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NCT05576467 | RECRUITING | Migraine

Treatment for Migraine and Mood
Sponsor:

Amanda Shallcross

Information provided by (Responsible Party):

Amanda Shallcross

Brief 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).

Condition or disease

Migraine

Depressive Symptoms

Intervention/treatment

MBCT-Telephone

MBCT-Video

Enhanced Usual Care (EUC)

Phase

NA

Detailed Description:

This study aims to set the stage for a future definitive large-scale Phase III trial in patients with migraine and depressive symptoms. This pilot is aimed at evaluating the feasibility and acceptability of the Telephone and Video MBCT and EUC in people with migraine (defined by the International Classification of Headache Disorders - 3) and depressive symptoms (defined by empirical cut-offs on the Patient Health Questionnaire - 9).

Study Type : INTERVENTIONAL
Estimated Enrollment : 144 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
Official Title : Treatment for Migraine and Mood (TEAM-M): A Randomized Controlled Trial of a Mindfulness-based Training Program
Actual Study Start Date : 2024-03-17
Estimated Primary Completion Date : 2025-06
Estimated Study Completion Date : 2025-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Treatment for Migraine and Mood

Location Details

NCT05576467

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

Albert Einstein College of Medicine

Bronx, New York, United States, 10461

RECRUITING

United States, North Carolina

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States, 27101

RECRUITING

United States, Ohio

The Cleveland Clinic

Cleveland, Ohio, United States, 44106