ANZCTR search results

The study will test the effectiveness of a universal version of a piloted intervention to support parents to bond with and care for their baby during pregnancy and in the early postnatal period. The universal intervention combines an attachment-focused mid-trimester ultrasound with parent support delivered online using “virtual home visits”, and is designed for delivery to all parents as a part of standard care at the Women's and Children's Hospital. The intervention aims to provide support to improve: (i) parents’ emotional bond with their unborn baby and their capacity to consider their unborn baby’s experiences (mentalisation); (ii) sensitive, responsive caregiving in the antenatal and postnatal period; (iii) understanding of normal patterns of infant distress in the new-born period, including how to effectively manage infant distress, and; (iv) ability to use safety planning to manage parental frustration during periods of persistent infant distress. By improving parents’ emotional attachment to their baby during pregnancy, and providing support to manage the challenges of the postnatal period, we seek to improve the health of the relationship between parents and their babies. This in turn may provide a healthier transition to parenthood and better mental health for infants. The study will also recruit consumer advocates and clinician representatives to (i) inform the development of the above parenting program; and (ii) form a qualitative study within the project to better understand perinatal experiences across multiple perspectives.

This study will trial a new personalised support program to help individuals diagnosed with obstructive sleep apnoea (OSA) improve adherence to their treatment. Despite the major impact OSA has on health and wellbeing, the current front-line treatment for OSA (continuous positive airway pressure; CPAP) is poorly tolerated. Co-designed with patients, this study will combine continuous monitoring and tailored support to better manage symptoms, troubleshoot treatment problems, and improve quality of life. We hypothesise that this program (SAMMA) will improve residual OSA severity, measured via the apnoea-hypopnea index (AHI), as well as health related quality of life, therapy use, and other OSA-related symptoms. This study will use a randomised controlled trial design, as well as health economics, to compare usual care to our tailored support program.

OptimalMe is a digitally enabled antenatal lifestyle intervention being implemented across one large Australian public health service, comprising three hospitals, to optimise gestational weight gain and related health outcomes. Using a stepped-wedge hybrid Type III design, the primary evaluation outcome includes implementation reach, fidelity, adoption, and cost-effectiveness. Secondary outcomes include gestational weight gain and routinely collected maternal–neonatal outcomes. All pregnant women >18 years, carrying a singleton pregnancy and not receiving specialist high-risk pregnancy care will receive access to a digital healthy lifestyle website (opt-in and self-selecting), with higher-risk women additionally receiving three structured telehealth coaching sessions of 30 minutes duration (opt-out as per routine care). Findings will provide real-world evidence on the feasibility and scalability of embedding digital lifestyle support into routine antenatal care for broad, public health benefit.

Study purpose: The aim of this study is to determine if a new investigational radiopharmaceutical product used to perform PET scans can distinguish participants who are not responding to immune check point inhibitor (ICI) treatment from those that are responding. Who is it for? Participants with resectable, locally advanced or metastatic solid malignancy intended for immune checkpoint inhibitor therapy either alone or in combination with chemotherapy and/or radiotherapy. Study details: Participants will complete two CDI-DX001 PET imaging tests to assess tumour uptake of CDI-DX001. The first of these tests will be done within 14 days before ICI therapy is started and the second will be done 3-7 days after administration of the second dose of therapy (approximately 3-5 weeks later). Vital signs (heart rate, blood pressure, and temperature), a physical exam, and an ECG will be conducted on the day of each scan. Participants will otherwise undertake standard of care treatment as per their treating oncologist. It is hoped that the findings of this study may contribute to earlier identification of non-response to immune checkpoint inhibitor (ICI) therapy, reduce delays in initiating subsequent treatment strategies, and inform the development of novel therapeutic approaches.

The study examines whether thinking styles in the perinatal period are associated with unwanted thought birthing people commonly experience in this time. The second aim of the study is to examine whether a very brief (15-30 minutes) online training can change these thinking styles.

This study evaluates the feasibility and efficacy of focused ultrasound neuromodulation (SUS) for the treatment of agitation in individuals with Alzheimer's disease. The intervention involves the use of the UltraThera system investigational device. The study hypothesis is that SUS can modulate brain activity to reduce the behavioural and psychological symptoms of dementia by applying low-intensity ultrasound waves to specific areas of the brain involved in emotion and behaviour.

1. This study is an early-stage clinical trial in healthy adults to understand how safe XYL-2499 is and how the body handles it. 2. XYL-2499 is an investigational medicine that affects certain brain pathways and is being developed for possible use in mental health conditions. 3. Participants will receive either a single dose or multiple doses of the study drug or a placebo, with careful monitoring throughout the study. 4. Doctors will closely monitor participants for side effects, changes in mood or perception, and effects on thinking or behavior using standard tests. 5. The study uses small groups, step-by-step dosing, and close medical supervision to help ensure participant safety

Youth depression is a global crisis. One in five young people will suffer from depression by age 25 making it the number one cause of disability in Australia and severely disrupting the social and vocational transition of young people into adulthood. Most burden of depression is caused by recurring or chronic episodes. Although some people only experience transient depressive symptoms, for 50-60% of young people depression becomes a prevailing chronic mental disorder with lifetime recurring episodes. Currently, we have no way of differentiating these groups. Identifying who is at risk for persistent depression, and therefore needs more intensive treatment, monitoring, or relapse prevention during the crucial early stage of illness, is critical to preventing poor outcomes and reducing the exorbitant personal and societal burden and costs associated with depression. In this longitudinal naturalistic clinical cohort study we aim to develop prognostic models for time in depression/ depression relapse in young people. ~1200 young people seeking help primarily for depression at headspace services nationally will be recruited to participate and assessed at baseline and every 2-months during 18 months of follow-up on clinical, demographic, psychosocial and cognitive characteristics. Opt-in components of the study include saliva samples for DNA extraction and daily mobile surveys.

This project aims to assess the acceptability and feasibility of embedding Physical Healthcare Navigator roles within multidisciplinary community mental health teams. Who is it for? You may be eligible for this study if you are 18 or older already accessing community-based mental health services from participating organisations and able to provide informed consent. Study details Those who are eligible will be provided with a four support sessions delivered by a designated navigator, who may be a peer worker, a carer with lived experience, or a mental health professional, and is embedded within a multidisciplinary community mental health team. Sessions are delivered in-person, online, or by phone according to participant preference and begin with a structured health needs assessment using the Neami Health Prompt. Following this assessment, navigators support participants to identify physical health screening and chronic disease management needs and assist them in navigating and accessing relevant health and preventive services. The navigator’s role is focused on coordination and service navigation rather than clinical care, with all health and mental health–related clinical decisions made by the treating mental health team or the relevant physical health professionals, such as general practitioners. It is hoped that the results from this study will help inform future efforts to increase health literacy with respect to accessing freely available cancer and other health screening checks. These findings will support future research and initiatives to address cancer outcome inequalities for people living with mental health conditions.

This research is likely to provide ‘proof of principle’ for a novel, ‘nutrient-based’ strategy – oral calcium supplementation – to reduce postprandial glycaemia in people with T2D by slowing gastric emptying, known to be integral to reductions in postprandial glycaemic excursions. The outcomes, if positive, will have major implications for the development of a novel, accessible, safe and cost-effective approach to the prevention and management of T2D.