BE WELL With Migraine: Brain Education and WELLness With Migraine
Part of paid clinical trials in Cambridge, Massachusetts.
- Sponsor
- Wake Forest University Health Sciences
- Study ID
- NCT05987592
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Brain Education and WELLness with Migraine Group A — BEHAVIORALBehavioral intervention that involves 8 weekly group virtual sessions with an instructor that may help improve migraine, plus access to an online platform with additional content and learning
- Brain Education and WELLness with Migraine Group B — BEHAVIORALBehavioral intervention that involves 8 weekly group virtual sessions with an instructor that may help improve migraine, plus access to an online platform with additional content and learning
Study Details
The goal of this randomized clinical trial is to evaluate two different non-drug, virtual treatment options designed to improve the lives of patients with migraine. Both interventions involve 8 weekly sessions and an online platform with additional content and learning. Participants can stay on all their medications during this study. Information from this study may help determine how to better treat migraine.
Key Dates
- Start date
- Jul 31, 2024
- Status verified
- Apr 2026
- Primary completion
- Jun 30, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 286 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Brain Education and WELLness with Migraine Group A8 weekly virtual sessions plus online platform
- Experimental: Brain Education and WELLness with Migraine Group B8 weekly virtual sessions plus online platform
Primary Outcome Measure
Disability assessed using monthly Migraine Disability Assessment (mMIDAS) - Change in Migraine Disability from baseline to 8 weeks [ Time Frame: Immediately post-intervention at 8 weeks ]
Central Contacts
- Hannah O'Brien336-713-5776
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cambridge Health Alliance - Center for Mindfulness and Compassion | Cambridge | Massachusetts | 02141 | Alexandra Comeau Paula Gardner, MD, MPH (SUB_INVESTIGATOR) Zev Schuman-Oliver, MD (SUB_INVESTIGATOR) |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | Rebecca E Wells, MD, MPH (PRINCIPAL_INVESTIGATOR) |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | Leigh A Chamberlin Scott Powers, PhD, ABPP (PRINCIPAL_INVESTIGATOR) |
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