ACT for High Frequency Migraine; A Virtual Mindfulness Intervention

Migraine Clinical Trial

Official title:

Acceptance and Commitment Therapy for High Frequency Episodic Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05003362
• Other study ID #: 2018P001239
• Status: Completed
• Phase: N/A
• Start date: October 25, 2020
• Est. completion date: November 23, 2021

Study information

• Verified date: July 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Mindfulness Training specifically for pain to be offered to migraine patients

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 23, 2021
• Est. primary completion date: November 23, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Behavioral:
• ACT
mindfulness intervention for patients with pain/migraine

Locations

Country	Name	City	State
United States	Brigham and Womens Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Massachusetts Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of a randomized controlled trial of ACT	Demonstrate that 48 patients can be successfully enrolled and randomized	one year
Secondary	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.	one year
Secondary	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.	one year
Secondary	Change in headache-related disability	Headache Related Disability measured using the validated HIT-6.	one year
Secondary	Change in quality of life.	Quality of life assessed using the Migraine Specific Quality of Life Questionnaire (MSQ).	one year
Secondary	Change in depression and anxiety.	Depression and anxiety assessed through the Hospital Anxiety and Depression Scale (HADS).	one year
Secondary	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.	one year
Secondary	Change in pain catastrophizing.	Pain Catastrophizing Scale (PCS) used to assess distress and rumination experienced due to migraine anticipation.	one year
Secondary	Change in distress tolerance.	Distress tolerance will be assessed through the Distress Tolerance Scale.	one year
Secondary	Change in physical activity.	Physical activity measured using the Godin Leisure Time Exercise questionnaire.	one year
Secondary	Change in perceived stress.	Perceived stress measured through the Perceived Stress Scale (PSS).	one year
Secondary	Change in mindfulness.	Mindful Attention and Awareness Scale (MAAS) used to measure receptive awareness and attention to the present.	one year
Secondary	Change in cortisol levels.	Salivary Cortisol will be collected to measure the cortisol awakening response.	one year