ANZCTR search results

Postnatal depression (PND) is a major public health issue, with potential serious adverse consequences for a mother’s health and that of her infant and family. In Australia, 17% of mothers experience depression; an estimated 53,000 women are affected each year, a significant health and economic burden. We aim to conduct a multi-site, two arm randomised controlled trial of telephone peer support (mother-to-mother) to prevent PND among new mothers. We are recruiting 1060 new mothers assessed as at increased risk of PND (i.e. score >9 and = 20 on the Edinburgh Postnatal Depression Scale) for this trial. Recruitment at the routine 4-10 week postpartum Maternal and Child Health (MCH) visit, from two local government areas commenced in May 2019, but discontinued in December 2019. Women are currently being recruited from the postnatal wards of two hospitals. At recruitment, women will be randomly allocated to the control group (standard care) or the peer support (intervention) group. Mothers allocated to peer support will receive proactive telephone-based support from a peer volunteer (mothers who have a history of and recovery from PND), in addition to all standard community services up until six months postpartum. Outcome data will be collected at 6 month postpartum. We will test if women allocated to telephone peer support are less likely to have depressive symptomatology, defined as a score >12, on the Edinburgh Postnatal Depression Scale (17% vs 25%) 6 months after the birth.

The primary aim of this research project is to determine if a 4-week course of low-dose subcutaneous ketamine is an effective treatment for young people (males and females aged 16-25 years) with moderate-to-severe depression. Participants will be randomised to receive either low-dose subcutaneous ketamine or a blinded control treatment that is therapeutically inactive (midazolam), given once a week for 4 weeks. Change in depression scores will be assessed at the end of the treatment phase at week 4, with further assessment at weeks 8 and 26 to assess whether treatment effects are sustained. We hypothesise that ketamine will be an effective treatment for moderate-to-severe depression in young people.

- Obese people undergoing total knee or hip arthroplasty (replacement) surgery for osteoarthritis have worse outcomes (complications, less favourable longer-term recovery) compared to non-obese people. - We hypothesise that a low inflammatory diet will be feasible and will encourage weight loss and will lower signs of inflammation in people with knee or hip arthritis awaiting joint replacement (arthroplasty). - We will test our hypothesis using a quasi experimental study design [Before (control) and after (intervention) study]. - Little is known about barriers and enablers to weight loss ad a low inflammatory diet amongst obese people with end-satge arthritis and from culturally and linguistically diverse backgrounds. We aim to explore this through individual and focus group interviews.

The purpose of this study is to determine if it is possible to use a very low calorie diet in obese patients prior to surgery. Who is it for? You may be eligible for this study if you are an overweight adult who is undergoing surgery to remove all or part of your liver. Study details Participants in this study will be randomly selected to undergo one of the following: Group 1: participants in this group will be required to undergo a very low calorie diet for 2 weeks prior to their surgery, including 3 replacement meals per day. Group 2: participants in this group will continue with routine preoperative care with their physician. All participants will have will have an ultrasound elastography to measure Liver stiffness (steatosis) and liver size, and will have an ICG Clearance test to investigate liver function. It is hoped that this research will help determine if very low calorie diets can be completed by participants in the 2 weeks prior to their surgery, and whether the low calorie diet has any effect on surgery outcomes.

Active Breed is a 12-week, gender-tailored men's health program targeting weight loss, physical activity, nutrition, mental health, and violence prevention. The program has been tested as a pilot RCT and will be delivered on a larger scale through this study. The program will be delivered through the Canterbury-Bankstown Bulldogs Rugby League club and will include weekly education and physical activity sessions held at the club's home stadium. Physical activity sessions include gym-based workouts in the first grade gym and touch football games on the sports ground.

Up to half of people living in residential aged care facilities (RACFs) have significant depression symptoms. Many residents are socially isolated in RACFs even though they are in communal living, and social isolation is a contributor to depression. The literature provides some evidence for ‘befriending’ in alleviating depression, anxiety, social isolation and loneliness as well as improving quality of life and wellbeing, but few studies have been conducted for older adults living in RACFs. Befriending is non-directive emotional and social support generally provided on a regular basis by volunteers. We propose a randomized controlled trial of befriending compared with treatment as usual to improve depression, anxiety, social support and loneliness among residents of RACFs. An economic evaluation will examine the costs and benefits of the program. Volunteers will be trained using beyondblue resources and a manual for befriending already developed but to be further modified by the investigators. If successful the befriending model can be translated to the wider aged care sector to more effectively support residents and to reduce the prevalence of depression, anxiety and loneliness and improve social support in RACFs.

This study will work with clinical teams in three acute hospitals to trial a feedback loop approach to promoting appropriate care and treatment for elderly patients at the end-of-life. The feedback loop is intended to provide a ‘flag’ to increase clinician awareness of the risk profile of their patients, and to prompt a tailored care review activity. It is expected that the use of this feedback intervention will improve care outcomes for elderly patients, specifically to increase appropriate care and treatment pathways and reduce the incidence of non-beneficial treatments. the study will report the impact on patients, and the costs and implementation issues of the feedback loop activity.

This is an open-label single-center study, to assess the safety, tolerability and efficacy of cannabidiol administered as ZYN002, a transdermal gel, for the treatment of child and adolescent patients with 22q11.2 Deletion Syndrome (22qDS). Male and female patients with 22qDS will be treated for 14 weeks. Patients taking Anti Epileptic Drug medications will have an additional one or two week Taper Period after the completion of doing with ZYN002. Approximately 20 male and female patients, ages 6 to < 18 years, will receive ZYN002.

Dance is a unique form of physical activity that involves complex movement, emotional expression, and social opportunities. While many avenues of research have suggested that dance offers a wide range of benefits to its participants, children with ASD often face barriers to participating in dance and have fewer opportunities to take part in recreational programs compared to their typically-developing peers. As a consequence, few studies have been able to assess the effects of participating in dance for these individuals and it remains unclear whether this unique activity offers any significant benefits to social, cognitive, emotional/behavioural and motor functioning. The current study aims to deliver a tailored classical/contemporary dance program to children with ASD to begin exploring the potential outcomes of participation. The primary aim will be to determine the feasibility and acceptability of the classical/contemporary AllPlay Dance program. We hypothesise that the program will be feasible, and acceptable to children with ASD, their parents, and the experienced dancers/ buddies acting in a supportive role. Data for this analysis will be collected from all participants within 8 weeks of completing the program. We will also explore the effect of the classical/contemporary AllPlay dance program on social, cognitive, emotional/behavioural and motor functioning for children with ASD. Data for these analyses will be collected from all ASD families regardless of group allocation within 8 weeks of the intervention group commencing (baseline) and completing (primary timepoint 1) the dance program.

According to the annual report from national joint replacement registry, around 32000 primary total hip replacements (THR) have been performed in 2017 in Australia. Reported prevalence of blood transfusion in THR is around 24%. Blood transfusions are associated with infectious risk and complications such as acute lung injury, and acute or delayed immune responses. Tranexamic acid (TXA) has been widely used for its anti- fibrinolytic effect in major joint replacement surgery. It has been shown to prevent excess bleeding and reduce the risk of blood transfusion following lower limb joint replacements. Current dosing of TXA for joint replacement surgery is not based on rigorous scientific evidence and dosing based on bleeding endpoints may be sub-optimal. In this study, we propose investigating the use of biomarkers to describe the extent of fibrinolysis as dosing endpoints for the physiological effect of TXA. From this, we will provide recommendations for effective dosing regimens of TXA in patients undergoing THR.