← Back to Search

Telehealth Behavioral Therapy for Migraines (TeleBMM Trial)

N/A
Recruiting
Led By Elizabeth K Seng, Ph.D.
Research Sponsored by Albert Einstein College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Capacity to consent
Current self-reported symptoms meeting the International Classification for Headache Disorders -- 3 criteria for migraine
Must not have
Meeting criteria for probable medication overuse headache
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 through week 12
Awards & highlights

Summary

This trial will study whether a behavior-based telehealth program can help manage migraines. The program includes an app, online patient manual, and regular check-ins.

Who is the study for?
This trial is for individuals aged 18-65 with a physician's diagnosis of migraine, experiencing 4 to 20 headache days per month. Participants must meet the International Classification for Headache Disorders criteria for migraine, be able to read English, and consent to join. Those with probable medication overuse headaches or psychiatric illnesses that could affect participation are excluded.
What is being tested?
The study tests a Telehealth Behavioral Migraine Management program in a single-arm pre-post pilot study. It includes using a mobile app diary, an online manual with interactive vignettes, four telehealth sessions lasting 50 minutes each, and three short check-ins of 15 minutes.
What are the potential side effects?
Since this intervention involves behavioral management through telehealth without medications, there may not be direct side effects like those associated with drugs. However, participants might experience discomfort from discussing their condition or stress from adhering to the protocol.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am able to understand and agree to the study's requirements.
Select...
I experience migraines as defined by international health standards.
Select...
I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am likely experiencing headaches due to overusing my medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 through week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 through week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of TeleBMM
Secondary study objectives
Headache frequency
Patient-rated satisfaction
Quality of Life (Migraine Specific)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Telehealth Behavioral Migraine ManagementExperimental Treatment1 Intervention
Participants will receive weekly online education sessions in the following categories: Relaxation, Early Warning Signs, Triggers, Medication Adherence, Reducing Migraine Impact, Stress Management, Biofeedback, and Relapse Prevention. Participants will receive four monthly 50-minute telehealth sessions with a doctoral psychology student in a clinical health psychology program covering these topics, and three check-ins to enhance adherence to behavior change strategies. Participants will complete a daily headache diary throughout the course of treatment.

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Science (NCATS)NIH
99 Previous Clinical Trials
36,251 Total Patients Enrolled
1 Trials studying Migraine
70 Patients Enrolled for Migraine
Albert Einstein College of MedicineLead Sponsor
294 Previous Clinical Trials
11,859,395 Total Patients Enrolled
4 Trials studying Migraine
337 Patients Enrolled for Migraine
National Center for Advancing Translational Sciences (NCATS)NIH
342 Previous Clinical Trials
410,448 Total Patients Enrolled
1 Trials studying Migraine
70 Patients Enrolled for Migraine

Media Library

Telehealth Behavioral Migraine Management Clinical Trial Eligibility Overview. Trial Name: NCT03982316 — N/A
Migraine Research Study Groups: Telehealth Behavioral Migraine Management
Migraine Clinical Trial 2023: Telehealth Behavioral Migraine Management Highlights & Side Effects. Trial Name: NCT03982316 — N/A
Telehealth Behavioral Migraine Management 2023 Treatment Timeline for Medical Study. Trial Name: NCT03982316 — N/A
~4 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top