Study protocol for a randomised-controlled study on emotion regulation training for adolescents with major depression: the KONNI study by Ellen Greimel, Lisa Feldmann, Charlotte Piechaczek, Frans Oort, Jürgen Bartling, Martin Schulte-Rüther, Gerd Schulte-Körne

“…Previously, it has been shown in healthy adults that a task-based training in CR is efficient to reduce negative affect, and that these effects translate into everyday life.This randomised controlled trial examines for the first time whether a task-based training in CR proves effective in MD adolescents. …”
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Acceptance commitment therapy (ACT) for psychological distress associated with inflammatory bowel disease (IBD): protocol for a feasibility trial of the ACTforIBD programme by Richard Gearry, Matthew Fuller-Tyszkiewicz, Andrew McCombie, Peter Gibson, Simon Knowles, Lisa Olive, Antonina Mikocka-Walus, Subhadra Evans, Leanne Raven, Daniel Romano, Eric O, Madeleine Dober, Leesa van Niekerk, Susan Chesterman

“…This study aims to evaluate the feasibility and preliminary efficacy of ACTforIBD to reduce psychological distress in patients with IBD. Using a randomised controlled trial, 25 participants will be randomised to ACTforIBD, and 25 patients to an active control condition.Ethics and dissemination This protocol has been approved by Deakin University Research Ethics Committee in September 2021 (Ref. 2021-263) and the New Zealand Central Health and Disability Ethics Committee in December 2021 (Ref. 2021 EXP 11384). …”
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Outcomes of psychiatric interviews and self-rated symptom scales in people on sick leave for common mental disorders: an observational study by Cecilia Björkelund, Dominique Hange, Jeanette Westman, Anna Nager, Jonas Hällgren, Ingmarie Skoglund, Sandra af Winklerfelt Hammarberg, Anna Finnes

“…Secondary aims were to investigate length of sick leave by diagnoses on sick leave certificates, diagnoses made in structured interviews and symptom severity.Design Observational study consisting of a secondary analysis of data from a randomised controlled trial and an observational study.Setting The regions of Stockholm and Västra Götaland, Sweden.Participants 480 people on sick leave for common mental disorders.Interventions Participants were examined with structured psychiatric interviews and self-rated symptom severity scales.Outcome measures (1) Sick leave certificate diagnoses, (2) diagnoses from the Mini International Neuropsychiatric Interview and the Self-rated Stress-Induced Exhaustion Disorder (SED) Instrument (s-ED), (3) symptom severity (Montgomery-Asberg Depression Rating Scale-self-rating version and the Karolinska Exhaustion Disorder Scale) and (4) number of sick leave days.Results There was little correspondence between diagnoses on sick leave certificates and diagnoses made in structured psychiatric interviews. …”
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Effectiveness of Ai Chi as Aquatic Intervention for Balance Impairments in Community-dwelling Older Adults in India: A Randomised Controlled Study by Purnima Singh, Pratap Chandra Sarma

“…Materials and Methods: This randomised controlled trial investigated the effectiveness of Ai Chi compared to Conventional aquatic therapy (Control group) in improving balance among community-dwelling older adults. …”
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Preferences of people with type 2 diabetes for telemedical lifestyle programmes in Germany: protocol of a discrete choice experiment by Veronika Gontscharuk, Andrea Icks, Michael Roden, Markus Vomhof, Sandra Grobosch, Jana Sommer, Jan Dyczmons

“…The final DCE is being implemented within a randomised controlled trial for investigating whether participation in a telemedical lifestyle intervention programme sustainably improves the HbA1c values in 850 members of a large German statutory health insurance with T2DM. …”
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Point-of-care tests, diagnostic uncertainty and antimicrobial stewardship in the ICU: procalcitonin or PCR to aid antibiotic-stop decisions – an observational cohort study by Luke Moore, Suveer Singh, Martine Nurek, Nabeela Mughal, Timothy Lau, Archit Singhal

“…PCT was more popular than PCR-POCT, but PCR-POCT was more likely to aid stop decisions.Their comparison, role, utility and selective deployment for influencing antibiotic-stop decisions more effectively require a large randomised controlled trial.…”
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Effectiveness and active ingredients of social prescribing interventions targeting mental health: a systematic review by Darren Flynn, Jason Scott, Matthew Cooper, Leah Avery, Linda Errington, Kirsten Ashley, Cara Jordan

“…Fifteen studies were uncontrolled before-and-after designs, one a randomised controlled trial and one a matched groups design. …”
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Understanding how older people with mild frailty engage with behaviour change to support their independence: a qualitative study by Benjamin Gardner, Louise Marston, Kate R Walters, Vari M Drennan, Rachael Frost, Paul Chadwick, Rebecca L Gould, Yolanda Barrado-Martin, Sarah Gibson, Rekha Elaswarapu, Rashmi Kumar, Kalpa Kharicha, Tasmin Alanna Rookes, Christina Avgerinou, Jane Hopkins, Jessica Catchpole, Claire Jowett

“…Objectives To explore barriers and facilitators to behaviour change in older people with mild frailty.Design Qualitative study.Setting Community-dwelling older people living with mild frailty.Participants 64 older people with mild frailty, workers delivering the service and stakeholders.Methods Semistructured interviews were conducted between July 2022 and May 2023 with participants in a randomised controlled trial (‘HomeHealth’) of a 6-month, home-based, personalised goal setting intervention, based around the Capability-Opportunity-Motivation-Behaviour model. …”
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Does an increase in physiological indexes predict better cognitive performance: the PhyCog randomised cross-over protocol in type 2 diabetes by Frederic Dutheil, Guillaume T Vallet, Igor Tauveron, Julien S Baker, Valentin Magnon, Jordan Mille, Valentin Brusseau, Laetitia Silvert, Marie Izaute

“…This study’s primary aim was to examine if improved physiological indexes predict improved cognitive variables in the context of a clinical intervention programme for type 2 diabetes (T2D).Method and analysis PhyCog will be a 22-week randomised controlled trial comparing cognitive performance between three arms: (1) physical activity (1 month), a 15-day wash-out, then cognitive training (1 month), (2) cognitive training (1 month), a 15-day wash-out and physical activity (1 month), and (3) an active breathing condition (psychoeducation and resonance frequency breathing for 1 month), then a 15-day wash-out, and combined physical activity and cognitive training (1 month), allowing to determine the most effective intervention to prevent cognitive impairment associated with T2D. …”
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The Acute VertEbRal AugmentaTion (AVERT) study: protocol for a randomised controlled, feasibility trial of spinal medial branch nerve block in hospitalised older patients with vert... by Avril Drummond, Opinder Sahota, Simon Bishop, Dritan Pasku, Apostolos Fakis, Anastasios Bastounis, Chia Wei Tan, Maribel Cameron, Yuriy Arlachov, Michal Czernicki

“…We therefore propose a prospective feasibility randomised controlled trial (RCT) to compare the role of MBNB to VP, in hospitalised older patients.Method A parallel, two-arm RCT with participants allocated on a 1:1 ratio to either standard care-VP or MBNB in hospitalised patients aged over 70 with acute osteoporotic vertebral fractures. …”
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Economic evaluation of a randomized controlled trial comparing mifepristone and misoprostol with misoprostol alone in the treatment of early pregnancy loss. by Charlotte C Hamel, Marcus P L M Snijders, Sjors F P J Coppus, Frank P H A Vandenbussche, Didi D M Braat, Eddy M M Adang

“…<h4>Methods and findings</h4>A cost-effectiveness analysis (CEA) from a healthcare perspective was performed alongside a randomised controlled trial (RCT) in which standard treatment with misoprostol only was compared with a combination of mifepristone and misoprostol, in women with EPL after a minimum of one week of unsuccessful management. …”
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RadBone: bone toxicity following pelvic radiotherapy – a prospective randomised controlled feasibility study evaluating a musculoskeletal health package in women with gynaecologica... by Janelle Yorke, Sarah O’Connell, Sally Taylor, Karen Johnson, Robert G Bristow, Martin Eden, Kate Haslett, John Moore, Rohit Kochhar, Victoria Chatzimavridou Grigoriadou, Lisa H Barraclough, Ivona Baricevic-Jones, Zoe Merchant, Thomas Westwood, Anthony David Whetton, Claire E Higham

“…The RadBone randomised controlled trial (RCT) aims to determine the feasibility and acceptability of a musculoskeletal health package (MHP) intervention in women undergoing pelvic radiotherapy for gynaecological malignancies and to preliminary explore clinical effectiveness of the intervention.Methods and analysis The RadBone RCT will evaluate the addition to standard care of an MHP consisting of a physical assessment of the musculoskeletal health, a 3-month prehabilitation personalised exercise package, as well as an evaluation of the fracture risk and if required the prescription of appropriate bone treatment including calcium, vitamin D and—for high-risk individuals—bisphosphonates. …”
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Impact of a two-way short message service (SMS) to support maternally administered childhood mid-upper arm circumference monitoring and expand malnutrition screening in Kenya: the... by Jennifer A Unger, Barbra A Richardson, Kirkby D Tickell, Mareme M Diakhate, Jeanne L Goodman, Arianna Rubin Means, Keshet Ronen, Carol Levin, Esther M Choo, Catherine Achieng, Mary Masheti, Benson O Singa, Christine J McGrath

“…Mobile health (mHealth) programmes may provide an opportunity to rapidly identify malnourished children in the community and link them to care.Methods and analysis This randomised controlled trial will recruit 1200 children aged 6–12 months at routine vaccine appointments in Migori and Homa Bay Counties, Kenya. …”
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Can electronic monitoring with a digital smart spacer support personalised medication adherence and inhaler technique education in patients with asthma?: Protocol of the randomised... by Job F. M. van Boven, Boudewijn H.J. Dierick, Maria Achterbosch, Sandra Been-Buck, Titia Klemmeier, Susanne J. van de Hei, Paul Hagedoorn, Huib A.M. Kerstjens, Janwillem W.H. Kocks

“…The aim of this study is to assess the feasibility of undertaking a definitive randomised controlled trial of personalised, smart spacer data-driven education and explore clinical benefits.Methods and analysis We present the design of the multicentre, randomised controlled OUtcomes following Tailored Education and Retraining: Studying Performance and AdherenCE feasibility trial of 2 months. …”
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Detection of atrial fibrillation in primary care with radial pulse palpation, electronic blood pressure measurement and handheld single-lead electrocardiography: a diagnostic accur... by Wim A M Lucassen, Henk C P M van Weert, Bjorn Winkens, Henri E J H Stoffers, J André Knottnerus, Steven B Uittenbogaart, Nicole Verbiest-van Gurp, Petra M G Erkens

“…Objective To determine the diagnostic accuracy of three tests—radial pulse palpation, an electronic blood pressure monitor and a handheld single-lead ECG device—for opportunistic screening for unknown atrial fibrillation (AF).Design We performed a diagnostic accuracy study in the intention-to-screen arm of a cluster randomised controlled trial aimed at opportunistic screening for AF in general practice. …”
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Keeping Active with Texting after Stroke (KATS): a single-arm feasibility and acceptability study of a behavioural intervention to promote community-based physical activity after s... by Gozde Ozakinci, Stephan U Dombrowski, Andrew Murphy, Albert Farre, Jenna Breckenridge, Jacqui H Morris, Linda A Irvine, Keith Jenkinson

“…Based on these findings, KATS will be further optimised before evaluating effectiveness in a randomised controlled trial.Trial registration number and protocol availability ISRCTN 13704805 https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/keeping-active-with-texting-after-stroke-kats/Protocol available https://www.isrctn.com/ISRCTN13704805?…”
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Meals, Education, and Gardens for In-School Adolescents (MEGA): study protocol for a cluster randomised trial of an integrated adolescent nutrition intervention in Dodoma, Tanzania by Wafaie W Fawzi, Dongqing Wang, Abbas Ismail, Leonard Kamanga Katalambula, Andrea R Modest, Tara Young, Mary Mwanyika-Sando, Amani Tinkasimile, Dominic Mosha, Augustine Malero, Said Vuai

“…MEGA is a cluster-randomised controlled trial, including six public secondary schools assigned to three different arms. …”
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BSG 2024 IBD guidelines protocol (standard operating procedures) by Philip Smith, Rachel Cooney, Jimmy Limdi, Sreedhar Subramanian, Polychronis Pavlidis, Ajay Verma, Said Din, Gordon W Moran, Naila Arebi, Shahida Din, Morris Gordon, Kamal V Patel, Klaartje Bel Kok, Dennis McGonagle, Matthew Shale, Ana-Maria Darie, Vasiliki Sinopoulou, Newton A C S Wong

“…A final consensus list of thematic questions within a ‘patient, intervention, comparison, outcome’ format has been produced and agreed in the final phase of the Delphi process.There will be a detailed technical evidence review with source data including systematic reviews appraised with AMSATAR 2 tool (Assessment of multiple systematic reviews), randomised controlled trial data that will be judged for risk of bias with the Cochrane tool and observational studies for safety concerns assessed through the Robins-I tool. …”
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Protocol for the implementation evaluation of an integrated paediatric and primary care model: Strengthening Care for Children (SC4C) by Yvonne Zurynski, Susan Woolfenden, Peter D Hibbert, Harriet Hiscock, Raghu Lingam, Karen Wheeler, Michael Hodgins, Jade Burley, Rachel Pelly, Jane Le, Sonia Khano, Tammy Meyers Morris, Stephanie Germano

“…This manuscript outlines a detailed protocol of an implementation evaluation embedded in a stepped-wedge cluster randomised controlled trial of a model of care, Strengthening Care for Children (SC4C), that integrates paediatric care in general practice. …”
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Effectiveness and Safety of Hair Growth Formulation Containing L.f (Teak) Leaf Extract: A Randomized, Double-Blind, Placebo-Controlled Study on Males with Androgenic Alopecia by Nutchaninad Tanuphol B.ATM, Neti Waranuch PhD, Vanuchawan Wisuitiprot PhD, Wudtichai Wisuitiprot PhD, Kamonlak Insumrong PhD, Prapapan Temkitthawon PhD, Nungruthai Suphrom PhD, Katechan Jampachaisri PhD, Corine Girard PhD, Kornkanok Ingkaninan PhD

“…Trial registration This study was retrospectively registered on International Standard Randomised Controlled Trial Number (ISRCTN.com); ISRCTN24541842 (registered on January 8, 2024).…”
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