Bronx MBCT-Migraine (BMBCT-M)

A

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

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.

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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