Digital Intervention Reduces Perinatal Anxiety During Pregnancy and Postpartum
Key Clinical Summary:
- A phase 2b randomized clinical trial involving 268 pregnant individuals in the United Kingdom found that the self-led Reducing Levels of Anxiety (RELAX) digital intervention significantly reduced anxiety compared with usual maternity care.
- At 8 weeks, participants receiving RELAX had lower anxiety scores on the 7-item Generalized Anxiety Disorder scale (GAD-7; mean difference, −1.5; 95% CI, −2.4 to −0.6; P = .001).
- Improvements in general anxiety, postnatal depression, and repetitive negative thinking (RNT) persisted at postpartum follow-up, although functional outcomes did not significantly differ between groups.
A self-led digital intervention targeting RNT significantly reduced anxiety during pregnancy and after childbirth among individuals at risk of escalating anxiety, according to findings published in JAMA Network Open. The UK-based RELAX randomized clinical trial found that participants receiving the intervention alongside usual maternity care experienced greater improvements in anxiety than those receiving usual care alone.
Study Findings
The RELAX phase 2b, multisite randomized clinical trial included 268 pregnant individuals between 16 and 28 weeks' gestation who reported high RNT and up to moderate anxiety. Participants were recruited through antenatal clinics or self-referral between June 2023 and July 2024.
Participants were randomized to usual maternity care alone or usual care plus RELAX, a pregnancy-tailored digital intervention using cognitive bias modification for interpretation. The self-led program consisted of twelve 17-minute sessions completed over 4 weeks.
Investigators assessed outcomes at baseline and 4, 8, and 36 weeks after randomization, with the final assessment occurring 12 to 24 weeks after childbirth. The primary outcome was anxiety severity at 8 weeks, measured using the GAD-7.
At 8 weeks, participants receiving RELAX had significantly lower anxiety scores than those receiving usual care alone (mean difference, −1.5; 95% CI, −2.4 to −0.6; P = .001).
The intervention group also demonstrated lower depressive symptoms on the Patient Health Questionnaire-9 (mean difference, −0.8; 95% CI, −1.5 to −0.1), RNT (mean difference, −2.7; 95% CI, −4.5 to −0.9), and perinatal anxiety (mean difference, −5.5; 95% CI, −8.2 to −2.8).
At postpartum follow-up, improvements persisted for general anxiety (mean difference, −1.0; 95% CI, −1.9 to −0.1), postnatal depression (mean difference, −1.3; 95% CI, −2.4 to −0.2), and RNT (mean difference, −2.4; 95% CI, −4.6 to −0.2).
Functional outcomes did not significantly differ between groups at either follow-up.
Clinical Implications
The findings suggest that pregnancy-tailored digital cognitive bias modification may help reduce anxiety among pregnant individuals with elevated RNT, a recognized risk factor for anxiety.
The intervention's self-led format, involving approximately 3.4 hours of sessions over 4 weeks, may offer a flexible approach to addressing anxiety during pregnancy. The researchers identified RELAX as a potentially scalable intervention that could be integrated into usual maternity care.
However, benefits were not observed across all outcomes. Although RELAX promoted more positive interpretations, this change did not mediate the reduction in anxiety at 8 weeks. Additionally, functioning did not significantly improve, and differences in perinatal anxiety, general depression, and worry were not sustained at postpartum follow-up.
Expert Commentary
“Given that perinatal anxiety is known to be costly in terms of human suffering and impact on the economy, reducing perinatal anxiety is important,” wrote Colette R. Hirsch, PhD, Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King’s College London, London, United Kingdom, and study coauthors.
“The evaluation, implementation, and delivery of perinatal tailored interventions, such as RELAX, should be a priority for research and clinical practice,” they concluded.
