Cognitive Behavioral Therapy Via Telehealth + Amitriptyline Compared to Cognitive Behavioral Therapy Via Telehealth: Pediatric Migraine Prevention (Responding With Evidence and Access for Childhood Headaches)

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 17
Healthy Volunteers: f
View:

• Diagnosis: Migraine with or without aura that meets the International Classification of Headache Disorders (ICHD) criteria 5 or presentation of continuous headache that includes migranous episodes based upon headache history obtained by site PI or designee. (includes presentation with or without medication overuse headache as well)

• Headache Frequency: 4 or more headache days based upon prospective headache diary of 28 days prior to randomization

• Amitriptyline Eligible: Site PI or medical staff determined participant to be eligible for clinical prescription of amitriptyline as a preventive treatment for migraine

• English fluency: Able to complete the study visits and questionnaires in English

Locations
United States
Alabama
University of Alabama at Birmingham Children's of Alabama
RECRUITING
Birmingham
Arizona
Phoenix Children's Hospital - Barrow Neurological Institute
RECRUITING
Phoenix
California
University of California San Francisco
RECRUITING
San Francisco
Colorado
University of Colorado/Children's Hospital Colorado
RECRUITING
Aurora
Delaware
Nemours Children's Health System
RECRUITING
Wilmington
Georgia
Clinical Integrative Research Center of Atlanta, Inc
RECRUITING
Atlanta
Kentucky
University of Louisville Health/Norton
RECRUITING
Louisville
Louisiana
Louisiana State Univ/Children's Hospital of New Orleans
RECRUITING
New Orleans
New York
Dent Neurological Institute
RECRUITING
Amherst
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Nationwide Childrens
RECRUITING
Columbus
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Tennessee
University of Tennessee Health Science Center/ LeBonheur Children's Hospital
RECRUITING
Memphis
West Virginia
Marshall Health
RECRUITING
Huntington
Contact Information
Primary
LeighAnn Chamberlin, MEd
leighann.chamberlin@cchmc.org
513-636-9739
Backup
Megan Pfeiffer
megan.pfeiffer@cchmc.org
513-636-1846
Time Frame
Start Date: 2023-08-22
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 400
Treatments
Experimental: CBT while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline)
This intervention consists of Cognitive Behavioral (CBT), a mind and body based intervention using education on gate control theory of pain, behavioral strategies such as muscle relaxation, activity pacing, and cognitive strategies including distraction, problem solving, and using calming self-statements. This arm will also take a daily oral dose of Amitriptyline, which will be clinically prescribed and managed by the patient's headache provider.
Experimental: CBT alone
This intervention arm consists of 6 Cognitive Behavioral Therapy (CBT), a mind and body based intervention using education on gate control theory of pain, behavioral strategies such as muscle relaxation, activity pacing, and cognitive strategies including distraction, problem solving, and using calming self-statements.
Sponsors
Leads: Children's Hospital Medical Center, Cincinnati
Collaborators: Patient-Centered Outcomes Research Institute

This content was sourced from clinicaltrials.gov