Post-traumatic HeadacheNCT02419131
Cognitive-Behavior Therapy for Posttraumatic Headache
A study testing Behavioral Headache Therapy, Cognitive Processing Therapy and Treatment as Usual in people with Post-traumatic Headache and PTSD, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post-traumatic Headache, PTSD
- What is being tested?
- Behavioral Headache Therapy, Cognitive Processing Therapy and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2015to 10 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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]
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Antonio VA Medical Center
San Antonio, Texas, 78229
About this study
Official title: 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.
Read the 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.
- Conditions
- Post-traumatic Headache, PTSD
- Being tested
- Behavioral Headache Therapy, Cognitive Processing Therapy, Treatment as Usual
- Medical subject headings
- Post-Traumatic Headache, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Headache TherapyBehavioural
A standard, manualized behavioral intervention for primary headache disorders
Cognitive Processing TherapyBehavioural
A gold-standard treatment for PTSD, called Cognitive Processing Therapy
Treatment as UsualBehavioural
Treatment as usual, receiving standard care for PTHA
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Headache Therapy | Experimental | A standard, manualized behavioral intervention for primary headache disorders Receives: Behavioral: Behavioral Headache Therapy |
| Cognitive Processing Therapy | Experimental | A gold-standard treatment for PTSD, called Cognitive Processing Therapy Receives: Behavioral: Cognitive Processing Therapy |
| Treatment as Usual | Active comparator | Treatment as usual, receiving standard care for PTHA Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache-related Disability Scores on the Headache Impact Test 6 (HIT-6)
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. The Headache Impact Test (HIT-6) is a questionnaire for measuring the impact of headache. A total of six questions are completed by the patient. They focus on daily activities such as work, education, home situation and leisure time. The HIT-6 gives a general overview of the impact of headache, including pain intensity, impairment and other items. Each of the six questions of the HIT-6 receives a score from 6-13. The final HIT-6 score can range from 36 to 78. A higher score indicates more disability due to headache.
Measured: 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)
Post-traumatic stress scores will be assessed over time. The PTSD Checklist for DSM-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Items on the PCL-5 correspond with DSM-5 criteria for PTSD. Respondents are asked to rate how bothered they have been by each of 20 items in the past month on a 5- point. Likert scale ranging from 0-4. Items are summed to provide a total severity score (range = 0-80). A higher score indicates more PTSD.
0 = Not at all 1 = A little bit 2 = Moderately 3 = Quite a bit 4 = Extremely
Measured: Baseline, 6 weeks (end of treatment), and 3 and 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study start1 May 2015
- Primary completion30 May 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post-traumatic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University
- Responsible party
- Sponsor
- Investigators
- Donald McGeary, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419131
- Sponsor's protocol ID
- HSC2014339H
- Status last verified
- Aug 2024
- First submitted
- 9 Apr 2015
- Last updated
- 13 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing as per CAP (Consortium to Alleviate PTSD) established protocol.
Publications
Nabity PS, McGeary CA, Eapen BC, Houle TT, Resick PA, Moring JC, Reed DE 2nd, Jaramillo CA, Penzien DB, Litz BT, Young-McCaughan S, Keane TM, Peterson AL, McGeary DD; Consortium to Alleviate PTSD. Post-traumatic headache phenotypic characteristics and treatment utilization. Cephalalgia. 2026 Mar;46(3):3331024261421527. doi: 10.1177/03331024261421527. Epub 2026 Mar 6.
PubMed 41789860McGeary 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.
PubMed 35759281Moring 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.
PubMed 35298210McGeary 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.
PubMed 32867535
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coalition to Alleviate PTSD: Randomized Clinical Trial of Cognitive-Behavior Therapy for Posttraumatic Headache
- ClinicalTrials.gov ID
- NCT02419131
- Acronym / sponsor ID
- HSC2014339H
- Conditions
- Post-traumatic Headache, PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Wake Forest University
- Study start
- 1 May 2015 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 17 Apr 2015 (estimated)
- Results
- Posted 13 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Behavioral Headache Therapy | Experimental | Behavioral: Behavioral Headache TherapyA standard, manualized behavioral intervention for primary headache disorders |
| Cognitive Processing Therapy | Experimental | Behavioral: Cognitive Processing TherapyA gold-standard treatment for PTSD, called Cognitive Processing Therapy |
| Treatment as Usual | Active comparator | Behavioral: Treatment as UsualTreatment as usual, receiving standard care for PTHA |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Headache TherapyA standard, manualized behavioral intervention for primary headache disorders | Behavioural | Behavioral Headache Therapy |
| Cognitive Processing TherapyA gold-standard treatment for PTSD, called Cognitive Processing Therapy | Behavioural | Cognitive Processing Therapy |
| Treatment as UsualTreatment as usual, receiving standard care for PTHA | Behavioural | Treatment as Usual |
Primary outcome
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
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. The Headache Impact Test (HIT-6) is a questionnaire for measuring the impact of headache. A total of six questions are completed by the patient. They focus on daily activities such as work, education, home situation and leisure time. The HIT-6 gives a general overview of the impact of headache, including pain intensity, impairment and other items. Each of the six questions of the HIT-6 receives a score from 6-13. The final HIT-6 score can range from 36 to 78. A higher score indicates more disability due to headache.
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
Post-traumatic stress scores will be assessed over time. The PTSD Checklist for DSM-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Items on the PCL-5 correspond with DSM-5 criteria for PTSD. Respondents are asked to rate how bothered they have been by each of 20 items in the past month on a 5- point. Likert scale ranging from 0-4. Items are summed to provide a total severity score (range = 0-80). A higher score indicates more PTSD. 0 = Not at all 1 = A little bit 2 = Moderately 3 = Quite a bit 4 = Extremely
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41789860Nabity PS, McGeary CA, Eapen BC, Houle TT, Resick PA, Moring JC, Reed DE 2nd, Jaramillo CA, Penzien DB, Litz BT, Young-McCaughan S, Keane TM, Peterson AL, McGeary DD; Consortium to Alleviate PTSD. Post-traumatic headache phenotypic characteristics and treatment utilization. Cephalalgia. 2026 Mar;46(3):3331024261421527. doi: 10.1177/03331024261421527. Epub 2026 Mar 6.
- Derived from this study: PubMed 35759281McGeary 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.
- Derived from this study: PubMed 35298210Moring 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.
- Derived from this study: PubMed 32867535McGeary 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.
- Individual participant dataSharing planned: Yes. Data sharing as per CAP (Consortium to Alleviate PTSD) established protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald McGeary, PhD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Headache Therapy, Cognitive Processing Therapy and Treatment as Usual in people with Post-traumatic Headache and PTSD, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02419131, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.