Cognitive-Behavior Therapy for Posttraumatic Headache

September 25, 2020 updated by: Donald McGeary, The University of Texas Health Science Center at San Antonio

Coalition to Alleviate PTSD: Randomized Clinical Trial of Cognitive-Behavior Therapy for Posttraumatic Headache

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

192

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • San Antonio VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 weeks (end of treatment), and 3 and 6 months post-treatment
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
Baseline, 6 weeks (end of treatment), and 3 and 6 months post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

Wake Forest University

Investigators

  • Principal Investigator: Donald McGeary, PhD, University of Texas Health Science Center, San Antonio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

May 30, 2019

Study Completion (Actual)

October 10, 2019

Study Registration Dates

First Submitted

April 9, 2015

First Submitted That Met QC Criteria

April 13, 2015

First Posted (Estimate)

April 17, 2015

Study Record Updates

Last Update Posted (Actual)

September 29, 2020

Last Update Submitted That Met QC Criteria

September 25, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC2014339H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data sharing as per CAP (Consortium to Alleviate PTSD) established protocol.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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