An interventional study of RELAXaHEAD Smartphone App and In-Person Training in Migraine, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
The investigators aim to determine the feasibility of a migraine self-management program.
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 50 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: RELAXaHEAD Smartphone App · Behavioral: In-Person Training
Behavioral: RELAXaHEAD Smartphone App · Behavioral: Virtual Training
Participants will receive access to the smartphone application RELAXaHEAD, which contains features for migraine self-management including a headache diary.
Participants will receive in-person training in migraine self-management techniques.
Participants will receive virtual training in migraine self-management techniques.
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
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.
Time frame: Month 2
Plan to share: 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.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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