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Cognitive-Behavior Therapy for Posttraumatic Headache

This study is currently recruiting participants.
Verified November 2017 by Wake Forest University Health Sciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT02419131
First Posted: April 17, 2015
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
The University of Texas Health Science Center at San Antonio
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  Purpose
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.

Condition Intervention
Post-traumatic Headache PTSD Behavioral: Behavioral Headache Therapy Behavioral: Cognitive Processing Therapy Behavioral: Treatment as Usual

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Coalition to Alleviate PTSD: Randomized Clinical Trial of Cognitive-Behavior Therapy for Posttraumatic Headache

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Headache-related disability scores on the Headache Impact Test 6 (HIT-6) [ Time Frame: Baseline, 6 weeks (end of treatment), and 3 and 6 months post-treatment ]
    Change in baseline headache-related disability will be assessed over time based on headache-related disability scores on the HIT-6 obtained at multiple time points: at the end of 6 weeks of treatment, and at 3 and 6 months post-treatment.


Secondary Outcome Measures:
  • Frequency of headache reported in daily diary records [ Time Frame: Twice daily for two weeks at baseline, twice daily during 6 weeks of treatment, and twice daily for two week periods at 3 and 6 months post-treatment ]
    Change in headache frequency over time (averaged over two-week intervals) from baseline, at the completion of 6 weeks of treatment, and at 3 and 6 months post-treatment. Participants will complete headache diaries twice daily (am and pm) via a secure online patient reporting website developed for this study and managed by study staff. A total of 168 daily diary entries will be collected during the study period

  • Scores for symptoms of post-traumatic stress on the PTSD Checklist-5 (PCL-5) [ Time Frame: Baseline, 6 weeks (end of treatment), and 3 and 6 months post-treatment ]
    Change in baseline post-traumatic stress scores will be assessed over time based on reports of post-traumatic stress symptoms on the PTSD-checklist (PCL-5) obtained at multiple time points: at the end of 6 weeks of treatment, and at 3 and 6 months post-treatment.


Estimated Enrollment: 285
Study Start Date: May 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Behavioral Headache Therapy
A standard, manualized behavioral intervention for primary headache disorders
Behavioral: Behavioral Headache Therapy
A standard, manualized behavioral intervention for primary headache disorders
Experimental: Cognitive Processing Therapy
A gold-standard treatment for PTSD, called Cognitive Processing Therapy
Behavioral: Cognitive Processing Therapy
A gold-standard treatment for PTSD, called Cognitive Processing Therapy
Active Comparator: Treatment as Usual
Treatment as usual, receiving standard care for PTHA
Behavioral: Treatment as Usual
Treatment as usual, receiving standard care for PTHA

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02419131


Contacts
Contact: Juan Carlos Aguilera, BS, BA 210-562-6737 aguileraj@uthscsa.edu
Contact: Clara Stiefel, BA 210-562-6744 stiefel@uthscsa.edu

Locations
United States, Texas
San Antonio VA Medical Center Recruiting
San Antonio, Texas, United States, 78229
Contact: Juan Carlos, BS         
Sponsors and Collaborators
Wake Forest University Health Sciences
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Donald B Penzien, PhD WakeForest School of Medicine
Principal Investigator: Donald McGeary, PhD University of Texas Health Science Center, San Antonio
  More Information

Additional Information:
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02419131     History of Changes
Other Study ID Numbers: HSC20140339H
First Submitted: April 9, 2015
First Posted: April 17, 2015
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data sharing as per CAP (Consortium to Alleviate PTSD) established protocol.

Additional relevant MeSH terms:
Headache
Post-Traumatic Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases