ANZCTR search results

Psychotic illness tends to emerge during adolescence, which is a stage of critical social development. One of the earliest signs of psychotic illness is social difficulties, which can cause young people to become withdrawn from everyday life. Psychotic symptoms like paranoia and hallucinations (hearing or seeing things that aren’t there) can make it hard for young people to function around others. These symptoms are usually triggered in social situations, which can make young people want to avoid them, ultimately making the problem worse and causing them to become more withdrawn. Psychological treatments like cognitive behavioural therapy can be effective for helping young people feel comfortable in social situations. However, these treatments are delivered in clinics, removed from the social situations where they need the most help, and are therefore have limited effectiveness. Virtual reality (VR) is a technology that involves wearing a headset which projects 3D images of real world environments onto a screen so the user feels like they are immersed in that environment. Users can interact with the virtual environment using hand controllers, and virtual characters (‘avatars’) are often present to simulate social interactions. Research has found that VR can be used to support treatment of social difficulties by guiding people to learn and practice social skills in virtual environments. This technology therefore has potential to help young people who experience symptoms of psychosis, which is yet to be explored. This research aims to evaluate a new VR treatment based on cognitive behavioural therapy for young people experiencing hallucinations (a common and distressing symptom of psychosis) to understand whether it is feasible and safe to deliver, and whether it has potential to improve social functioning.

The aim is to use Artificial Intelligence based tools for automated measurement of lesions/areas of ischemia in stroke patients. This data will be used for patient outcome prediction.

Australia has the highest prevalence of food allergy in the world, with at least one in every 32 (3.1%) infants developing peanut allergy and one in every 66 (1.5%) infants developing a cashew nut allergy, which are usually lifelong. Nut allergies place individuals and their families under enormous stress and have been shown to decrease quality of life. This trial aims to determine if the risk of developing peanut and cashew nut allergy during infancy can be reduced by a maternal diet rich in peanuts and cashew nuts during breastfeeding. A finding from our recent Western Australian pilot randomised controlled trial (ACTRN12617001465347) with 109 mother-infant pairs discovered that a maternal high-peanut diet, compared to a low-peanut diet, during the first six months of lactation may reduce the risk that her infant will develop a peanut allergy. We now propose a definitive efficacy randomised controlled trial, in order to provide high-quality evidence to inform maternal diet guidelines for peanut and cashew nut allergy prevention. If the hypothesis is correct, this will be a simple strategy to reduce nut allergies. If incorrect, this information will be paramount for informing breastfeeding women about food choices. Participating mothers will be randomly allocated into either a high-nut (minimum of 60 peanuts and 40 cashew nuts per week), or a low-nut (maximum of 20 peanuts and 12 cashew nuts per week) group, for 6 months from the birth of their baby. From six months of age after commencement of solid foods, both groups will be encouraged to include smooth peanut butter and cashew nut spread in their baby’s diet as per our current Australian infant feeding and allergy prevention guidelines. Infant peanut and cashew nut allergy outcomes will be assessed at 12 months of age. This trial has been co-designed with consumers who will continue to be involved in all stages.

The primary objective of this randomised controlled trial is to quantify the effect of tDCS and exercise on pain, disability and QoL in people with hip OA. Our secondary objectives include: 1) quantifying the influence of motor cortex excitability and CPM on treatment effects, and 2) quantifying the economic cost/ benefit of tDCS for improving health-related QoL in people with hip OA.

This study will determine the effect of highly targeted exercise on the bone health of people with multiple myeloma. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with multiple myeloma and you are currently taking bisphosphonates (bone active medication). Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of two groups. Participants allocated to the first group will be given an individual exercise program that consists of two supervised sessions and one at-home session per week. Participants in this group will be asked to complete these weekly sessions for 9 months. Participants allocated to the second group will be asked to continue with their current care program which may include exercise but will not include the weekly program described above. Participants in the second group will also be given information sheets to review from Myeloma Australia. All participants will be asked to undergo a series of assessments, including bone scans and exercise assessments at 3-months and 9-months after enrolment. It is hoped this research will demonstrate that bone-targeted exercise will not only maintain bone health but may delay the progression of bone tumours by altering the behaviour of bone cells. It is also hoped that this exercise program can increase muscle strength and physical function, and reduce pain, improving quality of life in people with multiple myeloma.

Currently, there is a critical lack of established mental health services or treatment programs for burnout, let alone services or programs tailored specifically for health professionals. Burnout is a work-related syndrome characterised by emotional exhaustion, disengagement from work, and a reduced sense of accomplishment. Burnout is notably prevalent among health professionals, especially due to the COVID-19 pandemic. Burnout is a cause for concern as it is related to poor mental health among health professionals, increased staff turnover, and reduced patient safety. To help address this, the Black Dog Institute (BDI) created an online self-guided cognitive behavioural program designed to support health professionals experiencing burnout. The “Navigating Burnout” program sits within BDI’s dedicated health professional support service – The Essential Network (TEN) – where health professionals can access a both digital and person-to-person services. In this study, we will conduct a 10-week randomised-controlled trial to examine the effectiveness and acceptability of a “blended care” version of Navigating Burnout in supporting doctors experiencing burnout, in which a clinical psychologist will work through Navigating Burnout with the participant. This blended care Navigating Burnout will be compared to (a) a self-guided version of the digital program where the participant will work through the program online by themselves and (b) an active attention control where participants will be provided with digital self-care.

Trans and gender diverse young people face an alarming rate of mental health difficulties. Due to their unique experiences, the lack of available tailored mental health interventions, and their preference for trans-informed digital delivery formats, there is a pressing need for an engaging and effective, evidence-based prevention intervention, designed with and for trans youth specifically. The aim of this project is to evaluate the efficacy, acceptability and feasibility of a mobile serious game adapted specifically for and with trans young people (SPARX-T) in preventing the onset and exacerbation of depressive symptoms, compared to a waitlist control.

Despite all treatment guidelines recommending exercise, 9 of 10 Australians with knee osteoarthritis (OA) are inactive. Most undergo surgery without trying exercise, despite evidence that exercise can delay/prevent surgery. However, exercise often hurts, reducing initial/sustained exercise engagement. Clinicians promise that pain will reduce over time as fitness increases/weight reduces. While evidence supports this promise, sustaining exercise is difficult. Arthritis Australia's Exercise Report identifies improving exercise engagement as key to improving osteoarthritis outcomes and Australia's National Arthritis Strategic Action Plan calls for new ways to increase uptake of exercise in people with arthritis. New virtual reality technology holds promise and may assist with reducing exercise barriers to increase exercise uptake/engagement. Using a parallel-group, randomised controlled trial, participants will be randomised to one of two active treatment groups. Both groups will receive 2 weekly in-person treatment sessions with a physiotherapist for a period of 6 weeks. Primary outcomes include the WOMAC and perceptually-regulated exercise.

The immune checkpoint inhibitors (ICI) are a form of cancer treatment that have resulted in significant improvement in the outcomes of the management of a number of malignancies. They work by activating the immune system and thereby promoting the destruction of cancer cells. The use of ICIs is limited by a group of side-effects known as immune related adverse events (irAEs). One of the more common irAEs is the development of inflammation of the large intestine known as ICI colitis. The treatment of ICI colitis is mostly aimed at suppressing the immune system and ‘switching off’ the overactive immune cells that are causing the inflammation. The use of treatments that suppress the Immune system may themselves result in significant side-effects by increasing the risk of infection. Immune suppression may have a detrimental impact on the outcome of the cancer being treated, by reducing the ability of the patient’s immune system to control the cancer. Who is it for? You may be eligible for this study if you are an adult who is receiving treatment for a solid cancer, who has experienced onset of colitis symptoms within 6 months of treatment commencement. Study details Participants in this study will be able to choose if they wish to receive the intervention or are considered part of the 'control' group. Participants who choose to receive the intervention will undergo a colonoscopy where they will receive a faecal transplant. If a participant chooses not to receive the intervention, they will continue with standard treatment as determined by their doctor. All participants will then be followed up for 8 weeks and asked to complete questionnaires and provide additional blood and stool samples. It is hoped that this study will help assess the efficacy and safety of Faecal Microbiota Transplant as first-line therapy in the treatment of ICI colitis.

Management of cancer is a rapidly evolving field, and it occurs in 4 stages: phase 1 (P1) to phase 4. P1 clinical trials are designed to test drug pharmacokinetic profiles and toxicity. However, most often patients enrol in these trials for potential therapeutic benefits. P1 trials often require participants to frequently interact with the health care team for various investigations and treatment. This time they spend interacting with the health care team has the potential to reduce quality time that participants could have utilised otherwise. This is called 'Time Toxicity' and it is defined as the time a participant spends organising and obtaining treatment including in/out-patient visits, hospitalisations, emergency care for side effects, travel and wait times, and follow-up tests. TT reported in participants undergoing cancer treatment has shown to carry a substantial burden, but its impact on the quality of life in participants undergoing P1 trials is not well explored. As such, it is often overlooked as a deciding factor in the consenting processes for the P1 trials. We aim to measure TT and assess its impact on the quality of life of participants enrolled in P1 oncology clinical trials through patient-reported outcomes. Who is it for? You may be eligible for this study if you are an adult with cancer who is going to take part in a phase 1 cancer clinical trial. Study details All participants in this study will continue with their phase 1 clinical trial, and will be asked to complete a diary for 3 months to report their time toxicity. Participants will also be asked to complete questionnaires and take part in a one-on-one interview describing their experiences and expectations at the start of the phase 1 clinical trial and after the three months (or earlier). It is hoped that this study will provide data that can help clinicians, patients, and families make the right treatment decisions.