Back to resultsEmotional Awareness and Expression Therapy (EAET) for Migraine
Primary Purpose
Migraine Disorders
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emotional Awareness and Expression Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Disorders
Eligibility Criteria
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 80% of the daily diaries during the baseline 30-day diary assessment.
Sites / Locations
- Dan KaufmannRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Emotional Awareness and Expression Therapy (EAET)
Arm Description
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.
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.
Change in migraine effects on quality of life at 3 month followup compared to baseline.
Changes in migraine-specific quality of life will be evaluated by comparing the MSQL scores at a 3-month follow-up to baseline. A higher score in the 3-month follow-up will indicate the long-term 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.
Change in allodynia at 3 months followup compared to baseline.
A change in allodynia score will be evaluated by comparing the allodynia questionnaire score at 3 months follow-up to baseline. A lower allodynia score at follow-up will indicate a long-term 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.
Change in anxiety levels at 3 months followup compared to baseline.
A change in the anxiety will be evaluated by comparing the PROMIS anxiety questionnaire score at three months follow-up to baseline. A lower anxiety score at follow-up will indicate the long-term 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.
Change in depression at three months followup compared to baseline.
A Change in depression score will be evaluated by comparing the PROMIS depression questionnaire score at follow-up vs. baseline. A lower score will indicate the long-term 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.
Change in emotional coping at three months followup compared to baseline.
A change in emotional coping will be evaluated by comparing the EAC-8 score at follow-up compared to baseline. A higher score at followup indicates the long-term 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.
Changes in positive/negative affect at 3-months followup compared to baseline.
A positive and negative affect change will be evaluated by comparing the PANAS questionnaire scores of both affects at followup to baseline. A higher score in positive affect and a lower score in negative affect at follow-up will indicate the long-term effectiveness of treatment in improving positive affect while reducing negative affect.
Full Information
NCT ID
NCT05755698
First Posted
February 10, 2023
Last Updated
April 20, 2023
Sponsor
University of Utah
Collaborators
Wayne State University
1. Study Identification
Unique Protocol Identification Number
NCT05755698
Brief Title
Emotional Awareness and Expression Therapy (EAET) for Migraine
Official Title
Evaluation of Emotional Awareness and Expression Therapy (EAET) as a Novel Migraine Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 4, 2023 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
March 4, 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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this feasibility study is to test 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 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, after the last session of the treatment, and at a 3-month follow-up after 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
Single Group Assignment
Model Description
The investigators will form groups of five participants with migraine who will experience a group-based EAET intervention.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (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, immediately after treatment, and at a 3-month follow-up.
Intervention Type
Behavioral
Intervention Name(s)
Emotional Awareness and Expression Therapy
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
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.
Time Frame
8 weeks after commencement of treatment.
Secondary Outcome Measure Information:
Title
Migraine effects on quality of life at baseline.
Description
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.
Time Frame
1 week before the treatment.
Title
Change in migraine effects on quality of life after treatment compared to baseline.
Description
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.
Time Frame
8 weeks after commencement of treatment.
Title
Change in migraine effects on quality of life at 3 month followup compared to baseline.
Description
Changes in migraine-specific quality of life will be evaluated by comparing the MSQL scores at a 3-month follow-up to baseline. A higher score in the 3-month follow-up will indicate the long-term effectiveness of treatment in increasing quality of life.
Time Frame
3 months after the end of the treatment.
Title
Allodynia levels at baseline.
Description
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.
Time Frame
1 week before the treatment.
Title
Change in allodynia after treatment compared to baseline.
Description
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.
Time Frame
8 weeks after commencement of treatment.
Title
Change in allodynia at 3 months followup compared to baseline.
Description
A change in allodynia score will be evaluated by comparing the allodynia questionnaire score at 3 months follow-up to baseline. A lower allodynia score at follow-up will indicate a long-term effectiveness of treatment in reducing symptoms of allodynia.
Time Frame
At 3 months followup after the end of treatment.
Title
Anxiety levels at baseline.
Description
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.
Time Frame
1 week before treatment
Title
Change in anxiety levels after treatment compared to baseline.
Description
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.
Time Frame
8 weeks after commencement of treatment.
Title
Change in anxiety levels at 3 months followup compared to baseline.
Description
A change in the anxiety will be evaluated by comparing the PROMIS anxiety questionnaire score at three months follow-up to baseline. A lower anxiety score at follow-up will indicate the long-term effectiveness of treatment in reducing anxiety.
Time Frame
At 3 months followup from the end of treatment.
Title
Depression levels at baseline.
Description
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.
Time Frame
1 week before treatment.
Title
Change in depression after treatment compared to baseline.
Description
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.
Time Frame
8 weeks after commencement of treatment.
Title
Change in depression at three months followup compared to baseline.
Description
A Change in depression score will be evaluated by comparing the PROMIS depression questionnaire score at follow-up vs. baseline. A lower score will indicate the long-term effectiveness of treatment in relieving depression.
Time Frame
At 3 months followup after end 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 week before treatment.
Title
Change in emotional coping after treatment compared to baseline.
Description
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.
Time Frame
8 weeks after commencement of treatment.
Title
Change in emotional coping at three months followup compared to baseline.
Description
A change in emotional coping will be evaluated by comparing the EAC-8 score at follow-up compared to baseline. A higher score at followup indicates the long-term effectiveness of the treatment in increasing emotional coping ability.
Time Frame
At three months followup after end of treatment
Title
Positive and negative affect at baseline
Description
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.
Time Frame
1 week before treatment.
Title
Changes in positive/negative affect at the end of treatment compared to baseline
Description
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.
Time Frame
8 weeks after commencement of treatment.
Title
Changes in positive/negative affect at 3-months followup compared to baseline.
Description
A positive and negative affect change will be evaluated by comparing the PANAS questionnaire scores of both affects at followup to baseline. A higher score in positive affect and a lower score in negative affect at follow-up will indicate the long-term effectiveness of treatment in improving positive affect while reducing negative affect.
Time Frame
At 3 months followup after treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 80% of the daily diaries during the baseline 30-day diary assessment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Kaufmann, PhD
Phone
8019138091
Email
dan.kaufmann@pharm.utah.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Lumley, PhD
Phone
313-577-2247
Email
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
Email
dan.kaufmann@pharm.utah.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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) for Migraine
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