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 — BEHAVIORAL
    Behavioral 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 — BEHAVIORAL
    Behavioral 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 A
    8 weekly virtual sessions plus online platform
  • Experimental: Brain Education and WELLness with Migraine Group B
    8 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

Locations (3)

FacilityCityStateZIPSite coordinators
Cambridge Health Alliance - Center for Mindfulness and CompassionCambridgeMassachusetts02141
Alexandra Comeau
Paula Gardner, MD, MPH (SUB_INVESTIGATOR)
Zev Schuman-Oliver, MD (SUB_INVESTIGATOR)
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157
Hannah O'Brien
336-713-5776
Rebecca E Wells, MD, MPH (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-3039
Leigh A Chamberlin
Scott Powers, PhD, ABPP (PRINCIPAL_INVESTIGATOR)

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