Mind Body Intervention for Chronic Migraine Headaches

The goal of this exploratory study is to test a mind-body interventional approach for the treatment of chronic migraines. The main goal is to obtain feasibility information on the protocol which has been used in other similar conditions. We will also evaluate multiple measurement tools in order to optimize a follow-up pilot study evaluating the impact of the protocol on migraines.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Migraines
• Intervention / Treatment: Behavioral: Mind-Body Intervention

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Masumi Prasad; Phone Number: 617-754-2882; Email: mprasad2@bidmc.harvard.edu
• Study Contact Backup: Name: Ashley Scafetta; Phone Number: 617-754-2882; Email: ascafett@bidmc.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Not yet recruiting
      • Beth Israel Deaconess Medical Center
      • Contact: Ashley Scafetta; Phone Number: 617-754-2882; Email: ascafett@bidmc.harvard.edu
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult (≥ 18 years of age)
2. Previously diagnosed with migraine headache based on ICHD-3 beta criteria 91
3. A score of ≥ 50 on the Headache Impact Test-6 self-report survey (moderate impact) 92
4. Presence of migraine headaches at least 5 days per month
5. Willing to engage in a Mind-Body intervention
6. Willing/able to participate in remote sessions

Exclusion Criteria:

1. Known history or suspicion of headaches due to organic cause (e.g. cancer, sinus infection, head trauma, cerebrovascular disease)
2. Diagnosis of other chronic pain syndromes that may cloud assessments (e.g. fibromyalgia, chronic idiopathic neck pain)
3. Diagnosis of cognitive impairment or dementia
4. Active addiction disorder, e.g. cocaine or IV heroin use, that would interfere with study participation
5. Major psychiatric comorbidity (e.g., schizophrenia). Anxiety and mild-moderate depression are not considered exclusions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mind-Body Intervention; A Novel Mind body technique for the intervention will be taught in lectures and group discussion sessions	Behavioral: Mind-Body Intervention; The mind-body intervention will include regular 1 to 2 hour educational sessions and lectures, as well as supplemental reading material. In addition, individualized sessions will be offered each week for students who have additional questions and/or need additional time with the material.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MIDAS	The 7-item Migraine Disability Assessment (MIDAS) is a commonly used and well validated self report survey for assessing migraine-related disability. Questions cover adverse life impacts (missed work, etc.), headache frequency, and headache intensity.	baseline, 4, 8, 13 and 20 weeks
HIT-6	The Headache Impact Test (HIT-6), a well-validated self reported survey, measures the impact of headaches on 6 aspects of health-related quality of life. A recent study has estimated that a change of 6-7 points was clinically meaningful in a cohort starting with a mean HIT-6 score of 65.0 (severe impact). The HIT-6 is a recommended NIH common data element for headache.	baseline, 4, 8, 13 and 20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Pain Inventory Questionnaire (Short Form)	The Brief Pain Inventory questionnaire, which has been validated by Keller et al., will be utilized to gauge pain intensity during the duration of the study. The question about current pain medications will be modified slightly to include current frequency of use.	baseline, 4, 8, 13 and 20 weeks
Pain Anxiety Symptom Scale (Short Form 20)	The short form Pain Anxiety Symptom Scale (PASS-20) is a 20 question survey assessing cognitive, avoidance, fear, and physiological anxiety due to pain. It has been validated by McCracken et al.	baseline, 4, 8, 13 and 20 weeks
Migraine Duration	We will ask participants to estimate how long, on the average, their migraine attacks lasted during the last two weeks.	baseline, 4, 8, 13 and 20 weeks
NRS-11	The 11-point Numeric Rating Scale (NRS-11) for headache pain intensity asks the patient to rate their pain intensity from 0 (no pain) to 10 (worst pain imaginable). The NRS-11 is recommended by the International Headache Society (IHS) for assessment of this parameter in clinical trials.	baseline, 4, 8, 13 and 20 weeks
GAMS	The single question Global Assessment of Migraine Severity (GAMS) captures a patient's assessment of their overall disease severity. The GAMS is being tested at this stage because there is an abundance of published baseline and variance data for comparison.	baseline, 4, 8, 13 and 20 weeks
Feedback on protocol	We will be receiving qualitative feedback on the protocol	13 weeks
Somatic Symptoms Score (SSS-8)	The 8 question Somatic Symptoms Score (SSS-8) is a validated, abbreviated version of the 15 question Patient Health Questionnaire (PHQ)-15. SSS-8 survey questions pertain to pain, the gastrointestinal system, fatigue, and cardiovascular complaints.	baseline, 4, 8, 13 and 20 weeks

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Michael Donnino, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: November 13, 2024
• First Submitted That Met QC Criteria: November 13, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 15, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Pain; Headaches; Migraines
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Migraine Disorders; Chronic Pain; Headache
• Other Study ID Numbers: 2024P000778A

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
• product manufactured in and exported from the U.S.: No