ANZCTR search results

This study aims to test the effectiveness of Transcranial Alternating Current Stimulation (tACS), a gentle non-invasive brain stimulation technique, in treating young people (16-30 years old) with depression. Participants will be randomised into three groups; theta tACS, alpha tACS or sham stimulation and will receive 30 treatment sessions over four-weeks. Depressive symptoms and cognition will be assessed pre-treatment, mid-treatment phase, post-treatment and at 3 month follow-up. It is anticipated that that active tACS will improve both depressive symptoms and cognition compared to sham tACS.

Polycystic ovary syndrome (PCOS) is a common condition which affects up to 18% of young women. It is caused by hormonal disturbances and is associated with significant reproductive, metabolic, and psychological complications. Hirsutism is defined as excessive hair growth in a woman. It is often a key concern for women with PCOS, but is often overlooked by health professionals. Conversely, it is of high importance as it has a deleterious effect on self-esteem, emotional wellbeing and quality of life, especially in women with PCOS. Laser hair removal therapy, is widely used and thought to be effective in reducing severity of hirsutism and improve quality of life but its use in women with PCOS is less well-studied. We intend to conduct a before and after trial to observe the efficacy of laser therapy in treating facial hirsutism in women with PCOS. We will assess changes in hirsutism severity and also its impact on psychological outcomes in women with PCOS.

Some brain aneurysms, when they bleed, are difficult or impossible to treat safely with "conventional" techniques. There is a device similar to a stent which has been used for 10 years to repair some aneurysms, called the Pipeline Embolisation Device, which has previously needed aspirin plus a stronger blood thinner before inserting it to prevent the device clotting and causing a stroke. The latest version of this device Pipeline-Shield), in use in Australia for 3 years now, has a coating which mimics the lining of blood vessels. This means that the stronger blood thinner may not be required to keep the device from clotting. We have been using the Pipeline-Shield with aspirin only to treat some patients with these "impossible" aneurysms under compassionate use for 2 years with very promising results. We hypothesise that using the device in this manner with aspirin only is safe, and that the device will clot only very rarely if used in this manner.

At present, the self-reflective resilience training (Mental Fitness Training) involves a 40-minute training brief and then 15 minutes of guided self-reflection writing activities each week for five weeks. Cadets are required to reflect on their stressor experiences, evaluate their initial approaches to coping with those stressors, and arrive at alternative strategies that could be applied to future demands. However, the research team and RMC leadership believe that the coping and emotion regulatory skills can be integrated into the training of core technical skills. Our objective is to design and test the efficacy of a new integrated self-reflection training involving RMC instructors (instructor Mental Fitness Training). Formally, we proposed three hypotheses for (1) mental health outcomes, (2) performance outcomes, and (3) mediations: H1(a): Indicative of greater expeditiousness of the integrated self-reflection training involving RMC instructors, the intervention group would report lower average mental ill-health symptoms and perceived stress at intermediate time points (T2/T3) compared to the control group, and a more gradual decline in mental ill-health symptoms and perceived stress between T2/T3 to T4 compared to the control H1(b): Indicative of greater efficacy of the integrated self-reflection training involving RMC instructor, the intervention group would report lower average mental ill-health symptoms and perceived stress compared to the control group at T4. H2: Indicative of greater efficacy of the integrated self-reflection training involving RMC instructors, the intervention group would demonstrate higher average performance scores across the four performance measures (foundation warfighting, merit points, command, and leadership and character) than the control group. H3: The effect of training condition on mental ill-health symptoms, perceived stress, and performance will be mediated by (a) perceived instructor support and (b) instructor encouragement of resilience training principles and strategies.

The study aims to evaluate the efficacy of a community-based assertive aftercare follow-up suicide prevention program in reducing repeat suicide attempts for people who have presented to the participating emergency departments following a suicide attempt or with high risk of suicide. A secondary aim of the study is to measure changes in known suicide risk factors (e.g. depressed mood, psychache) for people who participated in the intervention. The assertive follow-up intervention will be delivered by mental health clinicians and peer workers, using both face-to-face interventions and phone follow-up sessions, for a duration of four weeks (with an option of extension to 12 weeks). The intervention is based on the GROW coaching model and will utilise the Suicide Status Form-4 (SSF-4) from the Collaborative Assessment and Management of Suicide (CAMS) model (Jobes, 2016; Jobes, Jacoby, Cimbolic, & Hustead, 1997). Participants will be asked to outline the key issues that are contributing to their suicide risk, and in collaboration with a clinician, will produce a set of goals and objectives for addressing these issues in a set timeframe, and follow a stabilisation plan. Participants will re-rate their suicide risk factors and evaluate their goals and stabilisation plan at each contact with a clinician or peer worker. Quantitative and qualitative measures of progress toward goals, stabilisation plan and suicide risk will be monitored using the SSF-4 at each contact, measuring psychological pain, agitation, stress, hopelessness, self-hate and overall risk. It is hypothesised that; 1. Compared to health consumers who receive treatment as usual (TAU) following their episode of care in an emergency department as a result of a suicide attempt or high risk of suicide, participants of the Aftercare intervention will be significant less likely to re-present to an emergency department for suicide attempt or high risk of suicide. 2. Compared to health consumers who receive TAU following their episode of care in an emergency department for suicide attempt or high risk of suicide, participants of the Aftercare intervention will experience a significant reduction in the number repeat suicide attempts (as measured by re-presentations to an emergency department for a suicide attempt or being deemed to be at high risk of suicide). 3. Compared to health consumers who receive treatment as usual (TAU) following their episode of care in an emergency department as a result of a suicide attempt or high risk of suicide, participants of the Aftercare intervention will be significant less likely to die by any cause in 24 months. 4. Participants of the Aftercare intervention will show significant reductions in suicide risk factors following the intervention.

This experimental study seeks to investigate the effect of different labels for high blood pressure (e.g. hypertension vs high normal blood pressure) on treatment decision-making and psychosocial outcomes (perceived severity; level of concern), compared to a control group where no label is given. It will also explore whether any effect is affected by a) sharing absolute risk information and b) health literacy. Australian adults aged 40-50 with a normal risk of hypertension will be sampled. Only those with an average risk profile will be included in the study, to be presented with a hypothetical diagnosis and asked a number of survey questions investigating health literacy, treatment decision making, risk perception and perceived self-efficacy.

The overall aim of this proposal is to explore the link between stress-related eating behavior and treatment outcomes in people undergoing treatment for obesity. Patients who have been referred for surgical treatment for obesity (sleeve gastrectomy) will be invited to participate in a study in which half of them will be randomly allocated to using a very-low-energy diet (VLED) for 2 months while waiting for surgery. Participants will complete questionnaires, and have a meal test (involving collection of blood samples prior to and for 2 hours after a liquid meal) at the beginning of the study, and three months after the intervention (VLED or surgery), and 12 months after surgery. We hypothesise that stress-related eating will improve after sleeve gastrectomy, and will be associated with one or more hormones involved in appetite regulation.

This study's purpose is to assess new bones lesion(s) in prostate cancer participants starting androgen deprivation therapy (ADT). Who is it for? You may be eligible to join this study if you have prostate cancer with a high risk of metastatic disease and your treating doctor recommends starting ADT and targeted radiotherapy. Study Details: Participants in this study will undergo a 68Ga-PSMA PET CT at study entry. Participants will have two additional 68Ga-PSMA PET CT at 6 and 12 months. Participants will be followed up per routine clinical care. Participants have the option of providing optional blood test. It is hoped that this research will provide insight in the incidence and mechanism of bone lesions in advanced prostate cancer.

The purpose of this study is to identify if introducing a protocol to standardise post-cardiac surgery fluid resuscitation can reduce the amount of intravenous fluid administered and potential patient harm. By using a protocol and the calculated mean systemic filling pressure analogue, the amount of intravenous fluid received post-cardiac surgery can be restricted.

NP202 has been shown to reduce rhythm disturbances in heart muscle in the ventricles, and it is compelling to discover if it similarly reduces rhythm disturbances in heart muscle in the atria. As AF is the most common rhythm disturbance in the atria, it is the most suitable target to investigate a benefit. This is a single-centre, randomised, double blind, placebo controlled study to assess the efficacy, safety and tolerability of NP202. Subjects will be screened during routine interrogation of their cardiac device. Eligible subjects will have a high burden of paroxysmal atrial fibrillation. They will be randomised and administered their first dose of investigational product (IP) on Study Day 1. Subjects will take their IP dose once a day for 1 month (30 days). During this treatment period they will return to the site for study visits at Week 2, and Months 1, 2, and 3. Month 3 is the end of the Treatment Period. Subject will return for follow up and the final study visit at Month 4. A Data Monitoring Committee (DMC) will review safety data at agreed recruitment and progression milestones to provide independent oversight of subject safety. Armaron Bio Pty Ltd has provided the study drug at no cost. They have not have provided any funding and the study investigators have full intellectual property and rights over the study data.