Actively Recruiting
Does Acceptance and Commitment Therapy (ACT) Improve Disability in Chronic Migraine? A Randomized Headache Center Trial
Led by Brigham and Women's Hospital · Updated on 2025-10-31
40
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether Acceptance and Commitment Therapy (ACT), a behavioral treatment, can improve disability in adults with chronic migraine when added to their usual headache treatments. This trial focuses on whether ACT helps improve daily functioning and reduce headache frequency and pain, comparing results from patients receiving ACT plus usual care to those receiving usual care alone. The study is a randomized, open-label phase II pilot trial conducted at a single site. Participants assigned to ACT will attend eight virtual group sessions over two months, learning skills like acceptance, mindfulness, and committed actions to improve psychological flexibility and reduce migraine-related disability. After the training, they will practice ACT at home alongside their regular headache treatment. Those not assigned to ACT will continue with their usual treatment without additional intervention. Follow-up assessments will occur at 3, 6, and 12 months after baseline. During the study, participants will complete questionnaires at baseline and follow-up visits to assess disability, anxiety, catastrophizing, and mindfulness. They will also keep daily headache diaries to track headache frequency, pain, medication intake, and ACT practice. Attendance and adherence to the ACT sessions will be monitored. Participants may withdraw at any time, and safety monitoring includes recording reasons for discontinuation and adverse events. The total study duration for each participant is about one year.
CONDITIONS
Brief Title
Acceptance and Commitment Therapy to Improve Disability in Chronic Migraine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness and ability to engage in the consent process
- Willingness to participate in the study, despite randomization outcome
- Availability for the duration of the study
- Diagnosis of chronic migraine followed at the Graham Headache Center
- Access to the necessary resources for participating in a technology-based intervention
You will not qualify if you...
- Known major depression or other psychiatric condition
- Non-English speaking
- Secondary headache diagnosis
- Psychotherapy in the prior 18 months
- Any reason the provider feels would limit participant ability to learn or practice ACT
- Any previous experience with mindfulness or meditation approaches
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (virtual or in-person) for consent and baseline questionnaires
Duration - 2 months
Participants randomized to the Acceptance and Commitment Therapy (ACT) group will attend 8 virtual group therapy sessions over 2 months, focusing on mindfulness and psychological flexibility to improve disability related to chronic migraine. Participants randomized to usual treatment will continue their standard care without additional intervention.
8 virtual group sessions, each about 1 hour
Duration - Up to 12 months after baseline
All participants will complete follow-up assessments to measure changes in disability, anxiety, catastrophizing, and mindfulness at 3, 6, and 12 months after baseline.
3 virtual assessment visits at 3, 6, and 12 months
Trial Site Locations
Total: 1 location
1
Brigham and Women's / Faulkner Hospital
Boston, Massachusetts, United States, 02130
Actively Recruiting
Research Team
P
Paul Rizzoli, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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