Bronx MBCT-Migraine (BMBCT-M)

Albert Einstein College of Medicine

Status: Completed

Conditions: Migraine

Treatments: Behavioral: MBCT for Migraine

Study type: Interventional

Funder types: Other

Identifiers

NCT02443519

2015-4684

Details and patient eligibility

About

This randomized clinical trial aims to examine the effect of a standardized 8-week course of Mindfulness Based Cognitive Therapy for Migraine on migraine-related disability in people with migraine.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ICHD-3 beta headache diagnosis of migraine,
• self-reported and diary-confirmed 4-20 headache days per month
• aged 18-65
• ability to read English
• capacity to consent.

Exclusion criteria

• no ICHD-3 beta headache diagnosis of migraine
• fewer than 4 or greater than 20 headache days per month
• under 18 or over 65
• inability to read English
• lacking the capacity to consent
• utilization of new preventative pain treatments within four weeks of the baseline assessment, or a plan to utilize new preventive pain medications during the duration of the study
• severe psychiatric illness that would interfere with participation in the treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

MBCT for Migraine

Experimental group

Description:

In this arm, participants will receive 8 weeks of the manualized treatment Mindfulness Based Cognitive Therapy (MBCT; Day & Thorn). Participants will attend weekly 75-90 minute individual sessions for eight weeks. At each weekly session one of eight broad topics are addressed and discussed (Automatic-Pilot, Dealing with Barriers, Mindfulness of Breath, Staying Present, Allowing/Letting Be, Cognitive Restructuring, Self Care, Application to Headache Pain). Homework is assigned each week, and participants are expected to develop a daily formal mindfulness practice (body scan meditation, seated meditation, breathing meditation, etc). Participants are provided with a course manual, reading materials, and audio recordings to facilitate meditation practice.

Treatment:

Behavioral: MBCT for Migraine

Wait List/Treatment as Usual

No Intervention group

Description:

Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.