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
Reduction in anxiety levels as assessed with clinical global impression of severity scale
1.35 points
1.43 points
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 reduction in anxiety levels 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 reduction in anxiety levels 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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