A London-led clinical trial has found that a self-guided digital programme, offered alongside usual maternity care, reduced average anxiety scores among a selected group of pregnant participants compared with usual care alone.
The study involved 268 people who had a tendency towards repetitive negative thinking and anxiety levels up to moderate severity. It tested a programme called RELAX, which is designed to help users consider more positive or neutral interpretations of uncertain situations.
Researchers led by King’s College London randomly assigned half the participants to use the programme as well as receive usual care. The other half received usual care without the training. The results suggest a possible way to support some people at risk of worsening anxiety, but do not establish that the intervention will work for everyone.
What the trial found
At the main assessment, eight weeks after participants were assigned to a group, those offered RELAX had anxiety scores that were on average 1.5 points lower than those receiving usual care alone. The researchers used a seven-item questionnaire measuring general anxiety symptoms. The 95% confidence interval for the difference ranged from 0.6 to 2.4 points lower.
The scores were based on participants’ own reports, not diagnostic interviews. Anxiety scores also fell in the usual-care group, although by less than in the group offered the training.
At a later assessment, 36 weeks after allocation and after participants had given birth, general anxiety scores remained lower in the RELAX group. Scores were also lower on a measure of postnatal depression symptoms and on a measure of repetitive negative thinking.
Not every measure showed a lasting difference. At the later assessment, the researchers found no statistically significant difference between the groups on a separate measure of perinatal anxiety or on a general depression questionnaire. They also found no significant difference in work and social functioning at either the eight- or 36-week assessments.
An additional analysis, conducted after the study was designed, looked at a meaningful worsening in anxiety scores by eight weeks. The researchers reported this in 11 of 134 participants in the usual-care group and two of 134 in the group offered RELAX. The numbers were small, so that finding needs cautious interpretation.
How the training worked
Those assigned to RELAX were offered 12 online sessions over four weeks, using a computer, laptop or tablet. Each session involved listening to 30 scenarios, some related to pregnancy and others to everyday life. The exercises presented situations that could be interpreted in different ways and encouraged participants to consider more positive or neutral outcomes.
The intervention was developed with input from psychologists, clinicians, researchers and people with lived experience of perinatal anxiety. Of the 134 people assigned to receive it, 109 completed at least 10 sessions.
Everyone in the trial continued with usual care. This could include maternity monitoring, contact with a health visitor and information about referring themselves for psychological support. Some participants were already receiving psychological treatment or medication when the study began.
People were recruited through NHS maternity services and community routes, including through London hospital trusts. They were aged 18 or over and between 16 and 28 weeks pregnant at enrolment.
Who was studied
The trial was designed to test whether anxiety could be reduced in people considered at risk, rather than to assess treatment for everyone with a mental health condition. Screening excluded people with high anxiety scores, symptoms consistent with a current common psychiatric diagnosis or a current risk of suicide. It also excluded people with a history of stillbirth, neonatal death or multiple miscarriages.
Those criteria matter when interpreting the findings. The researchers said the results may not apply to groups excluded from the trial. They also noted that the sample included relatively few people with lower levels of educational attainment: most participants had a degree or higher qualification.
The research team is developing the programme into an app, LENS4Pregnancy, and working with people with lived experience, clinicians and others on plans for possible implementation. That does not mean the app is already part of routine maternity care.
Anyone concerned about their mental health during pregnancy can speak to their maternity team or GP. After birth, a GP, midwife or health visitor can also discuss concerns and the support available.
Featured image: AI-generated illustration.
