NCT02824250

Brief Summary

The primary aim of this study is to conduct a randomized controlled feasibility trial of MBSR for patients with moderate-to- severe migraine headache.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2016

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

March 9, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

June 18, 2020

Status Verified

June 1, 2020

Enrollment Period

1.9 years

First QC Date

June 7, 2016

Last Update Submit

June 16, 2020

Conditions

MigraineChronic Pain

Keywords

MigraineMindfulnessMBSR

Outcome Measures

Primary Outcomes (1)

  • recruitment rate

    number recruited per month

    18 months post recruitment start

Secondary Outcomes (2)

  • treatment adherence

    18 months post recruitment start

  • diary completion

    2 years post recruitment start

Study Arms (2)

MBSR + Usual Care

EXPERIMENTAL

8-week standard Mindfulness-Based Stress Reduction (MBSR) course + standard of care

Behavioral: MBSR

Usual Care

NO INTERVENTION

Standard of care

Interventions

MBSRBEHAVIORAL

Mindfulness-Based Stress Reduction (MBSR) is an 8-week classroom based program of mindfulness meditation and gentle yoga.

MBSR + Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • headaches per month (based on run-in headache diary)

You may not qualify if:

  • No meditation or MBSR during the past 6 months
  • Cognitively or emotionally impaired as judged by a research physician prior to randomization
  • Pregnant
  • Lack of English language skills
  • No new migraine medication in past month
  • Incomplete headache diary during run-in period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Palo Alto Medical Foundation Research Institute

Palo Alto, California, 94301, United States

Location

Related Publications (1)

  • Pressman A, Law H, Stahl R, Scott A, Jacobson A, Dean L, Sudat S, Obillo A, Avins A. 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). Trials. 2019 May 6;20(1):257. doi: 10.1186/s13063-019-3355-y.

    PMID: 31060619DERIVED

MeSH Terms

Conditions

Migraine DisordersChronic Pain

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2016

First Posted

July 6, 2016

Study Start

March 9, 2017

Primary Completion

February 7, 2019

Study Completion

May 31, 2020

Last Updated

June 18, 2020

Record last verified: 2020-06

Locations

US(1)