RELAXaHEAD for Headache Patients (Phase III)

Last updated: October 8, 2024
Sponsor: NYU Langone Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain

Oral Facial Pain

Pain (Pediatric)

Treatment

RELAXaHEAD Smartphone App Version 1

RELAXaHEAD Smartphone App Version 2

Clinical Study ID

NCT06077838
22-01208
  • Ages 16-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 criteriabased 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 thestart 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 offerpreventive treatment (>4 headache days/month and those with more frequent migrainesincluding chronic migraine but exclude those with continuous headaches (30days/month))

  • MSQv2 score <75 for role restrictive function to ensure participants have sufficientreduced quality of life to potentially benefit from the intervention (see if thereis a positive effect of the intervention)

Exclusion

Exclusion Criteria:

  • Patients who have had CBT, Biofeedback, or other Relaxation Therapy for migraine inthe past year

  • Alcohol or other substance abuse as determined by self-report or prior documentationin 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 severedepressive symptoms based on the PHQ-9 12-14 (in those with PHQ-8 scores >15, moreintense intervention targeted to the depression may be needed, as depression is asignificant predictor of migraine chronification and people with migraine andcomorbid depression are more likely to be refractory to migraine treatments and tosuffer from medication overuse)

  • Unable or unwilling to follow a treatment program that relies on written andaudio-taped materials

  • Not having a smartphone (we do not believe this exclusion criterion will adverselyaffect equitable subject selection because the subject population specific to ourresearch question would only be able to access this application via smartphone if itwere to become publicly available, including subjects without smartphones would notbe pertinent to our research question and overall study goals).

  • Pregnant (because hormonal fluctuations in pregnancy can affect migraine outcomes)

Study Design

Total Participants: 356
Treatment Group(s): 2
Primary Treatment: RELAXaHEAD Smartphone App Version 1
Phase:
Study Start date:
November 08, 2023
Estimated Completion Date:
August 31, 2028

Study 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.

Connect with a study center

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

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