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The RELAX phase 2b, multisite, parallel-group superiority randomized clinical trial included 268 pregnant individuals in the UK at 16–28 weeks' gestation with high repetitive negative thinking (RNT) and up to moderate anxiety (mean age 33.7 years). Participants received RELAX, a pregnancy-tailored cognitive bias modification for interpretation program (twelve 17-minute sessions over 4 weeks), plus usual maternity care, or usual care alone. At the 8-week primary endpoint, anxiety was significantly lower with RELAX (mean GAD-7 difference −1.5; 95% CI −2.4 to −0.6; P = .001). Depression (PHQ-9 −0.8; EPDS −1.1), RNT (−2.7), worry (−3.6) and perinatal anxiety (PASS −5.5) were also lower. At 36 weeks (12–24 weeks after birth), effects were sustained for general anxiety (−1.0), postnatal depression (EPDS −1.3) and RNT (−2.4). Functioning did not differ between groups, and the change in interpretation bias did not mediate the effect on anxiety. The authors concluded that integrating RELAX into maternity care for those at risk of increased anxiety has potential to improve maternal mental health.
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The RELAX phase 2b, multisite, parallel-group superiority randomized clinical trial included 268 pregnant individuals in the UK at 16–28 weeks' gestation with high repetitive negative thinking (RNT) and up to moderate anxiety (mean age 33.7 years). Participants received RELAX, a pregnancy-tailored cognitive bias modification for interpretation program (twelve 17-minute sessions over 4 weeks), plus usual maternity care, or usual care alone. At the 8-week primary endpoint, anxiety was significantly lower with RELAX (mean GAD-7 difference −1.5; 95% CI −2.4 to −0.6; P = .001). Depression (PHQ-9 −0.8; EPDS −1.1), RNT (−2.7), worry (−3.6) and perinatal anxiety (PASS −5.5) were also lower. At 36 weeks (12–24 weeks after birth), effects were sustained for general anxiety (−1.0), postnatal depression (EPDS −1.3) and RNT (−2.4). Functioning did not differ between groups, and the change in interpretation bias did not mediate the effect on anxiety. The authors concluded that integrating RELAX into maternity care for those at risk of increased anxiety has potential to improve maternal mental health.
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