Children's Hospital Medical Center, Cincinnati
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.
Headache
Headache Disorders
Headache, Migraine
Migraine
Migraine Disorders
Migraine With Aura
Migraine Without Aura
Chronic Migraine
CBT
Amitriptyline
NA
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 |
| Estimated Enrollment : | 400 participants |
| Masking : | SINGLE |
| Masking Description : | Only the principal investigator will remain blinded to the randomization assignment. All other study staff including the project manager, assistant project manager, study statistician, site investigators and study staff, participants, and their parents will be aware of the treatment assignment. |
| Primary Purpose : | TREATMENT |
| Official Title : | Cognitive Behavioral Therapy Via Telehealth + Amitriptyline Compared to Cognitive Behavioral Therapy Via Telehealth: Pediatric Migraine Prevention (Responding With Evidence and Access for Childhood Headaches) |
| Actual Study Start Date : | 2023-08-22 |
| Estimated Primary Completion Date : | 2027-07-31 |
| Estimated Study Completion Date : | 2027-12-31 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 10 Years to 17 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
University of Alabama at Birmingham Children's of Alabama
Birmingham, alabama, United States, 35233
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Phoenix Children's Hospital - Barrow Neurological Institute
Phoenix, arizona, United States, 85016-7710
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University of California San Francisco
San Francisco, California, United States, 94115
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University of Colorado/Children's Hospital Colorado
Aurora, Colorado, United States, 80045
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Nemours Children's Health System
Wilmington, Delaware, United States, 19810
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Clinical Integrative Research Center of Atlanta, Inc
Atlanta, Georgia, United States, 30328
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University of Louisville Health/Norton
Louisville, Kentucky, United States, 40292
RECRUITING
Louisiana State Univ/Children's Hospital of New Orleans
New Orleans, Louisiana, United States, 70118-5720
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Dent Neurological Institute
Amherst, New York, United States, 14226
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
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Nationwide Childrens
Columbus, Ohio, United States, 43205
RECRUITING
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
RECRUITING
University of Tennessee Health Science Center/ LeBonheur Children's Hospital
Memphis, Tennessee, United States, 38103
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Dell Children's Hospital-UT Health
Austin, Texas, United States, 78712
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Marshall Health
Huntington, West Virginia, United States, 25701