Treatment for Migraine and Mood (TEAM-M)

Amanda Shallcross

Status: Enrolling

Conditions: Depressive Symptoms; Migraine

Treatments: Behavioral: MBCT-Telephone; Behavioral: Enhanced Usual Care (EUC); Behavioral: MBCT-Video

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05576467

R01AT011005 (U.S. NIH Grant/Contract)

20225608

Details and patient eligibility

About

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).

Full 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).

Enrollment: 144 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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144 participants in 3 patient groups

MBCT-Telephone

Active Comparator group

Description:

8 weekly classes delivered via telephone.

Treatment:

Behavioral: MBCT-Telephone

MBCT-Video

Active Comparator group

Description:

8 weekly classes delivered via video.

Treatment:

Behavioral: MBCT-Video

Enhanced Usual Care (EUC)

Active Comparator group

Description:

8 weekly online modules delivered via web portal.

Treatment:

Behavioral: Enhanced Usual Care (EUC)