Clinical Trial
132 youth age 10 to 17 years with chronic daily headache will participate in a trial comparing combined behavioral and pharmacological treatment (N = 66) to pharmacological treatment (N = 66) over a five month period, with the goal of demonstrating greater reduction in headache frequency and headache-related disability for the combined versus the single therapy.
The primary objective of this study is to test the efficacy of combined behavioral and pharmacological treatment on two primary endpoints: headache frequency (# of headache days per month) and functional disability (PedMIDAS score).
The second major objective is to evaluate whether youth who receive combined behavioral and pharmacological treatment, including booster behavioral treatment sessions every 3 months, show sustained improvement in headache frequency and functional disability at 3, 6, 9, and 12 month follow-ups. The long term goal of this research is to establish effective treatments that will lead to sustained benefit in terms of significantly reduced headache frequency and significantly improved daily functioning in youth with chronic daily headache.
National Institutes of Health / National Institute of Neurological Disorders and Stroke (1 R01 NS050536-01A1)
Drug & Non-Drug Treatment of Pediatric Chronic Headache
(Direct Costs: $1,510,854)
