Emotional Awareness and Expression Therapy for Migraine

(EAET Trial)

Overseen By Mark Lumley, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Schizophrenia, Bipolar, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Emotional Awareness and Expression Therapy (EAET) to determine its effectiveness in reducing the frequency and severity of migraine attacks. Participants will divide into two groups: one will try the therapy immediately, while the other will wait and try it later. Each therapy group will attend 8 weekly online sessions that include lectures and exercises. The study seeks individuals who have experienced migraines for at least a year and have at least 4 migraine days each month. As an unphased trial, this study offers participants the chance to explore a novel therapy that could potentially enhance their quality of life.

Will I have to stop taking my current medications?

The trial requires that you have a stable medication regimen for at least 3 months before joining, so you should not change your current medications.

What prior data suggests that Emotional Awareness and Expression Therapy (EAET) is safe for treating migraines?

Research shows that Emotional Awareness and Expression Therapy (EAET) is generally safe and well-tolerated. Past studies have used EAET for conditions like fibromyalgia and chronic pain. Participants reported less pain and better overall outcomes after the therapy. These studies did not report any serious side effects directly linked to EAET.

Although the FDA has not yet approved EAET specifically for migraines, it has been tested for other conditions with positive safety results. EAET, a type of behavioral therapy, usually carries fewer risks than treatments involving medication. Participants engage in activities like discussions and exercises, which are unlikely to cause harm.

Overall, available research suggests that EAET is a safe option for those interested in trying it for migraines. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional migraine treatments that often rely on medications like triptans or preventive drugs to manage symptoms, Emotional Awareness and Expression Therapy (EAET) takes a different approach by addressing the emotional factors that may contribute to migraine attacks. Researchers are excited about EAET because it helps individuals identify and express suppressed emotions, potentially reducing the frequency and intensity of migraines without medication. This therapy is unique in its delivery as it involves engaging in 8 online sessions, offering a non-pharmaceutical option that empowers patients through psychological exploration and expression.

What evidence suggests that Emotional Awareness and Expression Therapy (EAET) might be an effective treatment for migraine?

Research has shown that Emotional Awareness and Expression Therapy (EAET), which participants in this trial will receive, can help reduce migraine pain. One study found that EAET was more effective than Cognitive Behavioral Therapy (CBT) in lessening pain severity after treatment. Early findings also suggest that EAET might significantly decrease migraine frequency. EAET helps people recognize and express their emotions, which can lower stress and improve overall well-being. This method appears promising as a new way to manage migraines. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have had migraines for at least a year.

I have been diagnosed with migraine by a neurologist.

My migraines significantly impact my daily life.

Exclusion Criteria

I haven't changed my migraine medication in the last 3 months.

Substantial cognitive impairment

Risk of violent behavior

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 month

Treatment

Participants engage in 8 weekly online sessions of Emotional Awareness and Expression Therapy (EAET) via Zoom, each lasting 2 hours, including lectures, exercises, discussions, and assignments.

8 weeks

8 online sessions

Follow-up

Participants are monitored for changes in migraine frequency, emotional coping, and quality of life after treatment.

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Emotional Awareness and Expression Therapy (EAET)

Trial Overview 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.

How Is the Trial Designed?

Group I: Emotional Awareness and Expression Therapy (EAET) Experimental Treatment 1 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 control Active Control 1 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.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Wayne State University

Collaborator

Trials

318

Recruited

111,000+

Citations

1. clinicaltrial.be clinicaltrial.be/en/details/266739?per_page=100&only_recruiting=0&only_eligible=0

Emotional Awareness and Expression Therapy (EAET) As ... A lower number of migraine days in a month after treatment will indicate the effectiveness of the treatment in reducing migraine frequency.

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05837650/emotional-awareness-and-expression-therapy-eaet-as-a-novel-migraine-treatment

Emotional Awareness and Expression Therapy (EAET) As ... In this research, the investigators will test how effective EAET is in people living with migraine.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11177167/

Emotional Awareness and Expression Therapy vs Cognitive ... The EAET was superior to CBT for the primary outcome of reduction in pain severity at posttreatment (estimate, −1.59 [95% CI, −2.35 to −0.83]; P ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11241822/

Alternative Treatments for Emotional Experiencing and ... The results showed a high level of approach to emotional coping predicted improvement after WED compared with RT and the control group. Compared ...

5. app.tpn.health app.tpn.health/education/emotional-awareness-and-expression-therapy-eaet-for-chronic-pain-

Emotional Awareness and Expression Therapy (EAET) for ... Preliminary data shows that EAET has tremendous potential as a novel and efficacious behavioral treatment for migraine. Participants who work with trauma and/or ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5680092/

Emotional awareness and expression therapy, cognitive ... EAET did not differ from CBT on the primary or most secondary outcomes, but compared to CBT, EAET led to significantly lower FM symptoms (d = 0.35) and ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0022399922003531

Internet-based emotional awareness and expression ... Primary outcomes were reductions of somatic symptoms (PHQ-15) and pain intensity (BPI-4) at post-treatment, with a 4-month evaluation of effect duration. We ...

8. frontiersin.org frontiersin.org/journals/pain-research/articles/10.3389/fpain.2022.1028561/full

“Pain, Stress, and Emotions”: Uncontrolled trial of a single- ... Conclusions: People taking this EAET class had reduced pain severity and interference and improvements in other pain-related outcomes.