Self-Guided Digital Intervention may Reduce Perinatal Anxiety, suggests study
A randomized clinical trial found that the self-led digital intervention RELAX, combined with usual care (UC), significantly reduced anxiety during pregnancy and the postnatal period compared with usual care alone. Integrating RELAX into maternity services for women at risk of escalating anxiety due to repetitive negative thinking (RNT) could offer a scalable, flexible approach to improving maternal mental health. The study was published in the JAMA Network Open by Colette R. and colleagues.
To investigate the effect of pregnancy-targeted cognitive bias modification for interpretation on prevention of anxiety escalation and reduction in depression and repetitive negative thoughts, researchers have carried out the RELAX trial, which is a 2-arm, parallel-group, superiority randomized trial, conducted in the UK antenatal clinics and via self-referral routes between June 2023 and July 2024, with end-of-trial assessments in April 2025.
For this purpose, 268 pregnant women who had high levels of RNT and mild to moderate anxiety at 16 to 28 weeks of gestation were recruited. They were randomized into two groups, with one receiving usual maternity care (UC) and another receiving the digital RELAX intervention plus UC. The intervention comprised 12 self-led online sessions, each lasting 17 minutes, which had to be done over 4 weeks.
Psychological tests were administered at baseline (T0), 4 weeks after randomization (T1), 8 weeks (T2; primary endpoint) and 36 weeks (T3; 12 to 24 weeks after birth). Primary outcome measure was maternal anxiety measured by the 7-item GAD-7 scale at T2, while secondary measures included EPDS, PHQ-9, RTQ-10, PSWQ, PASS, and WSAS.
Key findings:
- Primary and secondary analyses of statistical data among 268 randomized subjects (mean age 33.7 ± 3.9 years; 174 [64.9%] married) revealed significant short-term and prolonged mental health benefits.
- The RELAX plus UC group showed significantly lower anxiety scores than the UC group at the 8-week primary endpoint (T2) (mean GAD-7 difference, −1.5; 95% CI, −2.4 to −0.6; P = 0.001).
- Significant decreases at T2 were found in general depression (mean PHQ-9 difference, −0.8; 95% CI, −1.5 to −0.1), perinatal depression (mean EPDS difference, −1.1; 95% CI, −2.0 to −0.2), repetitive negative thinking (mean RTQ-10 difference, −2.7; 95% CI, −4.5 to −0.9), worry (mean PSWQ difference, −3.6; 95% CI, −5.9 to −1.3), and perinatal anxiety (mean PASS difference, −5.5; 95% CI, −8.2 to −2.8).
- At 36 weeks post randomization (12-24 weeks postpartum), RELAX showed prolonged decreases in general anxiety (mean GAD-7 difference, −1.0; 95% CI, −1.9 to −0.1), postnatal depression (mean EPDS difference, −1.3; 95% CI, −2.4 to −0.2), and repetitive negative thinking (mean RTQ-10 difference, −2.4; 95% CI, −4.6 to −0.2).
- There was no significant difference in functional impairment between groups at T2 (mean WSAS difference, −1.0) or T3 (mean WSAS difference, −0.8).
The randomized trial data from Phase 2b demonstrates that adding pregnancy-specific digital cognitive bias modification to regular pregnancy care can decrease the level of anxiety for pregnant women while maintaining psychological protection after birth. The research findings indicate that self-guided digital tools are an effective and readily available solution for maternal mental health improvement.
Reference:
Hirsch CR, Volkmer B, Sawjani Y, et al. RELAX Perinatal Digital Intervention to Prevent Increasing Anxiety: A Randomized Clinical Trial. JAMA Netw Open. 2026;9(11):e2640518. doi:10.1001/jamanetworkopen.2026.40518
