This comparative effectiveness study will clarify current first-line preventive treatment approaches for use by neurologists, psychologists, and primary care providers in the context of real world care, and will demonstrate the feasibility of Cognitive Behavioral Therapy (CBT) via telehealth for youth with migraine. The focus is on applying evidence-based care and enhancing access to it. CBT via telehealth while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline) will be compared to CBT via telehealth alone.
Migraine is the second most disabling disease in the world. Research has primarily focused on treating migraine in adults; however, approximately 10% of children and adolescents have migraine, suggesting that up to 7 million youth are impacted in the United States alone. Given that the majority of youth have migraine symptoms that persist into adulthood, there is a critical need to identify and improve access to the most effective preventive migraine treatments for this population as a means of reducing the long-term healthcare burden and functional impairment of this illness. This comparative effectiveness study will test CBT while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline) to CBT alone. Participants will be involved in the study for approximately 28 weeks, with the first 4 weeks being a baseline period and the next 8 weeks involving six telehealth CBT sessions for both study groups (CBT while taking a clinically-prescribed pill-based prevention therapy \[amitriptyline\] compared to CBT alone), and dose titration of clinically-prescribed medication (amitriptyline) for the CBT + clinically-prescribed, pill-based prevention therapy (amitriptyline) group. During the remaining 16 weeks the participants will maintain the dose of medication (in the CBT + clinically-prescribed, pill-based prevention therapy (amitriptyline) group) and attend "booster" CBT sessions held three times over 4 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
400
During an 8-week active treatment, participants will receive 6 telehealth CBT sessions, followed by a maintenance phase (16 weeks) when participants will receive 3 "booster" CBT sessions. The sessions will be conducted by teletherapists from the Clinical Coordinating Center at Cincinnati Children's using a standardized treatment manual. A parent/legal guardian will be included in 2 sessions teaching ways to be active coaches, encouraging use of effective coping skills and refraining from reinforcement of maladaptive coping. Each session will be about 45 minutes.
During an 8-week active treatment, participants will begin taking a daily pill (amitriptyline) prescribed and managed clinically by the site headache provider. Amitriptyline will be taken once a day before bedtime. The weight based dosage will gradually be increased based on tolerability and a standardized titration protocol during the 8 week active treatment. The participant will remain on a maximum tolerated dose for the final 16 weeks (maintenance).
University of Alabama at Birmingham Children's of Alabama
Birmingham, Alabama, United States
RECRUITINGPhoenix Children's Hospital - Barrow Neurological Institute
Phoenix, Arizona, United States
RECRUITINGUniversity of California San Francisco
San Francisco, California, United States
RECRUITINGUniversity of Colorado/Children's Hospital Colorado
Aurora, Colorado, United States
RECRUITINGNemours Children's Health System
Wilmington, Delaware, United States
RECRUITINGClinical Integrative Research Center of Atlanta, Inc
Atlanta, Georgia, United States
RECRUITINGUniversity of Louisville Health/Norton
Louisville, Kentucky, United States
RECRUITINGLouisiana State Univ/Children's Hospital of New Orleans
New Orleans, Louisiana, United States
RECRUITINGDent Neurological Institute
Amherst, New York, United States
RECRUITINGCincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
RECRUITING...and 4 more locations
Change in number of headache days
This outcome measures whether there is a 50% reduction in the number of headaches days based on a self reported daily headache diary, per 28-day period, between the two arms.
Time frame: baseline to weeks 4-8 to weeks 20-24 (post treatment)
Reduction to a PedMIDAS score of 20 or less
The PedMIDAS scale which evaluates the impact of headaches in school, home, play, and social activities, is comprised of six items that pertain to days missed in various activities over the past 90 days. Questions are answered by the youth in consultation with their parents and reviewed by study staff. The PedMIDAS scale is administered at baseline (covering the three months prior to enrollment) and at the endpoint visit (covering last three months of enrollment). This outcome measures whether there is a reduction in migraine related disability measured by the Pediatric Migraine Disability Scale (PedMIDAS) between the two arms. A reduction to a score of 20 or less, indicating mild impact of less is a meaningful outcome for patients and families and considered clinically significant.
Time frame: baseline to weeks 20-24 (post treatment)
Change in absolute headache disability score on PedMIDAS
The PedMIDAS scale which evaluates the impact of headaches in school, home, play, and social activities, is comprised of six items that pertain to days missed in various activities over the past 90 days. Questions are answered by the youth in consultation with their parents and reviewed by study staff. The PedMIDAS scale is administered at baseline (covering the three months prior to enrollment) and at the post treatment visit (covering last three months of enrollment). A total PedMIDAS score (sum of items 1-6) was used in this study. Scores range from 0-240; with a score of 0-10 indicating no disability, 11-30 mild disability, 31-50 moderate disability, and more than 50 severe disability in daily activities.
Time frame: baseline to weeks 20-24 (post treatment)
Change in absolute headache days
This outcome measures whether there is an absolute reduction in the number of headaches days based on a self reported daily headache diary, per 28-day period, between the two arms.
Time frame: baseline to weeks 4-8 to weeks 20-24 (post treatment)
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