ANZCTR search results

Obsessive-compulsive disorder (OCD) is a severe mental illness that can dramatically reduce quality of life. Despite use of best practise clinical management, many patients continue to experience symptoms and associated disability. Recent neuroimaging studies have shown that OCD is characterised by significant, yet specific, changes in the activity of macroscopic brain networks comprising of frontal and subcortical brain regions. Parallel to these developments, non-invasive brain stimulation techniques such as transcranial magnetic stimulation (TMS) have emerged as viable tools to modulate the activity of brain networks in both healthy and pathological populations. TMS has an established clinical role in the treatment of major depressive disorder. This project aims to assess the possible use of local TMS to selectively restore altered brain network activity and improve symptoms in people with OCD. To achieve this goal outpatient with OCD will be asked to undertake functional magnetic resonance imaging (fMRI) before and after a TMS intervention. If successful, the proposed project will represent the first demonstration that TMS can be used to selectively restore the altered function of widespread neural networks and improve symptoms in people diagnosed with OCD. Such an outcome will be instrumental to motivate larger clinical trials to test the efficiency of TMS as a treatment, or complementary treatment, for OCD.

The Unified Protocol for Adolescents (UP-A) is a transdiagnostic intervention for the treatment of anxiety and/or depressive disorders. The aim is to examine possible mechanisms by which the intervention produces change in participants (12-18 year olds with a primary anxiety or depressive diagnosis). 6-8 participants will be recruited and treated using the UP-A. Hypothesised mechanisms of change (e.g., improved emotion regulation) will be measured from session to session for each adolescent. Expected outcomes include: symptom reductions in participants and information about which treatment targets are associated with symptom reduction (i.e., mechanisms by which the intervention is working).

The Shake-a-Leg (SAL) health promotion program was developed by Hunter New England (HNE) Aboriginal Health Unit and has been implemented in primary schools across the Hunter New England Local Health District (HNELHD) over the last ten years. Shake-a-Leg has been developed as a culturally appropriate program for Aboriginal students and is delivered to whole classes, inclusive of both Aboriginal and non-Aboriginal students. The SAL program uses Aboriginal specific and mainstream materials and also features characteristics of effective school-based health promotion programs that are inclusive of being (1) Focused on health knowledge and health literacy competencies (2) Strategically planned to meet students’ developmental age, needs and local health issues, and (3) Informed by parents, community members and local health professionals. This proposed study aims to determine the effectiveness of the Shake-A-Leg program in improving health knowledge and behaviours in Aboriginal and Torres Strait Islander children attending government primary schools within the HNELHD. The primary outcomes are; change in knowledge and behaviours relating to nutrition and physical activity in Aboriginal students. The secondary outcomes include; increased self-efficacy as related to nutrition and physical activity, increased knowledge in oral health, alcohol and other drugs, identity, and bullying. Data from non-Aboriginal students will also be collected and analysed. This study will employ a cluster randomised controlled design. Eligible schools that agree to participate in the study will be randomly allocated to either an intervention or control group and stratified by school size and geographic location. The research will be conducted and reported in accordance with the requirements of the Consolidated Standards of Reporting Trials (CONSORT) Statement. All students both Aboriginal and non-Aboriginal in Years 5 and 6 attending schools allocated to the intervention group will receive the 6 week SAL program during school time. Outcome assessment via student surveys will be undertaken at baseline and post-intervention.

There is considerable concern internationally about chlamydia treatment failure. Studies have found that chlamydia treatment failure may be at least 8%, considerably higher than the 2-3% failure expected based on results of previous chlamydia treatment trials that with the exception of one trial, all used the less sensitive culture to measure antimicrobial cure. A treatment failure rate of 8% rather than 2-3% means a further nearly 3,000 in Australia and 70,000 women in the USA were inadequately treated for chlamydia in 2009, leading to longer duration of infection, increased risk of developing sequelae and continued transmission. It remains uncertain if this treatment failure is because of (1) re-infection by an untreated partner; (2) failure of the drug itself due to poor absorption from the stomach or low concentrations in female genital tissue where it is needed to work (3) the body’s immune system’s inability to fight the infection. We have received NHMRC funding to conduct a large cohort study of 450 women that aims to estimate azithromycin treatment failure for genital chlamydia infection. In order to understand failure due to (2) above (poor absorption), we propose to develop a test to measure the concentration of the drug in female cervical cellular material. We wish to determine whether azithromycin is present at the cervix in sufficient concentrations to kill chlamydia. This was done by Worm and colleagues in the early 1990s. The purpose of this study is to develop a test and specimen collection method that measures azithromycin absorption in cervical cellular material (mucus and cells) using a specimen that is practical and acceptable to women – self-collected vaginal swabs.

The purpose of this study is to determine whether there is a correlation between the height at which the veins on the back of the hand collapse, and the pressure measured by a central venous catheter in the heart (central venous pressure).The central venous pressure is used to guide how much fluid should be given to a patient, but is currently only available using invasive procedures performed in special departments within hospitals, such as intensive care. It would therefore be very helpful to be able to obtain this pressure using a non-invasive technique that could be used anywhere. This study will be performed on patients in intensive care with a central venous catheter already in place as part of their treatment. After the participant has provided consent, the head of the bed will be positioned at a slight angle (45 degrees), and the participant assisted to slowly raise their arm above the level of their chest. The veins on the back of the hand will be observed as the arm rises, and the height at which the veins collapse will be recorded. At the same time, the pressure reading via the central venous catheter that is constantly displayed on the monitor will be noted. The total time required should not be more than 15 minutes. A biostatistician will then analyse the readings to determine if there is correlation between the two measurements in each participant. There are no additional risks to participants in this study. All the risks associated with this study are related to use of the central venous catheter, which will already be present as part of their standard care.

Fibromyalgia is a complex chronic disorder affecting 2-4% of the population. It is a debilitating condition that has substantial consequences for the individual, their family and the economy. Current treatments are predominantly pharmacological interventions with either no evidence or little support for efficacy and/or associated with significant side effects. There is therefore an urgent need to develop non-pharmaceutical treatments. One potential option is pain cognition training, which is thought to work via the reconceptualization of maladaptive pain cognitions. Although a promising area, research in this field has shown only moderate effects at best. In this study, we will examine whether combining transcranial direct current stimulation (tDCS), a form of non-invasive brain stimulation, to pain cognition training enhances treatment outcomes by acting on synergistic neural processes. If successful in finding that the combined treatment is better than pain cognition training alone, this study has the potential to offer better patient care than is currently available. Forty adult participants with a diagnosis fibromyalgia will be recruited for this randomized, double-blind, placebo-controlled study. Participants will be randomized into one of two treatment groups (active tDCS with pain cognition training, or sham tDCS with pain cognition training) for a 4 week daily (Monday-Friday) treatment course. At each treatment session participants will receive 20 minutes of active tDCS or sham (placebo) tDCS, followed by 30 minutes of cognition training, 3 times per treatment week (i.e. tues-thurs for each of the four weeks). Participants will complete symptom-related questionnaires and undergo a pain assessment at baseline, at the end of each treatment week (1-4), as well as at a follow-up appointment one-month following the completion of treatment. Data collected from these questionnaires and the pain assessments will be compared between the active tDCS group and placebo tDCS group using repeated measures analysis.

In Alzheimer’s disease, a peptide called amyloid-beta is elevated and aggregate forms amyloid-beta (senile) plaques/ deposits in the brain and potentially in the retina. Curcumin (an ingredient of turmeric) may increase the ability to detect the plaques in the retina. Participants will be recruited from the existing AIBL study. Images will be taken of the participants retina using a camera, Participants will then be asked to take 3 days of Vitamin E supplements and 3 days of Curcumin powder. At visit 2 (after the curcumin dosing), images will be again taken of the participant's retinas. A comparison will be made of the participants retinas pre and curcumin post dosing to determine if it is possible to detect the presence of plaques. These results will be compared to the participant's PET scan conducted during the course of the AIBL study.

Early rehabilitation of intensive care (ICU) patients is essential to reduce the residual burden of ICU-acquired weakness. While various guidelines have been published regarding safety criteria for mobilizing ICU patients (eg Hodgson et al 2014), there is little clarity regarding the safety of mobilizing patients receiving drugs which support blood pressure (vasopressors). At Canberra Hospital ICU, we have a well-established routine practice of mobilizing ICU patients (eg Green et al 2016, Leditschke et al 2012, Green et al 2009), including those receiving vasopressors. Note that ‘mobilisation’ can include standing people in a relatively passive way (eg with tilt table equipment) and / or sitting patients over the edge of the bed etc. Thus we can mobilise even sedated and / or delirious patients if required. There is very little data about the relationship between vasopressor dose and mobility level that is achievable in ICU. We wish to describe our usual practice in detail, including accurate quantification of frequency of mobilisation and corresponding dosage of vasopressors. This information will be useful not just to inform our own future practice, but also to other ICU clinicians around the world who seek more clarity on safety criteria for mobilizing patients in ICU. This study is a simple retrospective audit of our usual practice which will allow us to describe our mobilisation practices across a 3 month period. All the information required for this study is already collected routinely in the Metavision computer program in ICU, thus this study will not pose any additional burden to patients or staff. It is intended that the results of this study would be published in a reputable critical care journal, as well as presented at scientific meetings.

Shoulder disorders are a leading cause of pain and disability in our society with 1 in 3 people experiencing shoulder pain at some stage in their lives. Recurrence is common and symptoms are often persistent. The rotator cuff muscles are considered the prime source of symptoms with a diagnosis of rotator cuff tendinopathy/sub-acromial pain syndrome (SPS) accounting for approximately 30% of all diagnoses made by GPs. Physiotherapy, particularly involving structured exercises, has been shown to be as effective as surgery in this patient group and is associated with less time off work and reduced adverse events. However, definitive conclusions have not been drawn regarding which specific types of exercise are most effective in the treatment of this condition. The aim of this study is to compare the effects on pain and function of three different rehabilitation programs, each incorporating one of three types of strengthening exercises - (i) isotonic concentric (ii), isotonic eccentric and (iii) isometric rotator cuff contractions - into a structured exercise-based physiotherapy rehabilitation program in patients diagnosed with rotator cuff tendinopathy/SPS.

Successful peripheral venous catheter (PVC) insertion and the decrease of catheter related complications that result in device failure is an important clinical objective and patient outcome. Although previous studies have identified the level of skill of the PVC inserter as a risk factor for catheter failure there is a paucity of information investigating the impact of a Vascular Access Specialist (VAS). We will use a single centre, randomised controlled trial to compare the clinical and economic outcomes of PVC inserted by a VAS against those inserted by a generalist inserter (standard care). As this is a pilot study, the primary aim of this study is to establish feasibility of the protocol and the planned processes. This will help to budget and plan correctly for the larger definitive trial. We will collect data on the success of screening and recruitment strategies; test our data collection processes and technology; cost the Research Nurse time required for the trial; and finalise sample size requirements for the larger trial. Participants will be eligible for inclusion in this trial if they are a medical or surgical patient over the age of 18 and are having a peripheral intravenous catheter inserted as part of their therapy (which is expected to remain in place for at least 24 hours). All participants enrolled in this trial will be randomly allocated (by chance) to have their PVC inserted by either a Vascular Access Specialist or a generalist inserter. Daily follow ups will then be carried out by a (blinded) Research Nurse until the time of device removal.