Post-Traumatic Headache
Conditions
Keywords
Headache, Behavior therapy, Brain Injuries, Traumatic
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALHeadache reprocessing
Behavior therapy focused on sensations and avoidance behaviors
BEHAVIORALHeadache education
Education about ways to limit and manage headaches
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Enrolled in healthcare at VA San Diego Healthcare System; 2. History of mild TBI (mTBI), or head injury that is below the diagnostic threshold for mTBI 3. Headache that had its lifetime onset or significantly worsened within 90 days of a concussive event 4. Headache has persisted for at least 90 days since its onset or worsening 5. No changes in past 3 months to medical management of headache or comorbid psychiatric symptoms, and no anticipated changes during the study interval 6. No current participation in psychological intervention for pain or headache
Exclusion criteria
1. History of moderate or severe traumatic brain injury 2. Uncontrolled bipolar, psychotic, or substance use disorder 3. Acute suicidality as determined by screening as high risk or has a history of suicide attempt within the past 1 year; 4. Other factors that would preclude participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment rate | Typically up to 3 months, from initial referral to decision to enroll or not | Number enrolled out of number approached |
| Attrition | 12 weeks | % of randomized who are lost to follow-up before week 12 |
| Attendance | During the 8-week intervention | Percent of participants attending 80+% of sessions |
| Homework completion | During the 8-week intervention | Percent of participants completing 80+% of homework |
| Credibility/Expectancy Questionnaire | Week 12 | Scale measuring how credible the intervention seemed to participants |
| Client Satisfaction Questionnaire | Week 12 | Scale measuring participant satisfaction with the intervention |
| Adverse events rated to the intervention | Full study period (28 weeks) | Adverse events determined to be caused by the intervention |
| Change in Headache Impact Test-6 score | Week 0 through Week 12 | A widely-used scale measuring the impact that headaches have on daily life. |
Countries
United States
Contacts
Primary ContactJoel Fishbein
Outcome results
None listed