Title {1} | RELAX – REducing Levels of AnXiety—in pregnancy and after birth. A study to see if a new online training (RELAX) can reduce anxiety in pregnant women and new mothers |
Trial registration {2a and 2b}. | ISRCTN 12754931. Registered 25th May 2023. |
Protocol version {3} | The current protocol version is 1.9, dated 18.01.2024 |
Funding {4} | This study is funded by the NIHR Efficacy and Mechanism Evaluation Programme (NIHR131161), an MRC and NIHR partnership. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. |
Author details {5a} |
SPIRIT guidance: Affiliations of protocol contributors. 1 Institute of Psychiatry, Psychology and Neuroscience, King’s College London, De Crespigny Park, London UK 2 Guy’s and St Thomas’ NHS Foundation Trust, c/o Department of Women’s and Children’s Health, 10th Floor, North Wing, St Thomas’ Hospital, Lambeth Palace Road, London UK 3 Department of Biostatistics & Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, De Crespigny Park, London UK 4 King’s College Hospital NHS Foundation Trust, Denmark Hill, London UK 5 Epsom and St Helier University Hospitals NHS Trust, Wrythe Lane, London UK 6 Mid Cheshire Hospitals NHS Foundation Trust, c/o Leighton Hospital, Middlewich Road, Crewe UK 7 South London and Maudsley NHS Foundation Trust, Maudsley Hospital, Denmark Hill, London UK 8 Warwick Clinical Trials Unit, Warwick Medical School, Warwick UK 9 Black Dog Institute, Randwick, Australia 10 School of Psychology, Faculty of Science, UNSW Sydney, Kensington, Australia |
Name and contact information for the trial sponsor {5b} |
Lead sponsor: King’s College London, 16 De Crespigny Park, London, SE5 8AF Co-sponsor: Guy’s & St Thomas’ NHS Foundation Trust, R&D Department, 16th Floor, Tower Wing, Great Maze Pond, London, SE1 9RT |
Role of sponsor {5c} | Study sponsors approved the study protocol. The funder (NIHR) will approve the main trial paper prior to submission. |