ACT for High Frequency Migraine; A Virtual Mindfulness Intervention

Study Overview
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Brief Summary
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Mindfulness Training specifically for pain to be offered to migraine patients

Detailed Description
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Patients with high frequency migraine will be randomized to UC or intervention. Those in intervention will attend a multi session training on Acceptance and Commitment Therapy. All participants will track responses.

Official Title
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Acceptance and Commitment Therapy for High Frequency Episodic Migraine

Conditions
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Migraine

Intervention / Treatment
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* Behavioral: ACT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women ages 18-65 Diagnosis of episodic migraine (according to International Classification for Headache Diagnosis criteria) 4-14 migraine days per month over the past 3 months No change in medication in the past 3 months Greater than 1 year of migraines Agreeable to participate, commit to all study procedures and to be randomized to either group Fluent in English Exclusion Criteria: Any unstable medical or psychiatric conditions requiring immediate treatment or could lead to difficulty complying with the protocol Active suicidal ideation Moderate to severe depression Current alcohol or substance abuse Recent Cognitive Behavioral Therapy, Mindfulness Based Cognitive Therapy, Dialectic Behavioral Therapy or Acceptance and Commitment Therapy within past 3 years Current use of narcotics Psychiatric hospitalization within past year Comorbid pain condition rated as more painful than migraine Starts new migraine treatment during study Inability to complete study visits

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: After screening, patients will be randomized and one group will receive the intervention. The investigators will do sequential interventions of the ACT
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: usual care<br>Subjects randomized to the usual care control group will continue using their usual medical care as prescribed by their physician. | |
| Active Comparator: ACT<br>An 8-week mindfulness-based group therapy. | Behavioral: ACT<br>* mindfulness intervention for patients with pain/migraine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of a randomized controlled trial of ACT | Demonstrate that 48 patients can be successfully enrolled and randomized | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preliminary data on the effectiveness of ACT on migraine frequency and migraine disability | Patient-completed migraine logs will be used to record the number of migraine days/month. Migraine disability will be measured using the validated Migraine Disability Assessment (MIDAS) questionnaire. | one year | 
| Change in migraine severity, duration, and medication use. | Severity of each migraine (1-10), duration (hours), and medicines taken assessed by patient-completed migraine logs. | one year | 
| Change in headache-related disability | Headache Related Disability measured using the validated HIT-6. | one year | 
| Change in quality of life. | Quality of life assessed using the Migraine Specific Quality of Life Questionnaire (MSQ). | one year | 
| Change in depression and anxiety. | Depression and anxiety assessed through the Hospital Anxiety and Depression Scale (HADS). | one year | 
| Change in pain acceptance and pain expectancy. | Pain acceptance assessed through the Chronic Pain Acceptance Questionnaire and pain expectancy during the migraine attacks assessed using the allodynia questionnaire. | one year | 
| Change in pain catastrophizing. | Pain Catastrophizing Scale (PCS) used to assess distress and rumination experienced due to migraine anticipation. | one year | 
| Change in distress tolerance. | Distress tolerance will be assessed through the Distress Tolerance Scale. | one year | 
| Change in physical activity. | Physical activity measured using the Godin Leisure Time Exercise questionnaire. | one year | 
| Change in perceived stress. | Perceived stress measured through the Perceived Stress Scale (PSS). | one year | 
| Change in mindfulness. | Mindful Attention and Awareness Scale (MAAS) used to measure receptive awareness and attention to the present. | one year | 
| Change in cortisol levels. | Salivary Cortisol will be collected to measure the cortisol awakening response. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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migraine, high frequency, ACT