ANZCTR search results

Research has shown that people with depression experience poorer treatment outcomes if they have had adverse childhood experiences; and that these experiences often intrude into their thinking, and at a rate similar to that of post-traumatic stress disorder (PTSD). Although cognitive behaviour therapy (CBT) has been found to be effective in the treatment of depression, a number of people treated with CBT do not recover, or relapse during follow-up. We wish to test the efficacy of an adjunct trauma-focused therapy — Imagery Rescripting (ImRs) – for the treatment of depressed patients receiving group CBT treatment. We hypothesise adjunct ImRs treatment will lead to a superior reduction in depression symptoms compared to control conditions of individual CBT and treatment as usual.

High rates of chronic disease persist in remote Indigenous communities in North East Arnhem Land. A community-developed and led nutrition and lifestyle program, Hope for Health (HfH), has been developed in Galiwin’ku, Elcho Island, with promising preliminary results. This trial seeks to evaluate the effectiveness and acceptability of this program and provides a wider platform to work with partners and the community towards structural changes in understanding about healthy nutrition, healthy food availability, school education and community initiatives around healthy lifestyle. Diet modification leading to even moderate weight loss drastically improves cardiometabolic risk in overweight and obese people. This study is a single arm pre and post study designed to develop an evidence base for an innovative community-developed and controlled, experiential learning program (HfH) that is based on the premise that traditional values and kinship are fundamental to physical health for Aboriginal Australians. Primary objective is to determine if the proportion of participants achieving weight loss following HfH at the end of the program in overweight and obese adults is at least 10%, as measured by achieving weight reduction from baseline of at least 5%. The study is performed in Galiwin'ku, Elcho Island, Northern Territory including 70 indigenous residents.

CO-Sprout clinical trial will investigate whether broccoli sprout powder capsules given to pregnant women infected with SARS-CoV-2 (COVID-19) can help reduce the duration of COVID-19 associated symptoms. Additional outcomes measured will include hospital admissions, maternal respiratory outcomes, obstetric and birthing outcomes, as well as neonatal outcomes. It is hoped that providing pregnant women with this natural supplement during COVID-19 infection, will help reduce the levels of inflammation and improve their symptoms hopefully leading to reduced need for hospital and ICU admissions. Broccoli sprout powder contains the naturally occurring phytonutrient sulforaphane which is hoped to improve maternal and neonatal outcomes during pregnancy from infection with the SARS-CoV-2 virus.

The aim of this program is to target psychological adjustment and cultural reintegration to civilian life. Research questions are: 1) Is the developed reintegration program feasible for delivery within an ex-service population? 2) Is the developed reintegration program acceptable to an ex-service population? 3) What are the initial psychosocial outcomes for participants of the reintegrating program? 4) What are the participant preferences and uptake of an online vs in-person ‘booster’ session? As this is a feasibility study, there are no specific hypotheses, however the following outcomes will be assessed: 1) Is there an overall change in participants Military-Civilian Adjustment and Reintegration Measure (M-CARM) scores and number of M-CARM needs. 2) Is there an overall change in psychosocial outcomes for depression, stress, anxiety, PTSD, and quality of life measures.

This is a single-center, double-blind, randomised, matched vehicle-controlled study designed to assess the safety, tolerability, and pharmacokinetics of GDD3898 topical gel following twice daily application for 12 weeks in over-weight or obese subjects with presumed NAFLD. The study will enrol 24 adult male or female over-weight or obese subjects including those with presumed Nonalcoholic Fatty Liver Disease who are 18 to 70 years of age. Subjects will be enrolled in two cohorts and will be treated with 1.75% GDD3898 topical gel twice daily or identical vehicle gel twice daily. After completion of treatment, all subjects will have a follow up visit 14 days after last application of study drug.

The Charlson Comorbidity Index (CCI) is a validated risk score for clinicians in predicting perioperative mortality and morbidity in comorbid patients. The CCI has been further refined with the Age-Adjusted Charlson Comorbidity Index (ACCI), adjusting the existing CCI score for increasing age. The ACCI has subsequently been validated in predicting short term and long-term outcomes including mortality, function outcomes and hospital length of stay across different surgical populations. The aim of this study is to assess if the ACCI is valid in patients aged greater than 90 years i.e. nonagenarians. Who is it for? You may be eligible for this study if you were aged > 90 years who underwent any surgical procedure for for any indication. Study details This study will be conducted using a review of medical records, and no patient contact is required. The study will review the medical records of nonagenarians who underwent any surgical intervention at the Austin Hospital over a 13-year period between 25 August 2008 and 8 June 2021. It is hoped that this research will help to provide a better understanding of predicting risk in nonagenarians undergoing minor and major surgery.

Around half of all people with diabetes and cardiovascular disease (CVD) experience mental health problems. This has devastating consequences for clinical outcomes, quality of life, as well as for the healthcare system. LISTEN (Low Intensity mental health Support via Telehealth Enabled Network) provides a telehealth solution for integrated low-intensity mental health and diabetes and CVD self-management support. LISTEN will be delivered by allied health professionals servicing the National Diabetes Services Scheme (NDSS) Helpline, including diabetes educators, nurses, and dieticians, who have undertaken our brief, evidence-based training program. Adults with diabetes and CVD will have access to up to four (45-60 minute) LISTEN sessions. In this trial we will evaluate if LISTEN is a feasible, effective and cost-effective solution for improving mental health outcomes in adults with diabetes and CVD. This important research will generate robust evidence needed by our partners (Diabetes Australia/NDSS and Diabetes Victoria) to inform clinical and commercial translation of LISTEN into a sustainable service, designed to have immediate and lasting positive impact on the mental health of people with diabetes and CVD.

The MOHMQuit trial aims to support maternity services to help women stop smoking in pregnancy. It comprises of an evidence-based intervention that includes smoking cessation support (SCS) training for maternity service leaders (leaders), and clinicians (midwives, obstetricians, Aboriginal health workers), and changes to the way SCS is recorded in the electronic medical records. It will be trialled at nine public maternity services in New South Wales (NSW). The MOHMQuit trial tests whether the intervention will increase (1) the number of women able to quit smoking in pregnancy (2) the amount of SCS offered to pregnant women who smoke (3) the amount of SCS clinicians report that they offer to women. The MOHMQuit trial also tests whether over time, pregnant women who smoke report increases in the SCS offered to them including (4) receiving advice on quitting smoking in pregnancy (5) being referred to a quitting program (e.g., NSW Quitline) (6) being given written self-help resources. The MQ trial will also test: (7) The cost-effectiveness of MOHMQuit using an economic evaluation. Finally, maternity service leaders will also be interviewed and complete questionnaires to assess how well the MOHMQuit trial has worked at each site.

Negative pressure wound therapy (NPWT) is a wound dressing system that provides sub-atmospheric pressure within a closed dressing. Evidence demonstrates that, when compared to standard treatment, the early application of NPWT to paediatric burns results in significant improvement in time to re-epithelialisation, with corresponding reduction sin the need for scar management and operating theatre time. Moreover, the total healthcare costs for treatment with NPWT were significantly lower (mean $903.69) per child when compared to standard silver dressings alone (mean $1,669.01). The demonstrated clinical and cost efficacy of NPWT calls for widespread implementation. Despite the demonstrated clinical efficacy and cost-effectiveness of NPWT, evidence-based guidelines for its incorporation into acute paediatric burn care have not yet been devised. We propose to facilitate the early implementation of NPWT into Emergency Department (ED) burn care practice to provide Australian children access to evidence-based treatment that may improve clinical outcomes and reduce healthcare costs. Partnering with Australia’s four major paediatric burns centres (The Children’s Hospital at Westmead, Perth Children’s Hospital, Queensland Children’s Hospital and Royal Children’s Hospital, Melbourne), we will co-design implementation strategies tailored to the complex acute burn care setting and evaluate the effectiveness of implementation. We hypothesise that the facilitated implementation will result in better adherence to early NPWT application in acute burn care settings (ED/burns centres). Leveraging previous, successful collaborations and international expertise of the CI team, results from this study will transform policy and practice to improve outcomes for Australian children.

Diabetic foot ulcer (DFU) is a common complication of diabetes with high rates for ulcer recurrence. We hypothesize that monthly Extracorporeal shockwave therapy (ESWT) and Electromagnetic stimulation therapy (EMST) will reduce the ulcer recurrence rates compared to the standard of care in a 12 month period.. We aim to test the hypothesis by determining the effect of monthly treatment on ulcer recurrence using Extracorporeal shockwave therapy (ESWT) and Electromagnetic stimulation therapy (EMST) along with standard of care and compared against standard of care in a 12 month randomized clinical trial.