RELAX (REducing Levels of AnXiety): a study protocol for a parallel two-arm randomised controlled trial evaluating a web-based early intervention for pregnant women with high levels of repetitive negative thinking to prevent escalating anxiety during pregnancy and after birth
Abstract Background Perinatal anxiety is common: up to 40% of pregnant women and new mothers experience high levels of anxiety. Given its prevalence, interventions that are low-intensity, highly accessible and cost-efficient, and target modifiable risk factors for anxiety are needed. Repetitive nega...
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BMC
2024-10-01
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| Online Access: | https://doi.org/10.1186/s13063-024-08516-9 |
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| author | Brittannia Volkmer Yogini Sawjani Mary Newburn Jo Bennett Megan McGovern Laura Bridle Nathalie Towner Laura McCabe Katherine Clark Sophie Webster Alison Hylton-Potts Lucy Mayer Gertrude Senevirante Debra Bick Jill Newby Kimberley Goldsmith Michelle L. Moulds Colette Hirsch |
| author_facet | Brittannia Volkmer Yogini Sawjani Mary Newburn Jo Bennett Megan McGovern Laura Bridle Nathalie Towner Laura McCabe Katherine Clark Sophie Webster Alison Hylton-Potts Lucy Mayer Gertrude Senevirante Debra Bick Jill Newby Kimberley Goldsmith Michelle L. Moulds Colette Hirsch |
| author_sort | Brittannia Volkmer |
| collection | DOAJ |
| description | Abstract Background Perinatal anxiety is common: up to 40% of pregnant women and new mothers experience high levels of anxiety. Given its prevalence, interventions that are low-intensity, highly accessible and cost-efficient, and target modifiable risk factors for anxiety are needed. Repetitive negative thinking (RNT)—such as worrying about ways things will go wrong in the future or ruminating about past negative events—is a risk factor for the development of anxiety. RNT is maintained by the tendency to generate negative interpretations of ambiguous situations. Methods A parallel two-arm randomised controlled trial will assess the efficacy of adding interpretation training (RELAX) to usual maternity care. Participants (N = 268) will be randomised to (i) 12 sessions of online interpretation training (RELAX) plus usual care, or (ii) usual care alone. We will assess anxiety, depression, RNT, and work and social adjustment at baseline, plus 4, 8 and 36 weeks later. Discussion Should the intervention result in lower levels of anxiety than usual care, it could be an accessible, cost-effective way to help women who are vulnerable to experiencing anxiety in the perinatal period. Trial registration ISRCTN 12754931. Registered 25th May 2023, prior to recruitment. |
| format | Article |
| id | doaj-art-185c9d4e0f504c3199b64fe883dcc51e |
| institution | OA Journals |
| issn | 1745-6215 |
| language | English |
| publishDate | 2024-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj-art-185c9d4e0f504c3199b64fe883dcc51e2025-08-20T02:11:49ZengBMCTrials1745-62152024-10-0125111910.1186/s13063-024-08516-9RELAX (REducing Levels of AnXiety): a study protocol for a parallel two-arm randomised controlled trial evaluating a web-based early intervention for pregnant women with high levels of repetitive negative thinking to prevent escalating anxiety during pregnancy and after birthBrittannia Volkmer0Yogini Sawjani1Mary Newburn2Jo Bennett3Megan McGovern4Laura Bridle5Nathalie Towner6Laura McCabe7Katherine Clark8Sophie Webster9Alison Hylton-Potts10Lucy Mayer11Gertrude Senevirante12Debra Bick13Jill Newby14Kimberley Goldsmith15Michelle L. Moulds16Colette Hirsch17Institute of Psychiatry, Psychology and Neuroscience, King’s College LondonInstitute of Psychiatry, Psychology and Neuroscience, King’s College LondonInstitute of Psychiatry, Psychology and Neuroscience, King’s College LondonInstitute of Psychiatry, Psychology and Neuroscience, King’s College LondonDepartment of Biostatistics & Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King’s College LondonKing’s College Hospital NHS Foundation TrustInstitute of Psychiatry, Psychology and Neuroscience, King’s College LondonDepartment of Women’s and Children’s Health, Guy’s and St Thomas’ NHS Foundation Trust, c/o, North Wing, St Thomas’ HospitalKing’s College Hospital NHS Foundation TrustKing’s College Hospital NHS Foundation TrustEpsom and St Helier University Hospitals NHS TrustMid Cheshire Hospitals NHS Foundation Trust, C/O Leighton HospitalSouth London and Maudsley NHS Foundation Trust, Maudsley HospitalWarwick Clinical Trials Unit, Warwick Medical SchoolBlack Dog InstituteDepartment of Biostatistics & Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King’s College LondonSchool of Psychology, Faculty of Science, UNSW SydneyInstitute of Psychiatry, Psychology and Neuroscience, King’s College LondonAbstract Background Perinatal anxiety is common: up to 40% of pregnant women and new mothers experience high levels of anxiety. Given its prevalence, interventions that are low-intensity, highly accessible and cost-efficient, and target modifiable risk factors for anxiety are needed. Repetitive negative thinking (RNT)—such as worrying about ways things will go wrong in the future or ruminating about past negative events—is a risk factor for the development of anxiety. RNT is maintained by the tendency to generate negative interpretations of ambiguous situations. Methods A parallel two-arm randomised controlled trial will assess the efficacy of adding interpretation training (RELAX) to usual maternity care. Participants (N = 268) will be randomised to (i) 12 sessions of online interpretation training (RELAX) plus usual care, or (ii) usual care alone. We will assess anxiety, depression, RNT, and work and social adjustment at baseline, plus 4, 8 and 36 weeks later. Discussion Should the intervention result in lower levels of anxiety than usual care, it could be an accessible, cost-effective way to help women who are vulnerable to experiencing anxiety in the perinatal period. Trial registration ISRCTN 12754931. Registered 25th May 2023, prior to recruitment.https://doi.org/10.1186/s13063-024-08516-9AnxietyRepetitive negative thinking (RNT)Perinatal mental healthDigital therapyCognitive bias modification (CBM)Prevention |
| spellingShingle | Brittannia Volkmer Yogini Sawjani Mary Newburn Jo Bennett Megan McGovern Laura Bridle Nathalie Towner Laura McCabe Katherine Clark Sophie Webster Alison Hylton-Potts Lucy Mayer Gertrude Senevirante Debra Bick Jill Newby Kimberley Goldsmith Michelle L. Moulds Colette Hirsch RELAX (REducing Levels of AnXiety): a study protocol for a parallel two-arm randomised controlled trial evaluating a web-based early intervention for pregnant women with high levels of repetitive negative thinking to prevent escalating anxiety during pregnancy and after birth Trials Anxiety Repetitive negative thinking (RNT) Perinatal mental health Digital therapy Cognitive bias modification (CBM) Prevention |
| title | RELAX (REducing Levels of AnXiety): a study protocol for a parallel two-arm randomised controlled trial evaluating a web-based early intervention for pregnant women with high levels of repetitive negative thinking to prevent escalating anxiety during pregnancy and after birth |
| title_full | RELAX (REducing Levels of AnXiety): a study protocol for a parallel two-arm randomised controlled trial evaluating a web-based early intervention for pregnant women with high levels of repetitive negative thinking to prevent escalating anxiety during pregnancy and after birth |
| title_fullStr | RELAX (REducing Levels of AnXiety): a study protocol for a parallel two-arm randomised controlled trial evaluating a web-based early intervention for pregnant women with high levels of repetitive negative thinking to prevent escalating anxiety during pregnancy and after birth |
| title_full_unstemmed | RELAX (REducing Levels of AnXiety): a study protocol for a parallel two-arm randomised controlled trial evaluating a web-based early intervention for pregnant women with high levels of repetitive negative thinking to prevent escalating anxiety during pregnancy and after birth |
| title_short | RELAX (REducing Levels of AnXiety): a study protocol for a parallel two-arm randomised controlled trial evaluating a web-based early intervention for pregnant women with high levels of repetitive negative thinking to prevent escalating anxiety during pregnancy and after birth |
| title_sort | relax reducing levels of anxiety a study protocol for a parallel two arm randomised controlled trial evaluating a web based early intervention for pregnant women with high levels of repetitive negative thinking to prevent escalating anxiety during pregnancy and after birth |
| topic | Anxiety Repetitive negative thinking (RNT) Perinatal mental health Digital therapy Cognitive bias modification (CBM) Prevention |
| url | https://doi.org/10.1186/s13063-024-08516-9 |
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