Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02419131 : Cognitive-Behavior Therapy for Posttraumatic Headache
PhaseN/A
AgesMin: 18 Years Max: 70 Years
Eligibility
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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02419131      |      Link to official Clinicaltrials.gov listing
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