Evidence map›Paper›PMID 31060619›Full record

ArticleTrials2019

Conducting a pilot randomized controlled trial of community-based mindfulness-based stress reduction versus usual care for moderate-to-severe migraine: protocol for the Mindfulness and Migraine Study (M&M).

Alice Pressman, Heather Law, Robert Stahl, Alex Scott, Alice Jacobson, Lisa Dean, Sylvia Sudat, Angelica Obillo, Andrew Avins

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02824250 (Mindfulness and Migraine), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.8field-weighted citation impact, top 28% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02824250 nacompletednot on this map

Mindfulness and Migraine: A Randomized Controlled Trial

TypeinterventionalSponsorCalifornia Pacific Medical Center Research InstituteRan2017 to 2020Enrolled66ConditionsMigraine, Chronic PainArmsMBSR
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. Mindfulness in migraine: A narrative review.Expert review of neurotherapeutics · 2020
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 1 country.

Alice PressmanSutter Health Research Development and Dissemination, 2121 North California Blvd, Walnut Creek, CA, 94596, USA. pressmar@sutterhealth.org.ORCID http://orcid.org/0000-0003-2775-3275
Heather LawSutter Health Research Development and Dissemination, 2121 North California Blvd, Walnut Creek, CA, 94596, USA.
Robert StahlInsight Santa Cruz a Buddhist Meditation Community, 119 Marnell Ave, Santa Cruz, CA, 95062, USA.
Alex ScottSutter Health Research Development and Dissemination, 2121 North California Blvd, Walnut Creek, CA, 94596, USA.
Alice JacobsonSutter Health Research Development and Dissemination, 2121 North California Blvd, Walnut Creek, CA, 94596, USA.
Lisa DeanSutter Health Research Development and Dissemination, 2121 North California Blvd, Walnut Creek, CA, 94596, USA.
Sylvia SudatSutter Health Research Development and Dissemination, 2121 North California Blvd, Walnut Creek, CA, 94596, USA.
Angelica ObilloPalo Alto Medical Foundation Research Institute, 795 El Camino Real, Palo Alto, CA, 94301, USA.
Andrew AvinsKaiser Permanente Northern California Division of Research, 2000 Broadway, Oakland, CA, 94612, USA.
Sutter Health · USKaiser Permanente · USPalo Alto Institute · US

Funding

Mindfulness and Migraine: A Randomized Controlled TrialR01AT009081 · NCCIH · CALIFORNIA PACIFIC MED CTR RES INSTITUTE · PI PRESSMAN, ALICE ROGOT · 2016 to 2018
$1.6M
National Center for Complementary and Integrative Health 1R01AT009081NCCIH NIH HHS R01 AT009081
6 · The paper itself

Abstract

backgroundMigraine is one of the most common neurological disorders in clinical practice and is a substantial cause of disability worldwide. Current approaches to therapy are primarily based on medication but are often limited by inadequate effectiveness and common side effects. Newer, more effective medications are expensive. Mindfulness-based stress reduction (MBSR), an 8-week classroom-based meditation intervention, is inexpensive, has no known side effects, and has demonstrated clinically meaningful effectiveness for several chronic-pain syndromes. In addition, MBSR has shown promising results for migraine therapy in a few small case studies and pilot studies. We present here the protocol for a two-arm randomized controlled pilot trial of MBSR for moderate-to-severe episodic migraine, which, if successful, will form the basis for a fully powered clinical trial. METHODS/

designThis study, set in Northern California, is a two-arm parallel-comparison single-blinded randomized controlled pilot trial with the goal of recruiting approximately 60 participants with moderate-to-severe episodic migraine. The feasibility outcomes include ability and time required to recruit, adherence to the MBSR treatment, and ability to measure outcomes using 31-day headache diaries and patient-reported questionnaire data. The active treatment arm consists of an 8-week community-based MBSR class plus usual care, and the wait-list control group is usual care. Recruitment is underway and expected to be complete by the end of 2018. DISCUSSION: To our knowledge, this is the first pragmatic trial in the U.S. of MBSR for migraine using community-based classes, and if it proves viable, we plan to conduct a fully powered trial to determine the effectiveness of the intervention for reducing headache days for moderate-to-severe episodic migraineurs.

trial registrationClinicaltrials.gov, NCT02824250 . Registered on 6 July 2016.

Indexed as

Community Health ServicesMindfulnessCaliforniaFeasibility StudiesHumansMeditationMigraine DisordersPilot ProjectsPragmatic Clinical Trials as TopicSeverity of Illness IndexSingle-Blind MethodStress, PsychologicalTime FactorsTreatment OutcomeBehavioral interventionFeasibilityHeadacheMigraineMindfulnessMindfulness-based stress reduction (MBSR)PainPilotPragmaticRCTTrial protocol

Identifiers

PMID31060619
PMCPMC6501281
OpenAlexW2947611977

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.