Mindfulness is often sold as a vague good. One of the more rigorous tests of it was narrow and specific: an eight-week class, head to head with a first-line prescription drug, in adults diagnosed with an anxiety disorder. The course came out roughly level with the medication on the main measure, with far fewer side effects.

The trial

The study, called TAME, was published in JAMA Psychiatry in November 2022 by Elizabeth Hoge and colleagues. It ran at three academic medical centers in Washington, New York and Boston between June 2018 and February 2020, and it was funded by the Patient-Centered Outcomes Research Institute, a federally created nonprofit that had no role in the analysis.

Researchers randomly assigned 276 adults aged 18 to 75 to one of two treatments. Each person had a primary diagnosis of generalized anxiety disorder, social anxiety disorder, panic disorder or agoraphobia. Half went into Mindfulness-Based Stress Reduction, usually shortened to MBSR. The other half took escitalopram, a widely prescribed antidepressant in the SSRI family that is approved for anxiety, starting at 10 mg a day and rising to 20 mg at week two if tolerated.

What the mindfulness group actually did

MBSR is a manualized program, so every class follows the same plan. Participants attended a 2.5-hour group class once a week for eight weeks, plus one full-day retreat in week five or six, and were asked to practice at home for about 45 minutes a day. The practices are the standard ones: guided body scans, sitting meditation that returns attention to the breath, and gentle movement. By the authors' count that is roughly 27 hours of class time, before any home practice.

The result

The main outcome was a clinician rating of anxiety severity called the Clinical Global Impression of Severity, scored by assessors who did not know which treatment each person had received. The trial was designed to test noninferiority: whether MBSR was not meaningfully worse than the drug.

After eight weeks, among the 208 people who completed treatment as planned, severity scores had fallen by about 1.35 points in the MBSR group and 1.43 points in the escitalopram group. Both groups ended at the same average score. The small gap fell well inside the margin set in advance, so the authors concluded MBSR was noninferior. A second analysis that included everyone randomized reached the same conclusion, and there were no meaningful differences at 12 or 24 weeks.

Side effects told a different story

Neither group had a serious adverse event. But 78.6 percent of people on escitalopram reported at least one study-related side effect, most often trouble sleeping, nausea and fatigue, compared with 15.4 percent of those in MBSR. Ten people stopped the drug because of side effects; nobody left the course for that reason. The most common complaint in the MBSR group, reported by about one in ten, was a temporary increase in anxiety.

What the trial does not show

The authors list the limits plainly. The two treatments were not matched for time and attention: the class group spent many more hours in contact with instructors and each other, which may have helped on its own. Participants and instructors knew which arm they were in; only the raters were blinded. Enrollment stopped at 276 rather than the planned 368 when the pandemic shut down in-person recruiting. The sample was about three quarters women, mostly white and highly educated, and drawn from three big-city academic centers, so it may not reflect everyone with anxiety.

It is also one trial. It shows that a structured, time-heavy course performed similarly to one drug at one dose range over eight weeks. It does not show that a meditation app, a five-minute breathing break or an unstructured practice would do the same, and it does not show that anyone already taking medication should stop.

Where it fits

Earlier research on mindfulness programs is mixed in quality, with many small or unblinded studies. TAME stands out because it was randomized, multicenter, used a blinded clinical rating and compared against an active treatment rather than a waiting list. That makes it one of the stronger pieces of evidence that a standardized course can be a reasonable option to discuss for diagnosed anxiety.

If you want to look into it

MBSR courses are taught by certified instructors in person and online, typically over eight weekly sessions. The trial protocol is public on ClinicalTrials.gov under NCT03522844 for anyone who wants the full design. For a diagnosed anxiety disorder, the trial is a useful paper to bring to a clinician when weighing options, including combining approaches.

This article reports research and expert guidance. It is not medical advice. Talk to your clinician before changing medication, treatment or a medical diet.

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