What side effects are associated with this type of intervention?

Common treatments for migraines include pharmacologic options like triptans, NSAIDs, and ergotamines, as well as nonpharmacologic therapies such as cognitive-behavioral therapy (CBT), acupuncture, and neuromodulation techniques. Triptans can cause side effects like dizziness, chest tightness, and fatigue. NSAIDs may lead to gastrointestinal issues, including ulcers and bleeding. Ergotamines are associated with nausea, vomiting, and potential cardiovascular risks. Nonpharmacologic treatments like CBT and acupuncture generally have fewer side effects, with acupuncture sometimes causing minor bruising or soreness at needle sites. Neuromodulation techniques, such as transcranial magnetic stimulation, may cause mild discomfort or tingling but are generally well-tolerated. Emotional Awareness and Expression Therapy (EAET) focuses on emotional processing and expression, and while specific side effects are not well-documented, it is generally considered safe with potential benefits in reducing migraine frequency and severity.

What prior FDA approvals exist?

The FDA has approved several treatments for migraine, including pharmacologic options like triptans (e.g., sumatriptan) and non-pharmacologic interventions such as transcranial magnetic stimulation (TMS) and noninvasive vagus nerve stimulation (nVNS). While there are no specific FDA-approved treatments that directly enhance emotional processing and expression like EAET, cognitive-behavioral therapy (CBT) and biofeedback, which are behavioral therapies aimed at reducing headache symptoms and improving emotional regulation, have shown efficacy in migraine management. These therapies align with the mechanism of EAET by addressing emotional and psychological factors contributing to migraine.

What other types of research exist?

Promising novel alternatives to EAET for migraine treatment include: 1) Eptinezumab, a monoclonal antibody targeting CGRP, shown to reduce migraine days in clinical trials. 2) Erenumab, another CGRP inhibitor, effective in patients with comorbid cluster headaches. 3) Acupuncture, which has demonstrated moderate efficacy in reducing migraine episodes with fewer adverse effects compared to drug treatments. These options offer different mechanisms and may be considered based on individual patient needs and responses.

← Back to Search

Emotional Awareness and Expression Therapy for Migraine (EAET Trial)

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month before the treatment.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new therapy called Emotional Awareness and Expression Therapy (EAET) for people with 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 neurologist's diagnosis of episodic or chronic migraine. They must have had migraines for at least a year, experience them at least four days per month, and have been on stable medication for three months. People with serious psychiatric disorders, recent changes in migraine meds, or involvement in other treatment studies cannot join.

What is being tested?

The study examines Emotional Awareness and Expression Therapy (EAET) to see if it can reduce the frequency and severity of migraines. Participants will be randomly placed into two groups: one receiving EAET through weekly online sessions and another as a control group that may receive treatment later.

What are the potential side effects?

Since EAET is a behavioral intervention involving therapy sessions rather than medication, side effects are not typical but could include emotional discomfort due to discussing personal feelings related to pain during the therapy.

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.

+9 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

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, and immediately after treatment.

Group II: Wait list controlActive Control1 Intervention

In this control arm, participants are required to wait 8 weeks until the treatment arm is completed and fill out questionnaires before and after the treatment date.

Do I qualify?Apply below to find out

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 pharmacological options like triptans, which work by constricting blood vessels and blocking pain pathways in the brain, and non-pharmacological options like transcranial magnetic stimulation (TMS) and remote electrical neuromodulation (REN), which modulate neural activity to reduce pain. Emotional Awareness and Expression Therapy (EAET) focuses on enhancing emotional processing and expression, potentially reducing migraine frequency and severity by addressing underlying emotional stressors. Understanding these mechanisms is crucial for migraine patients as it helps tailor treatments to individual needs, potentially improving efficacy and reducing the frequency and severity of migraine attacks.

Clinical Efficacy and Safety of Electroacupuncture in Migraine Treatment: A Systematic Review and Network Meta-Analysis.The Impact of Spinal Manipulation on Migraine Pain and Disability: A Systematic Review and Meta-Analysis.[Emotional impairments and their correction in patients with migraine].