ANZCTR search results

BrighterSide is a newly developed mobile phone app for adults with suicidal ideation. The app helps users develop and practice strategies to manage suicidal thoughts. It includes five modules based primarily on cognitive behavioural therapy (CBT) and dialectical behaviour therapy (DBT), with elements of acceptance and commitment therapy (ACT) and positive psychology. Each module includes psychoeducation and associated activities. The app includes a safety planning feature where users are encouraged to list their personal warning signs, activities/techniques they find helpful to manage distress, and contact details for support people. It also includes a ‘check-in’ feature that auto-appears when a user accesses the app for the first time each day. The check-in asks users how they are feeling today, whether they have thoughts of harming themselves, whether they feel able to keep themselves safe, and (if not) a link to their safety plan, contact numbers, and calming/distracting activities. This trial will assess the efficacy of the BrighterSide app in reducing severity of suicidal thoughts. The primary outcomes will be measured by comparing scores on the Suicidal Ideation Attributes Scale (SIDAS) between an intervention group and a waitlist control group at baseline, 6 weeks and at 12 weeks. Secondary outcomes include self-harm and coping ability. It is hypothesised that participants in the intervention group, relative to the control group, will report at follow-up: (1) greater reductions in suicidal ideation, (2) fewer incidents of self-harm/suicide attempts, (3) greater improvements in coping ability.

Exercise performance is impaired in hot conditions compared with temperate conditions. During exercise in such thermally stressful conditions, fluid loss through sweat production to liberate heat from the body is accelerated, which can adversely impact cardiovascular and thermoregulatory function and ultimately hinder exercise performance. To increase the total fluid pool available for sweat production, ingestion of nutritional aids such as glycerol and sodium prior to exercise may increase total body water above normal body water levels (i.e., euhydration) prior to exercise, which is known as hyperhydration. This topic requires further investigation to determine if hyperhydration is a viable preparation strategy for endurance running in hot conditions. The hypothesis for this study is that the combined ingestion of glycerol and sodium will result in a significantly greater fluid retention than that of glycerol or sodium ingested separately.

Osteoarthritis is a leading cause of disability with no cure. Current therapies are limited, with end-stage osteoarthritis treated with costly total joint replacement. There is an urgent unmet need for an effective disease-modifying drug to reduce the burden of the disease. Obesity and obesity-related metabolic and inflammatory factors are risk factors for knee osteoarthritis with people with osteoarthritis at increased risk of cardiovascular disease morbidity and mortality. Metformin, a safe, low-cost, well-tolerated first-line therapy for type 2 diabetes for over 60 years, affects these pathways with evidence from animal and human studies that metformin may reduce pain of knee osteoarthritis and reduce cardiovascular risk. We propose to test this in a randomised double-blind placebo-controlled trial in participants with knee osteoarthritis and obesity. AIMS: To determine whether metformin reduces knee pain over 6 months compared with placebo in people with knee osteoarthritis who are obese. PARTICIPANTS: 102 participants with knee osteoarthritis and obesity INTERVENTION: Metformin (2000 mg) once daily COMPARATOR: Identical placebo once daily OUTCOME: Change in knee pain assessed by visual analogue scale at 6 months SIGNIFICANCE: The repositioning of metformin, a cheap, safe, old drug for this new indication, offers an unprecedented opportunity to significantly and immediately impact the management of osteoarthritis in Australia and worldwide. It has very high potential for rapid translation being a safe, easy to use medication with medical practitioners who have repeatedly called for effective treatments for knee osteoarthritis familiar with its use. Metformin has the potential to significantly reduce disease burden and healthcare costs, while improving quality of life and reducing cardiovascular risk in people with knee osteoarthritis.

Effect of topical and oral Resveratrol on skin health, condition and visible signs of ageing, in healthy ageing females. This study aims to assess the effectiveness of Resveratrol for skin health parameters and visible signs of ageing compared to a placebo in otherwise healthy females aged over 40 years old. This study hypothesises that oral supplementation and topical application of Resveratrol will improve skin health parameters and ageing, including fine lines, wrinkles, uneven pigmentation, skin elasticity, hydration, visible pores and oxidative stress markers compared to the placebo products.

This study involves using a new imaging processor (TXI) while performing a colonoscopy looking for colon polyps (pre-cancerous growths). The aim is to assess whether TXI is able to detect more polyps than usual colonoscopic imaging. In order to determine if there is any significant difference, we will randomise patients either to a routine colonoscopy or to colonoscopy using TXI. We will then document the number of polyps found with each imaging type if they are confirmed as pre-cancerous when examined by a pathologist under the microscopy, then compare the two methods statistically.

This is a Phase I/IIa, double-blind, placebo-controlled study which is subdivided into 4 parts. Parts A-C will be conducted in healthy adult participants and Part D will be conducted in hospitalised COVID-19 patients with moderate illness. Part A (Cohorts 1-4) will be conducted as a single ascending dose (SAD) study, whereby healthy volunteers will be enrolled to receive a single dose of inhaled enoxaparin (or placebo). Three dose levels of inhaled enoxaparin will be explored in Part A (0.25, 0.5, 1 or 2 mg/kg/dose). Sentinel dosing will be employed for all dose level cohorts for Part A. Part B (Cohorts 5-6) will be conducted as a multiple ascending dose (MAD) study, whereby healthy volunteers will be enrolled to receive multiple doses of inhaled enoxaparin (or placebo). Two dose levels of inhaled enoxaparin will be explored in Part B (0.5 or 1 mg/kg/dose). In Part C (Cohorts 7-8), healthy volunteers will be enrolled to receive MADs of inhaled enoxaparin (or placebo) in combination with fixed doses of inhaled N-acetylcysteine . Two dose levels of inhaled enoxaparin will be explored in Part C (0.5 or 1 mg/kg/dose). Each dose of inhaled N-acetylcysteine will be 600 mg.Sentinel dosing will be employed for all dose level cohorts for Part C. In Part D (Cohort 9), COVID-19 patients will be enrolled to receive inhaled enoxaparin (or placebo) in combination with inhaled N-acetylcysteine (multiple dosing schedule), plus best supportive care treatment for COVID-19. The dose level of inhaled enoxaparin to be evaluated in Part D will be based on safety and tolerability data obtained in Part C, or placebo. Each dose of inhaled N-acetylcysteine will be 600 mg. Dosing in each cohort Part A-C will occur in a sequential manner. The decision to escalate between dose levels and proceed to the next cohort will be based on a review of the available safety and PK data by the Safety Review Committee (SRC). The SRC will consist of (at a minimum), the PI, an independent Medical Monitor and a Sponsor’s medical representative. Other individuals (e.g. medical experts) may be invited to participate at the discretion of the SRC.

Young people accessing community mental health services often have a history of complex trauma in addition to a wide array of mental health issues including anxiety, depression, borderline personality traits and poor interpersonal skills. Commonly this group of individuals suffer from social anxiety and report difficulties in connecting with peers. Standard treatment approaches vary, but tend to encompass both individual and group therapy with elements of cognitive behavioural therapy (CBT) and/or dialectical behavioural therapy (DBT). Dropout rates tend to be high however, with meta-analyses estimating dropout rates of 25-30% for both group and individual therapy. The current project aims to assess the efficacy of using a table-top role-playing game in a group setting as a means of improving both treatment adherence and treatment outcomes. Clients will play the popular table-top game “Dungeons and Dragons” in groups of eight, which requires them to take on the role of a character and work collaboratively with other characters to solve problems and achieve goals. The aim of this project is to investigate whether treatment principles embedded in a table-top role-playing game can improve both treatment adherence and treatment outcomes in a community mental-health setting. The primary research questions that this study seeks to address are: 1. Whether, relative to a wait-list group who receive treatment as usual, participating in the specialised group intervention significantly reduces self-reported social anxiety and daily-life interference from past trauma/stressful life events. 2. Whether, relative to a wait-list group who receive treatment as usual, participating in the specialised group intervention significantly improves self-reported self-esteem and reduces self-reported depressive symptoms.

The purpose of this study is to understand the feasibility and effects of adding 30 grams/day of nut butter to a usual diet compared to no nut butter of older adults living in the community for 12-weeks. The outcomes of this study include dietary intake, various health markers, and wellbeing indicators.

The purpose of this study is to determine whether high intensity interval training can improve health outcomes and influence the gut micro biome in breast, prostate and colorectal cancer survivors. Who is it for? You may be eligible for this study if you are an adult with confirmed breast, prostate or colorectal cancer, and are at least one month post-treatment completion for cancer. Study details: All participants will undertake an initial 4-week supervised training phase, with 3 sessions per week of exercise with an Accredited Exercise Physiologist or equivalent. Following the supervised phase, participants will enter a 6-month maintenance period where they will be asked to maintain 150 minutes of moderate intensity or 75 minutes of vigorous intensity or a combination, therefore meeting the Australian exercise oncology guidelines. It is hoped that this research will help determine if exercise, and especially high intensity exercise, is effective in positively influencing the gut microbiome and other health outcomes in cancer survivors.

Coronary calcification complicates the delivery and expansion of stents and is a risk factor for major adverse cardiovascular events such as cardiac death or myocardial infarction. Intravascular lithotripsy (IVL) provides a variation to currently available percutaneous coronary interventions by delivering an acoustic pressure wave within the balloon to modify calcium, and in doing so enhancing vessel accessibility and providing a better environment for stent deployment. IVL has shown safety and effectiveness in multicentre studies, and our study will confirm the benefits of IVL in the context of our local facility for optimising stent implantation in calcified coronary lesions.