT and BA for 
PTSD allows for a shorter treatment than would be required if each treatment were delivered independently. 
At its core, CABA involves using behavioral activation to identify meaningful goals and activities while 
simultaneously learning cognitive strategies to aid in working towards those goals. The initial stage of CABA 
will be devoted to psychoeducation on mTBI, psychoeducation on PTSD and BA, and lifestyle strategies that 

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can improve cognitive functioning and mood. After the initial phase, the Veteran will learn new cognitive 
compensatory skills each week that incorporate internal and external strategies to help manage problems with 
memory, attention, and executive functions. Participants are required to use a memory prosthetic of their 
choosing, either a paper day planner or an electronic calendar like a PDA or smart phone. Each participating 
site will offer paper day planners to participants. As part of this skills training, the Veteran and the provider will 
spend portions of each session applying the cognitive skills to real life situations. In CABA, the real life 
situation to which the cognitive skills will be applied will be chosen through the identification of goals and 
activities, which is a BA-specific intervention. For example, each week the Veteran and provider will work on 
scheduling activities that are reinforcing to the Veteran. If the cognitive skill for the week is learning to use a 
day planner, for homework that week the Veteran will apply the skill of using a day planner to aid in 
completion of the scheduled activity. When the Veteran returns the following week, the initial portion of the 
session will be spent reviewing the homework and problem-solving any barriers that the Veteran had with 
regard to completing the homework. As in BA for PTSD, attention is given to avoidance patterns (as well as 
cognitive factors) that may be interfering with increasing activation and goal attainment and to improving 
overall functionality. Behavioral analyses are maintained as a central tool for individualizing goals and 
interventions. 
Control Intervention: Treatment as Usual (TAU). TAU refers to the usual care for PTSD and mTBI provided 
in the VA clinics represented in our study. The VA sites employ routine screening for PTSD and mTBI, and 
providers at both sites are familiar with the VA Clinical Practice Guidelines for the treatment of PTSD and 
mTBI. Actual clinical practice varies between sites and between providers within sites, as is typical of the VA 
health care system in general. In order to standardize the practices of the two sites as much as possible and 
ensure that the practices reflect typical practices across VA medical centers, participants assigned to TAU will 
be first offered a referral for PTSD specialty treatment at each site (e.g, to the PTSD Clinical team at the 
Portland site and either the Deployment Health Clinic or the PTSD Outpatient Clinic at the VA Puget Sound ). 
Across these PTSD specialty clinics, psychosocial treatment options include skills focused interventions (e.g., 
skills for managing PTSD, either in group or individual modalities) and trauma-processing therapies. Emphasis 
is on providing evidenced-based psychotherapy for PTSD, and most providers are trained in and provide 
Prolonged Exposure (PE) and/or Cognitive Processing Therapy (CPT). TAU participants may also receive 
pharmacotherapy, either within PTSD specialty clinics or from primary care providers. To equate quantity of 
treatment across conditions, participants in TAU will be offered an evidence based treatment for PTSD (i.e., 
PE or CPT) which consists of 8-12 structured sessions designed to be delivered over a 14-weeks. Per our 
informed consent, we make Veterans aware of other treatments available and we are asking participants to 
not engage in CPT or PE concurrent to participating in CABA. However, at the end of participation, all 
Veterans will have the option of referral to CPT/PE. To ensure adequate attention to TBI-related difficulties, it 
will be directly communicated to the assigned PTSD care provider, referring provider, and primary care 
provider that the Veteran has been diagnosed with mTBI and may benefit from further assessment and 
treatment of mTBI-related difficulties. Cognitive problems are typically addressed in the Polytrauma, 
Neuropsychology, and Speech Pathology clinics and referrals to these clinics will be unrestricted. 
Therefore, TAU can be considered “optimized” usual care. Wewill record all treatment received. 
Procedures: Patients who screen positive for comorbid mTBI/PTSD may be offered a flyer describing the 
study by their provider. The flyer will include phone numbers to contact the study coordinator. By partial 
waiver of informed consent for screening purposes, interested participants can also be referred to the 

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study team by the participant’s provider to be contacted for prescreening or, at VA Puget Sound, can be 
identified through the Repository and Registry for Behavioral Neuroscience Research.  
Clinical providers may refer interested patients and document their willingness to be contacted by 
the study through CPRS via their progress notes and using templated language provided to them (See 
Appendix G). Clinicians may also send referral information via encrypted email with the same templated 
documentation (or comparable documentation that the Veteran is interested in hearing more about the 
study and gives permission for research staff to contact them). Following a chart review and preliminary 
phone screen to determine eligibility, potential participants will be scheduled for an initial telehealth (by video 
or telephone) appointment during which they will be consented to the study. Consented participants will be 
instructed to return the informed consent form (ICF) and Authorization for Use and Release of Individually Identifiable 
Health Information Collected for VHA Research (HIPAA form) to the study team using a prepaid and preaddressed 
envelope. Once received, a study team member will complete an assessment appointment with the participant via 
telehealth. After all eligibility criteria are met and the assessment is complete, If telehealth appointments are conducted 
via VA Video Connect (VVC) platform, participants may receive automated reminders and appointment links over 
email, consistent with procedures for clinical appointments using VVC. the study statistician will randomly assign 
eligible participants to one of the two treatment options and will notify the site study coordinator about 
randomization status. The site study coordinator or other appropriate research team member, will contact 
the participants to inform them of their group assignment. Those assigned to CABA will be contacted by 
their therapist and tele-or video-therapy will commence. Those assigned to TAU will be offered a referral for 
PTSD specialty care. The assessors will be blind to group status throughout the study whenever possible.  
Consistent with a national VA performance measure that requires 8 sessions to be delivered over a 14 
week period, participants will be contacted by phone by a blinded assessor for the mid-treatment 
assessment 7 weeks after the onset of treatment. Allowing 14 weeks to complete a 10 session treatment 
protocol accounts for cancellations and missed sessions. Participants will then be seen for follow-up 
assessments 14 weeks after initiating treatment. In order to minimize drop-out and maximize retention of 
individuals for intent-to-treat analyses, extensive efforts will be made to stay in contact with all study 
participants, including individuals who drop out of treatment. CABA participants who are deemed 
nonresponders or relapsers (do not evidence at least a 20% reduction in PTSD or cognitive symptoms) at 
the post-assessment or follow-up assessment (or an increase in suicidality or substance abuse), and other 
participants as clinically appropriate, will be offered alternative treatment or appropriate referrals. 
Blinding: Subject and facilitator blinding is not feasible due to the study design: a treatment group vs. a 
usual care group. The assessors will be blind to group status throughout the study. 
Randomization: Randomization tables will be prepared by Dr. Golshan, the statistician, at the beginning of 
the study, and he will notify the site study coordinator of the participant's randomization status. Over the 
course of the study, Dr. Golshan will monitor enrollment; if imbalance occurs, he will recommend appropriate 
adjustment. 
 
Risks to Subjects 
 
a. Human Subjects Involvement and Characteristics 
 
Participants will be 192 Veterans ≤ 55 years of age receiving clinical care at the VAPSHCS and VAPORHCS 

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(Portland and Vancouver campuses) and affiliated clinics, who meet diagnostic criteria for comorbid 
mTBI/PTSD.  Employees or students, pregnant women, economically and/or educationally disadvantaged 
persons, and terminally ill patients will be included. Based on the nature of the intervention, it is anticipated 
that this treatment will present minimal risk to these populations. Individuals with impaired decision making 
capacity, illiterate, or who have limited or no English language proficiency will be excluded on the basis of 
possible diminished cognitive ability that would compromise their involvement in this treatment. Prisoners will 
be excluded from the study as a result of this study being conducted on an outpatient basis only. There will be 
no restrictions on, ethnicity, or race, and both men and women will be included. Recruitment fliers will 
specifically include the statement, “women and members of minority groups are encouraged to participate.” 
Additional inclusion criteria include: 1) Diagnosis of PTSD made by use of the Clinician Administered PTSD 
Scale (Blake et al., 1990); 2) screened positive for mTBI on the Structured Interview for  Collecting Head 
Trauma Event Characteristics as outlined by the VA/DoD Clinical Practice Guideline for  Management of 
Concussion/mTBI and positively endorsed any of the Neurobehavioral Symptom Inventory (NSI; Cicerone & 
Kalmar, 1995) cognitive symptoms items (items 13-17); 3) English speaking, willing to attend weekly treatment 
telehealth sessions (if randomized to the CABA condition) and the follow-up assessments, and willing to refrain 
from  additional treatment for PTSD during the first 3 1/2 months of the active phase of treatment if they are 
assigned  to the CABA condition; and 4) willingness to participate in audio-recorded sessions. 
b. Sources of Materials 
 
Several sources of information will serve as data for the study, including neuropsychological assessments and 
standardized diagnostic interviews and questionnaires administered by study personnel, audiotaped treatment 
sessions for individuals assigned to the CABA group (to be used for supervision, determination of adherence 
and competence in the intervention, achieving reliability in ratings of adherence and competence and training 
purposes), daily monitoring forms for individuals in the CABA group, and information from medical records. 
Other than the information derived from the medical records, data will be collected solely for research 
purposes.  However, because of the clinically-relevant nature of much of this information, patients will be 
informed that these data may be reported in their medical record, as clinically indicated.  Data will be labeled 
with a code number that is unique to each patient in the study. All hard copy data will be stored in locked 
filing cabinets in locked rooms, while all electronic data will be stored in password-protected files in a limited 
access folder on the secure VA network drive. Data may be temporarily stored in a locked filing cabinet at 
the American Lake division until it can be transported to the Seattle VA. Data will be transported between 
American Lake and Seattle divisions by study staff in HIPAA-compliant locked containers. Each study site 
will maintain a key code that links that site’s patients with their coded identifier. This key code will be stored 
separately from all other study data and available and maintained only to the multisite co-PIs, the site PI’s, 
the multi-site project coordinator, and the site coordinators and research assistants. Any materials with 
protected health information (e.g., Informed Consents) will be stored in separate locked filing cabinets from 
coded materials to ensure the security of patient privacy. 
 
c. Potential Risks 
 
Minimal risk is anticipated with the current investigation. The psychotherapeutic intervention under 
investigation is consistent with the treatments recommended in the VA/DoD Clinical Care Guidelines for the 
treatment of PTSD and mTBI. Participants randomized to TAU will have identical opportunities for treatment  
as non-research patients. Regarding research risk, participants may experience anxiety and/or distress during 
the assessment procedure and during the course of treatment. Participants may also experience discomfort as 
a result of being audio recorded during the course of therapy.  Participants also might not experience 
symptomatic relief from the intervention. Potential study participants will be informed that they may choose not 
to participate in the study without risk to their medical care, and that similar interventions not being evaluated in 
the study are available in the facility without participation in the research. 
 

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All study personnel who conduct the assessments and interventions will be qualified, trained, and closely 
supervised by the co-Principal Investigators (co-PIs). Participants will be provided with emergency contact 
numbers. All participants will be clearly informed of their right to withdraw from the study at any point without 
adversely impacting their routine medical, psychiatric, or psychotherapeutic care. 
 
Safety monitoring will be performed by the study staff who conduct interviews, administer assessment 
questionnaires, conduct psychological and cognitive assessments, and conduct interventions. Adverse events 
will be reported immediately to the co-PIs, who will examine the patient and determine if any additional 
evaluation or treatment is needed. The co-PIs will recommend termination of participation, provide appropriate 
referrals, and engage in follow-up if substantial decline in functioning is observed. Referral will also be offered 
to non-responders and any participant who requests further treatment. The co-PIs will ensure that adverse 
events are properly reported to the IRB. The co-PIs will review all cumulative adverse events quarterly to 
determine if there are any systematic problems as the co-PIs will be ultimately responsible for all safety 
monitoring conducted for this study. 
 
Although the proposed study poses no serious risks to participants, participants may notify research personnel 
about pre-existing mental health issues that have not been previously identified by other VA providers. 
Therefore, participants will be referred to the VA’s Mental Health Division for further assessment and/or 
treatment if a previously undiagnosed psychiatric disorder is identified. We will inform participants of this 
procedure as part of the informed consent process and participants must agree to this procedure to be eligible 
to participate in the study. This ensures that we can adequately manage any pre-existing clinical issues that 
become apparent through subject evaluation. 
 
Adequacy of Protection from Risks 
 
a.  Protection Against Risk 
 
Trained, closely supervised staff will conduct the assessments and the intervention.  Assessors conducting 
diagnostic psychiatric interviews will have at least one year of graduate experience or equivalent work 
experience, and therapists will be master’s or doctoral level. Drs. Wagner and Storzbach, licensed clinical 
psychologists, will review weekly therapy tapes and attend to any difficulties encountered. In addition, 
participants will be provided with emergency contact numbers. Finally, all participants will be clearly informed 
of their right to withdraw at any point and Drs. Wagner and Storzbach will recommend termination of 
participation (and provide appropriate referral and follow-up) if substantial decline in functioning is observed 
(including significant increase in alcohol or drug use).  Referral will also be offered to nonresponders and any 
participant who requests further treatment. Specific procedures will be maintained to maximize the likelihood 
that participant research related material will secure and confidential.  Data will be stored in locked filing 
cabinets and computer databases, without names or other potentially identifiable information attached; 
identifiable information will be kept separately and a coding system will be used to link data and identifiers. 
 
All SAE’s, UAP’s, and protocol deviations occurring at either site will be communicated to the Co-PI’s 
immediately and necessary documentation will be submitted to the CIRB within stipulated timeframes and via 
designated channels in accordance with the VA Central IRB Table of Reporting Requirements. 
 
All study personnel will follow the policies and procedures for suicide prevention and management of suicidal 
behavior and its aftermath anywhere within the medical center or on the premises as outlined in the 
VAPORHCS Medical Center Memorandum No. 11-04 and in Memorandum TX-74 for Seattle both included in 
the study Suicide behavior protocol, Appendix A. 
Imminent risk Protection: The following protocol applies to participants who express indication of imminent 
risk or clinical emergency; this includes concerns about suicidality and homicidality. 

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Participants may express indicators of risk either to the study clinician or to the study assessor; the protocol 
differs for each of these groups and is discussed below: 
For study clinicians:  If a participant presents to his/her study clinician/Interventionist with a clinical 
emergency (e.g. suicidality), the study clinician should address the situation as clinically appropriate. 
Concerns about imminent risk should be prompted by an examination of the participant’s response to item #9 
on the BDI (score > 2) and/or clinical inquiry. The clinician must assess and intervene within the study 
treatment protocol but is not limited by the parameters of the protocol in cases of imminent risk. Instead, in 
such cases, clinicians should address these situations consistent with optimal standards of care including 
hospitalization if required (see Suicidal/Homicidal Behavior Protocol in Attachment A). 
 
In addition, any concerns of imminent risk among participants in the CABA condition are to be immediately 
communicated to the site investigators (Daniel Storzbach, Ph.D. at the VAPORHCS and Kathleen Pagulayan, 
Ph.D., at the VAPSHCS), including the course of action taken. The site PIs will review such cases and 
determine if additional intervention is necessary. This review and/or evaluation is not required of participants in 
the control group as they will be receiving usual VA care and evaluation and intervention for imminent risk will 
follow standard VA procedures. 
For study assessors:  Study assessors should follow the Suicidal/Homicidal Behavior Protocol under the 
following conditions: if a participant presents with a score of 2 or higher on item 9 on the Beck Depression 
Inventory, or when there is other information that suggests that the person may be at risk. Assessors must 
also contact the site investigators who will determine if additional intervention is necessary; this review and/or 
evaluation is not required of participants in the control group as they will be receiving usual VA care and 
evaluation and intervention for imminent risk will follow standard VA procedures. Participants may be 
connected via a “warm transfer” with the National Veterans Crisis Line or be instructed to go to their nearest 
medical facility’s emergency department. 
c. Potential Benefit of the Proposed Research to the Subject and Others 
 
Participants in both the CABA and TAU conditions may experience a reduction in PTSD and/or TBI symptoms 
as benefit to participation in this study, though those assigned to CABA may experience a greater reduction in 
PTSD and/or TBI symptoms. Given that many Veterans with comorbid mTBI/PTSD do not respond well to 
current EBTs for PTSD because their cognitive problems interfere with their ability to optimally engage in 
treatment, this study may offer a treatment option for those who would not otherwise benefit from care and the 
benefit of this combined treatment would be available first to those assigned to the CABA conditions and then 
offered to TAU participants after their completion of the study. The risk of increased anxiety or distress (in the 
assessment or treatment components of the study) is balanced by the potential benefit of reduced distress and 
anxiety over time for study participants. Further, since the provision of CABA is also expected to reduce 
long- term health care utilization, this intervention may also lessen the burden of primary care providers. 
 
d. Importance of Knowledge to Be Gained 
 
In order to more effectively meet the mental health needs of Veterans with mTBI/PTSD, the present study aims 
to evaluate the effectiveness of a new hybrid treatment, Cognitively-Augmented Behavioral Activation for the 
treatment of PTSD, cognitive-problems, and functional impairment. Demonstrating that an intervention 
specifically designed for the treatment of comorbid mTBI/PTSD is effective for both PTSD and cognitively- 
related functional impairment would be a significant innovation that would address a large gap in currently 
available treatments for Veterans. If the treatment is found to be efficacious, the CABA manual could be 

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quickly disseminated to all VHA facilities. The CABA intervention would not only be useful in PTSD specialty 
care clinics, but could also be implemented in rehabilitation settings such as Polytrauma or Neuropsychology 
Clinics, specifically targeting Veterans with mTBI/PTSD who may be hesitant to seek out traditional mental 
health treatment. With the program’s portability and ready availability, it will immediately be possible to deliver 
evidence-based treatment for Veterans with comorbid mTBI/PTSD. 
 
e. Data Banking 
 
Participants will be given the option to have their data banked for future research use in the Neuropsychology 
Data Repository Study #3508 managed by Dr. Maya O’Neil, housed at the VA Portland Health Care System 
and overseen by the VAPORHCS IRB.  Seattle participants may have the option to bank their data in an 
additional repository for future research use. This banking system, Repository and Registry for 
Behavioral Neuroscience Research, is managed by Dr. Elaine Peskind at the VA Puget Sound Health 
Care System and overseen by the VA Puget Sound Mental Illness Research, Education, and Clinical 
Center and VA Puget Sound IRB. All future research of data maintained within a research data repository 
will only occur after further Institutional Review Board and/or other applicable approvals to ensure the 
protection privacy. Participants are not required to provide this permission and not providing this permission 
will have no impact on their participation in the study, i.e., granting permission is not a condition of 
participating in the study.  
5.2 Recruitment Methods 
 
Subject recruitment and feasibility: Participants will be 192 male and female Veterans ≤ 55 years of age 
referred for PTSD treatment who meet diagnostic criteria for comorbid mTBI/PTSD. Participants will be 
recruited from the healthcare clinics of the VA Portland Health Care System and VA Puget Sound Health 
Care System. Potential participants will be recruited through clinic referrals at participating VA’s, flyers, 
recruitment events and patient medical record review followed by recruitment letters sent to patients who 
meet the requisite pre-screening criteria.  
 
Identification and recruitment of participants is detailed to occur in one of four ways: 
1) By Referral from provider: Study personnel will seek provider referrals from VA outpatient clinics, 
including MIRECC mTBI/Behavioral Specialty Clinic, Neurology, Primary Care, Mental Health, 
Neuropsychology, Rehabilitation Medicine, Polytrauma, and others; VA community-based outpatient 
clinics (CBOCs); local area Veterans centers; and National Guard and Reserve units. We will seek 
these provider referrals in conversations with colleagues, by word of mouth, by email, and via 
presentations from study staff to appropriate clinical staff.  Providers will be given detailed information 
about study inclusion/exclusion criteria, recruitment process, and treatment goals. They will also be 
given templated language to use in CPRS notes if Veterans have agreed to be contacted by study staff.  
Participants will be referred to the study by their provider through CPRS and documentation of their 
consent to be contacted by the study will be documented in CPRS by the referring provider.  
 
We may identify potentially eligible participants by reviewing weekly care panels of providers who 
provide services for Veterans with a history of mTBI and/or PTSD using administrative and manual 
CPRS review data pulls. Providers of potentially eligible Veterans identified by review of care panels 

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with upcoming appointments may be contacted via encrypted email to inform them about the study and 
to invite them to discuss the study with the potentially eligible Veteran(s).  
 
2) By Flyer and other advertising methods: Study staff will be responsible for disseminating IRB-
approved flyers at hospital health fair and hallway information tables as well as bulletin boards; at 
presentations by investigators; via emails to clinicians and staff; in highly trafficked areas and clinic 
waiting areas. The study may also be advertised on  VA Puget Sound research kiosks; VA Portland 
and Puget Sound electronic reader-boards; websites, and in newsletters. Participants will call the 
study phone number listed on a flyer for additional details regarding the study or if working with a 
clinician, may request that the clinician contact the study on their behalf using the referral template 
described above.  
 
3) By Recruitment Letter: A letter from the study, with an opt-out option may be mailed to potential 
participants identified through administrative VINCI-based data pulls and electronic review of 
aforementioned VA outpatient clinics, informing Veterans of the project.  If study staff have not received 
the opt-out postcard after 2 weeks, project staff will contact Veterans who were sent letters by 
telephone to assess eligibility and interest in participation and to arrange an enrollment visit.  Study staff 
will make a total of 3 calls to each listed number before deeming the participant as not interested. We 
will retain a list of individuals who were deemed not interested (either due to sending the opt-out 
postcard or non-response to recruitment calls) so that those individuals are not re-contacted in the 
future. We will contact no more than 500 Veterans using this approach. 
 
4) BNG Repository: We will also screen the VA Puget Sound BNG registry of individuals who have 
specifically indicated they are interested in hearing about future research opportunities; Veterans 
identified as being highly likely to be eligible will be sent information about the study by mail. This 
mailing will include an opt-out mechanism to decline further information described above. If the potential 
subjects do not return the opt-out form, we may follow up with them over the phone using our telephone 
script (no more than three times as described above).  
 
If a Veteran is found to be eligible for the study and agrees to participate, the study coordinator will 
schedule a diagnostic and pre-treatment interview. Potential participants will then meet with a staff-
member from the study, who will review study procedures (nature and frequency of assessments, nature 
of treatments, random assignment to treatments), answer any questions, and obtain written informed 
consent. During the COVID-19 pandemic, this interaction will take place over telehealth.  Primary care 
providers will follow routine treatment and referral procedures regardless of patient interest in the study. 
 
We expect similar enrollment and recruitment rates at the Portland and VA Puget Sound. There is evidence 
that a substantial pool of potential participants exists, suggesting that the goal of recruiting 192 participants 
over the course of the study is feasible. Even allowing for more rigorous diagnostic procedures, exclusionary 
criteria, and a moderate refusal rate, the sample size should be easily attained. Total enrollment for the study 
at both sites would be 96 participants per site (48 CABA and 48 TAU), for a total of 192 participants (96 
CABA and 96 TAU). 
 
Steps to minimize dropout rate: We had a relatively low non-completer rate 11% among subjects enrolled in 

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our funded CCT study with OEF/OIF Veterans with mTBI. We partially attribute the low non-completer rate to 
reminder phone calls and financial incentive. Since compensation and reminder phone calls will once again be 
used in the proposed study, we expect a low attrition rate. Subjects will be compensated for time involved in 
the study as described below. We will also call all subjects to remind them of each session and study visit. 
 
Reimbursement for time and travel: Compensating subjects for their participation reduces attrition rates. 
We plan to compensate participants at each assessment point. They will receive a payment of $50 after each 
of the first three assessments. For completion of all three assessments, total compensation will be $150. 
 
5.3 Informed Consent Procedures 
 
Informed Consent: This study will make use of a waiver of informed consent for screening purposes only. 
The waiver will cover the pre-screening period of the study during which, upon provider referral (or participant 
response to recruitment flyer and/or letter), the study coordinator will conduct a CPRS chart review and 
telephone pre-screen interview to confirm screening criteria before the pre-treatment assessment is scheduled 
where informed consent will be obtained and final eligibility will be confirmed. Eligible participants screened for 
the study will be mailed the study informed consent form, Authorization for Use and Release of Individually 
Identifiable Health Information Collected for VHA Research form (HIPAA form), and detailed instructions for 
completing the forms at the time of their consent appointment. A self-addressed, pre-stamped return envelope 
will be provided to each participant and will be tracked by study staff.  
 
Trained, closely supervised staff will conduct the informed consent procedure and the assessments.  
Assessors will be the study coordinators or research assistants and will have at least one year of graduate 
experience. These staff obtaining consent will have completed web-based courses with post-test on Human 
Research Protections and Good Clinical Practice, and will have received training from the co-PIs in obtaining 
informed consent. A copy of the signed consent form will be kept with the participant’s research materials and 
a copy will be given to the Veteran (participants who are consenting over the phone will be sent 2 copies of the 
consent so that they can keep one for their records). Information provided to the potential participant and 
included in the written consent form will include the following: 
 
• 
Invitation to participate because of the presence of comorbid mTBI/PTSD 
• 
Duration of the study (4 years) 
• 
The general purpose of the study 
• 
The randomization procedure 
• 
A description of the CABA intervention, including general content of sessions, expectations for between 
session practice, number of sessions, and the use of audiotaping of sessions 
• 
A description of TAU, including information about the PTSD specialty care clinic and the types of 
treatments offered by the PTSD specialty care clinic 
• 
A detailed description of the assessment procedures, including estimated time involved, the use of 
audiotaping (for assessment of reliability and treatment adherence), frequency of assessments 
• 
A description of alternative treatments within the facility, including medications and alternative 
psychotherapy 
• 
The expectation that additional psychotherapies not be participated in during the active phase of the CABA 
treatment [with specification that they will not be dropped from treatment if they do initiate additional 
treatment] 

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• 
Description of potential risks, discomfort, and inconveniences 
• 
The potential for loss of privacy and a description of efforts to protect confidentiality and privacy 
• 
Specific circumstances that may require loss of privacy (e.g., acknowledgement of suicidal intent) 
• 
The ability to decline participation or withdraw from the study at any time without jeopardizing treatment at 
the VA 
• 
Specification of payment for participation 
• 
Contact information for study personnel for questions 
 
Informed Consent Process via Telephone and Postal Mail 
A study staff member will arrange a time to conduct the informed consent process via telephone or video-
based telehealth platform such as VA Video Connect (VVC). Participants will have received a self-
addressed, stamped envelope along with two copies of the approved consent form and a cover letter. The 
cover letter will specify that research staff will call them to review the consent document, and that although 
Veterans are encouraged to review the forms in advance, they should not complete the forms until they 
have reviewed the forms with research staff at the scheduled informed consent session.  
 
 
5.4 Inclusion/Exclusion Criteria 
 
Inclusion criteria: 
 
1) Veterans ≤ 55 years of age enrolled at participating VA sites able to provide informed consent. 
 
2) Diagnosis of PTSD based on the Clinician Administered PTSD Scale60. 
3) Positive screen on the Structured Interview for Collecting Head Trauma Event Characteristics 
as per the VA/DoD Clinical Practice Guideline for Management of Concussion/mTBI; AND 
endorsed any of the Neurobehavioral Symptom Inventory (NSI)61 cognitive symptoms items (items 
13-17). 
4) English speaking, able to travel to the primary care clinics weekly for 10 sessions and for the 
follow- up assessments, and willing to refrain from additional mental health treatment during the 
first 3 1/2 months of the active phase of treatment if they are assigned to the CABA condition. 
 
5) Willingness to participate in audio-recorded sessions. 
 
Exclusion criteria: In order to maximize the generalizability and public health relevance of the study, 
exclusion criteria are minimized and based primarily on the well-being of the participant. 
 
1) Current diagnosis of moderate or severe substance (alcohol) use disorder using DSM-5 within the 
past 30 days. 
 
2) Current Bipolar or psychotic disorder (requirement to refrain from additional treatments might 
be harmful). 
3) Veterans with a history indicated by medical record review of a diagnosis of moderate, severe, 

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or penetrating TBI, or self-reported history on the Structured Interview for Collecting Head 
Trauma Event Characteristics of TBI with PTA greater than 24 hours or LOC greater than 30 
minutes. 
4) Active suicidal intent indicating significant clinical risk, which would suggest that a treatment 
specifically targeting this intent was indicated clients who report suicidal ideation without 
imminent risk will be admitted into the study. 
 
5) Initiated psychotropic medication, including Prazosin, within 4 weeks or changed dosage within 
2 weeks prior to the first assessment, as this would make it difficult to determine which 
treatment contributed to change in the CABA condition; additionally, started or changed 
dosage of sleep medication or low dosages of tricyclic antidepressant or trazodone for pain 
or sleep within 1 week prior to the first assessment.  Participants could be re-considered for 
eligibility after stability on medication was achieved. Enrollees will be asked, but not prohibited, 
to hold the doses of the current medications stable over the course of enrollment (though 
changes in medications after enrollment will not exclude them from on-going participation). 
 
6) Auditory or visual impairments that would compromise ability to participate cognitive 
rehabilitation group or benefit from compensatory strategies. 
. 
5.5 Study Evaluations 
 
Visit schedules 
Pre-enrollment screening: 
1) Medical Record Review: Study personnel will review each participant’s medical record, including their 
neuropsychological assessment records, to document severity and type of current cognitive status, medical 
and psychiatric history, current treatment, and medications. 
2) Clinical Screening Phone Interview: Study personnel will conduct a brief phone screening to ensure subjects 
meet initial eligibility criteria. Participants interested in the study will be asked to provide an email address for 
scheduling video telehealth appointments. 
 
Study Enrollment: All eligible participants will complete a consent visit including: 
Informed Consent: Study personnel will complete consent procedures. All effort will be made to ensure 
participants fully comprehend study procedures, risks, and benefits. 
 
Baseline Assessment: All eligible participants will complete a baseline assessment visit including: 
    Baseline Psychological and Cognitive Assessment Battery (see below). This includes assessment of  
exclusionary diagnoses as well a brief neuropsychological battery, diagnostic interviews, and self-report 
questionnaires of current emotional and post-concussive symptoms. If an individual is found not be eligible during 
this assessment, the assessment will be discontinued at that point.  
 
Treatment Visits: All eligible patients will be randomized (CABA or TAU). CABA participants will be assigned 
to a therapist and receive the 10-session intervention (during COVID-19 this will be completed using telehealth 
modalities); TAU participants will be referred to PTSD specialty care.  
 

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Mid-treatment Assessment: Participants will complete questionnaires at mid-treatment (approximately 7 
weeks after initiation of treatment) designed to assess current emotional and post-concussive symptoms.  
 
Post-treatment Assessment: Participants will complete a brief cognitive assessment battery, diagnostic 
interviews, and questionnaires designed to assess current emotional and post-concussive symptoms (see 
section B “Data Collection and Assessment” below for a list and description of each battery measure). This 
will take place approximately 14 weeks after the initiation of treatment.  
 
See Table 3 in section B “Data Collection and Assessment” below for a schedule of administration for each 
measure. Participants will be sent a response key via postal mail (see documents Survey Response Key 
and Response Key Cover Letter). Staff will read the questions to participants, who will respond to each item 
with the aid of the response key. If the response key is lost, a new one may be sent to them.  
 
Telephone Reminder Calls (Visits 1-14): The site coordinator or designated study staff member will contact 
participants by phone to remind them of the initial visit, mid-treatment assessment, and post-treatment 
assessment. CABA therapists may contact participants 1-2 days prior to treatment session to remind them of 
upcoming appointment; participants who are using VA Video Connect for the CABA sessions may also 
receive automated reminders of the appointment via email. Participants assigned to TAU will get standard VA 
reminder calls. 
 
Visits 2-6 and 8-12: During visits 2-6 and 8-12, subjects will attend weekly 90-minute individual sessions of 
the CABA intervention via telehealth and TAU (at a minimum, the opportunity to attend 10 90-minute 
individual sessions). 
 
Documentation in CPRS: A Research Screening/Enrollment/Disenrollment note will be entered into 
CPRS for all Veterans who consented into the study. An additional note documenting informed consent, 
completion of intake procedures, eligibility determination, and next steps will also be entered into CPRS 
following the baseline/intake visit. Disenrollment notes will be entered into CPRS at the completion of each 
Veteran’s participation in the study. Veteran assigned to the CABA condition will have session appointments 
entered into a research clinic and the study therapist will enter a note into CPRS summarizing the session 
content for each CABA treatment session.  
 
Compliance: Attendance will be recorded. Financial compensation and reminder calls will be used. 
 
Standardization of intervention delivery and testing between sites 
Therapists for CABA will be PhD-level psychologists or Master's level or greater mental health practitioners. 
Two therapists (one from each site) are experts in BA (Amy Wagner, PhD and Matthew Jakupcak, PhD). 
Several therapists from the Portland VA and VA Puget Sound were involved in writing the CCT and CABA 
manuals and have experience conducting these interventions. Remaining therapists will have competence in 
cognitive-behavioral approaches to PTSD and/or cognitive training. All therapists will be required to complete 
an initial training which will involve reading the treatment manual, research protocol, and treatment related 
materials, reviewing therapy tapes, and, when possible, attending a half-day training with Drs. Wagner, 
Jakupcak, or Storzbach. If therapists have significant experience/expertise in behavioral activation and/or cognitive 

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rehabilitation, the half day training requirement may be waived at the discretion of the study PIs. Dr. Wagner will 
review the session recordings of the first patient for each new therapist to ensure adherence to the treatment 
protocol and to provide clinical feedback when needed. Therapists are invited to participated in biweekly study 
phone calls to discuss clinical concerns, with more immediate consultation/supervision available with study PIs 
on an as needed basis.  
 
To assure treatment fidelity, audio recordings of sessions will be used to rate therapists on CABA treatment 
manual compliance. Sessions from both participating VA study sites will be digitally audio-recorded, and 20% 
of sessions will be randomly selected by Dr. Golshan, the study statistician, throughout the course of the 
proposed study for quality adherence and fidelity ratings. A member of the study team from the main study site 
(Portland VA), who will be selected and trained by the co-PIs, will serve as the adherence and fidelity rater. 
This rater will not be involved in delivering the treatment intervention and will be trained in adherence/fidelity 
coding. The rater and the Principal Investigator (Storzbach) will individually rate several practice tapes and any 
discrepancies in the practice coding will be discussed and reconciled. An adherence and fidelity instrument will 
be developed for use with the CABA manual (see Appendix 3 for the CCT fidelity instrument). Only when 
reliability has been demonstrated at 90% agreement will the rater begin independently coding treatment tapes 
from the proposed study. Adherence rate will be calculated as percentage of goals achieved by Dr. Golshan. 
Audio recordings will be examined on a monthly basis. The co-PIs will meet with the therapists and other 
study team members on a monthly basis to discuss any discrepancies, to review any adherence/fidelity rates 
below 80%, and to develop a plan for ensuring that all session goals are met. If adherence and fidelity 
monitoring reveals that any treatment goals have not been addressed, then the therapist will be retrained on 
the corresponding material to properly address those inefficiencies. The therapist will be recertified prior to 
returning to study. If it is not possible to provide the missing information (for example, because the treatment 
has ended), then those subjects will be excluded from the project’s dataset and statistical analyses. 
 
Project monitoring and oversight 
Routine communication and coordination between the study sites will primarily occur through joint 
teleconferenced team meetings. These meetings will be scheduled bi-weekly the first 6 months of the study 
and monthly the latter part of the first year, and then quarterly during years two and three. Additional meetings 
may occur on an as-needed basis. Some funding will be budgeted toward travel for site visits. 
 
Data Collection and Instruments 
 
1) Demographics and disorder/disease-related assessments. At the assessment visit, demographic 
information including age, gender, ethnicity, and education will be collected. We will document severity and 
type of current cognitive status, PTSD symptom severity, medical and psychiatric history, current treatment, 
and medications. We will also collect information about any new medication changes and/or changes in 
additional mental health treatment at the initial and follow-up treatment visits in an effort to track any changes 
in the initial eligibility criteria. 
2) Measures. The RR&D TBI RFA requires use of National Institute of Neurological Disorders and 
Stroke (NINDS) core Common Data Elements (CDEs) for TBI. All current (version 1) core CDE measures 
are included except the Cognition Subscale of the Functional Independence Measure (Cog-FIM) as the 
NINDS CDE website indicates that this measure is “Not sufficiently sensitive for mild TBI.” Assessment 
measures are not limited to TBI CDEs because of the need for measures of symptoms/functional effects of 

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PTSD or mTBI/PTSD.  
Select measures of the full testing battery will be used for telehealth administration. See below for more 
details: 
• 
Clinician Administered PTSD Scale (CAPS-V)60,66. A widely used diagnostic interview, provides 
an overall severity score and subscale scores for symptom clusters. 
• 
Posttraumatic Stress Disorder Checklist-Fifth Version (PCL-5)57,67. A widely used self-report measure 
of PTSD symptom severity. 
Global Outcome 
• 
Glasgow Outcome Scale Extended (GOS-E)96 A revision of the GOS, a commonly used global 
outcome measure in TBI studies; a core NINDS CDE. This test will not be administered during 
telehealth visits.   
Cognitive and TBI Symptom Severity 
• 
Rivermead Post Concussive Symptom Questionnaire (RPQ)95 will be used to measure 
postconcussive symptoms (PCS); a core NINDS CDE. This test will not be administered during 
telehealth visits.  
• 
Structured Interview for Collecting Head Trauma Event Characteristics (DoD HTEC) 62, head 
trauma history and to assess eligibility. 
• 
The Neurobehavioral Symptom Inventory (NSI)61 a PCS measure mandated for use in the VA, and 
is a NINDS TBI supplemental CDE recommended for use in Military studies. 
Cognitive Compensation 
• 
Memory Compensation Questionnaire (MCQ)70. Rates the extent to which patients use 
various strategies to improve memory performance. This test will not be administered during 
telehealth visits.  
Cognitive Functioning (all tests were selected because of their excellent validity and reliability, and the 
availability of large normative databases) 
• 
The Wide Range Achievement Test-4 (WRAT-4)71 Baseline ability, a NINDS supplemental TBI CDE. 
• 
Hopkins Verbal Memory Test–Revised (HVLT-R)72 A measure of verbal list learning and delayed recall. 
• 
Wechsler Adult Intelligence Scale–4th Edition, Digit Span Subtest (WAIS-IV)73 A WAIS-IV subtest 
that measures attention and working memory, and is a NINDS supplemental TBI CDE. 
• 
Wechsler Adult Intelligence Scale–3rd Edition, Symbol Search Subtest (WAIS-III)74 WAIS-III 
subtest measuring processing speed; component of WAIS PSI, a core NINDS TBI CDE. This 
test will not be administered during telehealth visits.  
• 
Trail Making Test (TMT)75 DKEFS- trails subtest is a visual-motor task used to measure flexibility 
in thinking (executive function) and processing speed, a core NINDS TBI CDE. This test will not 
be administered during telehealth visits.  
• 
Controlled Oral Word Association Test (COWAT)76 Verbal fluency, a supplemental NINDS TBI 
CDE.  
Depression: 
• 
Beck Depression Inventory-II (BDI-II)67 A widely used 21-item measure of current levels of 
depression.  
Psychiatric Disorders: 
• 
Mini-international Neuropsychiatric Interview – Depression, Substance Use Disorders, Manic Episode, 
Hypomanic Episode, and Psychotic Disorders subtests (MINI)77 Brief structured interview for the major 
Axis I psychiatric [DSM-V version will be substituted if available at the time of funding]. 

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• 
Brief Symptom Inventory 18 (BSI 18)78 Psychological symptom complaints; a core NINDS 
CDE. This test will not be administered during telehealth visits.  
Cognitive Related Functional Impairment: 
• Neuro-QOL79. Health-related quality of life assessment tool; a NINDS supplemental 
TBI CDE.  This test will not be administered during telehealth visits.   
Social Role Participation: 
• 
Craig Handicap Assessment Reporting Technique - Short Form (CHART-SF)80 Consisting of 6 
subscales; a NINDS core TBI CDE. This test will not be administered during telehealth visits.  
General Functioning: 
• Sheehan Disability Scale (ShDS)81. A brief self-report measure of functional 
impairment. This test will not be administered during telehealth visits.   
Quality of Life: 
• 
Satisfaction with Life Scale (SLS)69 A 5-item measure assessing global life satisfaction or quality of life. 
Participant Satisfaction: 
• 
The Client Satisfaction Questionnaire (CSQ-8)82 A questionnaire used routinely in the Seattle Post 
Deployment Health Services and PTSD Clinic to assess satisfaction with care. 
Other Measures: 
• 
Severity of Dependence Scale (SDS)83A 5-item measure assessing severity of substance dependence. 
This test will not be administered during telehealth visits.  
• 
Scale for Suicide Ideation (SSI)97, a 21-item interviewer-administered rating scale that measures the 
frequency and severity of suicidal ideation. This test will not be administered during telehealth visits.  
• 
Functional Outcomes of Sleep Questionnaire (FOSQ-10)98 A 10-item measure of sleep function. 
• 
Insomnia Severity Index (ISI)99 A 7-item measure of insomnia severity. This test will not be administered 
during telehealth visits.  
 
Scheduling of Assessment Measures: Assessment measures are administered at times indicated in Table 3. 
Table 3: Visit and Assessment Schedule (updated for telehealth visits) 
 
Visit 1,Wk. 0 
Visits 2-6 
Visit 7,Wk. 7 
Visits 8-12 
Visit 13,Wk. 14 
Duration 
180 mins 
90 mins 
60 mins 
90 mins 
180 mins 
Purpose 
screen + 
baseline 
intervention 
mid- 
assessment 
intervention 
post- 
assessment 
Informed Consent 
x 
Demographic 
x 
CAPS-V 
x 
x 
PCL-5 
x 
x 
x 
DoD HTEC 
x 
NSI 
x 
x 
x 
BDI-II 
x 
x 
x 
MINI – M,H,&P 
x 
MINI – MDD & 
SUD 
x 
SLS 
x 
x 
x 
CSQ 
x 
NP Battery 
x 
x 

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5.6 Data Analysis 
Statistical Analysis of Data 
 
Data integrity. Data will be collected at both participating sites: Portland VA and VA Puget Sound. The co-PIs 
and multi-site project coordinator will be located at the Portland VA. Trained study personnel will conduct the 
structured clinical screening interview. Similarly, a paper questionnaire will be used to guide the medical record 
review to ensure that the same historical information is gathered and coded for all subjects. The self-report 
questionnaires/surveys and psychological and cognitive assessment battery consists of standardized protocols 
with specific/scripted questions and scoring systems that quantify answers. All study personnel from all study 
sites who will be gathering data from these sources will be trained by the co-PIs regarding the collection of  
data and will have professional education and training as required for these instruments. 
Data will be labeled with a code unique to each patient. All hard copy data will be stored in locked filing 
cabinets in locked rooms, while electronic data will be stored in password-protected files in a limited access 
folder on the secure VA network drive. Each study site will maintain a key code that links that site’s patients 
with their coded identifier with key code stored separately from all other study data. Only the multisite and site 
PI’s and the multisite and site study coordinators and research assistants will have access to the key code 
linking document. Materials with protected health information will be stored in separate locked file cabinets 
from coded materials to ensure privacy. Special multilevel data security programs have been written into the 
network operating system to ensure that only authorized research personnel have access to the Center 
Network. Backups of daily changes are done regularly and all other data are backed up on a rotating 
schedule. An electronic archive of all data is kept offsite to insure against loss by fire, theft, etc. All statistical 
transfer routines are inherently secure via operating platform and contain no patient names or personal data. 
A database will be developed using Microsoft Access or Excel by the multi-site study team located at the 
Portland VA, and adapted from the current Merit study. The database will be tested and the final version will 
be distributed to participating study sites by the Portland VA data manager. Two study support persons 
located at each site will enter data from the hard copy forms into the database to ensure accuracy of data 
entry. All data entry discrepancies will be solved by the site study coordinator. Hard copy source documents 
will be kept and stored at the VA site location (Portland or VA Puget Sound) at which they were gathered; data 
collected at the American Lake Division will be transported securely to the Seattle Division for storage. For 
adherence monitoring, digital audio-recordings of sessions will be kept in limited access drive on the VA 
network. The recording will be coded, password- protected and encrypted. Following completion of the 
planned analyses, the statistician’s files will be sent back to the VA site to be stored with all other data and 
subject to all IRB-approved storage and deletion procedures. The statistician will be able to retain a data 
dictionary and all associated syntax and output files, provided that these files do not contain any identifiable 
data. Throughout the entire course of the study, the off-site statistician will only ever have access to coded 
data. Additionally, the off-site statistician holds a VA appointment with the San Diego VA and will only 
analyze and maintain databases from within the VA network. 
DATA ENTRY FLOW: The following sequence of events will be followed: 1) Assessment forms completed by 
clinical rater; 2) Forms reviewed by rater and data manager for completeness; 3) Assessment forms entered 
into database; 4) Data entry procedures verify key items, out of range and unacceptable values; 5) Data 

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added to database; 6) Programs run to check for missing data and for logic errors; 7) Data reviewed by 
investigators, clinical staff, and key data management personnel at regular protocol review meeting for final 
validity. 
 
DATA SAFETY MONITORING: Safety monitoring analyses will occur every six months from study inception 
through completion. The unblinded data manager will provide the blinded study statistician with a limited data 
set containing blinded group membership data, i.e., group membership that is numerically labeled but 
unidentifiable as treatment vs. control group. This dataset will also contain in-progress data safety variables 
including CAPS scores and any serious adverse events including 1) the onset of imminent risk of harm to self 
or others such as active thoughts of suicide or violence with expressed plan and intent to act; 2) the onset of 
psychotic and or manic symptoms; 3) a decline in global daily functioning indicating that inpatient mental 
health services are required for stabilization; 4) the onset or exacerbation of major medical illness that 
interferes with participation in regular outpatient mental health services. Differences between the treatment 
and control  groups will be analyzed using t-test comparisons.. We will consult with the CIRB and consider 
the appropriateness of study suspension if, at the set data monitoring time periods every six months, we find 
that either group of participants is experiencing, on average, an increase in CAPS scores of 12 or more points 
and/or is experiencing, on average significantly more SAE’s including those defined above. For serious  
adverse events, significance is defined as a statistically significant difference of p < .01 and/or a large effect 
size equivalent to a Cohen’s d value of .8 or greater. The two study PIs will be responsible for notifying and 
consulting the CIRB of any conditions meeting criteria for possible study suspension within one business day  
of discovery. 
Randomization procedures as well as overall multisite study interim, data safety monitoring and final data 
analyses will be conducted by our contracted statistician, Shah Golshan, Ph.D who is affiliated with University 
of California, San Diego. Dr. Golshan will receive a limited data set copied in encrypted format onto CD’s 
sent via secure FedEx with tracking services. This data set will be considered a limited data set due to 
inclusion of patient assessment dates and otherwise is de-identified. A Data Use Agreement will be pursued 
between the VAPORHCS and Dr. Golshan recognizing the agreement of the terms for use of this data which 
shall be transmitted and accessed strictly for data analysis purposes pursuant to the goals of this study. 
 
Sample size and power. Power analyses are performed for primary hypotheses 1a, 1b and 2a, 
incorporating the longitudinal nature of the design. We propose a Random Regression model (also known as 
Multilevel or Growth Curve Models) as a basis of the analysis. In this approach, the repeated measures over 
time for each individual subject form a trajectory that can be described by a relatively simple model with a 
few parameters, here a linear model described by intercept (baseline value) and slope (rate of change). With 
random assignment to groups, there should be no group differences in baseline values, and slopes 
differences reflect treatment effects. With repeated measures, repeated observations within subjects are 
potentially correlated, impacting tests of significance84. When within subject correlation is properly 
incorporated, the repeated measures analysis takes full advantage of all information obtained from each 
subject, thereby greatly increasing statistical power over cross-sectional methods85.This approach can model 
differential patterns over repeated assessments instead of totals at one point and therefore increases the 
reliability of the measurement of response (since the slope combines repeated measures which cancel much 
of the error of measurement), and increases the protection against the major effects of missing data (since 
one can impute from the non- missing data for that subject as well as for other similar subjects). These result 
in increased power to detect effects and precision of effect size estimation without increased sample size. 

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Power calculations can be made for repeated measures designs under specified assumptions86. Hedeker 
et al86 extend Diggle et al.’s87 method for various covariance structures. Procedures described by Hedeker et 
al86 for Random Regression Models were used for the proposed study to estimate needed sample size using 
RMASS (see Hedeker http://tigger.uic.edu/~hedeker/ml.html). Data from our previous studies were used to 
calculate effect sizes. The design consists of a 2 (sites) X 2 (CABA vs TAU) X 4 (baseline, 7, and 14 weeks) 
where the slope is the dependent measure. Site and Treatment by Site interaction were included as 
"nuisance parameters", that is, included to account for possible overall site effects (Site) or possible site 
differences in treatment effects (Treatments X Site). With a balanced design (equal numbers at each site in 
each group), ignoring these would not increase the probability of Type I error, but would increase the Error 
Sum of Squares (SS) and probability of Type II error. The main effect of treatment represents the common 
effect size across sites if there is one, or the average site effect, if there is heterogeneity across sites. This is 
true because sample sizes will be balanced across treatment groups and sites. In any case, the analysis 
procedures will include site and site interaction effects to avoid allowing site effects to bias treatment 
comparisons. However, if we detect imbalances between the treatment groups within each site, we will 
follow the primary analyses with subsequent analyses considering the imbalances to verify that conclusions 
are not affected by imbalances. 
Other assumptions needed are number of repeated measures, alpha-level, nature of the hypothesis (one- or 
two-sided), drop-out rate, and variance-covariance matrix of the longitudinal data. We assume an overall Type- 
I error levels alpha of .01 to .02, drop-out rate of 15%, and autoregressive covariance structure, with 
correlation between sequential assessments set at 0.45. Autoregressive covariance structures assume points 
closer together in time are more correlated than points further in time, which is more plausible compared to the 
equal correlation between all pair of assessments regardless of time separation assumed by the compound 
symmetry design. When multiple analyses are conducted for a given hypothesis, Type I error rates will be 
controlled 
by a Westfall-Young procedure, we would include an alpha level of .04 for Hypothesis 1a, .03 for 
Hypothesis 1b and 2a, and .05 for Hypothesis 2b. We estimate that with the proposed sample size of 192 
(15% drop-out) patients (96 for each of the two groups), the study will have minimum power of 80% to yield a 
statistically significant result for a medium effect size. Hedker et al.86 defined medium effect size in this model  
as a between-group difference increasing linearly from 0 at baseline to .5 SD units at the last time point. 
Hypothesis 2b is a cross-sectional hypothesis using data collected only in the week 14 of the study. The 
proposed sample size will provided us with a minimum power of 90% to detect a medium to large effect size. 
The former and foundational Behavioral Activation for PTSD study by Wagner and Jakupcak yielded the 
following rates which also informed our proposed sample size determination: 192 screened, 81 enrolled, 10 
dropped (12.3% dropout rate), 101 screen failures. 
 
Outcome analyses: Data analyses will proceed in stages. Descriptive statistics and exploratory graphing 
such as frequencies, means, standard deviations, stem and leaf diagrams, and scatterplots will be used to 
assess normality of data in terms of presence of skew and/or outliers. Continuous outcome data will be 
transformed if necessary using an appropriate transformation such as the log transform for skewed long 
tailed data. Prior experience with this kind of data leads us to expect that for all variables, the distributions 
will be skewed and the variances not homogeneous. Similarly, potential covariates will be summarized with 
descriptive statistics and graphs to determine the most appropriate way to treat these variables (e.g., 
continuous, categorical, or interval representation). For outcome measures acquired at baseline, 7, and 14 
weeks, the analytical approach will address the nature of the outcome, as well as accommodate the within 

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individual variability due to the repeated assessments. Results from will be inspected for bias due to drop-
outs or missing data. 
For major analyses of central hypotheses (1a-1b and 2a), we propose to use Mixed Effects modeling to 
account for clustered data (i.e., repeated assessments within individuals, treatment groups, and sites). The 
mixed effects approach provides more information and more power compared to cross-sectional analyses 
which focus on analysis of one summary index or time-until event methods and traditional analytic approaches 
such as a change score, end-point or repeated measures analysis of variance (ANOVA). This method allows 
inclusion of subjects with missing data or those who were terminated early in the study, without relying on 
data imputation procedures. Two specific forms of the Mixed effects model strategy are commonly 
implemented: random regression models, or hierarchical models (HLM) or multilevel models; and mixed 
model analysis of variance (MMANOVA). Each outcome variable will be graphed versus time for each 
subject to evaluate what function of time best describes the data. The mixed effects framework is robust with 
respect to drop-out and missing data, unless the drop-out mechanism or cause of missing is informative. We 
will use pattern-mixture models to assess if there is bias due to drop out or missing data. As described by 
Hedeker and Gibbons88, these mixed models allow us to assess whether important estimates are dependent 
on missing data patterns and provide overall estimates of effects by averaging over the various missing-data 
patterns. In addition, we will consider the extension of the Pattern-Mixture models as described by Guo et 
al89 which includes the incorporation of random effects in the Pattern mixture model, allowing subject-to-
subject heterogeneity. 
Missing data values will be minimized by intensive training of interviewers in techniques of clarifying 
answers and checking questionnaires while participants are on-site. When missing values are identified, we 
will employ several approaches. If possible, participants will be rescheduled for missed assessments. Missing 
data will be examined to assess randomness. The pattern of missing data will be examined according to the 
procedure recommended by Little and Rubin90 which includes comparing group differences in the primary 
outcomes of subjects with versus without missing data. The Mixed effects model allows inclusion of subjects 
with missing data or those who terminated the study early, without relying on data imputation procedures. 
 
Hypothesis 1a) PTSD symptom severity. Dependent variables: CAPS-V and PCL-5. 
 
Hypothesis 1b) Functional impairment. Dependent variables: HVLT-R, WAIS-IV (Digit Span subtest), 
DKEFS (Trails subtest), and COWAT (Verbal Fluency). 
Independent variables: Treatment group (2 levels, CABA and TAU), & Time (3 levels, Weeks 0, 7, and 
14). Statistical Analysis: We will analyze data on all randomized subjects in whom we have a baseline 
assessment and at least one post-baseline evaluation by Mixed effects model methods84, 91. Preliminary 
inspection of data will determine whether the outcome is nearly normal, or whether an appropriate 
transformation is required, or whether a generalized linear mixed model should be considered. The 
mixed effects model method provides an estimate of the individual variability around the population trend, 
the variability of the individual intercepts (baseline values) and slopes (changes across time), and the 
correlation between them. A fully saturated treatment by time model will be utilized for inference. Co-
variance structure will be chosen based on Akaikes Information Criterion (AIC). Random group level 
treatment effects will also be evaluated for importance based on the model AIC. This allows for any 
group level effects to be incorporated into the model. Denominator degrees of freedom will be calculated 
using the Kenward-Roger small sample correction. The design is a 2 (sites) X 2 (CABA vs TAU) X 3 
(baseline, 7, and 14 weeks). The interaction of Site and Treatment X Site will be included and tested as 

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"nuisance parameters". However, we do not anticipate any Treatment by Site or Site effects with the 
balanced design (equal numbers at each site in each group), our standard training procedure of both sites 
and standard operating procedure used by both sites. In any case, the analysis procedures will include 
site and site interaction effects to avoid allowing site effects to bias treatment comparisons. If we detect 
any imbalances between the treatment groups within each site, we will follow the primary analyses above 
with subsequent analyses considering the imbalances to verify that the conclusions are not affected by 
imbalances. Analyses will be conducted within and across nested levels of the study design; this will 
involve within-subject analyses (comparison of occasions of measurement nested within an individual), 
as well as between-subject analyses (comparison of the CABA and TAU groups, comparison of groups 
within a site, comparison of sites, etc). Any treatment group comparison can be adjusted for subject-
specific characteristics and adjustments for changes in these characteristics over the course of the study 
can be incorporated into single-subject analyses. All comparisons described in this section can be 
effectively analyzed using PROC MIXED in SAS statistical software. Based on our ongoing studies, we 
expect a drop-out rate of <15% after baseline assessment but prior to first post-baseline evaluation. The 
drop-out rate is taken into account in power analyses, see above. 
 
Hypothesis 2a) Patient-centered outcomes. Dependent variables: BDI-II, NSI, and SLS. Independent 
variables: Treatment group (2 levels, CABA and TAU), and Time (3 levels, Weeks 0,7,14). Statistical 
Analysis: Data will be analyzed similar to hypotheses 1a and 1b. 
 
Hypothesis 2b) Treatment satisfaction. Dependent variables: CSQ. Independent variables: Treatment 
group (2 levels, CABA and TAU). Statistical Analysis: Hypothesis 2b will be tested using Analysis of 
Variance, comparing the two groups on the treatment credibility and satisfaction (CSQ). 
 
Exploratory Investigation to Provide Guidance for Future Research Directions: 
Guidance for future research will be obtained through exploratory analyses including possible mediator and 
moderator variables in addition to secondary outcome variables, including measures of 
neuropsychological test performance and general functioning. We will also investigate whether CABA-
associated treatment gains are maintained over a 6 month follow-up period. The effect of moderator and 
mediator variables will be explored following the procedures recommended by Kraemer92, Cohen and 
Cohen93 and Busemeyer and Jones94. 
 
Anticipated time table: Table 4 depicts a four-year study plan with 6 months for start-up and 6 months 
termination; 156 weeks for enrollment and 6 month follow up assessments. The study will be fully 
enrolled within 39 months of the start of funding of the trial. The last group of subjects will exit by month 
42. 
 
Table 4. Anticipated Time Table 
Year One 
Year Two 
Year Three 
Year Four 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 

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Start-Up Phase: 
Establish infrastructure; staff 
hiring & training; IRB approval; 
complete manual; fidelity 
monitoring implementation; & set 
up data management systems. 
Data Acquisition: 
CABA: assessments + CABA; 
TAU: assessments; Tx fidelity 
Analysis and Dissemination: 
Data analysis; manuscript; manual 
dissemination 
 
Dissemination plan: We will present preliminary and final results at relevant national conferences. Our 
co- investigators are well-versed in conducting large-scale cyber-seminars for VA and DoD audiences. 
Drs. 
Storzbach and O’Neil have worked with the VA’s Center for Information Dissemination and Education 
Resources and Quality Enhancement Research Initiative to conduct multiple cyber-seminars for large, 
national audiences of over 500 participants at low- to no-cost, and plan do conduct such seminars on 
the findings from this trial. Multiple VA and DoD research reports and academic articles are planned for 
dissemination of findings. A website will be established and the treatment manual will be made 
available online. This trial would provide critical data on feasibility of providing PTSD treatment to 
Veterans with mTBI, which is a key issue for the VA and DoD. We expect to disseminate findings in 
multiple research reports throughout the course of the trial as well as at least 4 peer reviewed academic 
journal articles following trial completion. 
 
5.7 Withdrawalof Subjects 
Should any findings arise during assessment study visits which might affect the participant’s health or 
welfare, the study team will address those findings directly with participants during the assessment 
study visit within which the issues are discovered. The study team will use CPRS to identify the 
participant’s health care providers as well as communicate the findings with those providers and follow-
up via telephone as needed. 
 
The co-PIs will recommend termination of participation, provide appropriate referrals, and engage in 
follow-up  if substantial decline in functioning is observed at any assessment study visit for all 
participants and/or treatment visits for those assigned to the CABA treatment intervention. Participation 
in this study therefore, will be terminated at the discretion of study personnel (with final determination by 
co-PI’s), based upon clinical observations and judgments regarding the safety of continued participation 
to the patient’s physical and/or psychological health and well-being. Additionally, if participants fail to 
comply with important instructions that are part of the approved study protocol, such as actively abusing 
substances, participation will be terminated without consent. 
 
Although the proposed study poses no serious risks to participants, participants may notify research 
personnel about pre-existing mental health issues that have not been previously identified by other VA 
providers. Therefore, participants will be referred to the VA’s Mental Health Division for further 

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assessment and/or treatment if a previously undiagnosed psychiatric disorder is identified. We will 
inform participants of this procedure as part of the informed consent process and participants must 
agree to this procedure to be eligible to participate in the study. This ensures that we can adequately 
manage any pre-existing clinical issues that become apparent through subject evaluation. 
 
If a participant chooses to withdraw from the study, study personnel or Drs. Dan Storzbach or Amy Wagner 
will refer the patient back to their providers in Primary Care for further assessment of treatment needs. 
The reason for withdraw will be documented. Participants who choose to withdraw early will still be 
allowed to continue participation in follow-up assessments and would continue to receive financial 
reimbursement for doing so, but this would be completely voluntary. A possible consequence of a 
participant choosing to withdraw early from the study is that he/she will likely continue to experience 
cognitive and/or PTSD symptoms. Without treatment, these symptoms may worsen over time. 
 
 
6.0 
Reporting 
 
All SAE’s, UAP’s, and protocol deviations occurring at either site will be communicated to the Co-PI’s 
immediately and necessary documentation will be submitted to the CIRB within stipulated timeframes and via 
designated channels in accordance with the VA Central IRB Table of Reporting Requirements. 
 
 
7.0 
Privacy and Confidentiality 
 
This study will involve the use and collection of Protected Health Information (PHI). Multiple steps will be taken 
in the current investigation to protect the privacy and confidentiality of research participants. All study 
personnel will have current training in GCP procedures for the proper use, collection, and disclosure of PHI for 
research purposes. Study personnel will no longer have access to study data upon termination of employment. 
Per VA protocol, in the event of improper use and/or disclosure, the local ISO and Privacy Officer will be 
notified within one hour. A code number will be assigned to each participant and his/her information. Only the 
multi-site co-PI’s, the local site PI’s, the multi-site project coordinator, and the site coordinator will be  
authorized to link the code number to the participant. A Master List will be retained by the study coordinator 
that will allow us to match each participant’s code with their information; however, this Master List will be an 
electronic database that is password protected, and Informed Consent Forms will be stored in a double-locked 
cabinet apart from participant information. We will keep participant information in a separate electronic 
database that is password protected. 
 
Participants who are assigned to the CABA condition will have their therapy sessions audio-recorded using a 
hand held digital audio recorder.  However, these digital audio files will be identified by a number assigned to 
the participant and will not be marked with the participant’s name or other identifying information. These 
audio- recordings will be listened to by a member of the research staff to determine if the interventions are 
conducted accurately ("adherence checks"). The audio files will be uploaded into a secure, password-
protected folder on the VA network. These files will not contain identifying information audio recordings of 
sessions will be removed directly from the audio recorders immediately following the session to encrypted, 

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password protected, limited access drives on the VA network. Audio recorders with session content will not 
leave the session room before transfer. 
Adequacy of Privacy Protection. We will take multiple steps to protect participants’ privacy and 
confidentiality. All data will be labeled with a code number that is unique to each patient in the study, and 
maintained in a Subject Data File. We will NOT include any protected health information (PHI) in the Subject 
Data Files. Instead, we will code each Subject Data File with a unique numerical code, which will consist of 
the VA station number + 3 digits consecutively numbered in order of enrollment (e.g., 648-001, 648-002, etc.). 
All hard copy subject data will be stored in locked filing cabinets in locked rooms, while all electronic data will 
be stored in password-protected files in a limited access folder on the secure VA network drive. Each study 
site will maintain a Master List key code that links that site’s subjects with their coded identifier. This key code 
will be stored separately from all other study data. Only the multi-site co-PI’s, the local site PI’s, the multi-site 
project coordinator, and the site coordinator will have access to the Master List key code, and only IRB- 
approved study personnel will have access to Subject Data Files or Informed Consent Forms. We will analyze 
and report subject data in aggregate form and no PHI will be entered into these analyses or reports. 
 
 
8.0 
Communication Plan 
 
Routine communication and coordination between the study sites will primarily occur through joint 
teleconferenced team meetings. These meetings will be scheduled bi-weekly the first 6 months of the study 
and monthly the latter part of the first year, and then quarterly during years two and three. Additional meetings 
may occur on an as-needed basis.  Local site approvals will be sought after confirmation of multi-site approval 
is received. As per VA protocol, local site facility directors will be notified of local site research via the standard 
mechanism of the required PPQ (proposed project questionnaire) paperwork for local R&D approval, 
concurrent with CIRB local site applications. 
 
We will utilize the CIRB sharepoint site designated for our study as well as email to coordinate local site 
submissions. Once Multi-site approvals have been acquired, local sites will be informed of changes to the 
protocol, informed consent, and HIPAA authorization via email. Templates with the necessary changes 
tracked will be emailed to local site coordinators and uploaded onto the CIRB sharepoint site for this study. 
 
All SAE’s, UAP’s, and protocol deviations occurring at either site will be communicated to the Co-PI’s 
immediately and necessary documentation will be submitted to the CIRB within stipulated timeframes and via 
designated channels in accordance with the VA Central IRB Table of Reporting Requirements. Any SAE’s, 
UAP’s, and/or protocol deviations which will affect local site operations will be communicated immediately to 
local site PI’s and coordinators via email followed up by telephone confirmation. Templates of forms with 
tracked changes regarding SAE/UAP/PD information will be emailed to site coordinators to be edited for local 
site submission whenever applicable. 
 
All local sites will be required to strictly adhere to the most recently IRB-approved protocol of this study. 
Thorough review of the protocol will be a mandatory component of training for all study personnel and 
we will maintain both electronic and hard copy records with tracking logs of each dated version of the 
protocol. All study staff will be directed to refer to the protocol when operational questions arise. 

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Given the nature of this multisite study, in that the Portland site is both the multi-site study 
headquarters and a local site with the same staff members in place for the duties of both, a plan for 
notifying all local facility directors of termination of engagement at the local site level is not necessary. 
The Portland and Seattle sites will continue to recruit participants and operate normally until recruitment 
goals are met and/or until the timeframes of the study necessitate termination. At that point, local sites 
will submit applicable termination paperwork to the local R&D committees and the CIRB and the 
Portland site will continue to remain open for data analysis at the multi-site level. 

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9.0 
References 
 
1. Terrio, H., et al (2009). Traumatic brain injury screening: Preliminary findings in a US Army Brigade combat 
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