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Mind Body Intervention for Chronic Migraine Headaches

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a mind-body treatment for adults with ongoing migraines. It will check how well the study plan can be carried out and which tools to use to measure results in a future study.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • You have been diagnosed with migraines using the ICHD-3 beta guidelines.
  • You score 50 or higher on the Headache Impact Test-6, a survey about how headaches affect your life.
  • You have migraines at least 5 days each month.
  • You are willing to try a mind-body treatment.
  • You are willing and able to join sessions remotely.

Who can't join

  • Your headaches are known or suspected to come from another medical cause, such as cancer, a sinus infection, a head injury, or disease of blood vessels in the brain.
  • You have another long-term pain condition that could make results hard to judge, such as fibromyalgia or ongoing neck pain with no known cause.
  • You have been diagnosed with problems with memory or thinking, or with dementia.
  • You have an active addiction, such as cocaine or injected heroin use, that would interfere with taking part.
  • You have a major mental health condition, such as schizophrenia. Anxiety and mild to moderate depression do not rule you out.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (2)

MA