Coalition to Alleviate PTSD: Randomized Clinical Trial of Cognitive-Behavior Therapy for Posttraumatic Headache
Phase: NA
Conditions: Post-traumatic Headache, PTSD
Sponsor: The University of Texas Health Science Center at San Antonio

 
 
 
 
 
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COVER PAGE 
 
Official Study Title: Coalition to Alleviate PTSD: Randomized Clinical Trial of 
Cognitive-Behavior Therapy for Posttraumatic Headache 
 
NCT number: NCT02419131 
 
IRB Approval Date: 04.09.2020 
 
 
Unique Protocol ID: HSC2014339H 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
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1. PROTOCOL TITLE: Randomized Clinical Trial of Cognitive-Behavior Therapy for Posttraumatic Headache 
 
2. ABSTRACT: The purpose of this randomized clinical trial of 192 military Veterans with posttraumatic 
headache (PTHA) and co-morbid symptoms of posttraumatic stress is to compare an 8-session manualized 
clinic-based cognitive behavioral therapy (CCBT) headache intervention delivered over 6 weeks, to a 12-
session manualized Cognitive Processing Therapy – Cognitive only (CPT-C) for PTS delivered over 6 weeks, 
to Treatment As Usual (TAU) in the relief of both PTHA and PTS symptoms following therapy and at 3- and 6-
months. 
 
3. OBJECTIVES/SPECIFIC AIMS/RESEARCH QUESTIONS: The overall purpose of the study is to compare 
two talk therapies (CCBT and CPT-C) for the treatment of posttraumatic headache (PTHA) and co-morbid 
posttraumatic stress (PTS). The researchers hope to learn if a non-medication, cognitive behavioral treatment 
can result in noticeable reductions in PTHA intensity/severity and frequency as well as PTS symptom severity. 
 
4. BACKGROUND AND SIGNIFICANCE 
Posttraumatic headache (PTHA) is a singularly unique and vexing by-product of traumatic brain injury (TBI) 
offering numerous challenges both to the individuals experiencing them as well as the medical providers tasked 
with treating this growing problem (Monteith et al., 2009). Although PTHA is not a new phenomenon (there are 
reports of posttraumatic headache dating back to the 1700s), very little is known about headaches with onset 
or exacerbation after TBI. 
 
One of the greatest problems facing posttraumatic headache research is inconsistency in how PTHAs are 
defined. The 
most widely recognized definition is listed in the International Classification of Headache 
Disorders (ICHD-II), assembled by the International Headache Society. The ICHD-III (beta) criteria classify 
PTHA as a secondary headache attributed to head and/or neck trauma. PTHA symptoms can present similarly 
to primary headache conditions like migraine or tension- type headache, but the onset or exacerbation of the 
headache symptoms must be secondary to trauma exposure. Acute versus chronic PTHA is identified based 
on the duration and persistence of the posttraumatic headache. Posttraumatic headaches that resolve within 
3 months, or are present in individuals with trauma exposure less than 3 months ago, are classified as acute. 
If posttraumatic headache persists beyond 3 months, then it is considered chronic. There is also widespread 
agreement that PTHA goes beyond de novo headaches, including marked worsening of premorbid headache 
symptoms attributable to a traumatic event. 
 
Despite the significant incidence of PTHA among individuals who suffer TBI, very little is known about its 
treatment. To date, there are no controlled studies of PTHA treatment, and the nesting of PTHA symptoms 
within postconcussion 
syndrome makes this population unresponsive to typical primary headache 
medications. Many PTHA sufferers attempt self-treatment through the use of acetaminophen, ibuprofen, and 
opiate/triptan medication (usually prescribed for other reasons). Unfortunately, these over-the-counter or self-
prescribed medications do not effectively address PTHA   symptoms and may result in headache worsening 
through medication overuse. Over one-third of PTHA patients are referred to Neurology, where they are 
typically prescribed anticonvulsants, tricyclics, or gabapentin. Patients with PTHA 
referred to Neurology 
usually present with more severe and persistent PTHA symptoms, and few benefit from Neurology intervention. 
Less than one-third of those referred to Neurology actually present for their first appointment, and 40% of those 
who attend a first appointment fail to return for subsequent appointments. As a result, there are few studies of 
medication treatment in PTHA, and many patients refuse medication interventions due to concerns about 
headache worsening with medication overuse, inability to complete follow-up due to mTBI and PTHA disability, 
dislike of medications 
and side effects, and general mistrust of the medical system. Based on significant 
concerns about medical treatments and poor response to medical interventions, it is strongly recommended 
that PTHA be addressed through a comprehensive multidisciplinary treatment program offering evidence-
based, non-medical interventions for headache management. 
 

 
 
 
 
 
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Psychiatric comorbidities are common in headache (Breslau et al., 2003), and comorbid psychopathology has 
been linked to alterations in headache evolution and treatment response (Antonaci et al., 2011). Ruff et al. 
(2012) estimate that more than 80% of Veterans diagnosed with mTBI and PTHA also have PTSD. Although 
comorbid headache and PTSD may alter the effectiveness of interventions, there is some evidence to suggest 
that addressing PTSD directly can ameliorate health symptoms like headache (Shipherd et al., 2013). There 
are no studies, however, examining the influence of PTSD comorbidity in posttraumatic headache in a military 
population, so the gaps in PTHA intervention extend beyond targeted non- medication interventions to PTSD 
treatments that address PTHA through alterations in PTSD symptom severity. In fact, an ongoing PTSD trial 
overseen by Dr. Patricia Resick, has revealed subjective reports of headache improvement among military 
service members who are successfully treated for PTSD. We have chosen to add a treatment arm to this study 
design in which participants with PTHA and comorbid PTSD or PTS symptoms will be treated with a gold-
standard, manualized PTSD intervention (Cognitive Processing Therapy; CPT-C). Both CPT-C and the 
manualized headache intervention rely upon cognitive behavioral mechanisms that overlap and may produce 
relief for both disorders. 
 
5. RESEARCH DESIGN 
Due to the lack of studies exploring behavioral interventions for PTHA, this research is designed as a 
randomized clinical trial comparing an 8-session manualized CBT intervention for headaches (CCBT) to the 
12 session Cognitive Processing Therapy – Cognitive Only (CPT-C) to Treatment as Usual (TAU) for patients 
with co-morbid symptoms of PTHA and posttraumatic stress following military deployment and combat trauma. 
The resulting data will significantly add to the extant research by gathering preliminary evidence supporting 
the efficacy of a manualized migraine headache intervention in 192 post 9/11 military Veteran and active duty 
Service Members with PTHA. Assessments will occur prior to treatment and 1-, 3-, and 6- months (following 
treatment completion). Blood will be collected prior to treatment, during two of the sessions of the 6- week 
treatment phase for all participants and at 1- and 6-months following treatment in collaboration with the CAP 
Genomics and Basic Science Core (Douglas E. Williamson, Ph.D. – PI) to examine gene expression profiles 
links with PTHA that may be predictive of treatment outcomes. Veterans randomized to the TAU group will 
have an option to be treated clinically with either CCBT or CPT-C after their 6-month follow-up assessment is 
complete. 
 
6. RESEARCH PLAN 
 
6.1 Selection of Subjects 
 
6.1.1. 
Subject Population. Potential participants will be recruited from the STVHCS Polytrauma 
Rehabilitation Center (PRC), military medical treatment facilities, 
and from the local community. 
Recruitment will target veterans and active duty personnel having returned from a post-9/11 deployment 
with chronic PTHA and symptoms of posttraumatic stress. 
 
6.1.2. 
Source of Research Material. Please find a description of these measures at the end of this 
protocol. Assessments will be administered in person whenever possible.  However, in order to 
accommodate participant schedules and/or instances in which a participant may have left the local area at 
the time of a follow up assessment, we may collect full or partial assessments in person or via phone or 
electronic data capture using a secure link to the encrypted STRONG STAR database.  Assessments 
completed via phone or remote electronic data capture will not include biospecimen collection.  
Reasonable efforts will be made to collect all data as described in this protocol, but we expect some 
participants may not be able to complete part or all of any given follow up assessment. 
 
 

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Assessments 
PC/RA or IE 
BL TX Post 3MFU 6MFU  DC 
Demographics and Military Questionnaire 
PC/RA 
x 
 
 
 
 
 
History of Head Injuries and History of Head Injuries Addendum 
PC/RA 
x 
 
x 
x 
x 
 
Deployment Risk and Resiliency Inventory_2_Deployment Environment (DRRI_2_D) 
PC/RA 
x 
 
 
 
 
 
Deployment Risk and Resiliency Inventory_2_Postbattle Experiences (DRRI_2_P) 
PC/RA 
x 
 
 
 
 
 
Deployment Risk and Resiliency Inventory_2_Combat Experiences (DRRI_2_C) 
PC/RA 
x 
 
 
 
 
 
Life Events Checklist-5 (LEC-5) 
PC/RA 
x 
 
x 
x 
x 
 
Patient Health Questionnaire-9 (PHQ-9) 
PC/RA 
x 
  x 
x 
x 
x 
 
Depressive Symptom Index –Suicide Subscale (DSI-SS) 
PC/RA 
x 
 
x 
x 
x 
 
Generalized Anxiety Disorder-7 (GAD-7) 
PC/RA 
x 
 
x 
x 
x 
 
Alcohol Use Disorders Identification Test –Self Report (AUDIT) 
PC/RA 
x 
 
 
 
 
 
Quick Drinking Screen (QDS) 
PC/RA 
x 
 
x 
x 
x 
 
Fagerstrom Test for Nicotine Dependence (FTND) 
Self-report 
x 
 
x 
x 
x 
 
Fagerstrom Test for Nicotine Dependence-Smokeless Tobacco (FTND-ST) 
Self-report 
x 
 
x 
x 
x 
 
Headache Management Self-efficacy Scale (HMSE) 
PC/RA 
x 
 
x 
x 
x 
 
Headache-Specific Locus of Control Scale (HSLC) 
PC/RA 
x 
 
x 
x 
x 
 
Headache Impact Test (HIT-6) 
PC/RA 
x 
 
x 
x 
x 
x 
Neurobehavioral Symptom Inventory (NSI) 
PC/RA 
x 
 
x 
x 
x 
 
Credibility and Expectancy Questionnaire (CEQ) 
PC/RA 
 
x 
x 
 
 
 
Pre-Treatment Health Interview (+ BL PTHA addendum) 
IE 
x 
 
 
 
 
 
Post-Treatment Health Interview (+ FU PTHA addendum) 
IE 
 
 
x 
x 
x 
 
Structured Diagnostic Interview for Headache –Revised (SDIH-R) 
IE 
x 
 
x 
x 
x 
 
Ohio State University TBI Identification Method-Interview Form (OSU TBI-ID- 
SF) 
IE 
x 
 
 
 
 
 
Selection of Index Event for the CAPS-5 
IE 
x 
 
 
 
 
 
Clinician Administered PTSD Scale-5 (CAPS-5) 
IE 
x 
 
x 
x 
x 
 
Self-Injurious Thoughts and Behaviors Interview –Short Form 
IE 
x 
 
x 
x 
x 
 
Tinnitus Functional Index 
IE 
x 
 
x 
x 
x 
 
PTSD Checklist List-5 (PCL-5) 
PC/RA 
x 
x 
x 
x 
x 
x 
Cognitive Emotions Regulations Questionnaire –Short (CERQ-Short) 
PC/RA 
x 
 
x 
x 
x 
 
Posttraumatic Cognitions Inventory (PTCI) 
PC/RA 
x 
 
x 
x 
x 
 
Response to Stressful Experiences Scale (RSES) 
PC/RA 
x 
 
 
 
 
 
Patient Health Questionnaire-15 (PHQ-15) 
PC/RA 
x 
 
x 
x 
x 
 
Veterans Rand 12 Item Health Survey (VR-12) 
PC/RA 
x 
 
x 
x 
x 
 
PROMIS Sexual Function 
PC/RA 
x 
 
x 
x 
x 
 
Brief-Inventory of Psychosocial Functioning (B-IPF) 
PC/RA 
x 
 
x 
x 
x 
 
Insomnia Severity Index (ISI) 
PC/RA 
x 
 
x 
x 
x 
 
PROMIS Sleep-Related Impairment and Disturbance 
PC/RA 
x 
 
x 
x 
x 
 

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Assessments (cont.) 
PC/RA or IE BL TX Post 3MFU 6MFU DC 
Snoring, Tired, Observed, Blood Pressure (STOP) 
PC/R
A
x  
 
 
 
 
Community Reintegration of Injured Service Members (CRIS) 
PC/R
A
x  
x 
x 
x 
 
NIH Cognition Battery (via computer) 
PC/R
A
x  
x 
x 
x 
 
PTHA Study Missing Data Assessment 
PC/R
A
 
 
 
 
 
x 
Online Forms: 
1.) Daily Headache Dairy 2.) Profile 
of Mood States 3.) Sleep 
Quality/Quantity 4.) Daily Stress 
Inventory 
Participant will complete online entries twice 
daily. Entries will occur before, during, and 
after treatment for a total of 14 weeks. 
 
          * DC = participant discontinued participation (i.e., drop out of treatment or follow-up) 
 
6.1.3. Inclusion and Exclusion Criteria. 
 
Inclusion Criteria: 
▪ 
adult (ages 18 and above) 
▪ 
U.S. military Veterans and active duty personnel with military service during a post-9/11 deployment 
▪ 
have sustained a traumatic head injury. 
▪ 
have been diagnosed or report symptoms consistent with chronic (> 3 months) posttraumatic headache 
attributed to a traumatic injury. We are focusing on chronic PTHA due to the very low likelihood of headache 
remission after 3 months, the disability associated with chronic PTHA, and the high prevalence of chronic 
versus acute PTHA in this population. A positive PTHA diagnosis will be indicated for individuals with de novo 
headache onset after a concussion or exacerbation of pre-existing headache symptoms (increased frequency, 
duration, or 
intensity), which is consistent with the existing ICHD-IV diagnostic criteria for PTHA. PTHA 
inclusion will be based on a consultation with one of our PRC/Polytrauma System of Care (PSC) co-
PIs/overall study PI if symptoms consistent with chronic PTHA are reported, but the diagnosis is not already 
documented in the participant’s medical record. 
▪ 
If taking headache medication, participant must agree to work with their prescriber to remain on stable doses 
of any prescribed headache medications for the duration of the intervention and through the follow-ups as 
much as possible and as medically indicated.. 
▪ 
Participants must also report on the Clinician Administered PTSD Scale (CAPS-5) an exposure to a traumatic 
event (Criterion A) and at least one intrusion symptom (Criterion B). There is some evidence suggesting 40% 
comorbidity between PTSD and new onset headache, so it is reasonable to assume that at least half of all 
PTHA participants recruited for this study will have PTHA and comorbid PTS symptoms. The inclusion of 
PTS symptoms in this sample is vital based on reports indicating that PTS symptoms and PTSD actually 
increase vulnerability to PTHA and chronic headache in military populations. 
 
Exclusion Criteria: 
▪ 
Participant has had a recent and significant change in the nature of headache symptoms over the last 6 weeks 
prior to screening (as determined by the investigators). 
▪ 
Participants currently in CPT or prolonged exposure for PTSD. 
▪ 
Participant has medication overuse headache as guided by the Structured Diagnostic Headache Interview- 
Revised (Brief Version; SDIH-R) and clinical judgment. 
▪ 
Participant is unable to read or speak English at a 6th grade level. 
▪ 
Participant has had a psychiatric hospitalization in the last 6 months.  
▪ 
Participant is pregnant or plans to become pregnant during the trial (due to concerns about pregnancy-induced 
headache that may obscure findings) 
▪ 
Participant has a present psychiatric problem that warrants immediate treatment as indicated in CPRS, flagged 
by an IE during evaluation, or confirmed by a clinician through screening or review of CPRS notes. 
▪ 
Participant demonstrates significant cognitive impairment that could impact treatment adherence/benefit. 
 
6.1.4. Description of the Recruitment and Prescreening Process. 
Initial contact will be made through various mechanisms. Under an IRB approved HIPAA Waiver, Drs. Jaramillo, 

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Eapen or study staff will check the VA Computerized Patient Record System (CPRS) appointment schedules and 
examine CPRS medical records of STVHCS patients with upcoming appointments to help identify candidates that 
may benefit and qualify for the study. In this case, a potentially “qualified” candidate is a PRC patient presenting with 
a primary diagnosis of headache with a history of diagnosis for TBI and/or persistent post-concussive symptoms (e.g., 
tinnitus, dizziness) as noted in their CPRS record. Dr. Jaramillo, Dr. Eapen, or study staff will contact the veteran’s 
provider for the pending visit to inform them that their patient may qualify for the study. Patients will be given 
information about the study from their medical provider, and interested patients will be consented by study staff who 
are housed in the PRC (the provider will notify the study staff of the potential participant). Providers will be informed 
about the study through In-Service presentations twice a month and will be given approved fliers describing the study 
and inclusion criteria. If study staff are unavailable to meet with potential participants at that time, interested patients 
will give permission for study staff to contact them by signing a consent to contact form. Providers in all the clinics 
will be briefed on study goals and the inclusion/exclusion criteria to help guide their referrals. 
 
Study Investigators will consult with military treatment providers who may see patients that could benefit from the 
treatment provided by the study, and the study team may accept direct referrals from these providers.  Individuals 
may also be referred by other STRONG STAR studies. Potential participants may also self-refer in response to 
recruitment information on the STRONG STAR website at www.strongstar.org. Interested persons can call or walk 
in to the STRONG STAR offices. STRONG STAR also recruits using various social media sites (e.g. Facebook, 
Twitter, LinkedIn, etc.) and web search engines (e.g. Google Ads, Bing, etc.).  In addition, there may be events 
where information about STRONG STAR studies is provided and those interested may fill out a “consent to 
contact” form indicating that they would like a member of the research team to contact them at a later date to learn 
more about the study and schedule or complete pre-screening.  Research staff will field incoming phone calls and 
walk-ins.   
 
Interested individuals may directly contact the study coordinator on their own accord in response to recruitment 
materials distributed at the PRC/PSC clinics and locations in the local community frequented by veterans and service 
members, including military facilities.   Appearances by the study staff in public media may also generate self-referrals. 
Study staff will also review CPRS medical records of community referrals (if available) before consent to aid in pre-
screening and determining eligibility. Recruitment letters will be mailed to veterans or SMs registered at the STVHCS 
with a history of OEF/OIF/OND tour(s) through collaboration with the local VA OIF/OEF/OND program office or 
through research registry databases (or other open research studies) of willing Veteran or SM research participants 
who have consented to be contacted about further study opportunities. Recruitment materials will provide information 
about the study and contact information for both the study PI and study coordinator.  
 
Individuals interested in participating will be given information about the study including inclusion and exclusion criteria 
and they will be screened using the telephone pre-screen questionnaire to determine the possible presence of chronic 
PTHA, the presence of PTS symptoms, and any indicators that would exclude them from participation. Interested and 
qualified participants will then get additional information about the study and will meet with the study coordinator to 
be formally consented into the study and undergo a baseline assessment. 
 
6.1.5. Consent Process. 
The IRB Policy on Informed Consent Process and Informed Consent Documentation will be followed.  Potential 
participants will have the study explained to them by a trained research staff member in a safe and private location. 
The potential participant will be given a copy of the informed consent document (ICD) to read. After the individual 
has read the ICD they will be given the opportunity to take the consent home to discuss the research with family and 
friends. The Research Team will be available to answer any questions about the research. Once the potential 
participant has reached a decision, the advising staff member will go over the risks and benefits of the study and 
ensure the subject understands the research. The advising staff member will have the individual sign the consent 
form. A copy of the signed ICD will be given to the participant. The advising staff member will document the informed 
consent process in the medical record of veteran participants per VA guidelines.  Participants who discontinue 
participation before completing study treatment and follow-up assessments will be contacted by phone to complete a 
brief assessment of their symptoms and their reason(s) for discontinuing participation.  Consent for this assessment 
will be done verbally over the phone to prevent the need for an in-person visit for the veteran. 
 
6.1.6. Subject Screening Procedures. 

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Baseline assessment will occur following consent. Following the baseline assessment, participants found to meet the 
inclusion criteria for the study will be randomized into the study. Participants not meeting study inclusion criteria  
 
 

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will be informed and referred to appropriate care either as part of another study or using the local VA, military providers, 
and/or civilian resources as appropriate. 
 
6.1.7. Compensation for participation. 
Participants who are not active duty at the time of an assessment will receive $50 each time they complete 
comprehensive assessment measures at Baseline, 1, 3, or 6-month follow-up assessments for a possible total of 
$200.  Participants will also be paid $25 each time they get their blood drawn (Baseline, twice during treatment, and 
1-month and 6-months after treatment), for a possible total of $125.  Additionally, participants will be paid $20 at each 
appointment during treatment to offset the cost of travel and potential lost income.  Historically, the cost of traveling up to 
12 times during treatment has been a barrier for some participants in the study.  The possible total of $40 (2 sessions) to 
$240 (12 sessions) will help individuals who have long commutes, or may be hindered from lost work hours. Similarly, a 
payment of $0.50 will be given for each completed headache diary ($5 payment received with the milestone of 10 completed 
entries) for a possible total of $112. By completing all the diaries, the 4 assessments, up to 2-12 treatment sessions, and 
the 5 blood draws, participants could receive between $477 and $677 in total compensation. Participants who choose to 
withdraw from this study early will receive compensation for all assessments, treatment, diaries, and blood draws 
that they completed. Payment will be provided via a rechargeable MasterCard® ClinCard. The MasterCard® 
ClinCard is a debit card issued to the study participant. Funds are loaded onto card through the ClinCard website at  
www.clincard.com. Only authorized users will be able to access the ClinCard website to add funds with a username 
and password. The ClinCard funds will be available to recipients within 1 business day and can be used as the 
participant chooses. The participant will be notified that their name, address and date of birth will be shared with a 
third-party (ClinCard) solely for the purposes of payment processing. This information will only be used for the 
administration of the payment and will be kept strictly confidential.  There will be no compensation for participation in 
the brief assessment of symptoms and discontinuation reasons for participants who discontinued participation in this 
study before completing treatment and follow-up assessments. 
 
6.2. Study Procedures/Research Interventions.  
Consent & Baseline Assessment 
Individuals will visit the Audie L. Murphy VA Hospital (which is part of the South Texas Veterans Health Care System) 
or the UTHSCSA STRONG STAR clinic where they will learn more about the study, provide consent for participation. 
Baseline assessment will occur following consent. Most participants will be able to complete the baseline assessment 
at the same appointment, but individuals will be allowed to complete the baseline assessment appointment over two 
to three appointments if they prefer. 
 
If participants are referred from other STRONG STAR studies, testing completed within the past one month as part 
of the assessment for other STRONG STAR studies will be used as baseline testing for participation in this study as 
appropriate with participant consent.   
 
Participants found to meet inclusion/exclusion criteria will return to the clinic to have blood drawn as part of the baseline 
assessment, be oriented to the on-line daily diaries, and, if randomized to CPT-C, undergo a Trauma Interview 
conducted by the 
therapist who will be providing therapy. An appointment will be made for all participants 
approximately 2-weeks later to start treatment. The on-line headache diaries will be completed daily for approximately 
2-weeks. If participants miss a headache diary entry, they will receive a phone call from research staff as needed 
to encourage and remind them to complete the diary. 
 
Treatment 
• 
Clinic-Based Cognitive Behavioral Therapy (CCBT). The CCBT headache treatment consists of 8 one-hour 
sessions that participants will be asked to complete in approximately 6 weeks (participants will be seen once 
or twice each week). Each treatment will take place at the South Texas Veterans Healthcare System (Audie 
Murphy Hospital) or the UTHSCSA STRONG STAR clinic. The 8 CCBT treatment sessions will cover many 
topics including: relaxation training, identifying stress, planning for long-term stress management, solving 
problems that impact their headaches, dealing with thoughts about their headache, specific headache coping 
skills training, and how to maintain their gains from treatment. 
• 
Cognitive Processing Therapy-Cognitive Only (CPT-C). Cognitive Processing Therapy (CPT) is a trauma-
focused treatment that involves learning to recognize and challenge thoughts related to traumatic brain injury. 
Participants 
assigned to this treatment arm will be asked to meet with a study therapist twice a week for 

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approximately 6-weeks for a total of 12 one-hour sessions. Each treatment will take place at the South Texas 
Veterans Healthcare System (Audie Murphy Hospital) or the UTHSCSA STRONG STAR clinic. During this 
treatment, participants will be asked to think about how they received their traumatic brain injury and their 
beliefs about the meaning of the event, as well as their current beliefs about themselves and others. Topics 
such as safety, trust, control, self-esteem, and intimacy will be discussed. Participants will be expected to 
complete assignments outside of session to practice skills learned in treatment. 
• 
Treatment as Usual (TAU). Participants assigned into the Treatment as Usual (TAU) condition will receive 
treatment by their primary provider as indicated. The participants will meet with study staff twice during the 
treatment phase to complete assessments.  
 
Assessments 
• 
All participants regardless of treatment group will be asked to complete headache diary on-line twice a day. 
• 
Blood will be drawn prior to treatment, during two of the treatment sessions, and at the 1- and 6-month 
assessments. 
• 
Two weeks before the scheduled 1-, 3- and 6-month assessments, participants will once again be asked to 
complete headache diaries for two weeks prior to the evaluations. 
 
All evaluations will be audio-recorded and CCBT and CPT-C therapy sessions will be audio-recorded to make sure 
that the study staff is correctly following the study procedures. These recordings will be reviewed by research experts 
who are part of the research team. 
 
Assessment of Discontinued (i.e., treatment/assessment dropout) participants. 
• 
All participants who discontinued participation in this study before completing study treatment and follow-up 
assessments will be contacted by phone by a project coordinator or research assistant and asked about their 
willingness to participate in a 10-15 assessment of their symptoms and reason for discontinuing participation.  
Participants will have the option to opt in to the assessment by giving verbal consent over the phone. 
• 
Those who agree to participate will be asked questions about global change in headache and PTSD 
symptoms, their perceptions of study participation and study treatments, their reason(s) for discontinuing 
participation in the study, and verbal administration of the HIT-6 and PCL-5 to assess headache and PTSD 
symptom severity. 
 
6.2.1 Collection of Human Biological Specimens. 
All participants will have blood drawn prior to treatment, at two treatment sessions, and 1- and 6-months (following 
treatment completion) coordinated through the CAP Biomarkers and Genomics Core. A skilled phlebotomist will draw 
the samples. All blood samples will be collected at the Audie L. Murphy VA Hospital or the UTHSCSA STRONG STAR 
clinic. 
 
6.2.1.1 Laboratory evaluations and special precautions. 
All blood samples will be collected at the Audie L. Murphy VA Hospital or the UTHSCSA STRONG STAR clinic and 
then transported to the CAP Biomarkers and Genomics Core in the UTHSCSA Department of Psychiatry and Behavioral 
Sciences at the UT Health-Long School of Medicine in room 727F for processing and storage. This location is monitored 
24-7 by a wireless monitoring system on the Isensix system and has approval by the STVHCS and Central VA office 
as a VA-Approved Tissue Bank. The study staff will be available to offer assistance if the participant is distressed at 
any point during any procedures. 
 
6.2.1.2 Specimen storage. 
Biological specimens will be coded with a digital bar code that can be linked to the study and subject only by key-codes 
maintained by the CAP Data Management and Biostatistics Core. 
6.2.2 Data Collection. 
Hardcopies of data will be stored in locked file cabinets within a dedicated, cipher/keyed room at the Audie L. Murphy 
VA Hospital in the Polytrauma Rehabilitation Center or the UTHSCSA STRONG STAR clinic (iaw local Privacy 
policies). 
 
Electronic data will be stored on a FISMA compliant, secure, research database at UTHSCSA, 
https://delta.uthscsa.edu/ssdashboard/login.aspx.  The STRONG STAR data server is physically located at the 

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Advanced Data Center (ADC) has 24x7 onsite security, card key, biometric access controls and video surveillance. 
University of Texas Health Science Center at San Antonio (UTHSCSA) ADC facility also maintains Gen 2 firewall 
devices to protect and prohibit any unauthorized access to UTHSCSA data. All UTHSCSA network devices are 
monitored by state of the art monitoring applications that include configuration audit, management, and availability 
24x7.   
 
Statistical Consideration 
 
6.3.1 Sample Size Estimation. 
This study will consent approximately 438 study participants with the goal of having 192 participants randomized for 
analysis. 
 
6.3.2 Primary (i.e., primary outcome variables) and secondary endpoints. 
The primary outcomes are headache symptoms and PTSD symptoms. 
 
6.3.3 Data analysis. 
Treatment groups will be compared on baseline variables. Dropout during treatment resulting in lack of outcome data 
can 
bias analyses. If attrition can be successfully modeled with logistic regression on the basis of baseline 
characteristics, and 
particularly if there is evidence of differential attrition, strategies such as inverse probability 
weighting can supplement the 
outcome analyses. Assuming that headache disability data (HIT-6; our primary 
outcome for this research) is reasonably normally distributed across the sample, treatment effects of the clinical 
interventions (CCBT and CPT-C) over the Treatment as Usual- Control condition will be analyzed using a general 
linear mixed (GLM) model with baseline scores used as a covariate. Unlike ANOVA, mixed effects models permit 
heterogeneity of variance in the treatment groups. If HIT-6 data are non-normal, a generalized linear model will be 
used (e.g., Poisson regression). 
 
Two joint primary comparisons will be conducted comparing both active treatments to TAU. To adjust the alpha level 
for these joint hypotheses, we will interpret both at the alpha = 0.025 significance level. Secondary analyses will 
examine differences between the two active interventions as well as sensitivity analyses of the primary outcomes 
considering 
missing data, adherence to the protocol, or imbalances between the groups at baseline. Additional 
analyses will consider the secondary outcomes and differences between the groups at other time points. 
 
A recent study helped to guide our determination of what constitutes a clinically meaningful change in perceived 
headache disability and the proposed study was powered in light of these differences. In the primary care setting, HIT-
6 changes ranging from 2.5 (95% CI: -3.3 to -1.7) were perceived as “somewhat better” and changes up to 5.9 (95% 
CI: - 7.6 to -4.1) were perceived as “much better.” We considered a meaningful change as somewhere between these 
two global impressions and used this marker as an index of clinically significant between-group differences. Our 
study is powered to detect an effect size of 2.8 points between groups after controlling for baseline scores (i.e., a 
residualized change) and constitutes an effect that would be meaningful to most headache sufferers. Assuming an 
alpha level of 0.025, group sample sizes of n = 64 (N = 192), and a moderate correlation between the baseline scores 
and final endpoints (r = 0.50), we will have power = 0.80 to detect an effect size of d = 0.52 between both of the joint 
primary comparisons. In realistic terms, this will allow us to detect a change of 2.8 points on the HIT-6 between the 
active treatment and the controls. Changes smaller than this magnitude are unlikely to be clinically meaningful. 
 
6.4 Confidentiality. 
Confidentiality will be safeguarded through a number of Consortium controls already in place for existing studies. First, 
all assessments will occur in a private room. Completed hard-copy assessments will be stored in a file in a locked 
drawer that is located in a locked office at the VA or the UTHSCSA STRONG STAR clinic. Patient identifiers are 
removed from all charts and associated only with a number identifier. Data will be transcribed into the Consortium 
database by the study coordinator or a trained research assistant using a double-entry method. All digital research 
data files will be encrypted and password- protected on the UT Health Science Center’s FISMA-compliant network, 
with files accessible only to the Consortium Data 
Core. All UTHSCSA STRONG STAR network connectivity is 
segmented with Access Control Lists and is not accessible to any other UTHSCSA network segments. The STRONG 
STAR data server is physically located at the Advanced Data Center (ADC) has 24x7 onsite  
 
 

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security, card key, biometric access controls and video surveillance. University of Texas Health Science Center at San 
Antonio (UTHSCSA) ADC facility also maintains Gen 2 firewall devices to protect and prohibit any unauthorized access to 
UTHSCSA data. All UTHSCSA network devices are monitored by state of the art monitoring applications that include 
configuration audit, management, and availability 24x7. VA intervention and phone contacts will occur in the South Texas 
Veterans Health System at Audie Murphy VA Hospital in San Antonio, TX or the UTHSCSA STRONG STAR clinic. 
Dr. Carlos Jaramillo and Dr. Blessen Eapen have confirmed available office space for PTHA research. 
 
Biological specimens will be coded with a digital bar code that can be traced back to the study and subject only by 
key-codes maintained by the Data Management and Biostatistics Core. 
 
6.4.1 Certificate of Confidentiality. N/A 
 
7.1 RISKS/BENEFITS ASSESSMENT 
 
7.2 Risks. 
Risks and side effects related to the Clinic-based Cognitive Behavioral Treatment (CCBT), Cognitive Processing 
Therapy- Cognitive Only (CPT-C) for post-traumatic headache, and blood draws include those which are: 
 
Likely Risks, but Not Serious (expected to occur in less than 20 subjects out of 100), 
• 
Psychological distress during assessments and treatment may produce some discomfort or emotional distress 
and can even produce a temporary increase in some symptoms in less than half of the people receiving the 
treatment. Similarly, treatment may be associated with a temporary or occasional increase in symptoms of 
depression, anxiety, or other pre-existing psychiatric symptoms. 
• 
Discomfort, bruising or both, at the site of the needle puncture during blood sample collection. 
• 
Some people experience fainting, the formation of a small blood clot or swelling of the vein and surrounding 
tissue, or bleeding from the puncture site. 
• 
This research includes genetic research with the participant’s samples. Using new technology, information 
about DNA structure (genetic information) can be used to indicate risk for developing certain diseases. This 
genetic information is unique to the participant and may indicate changes in their future health status or life 
expectancy, or that of their children and other relatives. If released, these discoveries could be stressful and 
cause psychological difficulties or family problems. 
 
7.3 Potential Benefits. 
The possible benefit of participating in this study is improvements in the severity and frequency of headaches and 
PTSD symptoms as well as a better understanding of headaches and posttraumatic stress. 
 
8.0 ADVERSE EVENTS, UNANTICIPATED PROBLEMS, AND DEVIATIONS 
The IRB policy on reporting adverse events, unanticipated problems, and protocol deviations will be followed. 
 
9.1 WITHDRAWAL FROM STUDY PARTICIPATION. 
Participants may be withdrawn from the study if: 
▪ 
The researcher believes that it is not in their best interest to stay in the study. 
▪ 
The participant becomes ineligible to participate. 
▪ 
The participant’s condition changes and they need treatment that is not allowed while taking part in the study. 
▪ 
The participant does not follow instructions from the researchers. 
▪ 
The study is stopped. 
 
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49. Steer, R.A., Rissmiller, D.J., Ranieri, W.F., Beck, A.T. (1993). Dimensions of suicidal ideation in psychiatric 
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for DSM–5 (PCL-5). 
 
Description of Study Measures 
1. Ohio State University Traumatic Brain Injury Identification Short Form (OSU TBI-ID-SF): The OSU TBI-ID-SF is a 
6 item screener used to determine the likelihood an individual suffered a TBI. Those showing a history of probably 
TBI will be included in the study (Corrigan & Bogner, 2007). 
2. History of Head Injury: We will use a modified version of the Defense and Veterans Brain Injury Center (DVBIC) 
3 Item Screening Tool (Schwab, Baker, Ivins, Sluss-Tiller, Lux & Warden, 2006; Schwab, Ivins, Cramer, Johnson, 
Sluss-Tiller, Kiley, Lux & Warden, 2006) that was used in STRONG STAR. This instrument, initially called the 
Brief Traumatic Brain Injury Screen (BTBIS), was used as the gold standard for the diagnosis of TBI in a sample 
of soldiers returning from duty in Iraq and/or Afghanistan (Schwab, Ivins, et al., 2006). As recommended by the 
DVBIC, the 3- Question Screen will be considered positive when the participant endorses an injury (question 1) 
and altered consciousness (question 2, items A-E) for the worst head injury sustained while deployed. The form 
was modified for STRONG STAR and now CAP to capture the number of injuries, and to answer question 2 
based on the worst injury; the original form does not recognize the possibility of multiple head injuries during 
deployment. As the 3-Question Screen does not query head injuries prior to deployment, an additional four 
questions have been added to solicit information about each head injury sustained outside of deployment. 
3. Response to Stressful Experiences Scale (RSES) (previously known as the National Center for PTSD Trait 
Resilience Scale). The RSES is a 22-item questionnaire developed by a team of experts at the National Center 
for PTSD to assess trait-related cognitive, emotional, and behavioral resilience (Johnson, et al., 2008). It asks 
participants to assess how well each statement describes them, both during and after stressful events in their 
lives. Responses are 
given on a 5-point scale, with anchors 0 (not at all like me) to 4 (exactly like me). 
Psychometric testing in 1,014 active duty, reserve and veteran groups showed that the instrument has sound 
internal consistency (coefficient alpha 0.91 to 0.93) as well as good test-retest reliability over 7-days (reliability 
correlation = 0.87). The instrument correlated positively with another measure of resilience, the Connor-Davidson 
Resilience Scale (coefficient alpha 0.61 to 0.81) as well as unit cohesion (coefficient = 0.38), and post-deployment 
support (coefficient 0.36 to 0.56). The instrument correlated negatively with psychological symptom distress as 
assessed with the Patient Health Questionnaire - 9 (coefficient = -0.51), posttraumatic stress as assessed with 
the PCL-M (coefficient -0.23 to -0.39), and overall mental health as assessed with the Minnesota Multiphasic 
Personality Inventory-2 Neuroticism (coefficient = -0.35) 
demonstrating concurrent validity. Factor analysis 
revealed a six-factor model of resilience including subscales for 
active coping, meaning-making, cognitive 
flexibility, spirituality, self-efficacy, and restoration. 
4. Cognitive Emotions Regulation Questionnaire (CERQ)-Short. The CERQ was designed to assess cognitive coping 
strategies people tend to use, or what someone thinks, after having experienced  
threatening or stressful events (Garnefski, Kraaij, & Spinhoven, 2001). The CERQ can be used to assess 
cognitive strategies that characterize the individual’s style of responding to stressful events. Thirty six (36)-items 
are scored to produce nine subscales 
including: 1) Self-Blame, 2) Blaming Others, 3) Rumination, 4) 
Catastrophizing, 5) Positive Refocusing, 6) Planning, 7) Positive Reappraisal, 8) Putting into Perspective, and 9) 
Acceptance. The answer categories for each item range from 1 (almost never) to 5 (almost always). Individual 
subscale scores are obtained by summing up the scores belonging   to the particular subscale. The  
 
 

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higher the subscale score, the more a specific cognitive strategy is used.   Psychometric testing of the 36-item 
CERQ was conducted using a group of 547 secondary school students aged 12   to 16 attending a state school 
in the Netherlands. Internal consistency of the subscales ranged from 0.71 to 0.92. The CERQ was positively 
correlated with both depression and anxiety as assessed with the subscales of the  Symptom Check List-90. 
Test-retest 
reliability for each of the subscales at five months ranged from 0.41 to 0.59. The CERQ-short form (Garnefski & 
Kraaij, 2006) is an 18-item questionnaire that produces the same 9 subscales as the 36-item questionnaire.  A 
study of 611 adults from a general practitioner’s office practice in the Netherlands indicated 
that the internal 
consistency of the 2-item subscales remained acceptably high (α = 0.67 to 0.81). In support of the validity of the 
CERQ-short, correlations with outcome measures were comparable to reported results with the original CERQ in 
that the Rumination, Self-Blame and Catastrophizing subscales were related to more depression and anxiety 
symptoms, while the Positive Reappraisal subscale was related to fewer symptoms (Garnefski & Kraajj, 2006). 
5. Demographics: We will use a standard CAP form to gather relevant demographics including: age, gender, ethnicity, 
date of concussion/TBI, mechanism of concussion/TBI, number of past concussions/TBIs, relevant comorbid 
medical conditions (e.g., cognitive decline, musculoskeletal or neuropathic pain –especially presenting in the head 
or neck). 
6. Health Interview (Pre-Treatment) and Health Interview (Follow-Up) also, pre- and post- HI addendum: The Health 
Interview includes items regarding general health, hospitalizations, current and past psychiatric medications, 
thoughts 
about wanting to harm others, utilization of mental health services, utilization of outpatient medical 
services, and caffeine and tobacco use. Additionally, the health interview will include a review of the participant’s 
medical record to identify provider-assigned ICD-9 diagnostic codes for chronic and neuropathic pain. 
7. Generalized Anxiety Disorder Screener (GAD-7): The GAD-7 (Spitzer, Kroenke, Williams, & Lowe, 2006) will be 
used to assess generalized anxiety symptomology. This is a 7-item measure that asks participants to rate the 
frequency with which they have been bothered by anxiety symptoms within the past two weeks on a scale ranging 
from 0 (“not at    all”) to 3 (“nearly every day”). Scores on all items are summed to obtain a total severity score. 
Scores reflect no significant anxiety symptoms (0-4), mild anxiety symptoms (5-9), moderate anxiety symptoms 
(10-14), and severe anxiety symptoms (>15). Respondents also indicate the degree to which their anxious 
symptoms have made it   difficult for them to do their work, take care of things at home, or get along with other 
people, from “not difficult at all”   to “extremely difficult.” The GAD-7 has been shown to have high internal 
consistency (e.g., α = .89; Lowe et al., 2008) and has been shown to reliably discriminate between anxious and 
non-anxious diagnostic groups (Kroenke, Spitzer, Williams, & Lowe, 2010). 
8. Self-Injurious Thoughts and Behaviors Interview (SITBI): The Self-Injurious Thoughts and Behaviors Interview 
(SITBI; Nock, Holmberg, Photos, & Michel, 2007) is a structured interview assessing the presence, frequency, 
and characteristics of self-injurious and suicidal thoughts and behaviors. The SITBI will be administered by an 
Independent Evaluator, who will instruct the participants to answer the questions based on their entire lifetime of 
experience. The SITBI has shown high interrater reliability, test-retest reliability, and concurrent validity (Nock et 
al., 2007). 
9. Deployment Risk and Resilience Inventory (DRRI - II) Combat Experience, Postbattle Experiences, and 
Deployment 
Environment Sub-Scales: High- and low-intensity deployment stress exposure will be assessed 
using scales from the DRRI-2 (Vogt, Smith, King, & King, 2012). High intensity stressor exposures will be 
assessed using the DRRI-2 Combat Experiences and Postbattle Experiences subscales. Responses to these 
scales are on a 6-point Likert scale. The total score is the sum of the item scores, where higher scores signify 
greater exposure to combat or exposure to the consequences of combat, respectively. In addition, low-intensity 
deployment stress will be assessed with the DRRI-2 Deployment Environment subscale. Responses to this scale 
are on a 5-point Likert scale with anchors 1 (almost none of the time) to 5 (almost all of the time). The total score 
equals the sum of the item scores, where higher scores are indicative of a more difficult living and working 
environment 
10. Life Events Checklist (LEC-5): The LEC-5 (Weathers, Blake, Schnurr, Kaloupek, Marx, & Keane, 2013) includes 
the same list of 16 different potentially traumatic life events from the original LEC that are commonly associated 
with PTSD symptoms and designed to facilitate PTSD diagnosis (Gray, Litz, Hsu, & Lombardo, 2004). There is 
also a  blank for specifying an additional stressful event not encompassed in the 16 events. For each potentially 
traumatic life event, respondents rate their experience of that event on a 6-point nominal scale (1 = happened to 
me, 2 = witnessed it, 3 = learned about it, 4 = part of my job, 5 = not sure, and 6 = doesn’t apply). The primary 
addition to the LEC-5 is a category involving occupational exposure (“for example, paramedic, police, military,  
 
 

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or other first responder”). There has not been a publication on the psychometric properties of the LEC-5, but the 
measure is nearly identical to the original LEC. In a group of 108 undergraduate psychology students the LEC 
demonstrated good convergence with   the Traumatic Life Events Questionnaire (average kappa = 0.55) and 
correlated with  
the Posttraumatic Stress  Disorder Checklist – Civilian version (reliability coefficients 0.34 to 0.48). The LEC 
demonstrated good test-retest reliability over 7 days. In 131 combat veterans the LEC was related in the predicted 
directions with other measures of psychopathology known to be associated with potentially traumatic life events 
as assessed by the Posttraumatic Stress Disorder Checklist – Military version, Clinician-Administered PTSD 
Scale, and the Mississippi Scale for Combat-Related PTSD. 
11. Posttraumatic Cognitions Inventory (PTCI). The PTCI is a 36-item questionnaire that was developed to determine 
how an individual views the trauma and its sequelae in an attempt to understand both how PTSD develops and 
is maintained (Foa, Elhers, Clark, Tolin, & Orsillo, 1999). Using an emotional processing theory, Foa and her   
colleagues (1999) have suggested that PTSD is a consequence of disruptions in the normal processes of recovery 
when an individual has excessively rigid concepts about self and world rendering the person vulnerable if a 
traumatic event occurs. Thus the PTCI was developed as a measure of trauma-related thoughts and beliefs. It 
is comprised of three subscales (Negative Cognitions about the Self, Negative Cognitions about the World, and 
Self-Blame). The measure was tested in almost 600 adult volunteers recruited from two university PTSD 
treatment clinics as well as a university community. Approximately 65% (n=392) of individuals reported having 
experienced a trauma in which their own life or that of another person was perceived  
to be in danger and their response at the time included intense terror, horror, or helplessness (Criterion A event). 
The remaining 35% (n=162) denied such a traumatic experience. Of  those who had experienced a trauma, 170 
had PTSD symptoms of at least moderate severity while the remaining 185 reported a low symptom severity. 
The three subscales of the PTCI demonstrated internal consistency with alpha coefficients ranging from 0.86 to 
0.97. Convergent validity was demonstrated comparing the PTCI to appropriate 
subscales of the World 
Assumptions Scale and Personal Beliefs and Reactions Scale. Significant correlations between the appropriate 
subscales ranged from 0.20 to 0.85. The PTCI was able to differentiate individuals with and 
without PTSD 
demonstrating discriminate validity (sensitivity = 0.78, specificity = 0.93). Test–retest reliability for each of the 
three subscales at a 1-week interval ranged from 0.75 to 0.89 and for a 3-week interval ranged from 0.80 to  0.86. 
12. Structured Diagnostic Headache Interview-Revised (Brief Version; SDIH-R): The SDIH-R is a structured clinical 
interview assessing headache symptoms that conform to the ICHD-II criteria for primary and posttraumatic 
headache (Silberstein, 2000; Campbell, Penzien, & Wall, 2000). This interview will be administered at the baseline 
assessment session to further establish the participant’s headache diagnosis and again at post-treatment and 
six-month follow-ups 
(to help establish the perseverance or dissolution of the PTHA diagnosis in response to 
treatment. 
13. Daily Headache Diary (Online) (Goslin et al, 1999): Headache frequency and severity will be assessed via daily 
headache self-monitoring diaries. Patients will complete the assessment twice daily (during AM and PM), requiring 
5   to 10 minutes per assessment. Although the descriptions of when the various forms are completed are made 
in reference to a typical sleep-wake cycle, it is of note that the “morning” (AM) entry simply refers to the entry that 
is  made when a subject awakens and the “evening” (PM) entry is made at the end of their waking day (thus, the 
entries can easily be adapted for individuals doing shift  
work). They will record their headache intensity 2 times during the day using a 0 to 10 scale, with 0 representing 
"no headache" and 10 representing a headache that was "extremely painful—I can't do anything when I have this 
headache." From these diaries, 4 dependent measures will be computed for each assessed week: (a) days per 
week with a headache (days with headache greater than 2); (b) weekly headache frequency (total number of 
discrete headaches per week); (c) headache duration (total number of hours of headache per week with headache 
greater than 2); and (d) average peak headache intensity. The Headache Diary also tracks the occurrence of 
known headache triggers and medication use for headache management (prophylactic and abortive). 
14. Headache Impact Test-6 (HIT-6): The HIT-6 is a 6-item measure of headache-disability considered a gold standard 
in headache clinical and research work. Developed in 2003 (Kosinski et al, 2003), the HIT-6 has demonstrated 
excellent 
reliability (internal consistency = 0.89; test-retest reliability = 0.80) and validity (relative validity 
coefficients ranging from 0.82 to 1.00). There are almost 100 published studies of headache using the HIT-6, 
including previous studies of PTHA (Schwedt et al, 2007). 
15. Headache Management Self-Efficacy Scale (HMSE): This is a 25-item assessment rated on a 7 point Likert-type 
scale measuring one’s confidence at preventing headaches (French, Holyroyd, & Peinell, et al, 1999). 
 
 

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16. Headache Specific Locus of Control Scale (HSLC): The HSCL is a 33 item measures scored on a 5-point Likert–
type scale to measure an individual’s perceptions that headache problems and relief are determined by: individual 
behaviors, healthcare professionals, or chance factors (Martin, Holyroyd, & Penzien, 1990). 
17. Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) : The CAPS-5 is structured interview that assesses the 
DSM-5 criteria for PTSD (Weathers et al., 2013). Each item is rated on a severity scale ranging from 0 (Absent) to 
4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 symptoms. 
Additional items that are not included in the total score evaluate overall symptom duration, distress, impairment, 
dissociative symptoms, and global ratings by the interviewer. Validation studies are nearly complete to establish 
the 
psychometric properties of the CAPS-5 and findings will be reported in peer-reviewed publications. This 
interview is very similar to its predecessor, the CAPS for DSM-IV, which has been considered the gold standard 
for evaluating PTSD and demonstrated good reliability and validity (Weathers, Keane, & Davidson, 2001). In 
addition to reflecting diagnostic changes for PTSD in DSM-5, the CAPS-5 differs from the CAPS in that frequency 
and intensity ratings for each symptom are no longer scored separately, so the severity rating for each item 
determines whether a symptom is present or not. Subscale scores are calculated by summing severity scores for 
items in the following PTSD symptom clusters: re-experiencing, avoidance, negative alterations in cognitions and 
mood, and hyperarousal. 
18. PTSD Checklist –DSM-5 (PCL-5): The PCL-5 (Weathers, et al., 2010) is a 20-item self-report measure update of 
the PCL designed to assess PSTSD symptoms as defined by the DSM-5. The PCL-5 is currently available and 
has been shown to have good psychometric properties. 
19. Neurobehavioral Symptom Inventory (NSI): The NSI is a 21-item assessment of post-concussive symptoms with 
a 3- factor structure (somatic/sensory, affective, and cognitive) (Caplan et. al, 2010). 
20. Patient Health Questionnaire-9 (PHQ-9): The PHQ-9 is a widely used and well-validated instrument for measuring 
the severity of depressive symptoms (Kroenke, Spitzer, & Williams, 2001). It consists of 9 items that assess both 
affective and somatic symptoms related to depression and depressive disorders; these 9 items correspond to the 
diagnostic criteria for DSM MDD. Respondents rate the frequency with which they have been bothered by 
depressive symptoms on a scale ranging from 0 (“not at all”) to 3 (“nearly every day”). Scores on all items are 
summed to obtain a total severity score. Scores reflect no significant depressive symptoms (0-4), mild depressive 
symptoms (5-9), moderate depressive symptoms (10-14), moderately severe depressive symptoms (15-19), and 
severe depressive symptoms (>19). Respondents also indicate the degree to which their depressive symptoms 
have made it difficult for them to do their work, take care of things at home, or get along with other people, from 
“not difficult at all” to “extremely difficult.” The PHQ-9 has high internal consistency (e.g., alpha ranging from .83 
to .92; Cameron, Crawford, Lawton, & Reid, 2008), and correlates strongly with other measures of depression  
(Kroenke et al., 2001). 
21. Online Profile of Mood States-Short Form (POMS-SF; Shacham, 1983) online Each morning and evening, subjects 
will complete the POMS-SF. The POMS-SF is a 37-item scale which assesses distinct mood states. Each 
emotional adjective (e.g., “sad”) is rated on a 0 (“Not at all”) to 4 (“extremely”) scale. The measure takes 
approximately 1.5 – 3.5 minutes to complete. 
22. Online Daily Stress Inventory (DSI; Brantley et al., 1987) online Each evening subjects will complete the DSI. The   
DSI is a 58-item scale that allows a subject to identify stressful events that they have experienced in the last 24 
hours. For each item that is endorsed, a stressfulness impact rating is made ranging from 1 (“occurred but was 
not stressful”) to 7 (“caused me to panic”). 
23. Depressive Symptom Index – Suicidality Subscale (DSI-SS): The DSI-SS (Metalsky & Joiner, 1997) will be used 
to assess current suicidal ideation. The DSI-SS is a 4-item self-report measure of suicidal ideation that focuses 
on ideation, plans, perceived control over ideation, and impulses for suicide. It is being used as a core measure 
in the Military Suicide Research Consortium. Scores on each item range from 0 to 3, with higher scores reflecting 
greater severity of suicidal ideation. Instructions will instruct the participants to respond based on the past week. 
A systematic 
review of measures of suicidal ideation and behaviors found that the DSI-SS had evidence of 
excellent internal consistency and concurrent validity (Batterham et al., 2014). 
24. NIH Toolbox Cognition Battery: The NIH Toolbox is a recently developed comprehensive assessment tool with an 
emphasis on measuring outcomes in longitudinal epidemiologic studies and prevention or intervention trials across 
a 
lifespan (Akshoomoff, et al., 2014). The cognition battery is a brief and efficient computer-based 
neuropsychological test of the seven key cognitive domains: Executive Functioning, Episodic Memory, Working 
Memory, Processing Speed, Language, Attention and Reading. The oral reading subtest will not be administered 
to reduce subject burden. The battery requires only 20-30 minutes to administer. 

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25. Alcohol Use Disorders Identification Test (AUDIT) self-report version: The AUDIT (Babor et al., 2001) will be used 
to identify people with hazardous or harmful patterns of alcohol consumption and to index the severity of these  
problems. It will be administered as a self-report form. The AUDIT is a 10-item screening measure, developed by 
the World Health Organization (WHO), with three subscales (alcohol consumption, drinking behavior, and alcohol-
related problems) that are scored on a 4-point scale for a highest possible total score of 40. The AUDIT has good 
internal consistency (αs = .80-.93) as well as sensitivity and specificity (Saunders, Aasland, Babor, De La Fuente 
& Grant, 1993; see Reinert & Allen, 2007, for review). 
26. Quick Drinking Screen (QDS) self-report version: The QDS (Sobell et al., 2003) will be used to measure alcohol 
consumption. It consists of 4 items probing frequency and quantity of alcohol consumption. It will be administered 
in a self-report form. The QDS has been validated against the Timeline Followback daily estimation measure of 
alcohol use, and it shows good psychometric properties (Roy et al., 2008; Sobell et al., 2003). The QDS’s time-
frame will be modified to match the “last two weeks” probed by the mandated depression and anxiety instruments 
for CAP studies 
(PHQ-9 and GAD-7). Like these other measures, the QDS can be administered frequently 
throughout CAP trials to track changes in alcohol use. 
27. Brief Inventory of Psychosocial Functioning (B-IPF): This is a 7-item self-report instrument measuring respondents’ 
level of functioning in seven life domains: romantic relationship, relationship with children, family relationships, 
friendships and socializing, work, training and education, and activities of daily living (Marx, 2013). Respondents 
indicate the degree to which they had trouble in the last 30 days in each area  
on a 7-point scale ranging from “0 = Not at all” to “6 = Very much.” The B-IPF has demonstrated concurrent 
validity, and the full 80-item IPF from which it was created has strong test-retest reliability and internal consistency 
(Marx, 2013). 
28. Patient Health Questionnaire – 15 (PHQ-15): The PHQ-15 (Kroenke, Spitzer, & Williams, 2002) is an abbreviated 
version of the original PHQ that asks about somatic symptoms and symptom clusters that account for more than 
90% of physical complaints reported in an outpatient setting. The 15-item measure asks patients to report 
symptom severity on a scale ranging from 0 (“not bothered at all”) to 2 (“bothered a lot”). The PHQ-15 has been 
found to have excellent internal reliability (α = .80) and good convergent validity with scales such as the SF-12 
and other measures of symptom severity and functionality (Kroenke, Spitzer, & Williams, 2002). 
29. Veterans Rand 12-Item Health Survey (VR-12): The Veterans SF-12 was developed from the Veterans SF-36 (VR-
36) and adapted from the MOS SF-36, and spans the range of health domains from physical to psychological 
health 
status. The VR-36 has been widely used, distributed and documented in the Veterans Health 
Administration (VHA). The VR-36 assesses eight domains including physical functioning, role limitations due to 
physical problems, bodily 
pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and mental 
health. The eight scales are summarized into two summary scores, physical (PCS) and mental (MCS). Higher 
scores indicate better health. The VR-12 includes 12 items representing the eight domains from the VR-36 and 
two items measuring change in physical and mental health. The VR-12 explains 90% of the reliable variance of 
the VR-36 (Jones, et al., 2001). Using independent results from the Veterans Health Study and the 1996 National 
Survey of Ambulatory Care Patients, the results for the Veterans SF-12 corresponded very closely with the results 
for the Veterans SF-36 (Kazis, et al., 2004; Kazis, et al., 2006). 
30. Online Daily Diary Sleep Quantity/Quality (Lichstein et. al, 2004) online Each morning (once per day on 
awakening), subjects will record the following in the electronic diary: A) What time did you get out of bed this 
morning? B) What time did you go to bed last night? C) How long did it take for you to fall asleep after going to 
bed last night? D) How many times did you wake up during the night? E) How long were you awake during these 
awakenings in the night (in total)? F) About how long did you sleep during the night (altogether)? G) How would 
you rate the quality of your sleep? [0-4 scale; 0=poor; 2=fair; 4=excellent] H) How well (rested and refreshed) do 
you feel this morning? [0-4 scale; 0=not at all; 2=moderately; 4=very] I) Did you nap or doze yesterday before 
going to bed? (If so, what time and how long did you sleep)? 
31. Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance and Sleep-Related 
Impairment short forms: The PROMIS Sleep Disturbance and Sleep-Related Impairment short forms (Yu, Buysse, 
& Germain, 2012) are self-report measures of past-week sleep disturbance and past-week sleep-related 
impairment, 
respectively, derived from the larger PROMIS item banks (Buysse et al., 2010). Each short-form 
measure includes 8 items, with most items (symptoms) scored in intensity from 1 (“not at all”) to 5 “(very much”). 
Each measure has shown strong reliability and construct validity (Yu et al., 2012). 
32. Snoring, Tired, Observed, Blood Pressure (STOP) Sleep Apnea Screen (Chung et al., 2008). To better understand 

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administered to screen for sleep apnea. The STOP is a four-item questionnaire developed and validated in 211 
pre-operative surgical patients. Using the answering of 2 or more questions “yes,” the sensitivity of the STOP 
ranged from 66% to 80% as compared with the apnea-hypopnea index (AHI) of polysomnography depending 
upon the AHI cut-off used. Individuals answering “yes” to 2 or more of the questions will be advised that they may 
be at risk for having sleep apnea and advised that they may want to speak with their primary care provider to 
consider referral for an overnight sleep evaluation at the CRDAMC Sleep Clinic 
33. Insomnia Severity Index (ISI; Morin, 1993). The ISI is a 7-item self-report measure that assesses perceived 
severity  of insomnia. Each item uses a 4-point Likert type scale from 0 (not at all satisfied) to 4 (very much 
satisfied). The  items sum to produce a total score (range 0 – 28). The ISI has an internal consistency alpha 
coefficient of 0.74, and has shown convergent validity with other measures such as the Pittsburgh Sleep Quality 
Index (r = 0.67), the Dysfunctional Beliefs and Attitudes about Sleep (r = 0.55), and sleep diaries (range from 
0.32-0.91) (Bastien, Vallieres 
& Morin, 2001). 
34. Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Functioning Profile: The 
PROMIS questionnaires are a system of reliable measures of patient–reported health status for physical, mental, 
and social well–being developed with funding under the National Institutes of Health (NIH) Roadmap for Medical 
Research Initiative to re-engineer the clinical research enterprise (http://www.nihroadmap.nih.gov). PROMIS 
measures can be across a wide variety of chronic diseases and conditions and in the general population (Cella 
et al, 2010). One of the PROMIS instruments is a Sexual Functioning Inventory (Jeffery et al, 2009). The PROMIS 
Sexual Function Inventory provides scores on seven different sub-domains of sexual function: interest in sexual 
activity, vaginal discomfort (women only), lubrication (women only), erectile function (men only), orgasm, and 
global satisfaction with sex life.  Each question asks respondents to report on their experiences over the past 30 
days. With the exception of the orgasm sub-domain, all sub-domain scores are expressed as T scores (mean = 
50,   
standard deviation = 10). While the instrument is intended for broad use, almost all of the development work was 
with patients with cancer. Research  
is ongoing to expand development beyond cancer. In testing with 819 
individuals (388 males, 430 females, 1 person did not specify sex), correlations between the PROMIS Sexual 
Functioning Profile and corresponding sub-domains of 
two well-established measures, the Female Sexual 
Function Index (FSFI) and the International Index of Erectile Function (IIEF), ranged between .48 and .92. The 
sub-domains of the instrument discriminate between people who had and had not asked a provider about sexual 
problems. Test-retest correlations over one month are >.65 for all sub- domains (Sexual Function and Satisfaction 
Measures User Manual, 2012). 
35. Fagerstrom Test for Nicotine Dependence (FTND)/Fagerstrom Test for Nicotine Dependence – Smokeless 
Tobacco (FTND-ST): The FTND and FTND-ST are both 6-iem self-report measures that assesses severity of 
nicotine dependence and smokeless tobacco use, subsequently. Questions on both measures probe quantity of 
nicotine use and pattern. 
36. (PTHA-specific ) Credibility and Expectancy Questionnaire (CEQ). The CEQ is a 6-item measure that was 
designed to assess treatment expectancy and rationale credibility for use in clinical outcomes studies (Devilly & 
Borkovec, 2000). It has been expanded from a 5-item measure designed primarily to assess credibility (Borkovec 
& Nau, 1972), 4-items of which have been used by both Foa and Resick (P.A. Resick, personal communication, 
February 22, 2010; E.A. Hembree, personal communication, February 23, 2010; E. B. Foa, personal 
communication, February 25, 2010) with the name Expectancy of Therapeutic Outcomes (ETO). The 6-item CEQ 
assesses both whether the person cognitively understands how the therapy works (credibility) as well as whether 
the person affectively believes that the therapy will work for them personally (expectancy). The 6-item CEQ has 
been tested in 217 individuals including 68 
male Vietnam veterans and 58 female spouses, 69 individuals 
diagnosed with general anxiety disorder who had received treatment, and 22 individuals who had received either 
Cognitive Based Therapy (CBT) or Eye Movement Desensitization and Reprocessing (EMDR) for the treatment 
of PTSD. The scale demonstrated high internal consistency (alpha coefficients ranged from 0.84 to 0.85).  Test-
retest reliability over a one-week period was found to be 0.82 for expectancy and 0.75 for credibility. The CEQ 
was able to differentiate between two treatment rationales in 
one study, one with and one without an 
encompassing theory while maintaining equivalence between three rationales in another study. Responses to 
four questions are scored using a 9-point Likert scale (1= not at all, 9= extremely). Responses to two of the 
questions are scored using an 11-point Likert Scale (0% to 100%). The combined responses are used to generate 
a score for credibility and another score for expectancy. 

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37. The Community Reintegration of Injured Service Members (CRIS): The CRIS is a validated instrument using 
OIF/OEF cohorts and consists of three scales measuring extent of, perceived limitations in, and satisfaction with 
community reintegration. This is a pen-and-paper, 9-item measure. 
38. Tinnitus Functional Index: The Tinnitus Functional Index (TFI) was reported by Henry et al (2014). They report 
five stages of TFI development through which prototypes were developed, tested, and revised over a four-year 
period. The TFI has eight subscales that address the intrusiveness of tinnitus, the sense of control the patient 
has, cognitive interference, sleep disturbance, auditory issues, relaxation issues, quality of life, and emotional 
distress. 
39. PTHA Study Missing Data Assessment:  The PTHA Study Missing Data Assessment is a 5-item measure of global 
symptom improvement for headache and PTSD, perception of satisfaction and burdensomeness of study 
treatments, and reason(s) for discontinuing study participation.  This assessment will be used to assess missing 
data randomness and to categorize participants who discontinued study participation as a way to help impute 
missing data and improve future studies with these treatments in similar populations.