Emotional Awareness and Expression Therapy (EAET) for Migraine

NCT ID: NCT05755698

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-04

Study Completion Date

2024-03-04

Brief Summary

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The goal of this feasibility study is to test 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 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, after the last session of the treatment, and at a 3-month follow-up after treatment.

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

Detailed Description

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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.

Conditions

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Migraine Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The investigators will form groups of five participants with migraine who will experience a group-based EAET intervention.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Emotional Awareness and Expression Therapy (EAET)

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.

Group Type EXPERIMENTAL

Emotional Awareness and Expression Therapy

Intervention Type BEHAVIORAL

Each EAET session will use an educational lecture, discussion, in-class experiential exercises, and homework assignments. During sessions, participants will be encouraged to identify their stressors and experience and express their avoided or suppressed emotions, using exercises such as emotional disclosure, role playing, and the "empty chair" technique. Participants will be given homework assignments to complete between sessions, including expressive writing, identification of stressors and avoided emotions, and healthy communication skills practice. The planned topics of the EAET sessions include the emotions-stress-pain model, expressing and experiencing emotions (anger, sadness, hurt, etc.), letting go/forgiveness of self and others, and healthy communication, including assertiveness and intimacy.

Interventions

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Emotional Awareness and Expression Therapy

Each EAET session will use an educational lecture, discussion, in-class experiential exercises, and homework assignments. During sessions, participants will be encouraged to identify their stressors and experience and express their avoided or suppressed emotions, using exercises such as emotional disclosure, role playing, and the "empty chair" technique. Participants will be given homework assignments to complete between sessions, including expressive writing, identification of stressors and avoided emotions, and healthy communication skills practice. The planned topics of the EAET sessions include the emotions-stress-pain model, expressing and experiencing emotions (anger, sadness, hurt, etc.), letting go/forgiveness of self and others, and healthy communication, including assertiveness and intimacy.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 80% of the daily diaries during the baseline 30-day diary assessment.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wayne State University

OTHER

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Dan Kaufmann, Ph.D.

Research Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dan Kaufmann

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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Geumei AM, Mahfouz M, Aboul-Enein A. Intrahepatic vascular pathways: Hepatic arterioportal shunt. J Surg Res. 1968 Oct;8(10):463-70. doi: 10.1016/0022-4804(68)90109-1. No abstract available.

Reference Type BACKGROUND
PMID: 5680092 (View on PubMed)

Yarns BC, Lumley MA, Cassidy JT, Steers WN, Osato S, Schubiner H, Sultzer DL. Emotional Awareness and Expression Therapy Achieves Greater Pain Reduction than Cognitive Behavioral Therapy in Older Adults with Chronic Musculoskeletal Pain: A Preliminary Randomized Comparison Trial. Pain Med. 2020 Nov 1;21(11):2811-2822. doi: 10.1093/pm/pnaa145.

Reference Type BACKGROUND
PMID: 32451528 (View on PubMed)

Other Identifiers

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IRB_00163370

Identifier Type: -

Identifier Source: org_study_id