Digital intervention trial targets rising anxiety during pregnancy and after birth
A UK randomised clinical trial published in JAMA Network Open in November evaluated a self-led online intervention designed to reduce repetitive negative thinking among pregnant people with up to moderate anxiety. The 268-participant study reported lower anxiety and depressive symptoms with RELAX plus usual care than with usual care alone, while its selected sample and follow-up limit how widely the results can be applied.
What happened
The RELAX (Reducing Levels of Anxiety) phase 2b trial recruited 268 pregnant participants in the UK at 16 to 28 weeks’ gestation. They had high levels of repetitive negative thinking and up to moderate anxiety. Participants were randomly allocated to usual maternity care alone or to usual care plus a pregnancy-tailored, self-guided online programme of 12 sessions over four weeks. The trial assessed anxiety, depression, repetitive negative thinking and functioning before and after birth.
The paper reports that the intervention group had lower anxiety and repetitive negative thinking than the usual-care group across the reported pre- and post-birth assessments, alongside lower depressive symptom scores. The study was designed to test whether the intervention could prevent anxiety from increasing in a group selected for elevated repetitive negative thinking but not high baseline anxiety. It was not a trial of treatment for severe anxiety or a substitute for assessment and clinical care.
The intervention was developed with psychologists, clinicians, researchers and people with lived experience. King’s College London reports that 81.3% of the RELAX group completed at least ten of the twelve sessions. The team is developing an app version and implementation plans, which are separate from evidence that the app itself is effective in routine services.
The primary comparison was anxiety eight weeks after randomisation. On the GAD-7, the mean score was 1.5 points lower in the RELAX group than in usual care (95% confidence interval, 0.6 to 2.4 points lower). Anxiety remained lower at the 36-week assessment, which took place 12 to 24 weeks after birth. Some secondary differences in depression, repetitive negative thinking, worry and perinatal anxiety were present before birth; after birth, fewer of these outcomes remained statistically different.
The trial recruited between June 2023 and July 2024 and included follow-up assessment through April 2025. It tested a specific cognitive-bias modification programme, delivered as twelve sessions of about 17 minutes each over four weeks, rather than generic online counselling. Participants continued usual maternity care in both groups. The researchers did not find a significant difference in work and social functioning at either follow-up, and the proposed interpretation-bias mechanism did not explain the primary anxiety effect at the main endpoint.
The authors identify limits that matter for practice: outcomes were self-reported rather than established through diagnostic interviews, the sample had relatively few participants with lower educational attainment, and people with a history of multiple miscarriages or stillbirth were excluded. These factors constrain generalisability. The findings support further evaluation of RELAX alongside maternity care, but do not establish how it would perform when offered across a broader population or outside the study’s supported setting.
The measured differences should also be read against the participants’ baseline and the care they received. This was a prevention-focused trial among people with high repetitive negative thinking and up to moderate anxiety, not a treatment study for severe anxiety disorders. A digital programme may make structured support easier to access, but it cannot by itself resolve barriers such as language, connectivity, safety, time or the need for more intensive treatment. Any implementation should retain routes to clinician-led assessment and care.
Why it matters
The trial tests a preventive approach focused on a cognitive process associated with anxiety, delivered alongside existing maternity care. If further evaluated, a brief online option might help services reach people who do not have a diagnosed anxiety disorder or who are not receiving specialist psychological support. Its integration would still need clinical oversight, accessible alternatives and referral pathways for people whose symptoms are severe or worsening.
The results apply most directly to the trial’s specific UK sample and eligibility criteria. It was a phase 2b study with 268 participants; the findings do not establish population-wide effectiveness, long-term benefit, or equal access and acceptability across different languages, health systems and levels of digital access. The intervention should be understood as an addition to usual care, as tested, rather than a replacement for it.