drugset / Trial / NCT05889624
Responding With Evidence and Access for Childhood Headaches
Recruiting
400 enrolled
Children's Hospital Medical Center, Cincinnati
Patient-Centered Outcomes Research Institute · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
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.
Timeline
- Start
- 2023-08-22
- Primary completion
- 2027-07-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amitriptyline | Small molecule | — | Oral |