ANZCTR search results

The efficacy of the Grit wellbeing program, which targets psychological, emotional, and social wellbeing, will be examined in substance using populations, through a cohort analytic study, comparing Grit in combination with the a six week recovery program (at Mirikai residential rehabilitation centre) compared to the six week recovery program alone (at Logan House residential rehabilitation centre). There will be a minimum of 90 participants (45 at each site) aged 18-35. It is anticipated that those who participate in the Grit Wellbeing Program will have greater reductions in substance use and mental ill-health, show greater increases in wellbeing, resilience and social engagement than those who participate in standard treatment alone.

It is well established that physical activity is associated with many physical and psychological health benefits. Participating in regular physical activity during childhood is also vital for optimal growth and development and kids who are active show greater resilience and increased social-emotional wellbeing. However, more than 80% of adolescent girls do not meet government physical activity recommendations and there is a striking difference in activity levels between boys and girls at all ages. Current strategies to engage girls in physical activity and sports programs have had minimal impact and innovative approaches that address the underlying socio-cultural barriers that girls face are needed. Targeting fathers to take an active role in increasing their daughters’ physical activity levels may be one such innovation. The DADEE Program is an intervention which engages fathers in positive lifestyle role modelling and effective parenting strategies to improve the physical activity behaviours, physical confidence, sport skills and social-emotional wellbeing of their daughters. Importantly, DADEE also targets girls to improve the fitness and physical activity levels, and parenting skills of their fathers. The DADEE program has been previously been evaluated in an efficacy RCT (ACTRN12615000022561) and an effectiveness RCT (ACTRN12616001270404). The primary aim of this study is to research the long-term effectiveness of the DADEE program in a larger scale community roll-out. In total, 12 programs will be evaluated over three years using a non-randomized, prospective design with 12-month follow-up for each program.

BACKGROUND: The hybrid artificial pancreas or hybrid closed loop insulin pump (HCL) has been shown to be effective in improving glycaemia in individuals with type 1 diabetes (T1DM). Recently the Medtronic e-PID HCL algorithm with insulin feedback (670G 3.0 HCL system) has been modified (670G 3.1 HCL system) to enhance its effectiveness manage blood glucose levels. The impact of the modifications implemented in 670G 3.1 have yet to be demonstrated. AIMS: The study aims to compare the relative effectiveness of the two HCL systems in managing blood glucose levels METHODS: The study is a two-stage randomized crossover study in a supervised live in setting. Pump-experienced adults with type 1 diabetes will be recruited. Following a 1 week run-in, all participants will be assigned 670G 3.1 and 670G 3.0 HCL systems in random order for a period of 7 days each, with stages separated by 1 week. Interventions aimed at challenging glycaemic control hyperglycaemia will be implemented during each of the 7 days. OUTCOME MEASURES: Glucose control including CGM time in target glucose range and time in hyperglycaemic and hypoglycaemic ranges. Safety end points including number of episodes of hypoglycaemia and ketoacidosis, and system performance

This study aims to compare post-operative pain outcomes following the placement of rectus sheath catheters by surgeons and anaesthetist. A total of 72 patients will be included in this study, with 36 in each arm. One arm will receive rectus sheath catheters placed into the pre-peritoneal space intraoperatively by the operating surgeon, while the other arm will receive rectus sheath catheters placed under ultrasound guidance by an anaesthetist into the intrafasicular space. Both arms will then receive 20mL 0.2% Ropivacaine infusion through these catheters every 4 hrs for 3 days. The post-operative pain experience will be assessed by narcotic requirements which will be documented as IV morphine equivalents.

The aim of this study is to pilot test an online psychological intervention aimed at reducing anxiety, depression and fear of cancer recurrence in testicular cancer survivors. Who is it for? You may be eligible to join this study if you are aged 18 years or over and have completed active treatment for testicular cancer and are currently disease-free. Study details All study participants will receive a 12 week access to an interactive web-based intervention designed to reduce anxiety, depression and Fear of Cancer Recurrence (e-TC 2.0). e-TC 2.0 is comprised of six interactive modules, including psycho-educational material, short survivor and educational videos, and offline exercises. Modules were designed to take approximately an hour to complete, depending on level of engagement. The whole intervention is self-administered according to participants’ needs and interests, at their own pace. Participants can revisit the website at any time and use its resources. Eligible men will complete baseline questionnaires, engage with e-TC 2.0 over a period of 12 weeks and complete immediate and 3-month post-intervention questionnaires. A series of acceptability/satisfaction surveys are embedded within the website and the immediate post-intervention questionnaire. If shown to be feasible and acceptable, e-TC could be an innovative approach to delivering supportive care and could be widely disseminated for further evaluation (or as part of routine care) at little additional cost for testicular cancer survivors who are struggling to adjust and would otherwise not seek/receive help.

This study is a first-in-human, randomized, double-blind, placebo-controlled, study to evaluate safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of single ascending doses of IV administered ATYR1923 at doses up to 5 mg/kg in healthy volunteers. This study will include 6 separate cohorts with ascending doses.

Approximately 30% of patients referred to the outpatient Mental Health service at The Royal Children’s Hospital present with significant and impairing irritability, aggression and mood dysregulation. Irritability and mood dysregulation are defined as a proneness to anger that is out of proportion to the situation and which often leads to verbally or physically aggressive outbursts. Children who are highly irritable have been found to have poorer quality of life, daily functioning, and social functioning, and are at very high risk of developing multiple psychiatric disorders. Currently however, there are no evidence based treatments for irritability. As such this study aims to assess the feasibility and acceptability of a behavioural treatment program in children (aged 6-15 years) referred to the RCH outpatient mental health service with severe irritability, and to explore the impact on child and family outcomes. Participants will be randomised into usual care (n=15) or a 6 session intervention (n=15). The intervention consists of six hour-long weekly sessions. All participants will be assessed three months post-randomisation to assess preliminary outcomes.

Groups of healthy male subjects will be administered escalating single doses of PXS-5338K to examine the safety, pharmacokinetic and pharmacodynamic profiles of PXS-5338K. This study will also investigate the safety, pharmacokinetic and pharmacodynamic profiles after repeated doses of PXS-5338K over a 14 day period.

Depression is a common, severe and often difficult to treat illness. Repetitive transcranial magnetic stimulation (TMS), a non-invasive brain stimulation technique, is an effective and well tolerated treatment for depression. TMS uses magnetic pulses to stimulate and change the activity in areas of the brain related to depression, using a specialised coil placed on the head while the patient is awake and alert. Although TMS is effective, it takes a long time to induce clinical response, often 4-6 weeks. This limits its applicability in clinical practice and is associated with considerable treatment costs. Response to rTMS can be accelerated with intensive treatment schedules involving a number of treatments a day, but these are also time consuming. Theta burst stimulation (TBS), a type of TMS, appears to produce similar effects to standard TMS when applied on a daily basis but with markedly less time demands (3 minutes compared to 40 minutes per session). TBS would appear to be an ideal intervention to use in an intensive / accelerated format where multiple daily sessions could be applied but still in a limited amount of time. However, the optimal TBS treatment parameters, such as treatment intensity, are still unknown and require investigation. This study is therefore a randomised controlled trial to compare an accelerated TBS intervention to standard once daily TMS to evaluate its relative effectiveness and rapidity of antidepressant effect. We will also compare the relative efficacy of two different strengths of TBS to investigate the most effective TBS treatment parameters. Participants will receive 20 sessions of lower intensity TBS, higher intensity TBS or standard TMS over a 2 - 4 week period. Participants will take part in interviews at baseline, week 1, 2, 4 and 8-10. Participants responding to the treatment will be followed up for six months

The aim of this study is to compare self-collected versus practitioner collected samples for HPV-based cervical cancer screening. Who is it for? You may be eligible to join this study if you are a female aged 18 years or above, and are attending an appointment for a colposcopic procedure. Study details All participants in this study will attend a single clinical appointment, during which time they will self-collect a vaginal sample using a dry flocked swab. Following this, a healthcare practitioner will collect a cervical sample using a cervical collection device (brush/broom). Both samples will be tested for Human Papillomavirus (HPV) nucleic acid, and the results compared. The study will also examine the rate of invalid HPV results for both the self-collected and practitioner-collected samples. This study will contribute information on the sensitivity of a self collected sample for HPV-based cervical screening and may contribute to this method being adopted as part of the new HPV-based national cervical screening program due to begin in late 2017.