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Emotional Awareness and Expression Therapy (EAET) as a Novel Migraine Treatment (EAET)

Primary Purpose

Migraine Disorders

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Emotional Awareness and Expression Therapy (EAET)

About this trial

This is an interventional treatment trial for Migraine Disorders

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adults of all genders, ages 18-80. A diagnosis of either episodic or chronic migraine (with or without aura) by a licensed neurologist. A migraine disability assessment scores higher than 6. A stable medication regimen for a minimum of 3 months. Must have had migraines for at least 1 year. Must have a minimum of 4 migraine days per month. Exclusion Criteria: Serious psychiatric disorders (e.g., schizophrenia or bipolar disorder) uncontrolled with medications. Active suicidal ideation. Risk of violent behavior. Untreated alcohol or substance use disorder. Substantial cognitive impairment. A diagnosis of medication overuse headaches. Changes in migraine medication in the past 3 months. Enrollment in another treatment study. Current involvement in health-related litigation or disability application. Inability to use a computer and/or smartphone. limited access to the internet. Inability to communicate in English. Failure to complete at least 85% of the daily diaries during the baseline 30-day diary assessment.

Sites / Locations

Dan KaufmannRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Emotional Awareness and Expression Therapy (EAET)

Wait list control

Arm Description

In this experimental arm, participants are required to attend 8 online sessions and fill out questionnaires before treatment, and immediately after treatment.

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.

Outcomes

Primary Outcome Measures

Number of migraine days in a month at baseline.

Headache diary self report measure. Participants will record their migraine frequency on a daily basis for 1 month.

Change in the number of migraine days in a month after treatment compared to baseline.

Participants will record their migraine frequency on a daily basis for 1 month immediately after treatment. A change in a number of migraine days will be evaluated by comparing migraine frequency after the intervention to baseline. A lower number of migraine days in a month after treatment will indicate the effectiveness of the treatment in reducing migraine frequency.

Secondary Outcome Measures

Migraine effects on quality of life at baseline.

Quality of life will be evaluated using the Migraine Specific Quality of Life (MSQL) questionnaire. The minimum value is 14, and the maximum value is 84. A higher total value indicates a better quality of life.

Change in migraine effects on quality of life after treatment compared to baseline.

Changes in migraine-specific quality of life will be evaluated by comparing the MSQL scores after the treatment to baseline. A higher score after treatment will indicate the effectiveness of treatment in increasing quality of life.

Allodynia levels at baseline.

Allodynia will be evaluated using the allodynia questionnaire. The minimum value is 0 and the maximum value is 24. Values 0-2 indicate no allodynia, 3-5 mild allodynia, 6-8 moderate allodynia, and 9 or higher: severe allodynia.

Change in allodynia after treatment compared to baseline.

A change in the allodynia score will be evaluated by comparing the allodynia questionnaire score after treatment to baseline. A lower allodynia score after treatment will indicate the effectiveness of treatment in reducing symptoms of allodynia.

Anxiety levels at baseline.

Anxiety will be measured using the Patient Reported Outcome Measurement Information System (PROMIS) short anxiety questionnaire. The minimum value is 8 and the maximum value is 40. A higher score on this test indicates higher levels of anxiety.

Change in anxiety levels after treatment compared to baseline.

A change in anxiety will be evaluated by comparing the PROMIS anxiety questionnaire score after treatment to baseline. A lower anxiety score after treatment will indicate the effectiveness of treatment in reducing anxiety.

Depression levels at baseline.

Depression will be measured using the Patient Reported Outcome Measurement Information System (PROMIS) short depression questionnaire. The minimum score is 8 and the maximum score is 40. A higher score indicates a higher level of depression.

Change in depression after treatment compared to baseline.

A Change in depression score will be evaluated by comparing the PROMIS depression questionnaire score after treatment vs. baseline. A lower score will indicate the effectiveness of treatment in relieving depression.

Emotional coping at baseline.

Emotional coping will be measured using the Emotional Approach Coping scale 8 (EAC-8). The minimum score is 8 and the maximum score is 32. A higher score indicates a higher emotional coping ability.

Change in emotional coping after treatment compared to baseline.

A change in emotional coping will be evaluated by comparing the EAC-8 score after treatment vs. baseline. A higher score after treatment indicates the effectiveness of the treatment in increasing emotional coping ability.

Positive and negative affect at baseline

The positive and negative affect will be measured using the Positive and Negative Affect Schedule (PANAS) questionnaire. Both the positive and negative affect can have a minimum score of 10 and a maximum score of 50 independently. A higher score in either measure will indicate higher levels of positive or negative affect respectively.

Changes in positive/negative affect at the end of treatment compared to baseline.

A change in positive and negative affect will be evaluated by comparing the PANAS questionnaire scores of both affects after treatment to baseline. A higher score in positive affect and a lower score in negative affect after treatment will indicate the effectiveness of treatment in improving positive affect while reducing negative affect.

Full Information

NCT ID

NCT05837650

First Posted

April 19, 2023

Last Updated

April 28, 2023

Sponsor

University of Utah

Collaborators

Wayne State University

1. Study Identification

Unique Protocol Identification Number

NCT05837650

Brief Title

Emotional Awareness and Expression Therapy (EAET) as a Novel Migraine Treatment

Acronym

EAET

Official Title

Feasibility and Preliminary Efficacy of Emotional Awareness and Expression Therapy (EAET) as a Novel Migraine Treatment - Randomized Controlled Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2023 (Actual)

Primary Completion Date

March 31, 2024 (Anticipated)

Study Completion Date

March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Utah

Collaborators

Wayne State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

The participants are randomized to a treatment and waitlist control arms, each arm has 5-6 participants. Participants in the treatment arm will experience a group-based EAET intervention via Zoom. The investigators anticipate having 3 cohorts of treatment vs. controls in this study.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Emotional Awareness and Expression Therapy (EAET)

Arm Type

Experimental

Arm Description

In this experimental arm, participants are required to attend 8 online sessions and fill out questionnaires before treatment, and immediately after treatment.

Arm Title

Wait list control

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Emotional Awareness and Expression Therapy (EAET)

Intervention Description

Each EAET session will use an educational lecture, discussion, in-class experiential exercises, and homework assignments. During sessions, participants will be encouraged to identify their stressors and experience and express their avoided or suppressed emotions, using exercises such as emotional disclosure, role playing, and the "empty chair" technique. Participants will be given homework assignments to complete between sessions, including expressive writing, identification of stressors and avoided emotions, and healthy communication skills practice. The planned topics of the EAET sessions include the emotions-stress-pain model, expressing and experiencing emotions (anger, sadness, hurt, etc.), letting go/forgiveness of self and others, and healthy communication, including assertiveness and intimacy.

Primary Outcome Measure Information:

Title

Number of migraine days in a month at baseline.

Description

Headache diary self report measure. Participants will record their migraine frequency on a daily basis for 1 month.

Time Frame

1 month before the treatment.

Title

Change in the number of migraine days in a month after treatment compared to baseline.

Description

Time Frame

8 weeks after commencement of treatment.

Secondary Outcome Measure Information:

Title

Migraine effects on quality of life at baseline.

Description

Time Frame

1 month before the treatment.

Title

Change in migraine effects on quality of life after treatment compared to baseline.

Description

Time Frame

8 weeks after commencement of treatment.

Title

Allodynia levels at baseline.

Description

Time Frame

1 month before the treatment.

Title

Change in allodynia after treatment compared to baseline.

Description

Time Frame

8 weeks after commencement of treatment.

Title

Anxiety levels at baseline.

Description

Time Frame

1 month before the treatment.

Title

Change in anxiety levels after treatment compared to baseline.

Description

Time Frame

8 weeks after commencement of treatment.

Title

Depression levels at baseline.

Description

Time Frame

1 month before the treatment.

Title

Change in depression after treatment compared to baseline.

Description

Time Frame

8 weeks after commencement of treatment.

Title

Emotional coping at baseline.

Description

Emotional coping will be measured using the Emotional Approach Coping scale 8 (EAC-8). The minimum score is 8 and the maximum score is 32. A higher score indicates a higher emotional coping ability.

Time Frame

1 month before the treatment.

Title

Change in emotional coping after treatment compared to baseline.

Description

Time Frame

8 weeks after commencement of treatment.

Title

Positive and negative affect at baseline

Description

Time Frame

1 month before the treatment.

Title

Changes in positive/negative affect at the end of treatment compared to baseline.

Description

Time Frame

8 weeks after commencement of treatment.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dan Kaufmann, PhD

Phone

8019138091

dan.kaufmann@pharm.utah.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Mark Lumley, PhD

Phone

313-577-2247

mlumley@wayne.edu

Facility Information:

Facility Name

Dan Kaufmann

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84117

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

DAN KAUFMANN

Phone

801-913-8091

dan.kaufmann@pharm.utah.edu

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28796118

Citation

Lumley MA, Schubiner H, Lockhart NA, Kidwell KM, Harte SE, Clauw DJ, Williams DA. Emotional awareness and expression therapy, cognitive behavioral therapy, and education for fibromyalgia: a cluster-randomized controlled trial. Pain. 2017 Dec;158(12):2354-2363. doi: 10.1097/j.pain.0000000000001036.

Results Reference

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PubMed Identifier

32451528

Citation

Yarns BC, Lumley MA, Cassidy JT, Steers WN, Osato S, Schubiner H, Sultzer DL. Emotional Awareness and Expression Therapy Achieves Greater Pain Reduction than Cognitive Behavioral Therapy in Older Adults with Chronic Musculoskeletal Pain: A Preliminary Randomized Comparison Trial. Pain Med. 2020 Nov 1;21(11):2811-2822. doi: 10.1093/pm/pnaa145.

Results Reference

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Emotional Awareness and Expression Therapy (EAET) as a Novel Migraine Treatment

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