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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Behavior therapy focused on sensations and avoidance behaviors
Education about ways to limit and manage headaches
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States
Enrollment rate
Number enrolled out of number approached
Time frame: 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
Time frame: 12 weeks
Attendance
Percent of participants attending 80+% of sessions
Time frame: During the 8-week intervention
Homework completion
Percent of participants completing 80+% of homework
Time frame: During the 8-week intervention
Credibility/Expectancy Questionnaire
Scale measuring how credible the intervention seemed to participants
Time frame: Week 12
Client Satisfaction Questionnaire
Scale measuring participant satisfaction with the intervention
Time frame: Week 12
Adverse events rated to the intervention
Adverse events determined to be caused by the intervention
Time frame: 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.
Time frame: Week 0 through Week 12
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