What is the mechanism of action of this treatment?

Common treatments for migraine include remote electrical neuromodulation, transcranial magnetic stimulation (TMS), noninvasive vagus nerve stimulation (nVNS), and behavioral interventions like Emotional Awareness and Expression Therapy (EAET). Remote electrical neuromodulation and TMS work by altering neural activity to reduce pain perception, while nVNS stimulates the vagus nerve to modulate pain pathways. Behavioral interventions like EAET aim to reduce migraine frequency and severity by helping patients understand and express their emotions, potentially reducing stress and emotional triggers that can exacerbate migraines. These treatments are important as they offer non-pharmacological options that can be effective for patients who may not respond to or tolerate traditional medications.

What side effects are associated with this type of intervention?

Behavioral interventions for migraine, such as cognitive-behavioral therapy (CBT), biofeedback, relaxation training, and acupuncture, generally have fewer side effects compared to pharmacologic treatments. CBT and relaxation training are typically well-tolerated, with minimal side effects, though some individuals may experience temporary emotional discomfort as they confront stressors. Biofeedback is also considered safe, with rare reports of mild headaches or anxiety during initial sessions. Acupuncture may cause minor side effects such as soreness, minor bleeding, or bruising at needle sites. Overall, these non-pharmacologic treatments are associated with a low risk of adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for migraine, including pharmacological options like sumatriptan, dihydroergotamine, and ubrogepant. Additionally, non-pharmacological treatments such as transcranial magnetic stimulation (TMS) and noninvasive vagus nerve stimulation (nVNS) have also received FDA approval. While these treatments focus on acute symptom relief, behavioral interventions like Cognitive Behavioral Therapy (CBT) and biofeedback are commonly used to manage migraine by addressing stress and emotional factors, similar to the goals of Emotional Awareness and Expression Therapy (EAET). However, specific FDA approvals for behavioral interventions like EAET for migraine are not mentioned in the provided context.

What other types of research exist?

Promising alternatives to EAET for migraine treatment include: 1) Eptinezumab, a monoclonal antibody for migraine prevention, shown to reduce monthly migraine days in clinical trials. 2) Erenumab, another monoclonal antibody, effective for patients with comorbid cluster headaches and migraines. 3) Acupuncture, which has demonstrated moderate reduction in migraine episodes compared to no treatment and fewer adverse outcomes relative to prophylactic drugs. 4) Cognitive Behavioral Therapy (CBT), which has been effective in managing chronic pain, including migraines. 5) Transcutaneous Electrical Nerve Stimulation (TENS), which has shown efficacy in reducing pain in chronic conditions like fibromyalgia and may be beneficial for migraines.

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Emotional Awareness and Expression Therapy for Migraine

N/A

Recruiting

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A migraine disability assessment scores higher than 6.

Diagnosis of either episodic or chronic migraine (with or without aura) by a licensed neurologist.

Must not have

Serious psychiatric disorders uncontrolled with medications (e.g., schizophrenia or bipolar disorder).

Diagnosis of medication overuse headaches.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at three months followup after end of treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new therapy called Emotional Awareness and Expression Therapy (EAET) for people who suffer from migraines. EAET helps individuals recognize and express difficult emotions to reduce stress and emotional pain. The goal is to see if this therapy can lower the frequency and severity of migraine attacks.

Who is the study for?

This trial is for adults aged 18-80 with a diagnosis of episodic or chronic migraine, experiencing at least 4 migraine days per month. They must have had migraines for over a year and be on a stable medication regimen for the last 3 months. People with serious psychiatric disorders, recent changes in migraine meds, substance abuse issues, or involved in other studies can't join.

What is being tested?

The study tests Emotional Awareness and Expression Therapy (EAET) to see if it reduces the frequency and severity of migraines. Participants will attend eight weekly online sessions that include lectures, exercises, discussions, and homework assignments.

What are the potential side effects?

Since EAET is a behavioral intervention involving therapy sessions rather than medication, there may not be typical 'side effects.' However, discussing emotional topics could potentially cause temporary discomfort or emotional distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My migraines significantly impact my daily life.

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I have been diagnosed with migraine by a neurologist.

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My migraines significantly impact my daily life.

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My medication has not changed in the last 3 months.

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I have had migraines for over a year.

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I experience at least 4 migraine days each month.

Exclusion Criteria

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

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I do not have uncontrolled serious psychiatric disorders.

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I have been diagnosed with headaches caused by overusing medication.

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I cannot communicate in English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month before the treatment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month before the treatment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month before the treatment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the number of migraine days in a month after treatment compared to baseline.

Number of migraine days in a month at baseline.

Secondary study objectives

Allodynia levels at baseline.

Anxiety levels at baseline.

Change in allodynia after treatment compared to baseline.

+15 more

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: Emotional Awareness and Expression Therapy (EAET)Experimental Treatment1 Intervention

In this experimental arm, participants are required to attend 8 online sessions, and fill out questionnaires before treatment, immediately after treatment, and at a 3-month follow-up.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Emotional Awareness and Expression Therapy

2019

N/A

~260

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for migraine include remote electrical neuromodulation, transcranial magnetic stimulation (TMS), noninvasive vagus nerve stimulation (nVNS), and behavioral interventions like Emotional Awareness and Expression Therapy (EAET). Remote electrical neuromodulation and TMS work by altering neural activity to reduce pain perception, while nVNS stimulates the vagus nerve to modulate pain pathways. Behavioral interventions like EAET aim to reduce migraine frequency and severity by helping patients understand and express their emotions, potentially reducing stress and emotional triggers that can exacerbate migraines. These treatments are important as they offer non-pharmacological options that can be effective for patients who may not respond to or tolerate traditional medications.

Clinical Efficacy and Safety of Electroacupuncture in Migraine Treatment: A Systematic Review and Network Meta-Analysis.[Emotional impairments and their correction in patients with migraine].