ANZCTR search results

Anxiety disorders are the earliest emerging, most common and debilitating mental illnesses, yet 40-45% of anxious children do not respond to best-practice psychological treatment, cognitive behavioural therapy (CBT). For the past two decades, we have been examining fear conditioning and extinction (CON-EXT) markers of anxious children’s underlying threat sensitivity, positive valence, and cognitive control systems, and the markers that predict who will recover following CBT. We have developed a CON-EXT Profile to assess markers at the individual patient level and conducted studies of CBT enhancements that allow for personalised treatment. The next and most important step is to examine outcomes from personalised CBT relative to standard CBT. The primary aim of this project is to conduct a Phase III randomised controlled trial, in which anxious children, 7-12 years of age, are randomised to Stratified CBT, in which CBT is personalised to their CON-EXT markers (right CBT for each anxious child), compared to Standard CBT, in which anxious children receive standard CBT (one size fits all). It is hypothesised that a higher proportion of children will be in remission, and acceptability ratings and treatment completions will be higher, in Stratified CBT than Standard CBT at the post-treatment primary endpoint and 6-month follow-up.

Unfulfilled expectations of surgical outcomes are a major factor influencing patient-reported dissatisfaction following Total Knee Arthroplasty (TKA). In Australia, approximately 60,000 TKA procedures are performed annually, with numbers expected to increase over the next decade. Despite advancements in surgical procedures, 10-20% of patients report dissatisfaction with surgical outcomes, indicating a significant number of individuals experience sub-optimal outcomes. In the EXTOKA project, we will develop an educational program for patients focusing on formulating realistic expectations of surgical outcomes following TKA in the private healthcare sector. The success of the program will be assessed by comparing patients’ expectations before and after the program, and by comparing expectations of those who participate in the program to those who receive standard clinical care alone. Additionally, the project will determine if participation is associated with a higher level of expectation fulfilment and satisfaction with surgical outcomes. Project findings will inform efforts to improve patient health literacy associated with TKA, supporting patients to make more informed choices about their recovery journey. By setting meaningful, realistic and achievable expectations of surgical outcomes, there is potential to better target rehabilitation programs to support attaining individual patient goals, thereby connecting them to the right care at the right time.

Chronic Obstructive Pulmonary Disease (COPD) is a common, long-term health condition that usually co-exists with other long-term conditions (comorbidities), which can lead to low health-related quality of life and death. Poor inhaler device technique and medication adherence further impact management of COPD, and can be improved by tailored, self-management support. This pragmatic randomized controlled clinical trial will test a digital self-management support intervention to improve inhaler device technique and medication adherence, based on the COM-B Model, in people with COPD and comorbidities in the community. The PRISIMA Trial will rigorously test whether this intervention is effective in improving COPD-related quality of life, inhaler device technique, medication adherence for COPD and comorbidities, patient activation, exacerbations and hospital admissions due to COPD, and overall health-related quality of life. A qualitative and health economic evaluation will also be done to determine whether the intervention can be implemented in routine practice.

Study hypothesis - This study hypothesizes that non surgical management of first trimester retained products of conception has a high success rate and various ultrasound parameters can help in more accurate treatment selection with either expectant or medical management. Brief summary Retained products of conception ( RPOC) is a common occurrence after first trimester expectantly, medically or surgically managed miscarriage or termination of pregnancy. However, there is lack of evidence on the most ideal way to manage these patients, Surgical management has been the fall-back due to immediate results but comes with a high rate of complications such as intra-uterine adhesions which can lead to sub-fertility. On the other hand, non-surgical methods, not known to cause such complications, have shown promise but lack robust evidence. Hence, the purpose of our study is to determine the efficacy of non-surgical options in successfully managing RPOC. Participants aged 16-45 years presenting to the early pregnancy assessment unit and Emergency department (ED) with symptoms and ultrasound diagnosis of retained products of conception in first trimester of pregnancy will be consented, recruited and randomized to either expectant management or medical management with misoprostol. They will be followed up at 4 and 8 weeks for symptom review and progress ultrasounds to note successful management of RPOC. Success rates, ultrasound factors influencing success, short- and long-term complications will be noted.

This study aims to implement standardised sexual and reproductive health (SRH) screening into the Children’s Health Queensland (CHQ) Child and Youth Mental Health Service (CYMHS). CYMHS provides specialist outpatient mental health services to those up to 18 years of age with complex mental health needs. The intervention involves development and delivery of a brief training and education module designed to equip clinicians with the knowledge and confidence required to engage young people aged 12-17-years in consultations around their SRH and facilitate referrals for nurse-led SRH consultations where indicated, through which further SRH information, more advanced screening, and/or other care can be provided.

The intervention involves the use of clear aligners with a straight trimline, with control being aligners of a scalloped design. Participants are randomly assigned to start in aligners of either design. The predictability of the achieved tooth movement, according to each aligner design, will be assessed on a monthly basis. Tooth position data will be captured and superimposed to assess the predicted vs achieved tooth movements. The comfort and acceptability of each aligner type will be assess using a online questionnaire, using the validated tools of the OHIP-14 Questionnaide (Slade, Spencer, 1994) and the Visual Analogue scale. We hypothesise that using a straight trimline aligner may increase the predictability of orthodontic treatment with clear aligners.

Most people who receive alcohol and/or other drug (AOD) treatment in Australia are not provided with continuing care; however, those who are, have improved outcomes (Manning et al., 2017). In Australia, the employment of AOD Lived Experience Workers (LEW) is growing with most jurisdictions committing to building this workforce. LEWs have their own experience in building recovery resources and are ideally placed to provide cost-effective continuing care. However, the LEW workforce is still developing and LEWs describe a lack of structure and standardisation in their roles (Eddie et al., 2019). This project will test a peer-supported recovery planning intervention to assist people leaving AOD residential inpatient treatment to receive structured peer support, identify their recovery skills and assets, improve engagement with services, and access additional care and support. The study aims to compare the effectiveness of this peer-led continuing care intervention compared to treatment as usual using a randomised trial design. It is hypothesised that those who receive this continuing care intervention will have a greater growth in recovery capital compared to those who receive treatment as usual.

This study will test the safety and effectiveness of ADAM™ 2.0, a new contraceptive device for men, in a group of 30 healthy males aged 25 to 55 who are considering a vasectomy. Researchers believe that ADAM™ 2.0 can block sperm flow safely and could offer a reliable, non-hormonal, non-permanent alternative to traditional vasectomy. Participants will be closely monitored to assess how well the device works and to ensure their safety. The study aims to gather valuable information on the potential of ADAM™ 2.0 as a long-term contraceptive solution for men. The study hypothesis is that implanting a pre-formed, water-soluble hydrogel into the vas deferens will effectively block sperm flow into the ejaculate, thereby reducing sperm counts to near zero and preventing pregnancies.

This study is taking a novel approach to using predictive biomarkers to select people for lipid (fat) targeted treatments, to attempt to overcome hormone resistance in people with metastatic hormone resistant prostate cancer. There is increasing evidence that abnormal lipid (fat) metabolism promotes the growth of prostate cancer cells. We have previously shown that abnormal patterns of blood-borne lipids (called ceramides) can identify a group of people with metastatic hormone resistant prostate cancer who are likely to be resistant to the usual hormone treatments: abiraterone and enzalutamide. In the DARO-LIPID study, we will first identify which participants with metastatic hormone resistant prostate cancer have the high ceramide lipid signature through a blood test. Participants who do not have this lipid signature will receive usual care by their oncologist. Participants with this lipid signature who consent to the study will all receive darolutamide as standard of care. Participants will then be randomly split into two groups with one group also receiving the lipid drug called Opaganib to target the abnormal lipid changes and the second group receiving a placebo. The study is designed to see if Opaganib can increase the number of people who respond to darolutamide, and increase the time that they get benefit from the treatment. We will also look at how the Opaganib is affecting lipid/fat metabolism in the body/tumour.

This pilot trial will evaluate the feasibility and acceptability of a 12-week co-designed, dyadic physical activity intervention for autistic adults. Participants will invite a partner (e.g., a family member, carer, friend, mentor, or trainer) to co-plan, schedule, and engage in chosen physical activities. The partner acts as a supporter, and the pair has full autonomy to set goals and plan activities. The research team will provide workshops on the benefits of physical activity, the risks of sedentary behavior, daily personalized prompts, reminders, and fortnightly feedback. Autistic participants will also receive Fitbit and Sens devices to monitor their physical activity and sedentary behavior throughout the program. The intervention’s impact will be measured by changes in physical activity levels (measured in minutes per week), sedentary behavior (measured in minutes per week), and motivation for physical activity (measured by self-reported physical activity motivation scales). It is hypothesized that the intervention will lead to increased physical activity, reduced sedentary behavior, and improved motivation for physical activity at the end of the intervention compared to baseline measures.