Treatment for Migraine and Mood (Team-M) (TEAM-M)

NYU Langone Health

Status and phase: Completed; Phase 2

Conditions: Migraine; Depression

Treatments: Behavioral: MBCT-Telephone; Behavioral: MBCT-Video

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04992494

R01AT011005 (U.S. NIH Grant/Contract)

20-01911

Details and patient eligibility

About

The researchers propose a two-arm pilot study of telephone and video delivered Mindfulness-based Cognitive Therapy (MBCT-T and MBCT-V) in people with migraine and depressive symptoms.

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 first phase is aimed at fidelity optimization of MBCT-T and MBCT-V 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: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Currently meets ICHD-3 criteria for migraine using the Structured Diagnostic Interview for Headache
• Self-reported 4-14 headache days per month, with at least one attack meeting migraine criteria
• Score between 5-14 on the PHQ-9
• Age ≥ 18
• Ability to read and speak English
• Capacity to consent

Exclusion criteria

• Meeting ICHD-3 criteria for persistent headache attributed to traumatic injury to the head (post-traumatic headache) on the Structure Diagnostic Interview for Headache
• Changes in preventive migraine medication or anti-depressant medication within 6 weeks of intake; changes in longer-term migraine prevention (onobotulinum toxin A, anti-calcitonin gene related peptide treatment) within 3 months of intake
• Comorbid psychiatric illness or clinical features that would interfere with participant's ability to participate in or receive benefit from the MBCT 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
• Prior history of engaging in formal mindfulness-based interventions including: MBSR, MBCT, Acceptance and Commitment therapy, Dialectical Behavior Therapy
• Current meditation practice >3x/week

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

MBCT-T (Mindfulness-Based Cognitive Therapy - Telephone)

Experimental group

Description:

Mindfulness-based cognitive therapy delivered by Telephone

Treatment:

Behavioral: MBCT-Telephone

MBCT-V (Mindfulness-Based Cognitive Therapy - Video)

Experimental group

Description:

Mindfulness-based cognitive therapy delivered by Video

Treatment:

Behavioral: MBCT-Video