ANZCTR search results

This Research Project will involve a randomised control trial of an online mindfulness training program (MTP) designed specifically for medical students studying at UWA and University of Notre Dame, Fremantle, to assess the feasibility and effectiveness of the program with regards to reducing perceived stress and improving mindfulness, self-compassion and study engagement. The MTP has been developed to include brief, daily mindfulness meditation practices and brief, weekly video teachings on the applications of mindfulness meditation for medical students. The program will be delivered via an online platform. This delivery mode aims to minimise the time required by busy medical students to invest in the program while providing stress management and self-care skills that are traditionally not taught as part of medical school training. The program will be evaluated using both quantitative, including quantitative surveys before and after the program. We hypothesise that students who participate in the intervention will have improved levels of perceived stress, mindfulness, self-compassion and study engagement compared to controls who do not at the end of the 8-week program compared to baseline, with a number of intervention participants maintaining those improvements at 6-months post-intervention.

Early sepsis diagnosis is challenging for clinicians due to the non-specific nature of symptoms and the cross-over between clinical signs and symptoms of sepsis and those of other mild self-limited infections. Current diagnostic criteria for sepsis in children perform poorly, causing clinicians to rely on their own experience and judgement to diagnose sepsis. They must balance the risk of over-treatment, un-necessary hospitalisation, and overuse of broad spectrum antibiotics with the risk of delayed treatment, which is a known contributor to poor outcome and death from sepsis. The lack of clear diagnostic criteria also results in variable estimates of sepsis prevalence, severity, outcomes, cost, difficulty benchmarking care, and inconsistent enrolment strategies for clinical trials. The Biomarkers in Sepsis (BASIS) study will identify novel biomarkers (protein and mRNA) for early sepsis diagnosis and risk stratification. These will have the potential to save lives through commercialisation into point-of-care tests.

The Strength Study is a Phase 3 clinical trial evaluating the efficacy and safety of L-carnitine in treating muscle fatigue and weakness in children with Neurofibromatosis Type 1 (NF1). Children with NF1 often experience reduced muscle mass, muscle weakness, and motor function issues, impacting their quality of life. NF1 deficiency can lead to the accumulation of intramyocellular lipids in muscles. L-carnitine helps transport fatty acids into mitochondria for energy production and has been used to treat disorders of fatty acid metabolism. This study will assess L-carnitine's effects over 12 to 25 weeks in children aged 8 to 12 with NF1, measuring improvements in muscle strength and activity. The primary measures will include Z-score changes on functional assessments, hand-dynamometry, and data from the GENEActiv Actigraph.

The aim of this study is to determine whether a co-designed health literacy intervention can improve health literacy among inpatients admitted with their first presentation of acute coronary syndrome. Sixty participants will be randomised into either the intervention or control group. The intervention group will be provided with the Patient Discharge Action Plan in addition to usual discharge education. The control group will receive usual discharge education. Information about participants’ health literacy and other factors will be collected through self-report or medical records at baseline, 2-weeks and 3-months after discharge. Interviews will be also be offered at 3-months. Expected outcomes are that the intervention group will have a greater improvement in health literacy, lower anxiety and depression, emergency department presentations and higher attendance at cardiac rehabilitation compared to the control group at follow-up time-points.

Vision impairment (VI) is considered to be a serious public health issue, affecting more than 4 million people aged at least 40 years in the United States and at least 2.2 billion people worldwide. It is also estimated that over 13 million Australians have one or more chronic (long-term) eye conditions or VI, according to self-reported data from the Australian Bureau of Statistics (ABS). VI has a profound effect on overall levels of health related quality of life (HRQOL) in the individuals who suffer from it, and a significant association between VI and psychological issues such as anxiety and depression has been found. Although there is quite a robust association found in the literature regarding VI and the development of depression, anxiety remains an understudied topic as an associated psychological aspect of VI. Some studies have found that there is indeed a positive association between the incidence of VI and the development of anxiety, however other studies do not find a relationship. The aim of this study is to offer participants an 8-week self-directed psychological intervention program, which may impact psychological concerns such as anxiety and depression. An initial 2006 (unpublished) 8-week trial of Emotional Freedom Techniques (EFT) for eyesight conditions and anxiety found in a sample of 120 adult volunteers, there was a significant difference between men and women in terms of overall eyesight improvement (p=.022; Look, 2006). This research will also explore the psychological issues associated with VI in adults.

Complex perianal Crohn's fistulas are common with poor healing rates and high relapse rates despite long-term immune medications and repeated surgical procedures. Local fistula injection of stem cells derived from fat tissue is a new effective treatment.. We have completed a Phase I study using local injection of amniotic epithelial cells from the placenta in 10 adults with refractory complex Crohn's and reported the treatment as safe, well-tolerated and there was fistula improvement in 8 of 10 patients. In this study, we are using stem cell products produced from the amniotic cells instead as they also have medicinal properties. Participants will receive one or two injections of stem cell products into the fistula during examination under anaesthesia and undergo assessment using routine colonoscopy, blood tests, stool tests and MRI scans. We hypothesise that these stem cell products will be safe, well-tolerated and feasible to inject.

This study seeks to examine the efficacy of integrated psychological therapy for co-occurring traumatic stress and substance use among adolescents and young adults aged 12-25 years, delivered in person and via telehealth (i.e., video conferencing). Through this trial we hope to improve our understanding of how best to treat young people experiencing traumatic stress, who are also using alcohol or other drugs, and provide evidence for interventions with maximum reach and accessibility. Eligible participants will be randomly allocated to receive one of two treatments: i) Concurrent Treatment with Prolonged Exposure – Adolescent (COPE-A) delivered via telehealth; or ii) Concurrent Treatment with Prolonged Exposure – Adolescent (COPE-A) delivered in person. Both treatments consist of up to 16, one-on-one, sessions with a psychologist. Participants will also be asked to complete three research interviews at baseline (i.e., study entry), 4- and 12-months post baseline. The primary outcome is change in PTSD symptom severity. It is expected that pre- to post-treatment reductions in PTSD symptom severity in participants receiving COPE-A via telehealth will be non-inferior to reductions observed among participants receiving COPE-A in person. A range of secondary outcomes will also be examined including changes in substance use, emotional functioning and health-related quality of life.

The main aim of the study is to evaluate the safety and tolerability of single doses of APG990 in healthy participants. The results of this study will help inform the dosing and frequency of dosing in patients with inflammatory diseases such as atopic dermatitis, which is the anticipated main therapeutic use for APG990.

Based on the findings of a previous research findings (RMIT Ethics Ref: 24895), we noted that a digitally delivered Qigong program for older adults, the Qigong Plus Program, was both feasible and acceptable amongst pilot study participants. Therefore, this follow-up project will build upon previous findings and deliver an enhanced Qigong program for older adults that employs additional behaviour change interventions strategies to sustain participant engagement, both during the program and subsequently promoting long-term Qigong practice. The use of pre-recorded sessions allows the participant freedom to decide the timing for their program delivery, resulting in a heightened sense of perceived self-agency towards their health.

This project intends to implement the co-designed endometriosis guidelines into an Australian workplace, and seeks to understand if and how the education, supports and accommodations offered within the guidelines enable people with endometriosis to manage their pain while working; understand the impact of the guidelines on work and wellbeing outcomes for those with endometriosis; explore ways in which the guidelines impact workplace culture and support; and to refine and provide recommendations to finalise a set of national employer guidelines to support employees to manage endometriosis and to assist their supervisors to do so. It is hypothesised that after 12 months of the endometriosis guidelines being implemented, that employees with a diagnosis with endometriosis will have improved health-related quality of life, improved work outcomes (presenteeism, absenteeism, and retention). Additionally it is hypothesised there will be an improved perceived level of managerial support and improved workplace culture as perceived by the staff at the targeted workplace.