Comparing Meditation versus Medicine for Patients with Anxiety Disorders

Comparing Meditation versus Medicine for Patients with Anxiety Disorders - NCBI Bookshelf An official website of the United States government Here's how you know The .gov means it's official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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Author Information and Affiliations Authors Elizabeth Hoge , MD, MSc, 1 Eric Bui , MD, PhD, 2,3 Mihriye Mete , PhD, 4 Mary Ann Dutton , PhD, 1 Amanda W. Baker , PhD, 3 and Naomi M. Simon , MD, MSc 5 . Affiliations 1 Georgetown University Medical Center, Department of Psychiatry, Washington, DC, USA 2 University of Caen Normandy and Caen University Hospital, Caen, France 3 Massachusetts General Hospital/Harvard Medical School, Department of Psychiatry, Boston, USA 4 MedStar Health Research Institute, Department of Biostatistics and Epidemiology, Hyattsville, Maryland, USA 5 New York University Grossman School of Medicine, Department of Psychiatry, New York, USA Washington (DC): Patient-Centered Outcomes Research Institute (PCORI) ; 2023 Dec . Copyright and Permissions Copyright © 2023. Georgetown University. All Rights Reserved. This book is distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License which permits noncommercial use and distribution provided the original author(s) and source are credited. (See https://creativecommons.org/licenses/by-nc-nd/4.0/ Structured Abstract Background: Anxiety disorders are common, highly distressing, and impairing conditions. Although effective treatments exist, many patients do not have access to them or respond to them. Mindfulness-based interventions such as mindfulness-based stress reduction (MBSR) are popular and can decrease anxiety, but it is unknown how they compare with standard, first-line treatments. In addition, as virtual health care becomes increasingly common and may reduce barriers to care, it is important to determine how virtually delivered treatment compares with traditional, in-person treatments. Objectives: To determine whether MBSR is noninferior to escitalopram, a commonly used first-line psychopharmacologic treatment (both delivered in person) (aim 1); to determine whether MBSR delivered online is noninferior to MBSR delivered in person (aim 2); and to determine whether MBSR (delivered online) is noninferior to escitalopram (also delivered online) (aim 3). Methods: This randomized controlled study ( NCT03522844 ) included a noninferiority design with a prespecified noninferiority margin based on published trials and minimal clinically important difference scores. Participants were adults diagnosed with an anxiety disorder recruited by 3 urban medical centers and randomly assigned to 8 weeks of the drug escitalopram or 8 weeks of MBSR. The outcome was assessed by blinded clinical interviewers at baseline, the week 8 end point (end of the active intervention period), and follow-up visits (12 and 24 weeks). The primary outcome measure was the Clinical Global Impression of Severity. Results Aim 1 (in-person treatments): The primary (completer) noninferiority sample consisted of 208 patients (n = 102 MBSR; n = 106 escitalopram), with a mean (SD) age of 33 (13) years and 156 women (75%). At treatment end point, the Clinical Global Impression of Severity was reduced by mean (SD) 1.35 (1.06) points for MBSR and 1.43 (1.17) points for escitalopram. The difference (SE) between the treatment groups was −0.07 (0.16 [95% CI, −0.38 to 0.23]; P = .65), where the lower bound of the interval fell within the predefined noninferiority margin of −0.495, indicating noninferiority of MBSR compared with escitalopram. Aim 2: After online treatment delivery was completed, we compared in-person MBSR with online delivery of MBSR using videoconferencing. We found a difference between the treatment groups of −0.04 (95% CI, −0.33 to 0.25), where the lower bound of the interval fell within the predefined noninferiority margin of −0.40, indicating noninferiority of online MBSR compared with in-person MBSR. Aim 3: We also compared online MBSR and online delivery of pharmacotherapy with escitalopram, but the results were inconclusive. Conclusions: We conducted the first randomized controlled anxiety disorder treatment trial comparing a standardized, evidence-based, mindfulness-based intervention with pharmacotherapy and found that MBSR was noninferior to escitalopram. This rigorous, well-controlled study provides evidence for clinicians, insurers, and health care systems to recommend, include, and provide reimbursement for MBSR as an effective treatment for anxiety disorders. In addition, virtual delivery of MBSR using videoconferencing seems to be noninferior to in-person classes, increasing the delivery options for this intervention. Limitations: The study treatments were not matched for time and attention (participants in the MBSR group spent more time engaged in treatment-related activities than those in the escitalopram group). In addition, the sample was predominantly made up of women with a relatively high education level, and recruitment took place at 3 urban academic medical centers, which may limit the generalizability of findings. Background Anxiety Disorders and Mindfulness-Based Interventions Anxiety disorders, including generalized anxiety disorder (GAD), social anxiety disorder (SAD), panic disorder, and agoraphobia, are the most frequent psychiatric conditions in the United States, with a lifetime prevalence of approximately 30%. 1 , 2 Anxiety disorders are associated with significant distress and impairment in functioning 3 , 4 and increased risk for suicide. 4 Antidepressant medication and psychotherapy are considered first-line treatments, with a recent meta-analysis finding that overall, medication has a slightly higher effect size than psychotherapy. 5 Selective serotonin reuptake inhibitors (SSRIs) are considered first-line medication treatment options for anxiety disorders, 6 , 7 but they are only partially effective, with approximately half of patients failing to reach long-term recovery from anxiety and many more not adhering to their prescribed drug regimen. 8-11 For example, 1 antidepressant adherence study found that only about half of patients who initiated an SSRI accessed their first prescription refill. 12 Cognitive behavior therapy (CBT) is the best-supported psychotherapy for anxiety disorders, but it can be difficult to access and even unavailable in some geographic regions because of a lack of trained health care professionals. 13 Even when CBT is available, patients do not always follow up. In a study on anxiety disorders that examined pretreatment attrition rates, approximately 30% of patients who were referred to CBT by doctors did not end up undergoing treatment. 14 In addition, these treatments are typically provided in a mental health treatment setting, such as a psychiatric clinic, which unfortunately may be associated with stigma. 15 Approximately 10% to 20% of adult patients report stigma as a reason for not pursuing mental health treatment. 16 , 17 Thus, it is important to explore alternatives that are offered outside a mental health context and therefore may have better acceptability for some patients. Mindfulness-based interventions (MBIs) have become increasingly popular and are employed for a variety of psychological and physical complaints, including stress and anxiety. 18 Mindfulness meditation practice involves focusing on current thoughts, feelings, and physiological sensations and trains a person to act consciously rather than react unconsciously. 19 This approach helps the individual stay focused on (and increase acceptance of) present experience rather than getting absorbed in worries about the future. 20 Mindfulness meditation training has been manualized in a group format called mindfulness-based stress reduction (MBSR). 21 , 22 Several studies have demonstrated promising findings for MBIs in patients with anxiety. 23 , 24 In a tightly controlled randomized GAD trial, in which more than one-third of patients had another comorbid anxiety disorder, MBSR yielded greater symptom reduction than it did with an attention control condition. 25 Mindfulness-based interventions and CBT are similar in that they both involve the idea that the way we think about things and react to things can create suffering, but there are major differences in the theoretical frameworks and therapeutic practices. In CBT, the individual is instructed to notice their thoughts, but then evaluate and dispute cognitions and beliefs and sometimes to reject some thoughts and replace them with other thoughts. In mindfulness training, the individual is instructed to notice and accept the thought as a transient event occurring in the mind rather than a truth that defines the self; there is no rejecting of thoughts but rather the cultivation of a different relationship with the thoughts. To date, no clinical trial comparing an evidence-based MBI, such as MBSR, with a first-line pharmacologic treatment for anxiety disorders has been published. To clarify whether MBSR should be considered an alternative first-line intervention comparable to a gold-standard pharmacotherapy used in primary care, our aim was to compare MBSR with escitalopram, a European Medicines Agency– and FDA-approved gold-standard pharmacotherapy for the treatment of anxiety (aim 1). We hypothesized that MBSR would be noninferior to escitalopram in this study, called “Treatments for Anxiety: Mindfulness Meditation vs Escitalopram (TAME).” We also asked whether MBSR delivered online is noninferior to MBSR delivered in person (aim 2) and sought to determine whether MBSR (delivered online) is noninferior to escitalopram (also delivered online) (aim 3). Aims 2 and 3: Comparison of Virtual and In-Person Treatments Background Approximately 2 years into the duration of the trial, the COVID-19 pandemic became widespread and affected the delivery of care throughout the world, including in this trial. All study treatments and visits were transitioned to a virtual format. Therefore, questions were raised about the effectiveness of virtual MBSR and virtual pharmacotherapy and how they compared with in-person treatments and each other. Thus, we recognized that the COVID-19 pandemic presented an opportunity to obtain valuable new information; we added new aims and planned analyses to respond to questions that our patient panel and stakeholders care about—namely, how in-person and online delivery of care affect effectiveness. We had the opportunity to compare the outcomes of in-person MBSR and online MBSR, an especially important question given how little is known about online delivery of meditation training, as well as understanding the relative effectiveness of online MBSR compared with online medication treatment (a parallel question to our original, aim 1). It has already been suggested that MBSR delivered online by telehealth could reduce barriers to participation such as commute anxiety, time restrictions, and mobility impairment, 26 , 27 which points to the need to investigate the effectiveness of virtual vs in-person MBSR. This need is especially relevant now, given the pandemic and the rapid shift to telehealth/online care, including virtual MBSR delivery. Although mind-body treatments are already moving to online delivery across the nation without an evidence base for their effectiveness compared with in-person treatments, it is possible that they may not be as effective as their in-person counterparts, especially for anxiety disorders (for which exposure to real-life social interactions and engagement can be an important part of treatment). Studies that have reported anxiety outcomes and compared in-person and online delivery of group-based treatments such as yoga or psychotherapy present mixed evidence, with some studies showing no difference between the delivery modes 28 , 29 and others showing improvement in symptoms only for the in-person treatment group. 30 For example, in a study comparing CBT delivered in person vs online synchronous video conferencing, decreases in depression scores were comparable. 30 In contrast, in another study that used an MBI, the anxiety significantly improved in the in-person group but not the online group. 31 Neither study used a noninferiority design, however, which is the only way to definitively determine treatment equivalence (or noninferiority). Thus, although research with medical patients suggests that online mind-body interventions are both acceptable and feasible, this same research points to a critical gap and pressing need for an examination of the effectiveness of online treatments compared with those traditionally delivered in person. 32 Further, there is evidence that these virtual group-based treatments fall short in group process factors such as therapeutic alliance and group cohesion, 33 which could result in a poorer treatment experience, particularly for patients with anxiety disorders. Accordingly, we added 2 aims to our project. Aim 2 sought to compare MBSR delivered online with MBSR delivered in person. Randomizing for this aim was impossible as the in-person data were collected before the pandemic and the online MBSR data were collected during the pandemic. We hypothesized that online MBSR would be noninferior to in-person MBSR. Aim 3 was to compare online MBSR with online pharmacotherapy (escitalopram), with a parallel hypothesis to aim 1 that MBSR would be noninferior to escitalopram. Participation of Patients and Other Stakeholders We identified a patient panel composed of people with lived experience of anxiety disorders to inform decisions about topics such as participant recruitment and ways to make the study as comfortable an experience as possible for participants. In addition, we identified a panel of clinician and health care systems stakeholders to inform decisions about various topics, including participant safety and dissemination of study results. The patient panel was composed of 4 patients with anxiety (2 men and 2 women) with whom the researchers had established a relationship through their clinical practice. Some of the patient panel members were familiar with mindfulness meditation and others were not, and they represented a variety of perspectives about treatment strategies. The stakeholder panel was composed of a community psychiatrist, 2 representatives who each held dual roles of psychiatrist and executive of a payer/health care system, and the executive director of a large national organization that conducts anxiety disorder outreach to both the general public and mental health professionals. In the first phase of the study, we held conference calls monthly with our patient panel and every other month with our clinician and health care system stakeholders. Once the study was underway, consultation was needed less frequently; thus, this timeline shifted to a more fluid arrangement of holding conference calls with each panel every 3 to 4 months, with additional communications by email for more urgent questions as they came up. Panel meetings yielded thoughtful and fruitful discussions, resulting in important changes to several aspects of the study, including design, recruitment, safety, data collection, and dissemination. Regarding the design, patient panel members recommended measuring outcomes of the study treatments related to the subjective experience of anxiety and depression, side effects, and quality of life. With respect to recruitment, the patient panel shared valuable ideas, such as adding tearable strips of paper to flyers, making postings on NextDoor (a widely used neighborhood-centric form of social media), and arranging for our radio advertisement for the study read by a Black radio announcer in an effort to improve the racial diversity of our sample. Regarding safety, the stakeholder panel recommended that we include a clinician-rated measure of suicidality in addition to a self-report measure. Concerning data collection, the patient panel encouraged the research team to consider making it possible for study visits with patients to have the option of being completed by phone in extenuating circumstances; the stakeholder panel recommended we also collect data on trauma history because the presence of such history might influence treatment outcome. With respect to dissemination, the patient panel gave us ideas about using video to report on study findings, such as on websites of patient advocacy and information organizations like the Anxiety and Depression Association of America and the National Alliance on Mental Illness. Stakeholders provided several ideas, such as reaching out to national meditation centers, prominent mindfulness meditation leaders, and health/psychology social media influencers; reaching out to organizations with patient outreach/clinician outreach arms (eg, Anxiety and Depression Association of America); and seeking consultation from people familiar with the Centers for Medicare & Medicaid Services to find out how to pave the way for this treatment to become reimbursable. Our patient and stakeholder panels were instrumental in guiding the study throughout the COVID-19 pandemic and making major decisions during this period about the direction of the study. The patient panel advised against a return to in-person treatment in the summer and fall of 2021. Discussion during the meeting where this advice was brought forth centered on how requiring masks or vaccinations in an in-person MBSR class might negatively affect patients. Another concern was that the people willing to participate in an in-person MBSR class during the present COVID-19 era may differ significantly from the people only willing to participate in an in-person MBSR class before COVID-19, and thus the pooling of the data could introduce confounding variables. The panel also noted that there could be issues with requiring participants to show proof of vaccination. This guidance we received and followed was invaluable. We faced challenges in obtaining consistent attendance from 1 patient panel member and 1 stakeholder panel member and in finding mutually agreeable times to meet with panel members. Overall, however, our partnerships with the patients and stakeholders resulted in productive discussions that improved the design and integrity of the study and the general experience of the study for participants. Our patient panel and our stakeholder panel (representing health care systems, community practice, and patient advocacy) enthusiastically supported adding comparisons of outcomes for in-person vs online delivery of MBSR and the comparison of online delivery of MBSR vs online medication. They strongly indicated that this was a unique opportunity to rapidly learn more about this online delivery at a time when its implementation has far outpaced its evidence base and when information about patient acceptability, satisfaction, and effectiveness outcomes are much needed to guide real-world current decision-making for patients, health care professionals, and health care systems. Aim 1: Comparison of In-Person MBSR and Escitalopram Methods Participants Eligible participants were 18 to 75 years of age with a current primary diagnosis of GAD, SAD, panic disorder, or agoraphobia, as determined by structured psychiatric diagnostic interviews performed by trained clinicians on the study team. 34 A diagnosis was primary if it was determined by clinical judgment that it was the condition with the most severe symptoms and caused the greatest amount of interference and distress in the patient's daily life. All eligibility criteria and their rationales are described in Table 1 . Table 1 Inclusion and Exclusion Criteria. Of note, comorbidity with additional anxiety disorders and depressive disorders was permitted, but patients with a psychotic disorder; obsessive-compulsive disorder; bipolar disorder; developmental or organic mental disorders; or current posttraumatic stress disorder, bulimia or anorexia nervosa, or a substance use disorder were excluded to avoid confounding. Further, to minimize confounders and focus on individuals for whom both treatments could be a reasonable option in practice, participants were required to have limited prior experience with meditation (ie, could not have completed an MBSR course or equivalent meditation training within the past year or have an ongoing daily meditation practice) and could not be taking antidepressants, mood stabilizers, barbiturates, or antipsychotic medications. Recruitment methods included online, print, and radio advertisements. All participants provided written informed consent. Recruitment and Screening Procedures Participant recruitment occurred across 3 study sites: Georgetown University Medical Center in Washington, DC; New York University Langone in New York City; and Massachusetts General Hospital in Boston. Recruitment strategies included advertisements in print media, social media postings, flyers, postings at other primary care and psychiatric facilities and programs, and clinical referrals. Individuals who contacted study personnel underwent an initial phone screen to determine potential eligibility and interest in research participation. Participants needed to be willing to be randomly assigned to and participate in either an MBSR class or medication adherence and to complete study assessments. Interested patients who satisfied brief phone prescreening eligibility assessments were scheduled to meet with a trained study clinician evaluator to obtain written informed consent and subsequently completed a full evaluation to determine their psychiatric diagnosis and eligibility. Study Design For aim 1, we assessed the effectiveness of MBSR compared with escitalopram for anxiety disorders (ie, a primary diagnosis of GAD, panic disorder, agoraphobia, or SAD) by recruiting and randomly assigning treatment-seeking adults to 8 weeks of (1) MBSR delivered in a group format consistent with standard protocols (see the “ Interventions ” section later in this report) or (2) flexible-dose escitalopram. This 2-group, 3-site randomized controlled trial used a noninferiority study design that built on previously published data on the efficacy of escitalopram for anxiety disorder treatment compared with pill placebo in randomized controlled trials. 35-37 Based on our power calculations (see the section “ Sample Size and Noninferiority Margin ”), we initially aimed to randomly assign 368 participants across the 3 sites to either MBSR or escitalopram, anticipating that 276 would complete the protocol (ie, 25% dropout). In addition, treatment satisfaction, including dropout, and treatment adherence were considered important outcomes to guide conclusions about patient preferences and treatment responses. Patients who did not wish to stay in treatment (escitalopram or MBSR) could discontinue treatment but were requested to continue data-collection visits for the rest of the study all the way to the last study visit at week 24 so their data could be captured for the intention-to-treat (ITT) analysis. Assessment Instruments and Procedures Doctoral or master's-level independent clinical evaluators (IEs) blinded to treatment allocation assessed participants’ anxiety symptom severity throughout the study: pretreatment (baseline week 0 visit), midtreatment (week 4), posttreatment (week 8), and follow-up (weeks 12 and 24). The Iess used standard clinician-rated assessments to rate anxiety symptoms and severity. They were trained to conduct structured clinical interviews and received certification for this study under the direction of an IE trainer and supervisor. They participated in a monthly cross-site teleconference to discuss procedural questions that arose and to conduct checks on IE assessments for consistency and reliability. Interrater reliability ratings were used to calculate κ coefficients and to facilitate supervision, during which the IE trainer discussed potential disagreements and provided instruction to further enhance interrater reliability. If the IE became unblinded during a patient interview, the patient was transferred to the other IE (each site had 2) for the rest of the study to maintain blinding. To avoid unblinding, patients were reminded by the research assistant before each visit not to talk about their study treatment with the IE. Primary Outcome Measure The primary outcome was the Clinician Global Impression-Severity Scale (CGI-S), assessed by IEs blind to treatment assignment. 38-41 The CGI-S is widely used, has good psychometric properties, is treatment-sensitive, and is highly correlated with anxiety and depression scales across disorders. It is a 7-point scale of overall symptom severity performed by trained clinicians who interview the patient, and then select a rating where 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most ill patients. Secondary Outcomes Secondary outcomes included both clinician-rated and patient-reported measures and reflected outcomes important to patients and clinicians. The clinician-rated outcomes were the CGI-Improvement Scale, 38-40 the Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A; a clinician-rated instrument used to assess GAD severity), 42 the Liebowitz Social Anxiety Scale (a clinician-rated instrument used to assess SAD severity), 43 and the Panic Disorder Severity Scale. 44 Patient-reported outcomes were the Overall Anxiety Severity and Impairment Scale, 45-47 the Pittsburgh Sleep Quality Index, 48 the Penn State Worry Questionnaire (which assesses the severity, intensity, and frequency of worry), 49 the Beck Anxiety Inventory (a measure of somatic and cognitive symptoms of anxiety), 50 the PROMIS®-Satisfaction with Participation in Social Roles instrument, 51 the PROMIS-Emotional Distress Scales, 52 and the PROMIS-Ability to Participate in Social Roles and Activities instrument. 51 Interventions Escitalopram During the 8 weeks of randomized treatment with escitalopram, participants were interviewed at baseline; postbaseline medication pickup visit; weeks 1, 2, 4, and 6; the 8-week end point; and 12- and 24-week follow-up (9 visits total) by a study physician or nurse practitioner. The medication was provided to the participants by a study physician who reviewed and confirmed dosing instructions for the participant to self-administer for the period between baseline and week 12. For this drug, 10 to 20 mg is generally considered a therapeutic dose. Escitalopram was initiated at 10 mg/d; at week 2, escitalopram was increased to 20 mg/d if well tolerated (or delayed if not). Medication adherence was assessed by pill count (participants brought in their pill bottle) and a standardized adherence measurement. Side effects were assessed at each visit. Participants were instructed to contact study staff immediately if any significant side effects, symptomatic worsening, or suicidal ideation developed between visits. After week 8, if a patient desired to stay on the medication, that patient was provided with another 4-week supply by the study physician or nurse practitioner, who simultaneously worked with the participant on a plan for the transition to ongoing care after the study so that the patient could continue treatment, if desired. If a patient wanted to discontinue the study medication at week 8 or week 12, that patient was assisted in tapering off the medication. Mindfulness-based stress reduction This 8-week group-based course was developed by Jon Kabat-Zinn and colleagues 20 at the University of Massachusetts Center for Mindfulness. Weekly 2.5-hour-long classes were offered as well as 1 daylong weekend class during the sixth week. The classes instructed participants in the theory and practice of several forms of mindfulness meditation: a body scan (bringing awareness through the body systematically), breathing awareness (attention focused on the breath and other physical sensations), and mindfulness stretching exercises designed to bring awareness of the body and current experience of movement. Didactic teaching of the theory of mindfulness and experiential practice were both used during weekly classes and at-home audio recording–guided practice sessions. Participants were encouraged to continue practicing their meditation skills after the course ended, and they continued to have access to the audio recordings. Like the escitalopram participants, MBSR participants had check-in visits with a study physician or nurse practitioner at weeks 1, 2, 4, and 6; the 8-week end point; and 12- and 24-week follow-up visits. Fidelity Monitoring Mindfulness-based stress reduction instructors completed formal training and were considered qualified to teach by the University of Massachusetts Center for Mindfulness (or an equivalent training center). The study's MBSR expert investigator reviewed all potential MBSR teachers’ training and experience to confirm their qualifications for teaching participants in the study. Treatment integrity was further ensured through adherence monitoring by the MBSR expert overseeing the study, who reviewed the fifth session of each MBSR instructor's initial class, using audio-recorded sessions of MBSR and standardized adherence forms; feedback to instructors was provided, with changes made to the instructors if deemed necessary. IE Training and Interrater Reliability All clinician-rated outcome measures were assessed by blinded IEs. All IEs were required to complete a rating training, be certified, and be approved by both their site principal investigator and the cross-site IE supervisor before completing any study assessments. Of all assessments, 5% were randomly selected, rated, and used to calculate study interrater reliability. 53-55 Each month, IEs from all sites co-rated randomly selected audio-recorded IE assessments (SIGH-A, CGI-S, CGI-Improvement Scale). Data Analytic Strategy A randomization scheme stratified by study site and anxiety severity was generated for this study on April 25, 2018, by the study statistician using an online randomizer algorithm 56 and programmed in MedStar Health Research Institute's Research Electronic Data Capture (REDCap) database. 57 , 58 All investigators involved in decisions about entry of participants were blind to the randomization scheme. For this stratification, low anxiety severity was defined as a CGI-S score less than or equal to 4, and high anxiety severity was defined as a CGI-S score greater than 4. After the patient completed the baseline measures, an unblinded member of the study team (who did not perform any study assessments) obtained the treatment allocation of each new participant from the study's database in REDCap. Sample Size and Noninferiority Margin Sample size calculations were conducted in Power Analysis and Sample Size, version 16, software (NCSS, LLC) based on a noninferiority hypothesis for 2 unpaired means. A recent review of 8 noninferiority studies on behavioral treatments 59 found that the effect size used in the noninferiority margin calculations ranged between Cohen d = 0.26 and d = 0.6. The method from 1 included CBT trial for all anxiety disorders 60 was particularly relevant to the current trial and thus was used to determine the noninferiority margin for our sample size calculations. Norton and Barrera 60 proposed that the noninferiority margin be computed by multiplying the SD of the outcome measure by the meta-analytically derived effect size; their approach was derived from a standard methodology recommended for rigorous equivalence designs. 61 Following these formulae, we computed a noninferiority margin (SD) of 0.66 (1.1) points for CGI-S change scores multiplied by a moderate effect size of 0.60 based on other escitalopram trials across anxiety disorders. 36 , 62 To be more conservative, however, a noninferiority margin of 0.33 (0.3 × 1.1) was used for our sample size calculations. Next, we defined a largest clinically acceptable noninferiority margin following the literature by determining the halfway point between these 2 numbers (0.66 and 0.33) to get 0.495, (0.45 × 1.1) such that a difference of 0.495 or smaller would still allow us to declare MBSR to be noninferior to escitalopram treatment. Further support for the appropriateness of this margin comes from the literature, where a change of 1.0 unit, substantially higher than a margin of 0.495, is considered the minimal clinically important change score for the CGI-S and has been used to anchor definitions of clinically significant change across other measures. 63 , 64 As our primary analysis, we analyzed the per-protocol (completer) data set and the ITT primary data set as secondary, as typically done in noninferiority trials because of the theoretically increased chance of evidence in favor of noninferiority in ITT analyses. 65 Methods to Prevent and Monitor Missing Data and Reporting Procedures The data entry team members were trained on standardized and manualized procedures to collect, enter, and edit study data, which minimized missing data in the clinical data elements. Electronic data collection forms on REDCap were constructed such that missing data fields were immediately flagged for the user to go back and fill in. The study data manager administered the automated export of study data from REDCap to a relational study database in Microsoft Access 2000, allowing for systematic data querying and checking, and assisted with creating logical checks to identify data inconsistencies, omissions, and errors in real time during various phases of the study. Identified issues were then able to trigger queries, and any potential problems could be resolved promptly to reduce missing data and errors. During our regular study team meetings we reviewed data-collection procedures to troubleshoot emerging issues and refine collection methods to ensure accuracy and completeness. During the informed-consent process, the research team emphasized to the participants the importance of continued follow-up and completion of study forms. When a participant withdrew from the study, withdrawal reasons were carefully recorded and categorized, and we obtained permission to contact the participant for future data collection, such as outcome measurements. The proportion of patients with missing outcome data was reported by intervention group together with reasons for missingness. Missing data mechanisms can be classified as “missing completely at random,” “missing at random,” and “not missing at random.” Once the data collection was complete, we analyzed each outcome for missing data and conducted sensitivity analyses to assess the mechanism of missingness and to investigate the possible violation of missing-at-random assumption. We concluded that the missing data seemed to be missing at random as we did not find systematic differences in baseline characteristics of the patients with and without missing data. Then, we were able to use multiple imputation methods to impute missing end point data to assess our primary hypothesis testing using 2-sample t tests. Under the assumption of missing completely at random or missing at random, mixed models provided unbiased estimates of the treatment effect without needing data imputation. Therefore, we conducted longitudinal data analyses using linear mixed models that were robust to missing data. These models were adjusted by the baseline characteristics of the participants. Basic Statistical Analyses for Aim 1: Comparison of In-Person MBSR and In-Person Escitalopram Descriptive statistics were used to present demographic and clinical characteristics of the study participants using mean (SD) and median (range) for continuous variables and frequencies and percentages for categorical variables. Unadjusted differences between the groups at each time point were examined using 2-sample t tests, nonparametric rank tests, χ 2 , and Fisher exact test, as appropriate. Within-group changes were tested using paired t tests. All statistical analyses were conducted in Stata, version 15, software (StataCorp, LP). Primary outcome assessment (change from baseline to week 8) at end point was first conducted for the completer sample, and then for all randomly assigned participants (ITT sample) by imputing end point scores for noncompleters without week 8 data. End point CGI-S data were imputed using multiple imputation, with multivariate normal regression methods combining 50 imputed samples after establishing that missingness was at random. Noninferiority was evaluated by examining whether the noninferiority margin was within the 1-sided 97.5% CI of the mean difference in the change between the groups. The multivariate normal regression model for imputation included age, employment status, race, sex, site, use of benzodiazepines, primary diagnosis, total number of secondary diagnoses, baseline CGI-S score, and high vs low severity used in stratification. Secondary analyses of the primary outcome were conducted using linear mixed models to further examine the trends in CGI-S in the ITT sample, including data for baseline and weeks 4, 8, 12, and 24. The mixed models were adjusted by age, race, sex, site, baseline severity variable used for stratification, and number of secondary diagnoses and included interactions between treatment group and time indicators (dummy variables compared with baseline). Predicted margins were computed at each time point. Secondary outcomes were described and analyzed using similar statistical methods. Safety outcomes were assessed for all randomly assigned participants. All analyses were conducted in Stata, version 15 (commands: mi impute, mi estimate, xtmixed, margins, contrasts, marginsplot ). Subgroup Analyses/Heterogeneity of Treatment Effects We conducted analyses to address heterogeneity of effects in treatment differences by sex (male vs female), age (18-30, 31-44, ≥45 years), and primary diagnosis (GAD vs SAD) in the in-person sample (our largest sample) using linear regression models of the change in CGI-S score from the baseline CGI-S, the treatment indicator, subgroup variable, and their interaction. Changes to the Original Study Protocol for Aim 1 The original funded application did not include several disorder-specific, clinician-administered secondary outcome measures: the Panic Disorder Severity Scale, Liebowitz Social Anxiety Scale, and SIGH-A (described earlier). These measures were added early in the funded period to capture how symptoms of different anxiety disorders might be affected by the different treatments. In addition, the original funded application specified use of the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) during the clinician screening appointment; however, this instrument was replaced early in the funding period with the Mini International Neuropsychiatric Interview, which has good screening abilities, takes slightly less time, and is less expensive. Also, on the recommendation of our stakeholder panel, we changed our measure of suicidality from a self-report measure to a clinician-administered measure. There were a few additions to the battery of patient self-report surveys. Specifically, the Childhood Trauma Questionnaire, 66 Difficulties in Emotion Regulation Scale, 67 Self-Compassion Scale, 68 and PROMIS Sleep Disturbance Due to Worry Scale 69 were added. The inclusion and exclusion criteria were modified from the original protocol such that individuals with comorbid binge eating disorder were not excluded from participating (but comorbid anorexia or bulimia nervosa remained exclusion criteria). This was done to allow for more patients to participate and make the findings more generalizable. Changes to procedures for aims 2 and 3 As aims 2 and 3 were developed in response to the COVID-19 crisis, there were changes to the study procedures for these aims because of pandemic-related limitations, such as the restrictions against in-person visits. Specifically, in March 2020 we shifted from in-person to telehealth procedures for recruitment and study visits and dropped the requirement for blood tests and electrocardiogram, instead relying on the patient's medical record for this information when needed. During the treatment period, we stopped collecting vital signs (weight). The MBSR class was delivered through videoconferencing instead of in person. The other study procedures remained the same (inclusion and exclusion criteria, number of study visits, treatment format and content, safety assessments, and data collection). Because of the pandemic, the in-person phase of the study ended up recruiting fewer patients than projected (ultimately, 276 were randomly assigned). Despite this change, we still recruited the number of participants needed to complete our planned analyses for aim 1 with our predefined noninferiority margin. Results Of the 430 adults who consented to the study and were assessed by study clinicians, 276 met study criteria and were randomly assigned to MBSR (n = 136) or escitalopram (n = 140). In each group, 34 participants either did not begin (n = 34) or only partially received (n = 33) treatment or missed the end point study visit (n = 1), resulting in a completer sample of 208 participants. See Table 2 for participant characteristics and Figure 1 for the CONSORT diagram. Table 2 Baseline Characteristics: In-Person Sample (MBSR vs Escitalopram in Both the Randomly Assigned Sample and the Completer Sample). Figure 1 CONSORT Diagram. Baseline demographic characteristics were similar between the completer and full randomly assigned (ITT) samples and by treatment group within each sample ( Table 2 ). Both samples had high comorbidity, with the majority of patients having more than 1 disorder. Clinical severity at baseline was in the moderate to markedly ill range and did not differ by treatment group. Baseline (SD) CGI-S score was 4.44 (0.79) for MBSR and 4.51 (0.78) for escitalopram in the completers sample and 4.49 (0.77) vs 4.54 (0.83) in the randomly assigned sample. The dose of escitalopram (10 mg vs 20 mg) was not associated with outcomes in the escitalopram group. Primary outcome analyses on treatment completers at week 8 showed noninferiority for CGI-S improvement of MBSR compared with escitalopram in patients with anxiety disorders. Specifically, at week 8, the MBSR group improved (points [SD]) by 1.35 (1.06) and the escitalopram group by 1.43 (1.17) on average (see Table 3 .) The difference between the groups in the primary CGI-S outcome at week 8 (change in MBSR minus change in escitalopram) was −0.07 points (SE, 0.16), with a 95% CI of −0.38 to 0.23. The lower end of this CI (−0.38 points; 97.5% CI) is smaller than the prespecified noninferiority margin of −0.495, indicating the noninferiority of MBSR compared with escitalopram ( Figure 2 ). The CGI-S outcomes for each time point by treatment are reported in Table 3 . Table 3 In-Person Sample: Primary Outcome Assessment (CGI-S) for MBSR vs Escitalopram: Completer Sample . Figure 2 Noninferiority CIs of Primary Outcome for MBSR vs Escitalopram (Week 8 End Point). Sensitivity analyses on the ITT sample at week 8 using imputed data also showed a noninferiority of MBSR compared with escitalopram based on the improvement in CGI-S. We had 222 observations for CGI-S at week 8 regardless of participants’ completer status. Sensitivity analyses comparing baseline characteristics between participants with and without week 8 data suggested no systematic differences in missingness patterns. Multiple imputation was thus performed to impute CGI-S for participants with no end point assessment. Results summarized over 50 imputed samples generated a mean (SE) of 3.16 (0.11) for MBSR and 3.12 (0.11) for escitalopram at week 8. The difference between groups was estimated using a linear regression model of CGI-S score on treatment group indicator using imputed samples with no other covariates. The CGI-S was smaller on average by 0.04 points for the escitalopram group, but the difference was not statistically significant (95% CI, −0.33 to 0.26; P = .81). The mean (SE) improvement in the MBSR group was 1.34 (0.10), and it was 1.43 (0.11) in the escitalopram group. The difference between the groups (SE) was estimated to be −0.09 (0.15), with a 95% CI of −0.39 to 0.20. In addition, the lower end of this CI (−0.39 [97.5% CI]) fell within the prespecified noninferiority margin of −0.495, showing that MBSR was noninferior to escitalopram. Next, we examined the primary outcome at follow-up and found that both the MBSR and escitalopram groups continued to improve in the follow-up period ( Table 3 ). The mean (SD) CGI-S for treatment completers was 2.89 (1.09) in MBSR and 2.95 (1.07) in escitalopram (difference, −0.07; P = .67) at week 12, and 2.92 (1.17) in MBSR and 2.92 (1.03) in escitalopram (difference, 0.00; P > .99) at week 24. Longitudinal data were analyzed using a linear mixed model of CGI-S in the ITT sample, pooling data across 5 time points: baseline (n = 276), week 4 (n = 226), week 8 (n = 222), week 12 (n = 211), and week 24 (n = 202). Group trajectories over time, based on predicted means, are illustrated in Figure 3 . Results show that the adjusted mean difference between the groups is −0.09 points (lower bound of the 97.5% CI is −0.35) at week 8, further confirming noninferiority of MBSR to escitalopram. Figure 3 Predicted CGI-S Based on a Linear Mixed Model, Adjusted by Age, Sex, Race, Site, and Total Number of Secondary Diagnoses. Secondary outcome measures were compared between the groups (see Table 4 ). Overall, the majority of measures were very similar between the 2 treatment groups; this was consistent with our hypothesis that the 2 treatments (escitalopram and MBSR) are similar. Of the 11 secondary outcomes, only 2 were significantly different at the 8-week end point: the Beck Anxiety Inventory and the Penn State Worry Questionnaire, which both had a greater drop in anxiety symptoms in the escitalopram group. These differences disappeared, however, by the week 12 follow-up visit. Table 4 Secondary Outcomes . No serious adverse events occurred during the study across the 2 groups. At least 1 study-related adverse event occurred for 78.6% of participants (n = 110) randomly assigned to escitalopram and for 15.4% of participants (n = 21) randomly assigned to MBSR. Adverse events (considered possibly or definitely related to study treatment) that occurred in 5% or more of participants in the escitalopram group were insomnia/sleep disturbance (41%), nausea (35%), fatigue (26%), headache (18%), somnolence (14%), anorgasmia/delayed orgasm (11%), abnormal dreaming (9%), decreased appetite (9%), jitteriness (9%), decreased libido (7%), dizziness/lightheadedness/fainting (8%), increased sweating (6%), and anxiety (5%). The only adverse event (possibly or definitely related to treatment) that occurred in 5% or more of participants in the MBSR group was increased anxiety (11%). No participants discontinued treatment because of clinical worsening or emerging suicidality. The completion rate (completing at least 6 of the 9 MBSR sessions or at least 6 weeks of escitalopram) for participants was 75% for MBSR and 76.5% for escitalopram. At 12-week follow-up, 78% of the escitalopram group reported continued treatment, and 60% in MBSR had continued meditating (defined as at least 4 days a week). By 24-week follow-up, 58% were still taking escitalopram, while 28% in MBSR were still doing regular mindfulness meditation. Subgroup Analyses/Heterogeneity of Treatment Effects The interaction terms were not statistically significant in any of the 3 models for age, sex, or primary diagnosis. The variations in the sample size for these subgroup analyses, however, is a limitation. For example, women make up approximately 75% of the sample. Though there seems to be a trend showing that MBSR may be more effective for men, participants with SAD, and older participants based on the direction of the estimated coefficients for interaction terms, different analyses will need to be conducted with longitudinal data to increase the sample size and get more efficient estimates. Generally, across treatments , male and relatively older participants seem to have benefited more from the interventions. Based on 2-sample comparisons of the change in CGI-S by subgroup variables, average improvement was significantly higher (points [SD]) for men (1.76 [1.02]) than for women (1.25 [1.12]; P = .004). It was slightly higher for GAD than SAD (1.40 [1.07] vs 1.31 [1.19]; P = .58). There were no significant differences in improvement by age group (18-30 years, 1.30 [1.13]; 31-44 years, 1.48 [1.08]; ≥45 years, 1.43 [1.11]; P = .53) based on an analysis of variance of the change in CGI-S by age group. Our study was not sufficiently powered to explore heterogeneity of the effects. Aim 2, Comparison of In-Person MBSR and Online-Delivered MBSR, and Aim 3, Comparison Of Online-Delivered MBSR and Online-Delivered Escitalopram The data for aims 2 and 3 were collected during the COVID-19 pandemic, which allowed us to examine different types of treatment delivery (online, “virtual” treatments). We continued to recruit eligible participants and randomly assign them into either MBSR or escitalopram treatments delivered using online methods. Aim 2 focused on comparing the 2 delivery methods of MBSR, and aim 3 repeated the original aim 1 (drug vs MBSR) but with the treatments delivered online. Methods The study design, participants, recruitment, and random assignment (to MBSR or drug) were identical to those described in the aim 1 section; however, data collection for this aim occurred between May 2020 and December 2021 (during the COVID-19 pandemic). All medication visits occurred through a videoconference platform. The MBSR classes and retreat were also held by videoconference, and check-in visits with a study clinician for MBSR participants were conducted by phone or videoconference. Basic Statistical Analyses for Aim 2 Descriptive statistics were used to present demographic and clinical characteristics of the study participants using mean (SD) and median (range) for continuous variables and frequencies and percentages for categorical variables. Unadjusted differences between the groups at each time point were examined with 2-sample t tests, nonparametric rank tests, χ 2 tests, and Fisher exact test as appropriate. Within-group changes were tested using paired t tests. All statistical analyses were conducted in Stata, version 15 software. The aim 2 analyses were conducted to describe and test the differences in the characteristics of the participants in in-person and online MBSR intervention groups. Two-sample t tests and χ 2 tests were used for bivariate analyses. Because the participants were not randomly assigned to online vs in-person delivery of MBSR, the noninferiority hypothesis for this aim was tested by evaluating the 95% CI for the group difference, estimated in a linear regression model adjusted for confounders. We predefined a noninferiority margin of −0.40, which was smaller than the aim 1 noninferiority margin because we expected the 2 treatment groups (online MBSR and in-person MBSR) to be more similar. Linear mixed models were also used to examine the differences over time by combining the data for all available time points. Basic Statistical Analyses for Aim 3 Descriptive statistics were used to present demographic and clinical characteristics of the study participants using mean (SD) and median (range) for continuous variables and frequencies and percentages for categorical variables. Unadjusted differences between the groups at each time point were examined with 2-sample t tests, nonparametric rank tests, χ 2 tests, and Fisher exact tests as appropriate. Within-group changes were tested using paired t tests. All statistical analyses were conducted in Stata, version 15, software. In the second phase of the TAME study, participants were randomly assigned to online MBSR and online escitalopram with a 1:1 ratio. Because of the pandemic-related uncertainty and constraints on recruitment and budget, however, we could not sufficiently power the study to conduct a noninferiority design. Nonetheless, the analyses described in the “Aim 1” section were repeated to compare the effect of the interventions among online participants. Changes to the Original Study Protocol for Aims 2 and 3 As described, the original study protocol was modified during the COVID-19 pandemic to allow for virtual delivery of treatments and collection of data. These modifications entailed other smaller changes to the protocol. For example, medication adherence tracking was adjusted such that participants were asked to count and report the number of pills they had remaining (previously, participants physically brought in their pills for the research team to count). In addition, in this sample of online participants, there were 10 participants total across sites for whom the 6-month follow-up assessments were omitted because of funding limitations. Added to the other 10 participants who did not complete 6-month follow-up assessments because they dropped out, 6-month follow-up data for the online sample were not collected for 20 of 52 treatment completers (13%) but were available for 132 of 152 online treatment completers (87%). Results Results for Aim 2 Baseline characteristics of the participants in in-person and online MBSR treatment are presented in Table 5 . Because there was no randomization between in-person and online delivery of MBSR, we had to evaluate if the groups were balanced. To that end, we conducted bivariate analyses of the demographic and anxiety-related characteristics of the participants at baseline using 2-sample t tests, χ 2 tests, and Fisher exact tests as appropriate. Results in Table 5 show that the groups were similar in the distribution of gender, age, education, employment, marital status, primary diagnosis, and average number of comorbid diagnoses. Disorder severity, however, was significantly lower in the online group (high severity 36% online vs 50% in person; P = .03). The groups were also significantly different in race, particularly in Asian participants and those who selected “other” race, with a higher percentage of Asian participants in the online group (20% vs 9%; P = .03), and in ethnicity, with a lower percentage of Hispanic participants in the online group (5% vs 18%; P = .002). Table 5 Baseline Characteristics: MBSR Delivered Online vs In Person. The in-person and online groups were not significantly different at any point during the study period ( Table 6 ). On average, the CGI-S was slightly but not significantly higher in the in-person group at baseline (4.5 vs 4.3; P = .07). At week 8, the mean (SD) CGI-S score for the online group was 3.0 (1.1) and 3.1 (1.1) for the in-person group. The difference between the change in symptoms in MBSR in-person vs MBSR online was −0.04, where the lower bound of the interval fell within the predefined noninferiority margin of −0.40, indicating noninferiority of online MBSR compared with in-person MBSR. The 95% CI for the difference in the change in CGI-S was −0.33 to 0.25. Table 6 Online Sample: Primary Outcome Assessment (CGI-S) for In-Person vs Online MBSR . The assessment of the differences in CGI-S between the online and in-person groups for MBSR using linear regression models adjusted by potential confounders also supports the conclusion that the online MBSR is noninferior to in-person MBSR after controlling for baseline CGI-S score, primary diagnosis, sex, age, education, race, and marital status. When the change in CGI-S score was regressed on the in-person group compared with an online group indicator adjusted for the listed covariates, the estimated coefficient (SE) for the group difference was −0.03 (0.14 [95% CI, −0.31 to 0.25]). Adjusted R 2 for the model is 0.21, and the P value for the F test for the overall significance was less than .001 ( F 16,79 = 4.24; n = 196). Results for Aim 3 For aim 3, we compared online delivery of MBSR with online delivery of the drug escitalopram, with data collection occurring during the COVID-19 pandemic. Participants were recruited in the same way as before and randomly assigned to the 2 different treatments, but all study visits and treatment visits were conducted online. Baseline demographic characteristics were similar between treatment groups in the online phase of the study ( Table 7 ). Overall, 75% of the sample were female patients and 72% were White. The mean age (SD) was 35 (15) years. A large majority of the participants had GAD as their primary diagnosis (67% in MBSR and 61% in escitalopram). The percentage of participants with SAD was 27 in the MBSR group and 30 in the escitalopram group ( P = .45). The average (SD) number of secondary diagnoses was 1.1 (0.9) in the MBSR group and 1.2 (1.0) in the escitalopram group ( P = .74). Table 7 Baseline Characteristics: Online Sample. Clinical severity at baseline was in the moderate to markedly ill range and did not differ by treatment group ( Table 8 ). Baseline CGI-S (SD) score was 4.31 (0.75) for MBSR and 4.26 (0.78) for escitalopram in the online randomly assigned sample. Primary outcome analyses on all participants with available data at week 8 showed that the MBSR group improved by 1.29 (0.99) and the escitalopram group by 1.51 (1.01) points on average. The difference between the groups in the primary CGI-S outcome at week 8 (change in MBSR minus change in escitalopram) was −0.22 (SE, 0.16) with a 95% CI of −0.52 to 0.09. The lower end of this CI (−0.52 [97.5% CI]) is below the prespecified noninferiority margin of −0.495, resulting in inconclusive evidence for the noninferiority of online MBSR compared with online escitalopram. Table 8 Online Sample: Primary Outcome Assessment (CGI-S) for MBSR vs Escitalopram . Linear mixed models that were adjusted for age, sex, secondary diagnoses, and severity at baseline resulted in an estimated average difference of −0.24 units on the CGI-S between the groups at week 8. The 95% CI for this difference was −0.54 to 0.05. ITT analyses of the CGI-S online data adjusted for baseline characteristics also resulted in inconclusive evidence for the noninferiority of MBSR compared with escitalopram. Discussion Summary of Results Our in-person, prospective randomized clinical trial found that MBSR was noninferior to escitalopram to treat anxiety disorders; in addition, MBSR was safe and well tolerated, with many fewer adverse events associated with treatment than with escitalopram (aim 1). Our comparison of in-person MBSR and MBSR delivered live by teleconferencing showed that the virtual delivery was noninferior to in-person delivery (aim 2). The noninferiority test of online MBSR compared with online escitalopram was inconclusive (aim 3). Results in Context To our knowledge, this is the first study comparing a standardized, evidence-based MBI with a first-line medication for anxiety disorders. Our in-person aim 1 data robustly show that MBSR was noninferior to the commonly used and widely available first-line pharmacotherapy agent escitalopram. The noninferiority of MBSR to the drug was confirmed in both the completer (per-protocol) analysis and the ITT analysis. Our aim 2 data show that MBSR can be delivered equally well in a live or videoconference format. Escitalopram was a representative of the SSRI class of medications, and as such, it is possible that MBSR would be noninferior to an equivalent drug from the same class. We chose escitalopram because it is available in generic form, is generally well tolerated, and does not interact with other medications as much as other representatives from the SSRI group of medications. Potential to Affect Health Care Decision-Making Our results showing noninferiority of MBSR to a standard pharmacotherapy for treatment of anxiety suggests that mindfulness meditation should be considered as a potential first-line treatment option for adults with anxiety disorders. This study has broad public health relevance as findings provide support for clinicians to recommend MBSR as a treatment option for adults with anxiety disorders, and for insurers and health care systems to consider MBSR as a reimbursable clinical intervention. Study Limitations Treatments in this study were not matched for time and attention, as participants in the MBSR group spent more time engaged in treatment-related activities than those in the escitalopram group. This comparative effectiveness trial was designed to inform clinical decision-making in the real world, however, rather than test the theoretical efficacy of 2 time-matched groups, and contact with the research study team was matched between the groups, with the clinical safety and assessment visits using the same procedures and carried out by the same members of the study staff. Other limitations include a sample that was predominantly White, female, and with a relatively high education level; this means that the results from this trial may not be generalizable to groups with other demographic characteristics. Another limitation is the use of single-blinding procedures (although double-blinding was not possible). Future Research Confirmatory studies are needed to replicate these findings, including in groups with higher prevalence rates of anxiety such as individuals with low income levels. Future research should also examine the comparative efficacy of a closely related program, mindfulness-based cognitive therapy, with medication for the treatment of depressive disorders. This category of mental disorders is common, and a mindfulness-based treatment paradigm that is noninferior to standard medication therapy would be an asset to the field because many patients with depression are interested in nonmedication treatments. Other mindfulness-based treatments could be evaluated for anxiety and depressive disorders, such as mindful self-compassion, which may be able to address self-judgment, a behavior which has been correlated with depression levels. 70 Finally, mindfulness-based treatments and meditation interventions delivered online without synchronous human interactions (apps) should be separately evaluated for efficacy, as these types of programs differ greatly from online delivery of MBSR, which involves live videoconferencing. Because apps are asynchronous, it is possible that they will be inferior to programs with synchronous, human interactions; this would be consistent with a meta-analysis finding that online MBIs are not equally effective as traditional face-to-face MBIs in reducing depression and anxiety. 71 Conclusions We found that in our in-person trial, MBSR was noninferior to escitalopram for the treatment of anxiety disorders. This finding has broad public health relevance, as findings provide support for clinicians to recommend MBSR as a treatment option for adults with anxiety disorders, and for insurers and health care systems to consider MBSR as a reimbursable clinical intervention. We also compared in-person MBSR with online MBSR in a nonrandomly assigned sample. Although the in-person MBSR had a stronger effect, online MBSR was noninferior after we adjusted for baseline severity of symptoms. 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Contemp Clin Trials. 2020;91:105965. doi:10.1016/j.cct.2020.105965 [ PubMed : 32087339 ] [ CrossRef ] •. Hoge, EA, Bui E, Mete M, Dutton MA, Baker AW, Simon NM. Mindfulness-based stress reduction vs escitalopram for the treatment of adults with anxiety disorders: a randomized clinical trial. JAMA Psychiatry. 2023;80(1):13-21. doi:10.1001/jamapsychiatry.2022.3679 [ PMC free article : PMC9647561 ] [ PubMed : 36350591 ] [ CrossRef ] Acknowledgment Research reported in this report was funded through a Patient-Centered Outcomes Research Institute® (PCORI®) Award (CER-2017C1-6522). Further information available at: https://www.pcori.org/research-results/2017/comparing-meditation-versus-medicine-patients-anxiety-disorders#project_study_registation_information Original Project Title: Comparative Effectiveness of Mindfulness-Based Stress Reduction and Pharmacotherapy for Anxiety PCORI ID: CER-2017C1-6522 ClinicalTrials.gov ID: NCT03522844 Suggested citation: Hoge E, Bui E, Mete M, Dutton MA, Baker AW, Simon NM. (2023). Comparing Meditation versus Medicine for Patients with Anxiety Disorders . Patient-Centered Outcomes Research Institute (PCORI). https://doi.org/10.25302/12.2023.CER.2017C16522 Disclaimer The [views, statements, opinions] presented in this report are solely the responsibility of the author(s) and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute® (PCORI®), its Board of Governors or Methodology Committee. Copyright © 2023. Georgetown University. All Rights Reserved. This book is distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License which permits noncommercial use and distribution provided the original author(s) and source are credited. (See https://creativecommons.org/licenses/by-nc-nd/4.0/ Bookshelf ID: NBK619815 PMID: 41433683 DOI: 10.25302/12.2023.CER.2017C16522 Share Views PubReader Print View Cite this Page Hoge E, Bui E, Mete M, et al. Comparing Meditation versus Medicine for Patients with Anxiety Disorders [Internet]. Washington (DC): Patient-Centered Outcomes Research Institute (PCORI); 2023 Dec. doi: 10.25302/12.2023.CER.2017C16522 PDF version of this title (903K) In this Page Background Participation of Patients and Other Stakeholders Aim 1: Comparison of In-Person MBSR and Escitalopram Aim 2, Comparison of In-Person MBSR and Online-Delivered MBSR, and Aim 3, Comparison Of Online-Delivered MBSR and Online-Delivered Escitalopram Discussion Conclusions References Related Publications Acknowledgment Other titles in this collection PCORI Final Research Reports Related information NLM Catalog Related NLM Catalog Entries PMC PubMed Central citations PubMed Links to PubMed Recent Activity Clear Turn Off Turn On Comparing Meditation versus Medicine for Patients with Anxiety Disorders Comparing Meditation versus Medicine for Patients with Anxiety Disorders Your browsing activity is empty. Activity recording is turned off. Turn recording back on See more... 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