Mindfulness therapy for migraine and mood improvement
Treatment for Migraine and Mood (TEAM-M): A Randomized Controlled Trial of a Mindfulness-based Training Program
This study is testing if mindfulness therapy delivered over the phone or video can help people with migraines and depression feel better compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 3 sites (Bronx, New York and 2 other locations) |
| Trial ID | NCT05576467 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the feasibility and acceptability of Mindfulness-Based Cognitive Therapy (MBCT) delivered via telephone and video, compared to Enhanced Usual Care, for individuals experiencing migraines and depressive symptoms. Participants will be assessed based on their migraine frequency and depressive symptom severity using established diagnostic criteria. The goal is to gather preliminary data that will inform a larger Phase III trial in the future.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who experience 4-14 headache days per month and have mild to moderate depressive symptoms.
Not a fit: Patients with persistent headaches due to traumatic injury or those who have recently changed their migraine or antidepressant medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-pharmacological treatment option for patients suffering from both migraines and depressive symptoms.
How similar studies have performed: Previous studies have shown promise in using mindfulness-based interventions for managing chronic pain and mood disorders, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bronx, New York and 2 other locations
- Albert Einstein College of Medicine — Bronx, New York, United States (Recruiting)
- Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States (Recruiting)
- The Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Elizabeth K Seng, Ph.D. — Albert Einstein College of Medicine and Yeshiva University
- Study coordinator: Narissa McCarty, MS
- Email: mccartn3@ccf.org
- Phone: (216) 780-1931
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.