Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2025-12-28 @ 7:43 PM
Study NCT ID:
NCT05837650
Status:
COMPLETED
Last Update Posted:
2025-11-26
First Post:
2023-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Emotional Awareness and Expression Therapy (EAET) as a Novel Migraine Treatment
Sponsor:
University of Utah
Organization:
Study Overview
Official Title:
Feasibility and Preliminary Efficacy of Emotional Awareness and Expression Therapy (EAET) as a Novel Migraine Treatment - Randomized Controlled Pilot Study
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EAET
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: