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Behavioral Intervention
Brain Education and Wellness Program for Migraine
N/A
Recruiting
Led By Rebecca E Wells, MD, MPH
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-intervention at 32 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial tests two virtual treatments designed to improve migraine symptoms. 8 weekly sessions plus an online platform with content and learning are involved. Meds can stay the same during the study. Results may help improve migraine treatment.
Who is the study for?
This trial is for adults with migraines occurring 4-20 days a month, who've had migraines for at least a year. Participants must be fluent in English, able to attend 8 weekly online classes, and willing to keep headache logs. Pregnant women up to 16 weeks can join. Those with heavy alcohol/drug use, other clinical trial participation, meditation experience or unstable medical conditions are excluded.
What is being tested?
The study compares two non-drug virtual treatments aimed at improving life quality for migraine sufferers through an online platform over eight sessions. The effectiveness of these interventions will be evaluated while participants continue their usual migraine medications.
What are the potential side effects?
Since the interventions are non-drug educational programs focused on wellness and brain education delivered virtually, they do not have typical medication side effects; however, individual experiences may vary based on interaction with content.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-intervention at 32 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-intervention at 32 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Disability assessed using monthly Migraine Disability Assessment (mMIDAS) - Change in Migraine Disability from baseline to 8 weeks
Secondary study objectives
Anxiety assessed using Generalized Anxiety Disorder-7 (GAD-7) at 8 weeks - Change in anxiety from baseline to 8 weeks
Depression assessed using Patient Health Questionnaire (PHQ-8) Questionnaire - Change in Depression from baseline to 8 weeks
Disability assessed using monthly Migraine Disability Assessment (mMIDAS) at 20 weeks - Change in migraine disability from baseline to 20 weeks
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Brain Education and WELLness with Migraine Group BExperimental Treatment1 Intervention
8 weekly virtual sessions plus online platform
Group II: Brain Education and WELLness with Migraine Group AExperimental Treatment1 Intervention
8 weekly virtual sessions plus online platform
Find a Location
Who is running the clinical trial?
National Center for Complementary and Integrative Health (NCCIH)NIH
857 Previous Clinical Trials
671,649 Total Patients Enrolled
11 Trials studying Migraine
1,190 Patients Enrolled for Migraine
Wake Forest University Health SciencesLead Sponsor
1,394 Previous Clinical Trials
2,459,750 Total Patients Enrolled
6 Trials studying Migraine
655 Patients Enrolled for Migraine
Rebecca E Wells, MD, MPHPrincipal InvestigatorWake Forest University Health Sciences
4 Previous Clinical Trials
373 Total Patients Enrolled
3 Trials studying Migraine
229 Patients Enrolled for Migraine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have headaches from overusing my migraine medication.I regularly practice stress reduction techniques like meditation.I am pregnant and more than 16 weeks along.I have not tested positive for COVID-19 in the last 30 days.I have migraines, with headaches occurring 4-20 days a month.I haven't started any new migraine prevention treatments in the last 12 weeks or acute treatments in the last 4 weeks.I have had migraines for at least a year.I am 18 years old or older.My headaches significantly impact my daily life.I can attend 8 weekly online classes.I am pregnant and not more than 16 weeks along.
Research Study Groups:
This trial has the following groups:- Group 1: Brain Education and WELLness with Migraine Group B
- Group 2: Brain Education and WELLness with Migraine Group A
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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