Evaluating an Abbreviated Version of Mindfulness-Based Cognitive Therapy Delivered via Telephone or Videoconferencing Compared to Enhanced Usual Care-Treatment for Migraine and Mood (TEAM-M) Study: Protocol for a Three-Arm Multisite Randomized Controlled Feasibility Trial
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 sessions in person-creates substantial access barriers, particularly for patients who experience frequent debilitating migraine and mood symptoms.
Objective: The objective of the Treatment for Migraine and Mood (TEAM-M) 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 3-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 the criteria for migraine as defined by the International Classification of Headache Disorders 3rd edition, have ≥1 year of migraine history, and have mild to moderate depressive symptoms (scores 5-19 on the Patient Health Questionnaire-9).
Results: Our primary outcomes…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 145 participants or records.
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