Treatments for Anxiety: Meditation and Escitalopram (TAME)
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|ClinicalTrials.gov Identifier: NCT03522844|
Recruitment Status : Active, not recruiting
First Posted : May 11, 2018
Last Update Posted : September 20, 2021
|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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||368 participants|
|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)|
|Official Title:||Comparative Effectiveness of Mindfulness-Based Stress Reduction and Pharmacotherapy for Anxiety|
|Actual Study Start Date :||June 18, 2018|
|Estimated Primary Completion Date :||October 31, 2021|
|Estimated Study Completion Date :||November 30, 2021|
|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||
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.
- Clinical Global Impression of Severity scale [ Time Frame: 8 weeks ]The CGI is a measure of symptom severity and is rated by a clinician
- Clinical Global Impression- Improvement (CGI-I) [ Time Frame: 8 weeks ]The CGI-I measures symptom improvement and is rated by a clinician
- Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) [ Time Frame: 8 weeks ]The SIGH-A assesses general anxiety symptoms and is rated by a clinician
- Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: 8 weeks ]The LSAS measures social anxiety and is rated by a clinician
- Panic Disorder Severity Scale (PDSS) [ Time Frame: 8 weeks ]The PDSS measures panic symptom severity and is rated by a clinician
- Overall Anxiety Severity and Impairment Scale (OASIS) [ Time Frame: 8 weeks ]The OASIS is a patient-reported measure is anxiety symptoms
- Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 8 weeks ]The PSQI is a patient-reported measure of sleep
- Penn State Worry Questionnaire (PSWQ) [ Time Frame: 8 weeks ]The PSWQ is a patient-reported measure of worry
- Beck Anxiety Inventory (BAI) [ Time Frame: 8 weeks ]The BAI is a patient-reported measure is anxiety symptoms
- PROMIS-Satisfaction with Participation in Social Roles (SPSR) [ Time Frame: 8 weeks ]The PROMIS-SPSR is a patient-reported measure of contentment with social roles
- PROMIS- Emotional Distress Scales (ED) [ Time Frame: 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) [ Time Frame: 8 weeks ]The PROMIS-APSRA is a patient-reported measure of ability to perform usual social roles and activities
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522844
|United States, District of Columbia|
|Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20007|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, New York|
|New York University|
|New York, New York, United States, 10016|