journal
https://read.qxmd.com/read/38419096/an-e-mental-health-intervention-to-reduce-depression-symptoms-in-individuals-with-obesity-study-protocol-for-the-randomized-controlled-two-armed-confirmatory-lightmood-trial
#1
JOURNAL ARTICLE
Dilara Kocol, Sheila Geiger, Adam Schweda, Jil Beckord, Theresa Schadendorf, Christoph Jansen, Anita Robitzsch, Eva-Maria Skoda, Martin Teufel, Alexander Bäuerle
BACKGROUND: Patients with obesity often experience psychological distress, specifically depression symptoms. Due to various barriers, such as limitations of healthcare offers, digital interventions, for example medical apps, can provide a suitable approach to support affected people. In the envisaged prospective randomized controlled trial, we aim to examine the efficacy of the LightMood intervention. The LightMood intervention is a manualized and user-centered, digital intervention for patients with obesity, with a duration of 4 months, which contains elements of cognitive behavioral therapy and mindfulness-based and skills-based exercises...
February 28, 2024: Trials
https://read.qxmd.com/read/38419075/efficacy-of-chlorfenapyr-pyrethroid-and-piperonyl-butoxide-pyrethroid-long-lasting-insecticidal-nets-llins-compared-to-pyrethroid-only-llins-for-malaria-control-in-c%C3%A3-te-d-ivoire-a-three-group-cluster-randomised-trial
#2
JOURNAL ARTICLE
Colette Sih, Natacha Protopopoff, Alphonsine A Koffi, Ludovic P Ahoua Alou, Edouard Dangbenon, Louisa A Messenger, Manisha A Kulkarni, Marius G Zoh, Soromane Camara, Serge B Assi, Raphael N'Guessan, Jackie Cook
BACKGROUND: The massive scale-up of long-lasting insecticidal nets (LLIN) has led to a major reduction in malaria burden in many sub-Saharan African (SSA) countries. The World Health Organization (WHO) has recently issued a strong recommendation for the use of chlorfenapyr-pyrethroid LLINs compared to standard pyrethroid-only LLINs in areas of high insecticide resistance intensity. However, there is still a lack of conclusive evidence on the efficacy of piperonyl butoxide-pyrethroid (PBO-py) LLINs, especially in West Africa, where vector composition and resistance mechanisms may be different from vectors in East Africa...
February 28, 2024: Trials
https://read.qxmd.com/read/38419068/effects-of-a-chronotype-adapted-diet-on-weight-loss-cardiometabolic-health-and-gut-microbiota-study-protocol-for-a-randomized-controlled-trial
#3
JOURNAL ARTICLE
Monica Dinu, Sofia Lotti, Giuditta Pagliai, Antonia Napoletano, Marta Tristan Asensi, Ilaria Giangrandi, Rossella Marcucci, Amedeo Amedei, Barbara Colombini, Francesco Sofi
BACKGROUND: Obesity and its associated health complications have become a global public health concern, necessitating innovative approaches to weight management. One emerging area of research focuses on the influence of chronotype, an individual's preferred timing for daily activities, on eating habits, weight regulation, and metabolic health. Recent observational studies suggest that the misalignment between an individual's chronotype and external cues, such as meal timing, may contribute to metabolic dysregulation and obesity, but evidence from intervention studies is still limited...
February 28, 2024: Trials
https://read.qxmd.com/read/38419030/experience-with-a-hybrid-recruitment-approach-of-patient-facing-web-portal-screening-and-subsequent-phone-and-medical-record-review-for-a-neurosurgical-intervention-trial-for-chronic-ischemic-stroke-disability-pisces-iii
#4
JOURNAL ARTICLE
Brad J Kolls, Keith W Muir, Sean I Savitz, Lawrence R Wechsler, Julie G Pilitsis, Scott Rahimi, Richard L Beckman, Vincent Holmes, Peng R Chen, David S Albers, Daniel T Laskowitz
BACKGROUND: Recruitment of participants is the greatest risk to completion of most clinical trials, with 20-40% of trials failing to reach the targeted enrollment. This is particularly true of trials of central nervous system (CNS) therapies such as intervention for chronic stroke. The PISCES III trial was an invasive trial of stereotactically guided intracerebral injection of CTX0E03, a fetal derived neural stem cell line, in patients with chronic disability due to ischemic stroke. We report on the experience using a novel hybrid recruitment approach of a patient-facing portal to self-identify and perform an initial screen for general trial eligibility (tier 1), followed by phone screening and medical records review (tier 2) prior to a final in-person visit to confirm eligibility and consent...
February 28, 2024: Trials
https://read.qxmd.com/read/38414078/effectiveness-and-cost-effectiveness-of-a-transdiagnostic-intervention-for-alcohol-misuse-and-psychological-distress-in-humanitarian-settings-study-protocol-for-a-randomised-controlled-trial-in-uganda
#5
JOURNAL ARTICLE
Catharina F van der Boor, Dalili Taban, Wietse A Tol, Josephine Akellot, Melissa Neuman, Helen A Weiss, Giulia Greco, Anna Vassall, Carl May, Abhijit Nadkarni, Eugene Kinyanda, Bayard Roberts, Daniela C Fuhr
BACKGROUND: The war in South Sudan has displaced more than four million people, with Uganda hosting the largest number of South Sudanese refugees. Research in Uganda has shown elevated levels of alcohol misuse and psychological distress among these refugees. The World Health Organization (WHO) has developed a trans-diagnostic scalable psychological intervention called Problem Management Plus (PM +) to reduce psychological distress among populations exposed to adversities. Our study aims to evaluate the effectiveness and cost-effectiveness of the CHANGE intervention, which builds on PM + , to also address alcohol misuse through problem-solving therapy and selected behavioural strategies for dealing with alcohol use disorders...
February 27, 2024: Trials
https://read.qxmd.com/read/38409060/does-somatosensory-discrimination-therapy-alter-sensorimotor-upper-limb-function-differently-compared-to-motor-therapy-in-children-and-adolescents-with-unilateral-cerebral-palsy-study-protocol-for-a-randomized-controlled-trial
#6
JOURNAL ARTICLE
Lize Kleeren, Lisa Mailleux, Belinda McLean, Catherine Elliott, Griet Dequeker, Anja Van Campenhout, Jean-Jacques Orban de Xivry, Geert Verheyden, Els Ortibus, Katrijn Klingels, Hilde Feys
BACKGROUND: Besides motor impairments, up to 90% of the children and adolescents with unilateral cerebral palsy (uCP) present with somatosensory impairments in the upper limb. As somatosensory information is of utmost importance for coordinated movements and motor learning, somatosensory impairments can further compromise the effective use of the impaired upper limb in daily life activities. Yet, intervention approaches specifically designated to target these somatosensory impairments are insufficiently investigated in children and adolescents with uCP...
February 26, 2024: Trials
https://read.qxmd.com/read/38402192/comparing-the-effects-of-pulsed-and-radiofrequency-catheter-ablation-on-quality-of-life-anxiety-and-depression-of-patients-with-paroxysmal-supraventricular-tachycardia-a-single-center-randomized-single-blind-standard-controlled-trial
#7
JOURNAL ARTICLE
Ying Du, Shanshan Ma, Pan Yue, Ying Xu, Ya Wen, Mingzhu Ji, Lingxiao He, Dengbin Liao
BACKGROUND: Radiofrequency catheter ablation (RFCA) may lead to decreased quality of life (QOL) and increased anxiety and depression in patients with paroxysmal supraventricular tachycardia (PSVT), possibly due to the lack of selectivity of the ablation tissue and the long ablation time. In recent years, pulsed field ablation (PFA) has been used for the first time in China to treat PSVT patients because of its ability to ablate abnormal tissue sites in a precise and transient manner. This study was conducted to compare the effects of PFA and RFCA on QOL and psychological symptoms of PSVT patients...
February 24, 2024: Trials
https://read.qxmd.com/read/38395980/the-effect-of-a-cognitive-training-therapy-based-on-stimulation-of-brain-oscillations-in-patients-with-mild-cognitive-impairment-in-a-chilean-sample-study-protocol-for-a-phase-iib-2%C3%A2-%C3%A3-%C3%A2-3-mixed-factorial-double-blind-randomised-controlled-trial
#8
JOURNAL ARTICLE
Alejandra Figueroa-Vargas, Begoña Góngora, María Francisca Alonso, Alonso Ortega, Patricio Soto-Fernández, Lucía Z-Rivera, Sebastián Ramírez, Francisca González, Paula Muñoz Venturelli, Pablo Billeke
BACKGROUND: The ageing population has increased the prevalence of disabling and high-cost diseases, such as dementia and mild cognitive impairment (MCI). The latter can be considered a prodromal phase of some dementias and a critical stage for interventions to postpone the impairment of functionality. Working memory (WM) is a pivotal cognitive function, representing the fundamental element of executive functions. This project proposes an intervention protocol to enhance WM in these users, combining cognitive training with transcranial electrical stimulation of alternating current (tACS)...
February 23, 2024: Trials
https://read.qxmd.com/read/38395922/trial-protocol-for-the-building-resilience-through-socio-emotional-training-reset-programme-a-cluster-randomised-controlled-trial-of-a-new-transdiagnostic-preventative-intervention-for-adolescents
#9
JOURNAL ARTICLE
Essi Viding, Alex Lloyd, Roslyn Law, Peter Martin, Laura Lucas, Tom Chin-Han Wu, Nikolaus Steinbeis, Nick Midgley, René Veenstra, Jaime Smith, Lili Ly, Geoffrey Bird, Jennifer Murphy, David Plans, Marcus Munafo, Ian Penton-Voak, Jessica Deighton, Kathleen Richards, Mya Richards, Pasco Fearon
BACKGROUND: Adolescence is a period of heightened vulnerability to developing mental health problems, and rates of mental health disorder in this age group have increased in the last decade. Preventing mental health problems developing before they become entrenched, particularly in adolescents who are at high risk, is an important research and clinical target. Here, we report the protocol for the trial of the 'Building Resilience through Socioemotional Training' (ReSET) intervention. ReSET is a new, preventative intervention that incorporates individual-based emotional training techniques and group-based social and communication skills training...
February 23, 2024: Trials
https://read.qxmd.com/read/38395869/pain2-0-study-protocol-for-a-multicentre-randomised-controlled-trial-to-evaluate-the-efficacy-of-a-10-week-outpatient-interdisciplinary-multimodal-pain-therapy-to-manage-recurrent-pain-for-patients-with-risk-factors-of-developing-chronic-pain-in-germany
#10
JOURNAL ARTICLE
Sandra Meyer-Moock, Daniel Szczotkowski, Leonie Schouten, Frank Petzke, Lena Milch, Beatrice Metz-Oster, Louise Zinndorf, Christian Geber, Greta Hoffmann, Anke Preißler, Ursula Marschall, Felix Rottke, Anja Waidner, André Möller, Thomas Isenberg, Gabriele Lindena, Anne Gärtner, Ulrike Kaiser, Thomas Kohlmann
BACKGROUND: Up to 27% of the German population suffers from recurrent or persistent pain (lasting more than three months). Therefore, prevention of chronic pain is one major object of pain management interventions. The aim of this nationwide, multicentre, randomised controlled trial is to evaluate the efficacy of a 10-week ambulatory (outpatient) interdisciplinary multimodal pain therapy (A-IMPT) for patients with recurrent pain and at risk of developing chronic pain. This project was initiated by the German Pain Society (Deutsche Schmerzgesellschaft e...
February 23, 2024: Trials
https://read.qxmd.com/read/38389113/comparison-of-2d-4k-vs-3d-hd-laparoscopic-imaging-systems-in-bariatric-surgery-study-protocol-for-a-randomized-controlled-prospective-trial
#11
JOURNAL ARTICLE
Tibor A Zwimpfer, Nadja Stiegeler, Philip C Müller, Andreas Schötzau, Bernhard Fellmann-Fischer, Viola Heinzelmann-Schwarz, Ralph Peterli, Marko Kraljević
BACKGROUND: Vision is an important and defining element of laparoscopy and significantly affects the outcome of surgery in terms of time, error, and precision. Several new imaging systems have become available for laparoscopic surgery, including three-dimensional (3D) high-definition (HD) and two-dimensional (2D) ultra-high-resolution (4K) monitors. 3D HD systems offer a number of potential benefits to surgeons and patients over traditional 2D systems, including reduced operating time, blood loss, and hospital stay...
February 22, 2024: Trials
https://read.qxmd.com/read/38389093/understanding-implementation-of-findings-from-trial-method-research-a-mixed-methods-study-applying-implementation-frameworks-and-behaviour-change-models
#12
JOURNAL ARTICLE
Taylor Coffey, Paula R Williamson, Katie Gillies
BACKGROUND: Trial method research produces recommendations on how to best conduct trials. However, findings are not routinely implemented into practice. To better understand why, we conducted a mixed method study on the challenges of implementing trial method research findings into UK-based clinical trial units. METHODS: Three stages of research were conducted. Firstly, case studies of completed projects that provided methodological recommendations were identified within trial design, conduct, analysis, and reporting...
February 22, 2024: Trials
https://read.qxmd.com/read/38389089/evaluation-of-intensive-community-care-services-for-young-people-with-psychiatric-emergencies-study-protocol-for-a-multi-centre-parallel-group-single-blinded-randomized-controlled-trial-with-an-internal-pilot-phase
#13
JOURNAL ARTICLE
Thilipan Thaventhiran, Ben Hoi-Ching Wong, Izabela Pilecka, Saba Masood, Opeyemi Atanda, Joe Clacey, Jovanka Tolmac, Leon Wehncke, Liana Romaniuk, Margaret Heslin, Emma Tassie, Petrina Chu, Rhys Bevan-Jones, Ruth Woolhouse, Tauseef Mahdi, Veronika Beatrice Dobler, Mandy Wait, Paula Reavey, Sabine Landau, Sarah Byford, Toby Zundel, Dennis Ougrin
BACKGROUND: Over 3000 young people under the age of 18 are admitted to Tier 4 Child and Adolescent Mental Health Services (CAMHS) inpatient units across the UK each year. The average length of hospital stay for young people across all psychiatric units in the UK is 120 days. Research is needed to identify the most effective and efficient ways to care for young people (YP) with psychiatric emergencies. This study aims to evaluate the clinical effectiveness and cost-effectiveness of intensive community care service (ICCS) compared to treatment as usual (TAU) for young people with psychiatric emergencies...
February 22, 2024: Trials
https://read.qxmd.com/read/38388956/statistical-analysis-plan-for-the-phaco-tip-position-during-clear-corneal-phacoemulsification-surgery-tips-randomized-controlled-trial
#14
JOURNAL ARTICLE
Soujanya Kaup, Dimple Kondal, Siddharudha Shivalli, John Buchan
BACKGROUND: Cornea is the most important refractive media in the eye, and damage to the corneal endothelium is one of the most common causes of poor visual outcome following cataract surgery, particularly in those with predisposing factors. The role of phaco tip position during phacoemulsification on corneal endothelial damage is ambiguous, and there is no consensus regarding the most cornea-friendly phaco tip position (bevel-up or bevel-down). The objective of the trial is to compare the effect of phaco tip position (bevel-up vs...
February 22, 2024: Trials
https://read.qxmd.com/read/38388444/seroma-control-in-axillary-lymphadenectomy-with-glubran-2%C3%A2-without-drain-multicenter-prospective-randomized-clinical-trial-gala-nd-study-glubran-axillary-lymphadenectomy-ambulatory-no-drain
#15
JOURNAL ARTICLE
Sandra López Gordo, Neus Ruiz-Edo, Maria Teresa Fernández-Planas, Sara Viscaya-Martín, Cristina Serra-Serra
BACKGROUND: Seroma after breast cancer surgery is a frequent entity; therefore, different products have been described in literature with the aim to reduce it. The most studied ones have been the sealants products, being tested with aspirative drains. Symptomatic seroma represents the 19% after axillary lymphadenectomy without drains. The aim of this study is to analyze the effect of a sealant in the seroma control after axillary lymphadenectomy without drains and identify the risk factors related to symptomatic seroma...
February 22, 2024: Trials
https://read.qxmd.com/read/38383461/total-laparoscopic-partial-hepatectomy-versus-open-partial-hepatectomy-for-primary-left-sided-hepatolithiasis-study-protocol-for-a-randomized-controlled-trial
#16
JOURNAL ARTICLE
Shu-Bo Pan, Chun-Li Wu, Da-Chen Zhou, Qi-Ru Xiong, Xiao-Ping Geng, Hui Hou
BACKGROUND: The advantages of laparoscopic left-sided hepatectomy (LLH) for treating hepatolithiasis in terms of the time to postoperative length of hospital stay (LOS), morbidity, long-term abdominal wall hernias, hospital costs, residual stone rate, and recurrence of calculus have not been confirmed by a randomized controlled trial. The aim of this trial is to compare the safety and effectiveness of LLH with open left-sided hepatectomy (OLH) for the treatment of hepatolithiasis. METHODS: Patients with hepatolithiasis eligible for left-sided hepatectomy will be recruited...
February 22, 2024: Trials
https://read.qxmd.com/read/38383459/to-allow-or-avoid-pain-during-shoulder-rehabilitation-exercises-for-patients-with-chronic-rotator-cuff-tendinopathy-study-protocol-for-a-randomized-controlled-trial-the-pase-trial
#17
JOURNAL ARTICLE
Birgitte Hougs Kjær, Ann M Cools, Finn E Johannsen, Jeanette Trøstrup, Theresa Bieler, Volkert Siersma, Peter S Magnusson
BACKGROUND: Rotator cuff (RC) tendinopathy is the most reported shoulder disorder in the general population with highest prevalence in overhead athletes and adult working-age population. A growing body of evidence support exercise therapy as an effective intervention, but to date there are no prospective randomized controlled trials addressing pain as an intervention variable. METHODS: A single-site, prospective, pragmatic, assessor-blinded randomized controlled superiority trial...
February 21, 2024: Trials
https://read.qxmd.com/read/38383426/investigating-the-added-effects-of-guidance-in-digital-psychological-self-care-for-alcohol-problems-alva-protocol-for-a-randomized-factorial-optimization-trial
#18
JOURNAL ARTICLE
Christopher Sundström, Ekaterina Ivanova, Philip Lindner, Magnus Johansson, Martin Kraepelien
BACKGROUND: The continual development and implementation of effective digital interventions is one important strategy that may serve to bridge the well-known treatment gap related to problematic alcohol use. Research suggests that clinician guidance, provided in different ways during the digital intervention (i.e., written weekly messages, phone calls etc.), can boost intervention engagement and effects. Digital psychological self-care (DPSC) is a new delivery format wherein an unguided digital intervention is provided within the framework of a structured care process that includes initial clinical assessment and follow-up interviews...
February 21, 2024: Trials
https://read.qxmd.com/read/38383418/efficacy-of-functional-magnetic-resonance-imaging-guided-personalized-repetitive-transcranial-magnetic-stimulation-fmri-rtms-in-depressive-patients-with-emotional-blunting-study-protocol-for-a-randomized-controlled-trial
#19
JOURNAL ARTICLE
Yuyu Zhang, Nailong Tang, Lei Lei, Runxin Lv, Yaochi Zhang, Nian Liu, Haixia Chen, Min Cai, Huaning Wang
BACKGROUND: Emotional blunting is a symptom that has always been present in depressed patients. Repetitive transcranial magnetic stimulation (rTMS) is a safe and effective supplementary therapy for treating depression. However, the effectiveness and brain imaging processes of functional magnetic resonance imaging-guided personalized rTMS (fMRI-rTMS) in the treatment of depression with emotional blunting have not been observed in randomized controlled trials. METHODS: This study is a randomized, controlled, double-blind, and single-center clinical trial in which 80 eligible depressed patients with emotional blunting will be randomly assigned to two groups: a functional magnetic resonance imaging-guided personalized rTMS (fMRI-rTMS) group and a control group...
February 21, 2024: Trials
https://read.qxmd.com/read/38374040/the-efficacy-of-virtual-reality-technology-for-the-postoperative-rehabilitation-of-patients-with-cervical-spondylotic-myelopathy-csm-a-study-protocol-for-a-randomized-controlled-trial
#20
JOURNAL ARTICLE
Jiajun Wu, Zhongchuan Sun, Zhichao Ge, Dong Zhang, Jianghan Xu, Rilin Zhang, Xuecheng Liu, Qing Zhao, Hao Sun
BACKGROUND: Patients with cervical spondylosis myelopathy (CSM) may experience severe neurological dysfunction due to untimely spinal cord compression after surgery. These disorders may lead to sensory and motion disorders, causing considerable psychological distress. Recent studies found that virtual reality (VR) technology can be an effective tool for treating spinal cord injuries. Owing to this discovery, we developed an exploratory research project to investigate the impact of this intervention on the postoperative recovery of patients with CSM...
February 19, 2024: Trials
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