MigraineNCT06077838
RELAXaHEAD for Headache Patients (Phase III)
A study testing RELAXaHEAD Smartphone App Version 1 and RELAXaHEAD Smartphone App Version 2 in people with Migraine, run by NYU Langone Health at 1 site in United States.
Trial summary
This study is a fully powered, remote randomized control trial to evaluate RELAXaHEAD in people with migraine. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Migraine
- What is being tested?
- RELAXaHEAD Smartphone App Version 1 and RELAXaHEAD Smartphone App Version 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2023to 31 Aug 2028
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: A Single-Center Phase 3 Study of RELAXaHEAD: A Behavioral Approach to Remote Migraine Management in Primary Care
This study is a fully powered, remote randomized control trial to evaluate RELAXaHEAD in people with migraine.
Read the detailed description
Patients with migraine seen across diverse primary care practices (through three different affiliated hospitals and one of the largest family health center groups in the country) will be identified via an electronic medical record system. The investigators will randomize 356 participants and examine the potential benefits to two different smartphone based interventions between baseline and weeks 3-6. The investigators will also examine the persistence of effects up to 26 weeks post-treatment, mediators to explore mechanisms, and moderators to identify subgroups of patients for whom the intervention seems most effective.
- Conditions
- Migraine
- Being tested
- RELAXaHEAD Smartphone App Version 1, RELAXaHEAD Smartphone App Version 2
- Keywords
- Migraine, Smartphone App, Headache Diary, Headache Tracking
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RELAXaHEAD Smartphone App Version 1Behavioural
RELAXaHEAD is a smartphone application that allows users to track headache frequency and severity, sleep, medication, medication side effects, and menstrual cycle, and create personal notes daily. The RELAXaHEAD app has an option for users to view their data reports and charts.
RELAXaHEAD Smartphone App Version 2Behavioural
RELAXaHEAD is a smartphone application that allows users to track headache frequency and severity, sleep, medication, medication side effects, and menstrual cycle, and create personal notes daily. The RELAXaHEAD app has an option for users to view their data reports and charts. This version also contains audio materials.
| Study group | Role | What they receive |
|---|---|---|
| RELAX Group 1 | Active comparator | Participants will receive access to the RELAXaHEAD app version 1 which contains certain features for migraine self-management with written materials. Receives: Behavioral: RELAXaHEAD Smartphone App Version 1 |
| RELAX Group 2 | Active comparator | Participants will receive access to the RELAXaHEAD app version 2 which contains certain features for migraine self-management with written and audio materials. Receives: Behavioral: RELAXaHEAD Smartphone App Version 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Modified Monthly Migraine Disability Assessment Scale (mMIDAS) Score
5-item scale designed to measure disability over the previous 4 weeks. The total score is the sum of missed days due to a migraine from paid work, school, housework, and nonwork (family, social, and leisure) activities and days at paid work or housework where productivity was reduced by at least half. A decrease in scores indicates disability decreased during the observational period.
Measured: Baseline, Week 6
Secondary outcomes (2)
Change in Migraine Specific Quality of Life (MSQ) Version 2 Scores
14-item self-assessment of how migraine affects a patient's life. Items ranked on a 6-point Likert scale, where: 1 = None of the time; 2 = A little bit of the time; 3 = Some of the time; 4 = A good bit of the time; 5 = Most of the time; and 6 = All of the time. Raw dimension scores are computed as a sum of item responses and rescaled on a 0-100 scale; higher scores indicate better quality of life.
Measured: Baseline, Week 6
Change in Monthly Headache Days (MHDs)
MHDs data derived from the mMIDAS questionnaire and electronic diary.
Measured: Baseline, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start8 Nov 2023
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Mia T Minen, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077838
- Sponsor's protocol ID
- 22-01208
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2023
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: mia.minen@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.