HMHB
Trial question
What is the role of early prenatal CBT in pregnant women with mild anxiety?
Study design
Single center
Single blinded
RCT
Population
755 female patients.
Inclusion criteria: women who were ≤ 22 weeks pregnant and had at least mild anxiety without clinical depression.
Key exclusion criteria: current major depressive episode or life-threatening health conditions; significant learning disability; psychiatric disorder; medical disorders or severe maternal morbidity requiring inpatient management.
Interventions
N=380 prenatal CBT (Happy Mother-Healthy Baby program: individual-based CBT with 6 core and up to 6 booster sessions).
N=375 enhanced usual care (additional training of hospital staff in mental health treatment and counseling).
Primary outcome
Major depression, generalized anxiety disorder, or both, at 6 weeks postpartum
9.5%
29.7%
29.7 %
22.3 %
14.8 %
7.4 %
0.0 %
Prenatal cognitive behavioral
therapy
Enhanced usual
care
Significant
decrease ▼
NNT = 4
Significant decrease in major depression, generalized anxiety disorder, or both, at 6 weeks postpartum (9.5% vs. 29.7%; OR 0.19, 95% CI 0.14 to 0.28).
Secondary outcomes
Significant decrease in major depressive episode at 6 weeks postpartum (12% vs. 41%; OR 0.19, 95% CI 0.13 to 0.28).
Significant decrease in moderate-to-severe anxiety at 6 weeks postpartum (9% vs. 27%; OR 0.26, 95% CI 0.17 to 0.4).
Safety outcomes
No significant difference in serious adverse event.
Conclusion
In women who were ≤ 22 weeks pregnant and had at least mild anxiety without clinical depression, prenatal CBT was superior to enhanced usual care with respect to major depression, generalized anxiety disorder, or both, at 6 weeks postpartum.
Reference
Pamela J Surkan, Abid Malik, Jamie Perin et al. Anxiety-focused cognitive behavioral therapy delivered by non-specialists to prevent postnatal depression: a randomized, phase 3 trial. Nat Med. 2024 Mar;30(3):675-682.
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