A randomized controlled trial of a therapist-guided online intervention for depressed adults and its utility as an adjunctive to antidepressants and psychotherapy by Manuel Heinrich, Pavle Zagorscak, Christina Kampisiou, Johannes Bohn, Lars Schulze, Carmen Schaeuffele, Annette Brose, Christine Knaevelsrud

“…Moreover, little evidence is available if IBI has an add-on effect for individuals already receiving an evidence-based treatment such as antidepressants and/or psychotherapy. Method This parallel, two-arm RCT (1:1 allocation ratio, simple randomization) examines the effectiveness of a therapist-guided cognitive-behavioral IBI compared to unstandardized CAU in a self-selected sample of adults (≥ 18 years). …”
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Effectiveness of a Mobile Phone-Delivered Multiple Health Behavior Change Intervention (LIFE4YOUth) in Adolescents: Randomized Controlled Trial by Anna Seiterö, Pontus Henriksson, Kristin Thomas, Hanna Henriksson, Marie Löf, Marcus Bendtsen, Ulrika Müssener

“…Our results provide inconclusive evidence regarding weekly alcohol consumption and smoking abstinence. Trial RegistrationISRCTN Registry ISRCTN34468623; https://doi.org/10.1186/ISRCTN34468623…”
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Randomised controlled trial in an experimental online supermarket testing the effects of front-of-pack nutrition labelling on food purchasing intentions in a low-income population by Pilar Galan, Camille Buscail, Sandrine Péneau, Serge Hercberg, Chantal Julia, Raphaël Porcher, Philippe Ravaud, Isabelle Boutron, Emmanuelle Kesse-Guyot, Mathilde Touvier, Manon Egnell, Pauline Ducrot

“…The present study assessed the effects of the Nutri-Score on the nutritional quality of purchasing intentions among low-income individuals, compared with the current French labelling situation: references intakes (RIs) and no label, using a three-arm parallel-group randomised controlled trial.Methods Low-income active adults from the NutriNet-Santé cohort (household income below €1200/month) were asked to perform a shopping task in an experimental online supermarket after being randomised in one of the three conditions (Nutri-Score, RIs or no labelling). …”
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Community Occupational Therapy for people with dementia and family carers (COTiD-UK) versus treatment as usual (Valuing Active Life in Dementia [VALID]) study: A single-blind, rand... by Jennifer Wenborn, Aidan G O'Keeffe, Gail Mountain, Esme Moniz-Cook, Michael King, Rumana Z Omar, Jacqueline Mundy, Jane Burgess, Fiona Poland, Stephen Morris, Elena Pizzo, Myrra Vernooij-Dassen, David Challis, Susan Michie, Ian Russell, Catherine Sackley, Maud Graff, Tom Swinson, Nadia Crellin, Sinéad Hynes, Jacki Stansfeld, Martin Orrell

“…<h4>Methods and findings</h4>The study design was a multicentre, 2-arm, parallel-group, assessor-masked, individually randomised controlled trial (RCT) with internal pilot. …”
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DIAMONDS—a diabetes self-management intervention for people with severe mental illness: protocol for an individually randomised controlled multicentre trial by Tim Doran, Najma Siddiqi, Simon Gilbody, Rowena Jacobs, Patrick Doherty, Catherine Hewitt, Laura Mandefield, Simon Walker, Ian Kellar, Sarah Alderson, David Osborn, Vicki Johnson, Judith Watson, Gregor Russell, Steve Parrott, Jan Rasmus Boehnke, Peter A Coventry, Jinshuo Li, Richard Ian Gregory Holt, Judy Wright, David Shiers, Michelle Hadjiconstantinou, Keith Double, Claire Carswell, Jennifer V E Brown, Lucy Sheehan, Grace Catherine O’Carroll, Charlie Peck, R A Ajjan, Angela Ross, Mark Dawson

“…The DIAMONDS trial aims to evaluate the clinical and cost effectiveness of a novel, codesigned, supported diabetes self-management programme for people with T2DM and SMI.Methods and analysis This multicentre, two-armed, parallel, individually randomised controlled trial will be conducted in National Health Service mental health trusts across England. …”
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High-flow oxygen for children’s airway surgery: randomised controlled trial protocol (HAMSTER) by Julia Taylor, Kristen Gibbons, Susan Humphreys, Tara Williams, Andreas Schibler, Britta Sylvia von Ungern-Sternberg, Andrew Davidson, Justin Skowno, Fiona Taverner, Laura Burgoyne, David Sommerfield, Philip Stephens, Ben Hallett, Shyan Vijayasekaran, Nicola Slee, Hannah Burns, Marcin Sowa

“…The primary manuscript will be submitted for publication in a peer-reviewed journal.Trial registration number The HAMSTER is registered with the Australia and New Zealand Clinical TrialsRegistry: ACTRN12618000949280.…”
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Cognitive behavioural therapy in comparison to treatment as usual in young adults at high risk of developing bipolar disorder (Bipolar At Risk): a randomised controlled trial to in... by Sophie Parker, Lydia Pearson, Rebekah Carney, Richard P. Bentall, Matthew R. Broome, Emma Cernis, Timothy Clarke, Steven Jones, Katherine Moran, Jonathan Wilson, Isabel Coleman, Catherine Hewitt, Wendy Jones, Heather Law, Sarah Peters, Gemma Shields, David Shiers, Luke Strachan, Anton Strong, Judith Watson, Chris J. Sutton

“…Methods A multicentre, rater-masked randomised controlled trial with two parallel arms will compare cognitive behaviour therapy (CBT) for young people meeting BAR criteria (CBTBAR) + Treatment as Usual (TAU) vs. …”
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Chatbot-Delivered Stage of Change–Tailored Web-Based Intervention to Promote Physical Activity Among Inactive Community-Dwelling People Aged 65 years or More: Protocol for a Random... by Xue Liang, Fenghua Sun, Qingpeng Zhang, Yuan Fang, Fuk-yuen Yu, Danhua Ye, Borui Zhang, Qianwen Liao, Phoenix KH Mo, Zixin Wang

“…MethodsThis is a partially blinded (outcome assessors and data analysts) and parallel-group RCT. A total of 278 inactive community-dwelling people aged 65 years or more will be randomized evenly into either an intervention group or a control group. …”
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Effect of CYP3A4 inhibitor and induction on the pharmacokinetics and safety of FHND9041, a novel EGFR T790M inhibitor, in healthy Chinese by Chang Lu, Dongmei Cheng, Yunqiu Xie, Minghong Shang, Rongzhen Chen, Yongqiang Zhu, Jian Gong, Huan Zhou

“…Patients and methods This study employed a single-center, open-label, fixed-sequence design, comprising two parallel groups: Group 1 received FHND9041 40 mg in combination with Itraconazole, while Group 2 received Rifampicin in combination with FHND9041 80 mg. …”
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Evaluating the Effectiveness of a Roblox Video Game (Super U Story) in Improving Body Image Among Children and Adolescents in the United States: Randomized Controlled Trial by Nicole Paraskeva, Sharon Haywood, Jason Anquandah, Paul White, Mahira Budhraja, Phillippa C Diedrichs, Heidi Williamson

“…MethodsOverall, 1059 US-based girls and boys (n=460, 43.4% girls) aged 9 to 13 years (mean age 10.9, SD 1.36 years) from diverse ethnic, socioeconomic, and geographic backgrounds were recruited online via a research agency into a 3-arm, online, parallel randomized controlled trial. Participants were assigned to an intervention group, active control group (a Roblox game called Rainbow Friends 2 Story [Color Story]), or attention control group (web-based word search). …”
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Clinical and cost-effectiveness of an online-delivered group-based pain management programme in improving pain-related disability for people with persistent pain—protocol for a non... by Anthony Dowell, Sarah Gerard Dean, Leigh Hale, Andrew R Gray, Tristram Ingham, Bernadette Jones, Cheryl Davies, Rebecca Grainger, William Leung, Meredith Perry, Hemakumar Devan, Dagmar Hempel, Jessica Mills, Barbara Saipe, Edward Shipton

“…Phase II: The proposed iSelf-help trial is a pragmatic, multicentred, assessor-blinded, two-arm, parallel group, non-inferiority randomised controlled trial. …”
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Randomised placebo-controlled trial of combination ACE inhibitor and beta-blocker therapy to prevent cardiomyopathy in children with Duchenne muscular dystrophy? (DMD Heart Protect... by John P Bourke, Gillian Watson, Francesco Muntoni, Stefan Spinty, Helen Roper, Michela Guglieri, Chris Speed, Elaine McColl, Ashish Chikermane, Sandeep Jayawant, Satish Adwani, Tracey Willis, Jennifer Wilkinson, Andrew Bryant, Thomas Chadwick, Ruth Wood, Kate Bushby

“…Methods and analysis We are conducting a multicentre, parallel group, randomised, placebo-controlled study of combination therapy with an ACE inhibitor (perindopril) and a beta-blocker (bisoprolol) in boys with DMD aged 5–13 years, with normal LV function by echocardiographic criteria at the time of recruitment. …”
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The promoting effects of digital targeted cognitive training in medication treatment for children with ADHD: a randomized controlled trial by Chen Dang, Yu Zhu, Xiangsheng Luo, Lu Liu, Yuan Feng, Guisen Wu, Shaogen Zhong, Xin Wang, Jianzhao Zhang, Yike Zhu, Siqi Liu, Ziqi Liu, Li Qin, Xiaohui Ma, Yufeng Wang, Xiaoyi Wang, Jian Yang, Changming Wang, Li Sun

“…Methods This was a randomized parallel-group controlled trial. A total of 124 children with ADHD were randomly allocated to two groups: 64 received medication treatment alone (M), including atomoxetine (ATX) and methylphenidate (MPH); 60 received targeted cognitive training combined with medication (TCT + M), including TCT + ATX and TCT + MPH. …”
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Clinical and cost-effectiveness of a diabetes education and behavioural weight management programme versus a diabetes education programme in adults with a recent diagnosis of type... by Jennifer Bostock, Robbie Duschinsky, Stephen J Sharp, Stephen Morris, Simon J Griffin, Brett Doble, Alan Brennan, Amy L Ahern, Jenny Woolston, Emma Wells, Nazrul Islam, Emma Ruth Lawlor, Andrew J Hill, Ed Wilson, Carly A Hughes, Clare Boothby

“…Findings will be published in peer-reviewed scientific journals and communicated to other stakeholders as appropriate.Trial registration number ISRCTN18399564.…”
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Multicentre, randomised, open-label, phase IV–III study to evaluate the efficacy of cloxacillin plus fosfomycin versus cloxacillin alone in adult patients with methicillin-suscepti... by Joaquin López-contreras, Josep M Miró, Cristian Tebe, Jordi Carratalà, Guillermo Cuervo, Oriol Gasch, Miquel Pujol, Esther Calbo, Yolanda Meije, Ariadna Padullés, Sebastian Videla, José M Aguado, Francesca Gioia, Luis Eduardo López-Cortés, Sara Grillo, Rafael San-Juan, Silvia Gomez-Zorrilla, Aina Gomila-Grange, Simona Iftimie, Graciano Garcia-Pardo, Lucía Boix-Palop, Isabel Oriol, Alfredo Jover-Sáenz, Gorane Euba, Malen Aguirregabiria, Maria Jose Garcia-Pais, Jose Ramón Paño, Maria Luisa Pedro-Botet, Rosa Maria Benítez, Maria Teresa Pérez-Rodríguez, Maria Belén Loeches-Yagüe, Gertrudis Horna, Damaris Berbel, Maria Ángeles Domínguez, Sara Cobo, Pilar Hereu, Natàlia Pallarés

“…The results will be presented at international meetings and will be made available to patients and funders.Trial registration number The protocol has been approved by AEMPS with the Trial Registration Number EudraCT 2018-001207-37. …”
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Clinical effectiveness and cost-effectiveness of the rehabilitation enablement in chronic heart failure facilitated self-care rehabilitation intervention for people with heart fail... by John G F Cleland, Kate Jolly, Christi Deaton, Louise Taylor, Rod S Taylor, Aynsley Cowie, Alex McConnachie, Julia Frost, Colin Greaves, Chim C Lang, Emma McIntosh, Valerie Smith, Samantha van Beurden, Patrick J Doherty, Hasnain M Dalal, Tracy Ibbotson, Melvyn Hillsdon, Anna Placzek, Jessica C Bollen, Iain Squire, Emma Burrell, Nick Hartshorne-Evans, Elizabeth A Thomson, Claire O’Hare, Katie Dudman, Heather Fraser, Mohammad Jarallah

“…Results will be disseminated via peer-reviewed journal publication and conference presentations to researchers, service users and policymakers.Trial registration number ISRCTN47894539.…”
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ENHANCE-D: protocol for a pragmatic, 3-arm, randomised controlled trial comparing the impact of enhanced smoking cessation interventions to very brief advice for adult smokers in d... by Richard Holliday, Nina Wilson, Vicky Ryan, Chrissie Butcher, Tara Homer, Philippa Watts, Dorcas Kareithi, Paul Blaylock, Laura Ternent, Roland Finch, Susan M. Bissett, Adam Todd, Helen Hancock, Fiona Ellwood, David I. Conway, Nicholas S. Jakubovics, Ralf Kist, Richard D. Holmes, Linda Bauld, Philip M. Preshaw, Elaine McColl

“…Methods The ENHANCE-D trial is a multi-centre, pragmatic, definitive, 3-arm, parallel group, individually randomised controlled superiority trial, including an internal pilot, conducted in NHS dental settings. …”
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A randomised controlled trial of amygdala fMRI-neurofeedback versus sham-feedback in borderline-personality disorder – systematic literature review and introduction to the BrainSTE... by Christian Paret, Miroslava Jindrová, Nikolaus Kleindienst, Judith Eck, Hester Breman, Michael Lührs, Beatrix Barth, Thomas Ethofer, Andreas J. Fallgatter, Rainer Goebel, Andreas Hoell, Denise Lockhofen, Annika S. Reinhold, Simon Maier, Swantje Matthies, Christoph Mulert, Christian Schönholz, Ludger Tebartz van Elst, Christian Schmahl

“…This trial is a multi-center, patient- and investigator-blind, randomized, parallel-group superiority study with a planned interim-analysis once half of the recruitment target is met (N = 82). …”
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The effectiveness of convalescent plasma administered on the first day of admission for COVID-19 patients: an open-label randomized controlled trial by Saeed Mohammadi, Mandana Pouladzadeh, Hamidreza Kouhpayeh, Shamsi Okati, Mehdi Safdarian, Peyman Eshghi, Parastoo Moradi Choghakabodi, Shahabeddin Mashaei, Sharareh Sanei Sistani, Yalda Khani, Soheila Nasizadeh, Ahmad Reza Shamshiri, Amir Teimourpour, Haijuan Wang

“…Overall, the treatment appears to have few side effects, suggesting it may be a safe option for further evaluation in managing early COVID-19 symptoms. Trial registration:. This prospective, multicenter, two-parallel randomized controlled trial was prospectively registered in the Iranian Clinical Trials Registry (IRCT20200310046736N1).…”
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Longitudinal evidence for a mutually reinforcing relationship between white matter hyperintensities and cortical thickness in cognitively unimpaired older adults by Jose Bernal, Inga Menze, Renat Yakupov, Oliver Peters, Julian Hellmann-Regen, Silka Dawn Freiesleben, Josef Priller, Eike Jakob Spruth, Slawek Altenstein, Anja Schneider, Klaus Fliessbach, Jens Wiltfang, Björn H. Schott, Frank Jessen, Ayda Rostamzadeh, Wenzel Glanz, Enise I. Incesoy, Katharina Buerger, Daniel Janowitz, Michael Ewers, Robert Perneczky, Boris-Stephan Rauchmann, Stefan Teipel, Ingo Kilimann, Christoph Laske, Sebastian Sodenkamp, Annika Spottke, Anna Esser, Falk Lüsebrink, Peter Dechent, Stefan Hetzer, Klaus Scheffler, Stefanie Schreiber, Emrah Düzel, Gabriel Ziegler

“…Trial registration German Clinical Trials Register (DRKS00007966, 04/05/2015).…”
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