BridgeMD
New treatment option for Migraine
Official title RELAXaHEAD for Headache Patients (Phase III)
ClinicalTrials.gov ID: NCT06077838
What this study is testing
- What it's testing
- This study is a fully powered, remote randomized control trial to evaluate RELAXaHEAD in people with migraine.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 80
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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...
See the full eligibility 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 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...
- 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)
- 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...
- 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...
- Pregnant (because hormonal fluctuations in pregnancy can affect migraine outcomes)
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.