Cognitive-Behavior Therapy for Posttraumatic Headache

Completed · Not applicable

Conditions studied: Post-traumatic Headache, PTSD

In brief

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.

Key facts

Study ID: NCT02419131
Run by: The University of Texas Health Science Center at San Antonio
People needed: 193
Starts: 2015-05-01
Expected to finish: 2019-10-10
Last updated by the study team: 2024-08-13

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

San Antonio VA Medical Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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