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Active Not Recruiting
NCT05576467
Treatment for Migraine and Mood
Conditions: Migraine, Depressive Symptoms
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 145
Sponsor: Amanda Shallcross
Location: Albert Einstein College of Medicine The Bronx New York
Summary
The researchers propose a three-arm pilot study of Mindfulness-Based Cognitive Therapy (MBCT) delivered via telephone (MBCT-T), video (MBCT-V) or Enhanced Usual Care (EUC).
Eligibility Criteria
Inclusion Criteria:
* Currently meets ICHD-3 criteria for migraine using the American Migraine Prevalence and Prevention Diagnostic Module
* Self-reported 4-20 headache days per month
* Score between 5-19 on the PHQ-8
* Age ≥ 18
* Ability to read and speak English
* Capacity to consent
* ≥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 anti-depressant medication within 6 weeks of intake
* Starting or changing a migraine preventive treatment (i.e., oral medication, injection, preventive medicine, neuromodulatory device) within 12 weeks 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 MBCT-T intervention, including but not limited to: active suicidal ideation; current or recent history (in the last six months) of psychosis or mania; borderline, histrionic or narcissistic personality disorder; cognitive impairment; sensory disabilities;, discomfort participating in a group-based intervention, drug use
* Prior history of engaging in formal mindfulness-based interventions including: MBSR, MBCT, Acceptance and Commitment therapy, Dialectical Behavior Therapy
* Current daily meditation practice
* Unwilling to maintain stable current acute or preventive medication dosages for study duration
* Any condition that would prevent being a suitable candidate for the group intervention
* Medication overuse headache with migraine treatment
Source: ClinicalTrials.gov (NCT05576467). StuddyBuddy aggregates publicly available trial information.