Clinical trial NCT05003362: ACT for High Frequency Migraine; A Virtual Mindfulness Intervention
Official title: Acceptance and Commitment Therapy for High Frequency Episodic Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: migraine
high frequency
ACT
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts Institute of Technology
First posted: 2021-08-12
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of a randomized controlled trial of ACT
timeFrame: one year
Secondary outcomes:
measure: Preliminary data on the effectiveness of ACT on migraine frequency and migraine disability
timeFrame: one year
measure: Change in migraine severity, duration, and medication use.
timeFrame: one year
measure: Change in headache-related disability
timeFrame: one year
measure: Change in quality of life.
timeFrame: one year
measure: Change in depression and anxiety.
timeFrame: one year
measure: Change in pain acceptance and pain expectancy.
timeFrame: one year
measure: Change in pain catastrophizing.
timeFrame: one year
measure: Change in distress tolerance.
timeFrame: one year
measure: Change in physical activity.
timeFrame: one year
measure: Change in perceived stress.
timeFrame: one year
measure: Change in mindfulness.
timeFrame: one year
measure: Change in cortisol levels.
timeFrame: one year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Womens Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: carolyn bernstein, md
role: PRINCIPAL_INVESTIGATOR
References: