search
Back to results

ACT for High Frequency Migraine; A Virtual Mindfulness Intervention

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACT
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring migraine, high frequency, ACT

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women ages 18-65
  • Diagnosis of episodic migraine (according to International Classification for Headache Diagnosis criteria)
  • 4-14 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Brigham and Womens Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

usual care

ACT

Arm Description

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

An 8-week mindfulness-based group therapy.

Outcomes

Primary Outcome Measures

Feasibility of a randomized controlled trial of ACT
Demonstrate that 48 patients can be successfully enrolled and randomized

Secondary Outcome Measures

Preliminary data on the effectiveness of ACT on migraine frequency and migraine disability
Patient-completed migraine logs will be used to record the number of migraine days/month. Migraine disability will be measured using the validated Migraine Disability Assessment (MIDAS) questionnaire.
Change in migraine severity, duration, and medication use.
Severity of each migraine (1-10), duration (hours), and medicines taken assessed by patient-completed migraine logs.
Change in headache-related disability
Headache Related Disability measured using the validated HIT-6.
Change in quality of life.
Quality of life assessed using the Migraine Specific Quality of Life Questionnaire (MSQ).
Change in depression and anxiety.
Depression and anxiety assessed through the Hospital Anxiety and Depression Scale (HADS).
Change in pain acceptance and pain expectancy.
Pain acceptance assessed through the Chronic Pain Acceptance Questionnaire and pain expectancy during the migraine attacks assessed using the allodynia questionnaire.
Change in pain catastrophizing.
Pain Catastrophizing Scale (PCS) used to assess distress and rumination experienced due to migraine anticipation.
Change in distress tolerance.
Distress tolerance will be assessed through the Distress Tolerance Scale.
Change in physical activity.
Physical activity measured using the Godin Leisure Time Exercise questionnaire.
Change in perceived stress.
Perceived stress measured through the Perceived Stress Scale (PSS).
Change in mindfulness.
Mindful Attention and Awareness Scale (MAAS) used to measure receptive awareness and attention to the present.
Change in cortisol levels.
Salivary Cortisol will be collected to measure the cortisol awakening response.

Full Information

First Posted
July 20, 2021
Last Updated
July 29, 2023
Sponsor
Brigham and Women's Hospital
Collaborators
Massachusetts Institute of Technology
search

1. Study Identification

Unique Protocol Identification Number
NCT05003362
Brief Title
ACT for High Frequency Migraine; A Virtual Mindfulness Intervention
Official Title
Acceptance and Commitment Therapy for High Frequency Episodic Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 25, 2020 (Actual)
Primary Completion Date
November 23, 2021 (Actual)
Study Completion Date
November 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Massachusetts Institute of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Mindfulness Training specifically for pain to be offered to migraine patients
Detailed Description
Patients with high frequency migraine will be randomized to UC or intervention. Those in intervention will attend a multi session training on Acceptance and Commitment Therapy. All participants will track responses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
migraine, high frequency, ACT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
After screening, patients will be randomized and one group will receive the intervention. The investigators will do sequential interventions of the ACT
Masking
Outcomes Assessor
Masking Description
randomized control
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
usual care
Arm Type
No Intervention
Arm Description
Subjects randomized to the usual care control group will continue using their usual medical care as prescribed by their physician.
Arm Title
ACT
Arm Type
Active Comparator
Arm Description
An 8-week mindfulness-based group therapy.
Intervention Type
Behavioral
Intervention Name(s)
ACT
Intervention Description
mindfulness intervention for patients with pain/migraine
Primary Outcome Measure Information:
Title
Feasibility of a randomized controlled trial of ACT
Description
Demonstrate that 48 patients can be successfully enrolled and randomized
Time Frame
one year
Secondary Outcome Measure Information:
Title
Preliminary data on the effectiveness of ACT on migraine frequency and migraine disability
Description
Patient-completed migraine logs will be used to record the number of migraine days/month. Migraine disability will be measured using the validated Migraine Disability Assessment (MIDAS) questionnaire.
Time Frame
one year
Title
Change in migraine severity, duration, and medication use.
Description
Severity of each migraine (1-10), duration (hours), and medicines taken assessed by patient-completed migraine logs.
Time Frame
one year
Title
Change in headache-related disability
Description
Headache Related Disability measured using the validated HIT-6.
Time Frame
one year
Title
Change in quality of life.
Description
Quality of life assessed using the Migraine Specific Quality of Life Questionnaire (MSQ).
Time Frame
one year
Title
Change in depression and anxiety.
Description
Depression and anxiety assessed through the Hospital Anxiety and Depression Scale (HADS).
Time Frame
one year
Title
Change in pain acceptance and pain expectancy.
Description
Pain acceptance assessed through the Chronic Pain Acceptance Questionnaire and pain expectancy during the migraine attacks assessed using the allodynia questionnaire.
Time Frame
one year
Title
Change in pain catastrophizing.
Description
Pain Catastrophizing Scale (PCS) used to assess distress and rumination experienced due to migraine anticipation.
Time Frame
one year
Title
Change in distress tolerance.
Description
Distress tolerance will be assessed through the Distress Tolerance Scale.
Time Frame
one year
Title
Change in physical activity.
Description
Physical activity measured using the Godin Leisure Time Exercise questionnaire.
Time Frame
one year
Title
Change in perceived stress.
Description
Perceived stress measured through the Perceived Stress Scale (PSS).
Time Frame
one year
Title
Change in mindfulness.
Description
Mindful Attention and Awareness Scale (MAAS) used to measure receptive awareness and attention to the present.
Time Frame
one year
Title
Change in cortisol levels.
Description
Salivary Cortisol will be collected to measure the cortisol awakening response.
Time Frame
one year

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
patients will identify as female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women ages 18-65 Diagnosis of episodic migraine (according to International Classification for Headache Diagnosis criteria) 4-14 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
carolyn bernstein, md
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Womens Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02155
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

ACT for High Frequency Migraine; A Virtual Mindfulness Intervention

We'll reach out to this number within 24 hrs