Fidelity Measurement of a Mindfulness-Based Stress Reduction Intervention in a Randomized Controlled Feasibility Trial for Migraine Patients
human subjects research, pragmatic trials, chronic disease, clinical trials
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.
Methods: MBSR instructors will use a standardized curriculum developed at UMass. MBSR content oversight will be provided by a senior teacher who has founded several MBSR programs in health care settings. He will have primary responsibility for ensuring fidelity of the MBSR intervention by meeting with each teacher on a monthly basis to ensure adherence to the standard curriculum. He and the research team also will create an MBSR “fidelity checklist” for use by a research specialist who will record and listen to a randomly selected session for each instructor in order to monitor the teaching.
Results: Fidelity measurement is defined as the extent to which delivery of an intervention adheres to the protocol or program model as originally developed. Despite its importance, there has been little development of tools for measuring fidelity and evaluated methods for documenting the degree of fidelity in a clinical trial. This presentation will describe the details of our fidelity-assessment methodology; the MBSR “fidelity checklist” developed for this trial also will be shared for adaptation by other investigators conducting similar studies.
Conclusion: Proven fidelity of the MBSR intervention is needed for the results of this study to be generalizable for a fully powered phase III trial. In addition, the information we gain from fidelity measurement will help inform future studies of MBSR for migraine and other conditions.
Law H, Stahl B, Avins A, Sudat S, Jacobson A, Liu J, Dolginsky M, Dean L, Pressman A. Fidelity measurement of a mindfulness-based stress reduction intervention in a randomized controlled feasibility trial for migraine patients. J Patient Cent Res Rev. 2017;4:199-200.