Emotional Awareness and Expression Therapy for Migraine

Recruiting in Salt Lake City (>99 mi)

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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new therapy called Emotional Awareness and Expression Therapy (EAET) for people who suffer from migraines. EAET helps individuals recognize and express difficult emotions to reduce stress and emotional pain. The goal is to see if this therapy can lower the frequency and severity of migraine attacks.

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 data supports the effectiveness of the treatment Emotional Awareness and Expression Therapy (EAET) for migraine?

Behavioral treatments, like Emotional Awareness and Expression Therapy, have been shown to be safe and effective for managing migraines. Studies on similar therapies, such as rational-emotive therapy and acceptance and commitment therapy, suggest that these approaches can complement traditional treatments and improve outcomes for migraine sufferers. ^{1 2 3 4 5}

Is Emotional Awareness and Expression Therapy (EAET) safe for humans?

There is no specific safety data available for Emotional Awareness and Expression Therapy (EAET) in the provided research articles. However, similar behavioral therapies like cognitive behavioral therapy (CBT) for migraines have shown few adverse effects, suggesting that these types of therapies are generally safe. ^{1 6 7 8 9}

How is Emotional Awareness and Expression Therapy (EAET) different from other treatments for migraine?

Emotional Awareness and Expression Therapy (EAET) is unique because it focuses on helping patients recognize and express their emotions, which can be particularly beneficial for those whose migraines are linked to emotional stress. Unlike traditional migraine treatments that often focus on medication or physical relaxation techniques, EAET addresses the emotional and psychological aspects of migraine, offering a novel approach to managing this condition. ^{1 3 6 8 10}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Rational-emotive therapy in the management of migraine headache. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Message Framing and the Willingness to Pursue Behavioral Therapy: A Study of People With Migraine. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Short-term effectiveness of an online behavioral training in migraine self-management: a randomized controlled trial. [2014]

4. France pubmed.ncbi.nlm.nih.gov

Behavioral management of migraine. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy for high frequency episodic migraine without aura: Findings from a randomized pilot investigation. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Acceptance-Commitment Therapy for Women with Episodic Migraine: A Pilot Randomized Trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Behavioral Therapy Preferences in People With Migraine. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Emerging behavioral treatments for migraine. [2018]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Migraine Headache: A Systematic Review and Meta-Analysis. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

[Psychological therapy of migraine: systematic review]. [2021]