RELAX – REducing Levels of AnXiety - in pregnancy and after birth
Research type
Research Study
Full title
A randomised controlled trial of a web-based early intervention (RELAX) targeting repetitive negative thinking (RNT) in pregnant women: an evaluation of its impact on perinatal anxiety and the mechanism of change.
IRAS ID
307468
Contact name
Colette Hirsch
Contact email
Sponsor organisation
King’s College London
ISRCTN Number
ISRCTN12754931
Duration of Study in the UK
2 years, 2 months, 31 days
Research summary
Many women feel anxious during, and in the months following, their pregnancy. This anxiety can sometimes become sustained and extreme, and negatively impact their infant, other children, and partner.
Repetitive negative thinking (RNT) such as worry and rumination 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 address pregnant women’s daily concerns. LENS effectively trains people with high RNT to interpret uncertain/ambiguous information in realistic and more positive ways (Hirsch et al., 2018, 2020).
This RCT will test whether pregnant women with high RNT, who complete a web-based early intervention for perinatal anxiety (REducing Levels of AnXiety, RELAX) alongside usual care, experience less anxiety during pregnancy and after birth relative to those who only receive usual care.
All participants will receive usual care. Participants in the intervention condition will also complete RELAX, comprising 12 web-based training sessions, over 4 weeks. Participants listen to short, ambiguous scenarios that can be interpreted in both negative and positive ways. The scenarios are either resolved positively by the platform or participants must resolve the scenario positively themselves. Participants then imagine themselves in each positive outcome. Sessions will be completed at home, online on a computer, laptop or tablet.
Participants will complete questionnaire-based assessments at baseline (T0;16-28 weeks gestation), and 4-weeks (T1;20-32 weeks gestation), 8-weeks (T2;24-36 weeks gestation), and 36-weeks (T3;12-24 weeks post-birth) post-randomisation.
Participants will be recruited from NHS sites, including Guy’s and St Thomas’ and King’s College Hospital. Participants will also be recruited via non-NHS routes through King’s College London (e.g., social media, community pregnancy groups, charities and organisations (e.g., PaNDAS), online pregnancy forums etc.). The NIHR is funding the trial.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
22/WM/0273
Date of REC Opinion
19 Dec 2022
REC opinion
Favourable Opinion