Chronic daily headache (CDH; defined as 15 or more headache days per month) is a chronic pain condition associated with a great deal of pain, suffering and disability. Over one-third of patients seen in pediatric headache clinics have CDH. Development of effective interventions for youth with CDH could potentially prevent the progression of a very debilitating and costly condition into adulthood. There are currently no randomized clinical trials evaluating the treatment of CDH in pediatric patients. The current proposal is a randomized, controlled clinical trial testing the efficacy of combined behavioral and pharmacological treatment of chronic daily headache in youth age 10 to 17. Treatments combining pharmacological interventions with behavior change have been found to be efficacious in the treatment of adults with chronic pain, including headaches, but have been understudied in pediatric populations. In this study, we will investigate whether a combination of pain coping skills training (CST) and amitriptyline (AMI) is efficacious in reducing headache frequency, functional disability, and depressive symptoms in youth with CDH. Specifically, we will test the hypothesis that coping skills training combined with amitriptyline (CST+AMI) will be superior to amitriptyline + an attention control (AMI+ATT) after 20 weeks of treatment. Further, we will test whether subjects who receive CST+AMI will have significantly less frequent headache and reduced disability and depressive symptoms at 3, 6, 9, and 12 month follow-ups. Subjects (N=132) age 10 to 17 will be randomly assigned to one of the two treatment conditions. Subjects assigned to CST will complete 8 weekly sessions of coping skills training and two monthly maintenance-promoting sessions. Sessions will focus on teaching the youth biofeedback, muscle relaxation techniques, imagery, distraction, activity pacing, problem solving and use of calming techniques using a treatment manual specifically developed and pilot tested in youth with CDH. Subjects in the manualized ATT condition will receive the same amount of therapist support and attention but not the active behavioral intervention. Booster CST or ATT sessions will occur at each follow-up time point. Amitriptyline for all subjects will be stabilized at a dose of 1 mg/kg/day. Headache frequency, functional disability, pain and headache characteristics, quality of life, and depressive symptoms will be assessed before and after treatment, and reassessed at 3, 6, 9, and 12 months. The long term objective is to establish effective treatments for CDH in youth that lead to sustained benefits in terms of clinically significant reductions in headache frequency and functional disability. ? ? ?
