The overall purpose of the study is to compare two talk therapies (Clinic-Based Cognitive
Behavioral Therapy and Cognitive Processing Therapy-Cognitive Only) 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.
More than 100,000 military service members and veterans suffer from chronic headaches
resulting from a traumatic brain injury (TBI) sustained during deployment. Although that
population has seen a sharp increase in these posttraumatic headaches (PTHA), the condition
is extraordinarily difficult to treat. There is very little evidence guiding its management.
Complicating things is the fact that those who have suffered a traumatic injury during
deployment often have co-occurring symptoms of posttraumatic stress, which may worsen their
headaches or make them more difficult to treat.
To better inform our understanding of how to help our suffering war veterans, we developed a
study for the Consortium to Alleviate PTSD (CAP) addressing posttraumatic headache in war
veterans with co-occurring symptoms of posttraumatic stress.
A key aim of the study will be to evaluate whether a leading psychological therapy for
migraine headaches is effective with posttraumatic headaches. Investigators also seek to
determine if treatment for PTHA likewise improves problems with PTSD, and whether treatment
for PTSD simultaneously alleviates headaches.
To accomplish these aims, the study will have three arms, with participants placed randomly
into one of three treatment conditions:
1. Treatment as usual (e.g., receiving standard care for PTHA through the South Texas
Veterans Health Care System's Polytrauma Rehabilitation Center in San Antonio);
2. A gold standard, manualized cognitive-behavioral intervention for headache; or
3. A gold-standard treatment for PTSD, called Cognitive Processing Therapy.
- adult (ages 18 - 70 years old)
- U.S. military Veterans with military service during Operations Enduring Freedom (OEF),
Iraqi Freedom (OIF), and New Dawn (OND)
- have sustained a traumatic head injury
- have been diagnosed or report symptoms consistent with chronic (> 3 months)
posttraumatic headache attributed to a traumatic injury sustained as part of military
service. 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 Veteran population. A positive PTHA
diagnosis will be indicated for individuals with de novo headache onset within 3
months of a concussion or exacerbation of pre-existing headache symptoms (increased
frequency, duration, or intensity) within 3 months of traumatic injury. This is
consistent with the existing ICHD-III criteria for PTHA inclusion will be based on
either a pre-existing diagnosis of chronic PTHA documented in the Veteran's medical
record by a PRC/PSC provider or a Neurologist (e.g., ICD-10 code G44.329) or through
screening with one of our PRC/PSC co-PIs if the Veteran reports symptoms consistent
with chronic PTHA but has never had it documented in her/his medical record.
- Participants taking headache medication with a stable pattern of use for the prior 6
week period (including no prescribed changes in medical regimen).
- Participants must have some posttraumatic stress (PTS) symptoms based on a cut-off
score of at least 25 or above on the PTSD CheckList -Version (PCL-5), which all
participants will complete as part of their screening.
- Participants must also report on the Clinician Administered PTSD Scale (CAPS-5) an
exposure to a traumatic event (Criterion A), at least one intrusion symptom (Criterion
B), and at least one avoidance symptom (Criterion C). 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
- there has been a recent and significant change in the nature of headache symptoms over
the last 6 weeks prior to their screening (as determined by the investigators)
- Participants currently in CPT or prolonged exposure for PTSD.
- Participant has medication overuse headache as defined by the Structured Diagnostic
Headache Interview-Revised (Brief Version; SDIHR).
- the participant is unable to read or speak English at a 6th grade level
- they have had a psychiatric hospitalization in the last 12 months
- they currently meet a psychiatric diagnosis of substance abuse [based on Alcohol Use
Disorders Identification Test (AUDIT) assessment during screening]
- they are pregnant or plan to become pregnant during the trial (due to concerns about
pregnancy-induced headache that may obscure findings)
- if a psychiatric problem is present that warrants immediate treatment based upon
- if they demonstrate significant cognitive impairment that could impact treatment
Donald B Penzien, PhD
WakeForest School of Medicine
Juan Carlos Aguilera, BS, BA