Clinical trial NCT02419131: Cognitive-Behavior Therapy for Posttraumatic Headache
Official title: Coalition to Alleviate PTSD: Randomized Clinical Trial of Cognitive-Behavior Therapy for Posttraumatic Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-traumatic Headache
PTSD
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Wake Forest University
First posted: 2015-04-17
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 clinical judgment
* if they demonstrate significant cognitive impairment that could impact treatment adherence/benefit.

Primary outcomes:
measure: Headache-related Disability Scores on the Headache Impact Test 6 (HIT-6)
timeFrame: Baseline, 6 weeks (end of treatment), and 3 and 6 months post-treatment
measure: Scores for Symptoms of Post-traumatic Stress on the PTSD Checklist-5 (PCL-5)
timeFrame: Baseline, 6 weeks (end of treatment), and 3 and 6 months post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: San Antonio VA Medical Center
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Donald McGeary, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McGeary DD, Resick PA, Penzien DB, McGeary CA, Houle TT, Eapen BC, Jaramillo CA, Nabity PS, Reed DE 2nd, Moring JC, Bira LM, Hansen HR, Young-McCaughan S, Cobos BA, Mintz J, Keane TM, Peterson AL. Cognitive Behavioral Therapy for Veterans With Comorbid Posttraumatic Headache and Posttraumatic Stress Disorder Symptoms: A Randomized Clinical Trial. JAMA Neurol. 2022 Aug 1;79(8):746-757. doi: 10.1001/jamaneurol.2022.1567.
citation: Moring JC, Straud CL, Penzien DB, Resick PA, Peterson AL, Jaramillo CA, Eapen BC, McGeary CA, Mintz J, Litz BT, Young-McCaughan S, Keane TM, McGeary DD. PTSD symptoms and tinnitus severity: An analysis of veterans with posttraumatic headaches. Health Psychol. 2022 Mar;41(3):178-183. doi: 10.1037/hea0001113.
citation: McGeary DD, Resick PA, Penzien DB, Eapen BC, Jaramillo C, McGeary CA, Nabity PS, Peterson AL, Young-McCaughan S, Keane TM, Reed D, Moring J, Sico JJ, Pangarkar SS, Houle TT; Consortium to Alleviate PTSD. Reason to doubt the ICHD-3 7-day inclusion criterion for mild TBI-related posttraumatic headache: A nested cohort study. Cephalalgia. 2020 Oct;40(11):1155-1167. doi: 10.1177/0333102420953109. Epub 2020 Aug 31.