Adapting and testing a brief intervention to reduce maternal anxiety during pregnancy (ACORN): study protocol for a randomised controlled trial
© 2016 Wilkinson et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. This is the final version of the article. Available from Biomed Central via the DOI in this record.
Background: National guidelines in the UK, United States of America, Canada, and Australia have recently stressed the importance of identifying and treating antenatal anxiety and depression. However, there is little research into the most effective and acceptable ways of helping women manage their symptoms of anxiety and stress during pregnancy. Research indicates the necessity to consider the unique needs and concerns of perinatal populations to ensure treatment engagement, highlighting the need to develop specialised treatments which could be integrated within routine antenatal healthcare services. This trial aims to develop a brief intervention for antenatal anxiety, with a focus on embedding the delivery of the treatment within routine antenatal care. Methods/Design: This study is a two-phase feasibility trial. In phase 1 we will develop and pilot a brief intervention for antenatal anxiety, blended with group support, to be led by midwives. This intervention will draw on cognitive behavioural principles and wider learning from existing interventions that have been used to reduce anxiety in expectant mothers. The intervention will then be tested in a pilot randomised controlled trial in phase 2. The following outcomes will be assessed: (1) number of participants meeting eligibility criteria, (2) number of participants consenting to the study, (3) number of participants randomised, (4) number of sessions completed by those in the intervention arm, and (5) number of participants completing the post-intervention outcome measures. Secondary outcomes comprise: detailed feedback on acceptability, which will guide further development of the intervention; and outcome data on symptoms of maternal and paternal anxiety and depression, maternal quality of life, quality of couple relationship, mother-child bonding, infant temperament and infant sleep. Discussion: The study will provide important data to inform the design of a future full-scale randomised controlled trial of a brief intervention for anxiety during pregnancy. This will include information on its acceptability and feasibility regarding implementation within current antenatal services, which will inform whether ultimately this provision could be rolled out widely in healthcare settings. Trial registration: Current Controlled Trials ISRCTN95282830. Registered on 29 October 2014.
This paper presents independent research funded by the National Institute for Health Research (NIHR), Research for Patient Benefit (RfPB) programme (Grant Reference Number PB-PG-1112-29054). This study is sponsored by Central and North West London NHS Foundation Trust (www.cnwl.nhs.uk). The sponsor and funding body did not have any role in the design of the study, in the writing of the manuscript, or in the decision to submit the manuscript for publication and will not contribute to the collection, analysis, and interpretation of data. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. The study is being supported by the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) for North West London. The authors would also like to thank the Mental Health Clinical Research Network for all their support with recruitment, providing clinical support officers when necessary
Vol. 17, Article no. 156