Feasibility and Preliminary Efficacy of Emotional Awareness and Expression Therapy (EAET) as a Novel Migraine Treatment - Randomized Controlled Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Utah
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Number of migraine days in a month at baseline.
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults of all genders, ages 18-
- •A diagnosis of either episodic or chronic migraine (with or without aura) by a licensed neurologist.
- •A migraine disability assessment scores higher than
- •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.
Outcomes
Primary Outcomes
Number of migraine days in a month at baseline.
Time Frame: 1 month before the treatment.
Headache diary self report measure. Participants will record their migraine frequency on a daily basis for 1 month.
Change in the number of migraine days in a month after treatment compared to baseline.
Time Frame: 8 weeks after commencement of treatment.
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.
Secondary Outcomes
- Change in migraine effects on quality of life after treatment compared to baseline.(8 weeks after commencement of treatment.)
- Depression levels at baseline.(1 month before the treatment.)
- Change in emotional coping after treatment compared to baseline.(8 weeks after commencement of treatment.)
- Change in allodynia after treatment compared to baseline.(8 weeks after commencement of treatment.)
- Migraine effects on quality of life at baseline.(1 month before the treatment.)
- Allodynia levels at baseline.(1 month before the treatment.)
- Anxiety levels at baseline.(1 month before the treatment.)
- Change in anxiety levels after treatment compared to baseline.(8 weeks after commencement of treatment.)
- Change in depression after treatment compared to baseline.(8 weeks after commencement of treatment.)
- Positive and negative affect at baseline(1 month before the treatment.)
- Emotional coping at baseline.(1 month before the treatment.)
- Changes in positive/negative affect at the end of treatment compared to baseline.(8 weeks after commencement of treatment.)
Investigators
Dan Kaufmann, Ph.D.
Research Assistant Professor
University of Utah