Title: A randomised controlled trial of a web-based early intervention targeting repetitive negative thinking (RNT) in pregnant women: an evaluation of its impact on perinatal anxiety and the mechanism of change
Funder: Medical Research Council

Abstract: RELAX (REducing Levels of Anxiety) in Pregnancy Study_x000D_ _x000D_ The RELAX study is designed to test whether a particular kind of online training tailored to pregnant women (RELAX) is helpful in reducing anxiety during pregnancy and after birth. It is a randomised controlled trail, which is explained lower down._x000D_ _x000D_ Background_x000D_ _x000D_ Anxiety is common during and after pregnancy and is very distressing for women. It also increases the risk of children later developing psychological problems. There are very few treatments available to prevent this anxiety. Those that do exist require face-to-face contact with professionals; this limits access for women. We need an effective web-based method (intervention) that could prevent anxiety in pregnant women and new mothers._x000D_ _x000D_ One risk factor for anxiety is a tendency to engage in worry about the future or mulling over negative events from the past (repetitive negative thinking; RNT), such as ‘will my baby be healthy?’. Our research shows RNT is maintained by an unhelpful thinking habit of drawing negative conclusions from ambiguous or unclear information ‘my baby won’t be healthy’. We produced a simple, accessible, web-based training to help people stop drawing negative conclusions and instead make realistic, positive ‘my baby will be fine’ interpretations. So far, we know our training helps non-pregnant people with high levels of RNT and those with anxiety disorders, leading to less anxiety 3 months later. _x000D_ _x000D_ Recent work with pregnant women showed a single session of our training increased positive interpretations and reduced RNT in the short-term. Our planned research builds on this to use 10 20-minute sessions over 4 weeks (to support longer-term change). We will find out if RELAX prevents anxiety before and after birth. _x000D_ _x000D_ Research Plan_x000D_ _x000D_ Aim:_x000D_ _x000D_ To test if RELAX our pregnancy-tailored treatment prevents high anxiety during pregnancy and in new mothers._x000D_ _x000D_ Objectives:_x000D_ _x000D_ To conduct a study (a randomised controlled trial) to test:_x000D_ 1) if adding RELAX to usual pregnancy care prevents anxiety in pregnant women and new mothers_x000D_ 2) if the treatment does work, whether it reduces anxiety by changing interpretations _x000D_ _x000D_ Design & Methods:_x000D_ _x000D_ 268 pregnant women, 16-28 weeks pregnant and at risk of developing anxiety due to high levels of RNT, will either be offered (i) usual care plus RELAX, or (ii) usual care only. A computer decides which option a woman is offered (not a researcher or participant), so the 2 groups are similar in all respects. After treatment, any differences in anxiety between the groups are due to the treatment. _x000D_ _x000D_ RELAX sessions involve women listening at home (online) to descriptions of everyday situations that trigger RNT and that can be interpreted in both positive and negative ways. They are guided to make realistic positive interpretations and imagine themselves in that situation. Participants respond to 40 different RNT-related situations per session, with 10 sessions over 4 weeks. We will assess women’s habits of making negative interpretations at the start of the study and 1 month later. We will also measure women’s anxiety levels at the start and 1, 2 (third trimester) and 8 (4th month after birth) months later._x000D_ Patient & Public Involvement_x000D_ _x000D_ We worked with pregnant women and new mums with anxiety to develop the research. We will continue to work closely with them to adapt the stories, making them relevant to pregnant women’s day-to-day concerns and make sure we focus on their needs._x000D_ _x000D_ Impact & Dissemination_x000D_ _x000D_ We will publish our findings, give talks to pregnant women and midwives and, if our treatment works, make it available via the NHS, providing a low-cost, home-based method to prevent anxiety in pregnant women and new mothers.

Lay abstract: A randomised controlled trial of a web-based early intervention targeting repetitive negative thinking (RNT) in pregnant women: an evaluation of its impact on perinatal anxiety and the mechanism of change_x000D_ _x000D_ Summary of Research _x000D_ _x000D_ Research question: Do pregnant women with high levels of repetitive negative thinking (RNT) who receive a pregnancy-tailored intervention targeting RNT (plus usual care) experience less anxiety symptoms relative to those who receive usual care only? _x000D_ Background: Many women feel anxious at times during their pregnancy and in the months following the birth. For some women, this anxiety can become sustained and extreme, and have a negative impact on their infant, other children and partner._x000D_ RNT such as worry (i.e., focusing on multiple possible negative future outcomes) and rumination (i.e., mulling over negative past events) predicts and maintains anxiety. RNT is in turn maintained by a tendency to draw negative conclusions from uncertain/ambiguous information (interpretation bias). _x000D_ _x000D_ Our research will adapt our theory-driven, accessible, web-based intervention (Learning Effective New Strategies; LENS) for RNT to specifically address pregnant women’s day to day worries and concerns (Pregnancy-LENS). LENS effectively trains people with high RNT to interpret uncertain/ambiguous information in realistic and more positive ways (Hirsch et al., 2018, 2020)._x000D_ Aim: To conduct a randomised controlled trial to test whether pregnant women with high levels of RNT who complete an early intervention - Pregnancy-LENS plus usual care - report lower levels of anxiety during pregnancy and after birth relative to pregnant women who receive usual care. _x000D_ _x000D_ Methods: 268 women with high RNT and low to moderate anxiety (on the GAD-7) at between 16 to 28 weeks gestation (identified via NHS maternity services and community organisations or social media) will be randomly allocated to (i) Pregnancy-LENS plus usual care or (ii) usual care alone. _x000D_ _x000D_ Screening will take place on the Pregnancy-LENS platform and it will include measures of RNT (Repetitive Thinking Questionnaire, RTQ; McEvoy et al., 2010), anxiety (GAD-7), current common mental health disorder diagnosis (clinical interview schedule revised; CIS-R) and eligibility questions._x000D_ _x000D_ Study Inclusion criteria are as follows: being pregnant, at or beyond 16 weeks gestation, with high levels of RNT (RTQ>30, given that it is a risk factor for anxiety) and current anxiety up to only a moderate level (GAD-7<15, as this is an early intervention for perinatal anxiety), and having access to the internet and a computer/tablet._x000D_ _x000D_ Participants in both conditions will receive usual care. Usual care typically involves monitoring by maternity services, potentially receiving a continuity model of midwifery care, and/or regular contact with a health visitor and in extreme cases referral to mental health services._x000D_ _x000D_ Participants in the intervention condition will complete Pregnancy-LENS, in addition to receiving usual care. Pregnancy-LENS comprises 10 web-based sessions (of 25 minutes duration) that are completed over 30 days. Participants listen to short, ambiguous scenarios (40 per session) that can be interpreted in both negative and positive ways. For half of the trials the scenarios are resolved in positive way by the platform, and for the other half the participant is required to resolve the scenario positively themselves. Participants then imagine themselves in each positive outcome. _x000D_ _x000D_ We will assess anxiety (primary outcome GAD-7), RNT and depression at T0 baseline (16-28 weeks gestation), T1 1-month and T2 2-months post-randomisation (i.e., pre-birth), and again at T3 8-months post-randomisation (i.e., 12-24 weeks after birth), and assess our hypothesised mechanism of change (interpretation bias) at baseline and 1-month post-randomisation. An embedded pilot study with clear progression criteria confirmed by the Trial Steering Committee (TSC) will assess recruitment and assessment completion rates to ensure completion of the full trial is feasible in the time frame._x000D_ _x000D_ PPI involvement: Women with lived experience of anxiety during the perinatal period have shaped our research focus and plan. We will continue to collaborate extensively with them and convene a PPI group to ensure that we continue to be mindful of issues around equality, diversity and inclusion. Our PPI group will also help us develop materials pertinent to their day to day concerns that trigger anxiety, and provide feedback on adaptations to the intervention and trial plans. _x000D_ _x000D_ Impact & Dissemination: Pregnancy-LENS is an evidence-based, theory-driven, easy to administer, low-cost, accessible intervention. We will develop a sustainable model for dissemination so that following a subsequent effectiveness trial, pregnancy-LENS could easily be scaled-up and made available nationally (without mental health professional involvement) via maternity services, pregnancy support forums and community organisations. Our findings will be disseminated to maternity services, support organisations and community organisations (e.g., via Maternal Voices Partnership (MVP).

Research activity codes: 5.6 PSYCHOLOGICAL AND BEHAVIOURAL;6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH;REPRODUCTIVE HEALTH AND CHILDBIRTH