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NCT06077838Recruiting

RELAXaHEAD for Headache Patients (Phase III)

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

Source: ClinicalTrials.gov · Last updated 8 Oct 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Interventional
Enrollment
450 (estimated)
First submitted
5 Oct 2023
Start date
8 Nov 2023
Primary completion date
31 Aug 2028
Lead sponsor
NYU Langone Health
Diseases
Migraine
NCT number
NCT06077838

What you commit to

  • Study type: Interventional
  • Planned participants: 450
  • From 8 Nov 2023 to the primary completion date, 31 Aug 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)

Other

  • 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)

Who the study is looking for

  • 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)

Age in the registry: 16 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
NYU Langone Health
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.