MRI Outcomes of Mindfulness Meditation for Migraine

NCT02133209 | Completed DMC

• 2 other identifiers: NA_00091884R01AT007176
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 2

Brief Summary

112 migraine subjects will be initially randomly assigned to Mindfulness-Based Stress Reduction (MBSR) or a Stress Management for Headache group (SMH). Outcomes, including headache frequency and impact and brain activity, will be assessed at baseline, prior to intervention, and at 3-, 6-, and 12-months.

Conditions

Migraine

Keywords

migraine; headache; meditation; mindfulness based stress reduction; MBSR

Outcome Measures

Primary Outcomes (3)

• Change in headache frequency and impact

  Headache days per 28 days and headache-related disability (HIT-6)

  Baseline, 3, 6, and 12 months

• Change in gray matter volume

  Gray matter volume in the insula, dorsolateral prefrontal cortex, and cingulate

  Baseline, 3, and 6 months

• Change in Brain Function

  Overall activation of the dorsolateral prefrontal cortex and the task-positive cognitive network, and resting state connectivity to the insula

  Baseline, 3, and 6 months

Secondary Outcomes (3)

• Change in headache intensity

  Baseline, 3, 6, and 12 months

• Change in Brain Structure

  Baseline, 3, and 6 months

• Change in Whole Brain Function

  Baseline, 3, and 6 months

Study Arms (2)

Stress Management for Headaches

ACTIVE COMPARATOR

This intervention involves a standardized stress management for headaches (SMH) group intervention that focuses on stress and general stress management skills for managing migraine headaches.

Behavioral: Stress Management for Headaches

Mindfulness Based Stress Reduction

ACTIVE COMPARATOR

Intervention involves a standardized mindfulness-based stress reduction (MBSR) group intervention following the guidelines originally conceived and developed by the Center for Mindfulness in Medicine, Health Care and Society at the University of Massachusetts. The intervention also included an extended period of training in addition to the usual 8 weeks.

Behavioral: Mindfulness Based Stress Reduction

Interventions

Mindfulness Based Stress Reduction BEHAVIORAL

Mindfulness Based Stress Reduction (MBSR) involves focused attention while practicing moment-to-moment nonjudgmental awareness of the self with the goal of achieving emotional balance and clarity of thought. There will be 8 weekly sessions and a half day retreat followed by 4 bi-weekly sessions over a period of 4 months.

Mindfulness Based Stress Reduction

Stress Management for Headaches BEHAVIORAL

Intervention involves a standardized stress management for headaches (SMH) group intervention that focuses on stress and general stress management skills, headache symptoms and their management, sleep hygiene, and healthy eating. There will be 8 weekly sessions followed by 4 bi-weekly sessions over a period of 4 months.

Stress Management for Headaches

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are between 18 and 65 years of age
• Report between 4 and 14 headaches over 28 days
• Have a history of migraines lasting at least 1 year
• Are not currently using opioid ("narcotic") pain medication

You may not qualify if:

• Are unable to undergo MRI
• Pregnant, lactating, or planning to become pregnant
• Current use of opioid medications
• Are between 18 and 65 years of age
• Free of any acute or chronic pain condition and reports no history of migraines

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• University of Maryland: collaborator

Study Sites (2)

University of Maryland School of Dentistry

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins University, Bayview Medical Campus

Baltimore, Maryland, 21224, United States

Location

Related Publications (2)

• Burrowes SAB, Goloubeva O, Keaser ML, Haythornthwaite JA, Seminowicz DA. Differences in gray matter volume in episodic migraine patients with and without prior diagnosis or clinical care: a cross-sectional study. J Headache Pain. 2021 Oct 23;22(1):127. doi: 10.1186/s10194-021-01340-5.

  PMID: 34688253 DERIVED

• Burrowes SAB, Goloubeva O, Stafford K, McArdle PF, Goyal M, Peterlin BL, Haythornthwaite JA, Seminowicz DA. Enhanced mindfulness-based stress reduction in episodic migraine-effects on sleep quality, anxiety, stress, and depression: a secondary analysis of a randomized clinical trial. Pain. 2022 Mar 1;163(3):436-444. doi: 10.1097/j.pain.0000000000002372.

  PMID: 34407032 DERIVED

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jennifer A Haythornthwaite, Ph.D.

  Johns Hopkins University

  STUDY DIRECTOR

• David Seminowicz, Ph.D.

  University of Maryland

  PRINCIPAL INVESTIGATOR

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: SPONSOR

Study Record Dates

• First Submitted: April 21, 2014
• First Posted: May 7, 2014
• Study Start: May 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: August 8, 2018

Record last verified: 2018-08

Locations

US (2)