ACT for High Frequency Migraine; A Virtual Mindfulness Intervention

Brigham and Women's Hospital75 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Migraine

Interventions

ACTBEHAVIORAL

mindfulness intervention for patients with pain/migraine

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Brigham and Womens Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Feasibility of a randomized controlled trial of ACT

Demonstrate that 48 patients can be successfully enrolled and randomized

Time frame: one year

Secondary Outcomes

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.

Time frame: 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.

Time frame: one year

Change in headache-related disability

Headache Related Disability measured using the validated HIT-6.

Time frame: one year

Change in quality of life.

Quality of life assessed using the Migraine Specific Quality of Life Questionnaire (MSQ).

Time frame: one year

Change in depression and anxiety.

Depression and anxiety assessed through the Hospital Anxiety and Depression Scale (HADS).

Time frame: 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.

Time frame: one year

Data from ClinicalTrials.gov

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