ANZCTR search results

The purpose of this study is to explore the therapeutic benefits, tolerability and acceptability of psychedelic therapy using psilocybin and its potential to improve symptoms of treatment resistant depression (TRD), depression in people which has not resolved with a number of courses of standard treatment. Prior research has suggested that this type of treatment may have significant antidepressant effects, but we require further evidence to fully understand the therapeutic value, benefits, and risk of psilocybin in a treatment setting. The design includes an adaptive, dose finding, single phase 2b clinical trial exploring the efficacy and safety of psilocybin assisted psychotherapy (PAP) in the treatment of people diagnosed with treatment resistant major depressive disorder (TRD). If successful, this will lead to the conduct of a subsequent multi-site phase 3 trial to report findings of the therapeutic value, benefits and risks of psilocybin for the treatment of mental health conditions, including the size of effect, the quality of evidence and the relevance to real-world use in Australia.

The aim of this study is to use a 3D-printed scaffold made specifically for the patient to help improve the visual appearance and symmetry of their nose. The current treatment to improve symmetry to the nostril base is to use either bone graft which is prone to resorb with time or to use an artificial material which doesn’t grow with the child. We hope to overcome these shortcomings by implanting a biodegradable scaffold under the base of the nose to improve nostril shape. The scaffold will be placed during the same surgery as the patient’s secondary alveolar bone grafting procedure or secondary rhinoplasty. The scaffold is made from a material (polycaprolactone-tricalciumphosphate (mPCL-TCP)) that degrades over time allowing for their own tissue to grow into it leaving them with just their own tissue once the scaffold has fully degraded. The scaffold will typically fully degrade in 24 months.

NUDG-ED is a randomised trial that will investigate behavioural strategies to reduce the use of low-value care for low back pain in emergency department (ED). We will recruit ED clinicians who manage back pain, and patients 18 years or over presenting to ED with back pain with a musculoskeletal condition. We will randomly allocate hospital sites to receive i) waiting room messaging for patients on best care for back pain, ii) computer prompts reminding clinicians of the indications for imaging and opioids, iii) both interventions, or iv) no intervention. The primary outcome will be the proportion of low back pain encounters where a person received low-value diagnostic imaging or an opioid prescription at discharge from ED.

This study aims to assess whether a digital conversational agent can be used to effectively deliver a low intensity emotion regulation intervention to people who have sustained a minor to moderate injury in a motor vehicle accident. This is a cohort of people who are often under stress. The intervention has been designed with input from clinical psychology and computer science. The intervention encourages people to reflect on the current way they manage negative emotions and provides information and examples of evidence based adaptive emotion regulation strategies that have been identified as being critical for effective coping. The emotion regulation strategies included in the program include positive refocusing, reappraisal, acceptance, planning and problem solving and putting things into perspective. It is anticipated that completing this intervention will assist participants to learn strategies to assist them to regulate emotions which will in turn increase their confidence that they can cope at this challenging time. It is also anticipated that the program will assist in reducing participant's reported levels of distress.

This study will evaluate the effects of a fasting mimicking diet or an exercise program on immune biomarkers in breast cancer patients receiving (neo)adjuvant chemotherapy compared to a group of patients undergoing (neo)adjuvant chemotherapy without following a diet or exercise program. Who is it for? You may be eligible for this study if you are an adult woman aged 18 years or older, you have been diagnosed with breast cancer and you are scheduled to undergo or already receiving chemotherapy. Study details Participants who choose to enrol in this study will be offered to join one of three groups. Participants who choose to join the first group will be given a prescribed diet that is designed to mimic a fasting diet. The diet will be low calorie and low protein, participants will be asked to follow the diet 2 days before their chemotherapy infusion and continue it for 2 days after their infusion. Participants will then return to their usual diet until 2 days prior to their next infusion. Participants who choose to join the second group will be asked to attend a gym 2 or 3 days per week to complete supervised exercise routines. During weeks where participants are undergoing chemotherapy they will attend 2 sessions/week for 50-60 min per session. During the weeks without chemotherapy treatment, patients will attend 3 sessions/week for 50-60 min per session. Participants who do not wish to participate in either the diet or exercise groups may also enrol in this study and complete blood tests and questionnaires prior to and after completing their chemotherapy. These participants will act as the comparator group to determine if either the diet or exercise program has any effect on the cancer cells compared to chemotherapy alone. It is hoped this research will provide preliminary evidence as to whether following a fasting mimicking diet or an exercise program while undergoing chemotherapy for breast cancer can promote beneficial effects on immune biomarkers. . If either the diet or exercise program is shown to have a beneficial effect on breast cancer patients, a larger randomised clinical trial of one or both of these treatments may be undertaken

People with advanced Peripheral Artery Disease (PAD) require costly, complex surgery, and often have heart attacks, strokes, and amputation. Preventative care is poorly provided, and many people with PAD miss out on medications that improves long-term health and avoid complications. We hypothesise that involving a range of expert doctors in team-based care will improve recognition and treatment of cardiovascular risks compared to current care practices. This project aims to improve prevention of adverse cardiovascular outcomes in people with peripheral artery disease by providing multidisciplinary team-based care that is targeted to an individual person’s health needs. To do so, we will compare the cardiovascular risks of people treated according multidisciplinary team recommendations (measured using the SMART-REACH model) to those who receive current standard care. We will also measure patient and clinician experiences, and costs associated with the new team-based model of care.

Aim: To improve the quality of care in interventional radiology (IR) by determining the optimal form of anaesthesia for fistula interventions whilst optimising resources for Liverpool Hospital and SWS LHD. Primary objectives: To assess the efficacy and safety of regional anaesthesia for fistuloplasty in IR compared to conscious IV sedation. Secondary objectives: To assess proceduralist and patient satisfaction with regional anaesthesia compared to conscious IV sedation. Hypotheses: We hypothesise, based on anecdotal experience, preliminary data and evidence in the literature in other clinical settings, that regional anaesthesia (axillary or brachial plexus block) is safer and more effective than intravenous sedation for anaesthesia/pain relief during fistula interventions. We also propose that this will lead to improved proceduralist and patient satisfaction and reduced burden on resources.

SCoPE2 is evaluating different methods of self-collection to determine is alternative methods can be used with new HPV nucleic acid based assays to facilitate a wider range of options for HPV-based cervical screening. There is a lot of evidence demonstrating that self-collection is as good as clinician-collected for HPV-based cervical screening. SCoPE2 is looking to assess whether the method in this study produces similar results showing that self-collection is equivalent to clinician-collected samples for HPV-based cervical screening.

It is important that people with brain injury and stroke engage in rehabilitation activities outside of their clinical appointments to maximise their recovery. Issues with memory, motivation, and therapy engagement can make it difficult for clients to undertake activities between appointments. We have developed RehabChat – a motivational chatbot app - to assist with goal setting and achieving goals. RehabChat was co-designed with clients with brain injury and brain injury rehabilitation clinicians. RehabChat is easy to use and helps clients be motivated and involved in their rehabilitation to complete their practice activities and reach their goals. It is designed to be used alongside usual care by a client with brain injury or stroke, with their therapist providing clinical oversight. The client-clinician pair use RehabChat at weekly appointments to enter key rehabilitation information about the client’s goals and practice activities. The client then uses RehabChat independently in-between appointments for motivational cues and reminders which support the client to complete their prescribed practice activities. Results from earlier testing of RehabChat suggest that RehabChat supports client motivation and therapy engagement. This study aims to appraise how feasible and easy it is to use RehabChat alongside usual rehabilitation care. Each participant will first receive 1:1 training to use RehabChat. Client and clinician pairs will then use RehabChat for up to six weeks and provide feedback of their experiences and perceptions. The findings from this study will inform the development of a larger clinical trial.

Traumatic brain injury (TBI) is a complex chronic disease process with survivors facing unique and ongoing challenges over different recovery stages. Post-injury psychosocial and emotional adjustment problems are common and can reduce quality of life, functional recovery, and increase healthcare costs. The myTBI study aims to develop an online psychoeducation platform to improve psychosocial adjustment to TBI and enable continuing psychosocial support for individuals across acute, post-acute, and chronic phases of recovery. We hypothesise that psychoeducation will improve psychosocial adjustment after TBI and will have a significant impact on overall functional recovery and quality of life after TBI and reduce length of stay. Online education represents a cost-effective and scalable solution that can be directly and immediately implemented within existing health services without requiring highly specialised clinicians, and may be particularly effective for engaging the predominantly younger male TBI population.