Emotional Awareness and Expression Therapy (EAET) for Migraine

NCT05755698 | Terminated

• 1 other identifier: IRB_00163370
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (2)

• Number of migraine days in a month at baseline.

  Headache diary self report measure. Participants will record their migraine frequency on a daily basis for 1 month.

  1 month before the treatment.

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

  Participants will record their migraine frequency on a daily basis for 1 month immediately after treatment. A change in a number of migraine days will be evaluated by comparing migraine frequency after the intervention to baseline. A lower number of migraine days in a month after treatment will indicate the effectiveness of the treatment in reducing migraine frequency.

  8 weeks after commencement of treatment.

Secondary Outcomes (18)

• Migraine effects on quality of life at baseline.

  1 week before the treatment.

• Change in migraine effects on quality of life after treatment compared to baseline.

  8 weeks after commencement of treatment.

• Change in migraine effects on quality of life at 3 month followup compared to baseline.

  3 months after the end of the treatment.

• Allodynia levels at baseline.

  1 week before the treatment.

• Change in allodynia after treatment compared to baseline.

  8 weeks after commencement of treatment.

Study Arms (1)

Emotional Awareness and Expression Therapy (EAET)

EXPERIMENTAL

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.

Behavioral: Emotional Awareness and Expression Therapy

Interventions

Emotional Awareness and Expression Therapy 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.

Emotional Awareness and Expression Therapy (EAET)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• Wayne State University: collaborator

Study Sites (1)

Dan Kaufmann

Salt Lake City, Utah, 84117, United States

Location

Related Publications (2)

• 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.

  PMID: 5680092 BACKGROUND

• 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.

  PMID: 32451528 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: The investigators will form groups of five participants with migraine who will experience a group-based EAET intervention.

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: March 6, 2023
• Study Start: March 4, 2023
• Primary Completion: December 15, 2023
• Study Completion: March 4, 2024
• Last Updated: December 6, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)