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| Name | Class |
|---|---|
| Wake Forest University | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Headache Therapy | Experimental | A standard, manualized behavioral intervention for primary headache disorders |
|
| Cognitive Processing Therapy | Experimental | A gold-standard treatment for PTSD, called Cognitive Processing Therapy |
|
| Treatment as Usual | Active Comparator | Treatment as usual, receiving standard care for PTHA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Headache Therapy | Behavioral | A standard, manualized behavioral intervention for primary headache disorders |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | Baseline, 6 weeks (end of treatment), and 3 and 6 months post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald McGeary, PhD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Antonio VA Medical Center | San Antonio | Texas | 78229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41789860 | Derived | 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. | |
| 35759281 |
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Data sharing as per CAP (Consortium to Alleviate PTSD) established protocol.
At study completion when summary results are posted on ClinicalTrials.gov
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Subjects who were consented and randomized, but did not continue to therapy
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral Headache Therapy | A standard, manualized behavioral intervention for primary headache disorders Behavioral Headache Therapy: A standard, manualized behavioral intervention for primary headache disorders |
| FG001 | Cognitive Processing Therapy | A gold-standard treatment for PTSD, called Cognitive Processing Therapy |
| FG002 | Treatment as Usual | Treatment as usual, receiving standard care for PTHA Treatment as Usual: Treatment as usual, receiving standard care for PTHA |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Consent and Randomization |
|
| ||||||||||||||||||
| Randomization and Treatment |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral Headache Therapy | A standard, manualized behavioral intervention for primary headache disorders Behavioral Headache Therapy: A standard, manualized behavioral intervention for primary headache disorders |
| BG001 | Cognitive Processing Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent-to-treat | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks (end of treatment), and 3 and 6 months post-treatment |
|
Baseline to 6-month post-treatment follow-up for a total of approximately 7 months (+/- 2 weeks).
Adverse events were gathered at all study visits (i.e., treatment and assessment visits) and TAU participants were contacted twice during the treatment phase to assess for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Behavioral Headache Therapy | A standard, manualized behavioral intervention for primary headache disorders Behavioral Headache Therapy: A standard, manualized behavioral intervention for primary headache disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Psychiatric disorders | Systematic Assessment | Suicidal risk |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening PTSD symptoms | Psychiatric disorders | Systematic Assessment | PCL-5 score increase |
Trial limitations include the chosen primary outcome, blinding a behavioral trial, definition of PTH as headache onset within 3 months of head injury (instead of 7 days per ICHD-3 5.2.2), and missing data/dropout. Dropout and missing data from this trial were high, though consistent with dropout risk in this population.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tim Houle | Massachusetts General Hospital, Harvard Medical School | 617-724-2111 | thoule1@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 9, 2020 | Aug 12, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051298 | Post-Traumatic Headache |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Cognitive Processing Therapy | Behavioral | A gold-standard treatment for PTSD, called Cognitive Processing Therapy |
|
| Treatment as Usual | Behavioral | Treatment as usual, receiving standard care for PTHA |
|
| 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. |
| 35298210 | Derived | 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. |
| 32867535 | Derived | 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. |
| Completed 6-month Follow-up |
|
| Completed Post-Treatment Follow-up |
|
| Completed All Follow-up |
|
| Included in Analysis | Intent-to-treat analysis was primary: Treatment completion defined as: attending 6/8 CBTH sessions; attending 9/12 CPT sessions |
|
| COMPLETED | Completed all sessions |
|
| NOT COMPLETED |
|
|
A gold-standard treatment for PTSD, called Cognitive Processing Therapy Cognitive Processing Therapy: A gold-standard treatment for PTSD, called Cognitive Processing Therapy |
| BG002 | Treatment as Usual | Treatment as usual, receiving standard care for PTHA Treatment as Usual: Treatment as usual, receiving standard care for PTHA |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | 1 individual did not report gender | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | 2 individuals did not report ethnicity | Count of Participants | Participants |
|
| Race | 2 individuals did not report race | Count of Participants | Participants |
|
A standard, manualized behavioral intervention for primary headache disorders Behavioral Headache Therapy: A standard, manualized behavioral intervention for primary headache disorders 41 - contributed >= 1 HIT-6 outcome 40 - contributed >= 1 PCL-5 outcomes 65 - included in multiple imputation |
| OG001 | Cognitive Processing Therapy | A gold-standard treatment for PTSD, called Cognitive Processing Therapy Cognitive Processing Therapy: A gold-standard treatment for PTSD, called Cognitive Processing Therapy |
| OG002 | Treatment as Usual | Treatment as usual, receiving standard care for PTHA Treatment as Usual: Treatment as usual, receiving standard care for PTHA |
|
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks (end of treatment), and 3 and 6 months post-treatment |
|
|
|
|
| 0 |
| 65 |
| 0 |
| 65 |
| 0 |
| 65 |
| EG001 | Cognitive Processing Therapy | A gold-standard treatment for PTSD, called Cognitive Processing Therapy Cognitive Processing Therapy: A gold-standard treatment for PTSD, called Cognitive Processing Therapy | 0 | 64 | 0 | 64 | 2 | 64 |
| EG002 | Treatment as Usual | Treatment as usual, receiving standard care for PTHA Treatment as Usual: Treatment as usual, receiving standard care for PTHA | 0 | 64 | 0 | 64 | 0 | 64 |
|
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| D009422 | Nervous System Diseases |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| Male |
|
| Non-Hispanic |
|
| Asian |
|
| Black/African American |
|
| Native Hawaiian |
|
| White |
|
| Other |
|
|
| 3-Month Follow-up |
|
| 6-Month Follow-up |
|
| See above. | Mixed Models Analysis | Contrast of aggregate post-treatment outcomes between CPT and TAU | 0.01 | Contrast of aggregate post-treatment outcomes between CPT and TAU | Aggregated contrast CPT to TAU | -8.9 | 2-Sided | 95 | -15.9 | -1.9 | Superiority | Contrast of aggregate post-treatment outcomes between CPT and TAU |