Mind Body Intervention for Chronic Migraine Headaches
Recruiting · NCT06690060 · Interventional (participants receive a specific treatment) · Lead sponsor: Beth Israel Deaconess Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
Mind-Body Intervention
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
- Major psychiatric comorbidity (e.g., schizophrenia). Anxiety and mild-moderate depression are not considered exclusions.
Where it is running
2 locations listed across 1 US state.
- Beth Israel Deaconess Medical Center - Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center - Boston, Massachusetts, United States