Overview

Researchers for this study use the growing and popular approach to managing anxiety for the patients: MBSR. Mindful-Based Stress Reduction, or MBSR, is the practice of calm, mindful meditation to ease stress, anxiety, and overall help people through their days. Since this study focuses on patients with anxiety, the clinical trial researchers also combine MBSR with escitalopram, an antidepressant that is widely used to treat anxiety.

Study Information

This is an interventional, single-masking, randomized, parallel assignment. The primary purpose of the study is treatment. The study began on June 18, 2018 and is estimated to be completed by May 14, 2021. There is an estimated 370 participants.

Inclusion Criteria

• Men and women between 18 and 75 years old.
• Have an anxiety disorder including social anxiety disorder (SAD), generalized anxiety disorder (GAD), panic disorder, or agoraphobia
• Must understand the study’s procedures and be willing to participate in all testing visits and assigned treatments
• Participants must be able to give their informed consent to participate in the study

Exclusion Criteria

• Comorbid psychiatric disorder other than anxiety or depression, such as psychotic disorder, post-traumatic stress disorder, obsessive compulsive disorder, eating disorders, bipolar disorder; developmental or organic mental disorders
• Current (past 6 months) substance use disorders
• A serious medical condition that may result in surgery or hospitalization
• A history of head trauma causing loss of consciousness, or ongoing cognitive decline
• Inability to understand study procedures or informed consent process, or significant personality dysfunction that has a high probability of interfering with study participation (assessed during the clinical interview)
• Subjects who will not be compliant with the study procedures
• Pregnancy, shown through a urine test at screening. Not trying to get pregnant is also necessary to be included
• Subjects taking barbiturates, SSRIs, anti-depressants, or antipsychotics. Sleep medications (other than anti-depressants) and benzodiazepines will be allowed, if they have been taken at a stable dose 4 weeks prior to the start of the study. Also, if the patient plans to continue the same dose throughout the trial. Trazadone (for sleep) above 100mg will not be allowed
• Concurrent psychotherapy that has been started within 1 month of screen interview, or ongoing psychotherapy, no matter how long ago, directed specifically toward the treatment of anxiety (such as cognitive behavioral therapy).
• Individuals who have completed a course of Meditation-Based Stress Relief (MBSR), other meditation training in the last year, or have a daily meditation practice
• Individuals reporting suicidal thoughts or suicidal behaviors within the past year
• Individuals with a medical condition (i.e., epilepsy) that may be intensified by study treatment

Location

You may participate in this study at three locations:

• Georgetown University Medical Center in Washington, District of Columbia, U.S., 20007
• Massachusetts General Hospital in Boston, Massachusetts, U.S. 02114
• New York University in New York, New York, U.S. 10016

If you have any questions or concerns, feel free to contact Elizabeth A Hoge, MD at 202-687-0635 or at eah103@georgetown.edu. You may also contact Samantha R Philip, BS at 202-687-7283 or at sp1256@georgetown.edu.

Sponsors/Collaborators

This clinical trial is sponsored by Georgetown University and Patient-Centered Outcomes Research Institute.