A self-led digital therapy called RELAX has successfully prevented low levels of anxiety from escalating in pregnant people, according to a clinical trial led by King’s College London and published in JAMA Network Open. Tested on 268 participants experiencing high repetitive negative thinking, the four-week online intervention significantly reduced pre- and post-natal anxiety, depression, and worry compared to usual maternity care alone.
Digital Therapy Reduces Prenatal Anxiety and Depression
- What was tested: A 12-session web-based program called RELAX designed to help pregnant individuals reframe ambiguous everyday scenarios away from negative outcomes.
- The core finding: Participants receiving the digital therapy alongside standard care showed significantly lower rates of anxiety, depression, and repetitive negative thinking before and after birth, with control participants facing almost six times the chances of clinical deterioration.
- Clinical accessibility: The intervention is being developed as a mobile application called LENS4Pregnancy for broader integration into public health maternity pathways.
Study Targets Sub-Clinical Anxiety During Pregnancy
Perinatal anxiety affects approximately one in five pregnant women or birthing people, carrying well-documented risks such as preterm birth, lower infant birth weight, and impaired maternal responsiveness. Despite these high stakes, many individuals experiencing sub-clinical anxiety do not receive a formal diagnosis or targeted mental healthcare support. To address this gap, researchers designed a randomized clinical trial involving 268 participants aged 18 and older who were between 16 and 28 weeks gestation, reporting high traits of repetitive negative thinking and mild-to-moderate anxiety, but possessing no current psychiatric diagnosis or suicide risk.
Participants were divided evenly, with 134 individuals allocated to receive the RELAX training alongside usual maternity care, while the control group received usual care alone, which typically encompasses routine midwifery monitoring, potential contact from a health visitor, or self-referral routes to psychological services. The intervention itself consisted of 12 brief online sessions completed on a laptop or tablet over a four-week span. Each session required participants to listen to 30 ambiguous scenarios—some pregnancy-related and others drawn from common daily situations—and practice generating more positive or neutral interpretations.
Adherence to the digital therapy was notably high, with 81.3% of participants in the RELAX group completing at least 10 of the 12 prescribed sessions. The beneficial effects on anxiety, depression, and repetitive negative thinking were sustained when measured again 12 to 24 weeks postpartum. Participants who were offered usual care alone faced almost six times the chances of clinical anxiety deterioration compared to those who received the RELAX training.
| Trial Parameter | RELAX + Usual Care Group | Usual Care Only Group |
|---|---|---|
| Total Participants (N) | 134 | 134 |
| Gestation Age at Baseline | 16 – 28 weeks | 16 – 28 weeks |
| Intervention Adherence (≥10 sessions) | 81.3% | N/A (Control) |
| Primary Clinical Endpoint | Significantly reduced pre- and post-natal anxiety and repetitive negative thinking | Higher rates of anxiety escalation and clinical deterioration |
Targeting Repetitive Negative Thinking in Perinatal Care
Colette Hirsch, Professor in Cognitive Clinical Psychology at King’s College London and Deputy Theme Lead for Digital Therapies at the National Institute for Health and Care Research (NIHR) Biomedical Research Centre: Maudsley, explained the clinical rationale behind the approach. “Our digital therapy aims to address the symptom of repetitive negative thinking where people constantly consider the negative outcome of situations, and which has been shown to predict and maintain anxiety,” Hirsch stated, emphasizing that delivering the tool digitally allows health systems to reach a vast demographic of unsupported individuals.
The study was funded by the Efficacy and Mechanism Award—a partnership between the UKRI Medical Research Council (MRC) and the NIHR—and delivered through the NIHR Biomedical Research Centre at Maudsley. Building directly on the trial findings, the research team is actively collaborating with patients possessing lived experience of perinatal anxiety, clinicians, policymakers, and healthcare charities to translate the web platform into an accessible mobile application named LENS4Pregnancy.
Trial Excludes Patients with Severe Psychiatric Diagnoses
Patients presenting with severe clinical depression, active anxiety disorders, suicidal ideation, or existing psychiatric diagnoses were explicitly excluded from this trial’s safety criteria.
References
- Hirsch, C. R., et al. (2026). RELAX Perinatal Digital Intervention to Prevent Increasing Anxiety: A Randomized Clinical Trial. JAMA Network Open. DOI: 10.1001/jamanetworkopen.2026.40518
- National Institute for Health and Care Research (NIHR). Biomedical Research Centre: Maudsley. King’s College London Research Findings.
