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

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 Summary of Research 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? 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. 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). 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). 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. 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. 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. 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. 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. 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. 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. 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. 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).