Mind Body Intervention for Chronic Migraine Headaches
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mind-Body Intervention.
- Who it may be relevant to
- Registry conditions: Migraines, Chronic Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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.
Primary outcome measures
- MIDAS [Time frame: baseline, 4, 8, 13 and 20 weeks]
- HIT-6 [Time frame: baseline, 4, 8, 13 and 20 weeks]
Secondary outcome measures (7)
- Brief Pain Inventory Questionnaire (Short Form) [Time frame: baseline, 4, 8, 13 and 20 weeks]
- Pain Anxiety Symptom Scale (Short Form 20) [Time frame: baseline, 4, 8, 13 and 20 weeks]
- Somatic Symptoms Score (SSS-8) [Time frame: baseline, 4, 8, 13 and 20 weeks]
- Migraine Duration [Time frame: baseline, 4, 8, 13 and 20 weeks]
- NRS-11 [Time frame: baseline, 4, 8, 13 and 20 weeks]
- GAMS [Time frame: baseline, 4, 8, 13 and 20 weeks]
- Feedback on protocol [Time frame: 13 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Beth Israel Deaconess Medical Center — Boston
- Beth Israel Deaconess Medical Center — Boston
Identifiers
NCT: NCT06690060 · 2024P000778A