NCT06077838 RELAXaHEAD for Headache Patients (Phase III)
| NCT ID | NCT06077838 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 356 participants |
| Start Date | 2023-11-08 |
| Primary Completion | 2028-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 356 participants in total. It began in 2023-11-08 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a fully powered, remote randomized control trial to evaluate RELAXaHEAD in people with migraine.
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)
Contact & Investigator
Mia T Minen, MD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT06077838 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 80 Years, studying Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06077838 currently recruiting?
Yes, NCT06077838 is actively recruiting participants. Contact the research team at Mia.minen@nyulangone.org for enrollment information.
Where is the NCT06077838 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06077838 clinical trial?
NCT06077838 is sponsored by NYU Langone Health. The principal investigator is Mia T Minen, MD at NYU Langone Health. The trial plans to enroll 356 participants.
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