RECRUITING

RELAXaHEAD for Headache Patients (Phase III)

Conditions

Migraine Smartphone App Headache Diary Headache Tracking

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Single-Center Phase 3 Study of RELAXaHEAD: A Behavioral Approach to Remote Migraine Management in Primary Care

Quick Facts

Study Start:2023-11-08

Study Completion:2028-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06077838

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 continuous headaches (30 days/month)) * 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 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) * 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 application via smartphone if it were to become publicly available, including subjects without smartphones would not be pertinent to our research question and overall study goals). * Pregnant (because hormonal fluctuations in pregnancy can affect migraine outcomes)

Inclusion Criteria

Exclusion 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 continuous headaches (30 days/month))
* 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 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)
* 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 application via smartphone if it were to become publicly available, including subjects without smartphones would not be pertinent to our research question and overall study goals).
* Pregnant (because hormonal fluctuations in pregnancy can affect migraine outcomes)

Contacts and Locations

Study Contact

Mia T Minen, MD

CONTACT

2122637744

Mia.minen@nyulangone.org

Erin Waire

CONTACT

929-455-5584

Erin.Waire@nyulangone.org

Principal Investigator

Mia T Minen, MD

PRINCIPAL_INVESTIGATOR

NYU Langone Health

Study Locations (Sites)

NYU Langone Health

New York, New York, 10016

United States

Collaborators and Investigators

Sponsor: NYU Langone Health

Mia T Minen, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-08

Study Completion Date2028-08-31

Study Record Updates

Study Start Date2023-11-08

Study Completion Date2028-08-31

Terms related to this study

Keywords Provided by Researchers

Migraine
Smartphone App
Headache Diary
Headache Tracking

Additional Relevant MeSH Terms

Migraine