Migraine DisordersNCT05755698
Emotional Awareness and Expression Therapy (EAET) for Migraine
A study testing Emotional Awareness and Expression Therapy in people with Migraine Disorders, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Emotional Awareness and Expression Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2023to 4 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Emotional Awareness and Expression Therapy (EAET) As a Novel Migraine Treatment
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:
Read more
- 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.
Read the 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.
- Conditions
- Migraine Disorders
- Being tested
- Emotional Awareness and Expression Therapy
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Awareness and Expression TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Emotional Awareness and Expression Therapy (EAET) | Experimental | 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. Receives: Behavioral: Emotional Awareness and Expression Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month before the treatment.
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.
Measured: 8 weeks after commencement of treatment.
Secondary outcomes (18)
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.
Measured: 1 week before the treatment.
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.
Measured: 8 weeks after commencement of treatment.
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.
Measured: 3 months after the end of the treatment.
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.
Measured: 1 week before the treatment.
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.
Measured: 8 weeks after commencement of treatment.
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.
Measured: At 3 months followup after the end of treatment.
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.
Measured: 1 week before treatment
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.
Measured: 8 weeks after commencement of treatment.
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.
Measured: At 3 months followup from the end of treatment.
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.
Measured: 1 week before treatment.
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.
Measured: 8 weeks after commencement of treatment.
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.
Measured: At 3 months followup after end of treatment.
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.
Measured: 1 week before treatment.
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.
Measured: 8 weeks after commencement of treatment.
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.
Measured: At three months followup after end of treatment
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.
Measured: 1 week before treatment.
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.
Measured: 8 weeks after commencement of treatment.
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.
Measured: At 3 months followup after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start4 Mar 2023
- Primary completion15 Dec 2023
- Study completion4 Mar 2024
Why it stopped: Study was modified and a new entry in ClinicalTrials.gov was created
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The investigators will form groups of five participants with migraine who will experience a group-based EAET intervention.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Wayne State University
- Responsible party
- Principal investigator, Dan Kaufmann, Ph.D., University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755698
- Sponsor's protocol ID
- IRB_00163370
- Status last verified
- Apr 2023
- First submitted
- 10 Feb 2023
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28796118Yarns 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.
PubMed 32451528
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Emotional Awareness and Expression Therapy (EAET) As a Novel Migraine Treatment
- ClinicalTrials.gov ID
- NCT05755698
- Acronym / sponsor ID
- IRB_00163370
- Conditions
- Migraine Disorders
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was modified and a new entry in ClinicalTrials.gov was created
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Wayne State University
- Study start
- 4 Mar 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 4 Mar 2024 (actual)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The investigators will form groups of five participants with migraine who will experience a group-based EAET intervention.
| Arm | Type | Receives |
|---|---|---|
| Emotional Awareness and Expression Therapy (EAET) | Experimental | Behavioral: Emotional Awareness and Expression TherapyIn 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 may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotional Awareness and Expression TherapyEach 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. | Behavioural | Emotional Awareness and Expression Therapy (EAET) |
Primary outcome
Number of migraine days in a month at baseline.
Time frame: 1 month before the treatment.
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.
Time frame: 8 weeks after commencement of treatment.
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.
18 secondary outcomes
Migraine effects on quality of life at baseline.
Time frame: 1 week before the treatment.
Change in migraine effects on quality of life after treatment compared to baseline.
Time frame: 8 weeks after commencement of treatment.
Change in migraine effects on quality of life at 3 month followup compared to baseline.
Time frame: 3 months after the end of the treatment.
Allodynia levels at baseline.
Time frame: 1 week before the treatment.
Change in allodynia after treatment compared to baseline.
Time frame: 8 weeks after commencement of treatment.
Change in allodynia at 3 months followup compared to baseline.
Time frame: At 3 months followup after the end of treatment.
Anxiety levels at baseline.
Time frame: 1 week before treatment
Change in anxiety levels after treatment compared to baseline.
Time frame: 8 weeks after commencement of treatment.
Change in anxiety levels at 3 months followup compared to baseline.
Time frame: At 3 months followup from the end of treatment.
Depression levels at baseline.
Time frame: 1 week before treatment.
Change in depression after treatment compared to baseline.
Time frame: 8 weeks after commencement of treatment.
Change in depression at three months followup compared to baseline.
Time frame: At 3 months followup after end of treatment.
Emotional coping at baseline.
Time frame: 1 week before treatment.
Change in emotional coping after treatment compared to baseline.
Time frame: 8 weeks after commencement of treatment.
Change in emotional coping at three months followup compared to baseline.
Time frame: At three months followup after end of treatment
Positive and negative affect at baseline
Time frame: 1 week before treatment.
Changes in positive/negative affect at the end of treatment compared to baseline
Time frame: 8 weeks after commencement of treatment.
Changes in positive/negative affect at 3-months followup compared to baseline.
Time frame: At 3 months followup after treatment.
Results and safety
The study was stopped early (reason given: Study was modified and a new entry in ClinicalTrials.gov was created). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Background: PubMed 28796118Lumley 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.
- Background: PubMed 32451528Yarns 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Awareness and Expression Therapy in people with Migraine Disorders, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was modified and a new entry in ClinicalTrials.gov was created). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of migraine days in a month at baseline. (time frame: 1 month before the treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05755698, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.