Mind Body Intervention for Chronic Migraine Headaches

NCT06690060 | Recruiting

• 1 other identifier: 2024P000778A
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Migraines; Chronic Pain

Keywords

Migraines; Headaches; Chronic Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Brief Pain Inventory Questionnaire (Short Form)

  baseline, 4, 8, 13 and 20 weeks

• Pain Anxiety Symptom Scale (Short Form 20)

  baseline, 4, 8, 13 and 20 weeks

• Somatic Symptoms Score (SSS-8)

  baseline, 4, 8, 13 and 20 weeks

• Migraine Duration

  baseline, 4, 8, 13 and 20 weeks

• NRS-11

  baseline, 4, 8, 13 and 20 weeks

Study Arms (1)

Mind-Body Intervention

EXPERIMENTAL

A Novel Mind body technique for the intervention will be taught in lectures and group discussion sessions

Behavioral: Mind-Body Intervention

Interventions

Mind-Body Intervention BEHAVIORAL

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.

Mind-Body Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Known history or suspicion of headaches due to organic cause (e.g. cancer, sinus infection, head trauma, cerebrovascular disease)
• Diagnosis of other chronic pain syndromes that may cloud assessments (e.g. fibromyalgia, chronic idiopathic neck pain)
• Diagnosis of cognitive impairment or dementia
• Active addiction disorder, e.g. cocaine or IV heroin use, that would interfere with study participation

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Migraine Disorders; Chronic Pain; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Donnino, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Scafetta

CONTACT

617-754-2882; ascafett@bidmc.harvard.edu

Masumi Prasad

CONTACT

617-754-2882; mprasad2@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a cohort study in which all participants will receive the mind-body intervention. This is an exploratory study to help hone elements of the protocol through participant feedback and to determine variance and optimal survey measurement tools. We will not modify participant medication regimens and no pain or other medication prescriptions will be issued by the research team.

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 15, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)