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Telehealth Behavioral Therapy for Migraines (TeleBMM Trial)

N/A

Waitlist Available

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

No Placebo-Only Group

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

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I am able to understand and agree to the study's requirements.

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I experience migraines as defined by international health standards.

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am likely experiencing headaches due to overusing my medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0 through week 12

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met