Treatments for Anxiety: Meditation and Escitalopram

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.

Inclusion Criteria:

1. Men and women between 18 and 75 years old.

2. Have an anxiety disorder, including: social anxiety disorder (SAD), generalized
anxiety disorder (GAD), panic disorder, or agoraphobia

3. Must understand study procedure and willing to participate in all testing visits, and
treatment as assigned.

4. Participants must be able to give informed consent to the study procedures.

Exclusion Criteria:

1. 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; and current
(past 6 months) substance use disorders.

2. A serious medical condition that may result in surgery or hospitalization.

3. A history of head trauma causing loss of consciousness, or ongoing cognitive
impairment

4. Inability to understand study procedures or informed consent process, or significant
personality dysfunction likely to interfere with study participation (assessed during
the clinical interview).

5. Subjects who will be non-compliant with the study procedures. This may include planned
travel out of town.

6. Pregnancy as assessed by urine test at screen. Avoidance of pregnancy is also
necessary for inclusion in the study.

7. Subjects taking barbiturates, SSRIs, anti-depressants, or antipsychotics. Sleep
medications (other than anti-depressants) and benzodiazepines will be allowed, if has
been taken at stable dose 4 weeks prior to baseline and the patient plans to continue
at the same dose through the trial. Trazadone (for sleep) above 100mg will be
disallowed.

8. Concurrent psychotherapy initiated within 1 month of screen interview, or ongoing
psychotherapy of any duration directed specifically toward the treatment of anxiety
(such as cognitive behavioral therapy).

9. Individuals who have completed a course of MBSR or an equivalent meditation training
in the last year, or have an ongoing daily meditation practice

10. Individuals reporting significant active suicidal ideation or suicidal behaviors
within the past year.

11. Individuals with a medical condition (i.e., epilepsy) that may be exacerbated by study
treatment, as determined by a study physician or nurse practitioner based on history,
physical, and/or labs.