Actively Recruiting
Cognitive Behavioral Therapy Via Telehealth Plus Amitriptyline Compared to Cognitive Behavioral Therapy Alone for Pediatric Migraine Prevention
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-03-06
400
Participants Needed
15
Research Sites
21 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to improve preventive treatment options for children and adolescents with migraine, a condition that affects about 10% of youth and often continues into adulthood. The study compares two approaches: Cognitive Behavioral Therapy (CBT) delivered via telehealth combined with a clinically prescribed medication called amitriptyline, versus CBT alone. The goal is to enhance access to effective, evidence-based care for young people with migraine and to clarify current first-line treatment methods used by healthcare providers. Participants will be involved in the study for about 28 weeks. After a 4-week baseline period, they will receive six telehealth CBT sessions over 8 weeks. One group will also take daily amitriptyline medication, which will be prescribed and managed by their headache provider with dose adjustments during this period. For the following 16 weeks, the medication dose will be maintained while all participants attend three "booster" CBT sessions to support ongoing migraine prevention. Throughout the study, participants will complete headache diaries and questionnaires to track headache frequency and disability. Researchers will measure changes in headache days and disability scores from baseline to post-treatment. Safety and tolerability of both CBT and amitriptyline will be monitored from randomization through the end of the study. The study assesses how well these treatments work in real-world care for pediatric migraine.
CONDITIONS
Brief Title
Responding With Evidence and Access for Childhood Headaches
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of migraine with or without aura or continuous headache including migranous episodes based on clinical criteria
- At least 4 headache days in the 28 days before randomization
- Eligible for clinical prescription of amitriptyline as preventive migraine treatment
- Able to complete study visits and questionnaires in English
- Age between 10 and 17 years
You will not qualify if you...
- Currently receiving amitriptyline and/or CBT specific to headache care
- Taking other prescribed preventive migraine medication within a period less than 5 half-lives before baseline
- Currently treated with Botox or CGRP-based monoclonal antibodies for migraine prevention
- Pregnant youth
- Current or recent suicidal thoughts or attempts, history of bipolar disorder, prolonged QT interval, significant constipation, or gastroparesis
- Any other condition deemed by the investigator to interfere with study participation or medical care needs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 weeks
Participants complete a 4-week baseline period before starting treatment.
Duration - 8 weeks
Participants receive 6 telehealth Cognitive Behavioral Therapy (CBT) sessions over 8 weeks. Participants in the amitriptyline group also begin taking a daily pill with dosage gradually increased based on tolerability. CBT sessions include involvement of a parent/legal guardian in 2 sessions.
6 telehealth CBT sessions over 8 weeks
Duration - 16 weeks
Participants maintain the dose of amitriptyline if applicable and attend 3 "booster" CBT sessions over 16 weeks.
3 telehealth booster CBT sessions over 16 weeks
Trial Site Locations
Total: 15 locations
1
University of Alabama at Birmingham Children's of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Phoenix Children's Hospital - Barrow Neurological Institute
Phoenix, Arizona, United States, 85016-7710
Actively Recruiting
3
University of California San Francisco
San Francisco, California, United States, 94115
Actively Recruiting
4
University of Colorado/Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Nemours Children's Health System
Wilmington, Delaware, United States, 19810
Actively Recruiting
6
Clinical Integrative Research Center of Atlanta, Inc
Atlanta, Georgia, United States, 30328
Actively Recruiting
7
University of Louisville Health/Norton
Louisville, Kentucky, United States, 40292
Actively Recruiting
8
Louisiana State Univ/Children's Hospital of New Orleans
New Orleans, Louisiana, United States, 70118-5720
Actively Recruiting
9
Dent Neurological Institute
Amherst, New York, United States, 14226
Actively Recruiting
10
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
11
Nationwide Childrens
Columbus, Ohio, United States, 43205
Actively Recruiting
12
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
13
University of Tennessee Health Science Center/ LeBonheur Children's Hospital
Memphis, Tennessee, United States, 38103
Actively Recruiting
14
Dell Children's Hospital-UT Health
Austin, Texas, United States, 78712
Actively Recruiting
15
Marshall Health
Huntington, West Virginia, United States, 25701
Actively Recruiting
Research Team
L
LeighAnn Chamberlin, MEd
M
Megan Pfeiffer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here