TAME: Treatments for Anxiety: Meditation and Escitalopram

Sponsor

Georgetown University (Other)

Overall Status

Completed

CT.gov ID

NCT03522844

Collaborator

Patient-Centered Outcomes Research Institute (Other)

276

Enrollment

Locations

Arms

42.6

Actual Duration (Months)

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorders Generalized Anxiety Disorder Panic Disorder Social Anxiety Disorder Agoraphobia	Other: Mindfulness-Based Stress Reduction Drug: Escitalopram	Phase 4

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.

Adaptations and Additional Aims:

Due to the COVID-19 pandemic, the study was transitioned to a virtual format (on-line videoconference visits) in March 2020 as a pilot adaptation with the introduction of additional aims to explore the following: (1) the comparative effectiveness and treatment satisfaction for in-person MBSR versus virtual MBSR and (2) the comparative effectiveness of virtual MBSR versus virtual pharmacotherapy. An additional 202 participants were randomized to the virtual version of the study to support these aims.

Note about the in-person recruitment: Due to the impact of pandemic-related and participant-related confounders, it has not been possible to return to in-person treatments since March 2020. Before the pandemic, we had published a methods paper adopting (a priori) a non-inferiority margin of 0.495 points on the CGI-S for the analysis of the primary hypothesis. Although we were not able to enroll the proposed sample size of 368 due to the pandemic, with 276 patients randomized, we have sufficient statistical power of 80% for our original analysis to stop in person enrollment.

Study Design

Study Type:

Interventional

Actual Enrollment :

276 participants

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).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

Official Title:

Comparative Effectiveness of Mindfulness-Based Stress Reduction and Pharmacotherapy for Anxiety

Actual Study Start Date :

Jun 18, 2018

Actual Primary Completion Date :

Oct 31, 2021

Actual Study Completion Date :

Jan 5, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindfulness-Based Stress Reduction (MBSR)	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.
Active Comparator: Escitalopram	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 10 mg/day; 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.

Arm

Intervention/Treatment

Experimental: Mindfulness-Based Stress Reduction (MBSR)

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.

Active Comparator: Escitalopram

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 10 mg/day; 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.

Outcome Measures

Primary Outcome Measures

Clinical Global Impression of Severity scale [8 weeks]
The CGI is a measure of symptom severity and is rated by a clinician

Secondary Outcome Measures

Clinical Global Impression- Improvement (CGI-I) [8 weeks]
The CGI-I measures symptom improvement and is rated by a clinician
Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) [8 weeks]
The SIGH-A assesses general anxiety symptoms and is rated by a clinician
Liebowitz Social Anxiety Scale (LSAS) [8 weeks]
The LSAS measures social anxiety and is rated by a clinician
Panic Disorder Severity Scale (PDSS) [8 weeks]
The PDSS measures panic symptom severity and is rated by a clinician
Overall Anxiety Severity and Impairment Scale (OASIS) [8 weeks]
The OASIS is a patient-reported measure is anxiety symptoms
Pittsburgh Sleep Quality Index (PSQI) [8 weeks]
The PSQI is a patient-reported measure of sleep
Penn State Worry Questionnaire (PSWQ) [8 weeks]
The PSWQ is a patient-reported measure of worry
Beck Anxiety Inventory (BAI) [8 weeks]
The BAI is a patient-reported measure is anxiety symptoms
PROMIS-Satisfaction with Participation in Social Roles (SPSR) [8 weeks]
The PROMIS-SPSR is a patient-reported measure of contentment with social roles
PROMIS- Emotional Distress Scales (ED) [8 weeks]
The PROMIS-ED scales are patient-reported measures of emotional distress, such as anxiety and depression
PROMIS-Ability to Participate in Social Roles and Activities (APSRA) [8 weeks]
The PROMIS-APSRA is a patient-reported measure of ability to perform usual social roles and activities

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Georgetown University Medical Center	Washington	District of Columbia	United States	20007
2	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
3	New York University	New York	New York	United States	10016