Migraine
Conditions
Keywords
migraine, high frequency, ACT
Brief summary
Mindfulness Training specifically for pain to be offered to migraine patients
Detailed description
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.
Interventions
BEHAVIORALACT
mindfulness intervention for patients with pain/migraine
Sponsors
Brigham and Women's Hospital
Massachusetts Institute of Technology
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
randomized control
Intervention model description
After screening, patients will be randomized and one group will receive the intervention. The investigators will do sequential interventions of the ACT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of a randomized controlled trial of ACT | one year | Demonstrate that 48 patients can be successfully enrolled and randomized |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preliminary data on the effectiveness of ACT on migraine frequency and migraine disability | one year | 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. |
| Change in migraine severity, duration, and medication use. | one year | Severity of each migraine (1-10), duration (hours), and medicines taken assessed by patient-completed migraine logs. |
| Change in headache-related disability | one year | Headache Related Disability measured using the validated HIT-6. |
| Change in quality of life. | one year | Quality of life assessed using the Migraine Specific Quality of Life Questionnaire (MSQ). |
| Change in depression and anxiety. | one year | Depression and anxiety assessed through the Hospital Anxiety and Depression Scale (HADS). |
| Change in pain acceptance and pain expectancy. | one year | Pain acceptance assessed through the Chronic Pain Acceptance Questionnaire and pain expectancy during the migraine attacks assessed using the allodynia questionnaire. |
| Change in pain catastrophizing. | one year | Pain Catastrophizing Scale (PCS) used to assess distress and rumination experienced due to migraine anticipation. |
| Change in distress tolerance. | one year | Distress tolerance will be assessed through the Distress Tolerance Scale. |
| Change in physical activity. | one year | Physical activity measured using the Godin Leisure Time Exercise questionnaire. |
| Change in perceived stress. | one year | Perceived stress measured through the Perceived Stress Scale (PSS). |
| Change in mindfulness. | one year | Mindful Attention and Awareness Scale (MAAS) used to measure receptive awareness and attention to the present. |
| Change in cortisol levels. | one year | Salivary Cortisol will be collected to measure the cortisol awakening response. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORcarolyn bernstein, md
Brigham and Women's Hospital
Outcome results
None listed