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

MedStar author(s):
Citation: Contemporary Clinical Trials. 91:105965, 2020 04.PMID: 32087339Institution: MedStar Health Research InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Anxiety Disorders/th [Therapy] | *Citalopram/tu [Therapeutic Use] | *Meditation/mt [Methods] | *Mindfulness/mt [Methods] | *Serotonin Uptake Inhibitors/tu [Therapeutic Use] | Adolescent | Adult | Aged | Citalopram/ad [Administration & Dosage] | Citalopram/ae [Adverse Effects] | Equivalence Trials as Topic | Female | Humans | Male | Middle Aged | Research Design | Serotonin Uptake Inhibitors/ad [Administration & Dosage] | Serotonin Uptake Inhibitors/ae [Adverse Effects] | Severity of Illness Index | Young AdultYear: 2020ISSN:
  • 1551-7144
Name of journal: Contemporary clinical trialsAbstract: 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 8weeks 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. Copyright (c) 2020. Published by Elsevier Inc.All authors: Bui E, Dutton MA, Gabriel C, Hoge EA, Mete M, Philip SR, Simon NM, Suzuki R, Ward MJOriginally published: Contemporary Clinical Trials. :105965, 2020 Feb 19Fiscal year: FY2020Digital Object Identifier: Date added to catalog: 2020-02-26
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Journal Article MedStar Authors Catalog Article 32087339 Available 32087339

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 8weeks 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. Copyright (c) 2020. Published by Elsevier Inc.

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