Cognitive-Behavior Therapy for Posttraumatic Headache
Primary Purpose
Post-traumatic Headache, PTSD
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Headache Therapy
Cognitive Processing Therapy
Treatment as Usual
Sponsored by
About this trial
This is an interventional treatment trial for Post-traumatic Headache
Eligibility 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.
Sites / Locations
- San Antonio VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Behavioral Headache Therapy
Cognitive Processing Therapy
Treatment as Usual
Arm Description
A standard, manualized behavioral intervention for primary headache disorders
A gold-standard treatment for PTSD, called Cognitive Processing Therapy
Treatment as usual, receiving standard care for PTHA
Outcomes
Primary Outcome Measures
Headache-related disability scores on the Headache Impact Test 6 (HIT-6)
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.
Scores for symptoms of post-traumatic stress on the PTSD Checklist-5 (PCL-5)
Change in baseline post-traumatic stress scores will be assessed over time
Secondary Outcome Measures
Frequency of headache reported in daily diary records
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
Full Information
NCT ID
NCT02419131
First Posted
April 9, 2015
Last Updated
September 25, 2020
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
Wake Forest University
1. Study Identification
Unique Protocol Identification Number
NCT02419131
Brief Title
Cognitive-Behavior Therapy for Posttraumatic Headache
Official Title
Coalition to Alleviate PTSD: Randomized Clinical Trial of Cognitive-Behavior Therapy for Posttraumatic Headache
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2015 (Actual)
Primary Completion Date
May 30, 2019 (Actual)
Study Completion Date
October 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
Wake Forest University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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:
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);
A gold standard, manualized cognitive-behavioral intervention for headache; or
A gold-standard treatment for PTSD, called Cognitive Processing Therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Headache, PTSD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavioral Headache Therapy
Arm Type
Experimental
Arm Description
A standard, manualized behavioral intervention for primary headache disorders
Arm Title
Cognitive Processing Therapy
Arm Type
Experimental
Arm Description
A gold-standard treatment for PTSD, called Cognitive Processing Therapy
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Treatment as usual, receiving standard care for PTHA
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Headache Therapy
Intervention Description
A standard, manualized behavioral intervention for primary headache disorders
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy
Intervention Description
A gold-standard treatment for PTSD, called Cognitive Processing Therapy
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
Treatment as usual, receiving standard care for PTHA
Primary Outcome Measure Information:
Title
Headache-related disability scores on the Headache Impact Test 6 (HIT-6)
Description
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.
Time Frame
Baseline, 6 weeks (end of treatment), and 3 and 6 months post-treatment
Title
Scores for symptoms of post-traumatic stress on the PTSD Checklist-5 (PCL-5)
Description
Change in baseline post-traumatic stress scores will be assessed over time
Time Frame
Baseline, 6 weeks (end of treatment), and 3 and 6 months post-treatment
Secondary Outcome Measure Information:
Title
Frequency of headache reported in daily diary records
Description
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald McGeary, PhD
Organizational Affiliation
University of Texas Health Science Center, San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Antonio VA Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data sharing as per CAP (Consortium to Alleviate PTSD) established protocol.
Citations:
PubMed Identifier
35759281
Citation
McGeary DD, Resick PA, Penzien DB, McGeary CA, Houle TT, Eapen BC, Jaramillo CA, Nabity PS, Reed DE 2nd, Moring JC, Bira LM, Hansen HR, Young-McCaughan S, Cobos BA, Mintz J, Keane TM, Peterson AL. Cognitive Behavioral Therapy for Veterans With Comorbid Posttraumatic Headache and Posttraumatic Stress Disorder Symptoms: A Randomized Clinical Trial. JAMA Neurol. 2022 Aug 1;79(8):746-757. doi: 10.1001/jamaneurol.2022.1567.
Results Reference
derived
PubMed Identifier
35298210
Citation
Moring JC, Straud CL, Penzien DB, Resick PA, Peterson AL, Jaramillo CA, Eapen BC, McGeary CA, Mintz J, Litz BT, Young-McCaughan S, Keane TM, McGeary DD. PTSD symptoms and tinnitus severity: An analysis of veterans with posttraumatic headaches. Health Psychol. 2022 Mar;41(3):178-183. doi: 10.1037/hea0001113.
Results Reference
derived
PubMed Identifier
32867535
Citation
McGeary DD, Resick PA, Penzien DB, Eapen BC, Jaramillo C, McGeary CA, Nabity PS, Peterson AL, Young-McCaughan S, Keane TM, Reed D, Moring J, Sico JJ, Pangarkar SS, Houle TT; Consortium to Alleviate PTSD. Reason to doubt the ICHD-3 7-day inclusion criterion for mild TBI-related posttraumatic headache: A nested cohort study. Cephalalgia. 2020 Oct;40(11):1155-1167. doi: 10.1177/0333102420953109. Epub 2020 Aug 31.
Results Reference
derived
Links:
URL
https://tango.uthscsa.edu/strongstar/subs/cpinfo.asp?prj=500
Description
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