Treatments for Anxiety: Meditation and Escitalopram

  • STATUS
    Recruiting
  • End date
    May 14, 2021
  • participants needed
    368
  • sponsor
    Georgetown University
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Updated on 3 August 2020
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Investigator
Elizabeth A Hoge, M.D.
Primary Contact
Georgetown University Medical Center (7.9 mi away) Contact
+1 other location
anxiety
agoraphobia
panic disorder
social phobia
selective serotonin reuptake inhibitors
escitalopram
anxiety symptoms
anxiety disorder
social anxiety

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.

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.

Details
Treatment Escitalopram, Mindfulness-based stress reduction
Clinical Study IdentifierNCT03522844
SponsorGeorgetown University
Last Modified on3 August 2020

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Eligibility

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Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Panic Disorders or Phobia, Social or Anxiety Disorders (Pediatric) or ANXIETY NEUROSIS or Claustrophobia or Panic Disorder or Generalized Anxiety Diso...?
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 study procedure and be willing to participate in all testing visits and treatment as assigned
Participants must be able to give informed consent to the study procedures

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; and 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 impairment
Inability to understand study procedures or informed consent process, or significant personality dysfunction likely to interfere with study participation (assessed during the clinical interview)
Subjects who will be non-compliant with the study procedures. This may include planned travel out of town
Pregnancy as assessed by urine test at screen. Avoidance of pregnancy is also necessary for inclusion in the study
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
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)
Individuals who have completed a course of MBSR or an equivalent meditation training in the last year, or have an ongoing daily meditation practice
Individuals reporting significant active suicidal ideation or suicidal behaviors within the past year
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
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