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| ID | Type | Description | Link |
|---|---|---|---|
| 1IK2RD001566-01A1 | Other Grant/Funding Number | VA |
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This study will test a new treatment, called Headache reprocessing, for persistent post-traumatic headache. The new treatment will be compared to a headache education intervention. The main objectives of the study are to examine the feasibility, safety, and clinical appropriateness of the new treatment.
Persistent post-traumatic headache (PPTH) is a common, debilitating health condition affecting Veterans and civilians. Relative to other headache disorders, PPTH is especially severe and impairing. PPTH has no established first-line treatments at this time. This research seeks to develop a new behavioral treatment, called headache reprocessing, to target fear and avoidance behaviors and cognitions, and associated neural changes, that drive PPTH. This trial will test the feasibility, safety, and clinical appropriateness of Headache Reprocessing Therapy by comparing it to a headache education control condition in a randomized controlled trial. We will randomize 60 Veterans with PPTH to take part in this study. Headache reprocessing and the educational control intervention will be delivered in group format over eight sessions (one per week for eight weeks). This intervention has the potential to improve available treatment options for PPTH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Headache reprocessing | Experimental | Behavior therapy focused on sensations and avoidance behaviors |
|
| Headache education | Active Comparator | Education about ways to limit and manage headaches |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Headache reprocessing | Behavioral | Behavior therapy focused on sensations and avoidance behaviors |
|
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment rate | Number enrolled out of number approached | Typically up to 3 months, from initial referral to decision to enroll or not |
| Attrition | % of randomized who are lost to follow-up before week 12 | 12 weeks |
| Attendance | Percent of participants attending 80+% of sessions | During the 8-week intervention |
| Homework completion | Percent of participants completing 80+% of homework | During the 8-week intervention |
| Credibility/Expectancy Questionnaire | Scale measuring how credible the intervention seemed to participants | Week 12 |
| Client Satisfaction Questionnaire | Scale measuring participant satisfaction with the intervention | Week 12 |
| Adverse events rated to the intervention | Adverse events determined to be caused by the intervention | Full study period (28 weeks) |
| Change in Headache Impact Test-6 score | A widely-used scale measuring the impact that headaches have on daily life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joel Fishbein | Contact | (858) 642-3870 | joel.fishbein2@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Joel Fishbein | VA San Diego Healthcare System, San Diego, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System, San Diego, CA | San Diego | California | 92161-0002 | United States |
Final datasets in machine-readable format will be shared via PubMed Central
Available upon study completion, indefinite
Public access
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| ID | Term |
|---|---|
| D051298 | Post-Traumatic Headache |
| D006261 | Headache |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Headache education | Behavioral | Education about ways to limit and manage headaches |
|
| Week 0 through Week 12 |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |