TAME
Trial question
Is mindfulness-based stress reduction noninferior to escitalopram in adults with anxiety disorders?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
75.0% female
25.0% male
N = 208
208 patients (156 female, 52 male)
Inclusion criteria: adult patients with a diagnosed anxiety disorder
Key exclusion criteria: comorbid psychiatric disorder other than anxiety or depression; serious medical condition that may result in surgery/hospitalization; history of head trauma causing loss of consciousness; or ongoing cognitive impairment
Interventions
N=136 mindfulness-based stress reduction (mindfulness meditation group class taught in person for 8 weeks)
N=140 escitalopram (flexibly dosed from 10-20 mg daily PO)
Primary outcome
Anxiety levels reduction as assessed with clinical global impression of severity scale
1.35
1.43
1.4 points
1.1 points
0.7 points
0.4 points
0.0 points
Mindfulness-based stress
reduction
Escitalopram
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in anxiety levels reduction as assessed with clinical global impression of severity scale (1.35 points vs. 1.43 points; AD -0.07 points, 95% CI 0.23 to 0.38)
Safety outcomes
Significant difference in ≥ 1 study-related adverse event (15.4% vs. 78.6%).
Conclusion
In adult patients with a diagnosed anxiety disorder, mindfulness-based stress reduction was noninferior to escitalopram with respect to anxiety levels reduction as assessed with clinical global impression of severity scale.
Reference
Elizabeth A Hoge, Eric Bui, Mihriye Mete et al. Mindfulness-Based Stress Reduction vs Escitalopram for the Treatment of Adults With Anxiety Disorders: A Randomized Clinical Trial. JAMA Psychiatry. 2023 Jan 1;80(1):13-21.
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