Treatment for Migraine and Mood

Running, not enrolling · Not applicable

Conditions studied: Migraine, Depressive Symptoms

In brief

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).

Key facts

Study ID

NCT05576467

Run by

Amanda Shallcross

People needed

145

Starts

2024-03-17

Expected to finish

2026-10-20

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Albert Einstein College of Medicine — The Bronx, New York, United States
• Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States
• The Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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