ANZCTR search results

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.

Recent studies show that the incidence and severity of obstructive sleep apnoea (OSA) are influenced by the gain or sensitivity of the negative feedback loop controlling breathing (i.e. the loop gain), and that this influence is independent of the contributions made by anatomical and neuromuscular factors such as abnormalities of the soft palate or dysfunction of the oropharyngeal musculature. Accordingly, it follows that if we were to administer a drug that lowers an individuals loop gain, we would reduce the propensity for OSA and thereby ameliorate some, if not all, of the symptoms of sleep disordered breathing. We have evidence that administration of an orally-available drug, LGT-371, does indeed reduce the sensitivity of the peripheral and/or central chemoreceptors (and thereby overall loop gain) in an animal model of sleep disordered breathing and that it reduces the severity of sleep apnoea in the model. We now plan to test whether LGT-371 has a similar action in human subjects with OSA. The primary aim of this study is to assess the effect that LGT-371 has on sleep apnoea severity, loop gain and chemoreceptor sensitivity compared to placebo. Additional measures of sleep apnoea severity, cardiovascular markers (blood pressure & heart rate) and subjective sleepiness will also be assessed as secondary outcomes.

In the course of military training, personnel are trained to attend to cues in their environment that may signal threat, and in deployment situations this training can be life-saving. Upon return to civilian life however, constantly feeling alert and attending to cues that seem threatening can become a problem and in some cases this has been shown to be associated with the development of posttraumatic stress disorder (PTSD). PTSD is a common and often severe problem for many who serve in the military. In particular, it can involve constantly being on the lookout for danger, which may be compounded by training received during military training to be vigilant. Attention control training (ACT) is an intervention designed to modify the fluctuations in attention to threat that underpins PTSD. ACT is brief, computerised program that is delivered once weekly for four weeks. The trial will involve 1806 current serving personnel between 18 to 70 years of age who are transitioning out of the military within the next 12 weeks. Participation involves a number of short self-report assessments and attending weekly ACT or control training sessions over four consecutive weeks. All self-report assessments will be completed online using a mobile phone, and will be done four times in total: immediately before the intervention, immediately post-intervention (4 weeks), and at 3 and 12-months follow-up. The results of this trial will inform the broader military community both in Australia and overseas by improving our understanding of effective preventions for the development of mental health symptoms after military service.

Fibrosis, or hardening of tissues is a common side effect following cancer treatment, particularly radiotherapy. Evidence exists that combined treatment using Pentoxifylline (PTX) and Vitamin E (Vit E) reduces and even reverses fibrosis in breast cancer. This treatment is used at times in head and neck cancer but is not considered ‘routine’ treatment. The purpose of this study is to see whether this treatment can prevent relapse of hardened tissues in those with narrowing (called stricture) of the throat following head and neck cancer treatment. Who is it for? You may be eligible for this study if you are an adult who has completed treatment for head and neck cancer. Study details Participants will be randomly allocated to one of two groups: Group 1: 12 weeks of medication (pentoxifylline and vitamin E). Group 2: 12 weeks of placebo treatment. All participants will then be assessed one year later by endoscopy to measure the hardness of tissue in their throat. It is hoped that this study will demonstrate that this treatment is effective in reducing relapse of fibrosis in patients who have been treated with head and neck cancer.