RELAX Perinatal Digital Intervention to Prevent Increasing Anxiety: A Randomized Clinical Trial.
Colette R Hirsch, Brittannia Volkmer, Yogini Sawjani et al.
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In 30 seconds
This multisite, phase 2b randomized clinical trial tested whether a self-led, pregnancy-tailored digital cognitive bias modification intervention added to usual maternity care could prevent rising anxiety in pregnant participants with high repetitive negative thinking and up to moderate anxiety. Among 268 participants recruited in the UK at 16 to 28 weeks’ gestation, RELAX involved twelve 17-minute sessions over 4 weeks. At 8 weeks, anxiety was lower with RELAX plus usual care than with usual care alone (mean GAD-7 difference, -1.5; 95% CI, -2.4 to -0.6; P = .001); lower anxiety was also reported postnatally.
Key findings
- At 8 weeks, the mean GAD-7 difference was -1.5 (95% CI, -2.4 to -0.6; P = .001) for RELAX plus usual care versus usual care.
- At 8 weeks, depression, repetitive negative thinking, worry, and perinatal anxiety scores were significantly lower with RELAX plus usual care.
- Postnatally, lower general anxiety (mean GAD-7 difference, -1.0; 95% CI, -1.9 to -0.1), postnatal depression, and repetitive negative thinking were sustained.
- Functioning did not differ between groups at 8 weeks or postnatally; interpretation bias improved but did not mediate the anxiety effect.
Why it matters
Anxiety and repetitive negative thinking are relevant concerns during pregnancy and after birth. This trial suggests a brief, self-led digital intervention added to maternity care may reduce anxiety during pregnancy, with some effects persisting postnatally. The findings also distinguish symptom improvement from functional change: measured functioning did not differ between groups, and the proposed interpretation-bias mechanism did not explain the anxiety effect.
What to keep in mind
The trial enrolled participants with high repetitive negative thinking and up to moderate anxiety, so findings may not generalize to all pregnant people or those with more severe anxiety. Functioning did not improve, and the proposed mechanism did not mediate the anxiety effect.