NCT06795867 · Brigham and Women's Hospital
Acceptance and Commitment Therapy to Improve Disability in Chronic Migraine
What this study is about
The goal of this clinical trial is to learn if the behavioral treatment called Acceptance and Commitment Therapy (ACT) works to improve disability in adults with chronic migraine.
View original scientific description
The goal of this clinical trial is to learn if the behavioral treatment called Acceptance and Commitment Therapy (ACT) works to improve disability in adults with chronic migraine. The main questions it aims to answer are: Does the use of ACT added to usual treatment improve scores on questionnaires designed to measure daily functioning and activity? Does the use of ACT added to usual treatment improve scores on diaries designed to measure headache frequency and pain? Researchers will compare adding ACT to usual headache treatments to usual headache treatments without ACT. Participants who are selected for ACT will take 8 classes to learn ACT and then will practice it at home, in addition to their regular headache treatment. Those not selected will continue their regular headache treatment. Four times over the following year, participants will answer questions about their symptoms during each of four virtual visits.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 31, 2025 · Source of record for eligibility and locations