Health TrialsbyHealthPanel

RELAXaHEAD for Headache Patients (Phase III)

ConditionMigraine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-80
SponsorNYU Langone Health

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • RELAXaHEAD Smartphone App Version 1

    Behavioral

    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 2

    Behavioral

    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.

Treatment groups

450 Participants
are divided into 2 treatment groups
Group A: RELAX Group 1Active comparator 1 intervention
Group B: RELAX Group 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, Week 6

Secondary outcomes

1

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.

Time frame
Baseline, Week 6
2

Change in Monthly Headache Days (MHDs)

MHDs data derived from the mMIDAS questionnaire and electronic diary.

Time frame
Baseline, Week 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

National Institutes of Health (NIH)

Collaborator

Source ClinicalTrials.gov
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