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| Name | Class |
|---|---|
| Massachusetts Institute of Technology | OTHER |
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Mindfulness Training specifically for pain to be offered to migraine patients
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| usual care | No Intervention | Subjects randomized to the usual care control group will continue using their usual medical care as prescribed by their physician. | |
| ACT | Active Comparator | An 8-week mindfulness-based group therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT | Behavioral | mindfulness intervention for patients with pain/migraine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of a randomized controlled trial of ACT | Demonstrate that 48 patients can be successfully enrolled and randomized | one year |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
patients will identify as female
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| Name | Affiliation | Role |
|---|---|---|
| carolyn bernstein, md | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Womens Hospital | Boston | Massachusetts | 02155 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38011750 | Derived | Bernstein C, Lazaridou A, Paschali M, Vilsmark ES, Rist PM. Acceptance-Commitment Therapy for Women with Episodic Migraine: A Pilot Randomized Trial. J Integr Complement Med. 2024 May;30(5):478-486. doi: 10.1089/jicm.2023.0085. Epub 2023 Nov 27. |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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After screening, patients will be randomized and one group will receive the intervention. The investigators will do sequential interventions of the ACT
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randomized control
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 |
| D009422 | Nervous System Diseases |