We will assess the comparative effectiveness of Mindfulness-Based Stress Reduction (MBSR) compared to escitalopram (ESC) for patients with anxiety disorders (generalized anxiety disorder, panic disorder, agoraphobia, and social anxiety disorder), by randomizing patients to eight weeks of (1) MBSR or (2), flexible-dose escitalopram. This two-arm, three-site, randomized, controlled study will use a standard non-inferiority study design which incorporates previous data demonstrating that escitalopram is an effective treatment for anxiety and has been proven against pill placebo.  Based on non-inferiority driven power calculations (see Analysis plan), we plan to randomize 368 patients to either MBSR or medication.  We expect that 276 will complete the protocol after 25% dropout; however treatment satisfaction including dropout and intent-to-treatment outcomes will also be important assessments to guide conclusions about patient preferences and treatment responses.  This non-inferiority randomized design with standardized blinded assessments provides the most rigorous comparison data regarding comparison of the novel treatment of MBSR to a gold standard treatment, escitalopram. This study will provide crucial information to patients about effective and acceptable treatment strategies for anxiety.

We will examine several secondary outcome measures and exploratory outcomes. Overall Anxiety Severity and Impairment Scale (OASIS) is the secondary measure of anxiety symptoms. To assess satisfaction/acceptability of treatment, we will use the Client Satisfaction Questionnaire (CSQ) and the Reactions to Treatment Questionnaire (RTQ). To assess sleep outcomes, we will use the Pittsburgh Sleep Quality Index (PSQI), The Beck Anxiety Inventory (BAI) is a 21-item self-report inventory designed to measure severity of anxiety symptoms in psychiatric populations. The PROMIS - Emotional Distress scales (ED) will be used to assess emotional distress in the past 7 days, including depressive symptoms, anxiety symptoms, and anger. Other patient-reported measures include the Penn State Worry Questionnaire (PSWQ), the Inventory of Complicated Grief (ICG), and the Health Performance Questionnaire (HPQ). We will also use the Quick Inventory of Depressive Symptomatology, Self-Report, or QIDS-SR to measure depression severity including suicidality Other clinician-reported outcomes include the Liebowitz Social Anxiety Scale (LSAS), the Panic Disorder Severity Scale (PDSS), the Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A), the Clinician Global Impression-Severity and Improvement Scales (CGI-S and CGI-I), and the Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER).

Principal Investigator
Dr. Elizabeth Hoge, MD
Eligibility Criteria

We aim to enroll 368 participants total across the three study sites (GUMC, NYU, and MGH Boston).  With a projected dropout rate of 25%, we expect 276 completers.  Subjects must be between 18-75 years of age, have an anxiety disorder, and agree to participate in this randomized controlled study in which they will be randomized to either an MBSR class or medication.

Inclusion Criteria:

  1. Men and women between age 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, obsessive compulsive disorder, eating disorders, bipolar disorder; developmental or organic mental disorders; and current (past 6 months) substance use disorders as assessed by clinician at screening visit 
  2. A serious medical condition that may result in surgery or hospitalization.
  3. A history of head trauma causing prolonged 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 this study.
  7. Subjects taking benzodiazepines, barbiturates, SSRIs, anti-depressants, antipsychotics, or sedative medications
  8. Concurrent psychotherapy initiated within 2 months 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. 
     
Contact
Samantha Philip, sp1256@georgetown.edu, 202-682-7283
Location
Georgetown University, Mass General Hospital, NYU
State
DC
Study End Date