Fidelity Measurement of a Mindfulness-Based Stress Reduction Intervention in a Randomized Controlled Feasibility Trial for Migraine Patients

Abstract

Background: Mindfulness-based stress reduction (MBSR) is an 8-week meditation-based intervention developed by Jon Kabat-Zinn at the University of Massachusetts Medical Center (UMass) in the 1970s. Increasing evidence has shown effectiveness of MBSR for many patients with a variety of pain-related and functional disorders. In preparation for a fully powered randomized controlled clinical trial of MBSR for patients with moderate-to-severe migraine headache, we will conduct a two-arm, parallel-comparison randomized controlled feasibility trial of MBSR versus usual care for 60 migraine patients at a large health system. Documenting fidelity for practitioner-delivered interventions is a critical aspect of these trials for ensuring that delivery of the intervention adheres to consistent standards for integrative health care. Fidelity measurement is one of the main outcomes for this pilot study.