Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

ACT for High Frequency Migraine; A Virtual Mindfulness Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05003362
Recruitment Status : Recruiting
First Posted : August 12, 2021
Last Update Posted : August 12, 2021
Sponsor:
Collaborator:
Massachusetts Institute of Technology
Information provided by (Responsible Party):
Carolyn A. Bernstein, Brigham and Women's Hospital

Brief Summary:
Mindfulness Training specifically for pain to be offered to migraine patients

Condition or disease Intervention/treatment Phase
Migraine Behavioral: ACT Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Single (Outcomes Assessor)
Masking Description: randomized control
Primary Purpose: Treatment
Official Title: Acceptance and Commitment Therapy for High Frequency Episodic Migraine
Actual Study Start Date : October 25, 2020
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arm Intervention/treatment
No Intervention: usual care
Subjects randomized to the usual care control group will continue using their usual medical care as prescribed by their physician.
Active Comparator: ACT
An 8-week mindfulness-based group therapy.
Behavioral: ACT
mindfulness intervention for patients with pain/migraine




Primary Outcome Measures :
  1. Feasibility of a randomized controlled trial of ACT [ Time Frame: one year ]
    Demonstrate that 48 patients can be successfully enrolled and randomized


Secondary Outcome Measures :
  1. Preliminary data on the effectiveness of ACT on migraine frequency and migraine disability [ Time Frame: one year ]
    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.

  2. Change in migraine severity, duration, and medication use. [ Time Frame: one year ]
    Severity of each migraine (1-10), duration (hours), and medicines taken assessed by patient-completed migraine logs.

  3. Change in headache-related disability [ Time Frame: one year ]
    Headache Related Disability measured using the validated HIT-6.

  4. Change in quality of life. [ Time Frame: one year ]
    Quality of life assessed using the Migraine Specific Quality of Life Questionnaire (MSQ).

  5. Change in depression and anxiety. [ Time Frame: one year ]
    Depression and anxiety assessed through the Hospital Anxiety and Depression Scale (HADS).

  6. Change in pain acceptance and pain expectancy. [ Time Frame: one year ]
    Pain acceptance assessed through the Chronic Pain Acceptance Questionnaire and pain expectancy during the migraine attacks assessed using the allodynia questionnaire.

  7. Change in pain catastrophizing. [ Time Frame: one year ]
    Pain Catastrophizing Scale (PCS) used to assess distress and rumination experienced due to migraine anticipation.

  8. Change in distress tolerance. [ Time Frame: one year ]
    Distress tolerance will be assessed through the Distress Tolerance Scale.

  9. Change in physical activity. [ Time Frame: one year ]
    Physical activity measured using the Godin Leisure Time Exercise questionnaire.

  10. Change in perceived stress. [ Time Frame: one year ]
    Perceived stress measured through the Perceived Stress Scale (PSS).

  11. Change in mindfulness. [ Time Frame: one year ]
    Mindful Attention and Awareness Scale (MAAS) used to measure receptive awareness and attention to the present.

  12. Change in cortisol levels. [ Time Frame: one year ]
    Salivary Cortisol will be collected to measure the cortisol awakening response.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   patients will identify as female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05003362


Contacts
Layout table for location contacts
Contact: carolyn bernstein, md 617 732 9700 cabernstein@bwh.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
Brigham and Womens Hospital Recruiting
Boston, Massachusetts, United States, 02155
Contact: carolyn bernstein, md    617-732-9700    cabernstein@bwh.harvard.edu   
Principal Investigator: carolyn bernstein, md         
Sponsors and Collaborators
Brigham and Women's Hospital
Massachusetts Institute of Technology
Investigators
Layout table for investigator information
Principal Investigator: carolyn bernstein, md Brigham and Women's Hospital
Layout table for additonal information
Responsible Party: Carolyn A. Bernstein, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT05003362    
Other Study ID Numbers: 2018P001239
First Posted: August 12, 2021    Key Record Dates
Last Update Posted: August 12, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carolyn A. Bernstein, Brigham and Women's Hospital:
migraine
high frequency
ACT
Additional relevant MeSH terms:
Layout table for MeSH terms
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases