Trials
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Randomized Controlled Trial Multicenter Study
Electroacupuncture for chemotherapy-induced peripheral neuropathy: study protocol for a pilot multicentre randomized, patient-assessor-blinded, controlled trial.
Chemotherapy-induced peripheral neuropathy (CIPN) is the main dose-limiting side effect of neurotoxic chemotherapeutic agents. CIPN can lead not only to loss of physical function, difficulties in activities of daily living (ADLs), and decreased quality of life, but also to dose reduction, delay or even cessation of treatment. Currently, there are few proven effective treatments for CIPN. This randomized controlled clinical trial is designed to evaluate the effects and safety of electroacupuncture (EA) for patients with CIPN. ⋯ The results of this on-going study will provide clinical evidence for the effects and safety of EA for CIPN compared with sham EA.
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Randomized Controlled Trial Multicenter Study
Study to assess the effect of a structured communication approach on quality of life in secure mental health settings (Comquol): study protocol for a pilot cluster randomized trial.
Forensic mental health services have largely ignored examining patients' views on the nature of the services offered to them. A structured communication approach (DIALOG) has been developed with the aim of placing the patient's perspective on their care at the heart of the discussions between patients and clinicians. The effectiveness of the structured communication approach in community mental health services has been demonstrated, but no trial has taken place in a secure psychiatric setting. This pilot study is evaluating a 6-month intervention combining DIALOG with principles of solution-focused therapy on quality of life in medium-secure settings. ⋯ This study aims to (1) establish the feasibility of the trial design as the basis for determining the viability of a large full-scale trial, (2) determine the variability of the outcomes of interest (quality of life, levels of satisfaction, disturbance, ward climate and engagement with services), (3) estimate the costs of the intervention and (4) refine the intervention following the outcome of the study based upon the experiences of the nurses and patients. The intervention allows patients to have a greater say in how they are treated and targets care in areas that patients identify as important to them. It is intended to establish systems that support meaningful patient and caregiver involvement and participation.
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Randomized Controlled Trial Comparative Study
Acceptance and commitment therapy for anxious children and adolescents: study protocol for a randomized controlled trial.
Anxiety disorders affect approximately 10% to 20% of young people, can be enduring if left untreated, and have been associated with psychopathology in later life. Despite this, there is a paucity of empirical research to assist clinicians in determining appropriate treatment options. We describe a protocol for a randomized controlled trial in which we will examine the effectiveness of a group-based acceptance and commitment therapy program for children and adolescents with a primary diagnosis of anxiety disorder. For the adolescent participants we will also evaluate the elements of the intervention that act as mechanisms for change. ⋯ To the best of our knowledge, this study will be the largest trial of acceptance and commitment therapy in the treatment of children and young people to date. It will provide comprehensive data on the use of acceptance and commitment therapy for anxiety disorders and will offer evidence for mechanisms involved in the process of change. Furthermore, additional data will be obtained for the use of cognitive behavior therapy in this population and this research will illustrate the comparative effectiveness of these two interventions, which are currently implemented widely in contemporary clinical practice. Anticipated difficulties for the trial are the recruitment and retention of participants, particularly adolescents. To avert these concerns and maximize recruitment, several strategies will be adopted to optimize referral rates as well as reduce participant drop-outs.
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Randomized Controlled Trial Multicenter Study Comparative Study
Guided Application of Ventricular Catheters (GAVCA)--multicentre study to compare the ventricular catheter position after use of a catheter guide versus freehand application: study protocol for a randomised trail.
The standard technique for the placement of ventricular catheters (VC) comprises a high proportion of malpositioning of the catheter (12.5 to 40%). Technical advances such as neuronavigation or ultrasound have been shown to increase the accuracy of the procedure. Since these means result in significant technical and time consuming efforts, they are used for selected cases only. In order to simplify the controlled placement of ventricular catheters a newly developed smartphone assisted guiding tool has been introduced. In this study the efficacy and safety of this guiding tool is determined. ⋯ The Guided Application of Ventricular Catheters (GAVCA) trial compares the guided catheter positioning with the standard freehand technique of catheter placement in hydrocephalic patients. If superiority is shown, the standard technique may be changed with the advantage of a more reliable and safer positioning of the ventricular catheter with just a slight effort in time and pre-operative planning.
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Randomized Controlled Trial Comparative Study
A 12-week multidomain intervention versus active control to reduce risk of Alzheimer's disease: study protocol for a randomized controlled trial.
Disappointing results from clinical trials of disease-modifying interventions for Alzheimer's dementia (AD), along with reliable identification of modifiable risk factors in mid life from epidemiological studies, have contributed to calls to invest in risk-reduction interventions. It is also well known that AD-related pathological processes begin more than a decade before the development of clinical signs. These observations suggest that lifestyle interventions might be most effective when targeting non-symptomatic adults at risk of AD. To date, however, the few dementia risk-reduction programs available have targeted individual risk factors and/or were restricted to clinical settings. The current study describes the development of an evidence-based, theoretically-driven multidomain intervention to reduce AD risk in adults at risk. ⋯ The BBL program is a novel online intervention to reduce the risk of AD in middle-aged adults at risk. The trial is currently under way. It is hypothesized that participants in the intervention arms will make lifestyle changes in several domains, and that this will lead to a reduction in their AD risk profile. We also expect to show that health behavior change is underpinned by changes in psychological determinants of behavior. If successful, the findings will contribute to the development of further dementia risk reduction interventions, and thus contribute to the urgent need to lower dementia risk factors in the population to alter future projections of disease prevalence. Longer follow-up of BBL participants and replications using large samples are required to examine whether reduction in AD risk factors will be associated with reduced prevalence.