NCT05003362

Brief Summary

Mindfulness Training specifically for pain to be offered to migraine patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

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

Study Start

First participant enrolled

October 25, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2021

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

July 20, 2021

Last Update Submit

March 24, 2026

Conditions

Migraine

Keywords

migrainehigh frequencyACT

Outcome Measures

Primary Outcomes (1)

  • Feasibility of a randomized controlled trial of ACT

    Demonstrate that 48 patients can be successfully enrolled and randomized

    one year

Secondary Outcomes (12)

  • Preliminary data on the effectiveness of ACT on migraine frequency and migraine disability

    one year

  • Change in migraine severity, duration, and medication use.

    one year

  • Change in headache-related disability

    one year

  • Change in quality of life.

    one year

  • Change in depression and anxiety.

    one year

  • +7 more secondary outcomes

Study Arms (2)

usual care

NO INTERVENTION

Subjects randomized to the usual care control group will continue using their usual medical care as prescribed by their physician.

ACT

ACTIVE COMPARATOR

An 8-week mindfulness-based group therapy.

Behavioral: ACT

Interventions

ACTBEHAVIORAL

mindfulness intervention for patients with pain/migraine

ACT

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspatients will identify as female
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women ages 18-65
  • Diagnosis of episodic migraine (according to International Classification for Headache Diagnosis criteria)
  • migraine days per month over the past 3 months
  • No change in medication in the past 3 months
  • Greater than 1 year of migraines
  • Agreeable to participate, commit to all study procedures and to be randomized to either group
  • Fluent in English

You may not qualify if:

  • Any unstable medical or psychiatric conditions requiring immediate treatment or could lead to difficulty complying with the protocol
  • Active suicidal ideation
  • Moderate to severe depression
  • Current alcohol or substance abuse
  • Recent Cognitive Behavioral Therapy, Mindfulness Based Cognitive Therapy, Dialectic Behavioral Therapy or Acceptance and Commitment Therapy within past 3 years
  • Current use of narcotics
  • Psychiatric hospitalization within past year
  • Comorbid pain condition rated as more painful than migraine
  • Starts new migraine treatment during study
  • Inability to complete study visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Womens Hospital

Boston, Massachusetts, 02155, United States

Location

Related Publications (1)

  • Bernstein C, Lazaridou A, Paschali M, Vilsmark ES, Rist PM. Acceptance-Commitment Therapy for Women with Episodic Migraine: A Pilot Randomized Trial. J Integr Complement Med. 2024 May;30(5):478-486. doi: 10.1089/jicm.2023.0085. Epub 2023 Nov 27.

    PMID: 38011750DERIVED

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • carolyn bernstein, md

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
randomized control
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: After screening, patients will be randomized and one group will receive the intervention. The investigators will do sequential interventions of the ACT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 20, 2021

First Posted

August 12, 2021

Study Start

October 25, 2020

Primary Completion

November 23, 2021

Study Completion

November 23, 2021

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)