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Search / Trial NCT05576467

Treatment for Migraine and Mood

Launched by AMANDA SHALLCROSS · Oct 10, 2022

Trial Information

Current as of May 15, 2025

Recruiting

Keywords

Mindfulness Mindfulness Based Cognitive Therapy

ClinConnect Summary

This clinical trial is exploring how different methods of Mindfulness-Based Cognitive Therapy (MBCT) can help people who experience migraines and depressive symptoms. The study compares three ways to deliver MBCT: over the phone, through video, and an enhanced usual care approach. Researchers are looking for participants aged 18 and older who have been diagnosed with migraines and have experienced 4 to 14 headache days each month. Additionally, participants should have mild to moderate depressive symptoms, as indicated by their responses to a questionnaire.

If you decide to join the trial, you’ll be part of a study that aims to find out if these mindfulness techniques can improve your migraine symptoms and mood. You’ll need to keep a diary to track your headaches, and it's important that you have a stable medication routine during the study. The trial is currently recruiting participants, and it’s a great opportunity to contribute to research in this area while potentially finding relief from your symptoms.

Gender

ALL

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

About Amanda Shallcross

Amanda Shallcross is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes. With a focus on innovative therapies and a patient-centered approach, Amanda Shallcross oversees the design, implementation, and management of clinical trials across various therapeutic areas. Her extensive expertise in regulatory compliance and strategic planning ensures that trials are conducted efficiently and ethically, fostering collaboration among stakeholders to drive scientific progress. Through a commitment to excellence and transparency, Amanda Shallcross plays a pivotal role in bridging the gap between research and real-world healthcare solutions.

Locations

Bronx, New York, United States

Cleveland, Ohio, United States

Winston Salem, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Elizabeth K Seng, Ph.D.

Principal Investigator

Albert Einstein College of Medicine and Yeshiva University

Amanda J Shallcross, M.P.H., N.D.

Principal Investigator

The Cleveland Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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