Feasibility and acceptability of telephone-delivered mbct for migraine and depression (fate-MD)

The National Institutes of Health National Center for Complementary and Integrative Health awarded New York University $785,637 under the Research and Training in Complementary and Integrative Health program (CFDA 93.213) from June 2021 through May 2025. This Cooperative Agreement will support the development and pilot testing of telephone-delivered and video-based Mindfulness-Based Cognitive Therapy (MBCT) protocols for patients with migraine headaches and depressive symptoms.

Specifically, the award will fund the optimization of fidelity for MBCT protocols delivered by telephone (MBCT-T) or video (MBCT-V), including the creation of training protocols, facilitator manuals, and evaluation tools. The optimized protocols will be tested through the delivery of one MBCT-T and one MBCT-V group. If successful, the project will conduct a multi-site pilot randomized controlled trial of 144 participants to evaluate MBCT-T, MBCT-V, and enhanced usual care across three sites in New York and North Carolina. The results will inform the selection of remote-delivered MBCT approaches to be evaluated in a future definitive Phase III clinical trial to reduce migraine-related disability and depressive symptoms.

Abstract

Migraine is a common, painful and highly disabling disorder. Depressive symptoms are common in people with migraine and are associated with increased suffering. Despite the significant emotional, social, and economic burden of this comorbidity, no existing treatment adequately addresses both migraine disability and elevated depressive symptoms. Development of scalable and integrative treatments that address both migraine disability and comorbid depressive symptoms has been identified as a major GAP in migraine treatment. Mindfulness-based cognitive therapy (mbct) is an evidence-based and standardized treatment that is an excellent candidate for reducing disability and depressive symptoms in people with migraine. Our preliminary data show that mbct reduced migraine-related disability; however, during exit interviews, participants noted the burden of attending 8 weekly in-person sessions was a substantial barrier to accessing care. Our preliminary data suggest an abbreviated and telephone-delivered mbct (mbct-t) protocol is a feasible alternative to in-person treatment. However, video- based delivery (mbct-v) may improve patient engagement. This project aims to prepare for a definitive multi-site phase III trial of remote-delivered mbct-t or mbct-v or both in patients with migraine and depressive symptoms. During study 1, we will use guidelines from the NIH's behavioral change consortium to optimize fidelity mbct-t and mbct-v for patients with migraine (as defined by the international classification of headache disorders - 3) and depressive symptoms (as defined by empirical cut-offs on the patient health questionnaire - 9). Products developed during aim 1 will be: training protocols, facilitator treatment manuals, fidelity checklists, mbct-t/v adherence and competence scales, fidelity coding manuals. Products will be iteratively optimized using quantitative and qualitative fidelity metrics assessed at the patient-level (comprehension) and facilitator-level (corrective feedback, intervention delivery) following the delivery of one mbct-t and one mbct-v group led by a certified mbct facilitator at a site in new york, NY. Also, during study 1, a 22-hour training will be conducted for facilitators across two additional sites in the bronx, NY and winston-salem, NC. During study 2, we will conduct a multi-site pilot RCT (n=144) of mbct-t, mbct-v, and enhanced usual care (EUC). We will evaluate fidelity, feasibility, and acceptability of each arm across three sites in patients with migraine and depressive symptoms. Pre- specified decision rules for fidelity, feasibility, acceptability, and clinical utility will determine the arms of the future phase III trial evaluating remote-delivered mbct for migraine disability and depressive symptoms.