Mind and Body Approaches to Pain Reduction in Youth With Migraine

PHASE2CompletedINTERVENTIONAL
Enrollment

132

Participants

Timeline

Start Date

October 2, 2018

Primary Completion Date

February 24, 2025

Study Completion Date

June 30, 2025

Conditions
Headache, MigraineMigraineMigraine DisordersHeadache
Interventions
BEHAVIORAL

Cognitive Behavioral Therapy (CBT)

This intervention will consist of 8 weekly sessions. The duration of each session is about 45 minutes and will be led by a psychologist/therapist using a manualized protocol. About half of the sessions will be conducted in person and the remaining sessions will be offered via telehealth (Skype or phone).

DRUG

Placebo

The placebo pill will be administered once a day at home for 8 weeks, to be taken by mouth with or without food under the supervision of the participant's parent or guardian. To maintain blinding, all participants will receive 1 matching capsule as a daily dose to be taken each evening during the study.

DRUG

Amitriptyline

Amitriptyline will be administered once a day at home for 8 weeks, to be taken by mouth with or without food under the supervision of the participant's parent or guardian. To maintain blinding, all participants will receive 1 matching capsule as a daily dose to be taken each evening during the study. For this study, a dose of 0.25 mg/kg/day will be provided for the 1st 2 weeks, followed by a dose of 0.5 mg/kg/day for 2 weeks, 0.75 mg/kg/day for 2 weeks and a maximum dose of 1.0 mg/kg/day for 2 weeks based on tolerability. Participants experiencing tolerability issues, may be held a current dose rather than titrated to the next dosage if deemed appropriate by the study doctor.

BEHAVIORAL

Biofeedback-Assisted Relaxation Training (BART)

This intervention will consist of 8 weekly sessions. The duration of each session is about 45 minutes and will be led by a psychologist/therapist using a manualized protocol. About half of the sessions will be conducted in person and the remaining sessions will be offered via telehealth (Skype or phone).

BEHAVIORAL

Cognitive Reappraisal Training (CR)

This intervention will consist of 8 weekly sessions. The duration of each session is about 45 minutes and will be led by a psychologist/therapist using a manualized protocol. About half of the sessions will be conducted in person and the remaining sessions will be offered via telehealth (Skype or phone).

Trial Locations (1)

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

All Listed Sponsors
collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

lead

Children's Hospital Medical Center, Cincinnati

OTHER

NCT03472092 - Mind and Body Approaches to Pain Reduction in Youth With Migraine | Biotech Hunter | Biotech Hunter