ANZCTR search results

This cluster randomised controlled trial will test the effectiveness of a co-designed online educational help-seeking program against a psychoeducation alone (active control condition) program on improving help-seeking intentions in workplaces.

Obstructive sleep apnoea (OSA) is a condition in which a patient’s airway repeatedly narrows or closes during sleep. This leads to low levels of oxygen and multiple awakenings throughout the night. Many factors contribute to the blockage of the upper airway during sleep, including the shape, length and strength of the upper airway itself. Oral appliances can improve airway size and can thus also improve OSA. Similarly, exercises that are focused on strengthening the orofacial muscles (Orofacial Myofunctional Therapy) can improve the airway and, therefore, reduce OSA severity. Orofacial Myofunctional Therapy involves exercises targeted to facial and oropharyngeal structures (lips, tongue, and the soft palate) and typically involve aspects of suction, breathing, and chewing. There is some evidence supporting the concept that orofacial myofunctional therapy improves OSA symptoms in adult patients, alongside other benefits including reduced snoring and improvements in sleep quality, oxygen saturation levels and daytime sleepiness. These therapeutic benefits are hypothesised to arise from muscle gain in the upper airway, from improvements in upper airway muscle responsiveness, and from improved coordination in the way that different compartments of tongue and other pharyngeal muscles are recruited together. This trial investigates potential benefits of using the combination of a passive myofunctional oral device along with an active myofunctional device designed to strengthen the oral and facial musculature on OSA severity. Aim: This study will investigate the efficacy of an oral appliance combined with tongue muscle exercises in improving OSA severity. Hypotheses: (1) Wearing the oral appliance for 2 weeks will improve objective measures of OSA severity compared to a baseline assessment conducted prior to commencing wearing the device. (2) Wearing the oral appliance in combination with exercise will be superior to wearing the appliance without exercise in improving objective measures of OSA severity.

The current study aims to evaluate a recently developed online, skills-based educational tool, SkillED. The proposed program has been specifically developed to provide psychoeducation and motivation for individuals with a clinical or subclinical diagnoses of an eating disorder. Overall, we aim to investigate: (1) Program Effectiveness and Safety: The changes in participants’ eating disorder symptomology, general mental health, quality of life, self-perceived skill-level, understanding, knowledge and confidence in eating disorders and the motivation to seek help/treatment, in addition to self-harm and suicidal risk assessment and self-reported weight changes. (2) Program Evaluation: The extent to which participants find the program content and delivery format acceptable and useful, with identification of areas of improvement and consideration to the broader feasibility of online skill-based programs for individuals with an ED across the diagnostic spectrum. We anticipate that engagement with SkillED will result in improvements in eating disorder symptoms, overall wellbeing, knowledge and confidence in understanding of eating disorders, and increase motivation to seek treatment and actual help-seeking behaviours.

This study aims to evaluate the acceptability, feasibility, and short-term effects of a coach-supported, individually-tailored online parenting program for parents of adolescents with suicidal thoughts and/or behaviours in the context of anxiety or depression. The program aims to increase parental self-efficacy to support their teenage child by providing personalised feedback about their current parenting and equipping them with evidence-based parenting strategies to respond to adolescent suicidal thoughts/behaviours, and anxiety and depression. The online intervention consists of up to 13 parent self-guided modules covering different topics related to parenting an adolescent who has suicide risk in the context of anxiety or depression. Online modules are supplemented by up to 9 one-on-one videoconferencing sessions with a trained coach to support parents in making changes in their parenting. We aim to evaluate short-term effects of the program in improving 1) parental self-efficacy to respond to adolescent suicidal thoughts/behaviours, 2) parental self-efficacy in responding to adolescent non-suicidal self-injury 3) parenting behaviours to reduce adolescent anxiety and/or depression, 4) carer burden, 5) family functioning, 6) quality of mental health support, 7) adolescent symptoms of anxiety 8) adolescent symptoms of depression,, and 9) adolescent’s perception of parental support if they were suicidal or self-injurying. It is hypothesised that: (1) Parents will find PiP-SP+ acceptable and feasible to implement; (2) From pre- to post-intervention (4 months later), parents will report improvements in parenting self-efficacy, parenting competencies, family functioning, quality of mental health support, carer burden regarding management of their adolescent’s suicide risk and mental health problems. Additionally, parents will report reduced anxiety and depressive symptoms in their adolescent. (3) From pre- to post-intervention (4 months later), adolescents will report reductions in anxiety and depressive symptoms. Additionally, adolescents will report improvements in the perception of parental emotional support if they were suicidal or self-injuring.

Diabetic Peripheral Neuropathy (DPN) is a prevalent and debilitating condition. One way of detecting and managing DPN is to assess the Intrinsic Foot Muscles (IFM). Ultrasound (US) has been used to detect IFM muscular atrophy in DPN patients. In addition, exercise is beneficial in delaying the usual course of DPN, skin damage and ulceration. However, diabetic patients have lower physical activity rates due to limitations such as difficult access to therapy, poor compliance, and limited support to maintain exercise therapy. Therefore, this study aims to assess whether a newly developed biofeedback device, 'Archercise' – a foot muscle exercise and strengthening tool, can correlate IFM Cross-Sectional Area (CSA) measured by US with foot arch control and performance. From this, IFM muscular and functional changes can potentially be detected earlier. In addition, IFM strength and control can be monitored and improved.

Pain from a kidney stone is excruciating. Many people who present to an emergency department with kidney stone pain require admission to hospital and a trip to the operating room to insert a stent to help relieve the pain. The JiffyStent is an innovative medical device that allows the insertion of a ureteric stent in the emergency department without the prolonged wait and need to go to the operating room. This is a proof of concept pilot study to show that the JiffyStent device is able to quickly and correctly insert a stent into the ureters of patients while they are still in the emergency department. A successful outcome will lead to a pivotal multicentre clinical trial necessary for regulatory approval thereby making the JiffyStent device available for widespread use.

The primary aim of this study is to investigate the benefits of two sessions of behavioural experiments targeting negative beliefs about uncertainty compared to a waitlist control for generalized anxiety disorder. The secondary aim is to investigate the proposed mechanisms of action (i.e., intolerance of uncertainty, metacognitive beliefs, threat appraisals) that underpin generalized anxiety disorder. Participants in the treatment group will begin the intervention immediately, and their results will be compared with a waitlist control condition who will receive the same intervention after a one-week wait period.. Outcome measures will be administered at baseline, post treatment and 1-week follow-up. Based on existing studies of behavioural experiments for generalized anxiety disorder it is hypothesised that: 1) behavioural experiment condition will be more effective in reducing symptoms of excessive worry and anxiety than waitlist control at post-treatment and follow up; and 2) behavioural experiments will yield greater improvements in intolerance of uncertainty, metacognitive beliefs, and threat appraisals, compared to waitlist control.

The purpose of phase 1 study is to evaluate the Pharmacokinetics, Safety, Tolerability of APC201 in Healthy Adults.

Autophagy is a critical process that helps keep the body’s cells clean and healthy. It is thought to be sensitive to nutrition. Using a test performed on blood that we have developed to measure autophagic activity in humans, This project aims to determine whether a 4-week modification of dietary macronutrient profile (within the context of a balanced diet) in healthy adults will change autophagic activity.

This observational study will investigate injury characteristics and clinical assessments to measure post-concussion symptoms at different time points in the first year post injury and use this information to predict people who are more likely to have a poor outcome after concussion. Participants will be recruited via hospital emergency departments following initial medical practitioner assessment and concussion diagnosis. Once consented into the study, participants will complete a questionnaire about their concussion injury and medical history, in addition to having a blood and saliva sample taken. Other clinical assessments and an MRI scan will also be completed within 4 days of their injury. At 2 weeks, 1-, 3-, 6- and 12- months following injury, participants will be contacted via telephone to complete a follow up questionnaire about their concussion symptoms and quality of life post injury. Having a better understanding of people who are at risk of developing persistent symptoms following a concussion will enable more targeted and timely clinical care to minimise distress and disability that may be experienced as a result of injury.