Feasibility Trial of a Remotely-Delivered Mindfulness-Based Intervention for Adolescents with Migraine

PROJECT SUMMARY/ABSTRACT The goal of the proposed K23 Career Development Award is to provide the PI with the mentorship, knowledge, and skillset to develop into a patient-oriented independent investigator studying scalable, accessible behavioral and mind-body interventions for youth with migraine and other pain conditions. The mentoring team will provide the PI with training in randomized clinical trials, implementation science, and mind-body interventions. The training is integrated in a research proposal and planned clinical trial evaluating a remotely-delivered mindfulness-based intervention (MBI) group program adapted for adolescents with migraine. Migraine is the second leading cause of disability worldwide. Negative affectivity (depression, anxiety) is associated with worse pain-related disability and is particularly prevalent in the adolescent developmental period. Existing pharmacological and behavioral interventions for adolescent migraine do not target or change negative affectivity, are difficult to access, and for pharmacological intervention, are often no more effective than placebo. Scalable and accessible approaches that target negative affectivity may yield more efficacious treatment and reach more patients in need. MBIs hold promise to consider these needs. However, minimal research has studied MBIs for adolescents with migraine and none have considered patient-centered adaptations or designing for dissemination principles. The PI’s preparatory work for this K23 focused on Phase I (Design) of the ORBIT Model for Developing Behavioral Treatments for Chronic Diseases framework. In this phase, the PI adapted and refined a virtual group-based MBI to meet the unique needs of adolescents with migraine in partnership with interest holders (patients, parents, providers). Now for ORBIT Phase II (Preliminary Testing), the PI proposes a pilot feasibility randomized trial to test the feasibility and acceptability of the adapted intervention, BREATHE- Headache (BREATHE-HA) and Enhanced Standard-of-Care (attention-matched virtual, group headache education program) in 72 adolescents with frequent migraine (Aim 1). Parallel implementation science work will assess potential facilitators and barriers to implementation of virtual group-based interventions (like BREATHE- HA) in tertiary care settings (Aim 2) to bridge the translational science-to-practice gap. If this pilot study meets pre-determined feasibility and acceptability targets, it will provide a strong platform for the PI to undertake an adequately powered, hypothesis-testing pragmatic clinic-based efficacy trial in a future R01. Together, this work will provide a critical foundation for the PI to advance efficacy of and access to evidence-based behavioral and mind-body interventions for youth with migraine and chronic pain.