Acceptance and Commitment Therapy to Improve Disability in Chronic Migraine
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Brigham and Women's Hospital
- Study ID
- NCT06795867
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- acceptance and commitment therapy — BEHAVIORALa 'third wave behavioral management
Study Details
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. They will also keep a daily headache diary during the study
Key Dates
- Start date
- Apr 21, 2025
- Status verified
- Oct 2025
- Primary completion
- Dec 31, 2027
- Completion
- Mar 31, 2028
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: ACT plus usual treatmentthe addition of acceptance and commitment therapy to usual treatment
- No Intervention: Usual treatment aloneusual treatment without additional intervention
Primary Outcome Measure
Change in Headache Disability Index [ Time Frame: 3 months ]
Central Contacts
- Paul Rizzoli, MD617 983 7580
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Brigham and Women's / Faulkner Hospital | Boston | Massachusetts | 02130 |
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