Treatment for anxiety: Mindfulness meditation versus escitalopram (TAME): Design of a randomized, controlled non-inferiority trial.

Abstract

Anxiety disorders (generalized anxiety disorder, social anxiety disorder, panic disorder, and agoraphobia) are common, distressing, and impairing. While pharmacotherapy and psychotherapy are first-line treatment strategies for anxiety disorders, many patients are reluctant to take psychiatric medication, and many prefer to avoid any kind of mental health treatment due to stigma or distrust of traditional medical care. We present the trial protocol for the first study comparing first-line medication treatment with Mindfulness-Based Stress Reduction (MBSR), a popular mindfulness meditation training program, for the treatment of anxiety disorders. We will use a non-inferiority, comparative effectiveness trial design, in which individuals with diagnosed anxiety disorders will be randomized to either pharmacotherapy with escitalopram or MBSR for 8 weeks of treatment. Treatment outcome will be based on gold standard symptom severity measures assessed by trained independent evaluators blind to treatment allocation. Secondary outcomes will include key symptom and function measures, as well as tolerability and satisfaction with treatment. Findings will provide crucial information to inform decision making about the relative benefits of MBSR versus a first line medication for anxiety disorders by patients, medical care providers, healthcare insurers and other stakeholders.

• Authors: Elizabeth A Hoge, Eric Bui, Mihriye Mete, Samantha R Philip, Caroline Gabriel, Meredith J Ward, Rebecca Suzuki, Mary Ann Dutton, Naomi M Simon
• Journal: Contemporary clinical trials (Contemp Clin Trials) Vol. 91 Pg. 105965 (04 2020) ISSN: 1559-2030 [Electronic] United States
• PMID: 32087339 (Publication Type: Clinical Trial Protocol, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2020. Published by Elsevier Inc.

Chemical References

• Serotonin Uptake Inhibitors
• Citalopram

Topics

• Adolescent
• Adult
• Aged
• Anxiety Disorders (therapy)
• Citalopram (administration & dosage, adverse effects, therapeutic use)
• Equivalence Trials as Topic
• Female
• Humans
• Male
• Meditation (methods)
• Middle Aged
• Mindfulness (methods)
• Research Design
• Selective Serotonin Reuptake Inhibitors (administration & dosage, adverse effects, therapeutic use)
• Severity of Illness Index
• Young Adult