Search results for "Randomised"

A Multicentre, Randomised, Controlled Trial of a Combined Clinical Treatment for First-Episode Psychosis

2021

Introduction: There is evidence that early intervention contributes to improving the prognosis and course of first-episode psychosis (FEP). However, further randomised treatment clinical trials are needed. Objectives: The aim of this study was to compare the efficacy of a combined clinical treatment involving Cognitive Behavioural Therapy (CBT) as an adjunctive to treatment-as-usual (TAU) (CBT+TAU) versus TAU alone for FEP. Patients and methods: In this multicentre, single-blind, randomised controlled trial, 177 participants were randomly allocated to either CBT+TAU or TAU. The primary outcome was post-treatment patient functioning. Results: The CBT+TAU group showed a greater improvement in…

Ureteral Stones: Shockwave Lithotripsy or Ureteroscopy, Which is Best?

2021

Background Renal stone disease is common and can cause emergency presentation with acute pain due to ureteric colic. International guidelines have stated the need for a multicentre randomised controlled trial (RCT) to determine whether a non-invasive outpatient (shockwave lithotripsy [SWL]) or surgical (ureteroscopy [URS]) intervention should be the first-line treatment for those needing active intervention. This has implications for shaping clinical pathways. Objective To report a pragmatic multicentre non-inferiority RCT comparing SWL with URS. Design, setting, and participants This trial tested for non-inferiority of up to two sessions of SWL compared with URS as initial treatment for ur…

Comparing motivational, self-regulatory and habitual processes in a computer-tailored physical activity intervention in hospital employees - protocol…

2017

Abstract Background Most people do not engage in sufficient physical activity to confer health benefits and to reduce risk of chronic disease. Healthcare professionals frequently provide guidance on physical activity, but often do not meet guideline levels of physical activity themselves. The main objective of this study is to develop and test the efficacy of a tailored intervention to increase healthcare professionals’ physical activity participation and quality of life, and to reduce work-related stress and absenteeism. This is the first study to compare the additive effects of three forms of a tailored intervention using different techniques from behavioural theory, which differ accordin…

The effect of improvisational music therapy on the treatment of depression: protocol for a randomised controlled trial

2008

Background. Music therapy is frequently offered to individuals suffering from depression. Despite the lack of research into the effects of music therapy on this population, anecdotal evidence suggests that the results are rather promising. The aim of this study is to examine whether improvisational, psychodynamically orientated music therapy in an individual setting helps reduce symptoms of depression and improve other health-related outcomes. In particular, attention will be given to mediator agents, such as musical expression and interaction in the sessions, as well as to the explanatory potential of EEG recordings in investigating emotion related music perception of individuals with depr…

Effects of an eccentric training programme on hamstring strain injuries in women football players

2015

Summary Study aim: to test the hypothesis that an eccentric training programme applied on women football players would reduce the hamstring injury rate by improving thigh muscle balance and, particularly, hamstring strength. Material and methods: three football teams were recruited for this randomised controlled trial. They played in the first and second divisions in Spain. Players were randomised within clubs either to the intervention (eccentric exercises, n = 22) or control (control exercises, n = 21) groups, and randomisation was stratified according to previous history of thigh strains. The eccentric programme was divided into 3 phases, and each phase was composed of 7 weeks. Complianc…

Snacktivity™ to promote physical activity and reduce future risk of disease in the population: protocol for a feasibility randomised controlled trial…

2023

Abstract Background Many people do not regularly participate in physical activity, which may negatively impact their health. Current physical activity guidelines are focused on promoting weekly accumulation of at least 150 min of moderate to vigorous intensity physical activity (MVPA). Whilst revised guidance now recognises the importance of making small changes to physical activity behaviour, guidance still focuses on adults needing to achieve at least 150 min of MVPA per week. An alternative ‘whole day’ approach that could motivate the public to be more physically active, is a concept called Snacktivity™. Instead of focusing on achieving 150 min per week of physical activity, for example …

Music Therapy for Depression Enhanced With Listening Homework and Slow Paced Breathing: A Randomised Controlled Trial

2021

Introduction: There is evidence from earlier trials for the efficacy of music therapy in the treatment of depression among working-age people. Starting therapy sessions with relaxation and revisiting therapeutic themes outside therapy have been deemed promising for outcome enhancement. However, previous music therapy trials have not investigated this issue.Objective: To investigate the efficacy of two enhancers, resonance frequency breathing (RFB) and listening homework (LH), when combined with an established music therapy model (trial registration number ISRCTN11618310).Methods: In a 2 × 2 factorial randomised controlled trial, working-age individuals with depression were allocated into gr…

Inclusion of pregnant women in clinical trials of COVID-19 therapies: what have we learned?

2020

Evaluation of the UP4FUN Intervention: A Cluster Randomized Trial to Reduce and Break Up Sitting Time in European 10-12-Year-Old Children

2015

Background The UP4FUN intervention is a family-involved school-based intervention aiming at reducing and breaking up sitting time at home (with special emphasis on screen time), and breaking up sitting time in school among 10–12 year olds in Europe. The purpose of the present paper was to evaluate its short term effects. Methodology/Principal Findings A total of 3147 pupils from Belgium, Germany, Greece, Hungary and Norway participated in a school-randomized controlled trial. The intervention included 1–2 school lessons per week for a period of six weeks, along with assignments for the children and their parents. Screen time and breaking up sitting time were registered by self-report and to…

Interventions for reducing loneliness: An umbrella review of intervention studies

2020

Loneliness is a common phenomenon associated with several negative health outcomes. Current knowledge regarding interventions for reducing loneliness in randomised controlled trials (RCTs) is conflicting. The aim of the present work is to provide an overview of interventions to reduce loneliness, using an umbrella review of previously published systematic reviews and meta-analyses. We searched major databases from database inception to 31 March 2020 for RCTs comparing active versus non-active interventions for reducing loneliness. For each intervention, random-effects summary effect size and 95% confidence intervals (CIs) were calculated. For significant outcomes (p-value < 0.05), the GR…