ANZCTR search results

The aim of this pilot study is to investigate whether Contingency Management (CM) is acceptable and safe as an intervention for smoking cessation in young people with Borderline Personality Disorder (BPD) features. Existing patients of Orygen's HYPE clinic (N=40) between the ages of 15 and 25 (inclusive) will receive eight weekly sessions of CM in an open-label pilot study, with assessments at baseline, week 8, and follow-up at 16 weeks. The primary hypotheses are that CM will be an acceptable and safe intervention for cigarette smoking in young people with BPD features.

This is a Phase 1, blinded, randomized, placebo-controlled study of the administration of single-ascending doses (SAD) and multiple -ascending doses (MAD) of MYK-224 to healthy participants aged 18–45 years. The SAD and MAD phases of the study are nested. Once the informed consent form (ICF) is signed and eligibility has been established, healthy participants will be enrolled into cohorts of 8 participants randomized 6:2 to MYK-224:Placebo. During the SAD portion and because this is a first in human (FIH) study, a sentinel dosing plan will be employed at each dose level. The first 2 healthy participants of each cohort will be dosed as sentinels. One of the sentinel healthy participants will be randomized to receive MYK-224 and the other will be randomized to receive placebo. Following Safety Review Committee (SRC) review of safety data (including adverse events [AEs], vital signs, electrocardiogram [ECG], and labs [hematology, chemistry, urinalysis, prothrombin time [PT], activated partial thrombin time [aPTT]) 24 to 48 hours after dosing from the sentinel healthy participants, and if deemed appropriate, the remaining 6 healthy participants in the cohort will be dosed. During the food effect (FE) portion, a 2-period crossover design (in which one of the SAD cohorts returns after washout for second administration of the same dose) will be employed to determine the effect of food upon the PK.

This study is a pilot, feasibility randomised controlled trial to test the feasibility of a theory-based behaviour change intervention designed to promote help-seeking for mental health problems among older adults in Australia. The intervention aims to improve the three main components of the Theory of Planned Behaviour, which have been shown in previous research to influence mental health help-seeking: attitudes, subjective norms, and percevied behavioural control. The intervention was designed in consultation with key stakeholders. Adults aged 65 years and over living in metropolitan areas in Australia will be recruited online using Qualtrics research services. In keeping with a preventative, population health approach, inclusion is not dependant on mental health symptomatology. Participants will be randomly allocated to an intervention or comparison group using Qualtrics computer software. Participants in the intervention group will receive an information brochure based on the theory of planned behaviour. Participants in the comparison group will receive a brochure with general health information. The primary outcome is intervention feasibility. Secondary outcomes include intervention utility, retention, time spent reviewing the brochure, changes in help-seeking intention, attitudes, subjective norms and perceived behavioural control, and help-seeking behaviour. Data will be collected at baseline, immediately post-intervention and three weeks post-intervention. Descriptive statistics will be calculated to analyse the data. Intention to treat analysis will be used. Increasing the likelihood of older adults engaging professional mental health supports early may reduce the individual, social and economic burden of mental ill-health and promote healthy ageing.

The INFORM-AF Pilot Study is a quasi-experimental pre-post test, pilot-feasibility study of a novel digital education intervention delivered through mobile-based health (mHealth) technology targeted at patients living with atrial fibrillation, in Western and South Sydney. The study will evaluate the feasibility of this education program, in improving the Atrial Fibrillation (AF) patient’s knowledge and quality of life. The study will also assess the usability of the digital education intervention. The mHealth application is a smartphone-based spaced learning intervention and consists of six case scenario-based Atrial Fibrillation questions, based on a spaced timing algorithm, delivered over a 6-week period. The mHealth-based intervention is delivered by the QStream digital platform and is co-designed in consultation with stakeholders including patients living with AF, healthcare providers of AF patients and key opinion leaders from Stroke Foundation, Heart Foundation, NGOs and cardiovascular peak bodies. This is pilot feasibility study of this educational intervention is informed through our foundational qualitative research that has just concluded and is yet to be published. The study team interviewed a total of 45 participants including clinicians, expert key stakeholder and patients to identify the educational and self-management needs of patients living with AF. Data collection for this study will be conducted via pre and post implementation electronic surveys, and four follow up phone calls (a technical support check-in during the intervention at 3 weeks, and post-intervention outcome assessment at four time points - 6 weeks, 3 months, 6 months and 12 months).

Ageing is associated with a progressive deterioration of the immune system function, described as immunosenescence, which contributes to an increased risk of morbidity, poor responses to vaccination, and increased mortality in older persons. The COVID-19 pandemic has disproportionately impacted older people; particularly those living at residential aged care facilities (RACFs). In Australia, the death toll in RACFs has been devastating with two thirds of the current deaths in Victoria happening in residents of RACFs. Considering that calcium ß-Hydroxy-ß-Methylbutyrate (CaHMB), vitamin D, and protein supplementation have demonstrated a beneficial effect not only on the immune system but also on muscle mass and strength and respiratory function in frail older persons, we propose a cluster, randomised, placebo controlled trial administering residents in Victorian RACFs (n= 160) a multinutrient supplement versus usual care for 3 months. Overall, their immune response and improvement in muscle mass and strength, and respiratory function will be documented. Our results will fulfil an unmet need in this very high-risk population by testing whether a specialised nutritional supplement administered within a short period of time could prepare RACFs against this and potential future pandemics while preventing complications and adverse outcomes, and enhancing their immune response to current vaccines.

This study aims to compare the effectiveness of two online interventions for individuals with subclinical and mild OC symptoms. Through a randomised controlled design, we will compare the acceptability and effectiveness of the interventions in improving obsessions and compulsions, depression, anxiety, psychological flexibility and quality of life. We hypothesise that improvement in psychological flexibility will predict greater reduction in obsessions and compulsions and comorbid symptoms at post-treatment.

The MRI Linac is one of the newest and most technologically advanced radiotherapy machines used to treat cancer. Magnetic resonance imaging (MRI) is one of the best imaging tools available to guide radiotherapy. Linear accelerators (Linacs) are treatment machines used to deliver radiotherapy to treat cancers. By combining the MRI and Linac into an MRI-Linac, it allows the use of better images than standard X-rays to guide radiotherapy. The purpose of this study is to determine if it is feasible to use the bespoke MRI-Linac at Liverpool Hospital to treat patients. The data collected will be used in developing and improving the MRI-Linac for future cancer patients. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with cancer and will be receiving palliative radiotherapy. Study details All participants will need to attend at least two 1-hour sessions where the MRI-Linac machine will be used to guide radiotherapy treatments. If the MRI-Linac is being used effectively, as determined by your treating doctor, further radiotherapy treatments will also be guided using the MRI-Linac machine. This study will examine the patient experience, workflow, treatment accuracy, image quality, integration MRI-Linac clinical performance, radiotherapy quality and the treatment process. The data collected will be used in developing and improving the MRI-Linac for future cancer patients.

Dystonia is a neurological disorder causing involuntary muscle contractions, and is thought to be caused by abnormal firing of specific brain networks. There are a number of types of dystonia, each defined by the body region/s that are affected. For example, and relevant to the present application, cervical dystonia (CD) affects the muscles of the neck. The current ‘gold standard’ treatments for CD are the injection of botulinum toxin type A (botox) into the affected muscles, or deep brain stimulation via brain surgery in more severe cases. However, injections only treat patients’ symptoms, rather than the underlying substrate of the disorder, and include side effects such as muscle wasting, while surgery is invasive and can be risky. As such, new treatments for CD are needed. Repetitive transcranial magnetic stimulation (rTMS) has shown some promise in patients with CD, however, overall results have not yet been compelling enough to carry rTMS forward as an approved treatment method. rTMS in CD has been hindered by the fact that the particular brain region that should be stimulated is still unknown. This is because previous neuroimaging findings have identified many different brain regions as abnormal in CD. This research will build upon findings by Corp et al. (2019), who demonstrated that the somatosensory cortex is abnormal in CD patients. Thus, this will be the first study to investigate whether a form of rTMS (called continuous theta-burst stimulation, or cTBS) to this brain region can effectively relieve CD symptoms. Aim 1 of the project is to investigate whether cTBS is an effective treatment for CD symptoms. It is hypothesised that there will be a significant overall reduction in CD symptoms post-intervention, as measured by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS). CD symptoms will also be measured through kinematic testing using a custom-made device to measure head and neck angle, tilt, and position. Aim 2 of this study is to investigate neurophysiological changes within the somatosensory cortex, due to the application of cTBS. It is hypothesised that there will be significant changes in the excitability of the somatosensory cortex (as measured by IHI) after the application of real cTBS in comparison to sham stimulation. Further, it is hypothesised that there will be a correlation between these changes in excitability, and reductions in CD symptom scores (as measured by the TWSTRS).

Dysphagia is the term used to describe difficulty with swallowing. It is common condition and increases the risk of choking, pneumonia, malnutrition and dehydration which, in turn, can result in hospitalisation or even death. Dysphagia can have a major adverse impact on quality of life. A relatively new computer-based training program, called Biofeedback in Strength and Skill Training (BiSSkiT), was developed in New Zealand. BiSSkiT comprises a training protocol and accompanying software program, with surface electrodes as the underlying hardware, for the rehabilitation and outcome measurement of swallowing impairments. The effectiveness of the BiSSkiT program in clinical settings apart from Parkinson’s Disease has not been investigated to date. The overall purpose of this preliminary study is to evaluate whether the BiSSkiT computer-based program improves the swallowing ability of patients with chronic dysphagia.

The primary objective of this 3- arm randomised controlled trial, is to evaluate the effects of gait retraining interventions on proxy measures of medial knee load (early- and late-stance peak KAM, KAM impulse, and varus thrust) in people with medial knee osteoarthritis. This will be assessed at baseline, six weeks after the initial assessment and three months following this.