← 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
Physician diagnosis of migraine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 through week 12
Awards & highlights

TeleBMM Trial 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.Check my eligibility
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.See study design
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.

TeleBMM Trial 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 have been diagnosed with migraine by a doctor.
Select...
I experience headaches 4 to 20 days a month.
Select...
I experience migraines as defined by international health standards.
Select...
I am between 18 and 65 years old.

TeleBMM Trial 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

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

TeleBMM 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
36,350 Total Patients Enrolled
1 Trials studying Migraine
70 Patients Enrolled for Migraine
Albert Einstein College of MedicineLead Sponsor
285 Previous Clinical Trials
11,856,499 Total Patients Enrolled
4 Trials studying Migraine
337 Patients Enrolled for Migraine
National Center for Advancing Translational Sciences (NCATS)NIH
319 Previous Clinical Trials
401,711 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment recruiting individuals who are fifty and older?

"As specified in the study's inclusion criteria, the age range for participation is 18 to 65 years old."

Answered by AI

Who qualifies to be an enrollee in this medical experiment?

"The research team of this trial is actively seeking 20 individuals, aged 18 to 65 and with a physician-confirmed diagnosis of migraine who report having between 4 -20 headache days per month. Moreover, they must possess the capacity to offer informed consent."

Answered by AI

What is the maximum enrollment target for this clinical trial?

"Affirmative. The study record located on clinicaltrials.gov verifies that this research is still enrolling members, with the initial post dated September 15th 2020 and a recent amendment occurring November 14th 2022. 20 volunteers need to be sourced from 1 centre for inclusion in the trial."

Answered by AI

Is this research currently open to new participants?

"According to the information displayed on clinicaltrials.gov, this study is in ongoing recruitment mode with a start date of September 15th 2020 and its most recent update being made November 14th 2022."

Answered by AI
~1 spots leftby Jul 2024