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106. Human placental cytotrophoblast epigenome dynamics over gestation and alterations in placental disease

Author

Zhang, Bo, Kim, M Yvonne, Elliot, GiNell, Zhou, Yan, Zhao, Guangfeng, Li, Daofeng, Lowdon, Rebecca F, Gormley, Matthew, Kapidzic, Mirhan, Robinson, Joshua F, McMaster, Michael T, Hong, Chibo, Mazor, Tali, Hamilton, Emily, Sears, Renee L, Pehrsson, Erica C, Marra, Marco A, Jones, Steven JM, Bilenky, Misha, Hirst, Martin, Wang, Ting, Costello, Joseph F, and Fisher, Susan J

Subjects
Biological Sciences, Genetics, Human Genome, Clinical Research, Pediatric Research Initiative, Contraception/Reproduction, Biotechnology, Pediatric, 1.1 Normal biological development and functioning, Aetiology, Underpinning research, 2.1 Biological and endogenous factors, Reproductive health and childbirth, Good Health and Well Being, Acetylation, DNA Methylation, Enhancer Elements, Genetic, Epigenome, Female, Gene Expression Regulation, Developmental, Gestational Age, Histones, Humans, Lysine, Placenta Diseases, Pre-Eclampsia, Pregnancy, Protein Processing, Post-Translational, Trophoblasts, DNA methylation, H3K27ac, H3K9me3, chorionic villi, cytotrophoblast, gestational regulation, histone modification, human placenta, placental disease, preeclampsia, Medical and Health Sciences, Developmental Biology, Biochemistry and cell biology
Abstract

The human placenta and its specialized cytotrophoblasts rapidly develop, have a compressed lifespan, govern pregnancy outcomes, and program the offspring's health. Understanding the molecular underpinnings of these behaviors informs development and disease. Profiling the extraembryonic epigenome and transcriptome during the 2nd and 3rd trimesters revealed H3K9 trimethylation overlapping deeply DNA hypomethylated domains with reduced gene expression and compartment-specific patterns that illuminated their functions. Cytotrophoblast DNA methylation increased, and several key histone modifications decreased across the genome as pregnancy advanced. Cytotrophoblasts from severe preeclampsia had substantially increased H3K27 acetylation globally and at genes that are normally downregulated at term but upregulated in this syndrome. In addition, some cases had an immature pattern of H3K27ac peaks, and others showed evidence of accelerated aging, suggesting subtype-specific alterations in severe preeclampsia. Thus, the cytotrophoblast epigenome dramatically reprograms during pregnancy, placental disease is associated with failures in this process, and H3K27 hyperacetylation is a feature of severe preeclampsia.

Published
2021

107. The transcriptional landscape of Shh medulloblastoma.

Author

Skowron, Patryk, Farooq, Hamza, Cavalli, Florence MG, Morrissy, A Sorana, Ly, Michelle, Hendrikse, Liam D, Wang, Evan Y, Djambazian, Haig, Zhu, Helen, Mungall, Karen L, Trinh, Quang M, Zheng, Tina, Dai, Shizhong, Stucklin, Ana S Guerreiro, Vladoiu, Maria C, Fong, Vernon, Holgado, Borja L, Nor, Carolina, Wu, Xiaochong, Abd-Rabbo, Diala, Bérubé, Pierre, Wang, Yu Chang, Luu, Betty, Suarez, Raul A, Rastan, Avesta, Gillmor, Aaron H, Lee, John JY, Zhang, Xiao Yun, Daniels, Craig, Dirks, Peter, Malkin, David, Bouffet, Eric, Tabori, Uri, Loukides, James, Doz, François P, Bourdeaut, Franck, Delattre, Olivier O, Masliah-Planchon, Julien, Ayrault, Olivier, Kim, Seung-Ki, Meyronet, David, Grajkowska, Wieslawa A, Carlotti, Carlos G, de Torres, Carmen, Mora, Jaume, Eberhart, Charles G, Van Meir, Erwin G, Kumabe, Toshihiro, French, Pim J, Kros, Johan M, Jabado, Nada, Lach, Boleslaw, Pollack, Ian F, Hamilton, Ronald L, Rao, Amulya A Nageswara, Giannini, Caterina, Olson, James M, Bognár, László, Klekner, Almos, Zitterbart, Karel, Phillips, Joanna J, Thompson, Reid C, Cooper, Michael K, Rubin, Joshua B, Liau, Linda M, Garami, Miklós, Hauser, Peter, Li, Kay Ka Wai, Ng, Ho-Keung, Poon, Wai Sang, Yancey Gillespie, G, Chan, Jennifer A, Jung, Shin, McLendon, Roger E, Thompson, Eric M, Zagzag, David, Vibhakar, Rajeev, Ra, Young Shin, Garre, Maria Luisa, Schüller, Ulrich, Shofuda, Tomoko, Faria, Claudia C, López-Aguilar, Enrique, Zadeh, Gelareh, Hui, Chi-Chung, Ramaswamy, Vijay, Bailey, Swneke D, Jones, Steven J, Mungall, Andrew J, Moore, Richard A, Calarco, John A, Stein, Lincoln D, Bader, Gary D, Reimand, Jüri, Ragoussis, Jiannis, Weiss, William A, Marra, Marco A, Suzuki, Hiromichi, and Taylor, Michael D

Subjects
Humans, Medulloblastoma, Cerebellar Neoplasms, Signal Transduction, Gene Expression Regulation, Neoplastic, Adolescent, Adult, Middle Aged, Child, Child, Preschool, Infant, Female, Male, Hedgehog Proteins, Gene Regulatory Networks, Genetic Variation, Young Adult, Transcriptome, Pediatric Research Initiative, Brain Cancer, Pediatric, Rare Diseases, Genetics, Pediatric Cancer, Clinical Research, Brain Disorders, Neurosciences, Biotechnology, Human Genome, Cancer, 2.1 Biological and endogenous factors
Abstract

Sonic hedgehog medulloblastoma encompasses a clinically and molecularly diverse group of cancers of the developing central nervous system. Here, we use unbiased sequencing of the transcriptome across a large cohort of 250 tumors to reveal differences among molecular subtypes of the disease, and demonstrate the previously unappreciated importance of non-coding RNA transcripts. We identify alterations within the cAMP dependent pathway (GNAS, PRKAR1A) which converge on GLI2 activity and show that 18% of tumors have a genetic event that directly targets the abundance and/or stability of MYCN. Furthermore, we discover an extensive network of fusions in focally amplified regions encompassing GLI2, and several loss-of-function fusions in tumor suppressor genes PTCH1, SUFU and NCOR1. Molecular convergence on a subset of genes by nucleotide variants, copy number aberrations, and gene fusions highlight the key roles of specific pathways in the pathogenesis of Sonic hedgehog medulloblastoma and open up opportunities for therapeutic intervention.

Published
2021

113. Whole-genome characterization of lung adenocarcinomas lacking the RTK/RAS/RAF pathway

Author

Carrot-Zhang, Jian, Yao, Xiaotong, Devarakonda, Siddhartha, Deshpande, Aditya, Damrauer, Jeffrey S, Silva, Tiago Chedraoui, Wong, Christopher K, Choi, Hyo Young, Felau, Ina, Robertson, A Gordon, Castro, Mauro AA, Bao, Lisui, Rheinbay, Esther, Liu, Eric Minwei, Trieu, Tuan, Haan, David, Yau, Christina, Hinoue, Toshinori, Liu, Yuexin, Shapira, Ofer, Kumar, Kiran, Mungall, Karen L, Zhang, Hailei, Lee, Jake June-Koo, Berger, Ashton, Gao, Galen F, Zhitomirsky, Binyamin, Liang, Wen-Wei, Zhou, Meng, Moorthi, Sitapriya, Berger, Alice H, Collisson, Eric A, Zody, Michael C, Ding, Li, Cherniack, Andrew D, Getz, Gad, Elemento, Olivier, Benz, Christopher C, Stuart, Josh, Zenklusen, JC, Beroukhim, Rameen, Chang, Jason C, Campbell, Joshua D, Hayes, D Neil, Yang, Lixing, Laird, Peter W, Weinstein, John N, Kwiatkowski, David J, Tsao, Ming S, Travis, William D, Khurana, Ekta, Berman, Benjamin P, Hoadley, Katherine A, Robine, Nicolas, Network, TCGA Research, Arora, Kanika, Shah, Minita, Shelton, Jennifer, Bowlby, Reanne, Friedl, Verena, Goldman, Mary, Craft, Brian, Heiman, David I, Hajirasouliha, Iman, Ricketts, Camir, Anur, Pavana, Chiotti, Kami E, Caesar-Johnson, Samantha J, Demchok, John A, Ferguson, Martin L, Kemal, Anab, Tarnuzzer, Roy, Wang, Zhining, Yang, Liming, Spellman, Paul T, Raphael, Benjamin, Akbani, Rehan, Zhu, Jingchun, Jones, Steven JM, Shen, Hui, Meyerson, Matthew, Govindan, Ramaswamy, and Imielinski, Marcin

Subjects
Biological Sciences, Cancer Genomics, Human Genome, Rare Diseases, Lung, Lung Cancer, Cancer, Genetics, Biotechnology, 2.1 Biological and endogenous factors, Good Health and Well Being, Adenocarcinoma of Lung, Humans, Kelch-Like ECH-Associated Protein 1, Lung Neoplasms, Tachykinins, Whole Genome Sequencing, TCGA Research Network, TCGA, driver, genome analysis, lung adenocarcinoma, noncoding, oncogene, precision oncology, structural variation, tumor suppressor, whole genome sequencing, Biochemistry and Cell Biology, Medical Physiology, Biological sciences
Abstract

RTK/RAS/RAF pathway alterations (RPAs) are a hallmark of lung adenocarcinoma (LUAD). In this study, we use whole-genome sequencing (WGS) of 85 cases found to be RPA(-) by previous studies from The Cancer Genome Atlas (TCGA) to characterize the minority of LUADs lacking apparent alterations in this pathway. We show that WGS analysis uncovers RPA(+) in 28 (33%) of the 85 samples. Among the remaining 57 cases, we observe focal deletions targeting the promoter or transcription start site of STK11 (n = 7) or KEAP1 (n = 3), and promoter mutations associated with the increased expression of ILF2 (n = 6). We also identify complex structural variations associated with high-level copy number amplifications. Moreover, an enrichment of focal deletions is found in TP53 mutant cases. Our results indicate that RPA(-) cases demonstrate tumor suppressor deletions and genome instability, but lack unique or recurrent genetic lesions compensating for the lack of RPAs. Larger WGS studies of RPA(-) cases are required to understand this important LUAD subset.

Published
2021

114. 'Possible Selves' in Practice: How Students at Further Education Colleges in England Conceptualise University

Author

Jones, Steven, Hordósy, Rita, Mittelmeier, Jenna, Quyoum, Aunam, and McCaldin, Tamsin

Abstract

This paper reports on a project in the North of England that looks at the college-to-university decision-making processes of non-traditional students through the conceptual lens of 'Possible Selves', as initially developed by Markus and Nurius (1986) and applied to higher education by Harrison (2018), Henderson (2019) and others. Our data involves in-depth interviews with young people, and with the college staff responsible for advising and guiding them, at Further Education Colleges from which the rate of transition to university is lower than the national average. Our findings show that young people talk about their 'like-to-be' and 'like-to-avoid' futures in complex and self-regulated ways, often moderating how they articulate aspiration to align with external discourses, such as those projected by college staff. Students also demonstrate a keen awareness of structural limits, effectively constructing future selves which, though 'elaborated', reflect counter-reading of dominant narratives around financial self-improvement as achieved via the 'full' university experience. The 'Possible Selves' approach is therefore found to be enabling as a mediating artefact for researchers, and valuable for identifying policy-relevant points of tension between students and their college staff.

Published
2022
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123. Analysis of Ugandan cervical carcinomas identifies human papillomavirus clade-specific epigenome and transcriptome landscapes.

Author

Gagliardi, Alessia, Porter, Vanessa L, Zong, Zusheng, Bowlby, Reanne, Titmuss, Emma, Namirembe, Constance, Griner, Nicholas B, Petrello, Hilary, Bowen, Jay, Chan, Simon K, Culibrk, Luka, Darragh, Teresa M, Stoler, Mark H, Wright, Thomas C, Gesuwan, Patee, Dyer, Maureen A, Ma, Yussanne, Mungall, Karen L, Jones, Steven JM, Nakisige, Carolyn, Novik, Karen, Orem, Jackson, Origa, Martin, Gastier-Foster, Julie M, Yarchoan, Robert, Casper, Corey, Mills, Gordon B, Rader, Janet S, Ojesina, Akinyemi I, Gerhard, Daniela S, Mungall, Andrew J, and Marra, Marco A

Subjects
Humans, Papillomaviridae, Papillomavirus Infections, Signal Transduction, DNA Methylation, Up-Regulation, Adult, Aged, Middle Aged, Uganda, Uterine Cervical Neoplasms, Female, Promoter Regions, Genetic, Transcriptome, Epigenome, Promoter Regions, Genetic, Developmental Biology, Biological Sciences, Medical and Health Sciences
Abstract

Cervical cancer is the most common cancer affecting sub-Saharan African women and is prevalent among HIV-positive (HIV+) individuals. No comprehensive profiling of cancer genomes, transcriptomes or epigenomes has been performed in this population thus far. We characterized 118 tumors from Ugandan patients, of whom 72 were HIV+, and performed extended mutation analysis on an additional 89 tumors. We detected human papillomavirus (HPV)-clade-specific differences in tumor DNA methylation, promoter- and enhancer-associated histone marks, gene expression and pathway dysregulation. Changes in histone modification at HPV integration events were correlated with upregulation of nearby genes and endogenous retroviruses.

Published
2020

124. Epigenomic programming in early fetal brain development

Author

Li, Luolan, Maire, Cecile L, Bilenky, Misha, Carles, Annaïck, Heravi-Moussavi, Alireza, Hong, Chibo, Tam, Angela, Kamoh, Baljit, Cho, Stephanie, Cheung, Dorothy, Li, Irene, Wong, Tina, Nagarajan, Raman P, Mungall, Andrew J, Moore, Richard, Wang, Ting, Kleinman, Claudia L, Jabado, Nada, Jones, Steven JM, Marra, Marco A, Ligon, Keith L, Costello, Joseph F, and Hirst, Martin

Subjects
Biological Sciences, Bioinformatics and Computational Biology, Stem Cell Research, Clinical Research, Neurosciences, Stem Cell Research - Nonembryonic - Non-Human, Genetics, Underpinning research, 1.1 Normal biological development and functioning, Neurological, Brain, Epigenesis, Genetic, Epigenome, Female, Fetus, Gene Expression Regulation, Developmental, Humans, Neural Stem Cells, Pregnancy, Transcriptome, Twins, brain, cortex, DNA methylation, enhancer, epigenetics, fetal, ganglionic eminence, gestational week, neural progenitor cells, transcriptional network, Clinical Sciences
Abstract

Aim: To provide a comprehensive understanding of gene regulatory networks in the developing human brain and a foundation for interpreting pathogenic deregulation. Materials & methods: We generated reference epigenomes and transcriptomes of dissected brain regions and primary neural progenitor cells (NPCs) derived from cortical and ganglionic eminence tissues of four normal human fetuses. Results: Integration of these data across developmental stages revealed a directional increase in active regulatory states, transcription factor activities and gene transcription with developmental stage. Consistent with differences in their biology, NPCs derived from cortical and ganglionic eminence regions contained common, region specific, and gestational week specific regulatory states. Conclusion: We provide a high-resolution regulatory network for NPCs from different brain regions as a comprehensive reference for future studies.

Published
2020

125. An associative learning account for retrieval-induced forgetting

Author

Hiatt, Laura M. and Jones, Steven J.

Subjects
associative learning, spreading activation, prim-ing, cognitive architecture, retrieval-induced forgetting
Abstract

Retrieval-induced forgetting (RIF) is a paradigm where re-peated study and cue-based retrieval of words impair retrievalof related, but unstudied, words. We present a process model,situated in the ACT-R/E cognitive architecture, that accountsfor the RIF task using the architecture’s overarching theory ofassociative learning. In this theory, studying words strengthenstheir association with their related cues; this, in turn, weakensthe association between those cues and any other words theyare related to. We show this account fits a recent dataset thatexplores cueing in the RIF task (Perfect et al., 2004).

Published
2020

126. Nutraceutical approaches to non-alcoholic fatty liver disease (NAFLD): A position paper from the International Lipid Expert Panel (ILEP)

Author

Acosta, Julio, Al-Khnifsawi, Mutaz, Alnouri, Fahad, Amar, Fahma, Atanasov, Atanas G., Bajraktari, Gani, Banach, Maciej, Gouni-Berthold, Ioanna, Bhaskar, Sonu, Bielecka-Dąbrowa, Agata, Bjelakovic, Bojko, Bruckert, Eric, Bytyçi, Ibadete, Cafferata, Alberto, Ceska, Richard, Cicero, Arrigo F.G., Chlebus, Krzysztof, Collet, Xavier, Daccord, Magdalena, Descamps, Olivier, Djuric, Dragan, Durst, Ronen, Ezhov, Marat V., Fras, Zlatko, Gaita, Dan, Hernandez, Adrian V., Jones, Steven R., Jozwiak, Jacek, Kakauridze, Nona, Kallel, Amani, Katsiki, Niki, Khera, Amit, Kostner, Karam, Kubilius, Raimondas, Latkovskis, Gustavs, John Mancini, G.B., David Marais, A., Martin, Seth S., Martinez, Julio Acosta, Mazidi, Mohsen, Mikhailidis, Dimitri P., Mirrakhimov, Erkin, Miserez, Andre R., Mitchenko, Olena, Mitkovskaya, Natalya P., Moriarty, Patrick M., Mohammad Nabavi, Seyed, Nair, Devaki, Panagiotakos, Demosthenes B., Paragh, György, Pella, Daniel, Penson, Peter E., Petrulioniene, Zaneta, Pirro, Matteo, Postadzhiyan, Arman, Puri, Raman, Reda, Ashraf, Reiner, Željko, Radenkovic, Dina, Rakowski, Michał, Riadh, Jemaa, Richter, Dimitri, Rizzo, Manfredi, Ruscica, Massimiliano, Sahebkar, Amirhossein, Serban, Maria-Corina, Shehab, Abdullah M.A, Shek, Aleksandr B., Sirtori, Cesare R., Stefanutti, Claudia, Tomasik, Tomasz, Toth, Peter P., Viigimaa, Margus, Valdivielso, Pedro, Vinereanu, Dragos, Vohnout, Branislav, von Haehling, Stephan, Vrablik, Michal, Wong, Nathan D., Yeh, Hung-I, Zhisheng, Jiang, Zirlik, Andreas, Colletti, Alessandro, Mancini, John, Marais, David, Moriarty, Patrick, and Cicero, Arrigo Francesco Giuseppe

Published
2023
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132. Failure of human rhombic lip differentiation underlies medulloblastoma formation

Author

Hendrikse, Liam D., Haldipur, Parthiv, Saulnier, Olivier, Millman, Jake, Sjoboen, Alexandria H., Erickson, Anders W., Ong, Winnie, Gordon, Victor, Coudière-Morrison, Ludivine, Mercier, Audrey L., Shokouhian, Mohammad, Suárez, Raúl A., Ly, Michelle, Borlase, Stephanie, Scott, David S., Vladoiu, Maria C., Farooq, Hamza, Sirbu, Olga, Nakashima, Takuma, Nambu, Shohei, Funakoshi, Yusuke, Bahcheli, Alec, Diaz-Mejia, J. Javier, Golser, Joseph, Bach, Kathleen, Phuong-Bao, Tram, Skowron, Patryk, Wang, Evan Y., Kumar, Sachin A., Balin, Polina, Visvanathan, Abhirami, Lee, John J. Y., Ayoub, Ramy, Chen, Xin, Chen, Xiaodi, Mungall, Karen L., Luu, Betty, Bérubé, Pierre, Wang, Yu C., Pfister, Stefan M., Kim, Seung-Ki, Delattre, Olivier, Bourdeaut, Franck, Doz, François, Masliah-Planchon, Julien, Grajkowska, Wieslawa A., Loukides, James, Dirks, Peter, Fèvre-Montange, Michelle, Jouvet, Anne, French, Pim J., Kros, Johan M., Zitterbart, Karel, Bailey, Swneke D., Eberhart, Charles G., Rao, Amulya A. N., Giannini, Caterina, Olson, James M., Garami, Miklós, Hauser, Peter, Phillips, Joanna J., Ra, Young S., de Torres, Carmen, Mora, Jaume, Li, Kay K. W., Ng, Ho-Keung, Poon, Wai S., Pollack, Ian F., López-Aguilar, Enrique, Gillespie, G. Yancey, Van Meter, Timothy E., Shofuda, Tomoko, Vibhakar, Rajeev, Thompson, Reid C., Cooper, Michael K., Rubin, Joshua B., Kumabe, Toshihiro, Jung, Shin, Lach, Boleslaw, Iolascon, Achille, Ferrucci, Veronica, de Antonellis, Pasqualino, Zollo, Massimo, Cinalli, Giuseppe, Robinson, Shenandoah, Stearns, Duncan S., Van Meir, Erwin G., Porrati, Paola, Finocchiaro, Gaetano, Massimino, Maura, Carlotti, Carlos G., Faria, Claudia C., Roussel, Martine F., Boop, Frederick, Chan, Jennifer A., Aldinger, Kimberly A., Razavi, Ferechte, Silvestri, Evelina, McLendon, Roger E., Thompson, Eric M., Ansari, Marc, Garre, Maria L., Chico, Fernando, Eguía, Pilar, Pérezpeña, Mario, Morrissy, A. Sorana, Cavalli, Florence M. G., Wu, Xiaochong, Daniels, Craig, Rich, Jeremy N., Jones, Steven J. M., Moore, Richard A., Marra, Marco A., Huang, Xi, Reimand, Jüri, Sorensen, Poul H., Wechsler-Reya, Robert J., Weiss, William A., Pugh, Trevor J., Garzia, Livia, Kleinman, Claudia L., Stein, Lincoln D., Jabado, Nada, Malkin, David, Ayrault, Olivier, Golden, Jeffrey A., Ellison, David W., Doble, Brad, Ramaswamy, Vijay, Werbowetski-Ogilvie, Tamra E., Suzuki, Hiromichi, Millen, Kathleen J., and Taylor, Michael D.

Published
2022
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135. Safe, Inclusive Public Transport in Africa—Challenges and Opportunities Identified in Ghana and Namibia

Author

Jones, Steven, Adanu, Emmanuel, Adams, Charles, Ambunda, Robert, Angelidou, Margarita, Editorial Board Member, Farnaz Arefian, Fatemeh, Editorial Board Member, Batty, Michael, Editorial Board Member, Davoudi, Simin, Editorial Board Member, DeVerteuil, Geoffrey, Editorial Board Member, González Pérez, Jesús M., Editorial Board Member, Hess, Daniel B., Editorial Board Member, Jones, Paul, Editorial Board Member, Karvonen, Andrew, Editorial Board Member, Kirby, Andrew, Editorial Board Member, Kropf, Karl, Editorial Board Member, Lucas, Karen, Editorial Board Member, Maretto, Marco, Editorial Board Member, Modarres, Ali, Editorial Board Member, Neuhaus, Fabian, Editorial Board Member, Nijhuis, Steffen, Editorial Board Member, Aráujo de Oliveira, Vitor Manuel, Editorial Board Member, Silver, Christopher, Editorial Board Member, Strappa, Giuseppe, Editorial Board Member, Vojnovic, Igor, Editorial Board Member, Yamu, Claudia, Editorial Board Member, Zhao, Qunshan, Editorial Board Member, Acheampong, Ransford A., editor, Poku-Boansi, Michael, editor, and Uzondu, Chinebuli, editor

Published
2022
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145. Optically Controlled Stochastic Jumps of Individual Gold Nanorod Rotary Motors

Author

Shao, Lei, Andrén, Daniel, Jones, Steven, Johansson, Peter, and Käll, Mikael

Subjects
Physics - Optics
Abstract

Brownian microparticles diffusing in optical potential energy landscapes constitute a generic testbed for nonequilibrium statistical thermodynamics and has been used to emulate a wide variety of physical systems, ranging from Josephson junctions to Stirling engines. Here we demonstrate that it is possible to scale down this approach to nanometric length-scales by constructing a tilted washboard potential for the rotation of plasmonic gold nanorods. The potential depth and tilt can be precisely adjusted by modulating the light polarization. This allows for a gradual transition from continuous rotation to discrete stochastic jumps, which are found to follow Kramers dynamics in excellent agreement with stochastic simulations. The results widen the possibilities for fundamental experiments in statistical physics and provide new insights in how to construct light-driven nanomachines and multifunctional sensing elements., Comment: 6 pages, 4 figures

Published
2018
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150. Web-based intervention to improve quality of life in late stage bipolar disorder (ORBIT): randomised controlled trial protocol

Author

Fletcher, Kathryn, Foley, Fiona, Thomas, Neil, Michalak, Erin, Berk, Lesley, Berk, Michael, Bowe, Steve, Cotton, Sue, Engel, Lidia, Johnson, Sheri L, Jones, Steven, Kyrios, Michael, Lapsley, Sara, Mihalopoulos, Cathrine, Perich, Tania, and Murray, Greg

Subjects
Health Services and Systems, Health Sciences, Mental Health, Prevention, Clinical Trials and Supportive Activities, Cost Effectiveness Research, Health Services, Comparative Effectiveness Research, Clinical Research, Behavioral and Social Science, Serious Mental Illness, Brain Disorders, Bipolar Disorder, Depression, 6.6 Psychological and behavioural, Management of diseases and conditions, Evaluation of treatments and therapeutic interventions, 7.1 Individual care needs, Mental health, Good Health and Well Being, Affect, Cost-Benefit Analysis, Female, Humans, Internet, Male, Middle Aged, Mindfulness, Psychiatric Status Rating Scales, Quality of Life, Self-Management, Therapy, Computer-Assisted, Randomised controlled trial, Bipolar disorder, Web-based intervention, Psychoeducation, Quality of life, Stage, Mania, Clinical Sciences, Public Health and Health Services, Psychology, Psychiatry, Clinical sciences, Epidemiology, Clinical and health psychology
Abstract

BackgroundThe primary objective of this randomised controlled trial (RCT) is to establish the effectiveness of a novel online quality of life (QoL) intervention tailored for people with late stage (≥ 10 episodes) bipolar disorder (BD) compared with psychoeducation. Relative to early stage individuals, this late stage group may not benefit as much from existing psychosocial treatments. The intervention is a guided self-help, mindfulness based intervention (MBI) developed in consultation with consumers, designed specifically for web-based delivery, with email coaching support.Methods/designThis international RCT will involve a comparison of the effectiveness and cost-effectiveness of two 5-week adjunctive online self-management interventions: Mindfulness for Bipolar 2.0 and an active control (Psychoeducation for Bipolar). A total of 300 participants will be recruited primarily via social media channels. Main inclusion criteria are: a diagnosis of BD (confirmed via a phone-administered structured diagnostic interview), no current mood episode, history of 10 or more mood episodes, no current psychotic features or active suicidality, under the care of a medical practitioner. Block randomisation will be used for allocation to the interventions, and participants will retain access to the program for 6 months. Evaluations will be conducted at pre- and post- treatment, and at 3- and 6- months follow-up. The primary outcome measure will be the Brief Quality of Life in Bipolar Disorder Scale (Brief QoL.BD), collected immediately post-intervention at 5 weeks (T1). Secondary measures include BD-related symptoms (mania, depression, anxiety, stress), time to first relapse, functioning, sleep quality, social rhythm stability and resource use. Measurements will be collected online and via telephone assessments at baseline (T0), 5 weeks (T1), three months (T2) and six months (T3). Candidate moderators (diagnosis, anxiety or substance comorbidities, demographics and current treatments) will be investigated as will putative therapeutic mechanisms including mindfulness, emotion regulation and self-compassion. A cost-effectiveness analysis will be conducted. Acceptability and any unwanted events (including adverse treatment reactions) will be documented and explored.DiscussionThis definitive trial will test the effectiveness and cost-effectiveness of a novel QoL focused, mindfulness based, online guided self-help intervention for late stage BD, and investigate its putative mechanisms of therapeutic action.Trial registrationClinicalTrials.gov : NCT03197974 . Registered 23 June 2017.

Published
2018

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