Treatment for Migraine and Mood

Last updated: June 11, 2025
Sponsor: Amanda Shallcross
Overall Status: Active - Recruiting

Phase

N/A

Condition

Oral Facial Pain

Chronic Pain

Pain (Pediatric)

Treatment

Video

MBCT-Telephone

Enhanced Usual Care (EUC)

Clinical Study ID

NCT05576467
20225608
R01AT011005
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Currently meets ICHD-3 (International Classification for Headache Disorders - 3rdEdition) criteria for migraine using the American Migraine Prevalence and PreventionDiagnostic Module

  • Self-reported 4-14 headache days per month, with at least one attack meetingmigraine 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 attackmeeting migraine criteria

  • ≥1 year of migraine

Exclusion

Exclusion Criteria:

  • Meeting ICHD-3 criteria for persistent headache attributed to traumatic injury tothe head (post-traumatic headache) on the American Migraine Prevalence andPrevention Diagnostic Module

  • Changes in preventive migraine medication or anti-depressant medication within 6weeks of intake

  • Changes in longer-term migraine prevention (onabotulinum toxin A, injectable or oralanti-calcitonin gene related peptide treatment; neuromodulatory device) within 3months of intake

  • Changes in acute migraine treatment started within 4 weeks of enrollment

  • Comorbid psychiatric illness or clinical features that would interfere withparticipant's ability to participate in or receive benefit from the intervention,including but not limited to: active suicidal ideation; recent history of psychosisor mania; borderline, histrionic or narcissistic personality disorder; cognitiveimpairment; 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 (recordedfewer than 25/28 days)

  • Unwilling to maintain stable current acute or preventive medication dosages forstudy duration

  • Any condition that would prevent being a suitable candidate or interfere withmedical care needs

Study Design

Total Participants: 144
Treatment Group(s): 6
Primary Treatment: Video
Phase:
Study Start date:
March 17, 2024
Estimated Completion Date:
October 20, 2026

Study 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).

Connect with a study center

  • Albert Einstein College of Medicine

    Bronx, New York 10461
    United States

    Active - Recruiting

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina 27101
    United States

    Active - Recruiting

  • The Cleveland Clinic

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

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