ANZCTR search results

Difficulties getting to sleep, staying asleep and waking up too early, characterising insomnia, are widely prevalent in aging populations, with over 30-48% older adults reporting sleep issues. Sleep problems are often left untreated as it is viewed as part of the normal ageing process. Further, there are many barriers such as long waitlists, high financial costs and limited availability of trained service providers to accessing first-line treatments to insomnia like cognitive-behavioural therapy for insomnia (CBTi). Moreover, CBTi is found ineffective for 30-40% of the population. Thus, there is a critical need for alternative and accessible interventions to reduce the high health and financial burden that insomnia in older adults causes. Mindfulness-based therapy for insomnia (MBTi) which potentially targets both the cognitive arousal (e.g. dysfunctional beliefs about sleep) and metacognitive processes (e.g. bias in attention to sleep-related thoughts) that maintain insomnia may be a feasible alternative. MBTi has also been linked to improvements in mood and cognitive functioning. Overall, MBTi may have high clinical utility for older adults by reducing the cognitive-emotional arousal caused by aging and its related comorbidities. Further digitally-delivered MBTi in older adults have yet to be tested. A feasible, online intervention could potentially become a widely-disseminable, financially accessible and effective treatment for older adults. This would reduce the pressure on limited face-to-face service providers and allow a stepped-care approach to treatment.

Posttraumatic stress disorder (PTSD) is a serious debilitating disorder that negatively impacts a person’s daily life, and can result in diminished cognitive and psychosocial functioning, fractured relationships, inability to maintain employment, substance abuse, high-cost healthcare utilisation, increased depression and other mental and physical health co-morbidities. MDMA-assisted therapy has shown to be effective for the treatment of PTSD as it reduces defenses and fear of emotional injury, enhances communication, and increase empathy and compassion. The subjective effects of MDMA create a productive psychological state that enhances the therapeutic process. The purpose of this study is to investigate the safety and feasibility of delivering MDMA-assisted psychotherapy to patients with PTSD.

This is a prospective study to collect different human specimen types to be used in the test development, optimisation, analytical validation and clinical validation of new diagnostic tests for a range of infectious diseases. Primary Objectives: To optimise novel diagnostic tests for different infectious diseases. This will use a range of negative human specimen types as a clinical matrix with spiked-in microorganisms. Secondary Objectives: To undertake analytical test performance testing in early-stage validation studies using mock-infected human samples. Tertiary Objectives: To undertake clinical validation using the samples provided as negative controls. Investigational products: The sample obtained from this study are used in the test development, optimisation, analytical validation and clinical validation of new diagnostic tests for a range of infectious diseases. The point-of-care diagnostic tests are based on DNA/ RNA nucleic acid amplification, as well as lateral flow antigen/ antibody detection methods. These tests are for a range of infectious diseases including respiratory pathogens (e.g., SARS-CoV-2, influenza, tuberculosis), sexually transmitted infections, viral hepatitis (e.g., Hepatitis B, Hepatitis C), insect-borne disease (e.g., dengue, malaria), infectious viral diseases (e.g., monkeypox), and vaccine-preventable diseases (measles, tetanus). Comparator: The other sample will be used for gold-standard comparator test methods run in a laboratory. For example, laboratory-based RT-qPCR analysis, and serological assays (ELISA, IFA, CFA, agglutination assay, western blot). Outcome Measures: Samples obtained in this study will be used as a clinical matrix to optimise sample processing methods, reagent composition, result algorithms, and to ascertain early insights into test performance including sensitivity, specificity, and reproducibility. A subset of samples will be used as negative controls for clinical validation purposes, to estimate sensitivity and specificity.

A Phase I/IIa, first-in-human study of EDV nanocells packaged with SARS-CoV-2 spike protein and alpha galacosylceramide adjuvant (COVID-EDV) as a COVID-19 vaccine in immunocompromised patients. COVID-EDVs are being developed as a potential anti-COVID-19 vaccine to protect COVID-vulnerable people such as those suffering from cancer and who have a compromised immune system. This trial is a follow-up of the previous healthy volunteer trial ACTRN12621001159842. The primary objective of this trial is to assess the safety and tolerability of COVID-EDVs administered intramuscularly (IM) in non-COVID-19-infected immunocompromised patients. The study follows an open label, non-randomised study design using a COVID-EDV dose level that was determined previously in a healthy volunteer trial. The study is designed to assess the ability of COVID-EDV to stimulate and support the body’s immune response to produce antibodies that can fight COVID-19. The COVID-EDV vaccine will be administered as three injections on Day 1, 21 and at 4 months. Each participant must have a immunocompromised condition and will be involved in the study for 9 months. A total of 100 participants will be recruited to the study.

Interstitial lung disease (ILD) is a term for a group of lung conditions that are incurable, characterised by inflammation and scaring of the airways, persisting respiratory symptoms and progressive respiratory failure. People with interstitial lung disease often experience severe, long-term breathlessness, however there are few treatments specifically aimed at relieving this distressing symptom. Nasal high flow (NHF) therapy delivers heated, humidified air alone (or with entrained oxygen), thus enabling patients to tolerate high flows of up to 60L/min, which cannot normally be tolerated. NHF washes out carbon dioxide from airway dead space in the lungs to improve ventilation and also generates a low-level positive airway pressure that reduces airway resistance to reduce the work of breathing. NHF is an established treatment of hospitalised patients with acute respiratory failure. Given the lack of effective interventions to reduce breathlessness in people with ILD, NHF may be useful to alleviate this distressing symptom. However, the role of NHF in people with ILD patients and severe breathlessness (but without severe hypoxaemia) has not been formally investigated. This phase 3 crossover randomised controlled trial aims to: 1. investigate long-term domiciliary NHF therapy use in patients with ILD and severe breathlessness, who do not qualify for home long-term oxygen therapy (administered for >16 hours/day). However, portable oxygen therapy (used only on exertion) is permitted. 2. explore if domiciliary NHF therapy affects breathlessness, sleep, activity, and quality of life in people with ILD. 3. evaluate the feasibility, acceptability and utility of remote monitoring devices to support clinical trials being delivered entirely within the patient’s home. 4. investigate the inflammation pathways in ILD and to explore if NHF mediates inflammatory response in people with ILD.

Chronic pain affects millions of Australians and is the leading cause of disability globally. Frequently however, chronic pain is underdiagnosed and undertreated. In this pilot randomised controlled trial, we are investigating a co-designed, internet delivered mindfulness-based cognitive therapy (iMBCT) for chronic pain program to overcome these access barriers. From the inception of this research, we have adopted a community-based participatory research framework, which is a patient-centred and community driven approach that is well suited to treatment adaptation to improve access and uptake. Consumers and consumer representatives – including our partner, Chronic Pain Australia – are the grassroots voices that have shaped the development of this iMBCT program. In this trial, participants will be randomised to iMBCT or a delayed treatment control for process evaluation, and to determine the preliminary efficacy of iMBCT for reducing pain intensity (primary outcome) and improving quality of life indicators (secondary outcomes). We will also examine potential mediators and moderators underlying the expected improvements in pain-related outcomes.

This is a single centre, single arm study primarily examining the the safety, feasibility and acceptability of psilocybin-assisted psychotherapy in treatment resistant depression patients who are on concurrent psychotropic medication.

Despite strong evidence for getting patients up and moving in hospital to prevent functional decline and other common complications, patients spend only 8-14% of daytime hours standing or walking. Our recent work has identified numerous patient, staff, ward and organisational barriers which prevent patients being active during their hospital stay. In this study, we will design a mobility strategy with key stakeholders from across the Health Service and will implement this mobility strategy in 10 medical wards across four hospitals. To determine the effectiveness of the mobility strategy, we will evaluate patient activity levels, adoption of the mobility strategy and other clinical outcomes at baseline and follow up.

Corneal nerve disease (neuropathy) can negatively impact quality-of-life due to associated ocular surface disease, which promotes chronic pain and impaired vision, particularly in severe cases. Corneal neuropathy impairs the trophic and sensory functions of the corneal nerves, leading to reduced corneal sensitivity and disruptions to ocular surface integrity. The currently available techniques to measure corneal nerve function and structure are available only in research settings. Moreover, the techniques measuring corneal nerve function are primarily a measure of mechanical corneal sensation and not a composite measure of the corneal sensations. This is a major barrier to early-stage diagnosis and management of corneal neuropathy. So, robust measures of corneal nerve integrity that could be performed routinely in the clinic need to be developed. The main aim of this project is to investigate a new method for assessing corneal nerve integrity. Our approach involves quantifying subjective corneal sensory responses and the interaction between immune cells and nerves in the cornea (using non-invasive corneal imaging) in response to stimulating the cornea with sterile salt solutions. These approaches will be compared between healthy (control) corneas and corneas with nerve changes from LASIK. These findings will provide a foundation for determining whether these aspects of corneal nerve function might have the potential to be used in the future as a marker of corneal neuropathy. The identification of a suitable non-invasive biomarker of corneal nerve fibre integrity has the capacity to be translated into the clinic, for enhanced early detection of corneal nerve damage.

[ Why Are We Doing This Research? ] The purpose of this study is to implement and test the effectiveness of a new care model that will be coordinated by specialist cancer nurses while also involving medical specialists (oncologists, and general practitioners/GPs) for follow-up care of people with neuroendocrine neoplasms. [ Who Is It For? ] You may be eligible for this study if you are aged 18 or older and have a neuroendocrine neoplasm [ Study Details ] Participants in this study will be randomly allocated to one of two groups. Participants in one group will be receiving usual, specialist-led follow-up care and information from Neuroendocrine Cancer Australia for up to 5 years. The other group will undergo the nurse-coordinated care model. This involves 1) a 1-hour nurse-led consultation with a specialist neuroendocrine nurse (SNN) to develop a survivorship care plan, 2) a multidisciplinary case-conference involving the GPs, nurses (including a SNN) +/- another hospital-based allied health professional (depending on patients’ needs) to finalise the survivorship care plan, and 3) a GP and specialist follow-up schedule for 12 months, and up to 5 years. As part of the study all participants will answer a series of questionnaires at baseline, 6 months, and 12 months. It is hoped this research will demonstrate that the new model of care increases patient quality of life and health care experience and improve follow-up care for people living with neuroendocrine neoplasms.