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Emotional Awareness and Expression Therapy for Migraine
N/A
Recruiting
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A migraine disability assessment scores higher than 6.
Diagnosis of either episodic or chronic migraine (with or without aura) by a licensed neurologist.
Must not have
Serious psychiatric disorders uncontrolled with medications (e.g., schizophrenia or bipolar disorder).
Diagnosis of medication overuse headaches.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at three months followup after end of treatment
Awards & highlights
No Placebo-Only Group
Summary
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since EAET is a behavioral intervention involving therapy sessions rather than medication, there may not be typical 'side effects.' However, discussing emotional topics could potentially cause temporary discomfort or emotional distress.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My migraines significantly impact my daily life.
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I have been diagnosed with migraine by a neurologist.
Select...
My migraines significantly impact my daily life.
Select...
My medication has not changed in the last 3 months.
Select...
I have had migraines for over a year.
Select...
I experience at least 4 migraine days each month.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have uncontrolled serious psychiatric disorders.
Select...
I have been diagnosed with headaches caused by overusing medication.
Select...
I cannot communicate in English.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month before the treatment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month before the treatment.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in the number of migraine days in a month after treatment compared to baseline.
Number of migraine days in a month at baseline.
Secondary study objectives
Allodynia levels at baseline.
Anxiety levels at baseline.
Change in allodynia after treatment compared to baseline.
+15 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Emotional Awareness and Expression Therapy (EAET)Experimental Treatment1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Emotional Awareness and Expression Therapy
2019
N/A
~260
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for migraine include remote electrical neuromodulation, transcranial magnetic stimulation (TMS), noninvasive vagus nerve stimulation (nVNS), and behavioral interventions like Emotional Awareness and Expression Therapy (EAET). Remote electrical neuromodulation and TMS work by altering neural activity to reduce pain perception, while nVNS stimulates the vagus nerve to modulate pain pathways.
Behavioral interventions like EAET aim to reduce migraine frequency and severity by helping patients understand and express their emotions, potentially reducing stress and emotional triggers that can exacerbate migraines. These treatments are important as they offer non-pharmacological options that can be effective for patients who may not respond to or tolerate traditional medications.
Clinical Efficacy and Safety of Electroacupuncture in Migraine Treatment: A Systematic Review and Network Meta-Analysis.[Emotional impairments and their correction in patients with migraine].
Clinical Efficacy and Safety of Electroacupuncture in Migraine Treatment: A Systematic Review and Network Meta-Analysis.[Emotional impairments and their correction in patients with migraine].
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,138 Previous Clinical Trials
1,791,646 Total Patients Enrolled
1 Trials studying Migraine
109 Patients Enrolled for Migraine
Wayne State UniversityOTHER
314 Previous Clinical Trials
110,068 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot communicate in English.My migraines significantly impact my daily life.You have not received treatment for alcohol or drug addiction.You have significant problems with thinking and memory.I am between 18 and 80 years old.I have been diagnosed with headaches caused by overusing medication.I do not have uncontrolled serious psychiatric disorders.You are currently thinking about hurting yourself.You have a risk of becoming violent.I have been diagnosed with migraine by a neurologist.My medication has not changed in the last 3 months.I have had migraines for over a year.I experience at least 4 migraine days each month.I haven't changed my migraine medication in the last 3 months.My migraines significantly impact my daily life.
Research Study Groups:
This trial has the following groups:- Group 1: Emotional Awareness and Expression Therapy (EAET)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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