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RELAXaHEAD for Headache Patients (Phase III)

A Single-Center Phase 3 Study of RELAXaHEAD: A Behavioral Approach to Remote Migraine Management in Primary Care

Who can join

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

Age
16 Years to 80 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

Not stated in the study description — ask the study team about visits and procedures.

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 tests the RELAXaHEAD app in people age 16 and older who have migraines. The study takes place remotely, and people are assigned to study groups by chance.

This study is a fully powered, remote randomized control trial to evaluate RELAXaHEAD in people with migraine.

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

Eligibility

Who can join

  • Speak English, since the tested app is only available in English.
  • Be age 16 or older.
  • Meet the study’s medical guidelines for migraines.
  • Have had headaches for at least 1 year, with a steady pattern for more than 3 months.
  • Agree not to change medicines used to prevent headaches for 3 months before the trial and during the 6 weeks of treatment.
  • Have headaches on 4 to 29 days each month.
  • Score below 75 on the daily activity part of the MSQv2 survey, showing that migraines limit daily life.

Who can't join

  • Have had migraine treatment in the past year using cognitive behavioral therapy (therapy to change thoughts and behaviors), biofeedback (training to control body responses), or other relaxation therapy.
  • Have alcohol or other substance abuse reported by you or listed in your medical record.
  • Have headaches caused by using headache medicine too often, or use opioids or barbiturates.
  • Score above 15 on the PHQ-8 depression survey, which suggests more serious depression symptoms.
  • Cannot or do not want to follow a treatment program using written materials and audio recordings.
  • Do not have a smartphone.
  • Are pregnant.

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

Official eligibility criteria

Inclusion Criteria: * English speaking. (At this time, the validated app is only available in English.) * ≥16 years of age * Meets International Classification of Headache Disorder (ICHD)-3 migraine criteria based on Information in the Study Manual * Headaches for ≥1 year with a stable pattern for the past \>3 months * Agreement to not make any preventive medication changes for the 3 months before the start of the trial and then the 6 weeks of the intervention part of the study * 4-29 headache days a month (so that we include those in whom we typically offer preventive treatment (\>4 headache days/month and those with more frequent migraines including chronic migraine but exclude those with continuous headaches (30 days/month)) * MSQv2 score \<75 for role restrictive function to ensure participants have sufficient reduced quality of life to potentially benefit from the intervention (see if there is a positive effect of the intervention) Exclusion Criteria: * Patients who have had CBT, Biofeedback, or other Relaxation Therapy for migraine in the past year * Alcohol or other substance abuse as determined by self-report or prior documentation in the medical record * Diagnosis of medication overuse headache and/or opioid or barbiturate use * PHQ-8 scores greater than 15, indicate a conservative score of moderately severe depressive symptoms based on the PHQ-9 12-14 (in those with PHQ-8 scores \>15, more intense intervention targeted to the depression may be needed, as depression is a significant predictor of migraine chronification and people with migraine and comorbid depression are more likely to be refractory to migraine treatments and to suffer from medication overuse) * Unable or unwilling to follow a treatment program that relies on written and audio-taped materials * Not having a smartphone (we do not believe this exclusion criterion will adversely affect equitable subject selection because the subject population specific to our research question would only be able to access this application via smartphone if it were to become publicly available, including subjects without smartphones would not be pertinent to our research question and overall study goals). * Pregnant (because hormonal fluctuations in pregnancy can affect migraine outcomes)

Study sites (1)

NY