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OpenTrials
Completed

NCT Number: NCT05003362

ACT for High Frequency Migraine; A Virtual Mindfulness Intervention

Mindfulness Training specifically for pain to be offered to migraine patients

Completed

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Womens Hospital

Boston, Massachusetts, 02155, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACT

Behavioral

mindfulness intervention for patients with pain/migraine

Primary outcomes

  1. Feasibility of a randomized controlled trial of ACT

    Time frame: one year

    Demonstrate that 48 patients can be successfully enrolled and randomized

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Massachusetts Institute of Technology

Registry information

Official study title

Acceptance and Commitment Therapy for High Frequency Episodic Migraine

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 12, 2021
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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