A Phase 4 interventional study of Mindfulness-Based Stress Reduction and Escitalopram in Anxiety Disorders, Generalized Anxiety Disorder and Panic Disorder, sponsored by Georgetown University. Completed at 3 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-01-11.
Sponsored by Georgetown University · Phase 4, Interventional, and Treatment
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.
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.
7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's enrollment of 276 is above the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Georgetown University is the lead sponsor of 292 studies on the registry; 40 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Mindfulness-Based Stress Reduction
Drug: Escitalopram
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.
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
The CGI is a measure of symptom severity and is rated by a clinician
Time frame: 8 weeks
Clinical Global Impression- Improvement (CGI-I)
The CGI-I measures symptom improvement and is rated by a clinician
Time frame: 8 weeks
Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A)
The SIGH-A assesses general anxiety symptoms and is rated by a clinician
Time frame: 8 weeks
Liebowitz Social Anxiety Scale (LSAS)
The LSAS measures social anxiety and is rated by a clinician
Time frame: 8 weeks
Panic Disorder Severity Scale (PDSS)
The PDSS measures panic symptom severity and is rated by a clinician
Time frame: 8 weeks
Overall Anxiety Severity and Impairment Scale (OASIS)
The OASIS is a patient-reported measure is anxiety symptoms
Time frame: 8 weeks
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a patient-reported measure of sleep
Time frame: 8 weeks
Penn State Worry Questionnaire (PSWQ)
The PSWQ is a patient-reported measure of worry
Time frame: 8 weeks
Beck Anxiety Inventory (BAI)
The BAI is a patient-reported measure is anxiety symptoms
Time frame: 8 weeks
PROMIS-Satisfaction with Participation in Social Roles (SPSR)
The PROMIS-SPSR is a patient-reported measure of contentment with social roles
Time frame: 8 weeks
PROMIS- Emotional Distress Scales (ED)
The PROMIS-ED scales are patient-reported measures of emotional distress, such as anxiety and depression
Time frame: 8 weeks
PROMIS-Ability to Participate in Social Roles and Activities (APSRA)
The PROMIS-APSRA is a patient-reported measure of ability to perform usual social roles and activities
Time frame: 8 weeks
Plan to share: No
Ran from Jun 2018 to primary completion in Oct 2021, 40 months.
Of 52 non-industry phase 4 interventional studies under Anxiety Disorders, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 47. This study's 40 months is above that.
Counting every sponsor, half of 59 studies reached it within 27 months; a quarter within 16 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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