RECRUITING

Treatment for Migraine and Mood

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Conditions

MigraineDepressive Symptomsmindfulnessmindfulness-based cognitive therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Treatment for Migraine and Mood (TEAM-M): A Randomized Controlled Trial of a Mindfulness-based Training Program

Quick Facts

Study Start:2024-03-17
Study Completion:2025-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05576467

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Currently meets ICHD-3 (International Classification for Headache Disorders - 3rd Edition) criteria for migraine using the American Migraine Prevalence and Prevention Diagnostic Module
  2. * Self-reported 4-14 headache days per month, with at least one attack meeting migraine criteria
  3. * Score between 5-14 on the PHQ-9 (Patient Health Questionnaire)
  4. * Age ≥ 18
  5. * Ability to read and speak English
  6. * Capacity to consent
  7. * Prospective diary-confirmed 4-14 headache days per month, with at least one attack meeting migraine criteria
  8. * ≥1 year of migraine
  1. * 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
  2. * Changes in preventive migraine medication or anti-depressant medication within 6 weeks of intake
  3. * 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
  4. * Changes in acute migraine treatment started within 4 weeks of enrollment
  5. * 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
  6. * 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
  7. * Current daily meditation practice
  8. * Inability to adhere to headache diary during baseline evaluation period (recorded fewer than 25/28 days)
  9. * Unwilling to maintain stable current acute or preventive medication dosages for study duration
  10. * Any condition that would prevent being a suitable candidate or interfere with medical care needs

Contacts and Locations

Study Contact

Narissa McCarty, MS
CONTACT
(216) 780-1931
mccartn3@ccf.org
Devyn Gaskins
CONTACT
(216) 448-8705
gaskind@ccf.org

Principal Investigator

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

Study Locations (Sites)

Albert Einstein College of Medicine
Bronx, New York, 10461
United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27101
United States
The Cleveland Clinic
Cleveland, Ohio, 44106
United States

Collaborators and Investigators

Sponsor: Amanda Shallcross

  • 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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-17
Study Completion Date2025-07

Study Record Updates

Study Start Date2024-03-17
Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

  • mindfulness
  • mindfulness-based cognitive therapy

Additional Relevant MeSH Terms

  • Migraine
  • Depressive Symptoms