Emotional Awareness and Expression Therapy for Migraine

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: 9

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Emotional Awareness and Expression Therapy (EAET) might help people with migraines. The researchers aim to determine if EAET can reduce the frequency and severity of migraines. Participants will attend eight weekly online sessions and complete questionnaires. This trial suits individuals who have experienced migraines for over a year, have at least four migraine days each month, and have maintained a stable medication plan for at least three months. Participants can try this promising new therapy at no cost. As an unphased trial, this study offers a unique opportunity to explore a novel therapy that could significantly improve quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that you have been on a stable medication regimen for at least 3 months before joining. This suggests you should continue your current medications during the trial.

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

Research has shown that Emotional Awareness and Expression Therapy (EAET) is generally well-tolerated. In one study, participants in EAET classes experienced less severe pain and improvements in other pain-related areas, suggesting that EAET might help reduce migraine pain.

Another study compared EAET to Cognitive Behavioral Therapy (CBT) and found that EAET significantly reduced symptoms in people with fibromyalgia, a condition that causes pain and tiredness. This indicates that EAET could be a safe option for managing pain-related conditions.

Overall, existing research suggests that EAET is generally safe and can positively affect pain and symptom management. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard migraine treatments that often rely on medications like triptans or anti-inflammatory drugs, Emotional Awareness and Expression Therapy (EAET) focuses on the mind-body connection. EAET is unique because it addresses the emotional factors that can trigger or exacerbate migraines, offering a non-drug approach to managing the condition. This treatment is delivered through online sessions, making it accessible and convenient for participants. Researchers are excited about EAET because it has the potential to provide relief without the side effects associated with medication, offering a holistic alternative to traditional migraine management.

What evidence suggests that Emotional Awareness and Expression Therapy might be an effective treatment for migraines?

Research has shown that Emotional Awareness and Expression Therapy (EAET) can reduce the frequency and severity of migraines. One study found that EAET was more effective than Cognitive Behavioral Therapy (CBT) in easing pain. Early findings suggest that EAET could be a promising new treatment for migraines. Participants in this trial will engage in EAET through 8 online sessions. Specifically, those who learned to better understand and express their emotions noticed improvements in their symptoms. This suggests that focusing on emotions might be a useful approach for managing migraines. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with a diagnosis of episodic or chronic migraine, experiencing at least 4 migraine days per month. They must have had migraines for over a year and be on a stable medication regimen for the last 3 months. People with serious psychiatric disorders, recent changes in migraine meds, substance abuse issues, or involved in other studies can't join.

Inclusion Criteria

My migraines significantly impact my daily life.

I have been diagnosed with migraine by a neurologist.

My medication has not changed in the last 3 months.

Exclusion Criteria

I cannot communicate in English.

You have not received treatment for alcohol or drug addiction.

You have significant problems with thinking and memory.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-4 weeks

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 visits (virtual)

Follow-up

Participants are monitored for changes in migraine frequency, quality of life, and emotional coping at 3 months after treatment.

3 months

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Emotional Awareness and Expression Therapy (EAET)

Trial Overview The study tests Emotional Awareness and Expression Therapy (EAET) to see if it reduces the frequency and severity of migraines. Participants will attend eight weekly online sessions that include lectures, exercises, discussions, and homework assignments.

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, immediately after treatment, and at a 3-month follow-up.

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+

Published Research Related to This Trial

Behavioral treatments for migraines, including biofeedback and relaxation techniques, can reduce migraine frequency by 35-45%, with effect sizes ranging from 0.4 to 0.6, indicating moderate efficacy.

Cognitive-behavioral treatment, when used as part of a multimodal approach, improves migraine activity by an average of 39% and can be effectively combined with pharmacological treatments for enhanced results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychological therapy of migraine: systematic review]. Fritsche, G., Kröner-Herwig, B., Kropp, P., et al.[2021]

A study of 401 participants with migraines found that most preferred in-person or smartphone-based behavioral therapies for migraine prevention, rather than telephone-based options.

Despite the effectiveness of these therapies, many participants were not willing to pay out of pocket for them, indicating a need for insurance coverage to increase utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Therapy Preferences in People With Migraine. Minen, MT., Jalloh, A., Begasse de Dhaem, O., et al.[2021]

In a randomized controlled trial with 368 participants, online behavioral training (BT) did not significantly reduce migraine attack frequency compared to a waitlist control group, with both groups experiencing a similar 20-25% decrease.

However, participants who completed the BT showed significant improvements in migraine-related self-efficacy and developed a more internal locus of control, suggesting that while BT may not reduce attack frequency, it can enhance participants' confidence and management of their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term effectiveness of an online behavioral training in migraine self-management: a randomized controlled trial. Kleiboer, A., Sorbi, M., van Silfhout, M., et al.[2014]

Behavioral treatments for migraine have gained significant research attention over the past 25 years, focusing on their effectiveness compared to other treatments and how they can work alongside medications.

Current studies are exploring various aspects of behavioral treatments, including cost-effective delivery models and the long-term maintenance of treatment effects, which are crucial for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral management of migraine. Andrasik, F.[2007]

In a study of 401 individuals with migraines, different ways of presenting information (message framing) did not significantly affect their willingness to seek behavioral treatments for migraine prevention.

Despite behavioral treatments being safe and effective, only 12.5% of participants had previously used such therapies, indicating a need for better strategies to encourage their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Message Framing and the Willingness to Pursue Behavioral Therapy: A Study of People With Migraine. Jalloh, A., Begasse de Dhaem, O., Seng, E., et al.[2022]

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.