ACT for High Frequency Migraine; A Virtual Mindfulness Intervention

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05003362
• Collaborator: Massachusetts Institute of Technology (Other)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 26.2
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

Mindfulness Training specifically for pain to be offered to migraine patients

Condition or Disease	Intervention/Treatment	Phase
Migraine	Behavioral: ACT	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: After screening, patients will be randomized and one group will receive the intervention. The investigators will do sequential interventions of the ACTAfter screening, patients will be randomized and one group will receive the intervention. The investigators will do sequential interventions of the ACT
• Masking: Single (Outcomes Assessor)
• Masking Description: randomized control
• Primary Purpose: Treatment
• Official Title: Acceptance and Commitment Therapy for High Frequency Episodic Migraine
• Actual Study Start Date: Oct 25, 2020
• Actual Primary Completion Date: Apr 30, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Feasibility of a randomized controlled trial of ACT [one year]

   Demonstrate that 48 patients can be successfully enrolled and randomized

Secondary Outcome Measures

1. 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.

2. 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.

3. Change in headache-related disability [one year]

   Headache Related Disability measured using the validated HIT-6.

4. Change in quality of life. [one year]

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

5. Change in depression and anxiety. [one year]

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

6. 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.

7. Change in pain catastrophizing. [one year]

   Pain Catastrophizing Scale (PCS) used to assess distress and rumination experienced due to migraine anticipation.

8. Change in distress tolerance. [one year]

   Distress tolerance will be assessed through the Distress Tolerance Scale.

9. Change in physical activity. [one year]

   Physical activity measured using the Godin Leisure Time Exercise questionnaire.

10. Change in perceived stress. [one year]

    Perceived stress measured through the Perceived Stress Scale (PSS).

11. Change in mindfulness. [one year]

    Mindful Attention and Awareness Scale (MAAS) used to measure receptive awareness and attention to the present.

12. Change in cortisol levels. [one year]

    Salivary Cortisol will be collected to measure the cortisol awakening response.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Womens Hospital	Boston	Massachusetts	United States	02155

Sponsors and Collaborators

• Brigham and Women's Hospital
• Massachusetts Institute of Technology

Investigators

• Principal Investigator: carolyn bernstein, md, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Carolyn A. Bernstein, Principal Investigator, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT05003362
• Other Study ID Numbers: 2018P001239
• First Posted: Aug 12, 2021
• Last Update Posted: Jul 22, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Carolyn A. Bernstein, Principal Investigator, Brigham and Women's Hospital: migraine; high frequency; ACT
• Additional relevant MeSH terms: Migraine Disorders

Study Results

No Results Posted as of Jul 22, 2022