NCT03522844

Treatments for Anxiety: Meditation and Escitalopram

Comparative Effectiveness of Mindfulness-Based Stress Reduction and Pharmacotherapy for Anxiety

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

We propose the first randomized, controlled study to assess the comparative effectiveness of Mindfulness-Based Stress Reduction (MBSR) with a medication for anxiety disorders. We will use escitalopram, gold-standard SSRI treatment for patients with anxiety disorders, and will examine the comparative effectiveness of the two treatments on anxiety symptoms and other outcomes important to patients.

Detailed description

Mindfulness meditation treatments have been growing in popularity and becoming widely disseminated, and people with anxiety are interested in mindfulness. A benefit of mindfulness interventions is that they can be provided outside of a mental health setting, which may make them more acceptable to patients. Although mindfulness meditation is gaining popularity, there is no information how this treatment strategy compares with standard treatment, such as with medication. Patients need more information about the comparison of treatments to be able to make informed decisions about their health care. We propose the first randomized, controlled study to assess the comparative effectiveness of Mindfulness-Based Stress Reduction (MBSR) compared to escitalopram, a standard medication for patients with anxiety disorders such as generalized anxiety disorder, social anxiety disorder, panic disorder, and agoraphobia. Patients will be randomized into two 8-week treatments: (1) MBSR and (2) escitalopram. To enroll the necessary sample, we will utilize three study sites in different geographic locations that each have strong clinical and research infrastructures: Georgetown University Medical Center, Massachusetts General Hospital and New York University Langone Medical Center. Thus, we will take advantage of three productive teams with previous successful collaborations and experience in mind-body treatment studies. Adaptations and Additional Aims: Due to the COVID-19 pandemic, the study was transitioned to a virtual format (on-line videoconference visits) in March 2020 as a pilot adaptation with the introduction of additional aims to explore the following: (1) the comparative effectiveness and treatment satisfaction for in-person MBSR versus virtual MBSR and (2) the comparative effectiveness of virtual MBSR versus virtual pharmacotherapy. An additional 202 participants were randomized to the virtual version of the study to support these aims. Note about the in-person recruitment: Due to the impact of pandemic-related and participant-related confounders, it has not been possible to return to in-person treatments since March 2020. Before the pandemic, we had published a methods paper adopting (a priori) a non-inferiority margin of 0.495 points on the CGI-S for the analysis of the primary hypothesis. Although we were not able to enroll the proposed sample size of 368 due to the pandemic, with 276 patients randomized, we have sufficient statistical power of 80% for our original analysis to stop in person enrollment.

Conditions

• Anxiety Disorders
• Generalized Anxiety Disorder
• Panic Disorder
• Social Anxiety Disorder
• Agoraphobia

Interventions

Type	Name	Description
OTHER	Mindfulness-Based Stress Reduction	Participants randomized to the MBSR intervention will consist of an 8-week Mindfulness-Based Stress Reduction (MBSR) program, taught and facilitated by a trained instructor. The classes instruct participants in the theory and practice of several forms of mindfulness meditation: a body scan, breathing awareness, and mindfulness stretching exercises designed to bring awareness of the body and current experience of movement. The intervention will include a weekly class for 8 weeks and classes will be 2.5 hours in duration. The intervention will also include a 1-day (7 hours) retreat on a weekend at the end of the program. Participants will also be asked to engage in 45 minutes of practice at home on a daily basis, as well as informal practice assignments that instruct participants to bring mindfulness to current daily activities.
DRUG	Escitalopram	Escitalopram is an antidepressant, widely used to treat anxiety disorders. During the 8 weeks of randomized treatment with escitalopram, subjects will be seen regularly by a study physician. The pill medication will be initiated at 10 mg/day; at week 2, dosage will be increased to 20 mg/day if well tolerated (or delayed if not). Side effects will be assessed at each visit and recorded.

Timeline

• Start date: 2018-06-18
• Primary completion: 2021-10-31
• Completion: 2022-01-05
• First posted: 2018-05-11
• Last updated: 2022-01-11

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study