Acceptance and Commitment Therapy to reduce disability in adults with chronic migraine
Does Acceptance and Commitment Therapy (ACT) Improve Disability in Chronic Migraine? A Randomized Headache Center Trial
NA · Brigham and Women's Hospital · NCT06795867
This trial will test whether adding Acceptance and Commitment Therapy (ACT) to usual care helps adults with chronic migraine improve daily functioning and reduce headache frequency and pain.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06795867 on ClinicalTrials.gov |
What this trial studies
Adults with chronic migraine who are followed at the Graham Headache Center will be randomized to receive eight ACT classes plus home practice in addition to their regular headache treatment or to continue their regular treatment without ACT. Participants will complete daily headache diaries and take part in four virtual visits over the following year to report symptoms and functioning. The trial focuses on disability and daily functioning questionnaires as primary outcomes, alongside measures of headache frequency and pain. Patients with major psychiatric conditions, recent psychotherapy, non-English speakers, or prior mindfulness experience are excluded and participants must have access to the required technology.
Who should consider this trial
Good fit: Ideal candidates are adults with a diagnosis of chronic migraine who are followed at the Graham Headache Center, can use the required technology, speak English, and do not have major psychiatric comorbidity or recent psychotherapy.
Not a fit: People with active major depression or other significant psychiatric conditions, non-English speakers, those who recently received psychotherapy, or those unable to use the required technology may be excluded or unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, adding ACT could reduce disability and improve daily functioning for people with chronic migraine even when medications alone are insufficient.
How similar studies have performed: Behavioral therapies, including ACT and other third-wave cognitive approaches, have shown benefit for chronic pain and some studies suggest reductions in disability for headache patients, though focused evidence in chronic migraine remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boston, Massachusetts
- Brigham and Women's / Faulkner Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Study coordinator: Paul Rizzoli, MD
- Email: prizzoli@bwh.harvard.edu
- Phone: 617 983 7580
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Migraine, migraine, chronic migraine, behavioral management, acceptance and commitment therapy