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Text message support versus group program for pain self-management in people with ongoing pain after early breast cancer (TEMPO-P study)
Expand descriptionThis study aims to investigate whether a 5-week text message program to support pain self-management works at least as well as a 5-week personally tailored cognitive behavioural therapy (CBT)-based pain self-management program run by a hospital pain clinic. Who is it for? You may be eligible for this study if you are an adult who has finished treatment for early-stage breast cancer and continue to experience ongoing pain that affects daily life. Study details About 80 participants will take part in this study. Participants will be randomly allocated (like flipping a coin) to one of two groups: - a mobile phone program that sends two supportive text messages per day for 5 weeks, or - a personally tailored cognitive behavioural therapy (CBT)-based pain self-management program delivered through the hospital pain clinic (format may be group-based, individual sessions, or self-guided materials based on an initial assessment). Both groups will also receive a self-help pain management book and workbook, and will continue to receive all their usual care from their doctors. Participants will complete short online questionnaires about pain, daily activities, mood, fatigue, work, and satisfaction at the start of the study, at 5 weeks, 9 weeks, and 3 months after starting the program. Some participants may also be invited to take part in a one-off telephone interview about their experience. It is hoped that the results of this study will show whether the text message program can be a convenient and acceptable alternative to group pain self-management programs for people living with pain after breast cancer.
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Internet-delivered Wellbeing Training for First Responders
Expand descriptionThis randomised controlled trial aims to evaluate a self-paced online training program called ‘Agile Mind’, designed to support the wellbeing of Emergency Service Workers and protect against common symptoms of depression, anxiety, and PTSD. The program was developed based on the principles of Acceptance and Commitment Therapy, an evidence-based psychotherapy intervention that is used to increase psychological flexibility. Psychological flexibility is the ability to accept uncomfortable situations and respond in ways that align with personal values, and was chosen to be the focus of Agile Mind due to previous research suggesting that it is protective against the development of mental health conditions (especially PTSD). The research questions that the trial seeks to address are whether Agile Mind is relevant and suitable for an emergency service worker population, and whether it leads to changes in this population's reported wellbeing, mental health symptoms, resilience, psychological flexibility, and work performance. To assess the scientific effects of Agile Mind, it will be compared against another a self-paced online training program called 'Wellbeing' (designed for the general working population), as well as a Waitlist control group that will not receive access to a program until later in the study.
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A Study to Assess the Effect of Acid-Reducing Medicines on ATH434 in Healthy Volunteers
Expand descriptionThis Phase 1 study evaluates the effect of esomeprazole (proton pump inhibitor), on the PK and safety of ATH434 in healthy volunteers. The primary hypothesis is that co-administration of esomeprazole will not significantly change the systemic exposure of a single 75 mg dose of ATH434. The study also aims to confirm the safety and tolerability of combining these treatments, using a fixed-sequence crossover design to compare ATH434 levels with and without esomeprazole.
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A randomised controlled trial comparing the cost effectiveness of jaw-in-a-day (JIAD) surgery versus standard jaw reconstruction with delayed prosthetic rehabilitation.
Expand descriptionThis study aims to compare the costs and overall value of jaw-in-a-day (JIAD) surgery with the standard approach, where teeth are replaced some-time after jaw reconstruction surgery. Who is it for? You may be eligible for this study if you are male or female, aged 18 years or older undergoing jaw reconstruction with an osseous free flap, suitable for dental implant placement, with American Society of Anesthesiologists (ASA) score I-III, and able to self-care and maintain good dental hygiene. Study details Participants who choose to enrol in this study will be randomised to either JIAD or standard jaw reconstruction. JIAD involves replacing the missing teeth at the same time as the jaw reconstruction surgery, instead of the standard approach where teeth are replaced some-time after jaw reconstruction surgery. The Head and Neck Reconstructive surgery is planned and will take 6-10 hours (standard of care). After surgery, participants will attend routine outpatient clinic visits, and CT scans will be collected every three months for the first year as part of standard care. Will also complete questionnaires at the above time points. In the second year, this process will continue every six months. It is hoped this research will help others in the future who may benefit from gathering new information about the cost and value of different ways of replacing missing teeth after the jaw reconstruction.
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Better Bedtimes: A brief behavioural sleep intervention for insomnia in middle childhood
Expand descriptionBetter Bedtimes is a brief, two-session psychologist-delivered intervention designed to help children aged 6 to 11 years fall asleep faster and stay asleep throughout the night. The primary aim of this study is to evaluate the efficacy and acceptability of the intervention for children with insomnia symptoms. A secondary exploratory aim is to compare outcomes between children with and without a comorbid anxiety disorder.
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PANDA: Psilocybin-assisted therapy for treatment of alcohol use disorder and comorbid depression
Expand descriptionWe aim to assess feasibility, acceptability and preliminary results of the effectiveness of psilocybin in the treatment of alcohol use disorder (AUD) and depressive symptoms, in addition to routine alcohol and other drug (AOD) treatment. This pilot study will use a single dose of psilocybin in addition to standard counselling care for people experiencing co-morbid AUD and depression. Ten participants will be recruited from advertising and clinician referrals at the study site.
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CLinician-perfOrmed bedside ulTrasound for Screening for Proximal deep venOus Thrombosis in Intensive Care Unit (the CLOT-SPOT study)
Expand descriptionThis prospective observational study aims to evaluate bedside two-zone lower limb compression point-of-care ultrasound (POCUS) for the detection of deep vein thrombosis (DVT) in critically ill adults.
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Comparing ALternative Models of carE to manage diabetes Distress (CALMED): A type 1 hybrid implementation - effectiveness trial to improve psychological and glycaemic outcomes and avoid hospitalisations in people with type 1 diabetes.
Expand descriptionThe current study aims to address a major gap in care for people with diabetes distress (DD). By conducting a pragmatic randomised controlled trial, the goal is to compare three models of care for people with DD: i) SMOC (recommend GP to refer patient to a psychologist via the mental health care plan) ii) IMOC (individual assessment and management of DD by a DM-informed psychologist) and iii) GMOC (6-session behavioural therapy program delivered via Virtual Care group by DM-informed psychologist and diabetes educator; 3-6 participants per group). Specifically, the study aims to determine the comparative efficacy of GMOC, IMOC and SMOC in improving DD, glycaemic control and reducing hospitalisations in patients with T1DM and DD. The cost effectiveness of each Model of Care will also be examined. The research will generate new knowledge and evidence regarding sustainable models of care addressing an urgent clinical need, as diabetes places an increasing burden on our health system.
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Optimising Green Spaces in Specialist and Mainstream Primary Schools: The Green Schools Project Protocol
Expand descriptionWorking closely with industry and education stakeholders, this project will generate vital evidence regarding the potential benefits of green spaces for social and emotional well-being, nature connection, and school enjoyment among students and nature connection and occupational well-being/engagement among staff. It will also explore barriers and facilitators to green space innovation and provide insights on the processes of co-designing, adopting and implementing greening. This project will address current gaps in the field by assessing the impacts of co-designed school greening interventions at both specialist and mainstream primary schools. Specialist schools focus on vulnerable communities and are an over-looked setting. This research is also novel in its inclusion of both indoor and outdoor greening and a focus on the impacts of greening for both students and school staff. Finally, it will foster an understanding of the real-world implications of real-world retrofitted greening interventions at multiple schools, enabling the production of practical and policy-relevant greening recommendations for both specialist and mainstream schools.
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Exploring a health app to support daily tasks and wellbeing for caregivers and people with cognitive decline
Expand descriptionThis study is testing a smartphone app called Perx, designed to help people with cognitive decline and their caregivers manage daily health and wellbeing tasks. Participants will use the app to track tasks like taking medications, attending appointments, and completing optional wellbeing activities. Caregivers will also have access to supportive content developed with dementia specialists. The study aims to understand enrollment feasibility, how engaged participants are, and whether it helps with daily routines and adherence to health tasks. Insights from this pilot will help improve the app and inform future studies to better support people living with cognitive changes and their caregivers.