Bronx MBCT-Migraine

NCT02443519 | Completed Results DMC

• 1 other identifier: 2015-4684
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Migraine

Keywords

Mindfulness; MBCT; Cognitive Therapy; Disability

Outcome Measures

Primary Outcomes (2)

• Proportion of People With "Severe" Scores on the Migraine Disability Assessment

  The MIDAS is a 5-item, self-report instrument that assesses the number of days in the past three months participants experienced partially or fully reduced functioning in a variety of contexts (work, school, social). MIDAS scores are totaled and interpreted in the following grades: 0-5 = Grade I (Little or no disability); 6-10 = Grade II (Mild disability); 11-20 = Grade III (Moderate disability); 21+ = Grade IV (Severe disability). Scores were dichotomized at "Not Severe" (Grades I, II, and III) and "Severe "(Grade IV). The outcome was the proportion of participants who reported "Severe Disability."

  Change from Month 1 to Month 4

• Headache-Related Disability Index

  25-item, self-report questionnaire of the emotional and functional impact of headache on daily activities. Total scores range from 0-100, with higher scores indicating higher levels of disability.

  Change from Month 1 to Month 4

Secondary Outcomes (10)

• Headache Days (Over Course of 1 Month)

  Change from Month 1 to Month 4

• Average Headache Severity for Headache Days Recorded Over 30 Days

  Change from Month 1 to Month 4

• The Pain Catastrophizing Scale

  Change from Month 1 to Month 4

• Chronic Pain Acceptance Questionnaire

  Change from Month 1 to Month 4

• Five Facet Mindfulness Questionnaire

  Change from Month 1 to Month 4

Study Arms (2)

MBCT for Migraine

EXPERIMENTAL

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.

Behavioral: MBCT for Migraine

Wait List/Treatment as Usual

NO INTERVENTION

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

Interventions

MBCT for Migraine BEHAVIORAL

8 75-90 minute individual sessions of the manualized Mindfulness-based Cognitive Therapy plus a manual and homework

MBCT for Migraine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead

Study Sites (1)

Yeshiva University

The Bronx, New York, 10461, United States

Location

Related Publications (2)

• Best RD, Ozmeral A, Grinberg AS, Smitherman TA, Seng EK. Pain acceptance as a change mechanism for mindfulness-based cognitive therapy for migraine. J Behav Med. 2024 Jun;47(3):471-482. doi: 10.1007/s10865-024-00475-5. Epub 2024 Feb 26.

  PMID: 38407727 DERIVED

• Seng EK, Conway AB, Grinberg AS, Patel ZS, Marzouk M, Rosenberg L, Metts C, Day MA, Minen MT, Buse DC, Lipton RB. Response to Mindfulness-Based Cognitive Therapy Differs Between Chronic and Episodic Migraine. Neurol Clin Pract. 2021 Jun;11(3):194-205. doi: 10.1212/CPJ.0000000000000984.

  PMID: 34484887 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Elizabeth Seng
• Organization: Yeshiva University & Albert Einstein College of Medicine

elizabeth.seng@yu.edu

646-592-4368

Study Officials

• Elizabeth K Seng, Ph.D.

  Yeshiva University/Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 8, 2015
• First Posted: May 14, 2015
• Study Start: July 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: February 1, 2019
• Last Updated: October 12, 2020
• Results First Posted: October 12, 2020

Record last verified: 2020-09

Locations

US (1)