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Treatments for Anxiety: Meditation and Escitalopram (TAME)

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ClinicalTrials.gov Identifier: NCT03522844
Recruitment Status : Recruiting
First Posted : May 11, 2018
Last Update Posted : April 15, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Elizabeth Hoge, Georgetown University

Tracking Information
First Submitted Date  ICMJE May 1, 2018
First Posted Date  ICMJE May 11, 2018
Last Update Posted Date April 15, 2019
Actual Study Start Date  ICMJE June 18, 2018
Estimated Primary Completion Date January 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2018)
Clinical Global Impression of Severity scale [ Time Frame: 8 weeks ]
The CGI is a measure of symptom severity and is rated by a clinician
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03522844 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2018)
  • Overall Anxiety Severity and Impairment Scale (OASIS) [ Time Frame: 8 weeks ]
    The OASIS is a measure is anxiety symptoms
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 8 weeks ]
    The PSQI is a measure of sleep
  • Penn State Worry Questionnaire (PSWQ) [ Time Frame: 8 weeks ]
    The PSWQ is a patient-reported measure of worry
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatments for Anxiety: Meditation and Escitalopram
Official Title  ICMJE Comparative Effectiveness of Mindfulness-Based Stress Reduction and Pharmacotherapy for Anxiety
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants will be randomized to receive one of two treatments over the course of 8-weeks. One group will participate in an 8-week Mindfulness-Based Stress Reduction Course and the other group will receive a daily medication treatment (escitalopram).
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Anxiety Disorders
  • Generalized Anxiety Disorder
  • Panic Disorder
  • Social Anxiety Disorder
  • Agoraphobia
Intervention  ICMJE
  • 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 5 mg/day; which will be continued to week 1, when it will be increased to 10 mg/day if well tolerated (or delayed if not). 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.
Study Arms  ICMJE
  • Experimental: Mindfulness-Based Stress Reduction (MBSR)
    Intervention: Other: Mindfulness-Based Stress Reduction
  • Active Comparator: Escitalopram
    Intervention: Drug: Escitalopram
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 1, 2018)
370
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 14, 2021
Estimated Primary Completion Date January 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Elizabeth A Hoge, MD 202-687-0635 eah103@georgetown.edu
Contact: Samantha R Philip, BS 202-687-7283 sp1256@georgetown.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03522844
Other Study ID Numbers  ICMJE 2017-1464
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Elizabeth Hoge, Georgetown University
Study Sponsor  ICMJE Georgetown University
Collaborators  ICMJE Patient-Centered Outcomes Research Institute
Investigators  ICMJE Not Provided
PRS Account Georgetown University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP