Recruiting

Mind Body Intervention

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT06690060

Conditions

Migraines

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mind-Body Intervention

Study Details

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

Study ID

NCT06690060

Start date

Nov 15, 2024

Status verified date

Mar, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mind-Body Intervention

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

Interventions

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.

Primary outcome measure

  • MIDAS [ Time Frame: baseline, 4, 8, 13 and 20 weeks ]
  • HIT-6 [ Time Frame: baseline, 4, 8, 13 and 20 weeks ]

Central Contacts and Locations

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02115

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Mar 17, 2026

Last verified

Mar, 2026

Keywords

  • Migraines
  • Headaches
  • Chronic Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2026-03-17.