Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 12:26 AM
NCT ID:
NCT05576467
Eligibility Criteria:
Inclusion Criteria:
* Currently meets ICHD-3 (International Classification for Headache Disorders - 3rd Edition) criteria for migraine using the American Migraine Prevalence and Prevention Diagnostic Module
* Self-reported 4-14 headache days per month, with at least one attack meeting migraine criteria
* Score between 5-14 on the PHQ-9 (Patient Health Questionnaire)
* Age ≥ 18
* Ability to read and speak English
* Capacity to consent
* Prospective diary-confirmed 4-14 headache days per month, with at least one attack meeting migraine criteria
* ≥1 year of migraine
Exclusion Criteria:
* Meeting ICHD-3 criteria for persistent headache attributed to traumatic injury to the head (post-traumatic headache) on the American Migraine Prevalence and Prevention Diagnostic Module
* Changes in preventive migraine medication or anti-depressant medication within 6 weeks of intake
* Changes in longer-term migraine prevention (onabotulinum toxin A, injectable or oral anti-calcitonin gene related peptide treatment; neuromodulatory device) within 3 months of intake
* Changes in acute migraine treatment started within 4 weeks of enrollment
* Comorbid psychiatric illness or clinical features that would interfere with participant's ability to participate in or receive benefit from the intervention, including but not limited to: active suicidal ideation; recent history of psychosis or mania; borderline, histrionic or narcissistic personality disorder; cognitive impairment; sensory disabilities; bipolar disorder; obsessive-compulsive disorder, drug use
* Prior history of engaging in formal mindfulness-based interventions including: MBSR (Mindfulness-based stress reduction), MBCT (Mindfulness-based cognitive therapy), Acceptance and Commitment therapy, Dialectical Behavior Therapy
* Current daily meditation practice
* Inability to adhere to headache diary during baseline evaluation period (recorded fewer than 25/28 days)
* Unwilling to maintain stable current acute or preventive medication dosages for study duration
* Any condition that would prevent being a suitable candidate or interfere with medical care needs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05576467
Study Brief:
Protocol Section:
NCT05576467