BMJ open
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Randomized Controlled Trial
Third-wave cognitive therapy versus mentalisation-based treatment for major depressive disorder: a randomised clinical trial.
To compare the benefits and harms of third-wave cognitive therapy versus mentalisation-based therapy in a small sample of depressed participants. ⋯ Third-wave cognitive therapy may be more effective than mentalisation-based therapy for depressive symptoms measured on the HDRS. However, more randomised clinical trials are needed to assess the effects of third-wave cognitive therapy and mentalisation-based treatment for depression.
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Randomized Controlled Trial
EdAl-2 (Educació en Alimentació) programme: reproducibility of a cluster randomised, interventional, primary-school-based study to induce healthier lifestyle activities in children.
To assess the reproducibility of an educational intervention EdAl-2 (Educació en Alimentació) programme in 'Terres de l'Ebre' (Spain), over 22 months, to improve lifestyles, including diet and physical activity (PA). ⋯ Our school-based intervention is feasible and reproducible by increasing after-school PA (to ≥4 h/week) in boys. Despite this improvement, there was no change in BMI and prevalence of OB.
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Randomized Controlled Trial
Efficacy of a dual-ring wound protector for prevention of incisional surgical site infection after Whipple's procedure (pancreaticoduodenectomy) with preoperatively-placed intrabiliary stents: protocol for a randomised controlled trial.
Among surgical oncology patients, incisional surgical site infection is associated with substantially increased morbidity, mortality and healthcare costs. Moreover, while adults undergoing pancreaticoduodenectomy with preoperative placement of an intrabiliary stent have a high risk of this type of infection, and wound protectors may significantly reduce its risk, no relevant studies of wound protectors yet exist involving this patient population. This study will evaluate the efficacy of a dual-ring wound protector for prevention of incisional surgical site infection among adults undergoing pancreaticoduodenectomy with preoperatively-placed intrabiliary stents. ⋯ This will be the first randomised trial to evaluate the efficacy of a dual-ring wound protector for prevention of incisional surgical site infection among patients undergoing pancreaticoduodenectomy. Results of this study are expected to be available in 2016/2017 and will be disseminated using an integrated and end-of-grant knowledge translation strategy.
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Randomized Controlled Trial
Self-management support using an Internet-linked tablet computer (the EDGE platform)-based intervention in chronic obstructive pulmonary disease: protocol for the EDGE-COPD randomised controlled trial.
The potential for telehealth-based interventions to provide remote support, education and improve self-management for long-term conditions is increasingly recognised. This trial aims to determine whether an intervention delivered through an easy-to-use tablet computer can improve the quality of life of patients with chronic obstructive pulmonary disease (COPD) by providing personalised self-management information and education. ⋯ The Research Ethics Committee for Berkshire-South Central has provided ethical approval for the conduct of the study in the recruiting regions. The results of the study will be disseminated through peer review publications and conference presentations.
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Randomized Controlled Trial
Paramedic-supplied 'Take Home' Naloxone: protocol for cluster randomised feasibility study.
'Take Home' Naloxone (THN) kits for use by peers in the event of an opioid overdose may reduce further overdose and deaths, but distribution through Drugs Services may not reach those at highest risk. Attendance by paramedics at emergency calls for patients who have suffered an overdose presents an opportunity to distribute THN kits. In this feasibility study we will assess the acceptability of this intervention, and gather data to inform definitive trial planning. ⋯ Ethical approval for this study was granted on 7 December 2011, by South East Wales Research Ethics Committee, Panel C. Results of this study will be reported through peer-reviewed scientific journals, conference presentations and internal organisational report. We will also seek to report our findings through local and national substance misuse networks and publications.