Cognitive-Behavior Therapy for Posttraumatic Headache

• ClinicalTrials.gov Identifier: NCT02419131
• Recruitment Status: Active, not recruiting
• First Posted: April 17, 2015
• Last Update Posted: December 20, 2019
• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborator: Wake Forest University
• Information provided by (Responsible Party): The University of Texas Health Science Center at San Antonio

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Post-traumatic Headache; PTSD	Behavioral: Behavioral Headache Therapy; Behavioral: Cognitive Processing Therapy; Behavioral: Treatment as Usual	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 192 participants
• 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
• Study Start Date: May 2015
• Actual Primary Completion Date: May 30, 2019
• Estimated Study Completion Date: June 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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

Secondary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• 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

Locations

United States, Texas

San Antonio VA Medical Center

San Antonio, Texas, United States, 78229

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio

Wake Forest University

Investigators

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

More Information

Additional Information:

Related Info 

• Responsible Party: The University of Texas Health Science Center at San Antonio
• ClinicalTrials.gov Identifier: NCT02419131
• Other Study ID Numbers: HSC2014339H
• First Posted: April 17, 2015
• Last Update Posted: December 20, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Data sharing as per CAP (Consortium to Alleviate PTSD) established protocol.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Post-Traumatic Headache; Headache; Pain; Neurologic Manifestations; Signs and Symptoms; Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases