ANZCTR search results

This is a randomised, placebo controlled cross-over study to assess the efficacy and safety of Ziziphus spinosa seeds in people with insomnia compared to placebo. This study aims to determine if Ziziphus spinosa seeds can improve sleep in people with insomnia, in terms of sleep quality, quantity, and associated daytime symptoms; and to determine its safety profile for insomnia. It is expected that Ziziphus spinosa seeds will alleviate some significant symptoms of insomnia and improve sleep quality, quantity, and associated daytime symptoms.The study integrates rigorous clinical trial design and research methodology and will guide the appropriate use of Chinese herbal medicine in clinical practice.

High intake of discretionary food and drinks contribute to the excessive burden of chronic disease experienced by Indigenous Australians living in remote Australia. In collaboration with the Arnhem Land Progress Aboriginal Corporation (ALPA; who manage 25 stores in remote Australia) we will test an intervention to reduce sales of discretionary products in remote Australian communities. Stores randomised to the intervention group will be supported by ALPA to reduce merchandising (i.e., availability and display) of four food categories (sugar, sugar sweetened beverages, sweet biscuits and confectionery) that in total provide 73% of discretionary foods and 90% of free sugars. The remaining stores (50% of total) will serve as controls. Electronic store sales data will be collected over the baseline period, 12-week intervention period and 24-week post intervention to objectively assess change in healthiness of purchases and gross store profit. This research will greatly advance our understanding of how the retail food environment can be used to improve population level dietary intake globally. We hypothesise that intervention stores will have a significant reduction in free sugars from food and drinks purchased (measured using sales data) compared with control stores over the 12 weeks of strategy compared to the baseline and this will be sustained over the 24 weeks post end of the intervention.

The Dizzy PT project is looking at the feasibility of a new model of service, whereby a vestibular trained Physiotherapist is able to assess and treat patients in the ED who are presenting with dizziness, vertigo or imbalance. The feasibility of this will be established by comparing the new model (intervention period) with current practice (control period). We hypothesise that not only will the new model of care be feasible, it will also provide better outcomes for these patients, and improve adherence to evidence-based best practice clinical care.

Depression is common in patients who have advanced life-limiting illness. There are significant time pressures for antidepressants to have rapid-onset effect in some palliative care patients. Most antidepressants, due to their slow onset of action, have limited therapeutic benefits in patients with extremely short prognoses or those with severe depression that require rapid effect while waiting for the typical antidepressants to take effect. In the psychiatry literature, subanaesthetic doses of ketamine are emerging as a novel rapid-onset antidepressant for treatment resistant major depression with high response rates, though having short-lived effect. There has been no similar trial done using ketamine to treat even de novo depression in the population with advanced life-limiting illness. There is a need to explore the activity of ketamine in palliative care patients, particularly those with very limited prognosis and/or severe depression that require immediate intervention where typical antidepressants are of limited utility for depression. Further evidence may potentially allow ketamine to be used to treat severe depression in patients with very limited but uncertain prognosis (e.g. in the range of weeks) and be considered as a bridging therapy for those who have a longer prognosis for the typical antidepressants to have effects. Prior to researchers committing to a larger phase 2/3 double blinded, cross over, randomised controlled trial, testing the activity of ketamine as antidepressant in the palliative care population, a feasibility study will be conducted with the aim to investigate: the number of patients who participate in, and subsequently complete, the ketamine intervention; the potential effects of ketamine; and the safety and tolerability of ketamine in this population. Patients known to the palliative care services in the acute hospital, palliative care units or in the community with advanced life limiting illness and major depressive disorder in Australia will be included in this study. The intervention is an individually tailored subcutaneous infusion of ketamine, given at weekly intervals by response, commencing with 0.1-0.4mg/kg over 2 hours, up to 4 doses (4 weeks) with the maximal dose of 0.4mg/kg. This is followed by 4 weeks of follow up. Commencement and titration of a typical antidepressant for depression by the treating clinical team’s choice if clinically appropriate (given 48 hours apart from ketamine administration) is allowed for ethical reasons. Primary Outcome is the number of palliative care patients completing through each stage of the study. Main secondary outcomes include serious side effects (CTCAE), psychotomimetic and dissociative symptoms (BPRS/CADSS), depression score (MADRS), quality of life score (Q-LES-Q-SF) and Numeric Pain Rating Scale.

In a series of preliminary studies we initially developed a 12-item questionnaire known as the Frequency of Actions and Thoughts Scale (FATS; Terides et al., 2018; Terides et al., 2016) which measures coping skills and behaviours. The FATS can be administered inside and outside of therapy, and on a very frequent basis. It is highly acceptable for people experiencing distress and is psychometrically sound. Evidence for the utility of the FATS was strong, indicating that coping skills use and the practice of certain behaviours, measured using the FATS, is closely related to emotional wellbeing – both during and after therapy. We have begun a programme of research to replicate and extend this early work. We have recently conducted a survey with more than 3,000 Australian respondents, further testing the relationship between behaviours, activities, symptoms of mood, anxiety, and levels of satisfaction with life. This survey included a larger sample of questions than used in the FATS. The results of this survey support our model that there are sets of core activities and everyday behaviours strongly associated with emotional health. We have included these key behaviours and activities in the Things You Do Questionnaire (TYDQ), which we believe can predict symptoms of anxiety and depression and, conversely, satisfaction with life. During the present study we want to examine the relationship between everyday activities and behaviours (as measured by the TYDQ) and reductions in symptoms of anxiety and depression associated with treatment. We wish to explore whether there are certain activities and behaviours that are more related to symptoms of anxiety and depression and that change more during during treatment. Thus, the purpose of this study is not specifically to evaluate the Wellbeing Course; instead we will be using it as a means to explore the relationship between certain behaviours and emotional wellbeing, and to further evaluate and develop the TYDQ.

The primary aim of this study is to evaluate the behavioural, cognitive, and psychosocial outcomes of an integrated intervention (i.e., traditional fluency intervention + Acceptance & Commitment Therapy) to simultaneously address stuttered speech frequency and the self-efficacy beliefs of adults who stutter. Expected outcomes include: significant, positive improvements in stuttering severity, self-efficacy, and psychological flexibility. In addition to determining the feasibility of such an integrated intervention, we hope that this research will provide further information regarding the relationship of self-efficacy to treatment outcomes and psychosocial functioning for adults who stutter that may help to inform evidence-based practice in our field. We anticipate that this trial will provide support for a multidimensional approach to the treatment of adults who stutter that ensures durable changes to speech fluency and various psychosocial variables over time.

Background: South Western Sydney Local Health District (SWSLHD) is characterised by its rapid population growth and rich cultural diversity, with 36% of the population born overseas. Compared to the rest of Australia, residents in SWSLHD have a higher prevalence of diabetes (6.3%). At the hospitals in SWSLHD, the average length of stay (LOS) for all admissions in 2014 was 3.9 days, while the average LOS was 6.3 days for patients with diabetes as a secondary diagnosis. The increase in LOS translated to an extra 57,470 bed days in 2014 across SWSLHD. Local audits demonstrate that the current model of care for inpatient diabetes management is inadequate, with patients with diabetes having poor glycaemic control during admission, longer LOS and greater risk of morbidity and mortality. The model of an inpatient diabetes team (IPDT) has been advocated based on observational evidence showing benefits in the United Kingdom. The value of such an approach has not been demonstrated in a randomised controlled trial in Australia or elsewhere. Hypothesis: Implementation of inpatient diabetes teams (IPDT) in intervention wards will improve the glycaemic control of patients admitted in hospital and reduce their length of stay. Objective: The objectives of the study are to test whether an inpatient diabetes team (IPDT) that provides routine review of inpatients with diabetes on randomly selected wards compared with “control" (business as usual) wards improves short and medium term clinical outcomes. We propose that an intervention with the IPDT will: 1) improve glycaemic control for inpatients with diabetes 2) reduce LOS, medication error and morbidity of inpatients with diabetes 3) reduce hospitalisation costs for patients with diabetes in SWSLHD 4) reduce early readmission rates for patients with diabetes discharged from hospital

This study is a prospective feasibility study evaluating the implantation procedure and stimulation effects of tibial and/or saphenous nerve stimulation on patients with overactive bladder (OAB). Participants who meet the selection criteria will be enrolled in this study will be implanted with a neurostimulator system and randomised (2:1) to receive tibial or saphenous nerve stimulation. The purpose of this study is to evaluate the implantation procedure and stimulation paresthesia of tibial or saphenous nerve stimulation on patients with OAB using a commercial lead and the effects the stimulation has on symptoms of OAB. This study will help in the design a novel implanted stimulator and introducer and in the development of a larger scale study to evaluate the safety and effectiveness of the implant. All participants will receive stimulation for 5 consecutive days before having their lead removed and returning for a final follow-up visit 14 days post-removal. Participants will be assessed for number of bladder voids, paresthesia coverage & quality, quality of life and incidence of adverse events.

This study is aiming to assess sun exposure and sunburn patterns among purchasers of the Ugly Xmas Rashie/Cycling Jersey. Who is it for? You may be eligible for this study if you are aged 18 or older, and have purchased an Ugly Xmas Rashie/Cycling Jersey during the recruitment period (expected October 2018-December 2018). Study details All participants will complete a baseline survey, use their purchased Rashie/Jersey, and UV indicating stickers. Throughout the 3-month period, participants will use the clothing and stickers at their discretion. After 3-months participants will partake in a 15-20 minute online survey about their experience using the clothing, stickers, any sunburn experienced and sun exposure behaviours. It is hoped this research will show participants are satisfied with their sun protective clothing and it improves sun protection strategies and reduces sunburn incidence.

The aim of this pilot feasibility study is to test the efficiency of the Support for New Mums smartphone application (app) on maternal self-efficacy, psychological well-being, social support and maternal satisfaction from hospital discharge to 6 months post birth. The cost-effectiveness of the intervention will also be evaluated as compared to routine postnatal care.