MigraineNCT06077812
NYU Langone Health Headache Center Learning Migraine Self-Management Techniques Study
A study testing RELAXaHEAD Smartphone App, In-Person Training and Virtual Training in people with Migraine, run by NYU Langone Health at 1 site in United States.
Trial summary
The investigators aim to determine the feasibility of a migraine self-management program. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- RELAXaHEAD Smartphone App, In-Person Training and Virtual Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2023to 10 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking. (At this time, the validated app is only available in English.)
- 18-65 years of age
- Meets International Classification of Headache Disorder (ICHD)-3 migraine criteria based on a headache specialist or neurologist
- Headaches for ≥1 year
- Has not begun a new migraine preventative medication in the last month
- Agreement to not make any preventive medication changes from the time of trial start until 3 months after beginning the study (Note - Acute medications may be changed if needed. Changes in preventive and acute medication and the time initiated will be recorded to evaluate the potential for medication confounds)
- 4-29 headache days a month (so the study includes those in whom the investigators typically offer preventive treatment [>4 headache days/month] and those with more frequent migraines including chronic migraine [15 days or more/month] but exclude those with continuous headaches)
Who cannot join
- Diagnosis of Medication Overuse Headache (MOH)
- Patients who have had Cognitive Behavioral Therapy, 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
- Current opioid or barbiturate use
- PHQ-8 scores greater than 15, indicating a conservative score of moderately severe depressive symptoms based on the PHQ-9 (in this group, more intense psychological 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 develop medication overuse headache)
- Unable or unwilling to follow a treatment program that relies on written and audio-taped materials
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- Coronary heart disease, heart attack, stroke, diabetes mellitus Type 1 or II
- Pregnant (because hormonal fluctuations in pregnancy can affect migraine outcomes)
- Other physical limitations which would prevent participating in the standard protocol of biofeedback being studied
Trial locations and contacts
1 site in 1 country.
About this study
The investigators aim to determine the feasibility of a migraine self-management program.
Read the detailed description
Patients with migraine seen by neurologists/headache specialists within or affiliated with the NYU Langone Health system will be identified via electronic medical record system, or in person. The investigators will randomize 50 participants to an in-person migraine self-management protocol, or a remote migraine self-management protocol. The investigators will examine benefits through follow-up at 2, 4, and 6 month time points.
- Conditions
- Migraine
- Being tested
- RELAXaHEAD Smartphone App, In-Person Training, Virtual Training
- Keywords
- Migraine, Self-Management, Headache, Behavioral Intervention
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RELAXaHEAD Smartphone AppBehavioural
Participants will receive access to the smartphone application RELAXaHEAD, which contains features for migraine self-management including a headache diary.
In-Person TrainingBehavioural
Participants will receive in-person training in migraine self-management techniques.
Virtual TrainingBehavioural
Participants will receive virtual training in migraine self-management techniques.
| Study group | Role | What they receive |
|---|---|---|
| In-Person Migraine Self-Management | Active comparator | Not described Receives: Behavioral: RELAXaHEAD Smartphone App; Behavioral: In-Person Training |
| Remote Migraine Self-Management | Active comparator | Not described Receives: Behavioral: RELAXaHEAD Smartphone App; Behavioral: Virtual Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of In-Person Sessions Attended by Participants in the In-Person Migraine Self-Management Arm
Measured: Up to Month 2
Number of Days of At-Home Practice
Measured: Up to Month 2
Satisfaction Scores
Assessment of satisfaction with the intervention using a Likert scale from 1 to 5 with 1 being strongly disagree, and 5 being strongly agree; the total score is the response; higher scores indicate greater satisfaction with the intervention.
Measured: Month 2
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 start27 Nov 2023
- Primary completion6 Aug 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mia T Minen, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077812
- Sponsor's protocol ID
- 22-01149
- Status last verified
- Dec 2024
- First submitted
- 5 Oct 2023
- Last updated
- 16 Dec 2024
- 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 Dr. Mia Minen (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.
Publications
Szuhany KL, Dorf J, Bostic RC, Fanning KM, Minen MT. Predictors of response to biofeedback-assisted relaxation for migraine: An exploratory analysis. Cephalalgia. 2026 Jun;46(6):3331024261441579. doi: 10.1177/03331024261441579. Epub 2026 Jun 1.
PubMed 42220255
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NYU Langone Health Headache Center Learning Migraine Self-Management Techniques Study
- ClinicalTrials.gov ID
- NCT06077812
- Acronym / sponsor ID
- 22-01149
- Conditions
- Migraine
- Keywords
- Migraine, Self-Management, Headache, Behavioral Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to determine the feasibility of a migraine self-management program.
Detailed description
Patients with migraine seen by neurologists/headache specialists within or affiliated with the NYU Langone Health system will be identified via electronic medical record system, or in person. The investigators will randomize 50 participants to an in-person migraine self-management protocol, or a remote migraine self-management protocol. The investigators will examine benefits through follow-up at 2, 4, and 6 month time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-Person Migraine Self-Management | Active comparator | Behavioral: RELAXaHEAD Smartphone App, Behavioral: In-Person Training |
| Remote Migraine Self-Management | Active comparator | Behavioral: RELAXaHEAD Smartphone App, Behavioral: Virtual Training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- English speaking. (At this time, the validated app is only available in English.)
- 18-65 years of age
- Meets International Classification of Headache Disorder (ICHD)-3 migraine criteria based on a headache specialist or neurologist
- Headaches for ≥1 year
- Has not begun a new migraine preventative medication in the last month
Key exclusion criteria (9 listed)
- Diagnosis of Medication Overuse Headache (MOH)
- Patients who have had Cognitive Behavioral Therapy, 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
- Current opioid or barbiturate use
- PHQ-8 scores greater than 15, indicating a conservative score of moderately severe depressive symptoms based on the PHQ-9 (in this group, more intense psychological 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 develop medication overuse headache)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RELAXaHEAD Smartphone AppParticipants will receive access to the smartphone application RELAXaHEAD, which contains features for migraine self-management including a headache diary. | Behavioural | In-Person Migraine Self-Management, Remote Migraine Self-Management |
| In-Person TrainingParticipants will receive in-person training in migraine self-management techniques. | Behavioural | In-Person Migraine Self-Management |
| Virtual TrainingParticipants will receive virtual training in migraine self-management techniques. | Behavioural | Remote Migraine Self-Management |
Primary outcome
Number of In-Person Sessions Attended by Participants in the In-Person Migraine Self-Management Arm
Time frame: Up to Month 2
Number of Days of At-Home Practice
Time frame: Up to Month 2
Satisfaction Scores
Time frame: Month 2
Assessment of satisfaction with the intervention using a Likert scale from 1 to 5 with 1 being strongly disagree, and 5 being strongly agree; the total score is the response; higher scores indicate greater satisfaction with the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Derived from this study: PubMed 42220255Szuhany KL, Dorf J, Bostic RC, Fanning KM, Minen MT. Predictors of response to biofeedback-assisted relaxation for migraine: An exploratory analysis. Cephalalgia. 2026 Jun;46(6):3331024261441579. doi: 10.1177/03331024261441579. Epub 2026 Jun 1.
- Individual participant dataSharing planned: 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 Dr. Mia Minen (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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mia T Minen, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RELAXaHEAD Smartphone App, In-Person Training and Virtual Training in people with Migraine, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of In-Person Sessions Attended by Participants in the In-Person Migraine Self-Management Arm (time frame: Up to Month 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06077812, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.