ANZCTR search results

This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study. The study will be conducted in 2 parts: a single ascending dose (SAD) part (Part 1) followed by a multiple ascending dose (MAD) part (Part 2). Part 1 consists of two single-dose cohorts receiving either active therapy, AT-301B, or the placebo comparator AT-301A. Part 2 is a multiple dose arm with cohorts receiving either AT-301A or AT-301B for 14 days. The primary objective of the study is to evaluate the safety and tolerability of single and multiple doses of AT-301 administered via nasal instillation to healthy volunteers

This study is a three-arm randomised control trial of an online intervention to reduce alcohol consumption in middle-aged women. The underlying theory for the intervention is based on the assumptions of the Integrated Behavioural Model (Fishbein, 2000) and the Transtheoretical Model of Change (Prochaska, 1979). Participants in the intervention will have access to core features that include goal setting, tracking of alcohol consumption, four modules of content, and associated challenges to operationalise their learnings. Participants will also complete Ecological Momentary Assessments (EMA) to record their alcohol consumption twice weekly over a 6-week period. We hypothesise that by the end of the intervention, participants in the online intervention group will report a significantly lower alcohol consumption than participants of the control group without weekly assessment (H1a). We also hypothesise that by the of the intervention period, participants in the online intervention group will display significant increases in; their awareness of harms associated with alcohol consumption (H2a), their motivation to reduce their alcohol consumption (H2b), social support (H2c),and current health status (H2d); and significant decreases in alcohol-related harm (H2e) and current level of stress (H2f), when compared to the control group without weekly assessment.

This trial evaluates a transsdiagnostic program that helps people to cope with stress in times of crisis. The program, titled Positive Mood Program (PMP), trains people to engage in positive activities, mood enhancement, social connections, and stress management. This program has been shown to reduce stress and depression, particularly at times of stress. This project aims to conduct a rapid trial of a brief psychological intervention, the Positive Mood Program (PMP), to reduce distress and improved mood associated with concerns about COVID-19. There is an urgent need for publicly available strategies to reduce COVID-19 related distress. This brief program will be offered via videoconferencing in to allow for social distancing on a group basis. We hypothesise that PMP will result in greater reductions in distress and worry relative to provision of the same strategies provided to participants who can work on them in a self-guided manner. Adults who screen positive for psychological distress will be randomized to PMP or a control condition. PMP will comprise 7 x 60-minute sessions delivered by a clinical psychologist via videoconferencing to groups of 4 people at a time. The control arm will provide people with handouts to work through the strategies in a self-guided manner. All participants will be assessed at baseline, post-intervention, and 3 months follow-up. Participants will be reimbursed $50 for completing all assessments.

Pain during outpatient intrauterine device (IUD) insertion and fear of that pain are barriers to people selecting them as long term reversible contraceptives. Methoxyflurane is an inhaled pain relief medication which has widespread application in conscious surgical procedures. This is the first study to assess the acceptability of methoxyflurane for patients having outpatient IUD insertions. Aims: Our hypothesis is that patients using methoxyflurane during their outpatient (awake) intrauterine device insertion would find the medication acceptable and would want to have it in the same situation again. Materials and Methods: Open, single-centre, single arm pilot study. 30 participants and their clinicians completed questionnaires at the time of their IUD insertion.

The aim of this project is to investigate the influence of white noise on auditory and language processing and examine how this influence is modulated by changes in dopamine. More specifically, we will combine the behavioural manipulations of auditory white noise and word learning with the pharmacological manipulation of dopamine, which is the neurotransmitter implicated in learning and attentional processes. Our objective is to quantify the influence of white noise and dopamine by measuring the accuracy of people’s responses for the word-learning tasks as well as using fMRI to measure changes in brain activity while people perform the tasks.

With the emergence of the novel COVID-19 virus, medical staff are continuing to expose and put themselves at risk in their day to day work. This virus is known to spread through primarily droplet exposure. Frontline medical staff are at highest risk in being exposed to droplets from the potential asymptomatic or mild COVID-19 individuals. A simple, but effective, means to reduce droplet spread is the use of face masks. However, wearing face masks outside operating theatres is not routine practice in Australian Hospitals, as such, there is concern that it could cause fear and anxiety in already stressed patients. Such concern has caused a dilemma among some medical staff with regards to masking or de-masking while at work. In order to find out whether this concern is real, i.e., how patients feel about the change in practice by medical staff wearing face masks, we designed this written questionnaire survey to examine patients’ attitudes towards masking the medical staff at work during COVID-19 pandemic.

Heart attack is the leading cause of morbidity and mortality globally, claiming 8,623 Australian lives in 2014 (i.e. 24 deaths/day). The heart attack is caused by the blockage of the blood flow in the heart, requiring emergent life-saving treatment to restore the blood flow using a balloon or a stent. For the last 30 years, however, death rates for the heart attack have not improved. One of the key reasons for this is the blockage of smaller micro-vessels of the heart. This micro-vessel abnormality occurs in up to 60% of patients with heart attacks and is independently associated with worse outcomes. Nevertheless, currently no established therapeutic options exist. Therefore, we will perform a prospective randomised controlled trial (RCT) to treat the micro-vessel blockages with a novel method using ultrasound with contrast agent (i.e. sonothrombolysis). Many animal studies have demonstrated that sonothrombolysis can break up blood clots of both large and small vessels, and improve the blood flow. A recent, single-centre human RCT led by Prof Porter in USA confirmed that sonothrombolysis opens the micro-vessel blockages after heart attack and improves the heart function. Next logical step is to evaluate this method in multicentre setting with a larger scale. After close communications with Prof Porter, we established our protocol for a prospective multicentre RCT with sham procedure to test our hypothesis that additional sonothrombolysis to standard treatment for heart attack would reduce heart muscle damage and improve heart function in short term and improve patient survival long term. We will run this trial across three Australian hospitals. We will be studying their outcomes during their hospital stay and following their progress with cardiac imaging over 6 months. The findings from this trial have the potential to significantly improve the overall prognosis for patients having a life-threatening heart attack and to change our standard of care and clinical guidelines.

This project will develop and test a new online tool to help people with low health literacy make decisions about reducing cardiovascular disease (CVD) risk. We will develop a more user-friendly version of our existing patient decision aid to improve understanding of CVD risk, intentions to change lifestyle, and self-reported behaviour after 1 month. We will test different versions of the tool in a diverse online community sample with varying levels of health literacy, using a randomised trial design. This will compare health-literate design to standard information, and explore whether 'heart age' is a useful addition to 5-year CVD risk.

The Illicit Project is a neuroscience-based, drug education program designed for High School students aged 16-19years. The three-class program aims to upskill and empower young people to make informed health decision and reduce the harms of substance use. We hypothesise that the program will help to reduce the risky use of alcohol and other drugs and the associated harms over the short-term.

In this statewide study we aim to test a tool that has been designed for incentivising and educating vaccination among the school age population. The primary outcome will measure the proportion of vaccination rates of those incentivised to do so with the collection of the vaccine card game ‘Vaxcards’. Secondary outcome measures will assess the effectiveness for the tool to increase knowledge and move attitudes towards behaviour change among school age vaccine recipients and their parents. We hypothesise that consent form return rates for community school vaccination will increase to those offered a pack of vaxcards. We also hypothesized that children and parents who receive a pack of vaxcards will show improved knowledge, attitudes and behaviors towards vaccination. We will be testing several arms of the intervention to see the most effective means of delivery and timing of the intervention.