Mind-body approach for treating chronic migraines
Mind Body Intervention for Chronic Migraine Headaches
This study is testing a mind-body program to see if it can help adults with chronic migraines feel better and manage their symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT06690060 on ClinicalTrials.gov |
What this trial studies
This exploratory study aims to evaluate the feasibility of a mind-body intervention for individuals suffering from chronic migraines. The study will assess various measurement tools to optimize a follow-up pilot study that will investigate the intervention's impact on migraine frequency and severity. Participants will engage in remote sessions designed to enhance their coping strategies and overall well-being. The study focuses on adults who experience migraines at least five days a month and have a moderate impact on their daily lives.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of chronic migraines experiencing significant impact on their daily lives.
Not a fit: Patients with migraines due to organic causes or those with other chronic pain syndromes may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a non-pharmacological treatment option for patients suffering from chronic migraines.
How similar studies have performed: Other studies have shown promise with mind-body interventions for various chronic pain conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Boston, Massachusetts and 1 other locations
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Not_yet_recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Michael Donnino, MD — Beth Israel Deaconess Medical Center
- Study coordinator: Ashley Scafetta
- Email: ascafett@bidmc.harvard.edu
- Phone: 617-754-2882
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.