ACT for High Frequency Migraine; A Virtual Mindfulness Intervention

Not Applicable

Completed

• Conditions: Migraine
• Interventions: Behavioral: ACT

• Registration Number: NCT05003362
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study Start: 2020-10-25
• Study First Submitted: 2021-07-20
• Study First Submitted QC: 2021-08-05
• Study First Posted: 2021-08-12
• Primary Completion: 2021-11-23
• Study Completion: 2021-11-23
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-29
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ACT	ACT	An 8-week mindfulness-based group therapy.

Primary Outcome Measures

Name	Time	Method
Feasibility of a randomized controlled trial of ACT	one year	Demonstrate that 48 patients can be successfully enrolled and randomized

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Brigham and Womens Hospital; 🇺🇸 Boston, Massachusetts, United States