RightFit
RecruitingNot applicable

Responding With Evidence and Access for Childhood Headaches

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
10 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 months
  • Procedures mentioned: Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "CBT via telehealth while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline) will be compared to CBT via telehealth alone."
  • "This comparative effectiveness study will test CBT while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline) to CBT alone."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for young people with migraines. It compares cognitive behavioral therapy (CBT), which teaches skills to manage headaches, through video visits with and without amitriptyline, a pill used to prevent migraines.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have migraines with or without aura (warning signs, such as vision changes), or constant headaches that include migraine episodes, as confirmed by the study team.
  • May have headaches linked to using headache medicine too often.
  • Have at least 4 headache days recorded in a diary over 28 days before being assigned to a study group.
  • The study medical team agrees that amitriptyline is a suitable migraine prevention treatment for you.
  • Can complete study visits and forms in English.

Who can't join

  • Currently take amitriptyline or receive CBT for headaches.
  • Take another prescribed migraine prevention medicine, or stopped it too recently before the study's starting phase. The required wait depends on the medicine.
  • Currently receive Botox or CGRP antibody medicines to prevent migraines.
  • Are pregnant.
  • Have current or ongoing thoughts of suicide, or attempted suicide in the past 6 months.
  • Have a history of bipolar disorder or prolonged QT, a heart rhythm problem.
  • Have significant constipation or gastroparesis, a condition that slows stomach emptying.
  • Have another condition that the study doctor believes makes the study unsuitable or could interfere with your medical care.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study sites (15)

AL

AZ

CA

CO

DE

GA

KY

LA

NY

OH

PA

TN

TX

WV