Pregnant women or birthing people with undiagnosed anxiety could benefit from a new digital therapy, according to a clinical trial led by King's College London.
Published in JAMA Network Open, the results from the REducing Levels of AnXiety (RELAX) study have shown that a self-led digital therapy significantly reduced participants' pre-and post-birth anxiety compared to participants who received usual care. The study was funded by the National Institute for Health and Care Research (NIHR) and delivered through the NIHR Biomedical Research Centre: Maudsley.
The trial also found that, compared to usual care, the RELAX digital therapy lowered levels of depression before and after birth, as well as levels of repetitive negative thinking (RNT) - a risk factor and symptom that is central to anxiety and that the therapy targeted.
Building on previous research which has shown that this digital therapy approach can be effective in helping those with high levels of anxiety, this was the first time this approach has been trialled in preventing low levels of anxiety escalating.
Anxiety disorders affect 1 in 5 pregnant women or birthing people. Research has shown that this perinatal anxiety increases during pregnancy and can have adverse consequences such as increased likelihood of preterm birth, lower birth weight, reduced maternal responsiveness to infants and risk of children developing psychological disorders.
Lead researcher on the study, Professor Colette Hirsch, Professor in Cognitive Clinical Psychology, King's College London and Deputy Theme Lead for Digital Therapies at NIHR BRC: Maudsley said: "We know there is a large unmet need amongst those women who experience anxiety before and after birth, but who do not have a diagnosis and who often do not receive mental healthcare support. If left untreated, this anxiety can lead to further challenges for parent and child.
"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. This is the first study to show that a digital therapy addressing this type of thinking prevents the increase of anxiety during pregnancy. Integrating RELAX into maternity care for those with, or at risk of increasing anxiety has the potential to improve maternal mental health and by taking a digital approach we can reach a large number of people."
REducing Levels of AnXiety (RELAX) is a multi-session online intervention co-created by psychologists, researchers, clinicians and people with lived and professional experience of perinatal anxiety.
One study participant who received the RELAX training said: "I found that's had quite a big impact on me actually…I'm finding that I'm coping much better with the worries that I am having...So, for example, we went for our 20-week scan… I was actually quite excited about the scan. And previously, scans have been a real trigger for me."
The randomized clinical trial (RCT) aimed to test whether adding RELAX to usual care prevents anxiety increasing during pregnancy and after birth for people with high repetitive negative thinking and up to moderate anxiety, compared to usual care alone. Usual care involves maternity services monitoring, potentially contact from a health visitor, and/or being offered information on self-referral to psychological services.
There were 268 participants in total and 134 were allocated to the group who received RELAX training which consisted of 12 brief online RELAX sessions completed on a laptop, or tablet over four weeks and they also continued usual care. Each session involved listening to 30 scenarios. Scenarios targeted worry and rumination and provided examples of everyday ambiguous situations that could be interpreted in either a positive/neutral or negative manner. Scenarios were either pregnancy-related or based on common everyday situations which pregnant women would encounter. The intervention trained them to generate more positive interpretations, in keeping with people who do not suffer from anxiety or repetitive negative thinking.
Study participants were 16 – 28 'weeks' gestation, over 18 and had reported high traits of repetitive negative thinking and up to moderate levels of anxiety. They were only accepted for the study if they had no current psychiatric diagnosis or risk of suicide. They were recruited from maternity services or the community and completed screening questionnaires on the study website and were then assessed through screening calls with the study team and measuring anxiety using the Generalised Anxiety Disorder-7(GAD-7) score. People were then randomly allocated to the RELAX sessions plus usual care or to assessments plus usual care only.
81.3% of the participants in the RELAX + usual care group completed at least 10 of the 12 sessions. The majority of participants were positive about their experience of using RELAX and said they would recommend using it to others.
Professor Hirsch added: "Pregnancy can be such a cherished and critical time, but it is also a time when everyday situations can cause worry and anxiety. As a digital therapy that can be used by pregnant and birthing people in their own homes, RELAX has the potential to prevent this anxiety escalating when it is still manageable, aligning with many of aspects of the NHS 10-year plan and providing much-needed support to this group."
Following stakeholder and user feedback, RELAX is now being developed into an app called LENS4Pregnancy. The study team is working with people with lived experience of anxiety, during and after pregnancy, clinicians and policymakers, charities and health service providers to develop implementation plans.
The RELAX study was funded by the Efficacy and Mechanism Award, a UKRI Medical Research Council (MRC) and National Institute for Health and Care Research (NIHR) partnership and delivered through the NIHR Biomedical Research Centre: Maudsley.
