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1. Do Adolescents Like School-Based Mindfulness Training? Predictors of Mindfulness Practice and Responsiveness in the MYRIAD Trial

Author

Ahmed, Saz, Allwood, Matt, Ball, Susan, Bennett, Marc, Blakemore, Sarah-Jayne, Casey, Triona, De Wilde, Katherine, Dunning, Darren, Farley, Eleanor-Rose, Fletcher, Katie, Foulkes, Lucy, Ganguli, Poushali, Griffin, Cait, Griffiths, Kirsty, Jones, Ben, Kappelmann, Nils, Komninidou, Konstantina, Knight, Rachel, Laws, Suzannah, Leung, Jovita, Medlicott, Emma, Nuthall, Elizabeth, Parker, Jenna, Phillips, Alice, Raja, Anam, Palmer, Lucy, Petit, Ariane, Pi-Sunyer, Blanca Piera, Pryor-Nitsch, Isobel, Radley, Lucy, Sakhardande, J. Ashok, Shackleford, Jem, Sonley, Anna, Taylor, Laura, Tickell, Alice, Vainre, Maris, Viner, Russell M., Wainman, Brian, Warriner, Lucy, Montero-Marin, Jesus, Hinze, Verena, Crane, Catherine, Dalrymple, Nicola, Kempnich, Maria E.J., Lord, Liz, Slaghekke, Yasmijn, Tudor, Kate, Byford, Sarah, Dalgleish, Tim, Ford, Tamsin J., Greenberg, Mark T., Ukoumunne, Obioha C., Williams, J. Mark G., and Kuyken, Willem

Published
2023
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2. The Role of Schools in Early Adolescents’ Mental Health: Findings From the MYRIAD Study

Author

Ahmed, Saz, Ball, Susan, Bennett, Marc, Dalrymple, Nicola, Dunning, Darren, Fletcher, Katie, Foulkes, Lucy, Ganguli, Poushali, Griffin, Cait, Griffiths, Kirsty, Komninidou, Konstantina, Knight, Rachel, Laws, Suzannah, Leung, Jovita, Parker, Jenna, Pi-Sunyer, Blanca Piera, Sakhardande, J. Ashok, Shackleford, Jem, Tudor, Kate, Vainre, Maris, Wainman, Brian, Ford, Tamsin, Degli Esposti, Michelle, Crane, Catherine, Taylor, Laura, Montero-Marín, Jesús, Blakemore, Sarah-Jayne, Bowes, Lucy, Byford, Sarah, Dalgleish, Tim, Greenberg, Mark T., Nuthall, Elizabeth, Phillips, Alice, Raja, Anam, Ukoumunne, Obioha C., Viner, Russell M., Williams, J. Mark G., Allwood, Matt, Aukland, Louise, Casey, Tríona, De Wilde, Katherine, Farley, Eleanor-Rose, Kappelmann, Nils, Lord, Liz, Medlicott, Emma, Palmer, Lucy, Petit, Ariane, Pryor-Nitsch, Isobel, Radley, Lucy, Warriner, Lucy, Sonley, Anna, and Kuyken, Willem

Published
2021
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3. Do Adolescents Like School-Based Mindfulness Training? Predictors of Mindfulness Practice and Responsiveness in the MYRIAD Trial

Author

Montero-Marin, Jesus, primary, Hinze, Verena, additional, Crane, Catherine, additional, Dalrymple, Nicola, additional, Kempnich, Maria E.J., additional, Lord, Liz, additional, Slaghekke, Yasmijn, additional, Tudor, Kate, additional, Byford, Sarah, additional, Dalgleish, Tim, additional, Ford, Tamsin J., additional, Greenberg, Mark T., additional, Ukoumunne, Obioha C., additional, Williams, J. Mark G., additional, Kuyken, Willem, additional, Ahmed, Saz, additional, Allwood, Matt, additional, Ball, Susan, additional, Bennett, Marc, additional, Blakemore, Sarah-Jayne, additional, Casey, Triona, additional, De Wilde, Katherine, additional, Dunning, Darren, additional, Farley, Eleanor-Rose, additional, Fletcher, Katie, additional, Foulkes, Lucy, additional, Ganguli, Poushali, additional, Griffin, Cait, additional, Griffiths, Kirsty, additional, Jones, Ben, additional, Kappelmann, Nils, additional, Komninidou, Konstantina, additional, Knight, Rachel, additional, Laws, Suzannah, additional, Leung, Jovita, additional, Medlicott, Emma, additional, Nuthall, Elizabeth, additional, Parker, Jenna, additional, Phillips, Alice, additional, Raja, Anam, additional, Palmer, Lucy, additional, Petit, Ariane, additional, Pi-Sunyer, Blanca Piera, additional, Pryor-Nitsch, Isobel, additional, Radley, Lucy, additional, Sakhardande, J. Ashok, additional, Shackleford, Jem, additional, Sonley, Anna, additional, Taylor, Laura, additional, Tickell, Alice, additional, Vainre, Maris, additional, Viner, Russell M., additional, Wainman, Brian, additional, and Warriner, Lucy, additional

Published
2023
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4. School-based mindfulness training in early adolescence: what works, for whom and how in the MYRIAD trial?

Author

Montero-Marin, Jesus, Allwood, Matthew, Ball, Susan, Crane, Catherine, De Wilde, Katherine, Hinze, Verena, Jones, Benjamin, Lord, Liz, Nuthall, Elizabeth, Raja, Anam, Taylor, Laura, Tudor, Kate, Blakemore, Sarah-Jayne, Byford, Sarah, Dalgleish, Tim, Ford, Tamsin, Greenberg, Mark T., Ukoumunne, Obioha C, Williams, J. Mark G., and Kuyken, Willem

Subjects
Psychiatry and Mental health
Abstract

BackgroundPreventing mental health problems in early adolescence is a priority. School-based mindfulness training (SBMT) is an approach with mixed evidence.ObjectivesTo explore for whom SBMT does/does not work and what influences outcomes.MethodsThe My Resilience in Adolescence was a parallel-group, cluster randomised controlled trial (K=84 secondary schools; n=8376 students, age: 11–13) recruiting schools that provided standard social–emotional learning. Schools were randomised 1:1 to continue this provision (control/teaching as usual (TAU)), and/or to offer SBMT (‘.b’ (intervention)). Risk of depression, social–emotional–behavioural functioning and well-being were measured at baseline, preintervention, post intervention and 1 year follow-up. Hypothesised moderators, implementation factors and mediators were analysed using mixed effects linear regressions, instrumental variable methods and path analysis.FindingsSBMT versus TAU resulted in worse scores on risk of depression and well-being in students at risk of mental health problems both at post intervention and 1-year follow-up, but differences were small and not clinically relevant. Higher dose and reach were associated with worse social–emotional–behavioural functioning at postintervention. No implementation factors were associated with outcomes at 1-year follow-up. Pregains−postgains in mindfulness skills and executive function predicted better outcomes at 1-year follow-up, but the SBMT was unsuccessful to teach these skills with clinical relevance.SBMT as delivered in this trial is not indicated as a universal intervention. Moreover, it may be contraindicated for students with existing/emerging mental health symptoms.Clinical implicationsUniversal SBMT is not recommended in this format in early adolescence. Future research should explore social−emotional learning programmes adapted to the unique needs of young people.

Published
2022

5. Mixed-methods feasibility study to inform a randomised controlled trial of proton pump inhibitors to reduce strictures following neonatal surgery for oesophageal atresia

Author

Mitchell, Tracy Karen, primary, Hall, Nigel J, additional, Yardley, Iain, additional, Cole, Christina, additional, Hardy, Pollyanna, additional, King, Andy, additional, Murray, David, additional, Nuthall, Elizabeth, additional, Roehr, Charles, additional, Stanbury, Kayleigh, additional, Williams, Rachel, additional, Pearce, John, additional, and Woolfall, Kerry, additional

Published
2023
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7. Effectiveness and cost-effectiveness of universal school-based mindfulness training compared with normal school provision in reducing risk of mental health problems and promoting well-being in adolescence: the MYRIAD cluster randomised controlled trial

Author

Kuyken, Willem, primary, Ball, Susan, additional, Crane, Catherine, additional, Ganguli, Poushali, additional, Jones, Benjamin, additional, Montero-Marin, Jesus, additional, Nuthall, Elizabeth, additional, Raja, Anam, additional, Taylor, Laura, additional, Tudor, Kate, additional, Viner, Russell M, additional, Allwood, Matthew, additional, Aukland, Louise, additional, Dunning, Darren, additional, Casey, Tríona, additional, Dalrymple, Nicola, additional, De Wilde, Katherine, additional, Farley, Eleanor-Rose, additional, Harper, Jennifer, additional, Kappelmann, Nils, additional, Kempnich, Maria, additional, Lord, Liz, additional, Medlicott, Emma, additional, Palmer, Lucy, additional, Petit, Ariane, additional, Philips, Alice, additional, Pryor-Nitsch, Isobel, additional, Radley, Lucy, additional, Sonley, Anna, additional, Shackleford, Jem, additional, Tickell, Alice, additional, Blakemore, Sarah-Jayne, additional, Team, The MYRIAD, additional, Ukoumunne, Obioha C, additional, Greenberg, Mark T, additional, Ford, Tamsin, additional, Dalgleish, Tim, additional, Byford, Sarah, additional, and Williams, J Mark G, additional

Published
2022
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8. Effectiveness of universal school-based mindfulness training compared with normal school provision on teacher mental health and school climate: results of the MYRIAD cluster randomised controlled trial

Author

Kuyken, Willem, primary, Ball, Susan, additional, Crane, Catherine, additional, Ganguli, Poushali, additional, Jones, Benjamin, additional, Montero-Marin, Jesus, additional, Nuthall, Elizabeth, additional, Raja, Anam, additional, Taylor, Laura, additional, Tudor, Kate, additional, Viner, Russell M, additional, Allwood, Matthew, additional, Aukland, Louise, additional, Dunning, Darren, additional, Casey, Tríona, additional, Dalrymple, Nicola, additional, De Wilde, Katherine, additional, Farley, Eleanor-Rose, additional, Harper, Jennifer, additional, Hinze, Verena, additional, Kappelmann, Nils, additional, Kempnich, Maria, additional, Lord, Liz, additional, Medlicott, Emma, additional, Palmer, Lucy, additional, Petit, Ariane, additional, Philips, Alice, additional, Pryor-Nitsch, Isobel, additional, Radley, Lucy, additional, Sonley, Anna, additional, Shackleford, Jem, additional, Tickell, Alice, additional, Team, MYRIAD, additional, Blakemore, Sarah-Jayne, additional, Ukoumunne, Obioha C, additional, Greenberg, Mark T, additional, Ford, Tamsin, additional, Dalgleish, Tim, additional, Byford, Sarah, additional, and Williams, J Mark G, additional

Published
2022
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9. The Role of Schools in Early Adolescents’ Mental Health: Findings From the MYRIAD Study

Author

Ford, Tamsin, primary, Degli Esposti, Michelle, additional, Crane, Catherine, additional, Taylor, Laura, additional, Montero-Marín, Jesús, additional, Blakemore, Sarah-Jayne, additional, Bowes, Lucy, additional, Byford, Sarah, additional, Dalgleish, Tim, additional, Greenberg, Mark T., additional, Nuthall, Elizabeth, additional, Phillips, Alice, additional, Raja, Anam, additional, Ukoumunne, Obioha C., additional, Viner, Russell M., additional, Williams, J. Mark G., additional, Allwood, Matt, additional, Aukland, Louise, additional, Casey, Tríona, additional, De Wilde, Katherine, additional, Farley, Eleanor-Rose, additional, Kappelmann, Nils, additional, Lord, Liz, additional, Medlicott, Emma, additional, Palmer, Lucy, additional, Petit, Ariane, additional, Pryor-Nitsch, Isobel, additional, Radley, Lucy, additional, Warriner, Lucy, additional, Sonley, Anna, additional, Kuyken, Willem, additional, Ahmed, Saz, additional, Ball, Susan, additional, Bennett, Marc, additional, Dalrymple, Nicola, additional, Dunning, Darren, additional, Fletcher, Katie, additional, Foulkes, Lucy, additional, Ganguli, Poushali, additional, Griffin, Cait, additional, Griffiths, Kirsty, additional, Komninidou, Konstantina, additional, Knight, Rachel, additional, Laws, Suzannah, additional, Leung, Jovita, additional, Parker, Jenna, additional, Pi-Sunyer, Blanca Piera, additional, Sakhardande, J. Ashok, additional, Shackleford, Jem, additional, Tudor, Kate, additional, Vainre, Maris, additional, and Wainman, Brian, additional

Published
2021
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10. Safety and Immunogenicity of Novel Adenovirus Type 26– and Modified Vaccinia Ankara–Vectored Ebola Vaccines: A Randomized Clinical Trial

Author

Milligan, Iain D., Gibani, Malick M., Sewell, Richard, Clutterbuck, Elizabeth A., Campbell, Danielle, Plested, Emma, Nuthall, Elizabeth, Voysey, Merryn, Silva-Reyes, Laura, McElrath, M. Juliana, De Rosa, Stephen C., Frahm, Nicole, Cohen, Kristen W., Shukarev, Georgi, Orzabal, Nicola, van Duijnhoven, Wilbert, Truyers, Carla, Bachmayer, Nora, Splinter, Daniel, Samy, Nathaly, Pau, Maria Grazia, Schuitemaker, Hanneke, Luhn, Kerstin, Callendret, Benoit, Van Hoof, Johan, Douoguih, Macaya, Ewer, Katie, Angus, Brian, Pollard, Andrew J., and Snape, Matthew D.

Published
2016
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11. Does depression moderate the relationship between pain and suicidality in adolescence? A moderated network analysis

Author

Hinze, Verena, primary, Ford, Tamsin, additional, Crane, Catherine, additional, Haslbeck, Jonas M.B., additional, Hawton, Keith, additional, Gjelsvik, Bergljot, additional, Allwood, Matthew, additional, Aukland, Louise, additional, Casey, Triona, additional, De Wilde, Katherine, additional, Farley, Eleanor-Rose, additional, Fletcher, Katie, additional, Kappelmann, Nils, additional, Kuyken, Prof. Willem, additional, Laws, Suzannah, additional, Lord, Liz, additional, Medlicott, Emma, additional, Montero-Marin, Dr. Jesus, additional, Nuthall, Elizabeth, additional, Palmer, Dr. Lucy, additional, Petit, Ariane, additional, Philips, Alice, additional, Pryor-Nitsch, Isobel, additional, Radley, Lucy, additional, Raja, Anam, additional, Shackleford, Jeremy, additional, Sonley, Anna, additional, Taylor, Dr. Laura, additional, Warriner, Lucy, additional, Williams, Prof. J.Mark G., additional, Bennett, Marc, additional, Dalgleish, Prof. Tim, additional, Dunning, Darren, additional, Griffiths, Kirsty, additional, Knight, Rachel, additional, Vainre, Maris, additional, Ahmed, Saz, additional, Blakemore, Prof. Sarah-Jayne, additional, Pi-Sunyer, Blanca Piera, additional, Foulkes, Lucy, additional, Leung, Jovita, additional, Sakhardande, Ashok, additional, Ukoumunne, Dr. Obioha C, additional, Ball, Susan, additional, Byford, Prof. Sarah, additional, Ganguli, Poushali, additional, Greenberg, Prof. Mark T., additional, Viner, Prof Russell M., additional, and Wainman, Brian, additional

Published
2021
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12. Update to the effectiveness and cost-effectiveness of a mindfulness training programme in schools compared with normal school provision (MYRIAD): study protocol for a randomised controlled trial

Author

Montero-Marin, Jesus, Nuthall, Elizabeth, Byford, Sarah, Crane, Catherine, Dalgleish, Tim, Ford, Tamsin, Ganguli, Poushali, Greenberg, Mark T, Ukoumunne, Obioha C, Viner, Russell M, Williams, J Mark G, MYRIAD Team, Kuyken, Willem, Kuyken, Willem [0000-0002-8596-5252], and Apollo - University of Cambridge Repository

Subjects
lcsh:R5-920, Schools, Resilience, Adolescent, Depression, 030503 health policy & services, Prevention, Cost-Benefit Analysis, Medicine (miscellaneous), COVID-19, Update, Adolescence, 03 medical and health sciences, 0302 clinical medicine, Mental Health, Treatment Outcome, Humans, Pharmacology (medical), 030212 general & internal medicine, lcsh:Medicine (General), 0305 other medical science, Mindfulness, Pandemics, Protocol update, Randomized Controlled Trials as Topic
Abstract

Background MYRIAD (My Resilience in Adolescence) is a superiority, parallel group, cluster randomised controlled trial designed to examine the effectiveness and cost-effectiveness of a mindfulness training (MT) programme, compared with normal social and emotional learning (SEL) school provision to enhance mental health, social-emotional-behavioural functioning and well-being in adolescence. The original trial protocol was published in Trials (accessible at 10.1186/s13063-017-1917-4). This included recruitment in two cohorts, enabling the learning from the smaller first cohort to be incorporated in the second cohort. Here we describe final amendments to the study protocol and discuss their underlying rationale. Methods Four major changes were introduced into the study protocol: (1) there were changes in eligibility criteria, including a clearer operational definition to assess the degree of SEL implementation in schools, and also new criteria to avoid experimental contamination; (2) the number of schools and pupils that had to be recruited was increased based on what we learned in the first cohort; (3) some changes were made to the secondary outcome measures to improve their validity and ability to measure constructs of interest and to reduce the burden on school staff; and (4) the current Coronavirus Disease 2019 (SARS-CoV-2 or COVID-19) pandemic both influences and makes it difficult to interpret the 2-year follow-up primary endpoint results, so we changed our primary endpoint to 1-year follow-up. Discussion These changes to the study protocol were approved by the Trial Management Group, Trial Steering Committee and Data and Ethics Monitoring Committees and improved the enrolment of participants and quality of measures. Furthermore, the change in the primary endpoint will give a more reliable answer to our primary question because it was collected prior to the COVID-19 pandemic in both cohort 1 and cohort 2. Nevertheless, the longer 2-year follow-up data will still be acquired, although this time-point will be now framed as a second major investigation to answer some new important questions presented by the combination of the pandemic and our study design. Trial registration International Standard Randomised Controlled Trials ISRCTN86619085. Registered on 3 June 2016.

Published
2021

13. T cell and antibody responses induced by a single dose of ChAdOx1 nCoV-19 (AZD1222) vaccine in a phase 1/2 clinical trial

Author

Ewer, Katie J., Barrett, Jordan R., Belij-Rammerstorfer, Sandra, Sharpe, Hannah, Makinson, Rebecca, Morter, Richard, Flaxman, Amy, Wright, Daniel, Bellamy, Duncan, Bittaye, Mustapha, Dold, Christina, Provine, Nicholas M., Aboagye, Jeremy, Fowler, Jamie, Silk, Sarah E., Alderson, Jennifer, Aley, Parvinder K., Angus, Brian, Berrie, Eleanor, Bibi, Sagida, Cicconi, Paola, Clutterbuck, Elizabeth A., Chelysheva, Irina, Folegatti, Pedro M., Fuskova, Michelle, Green, Catherine M., Jenkin, Daniel, Kerridge, Simon, Lawrie, Alison, Minassian, Angela M., Moore, Maria, Mujadidi, Yama, Plested, Emma, Poulton, Ian, Ramasamy, Maheshi N., Robinson, Hannah, Song, Rinn, Snape, Matthew D., Tarrant, Richard, Voysey, Merryn, Watson, Marion E. E., Douglas, Alexander D., Hill, Adrian V. S., Gilbert, Sarah C., Pollard, Andrew J., Lambe, Teresa, Ali, Aabidah, Allen, Elizabeth, Baker, Megan, Barnes, Eleanor, Borthwick, Nicola, Boyd, Amy, Brown-O’Sullivan, Charlie, Burgoyne, Joshua, Byard, Nicholas, Puig, Ingrid Cabrera, Cappuccini, Federica, Cho, Jee-Sun, Clark, Elizabeth, Crocker, Wendy E. M., Datoo, Mehreen S., Davies, Hannah, Donnellan, Francesca R., Dunachie, Susanna Jane, Edwards, Nick J., Elias, Sean C., Furze, Julie, Gilbride, Ciaran, Gorini, Giacomo, Gupta, Gaurav, Harris, Stephanie A., Hodgson, Susanne H. C., Hou, Mimi M., Jackson, Susan, Jones, Kathryn, Kailath, Reshma, King, Lloyd, Larkworthy, Colin W., Li, Yuanyuan, Lias, Amelia M., Linder, Aline, Lipworth, Samuel, Ramon, Raquel Lopez, Madhavan, Meera, Marlow, Emma, Marshall, Julia L., Mentzer, Alexander J., Morrison, Hazel, Moya, Nathifa, Mukhopadhyay, Ekta, Noé, Andrés, Nugent, Fay L., Pipini, Dimitra, Pulido-Gomez, David, Lopez, Fernando Ramos, Ritchie, Adam John, Rudiansyah, Indra, Salvador, Stephannie, Sanders, Helen, Satti, Iman, Shea, Adam, Silk, Sarah, Spencer, Alexandra J., Tanner, Rachel, Taylor, Iona Jennifer, Themistocleous, Yrene, Thomas, Merin, Tran, Nguyen, Truby, Adam, Turner, Cheryl, Turner, Nicola, Ulaszewska, Marta, Worth, Andrew T., Kingham-Page, Lucy, Alvarez, Marco Polo Peralta, Anslow, Rachel, Bates, Louise, Beadon, Kirsten, Beckley, Rebecca, Beveridge, Amy, Bijker, Else Margreet, Blackwell, Luke, Burbage, Jamie, Camara, Susana, Carr, Melanie, Colin-Jones, Rachel, Cooper, Rachel, Cunningham, Christina J., Demissie, Tesfaye, Maso, Claudio Di, Douglas, Naomi, Drake-Brockman, Rachael, Drury, Ruth Elizabeth, Emary, Katherine R. W., Felle, Sally, Feng, Shuo, Silva, Carla Ferreira Da, Ford, Karen J., Francis, Emma, Gracie, Lara, Hamlyn, Joseph, Hanumunthadu, Brama, Harrison, Daisy, Hart, Thomas C., Hawkins, Sophia, Hill, Jennifer, Howe, Elizabeth, Howell, Nicola, Jones, Elizabeth, Keen, Jade, Kelly, Sarah, Kerr, David, Khan, Liaquat, Kinch, Jasmin, Koleva, Stanislava, Lees, Emily A., Lelliott, Alice, Liu, Xinxue, Marchevsky, Natalie G., Marinou, Spyridoula, McEwan, Joanne, Morey, Ella, Morshead, Gertraud, Muller, Jilly, Munro, Claire, Murphy, Sarah, Mweu, Philomena, Nuthall, Elizabeth, O’Brien, Katie, O’Connor, Daniel, O’Reilly, Peter John, Oguti, Blanché, Osborne, Piper, Owino, Nelly, Parker, Kaye, Pfafferott, Katja, Phillips, Daniel, Provstgaard-Morys, Samuel, Ratcliffe, Helen, Rawlinson, Thomas, Rhead, Sarah, Roberts, Hannah, Sanders, Katherine, Silva-Reyes, Laura, Rollier, Christine S., Smith, Catherine C., Smith, David J., Stockdale, Lisa, Szigeti, Anna, Thomas, Tonia M., Thompson, Amber, Tomic, Adriana, Tonks, Susan, Varughese, Rachel, Verheul, Marije K., Vichos, Iason, Walker, Laura, White, Caroline, White, Rachel, Yao, Xin Li, Conlon, Christopher P., Frater, John, Cifuentes, Liliana, Baleanu, Ioana, Bolam, Emma, Boland, Elena, Brenner, Tanja, Damratoski, Brad E., Datta, Chandra, Muhanna, Omar El, Fisher, Richard, Galian-Rubio, Pablo, Hodges, Gina, Jackson, Frederic, Liu, Shuchang, Loew, Lisa, Morgans, Roisin, Morris, Susan Jane, Olchawski, Vicki, Oliveria, Catarina, Parracho, Helena, Pabon, Emilia Reyes, Tahiri-Alaoui, Abdessamad, Taylor, Keja, Williams, Paul, Zizi, Dalila, Arbe-Barnes, Edward H., Baker, Philip, Batten, Alexander, Downing, Charlotte, Drake, Jonathan, English, Marcus Rex, Henry, John Aaron, Iveson, Poppy, Killen, Annabel, King, Thomas B., Larwood, Jessica P. J., Mallett, Garry, Mansatta, Kushal, Mirtorabi, Neginsadat, Patrick-Smith, Maia, Perring, James, Radia, Kajal, Roche, Sophie, Schofield, Ella, Naude, Rebecca te Water, Towner, James, Baker, Natalie, Bewley, Kevin R., Brunt, Emily, Buttigieg, Karen R., Carroll, Miles W., Charlton, Sue, Coombes, Naomi S., Elmore, Michael J., Godwin, Kerry, Hallis, Bassam, Knott, Daniel, McInroy, Lorna, Shaik, Imam, Thomas, Kelly, Tree, Julia A., Blundell, Caitlin L., Cao, Michelangelo, Kelly, Dearbhla, Schmid, Annina, Skelly, Donal T., Themistocleous, Andreas, Dong, Tao, Field, Samantha, Hamilton, Elizabeth, Kelly, Elizabeth, Klenerman, Paul, Knight, Julian C., Lie, Yolanda, Petropoulos, Christos, Sedik, Cynthia, Wrin, Terri, Meddaugh, Gretchen, Peng, Yanchun, Screaton, Gavin, and Stafford, Elizabeth

Subjects
0301 basic medicine, biology, business.industry, T cell, Immunogenicity, General Medicine, Vaccine efficacy, General Biochemistry, Genetics and Molecular Biology, Vaccination, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, medicine.anatomical_structure, Immune system, Immunity, 030220 oncology & carcinogenesis, Immunology, biology.protein, medicine, Cytotoxic T cell, Antibody, business
Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of Coronavirus Disease 2019 (COVID-19), has caused a global pandemic, and safe, effective vaccines are urgently needed1. Strong, Th1-skewed T cell responses can drive protective humoral and cell-mediated immune responses2 and might reduce the potential for disease enhancement3. Cytotoxic T cells clear virus-infected host cells and contribute to control of infection4. Studies of patients infected with SARS-CoV-2 have suggested a protective role for both humoral and cell-mediated immune responses in recovery from COVID-19 (refs. 5,6). ChAdOx1 nCoV-19 (AZD1222) is a candidate SARS-CoV-2 vaccine comprising a replication-deficient simian adenovirus expressing full-length SARS-CoV-2 spike protein. We recently reported preliminary safety and immunogenicity data from a phase 1/2 trial of the ChAdOx1 nCoV-19 vaccine (NCT04400838)7 given as either a one- or two-dose regimen. The vaccine was tolerated, with induction of neutralizing antibodies and antigen-specific T cells against the SARS-CoV-2 spike protein. Here we describe, in detail, exploratory analyses of the immune responses in adults, aged 18–55 years, up to 8 weeks after vaccination with a single dose of ChAdOx1 nCoV-19 in this trial, demonstrating an induction of a Th1-biased response characterized by interferon-γ and tumor necrosis factor-α cytokine secretion by CD4+ T cells and antibody production predominantly of IgG1 and IgG3 subclasses. CD8+ T cells, of monofunctional, polyfunctional and cytotoxic phenotypes, were also induced. Taken together, these results suggest a favorable immune profile induced by ChAdOx1 nCoV-19 vaccine, supporting the progression of this vaccine candidate to ongoing phase 2/3 trials to assess vaccine efficacy. A single dose of the ChAdOx1 nCoV-19 vaccine elicits antibodies and cytokine-producing T cells that might help control or prevent SARS-CoV-2 infection.

Published
2020
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15. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial

Author

Folegatti, Pedro M, primary, Ewer, Katie J, additional, Aley, Parvinder K, additional, Angus, Brian, additional, Becker, Stephan, additional, Belij-Rammerstorfer, Sandra, additional, Bellamy, Duncan, additional, Bibi, Sagida, additional, Bittaye, Mustapha, additional, Clutterbuck, Elizabeth A, additional, Dold, Christina, additional, Faust, Saul N, additional, Finn, Adam, additional, Flaxman, Amy L, additional, Hallis, Bassam, additional, Heath, Paul, additional, Jenkin, Daniel, additional, Lazarus, Rajeka, additional, Makinson, Rebecca, additional, Minassian, Angela M, additional, Pollock, Katrina M, additional, Ramasamy, Maheshi, additional, Robinson, Hannah, additional, Snape, Matthew, additional, Tarrant, Richard, additional, Voysey, Merryn, additional, Green, Catherine, additional, Douglas, Alexander D, additional, Hill, Adrian V S, additional, Lambe, Teresa, additional, Gilbert, Sarah C, additional, Pollard, Andrew J, additional, Aboagye, Jeremy, additional, Adams, Kelly, additional, Ali, Aabidah, additional, Allen, Elizabeth, additional, Allison, Jennifer L., additional, Anslow, Rachel, additional, Arbe-Barnes, Edward H., additional, Babbage, Gavin, additional, Baillie, Kenneth, additional, Baker, Megan, additional, Baker, Natalie, additional, Baker, Philip, additional, Baleanu, Ioana, additional, Ballaminut, Juliana, additional, Barnes, Eleanor, additional, Barrett, Jordan, additional, Bates, Louise, additional, Batten, Alexander, additional, Beadon, Kirsten, additional, Beckley, Rebecca, additional, Berrie, Eleanor, additional, Berry, Lisa, additional, Beveridge, Amy, additional, Bewley, Kevin R., additional, Bijker, Else Margreet, additional, Bingham, Tracey, additional, Blackwell, Luke, additional, Blundell, Caitlin L., additional, Bolam, Emma, additional, Boland, Elena, additional, Borthwick, Nicola, additional, Bower, Thomas, additional, Boyd, Amy, additional, Brenner, Tanja, additional, Bright, Philip D., additional, Brown-O'Sullivan, Charlie, additional, Brunt, Emily, additional, Burbage, Jamie, additional, Burge, Sharon, additional, Buttigieg, Karen R., additional, Byard, Nicholas, additional, Cabera Puig, Ingrid, additional, Calvert, Anna, additional, Camara, Susana, additional, Cao, Michelangelo, additional, Cappuccini, Federica, additional, Carr, Melanie, additional, Carroll, Miles W., additional, Carter, Victoria, additional, Cathie, Katrina, additional, Challis, Ruth J., additional, Charlton, Sue, additional, Chelysheva, Irina, additional, Cho, Jee-Sun, additional, Cicconi, Paola, additional, Cifuentes, Liliana, additional, Clark, Helen, additional, Clark, Elizabeth, additional, Cole, Tom, additional, Colin-Jones, Rachel, additional, Conlon, Christopher P., additional, Cook, Aislinn, additional, Coombes, Naomi S., additional, Cooper, Rachel, additional, Cosgrove, Catherine A., additional, Coy, Karen, additional, Crocker, Wendy E.M., additional, Cunningham, Christina J., additional, Damratoski, Brad E., additional, Dando, Lynne, additional, Datoo, Mehreen S., additional, Davies, Hannah, additional, De Graaf, Hans, additional, Demissie, Tesfaye, additional, Di Maso, Claudio, additional, Dietrich, Isabelle, additional, Dong, Tao, additional, Donnellan, Francesca R., additional, Douglas, Naomi, additional, Downing, Charlotte, additional, Drake, Jonathan, additional, Drake-Brockman, Rachael, additional, Drury, Ruth Elizabeth, additional, Dunachie, Susanna Jane, additional, Edwards, Nick J., additional, Edwards, Frances D.L., additional, Edwards, Chris J., additional, Elias, Sean C., additional, Elmore, Michael J., additional, Emary, Katherine R.W., additional, English, Marcus Rex, additional, Fagerbrink, Susanne, additional, Felle, Sally, additional, Feng, Shuo, additional, Field, Samantha, additional, Fixmer, Carine, additional, Fletcher, Clare, additional, Ford, Karen J., additional, Fowler, Jamie, additional, Fox, Polly, additional, Francis, Emma, additional, Frater, John, additional, Furze, Julie, additional, Fuskova, Michelle, additional, Galiza, Eva, additional, Gbesemete, Diane, additional, Gilbride, Ciaran, additional, Godwin, Kerry, additional, Gorini, Giacomo, additional, Goulston, Lyndsey, additional, Grabau, Caroline, additional, Gracie, Lara, additional, Gray, Zoe, additional, Guthrie, Lucy Belle, additional, Hackett, Mark, additional, Halwe, Sandro, additional, Hamilton, Elizabeth, additional, Hamlyn, Joseph, additional, Hanumunthadu, Brama, additional, Harding, Irasha, additional, Harris, Stephanie A., additional, Harris, Andrew, additional, Harrison, Daisy, additional, Harrison, Clare, additional, Hart, Thomas C., additional, Haskell, Louise, additional, Hawkins, Sophia, additional, Head, Ian, additional, Henry, John Aaron, additional, Hill, Jennifer, additional, Hodgson, Susanne H.C., additional, Hou, Mimi M., additional, Howe, Elizabeth, additional, Howell, Nicola, additional, Hutlin, Cecilia, additional, Ikram, Sabina, additional, Isitt, Catherine, additional, Iveson, Poppy, additional, Jackson, Susan, additional, Jackson, Frederic, additional, James, Sir William, additional, Jenkins, Megan, additional, Jones, Elizabeth, additional, Jones, Kathryn, additional, Jones, Christine E., additional, Jones, Bryony, additional, Kailath, Reshma, additional, Karampatsas, Konstantinos, additional, Keen, Jade, additional, Kelly, Sarah, additional, Kelly, Dearbhla, additional, Kerr, David, additional, Kerridge, Simon, additional, Khan, Liaquat, additional, Khan, Uzma, additional, Killen, Annabel, additional, Kinch, Jasmin, additional, King, Thomas B., additional, King, Lloyd, additional, King, Jade, additional, Kingham-Page, Lucy, additional, Klenerman, Paul, additional, Knapper, Francesca, additional, Knight, Julian C., additional, Knott, Daniel, additional, Koleva, Stanislava, additional, Kupke, Alexandra, additional, Larkworthy, Colin W., additional, Larwood, Jessica P.J., additional, Laskey, Anna, additional, Lawrie, Alison M., additional, Lee, Arlene, additional, Ngan Lee, Kim Yee, additional, Lees, Emily A, additional, Legge, Helen, additional, Lelliott, Alice, additional, Lemm, Nana-Marie, additional, Lias, Amelia M., additional, Linder, Aline, additional, Lipworth, Samuel, additional, Liu, Xinxue, additional, Liu, Shuchang, additional, Lopez Ramon, Raquel, additional, Lwin, May, additional, Mabesa, Francesca, additional, Madhavan, Meera, additional, Mallett, Garry, additional, Mansatta, Kushal, additional, Marcal, Ines, additional, Marinou, Spyridoula, additional, Marlow, Emma, additional, Marshall, Julia L., additional, Martin, Jane, additional, McEwan, Joanne, additional, McInroy, Lorna, additional, Meddaugh, Gretchen, additional, Mentzer, Alexander J., additional, Mirtorabi, Neginsadat, additional, Moore, Maria, additional, Moran, Edward, additional, Morey, Ella, additional, Morgan, Victoria, additional, Morris, Susan Jane, additional, Morrison, Hazel, additional, Morshead, Gertraud, additional, Morter, Richard, additional, Mujadidi, Yama F., additional, Muller, Jilly, additional, Munera-Huertas, Tatiana, additional, Munro, Claire, additional, Munro, Alasdair, additional, Murphy, Sarah, additional, Munster, Vincent J., additional, Mweu, Philomena, additional, Noé, Andrés, additional, Nugent, Fay L., additional, Nuthall, Elizabeth, additional, O'Brien, Katie, additional, O'Connor, Daniel, additional, Oguti, Blanché, additional, Oliver, Jennifer L., additional, Oliveira, Catarina, additional, O'Reilly, Peter John, additional, Osborn, Mairead, additional, Osborne, Piper, additional, Owen, Cathy, additional, Owens, Daniel, additional, Owino, Nelly, additional, Pacurar, Mihaela, additional, Parker, Kaye, additional, Parracho, Helena, additional, Patrick-Smith, Maia, additional, Payne, Victoria, additional, Pearce, Jennifer, additional, Peng, Yanchun, additional, Peralta Alvarez, Marco Polo, additional, Perring, James, additional, Pfafferott, Katja, additional, Pipini, Dimitra, additional, Plested, Emma, additional, Pluess-Hall, Helen, additional, Pollock, Katrina, additional, Poulton, Ian, additional, Presland, Laura, additional, Provstgaard-Morys, Samuel, additional, Pulido, David, additional, Radia, Kajal, additional, Ramos Lopez, Fernando, additional, Rand, Jade, additional, Ratcliffe, Helen, additional, Rawlinson, Thomas, additional, Rhead, Sarah, additional, Riddell, Amy, additional, Ritchie, Adam John, additional, Roberts, Hannah, additional, Robson, Joanna, additional, Roche, Sophie, additional, Rohde, Cornelius, additional, Rollier, Christine S., additional, Romani, Rossana, additional, Rudiansyah, Indra, additional, Saich, Stephen, additional, Sajjad, Sara, additional, Salvador, Stephannie, additional, Sanchez Riera, Lidia, additional, Sanders, Helen, additional, Sanders, Katherine, additional, Sapaun, Shari, additional, Sayce, Chloe, additional, Schofield, Ella, additional, Screaton, Gavin, additional, Selby, Beatrice, additional, Semple, Calum, additional, Sharpe, Hannah R., additional, Shaik, Imam, additional, Shea, Adam, additional, Shelton, Holly, additional, Silk, Sarah, additional, Silva-Reyes, Laura, additional, Skelly, Donal T., additional, Smee, Heather, additional, Smith, Catherine C., additional, Smith, David J., additional, Song, Rinn, additional, Spencer, Alexandra J., additional, Stafford, Elizabeth, additional, Steele, Amy, additional, Stefanova, Elena, additional, Stockdale, Lisa, additional, Szigeti, Anna, additional, Tahiri-Alaoui, Abdessamad, additional, Tait, Moira, additional, Talbot, Helen, additional, Tanner, Rachel, additional, Taylor, Iona Jennifer, additional, Taylor, Victoria, additional, Te Water Naude, Rebecca, additional, Thakur, Nazia, additional, Themistocleous, Yrene, additional, Themistocleous, Andreas, additional, Thomas, Merin, additional, Thomas, Tonia M., additional, Thompson, Amber, additional, Thomson-Hill, Samantha, additional, Tomlins, Jennifer, additional, Tonks, Susan, additional, Towner, James, additional, Tran, Nguyen, additional, Tree, Julia A., additional, Truby, Adam, additional, Turkentine, Kate, additional, Turner, Cheryl, additional, Turner, Nicola, additional, Turner, Sally, additional, Tuthill, Toby, additional, Ulaszewska, Marta, additional, Varughese, Rachel, additional, Van Doremalen, Neeltje, additional, Veighey, Kristin, additional, Verheul, Marije K., additional, Vichos, Iason, additional, Vitale, Elia, additional, Walker, Laura, additional, Watson, Marion E.E., additional, Welham, Benjamin, additional, Wheat, Julie, additional, White, Caroline, additional, White, Rachel, additional, Worth, Andrew T., additional, Wright, Danny, additional, Wright, Suzie, additional, Yao, Xin Li, additional, and Yau, Yasmine, additional

Published
2020
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16. The effectiveness and cost-effectiveness of a mindfulness training programme in schools compared with normal school provision (MYRIAD):Study protocol for a randomised controlled trial

Author

Kuyken, Willem, Nuthall, Elizabeth, Byford, Sarah, Crane, Catherine, Dalgleish, Tim, Ford, Tamsin, Greenberg, Mark T., Ukoumunne, Obioha C., Viner, Russell M., Williams, J. Mark G., Brett, Daniel, Lord, Liz, Palmer, Lucy, Sonley, Anna, Taylor, Laura, Raja, Anam, and Casey, Triona

Subjects
Schools, Resilience, Depression, Prevention, Mindfulness, Adolescence
Abstract

Background: Mindfulness-based approaches for adults are effective at enhancing mental health, but few controlled trials have evaluated their effectiveness or cost-effectiveness for young people. The primary aim of this trial is to evaluate the effectiveness and cost-effectiveness of a mindfulness training (MT) programme to enhance mental health, wellbeing and social-emotional behavioural functioning in adolescence. Methods/design: To address this aim, the design will be a superiority, cluster randomised controlled, parallel-group trial in which schools offering social and emotional provision in line with good practice (Formby et al., Personal, Social, Health and Economic (PSHE) Education: A mapping study of the prevalent models of delivery and their effectiveness, 2010; OFSTED, Not Yet Good Enough: Personal, Social, Health and Economic Education in schools, 2013) will be randomised to either continue this provision (control) or include MT in this provision (intervention). The study will recruit and randomise 76 schools (clusters) and 5700 school students aged 12 to 14years, followed up for 2years. Discussion: The study will contribute to establishing if MT is an effective and cost-effective approach to promoting mental health in adolescence. Trials registration: International Standard Randomised Controlled Trials, identifier: ISRCTN86619085. Registered on 3 June 2016.

Published
2017

17. The effectiveness and cost-effectiveness of a mindfulness training programme in schools compared with normal school provision (MYRIAD): study protocol for a randomised controlled trial

Author

Kuyken, Willem, Nuthall, Elizabeth, Byford, Sarah, Crane, Catherine, Dalgleish, Tim, Ford, Tamsin, Greenberg, Mark T., Ukoumunne, Obioha C., Viner, Russell M., and Williams, J. Mark G.

Subjects
Male, Mental Health Services, Time Factors, Adolescent, Cost-Benefit Analysis, Emotions, Child Behavior, Study Protocol, Risk Factors, Surveys and Questionnaires, Humans, Child, Social Behavior, School Health Services, Schools, Resilience, Depression, Prevention, Health Care Costs, Resilience, Psychological, United Kingdom, Adolescence, Psychotherapy, Mental Health, Treatment Outcome, Adolescent Behavior, Research Design, Female, Mindfulness
Abstract

Background Mindfulness-based approaches for adults are effective at enhancing mental health, but few controlled trials have evaluated their effectiveness or cost-effectiveness for young people. The primary aim of this trial is to evaluate the effectiveness and cost-effectiveness of a mindfulness training (MT) programme to enhance mental health, wellbeing and social-emotional behavioural functioning in adolescence. Methods/design To address this aim, the design will be a superiority, cluster randomised controlled, parallel-group trial in which schools offering social and emotional provision in line with good practice (Formby et al., Personal, Social, Health and Economic (PSHE) Education: A mapping study of the prevalent models of delivery and their effectiveness, 2010; OFSTED, Not Yet Good Enough: Personal, Social, Health and Economic Education in schools, 2013) will be randomised to either continue this provision (control) or include MT in this provision (intervention). The study will recruit and randomise 76 schools (clusters) and 5700 school students aged 12 to 14 years, followed up for 2 years. Discussion The study will contribute to establishing if MT is an effective and cost-effective approach to promoting mental health in adolescence. Trials registration International Standard Randomised Controlled Trials, identifier: ISRCTN86619085. Registered on 3 June 2016. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1917-4) contains supplementary material, which is available to authorized users.

Published
2017

19. Heterologous Prime-Boost Schedules of Replication-Defective Adenovirus Serotype 26 and Modified Vaccinia Virus Ankara Vector Vaccines Expressing Ebola Virus Glycoprotein Are Immunogenic and Well Tolerated in Healthy Adults

Author

Milligan, Iain, primary, Gibani, Malick, additional, Campbell, Danielle, additional, Clutterbuck, Elizabeth, additional, Sewell, Richard, additional, Plested, Emma, additional, Nuthall, Elizabeth, additional, Voysey, Merryn, additional, Quintana, Nicola Orzabal De La, additional, Shukarev, Georgi, additional, Truyers, Carla, additional, Duijnhoven, Wilbert Van, additional, Luhn, Kerstin, additional, Douoguih, Macaya, additional, Ewer, Katie, additional, Hill, Adrian V. S., additional, Angus, Brian, additional, Pollard, Andrew J., additional, and Snape, Matthew, additional

Published
2015
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22. Safety and Immunogenicity of Novel Adenovirus Type 26– and Modified Vaccinia Ankara–Vectored Ebola Vaccines

Author

Milligan, Iain D., Gibani, Malick M., Sewell, Richard, Clutterbuck, Elizabeth A., Campbell, Danielle, Plested, Emma, Nuthall, Elizabeth, Voysey, Merryn, Silva-Reyes, Laura, McElrath, M. Juliana, De Rosa, Stephen C., Frahm, Nicole, Cohen, Kristen W., Shukarev, Georgi, Orzabal, Nicola, van Duijnhoven, Wilbert, Truyers, Carla, Bachmayer, Nora, Splinter, Daniel, Samy, Nathaly, Pau, Maria Grazia, Schuitemaker, Hanneke, Luhn, Kerstin, Callendret, Benoit, Van Hoof, Johan, Douoguih, Macaya, Ewer, Katie, Angus, Brian, Pollard, Andrew J., and Snape, Matthew D.

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23. Effectiveness of universal school-based mindfulness training compared with normal school provision on teacher mental health and school climate: results of the MYRIAD cluster randomised controlled trial.

Author

Kuyken W, Ball S, Crane C, Ganguli P, Jones B, Montero-Marin J, Nuthall E, Raja A, Taylor L, Tudor K, Viner RM, Allwood M, Aukland L, Dunning D, Casey T, Dalrymple N, De Wilde K, Farley ER, Harper J, Hinze V, Kappelmann N, Kempnich M, Lord L, Medlicott E, Palmer L, Petit A, Philips A, Pryor-Nitsch I, Radley L, Sonley A, Shackleford J, Tickell A, Team M, Blakemore SJ, Ukoumunne OC, Greenberg MT, Ford T, Dalgleish T, Byford S, and Williams JMG

Abstract

Background: Education is broader than academic teaching. It includes teaching students social-emotional skills both directly and indirectly through a positive school climate., Objective: To evaluate if a universal school-based mindfulness training (SBMT) enhances teacher mental health and school climate., Methods: The My Resilience in Adolescence parallel group, cluster randomised controlled trial (registration: ISRCTN86619085; funding: Wellcome Trust (WT104908/Z/14/Z, WT107496/Z/15/Z)) recruited 85 schools (679 teachers) delivering social and emotional teaching across the UK. Schools (clusters) were randomised 1:1 to either continue this provision (teaching as usual (TAU)) or include universal SBMT. Data on teacher mental health and school climate were collected at prerandomisation, postpersonal mindfulness and SBMT teacher training, after delivering SBMT to students, and at 1-year follow-up., Finding: Schools were recruited in academic years 2016/2017 and 2017/2018. Primary analysis (SBMT: 43 schools/362 teachers; TAU: 41 schools/310 teachers) showed that after delivering SBMT to students, SBMT versus TAU enhanced teachers' mental health (burnout) and school climate. Adjusted standardised mean differences (SBMT minus TAU) were: exhaustion (-0.22; 95% CI -0.38 to -0.05); personal accomplishment (-0.21; -0.41, -0.02); school leadership (0.24; 0.04, 0.44); and respectful climate (0.26; 0.06, 0.47). Effects on burnout were not significant at 1-year follow-up. Effects on school climate were maintained only for respectful climate. No SBMT-related serious adverse events were reported., Conclusions: SBMT supports short-term changes in teacher burnout and school climate. Further work is required to explore how best to sustain improvements., Clinical Implications: SBMT has limited effects on teachers' mental and school climate. Innovative approaches to support and preserve teachers' mental health and school climate are needed., Competing Interests: Competing interests: WK is the Director of the Oxford Mindfulness Centre and receives royalties for several books on mindfulness. JMGW is former Director of the Oxford Mindfulness Centre and receives royalties for several books on mindfulness., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Published
2022
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24. Effectiveness and cost-effectiveness of universal school-based mindfulness training compared with normal school provision in reducing risk of mental health problems and promoting well-being in adolescence: the MYRIAD cluster randomised controlled trial.

Author

Kuyken W, Ball S, Crane C, Ganguli P, Jones B, Montero-Marin J, Nuthall E, Raja A, Taylor L, Tudor K, Viner RM, Allwood M, Aukland L, Dunning D, Casey T, Dalrymple N, De Wilde K, Farley ER, Harper J, Kappelmann N, Kempnich M, Lord L, Medlicott E, Palmer L, Petit A, Philips A, Pryor-Nitsch I, Radley L, Sonley A, Shackleford J, Tickell A, Blakemore SJ, Team TM, Ukoumunne OC, Greenberg MT, Ford T, Dalgleish T, Byford S, and Williams JMG

Abstract

Background: Systematic reviews suggest school-based mindfulness training (SBMT) shows promise in promoting student mental health., Objective: The My Resilience in Adolescence (MYRIAD) Trial evaluated the effectiveness and cost-effectiveness of SBMT compared with teaching-as-usual (TAU)., Methods: MYRIAD was a parallel group, cluster-randomised controlled trial. Eighty-five eligible schools consented and were randomised 1:1 to TAU (43 schools, 4232 students) or SBMT (42 schools, 4144 students), stratified by school size, quality, type, deprivation and region. Schools and students (mean (SD); age range=12.2 (0.6); 11-14 years) were broadly UK population-representative. Forty-three schools (n=3678 pupils; 86.9%) delivering SBMT, and 41 schools (n=3572; 86.2%) delivering TAU, provided primary end-point data. SBMT comprised 10 lessons of psychoeducation and mindfulness practices. TAU comprised standard social-emotional teaching. Participant-level risk for depression, social-emotional-behavioural functioning and well-being at 1 year follow-up were the co-primary outcomes. Secondary and economic outcomes were included., Findings: Analysis of 84 schools (n=8376 participants) found no evidence that SBMT was superior to TAU at 1 year. Standardised mean differences (intervention minus control) were: 0.005 (95% CI -0.05 to 0.06) for risk for depression; 0.02 (-0.02 to 0.07) for social-emotional-behavioural functioning; and 0.02 (-0.03 to 0.07) for well-being. SBMT had a high probability of cost-effectiveness (83%) at a willingness-to-pay threshold of £20 000 per quality-adjusted life year. No intervention-related adverse events were observed., Conclusions: Findings do not support the superiority of SBMT over TAU in promoting mental health in adolescence., Clinical Implications: There is need to ask what works, for whom and how, as well as considering key contextual and implementation factors., Trial Registration: Current controlled trials ISRCTN86619085. This research was funded by the Wellcome Trust (WT104908/Z/14/Z and WT107496/Z/15/Z)., Competing Interests: Competing interests: WK is the Director of the Oxford Mindfulness Centre and receives royalties for several books on mindfulness. JMGW is former Director of the Oxford Mindfulness Centre and receives royalties for several books on mindfulness., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Published
2022
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25. School-based mindfulness training in early adolescence: what works, for whom and how in the MYRIAD trial?

Author

Montero-Marin J, Allwood M, Ball S, Crane C, De Wilde K, Hinze V, Jones B, Lord L, Nuthall E, Raja A, Taylor L, Tudor K, Blakemore SJ, Byford S, Dalgleish T, Ford T, Greenberg MT, Ukoumunne OC, Williams JMG, and Kuyken W

Abstract

Background: Preventing mental health problems in early adolescence is a priority. School-based mindfulness training (SBMT) is an approach with mixed evidence., Objectives: To explore for whom SBMT does/does not work and what influences outcomes., Methods: The My Resilience in Adolescence was a parallel-group, cluster randomised controlled trial (K=84 secondary schools; n=8376 students, age: 11-13) recruiting schools that provided standard social-emotional learning. Schools were randomised 1:1 to continue this provision (control/teaching as usual (TAU)), and/or to offer SBMT ('.b' (intervention)). Risk of depression, social-emotional-behavioural functioning and well-being were measured at baseline, preintervention, post intervention and 1 year follow-up. Hypothesised moderators, implementation factors and mediators were analysed using mixed effects linear regressions, instrumental variable methods and path analysis., Findings: SBMT versus TAU resulted in worse scores on risk of depression and well-being in students at risk of mental health problems both at post intervention and 1-year follow-up, but differences were small and not clinically relevant. Higher dose and reach were associated with worse social-emotional-behavioural functioning at postintervention. No implementation factors were associated with outcomes at 1-year follow-up. Pregains-postgains in mindfulness skills and executive function predicted better outcomes at 1-year follow-up, but the SBMT was unsuccessful to teach these skills with clinical relevance.SBMT as delivered in this trial is not indicated as a universal intervention. Moreover, it may be contraindicated for students with existing/emerging mental health symptoms., Clinical Implications: Universal SBMT is not recommended in this format in early adolescence. Future research should explore social-emotional learning programmes adapted to the unique needs of young people., Competing Interests: Competing interests: WK is the director of the Oxford Mindfulness Centre and receives royalties for several books on mindfulness. JMGW is former director of the Oxford Mindfulness Centre and receives royalties for several books on mindfulness., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Published
2022
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26. Update to the effectiveness and cost-effectiveness of a mindfulness training programme in schools compared with normal school provision (MYRIAD): study protocol for a randomised controlled trial.

Author

Montero-Marin J, Nuthall E, Byford S, Crane C, Dalgleish T, Ford T, Ganguli P, Greenberg MT, Ukoumunne OC, Viner RM, Williams JMG, and Kuyken W

Subjects
Adolescent, COVID-19, Humans, Mental Health, Mindfulness economics, Pandemics, Randomized Controlled Trials as Topic, Treatment Outcome, Cost-Benefit Analysis, Mindfulness education, Schools
Abstract

Background: MYRIAD (My Resilience in Adolescence) is a superiority, parallel group, cluster randomised controlled trial designed to examine the effectiveness and cost-effectiveness of a mindfulness training (MT) programme, compared with normal social and emotional learning (SEL) school provision to enhance mental health, social-emotional-behavioural functioning and well-being in adolescence. The original trial protocol was published in Trials (accessible at https://doi.org/10.1186/s13063-017-1917-4 ). This included recruitment in two cohorts, enabling the learning from the smaller first cohort to be incorporated in the second cohort. Here we describe final amendments to the study protocol and discuss their underlying rationale., Methods: Four major changes were introduced into the study protocol: (1) there were changes in eligibility criteria, including a clearer operational definition to assess the degree of SEL implementation in schools, and also new criteria to avoid experimental contamination; (2) the number of schools and pupils that had to be recruited was increased based on what we learned in the first cohort; (3) some changes were made to the secondary outcome measures to improve their validity and ability to measure constructs of interest and to reduce the burden on school staff; and (4) the current Coronavirus Disease 2019 (SARS-CoV-2 or COVID-19) pandemic both influences and makes it difficult to interpret the 2-year follow-up primary endpoint results, so we changed our primary endpoint to 1-year follow-up., Discussion: These changes to the study protocol were approved by the Trial Management Group, Trial Steering Committee and Data and Ethics Monitoring Committees and improved the enrolment of participants and quality of measures. Furthermore, the change in the primary endpoint will give a more reliable answer to our primary question because it was collected prior to the COVID-19 pandemic in both cohort 1 and cohort 2. Nevertheless, the longer 2-year follow-up data will still be acquired, although this time-point will be now framed as a second major investigation to answer some new important questions presented by the combination of the pandemic and our study design., Trial Registration: International Standard Randomised Controlled Trials ISRCTN86619085 . Registered on 3 June 2016.

Published
2021
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