ACT for High Frequency Migraine; A Virtual Mindfulness Intervention

Acceptance and Commitment Therapy for High Frequency Episodic Migraine

Mindfulness Training specifically for pain to be offered to migraine patients

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Behavioral: ACT

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02155
      • Brigham and Womens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Massachusetts Institute of Technology
• Investigators: Principal Investigator: carolyn bernstein, md, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2020
• Primary Completion (Actual): November 23, 2021
• Study Completion (Actual): November 23, 2021

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: August 5, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 29, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: migraine; ACT; high frequency
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 2018P001239

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No