HeadacheNCT05889624
Responding With Evidence and Access for Childhood Headaches
A study testing CBT and Amitriptyline in people with Headache and Headache Disorders, run by Children's Hospital Medical Center, Cincinnati at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Headache, Headache Disorders, Headache, Migraine
- What is being tested?
- CBT and Amitriptyline
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 15 sitesUnited States
- Study dates
- 22 Aug 2023to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Current treatment includes amitriptyline and/or CBT specific to headache care
- Current prescribed preventive antimigraine medication within a period equivalent to < 5 half-lives of that medication before entering the baseline phase
- Current treatment with onabotulinumtoxinA (Botox) or CGRP-based monoclonal antibody medications for migraine prevention
- Youth who are pregnant
- Report of current or ongoing suicidal thoughts. Suicide attempt within the past six months. History of bipolar disorder, prolonged QT, or pre-existing significant constipation or gastroparesis
- Any and all other diagnoses or conditions which, in the opinion of the site investigator, would prevent the patient from being a suitable candidate for the study or interfere with the medical care needs of the participant
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
United States15 sites, 15 recruiting
- Recruiting
Dent Neurological Institute
Amherst, New York, 14226
Andrea Bryan, 716-250-2017, abryan@dentinstitute.com
Jennifer McVige, MD
- Recruiting
Clinical Integrative Research Center of Atlanta, Inc
Atlanta, Georgia, 30328
Jazmine Roman, 678-528-0961, jroman@pandaneuro.com
Frank Berenson, MD
- Recruiting
University of Colorado/Children's Hospital Colorado
Aurora, Colorado, 80045
Andrew Levine, andrew.levine@childrenscolorado.org
Marcy Yonker, MD
- Recruiting
Dell Children's Hospital-UT Health
Austin, Texas, 78712
Valerie Cuellar, 512-324-0000 ext. 15825, valerie.cuellar@utexas.edu
Sara Pavitt, MD
- Recruiting
University of Alabama at Birmingham Children's of Alabama
Birmingham, Alabama, 35233
Julio Sebastian Domingo, 205-638-6821, jsebastiandomingo@uabmc.edu
Scott Turner, DNP
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Paula LaFollette, 513-636-1840, reachstudy@cchmc.org
Joanne Kacperski, MD
- Recruiting
Nationwide Childrens
Columbus, Ohio, 43205
Alyssa Deeter, Alyssa.Deeter@nationwidechildrens.org
Ann Pakalnis, MD
- Recruiting
Marshall Health
Huntington, West Virginia, 25701
Hillary Salava, 304-691-6859, riegel@marshall.edu
Ivan Lopez, MD
- Recruiting
Norton Children's Neuroscience Institute/ UofL School of Medicine
Louisville, Kentucky, 40292
Lauren Evanczyk, lauren.evanczyk@nortonhealthcare.org
Elizabeth Doll, MD
- Recruiting
University of Tennessee Health Science Center/ LeBonheur Children's Hospital
Memphis, Tennessee, 38103
Talia Hill, talia.hill@lebonheur.org
Ankita Gosh, MD
- Recruiting
Louisiana State Univ/Children's Hospital of New Orleans
New Orleans, Louisiana, 70118-5720
Kathryn Peneguy, Kathryn.Peneguy@lcmchealth.org
Rashmi Rao, MD
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Blanca Marquez de Prado, 267-602-9784, marquezdeb@chop.edu
Christina Szperka, MD
- Recruiting
Phoenix Children's Hospital - Barrow Neurological Institute
Phoenix, Arizona, 85016-7710
Nigel Negm, nnegm@phoenixchildrens.com
Reena Rastogi, Md
- Recruiting
University of California San Francisco
San Francisco, California, 94115
Rahel Abraham, Rahel.Abraham@ucsf.edu
Hannah Shapiro, MD
- Recruiting
Nemours Children's Health System
Wilmington, Delaware, 19810
Jessica Rayfield, 302-651-6979, jessica.rayfield@nemours.com
Judy Adelizzi-Delany, DNP
About this study
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)
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.
Read the detailed description
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.
- Conditions
- Headache, Headache Disorders, Headache, Migraine, Migraine, Migraine Disorders, Migraine With Aura
- Being tested
- CBT, Amitriptyline
- Keywords
- headache, migraine, cognitive behavioral therapy, pediatrics, diaphragmatic breathing, progressive muscle relaxation, imagery, relaxation, biofeedback
- Medical subject headings
- Headache, Headache Disorders, Migraine Disorders, Migraine with Aura, Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBTBehavioural
Also called Cognitive Behavioral Therapy
During an 8-week active treatment, participants will receive 6 telehealth CBT sessions, followed by a maintenance phase (16 weeks) when participants will receive 3 "booster" CBT sessions. The sessions will be conducted by teletherapists from the Clinical Coordinating Center at Cincinnati Children's using a standardized treatment manual. A parent/legal guardian will be included in 2 sessions teaching ways to be active coaches, encouraging use of effective coping skills and refraining from reinforcement of maladaptive coping. Each session will be about 45 minutes.
AmitriptylineDrug
During an 8-week active treatment, participants will begin taking a daily pill (amitriptyline) prescribed and managed clinically by the site headache provider. Amitriptyline will be taken once a day before bedtime. The weight based dosage will gradually be increased based on tolerability and a standardized titration protocol during the 8 week active treatment. The participant will remain on a maximum tolerated dose for the final 16 weeks (maintenance).
| Study group | Role | What they receive |
|---|---|---|
| CBT while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline) | Experimental | 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. Receives: Behavioral: CBT; Drug: Amitriptyline |
| CBT alone | Experimental | 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. Receives: Behavioral: CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of headache days
This outcome measures whether there is a 50% reduction in the number of headaches days based on a self reported daily headache diary, per 28-day period, between the two arms.
Measured: baseline to weeks 4-8 to weeks 20-24 (post treatment)
Reduction to a PedMIDAS score of 20 or less
The PedMIDAS scale which evaluates the impact of headaches in school, home, play, and social activities, is comprised of six items that pertain to days missed in various activities over the past 90 days. Questions are answered by the youth in consultation with their parents and reviewed by study staff. The PedMIDAS scale is administered at baseline (covering the three months prior to enrollment) and at the endpoint visit (covering last three months of enrollment).
This outcome measures whether there is a reduction in migraine related disability measured by the Pediatric Migraine Disability Scale (PedMIDAS) between the two arms. A reduction to a score of 20 or less, indicating mild impact of less is a meaningful outcome for patients and families and considered clinically significant.
Measured: baseline to weeks 20-24 (post treatment)
Secondary outcomes (4)
Change in absolute reduction in severe headache days
This outcome measures whether there is an absolute reduction in the number of severe headache days based on a self-reported daily headache diary, per 28-day period, between the two arms.
Measured: baseline to weeks 20-24 (post treatment)
Change in absolute headache days
This outcome measures whether there is an absolute reduction in the number of headache days based on a self-reported daily headache diary, per 28-day period, between the two arms.
Measured: baseline to weeks 4-8 to weeks 20-24 (post treatment)
Change in absolute headache disability score on PedMIDAS
The PedMIDAS scale which evaluates the impact of headaches in school, home, play, and social activities, is comprised of six items that pertain to days missed in various activities over the past 90 days. Questions are answered by the youth in consultation with their parents and reviewed by study staff. The PedMIDAS scale is administered at baseline (covering the three months prior to enrollment) and at the post treatment visit (covering last three months of enrollment).
A total PedMIDAS score (sum of items 1-6) was used in this study. Scores range from 0-240; with a score of 0-10 indicating no disability, 11-30 mild disability, 31-50 moderate disability, and more than 50 severe disability in daily activities.
Measured: baseline to weeks 20-24 (post treatment)
Safety and tolerability of treatments (CBT and Amitriptyline)
This outcome measures the safety and participant satisfaction of both treatment arms by examining the number of participants who complete the CBT sessions (both arms) and the number of participants who continue to take the Amitriptyline (CBT+pill group).
Measured: randomization to weeks 20-24 (post treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start22 Aug 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Scott Powers, PhD, Principal investigator, Cincinnati Childrens Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889624
- Sponsor's protocol ID
- REACH Study
- Other IDs
- MP-2021C3-24936
- Status last verified
- Sep 2026
- First submitted
- 10 May 2023
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No