Emotional Awareness and Expression Therapy (EAET) as a Novel Migraine Treatment

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Migraine Disorders

Treatments: Behavioral: Emotional Awareness and Expression Therapy (EAET)

Study type: Interventional

Funder types: Other

Identifiers

NCT05837650

IRB_00164970

Details and patient eligibility

About

This study tests the effect of a new behavioral intervention, Emotional Awareness and Expression Therapy (EAET), as a possible new treatment for people living with migraine.

The main questions it aims to answer are:

Can EAET lower the frequency and severity of migraine attacks? What are the elements that can explain EAET's effect?

Requirements from Participants:

Participants will be randomized into either a treatment or control arms. Those who are assigned to the control arm are eligible to receive the treatment in the next cohort.

Participants assigned to the treatment arms are expected to engage in 8 weekly online sessions via Zoom (sessions are 2 hours long). Each session has a lecture, in-class exercises, discussion, and weekly assignments.

Each participant is required to fill out questionnaires before the first session, and after the last session of the treatment.

Participants will benefit from a new and promising intervention that can significantly help with their migraines at no cost.

Full description

Migraine is a debilitating disorder that affects many people worldwide. Despite the new migraine medications and the recommended complementary interventions for migraine, most people living with migraine are not migraine-free and continue to experience debilitating headaches. Chronic stress and past traumatic experiences are known to contribute to the development of migraine and to the transition from episodic to chronic migraine. Although current behavioral interventions focus on "calming down" the body and mind, a different approach is to help individuals identify and express difficult emotions, release emotionally difficult experiences, and acquire new skills to help manage interpersonal relationships. Emotional Awareness and Expression Therapy (EAET) is a new intervention that focuses on this approach and has shown promising results in patients with different chronic pain conditions. In this research, the investigators will test how effective EAET is in people living with migraine.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults of all genders, ages 18-80.
• A diagnosis of either episodic or chronic migraine (with or without aura) by a licensed neurologist.
• A migraine disability assessment scores higher than 6.
• A stable medication regimen for a minimum of 3 months.
• Must have had migraines for at least 1 year.
• Must have a minimum of 4 migraine days per month.

Exclusion criteria

• Serious psychiatric disorders (e.g., schizophrenia or bipolar disorder) uncontrolled with medications.
• Active suicidal ideation.
• Risk of violent behavior.
• Untreated alcohol or substance use disorder.
• Substantial cognitive impairment.
• A diagnosis of medication overuse headaches.
• Changes in migraine medication in the past 3 months.
• Enrollment in another treatment study.
• Current involvement in health-related litigation or disability application.
• Inability to use a computer and/or smartphone.
• limited access to the internet.
• Inability to communicate in English.
• Failure to complete at least 85% of the daily diaries during the baseline 30-day diary assessment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Emotional Awareness and Expression Therapy (EAET)

Experimental group

Description:

In this experimental arm, participants are required to attend 8 online sessions and fill out questionnaires before treatment, and immediately after treatment.

Treatment:

Behavioral: Emotional Awareness and Expression Therapy (EAET)

Wait list control

No Intervention group

Description:

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.