Treatment for Migraine and Mood (TEAM-M) study: Protocol for a three-arm multi-site randomized controlled feasibility trial comparing an abbreviated version of mindfulness-based cognitive therapy delivered via telephone or videoconferencing to enhanced usual care (Preprint)

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Abstract
BACKGROUND Migraine ranks among the leading causes of disability worldwide. Comorbid depressive symptoms are highly prevalent in patients with migraine and are associated with worsened pain severity, greater migraine-related disability, and poorer migraine prognosis. Despite this burdensome comorbidity, the treatment of these co-occurring disorders has rarely been studied. While Mindfulness-Based Cognitive Therapy (MBCT) shows promise for addressing both migraine-related disability and depressive symptoms, its traditional format—8 weekly, 2-hour in-person sessions—creates substantial access barriers, particularly for patients who experience frequent debilitating migraine and mood symptoms. OBJECTIVE The objective of the TEAM-M (Treatment for Migraine and Mood) trial is to evaluate the feasibility of an abbreviated MBCT intervention (MBCT-Brief) delivered via telephone or videoconferencing in adults with migraine and elevated depressive symptoms. METHODS TEAM-M is a three-site trial with a goal sample size of 145 adults with episodic migraine and elevated depressive symptoms randomized to MBCT-Brief telephone, MBCT-Brief videoconferencing, or enhanced usual care (EUC). To be eligible, participants must meet criteria for migraine as defined by the International Classification for Headache Disorders, 3rd Edition, have ≥1 year of migraine history, and have mild-moderate depressive symptoms (score 5–19 on the Patient Health Questionnaire). RESULTS Our primary outcomes include feasibility, acceptability, and fidelity of treatment. Our secondary outcomes include headache disability, migraine-specific quality of life, and depressive symptoms. We began recruitment in November 2023. To date, we have randomized 145 participants, and of these, 81 have completed the intervention. We completed enrollment in January 2026. CONCLUSIONS The TEAM-M trial addresses a gap in clinical care by evaluating an abbreviated version of MBCT that has scalability and accessibility advantages over full-length MBCT and the potential to address both migraine and depressive symptoms. By reducing time commitment and maintaining core MBCT components, MBCT-Brief has the potential to address significant access barriers that often prevent patients from receiving evidence-based healthcare for comorbid physical and mental health symptoms. The remote-delivery model offers enhanced scalability. This trial will also yield information about potential differences in telephone versus videoconferencing delivery that will inform optimal integration into existing primary care and mental health clinic workflows, allowing for improving access to specialized care for mental health and migraine across diverse healthcare settings. CLINICALTRIAL ClinicalTrials.gov NCT05576467. Registered on October 10, 2022.

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