ANZCTR search results

Pregnancy and postpartum periods are critical times for the ~300,000 families who welcome a newborn in Australia annually. During pregnancy, ~70% of birthing parents report sleep disturbance, and our pilot data showed that 1 in 3 experience symptoms of insomnia that may require clinical attention. As women cope with these significant sleep disruptions, they may also develop unhelpful sleep-related cognitions/behaviours, which can perpetuate sleep problems well into the postpartum period. The use of Cognitive Behavioural Therapy for Insomnia has been shown to result in significantly reduced prenatal insomnia, and benefits to sleep and sleep-related functioning were evident in a long-term follow up at 2 years postpartum (Bei et al., 2021). However, these evidence-based sleep interventions are not currently part of routine perinatal care in Australia. Therefore the SHINE RCT aims to evaluate the effectiveness, cost-effectiveness, and implementation potential of a scalable CBT-based Healthy Sleep program for the pregnancy and postpartum period to expedite its translation to the wider community. There are 3 specific aims: 1. To evaluate the effectiveness of the CBT program against an active control condition. 2. To conduct a health economic evaluation comparing CBT to usual care, examining (1) whether cost savings from reduced health service utilisation offset the direct cost of the intervention, and (2) if not cost-saving, whether the hypothesised improvements in sleep and daytime functioning are worth the additional cost of the intervention. 3. To explore barriers and enablers to wider implementation to promote future successful implementation and sustainability.

Chronic pain affects 20% of the adult population in Australia, and can negatively impact all aspects of an individual's life - physical mobility, mood, sleep, occupational functioning and social activities. Our healthcare system cannot cope with the demand of this chronic illness, and community resources have been under-utilised to date. This project, Our Recovery, draws on the 12 Step Consumer-Led Framework used by the Alcoholics Anonymous movement and translates it into an online, evidence-based support program for individuals with chronic pain. This feasibility trial will randomly allocate adults aged 18-65 into the Our Recovery program, or usual care. Treatment satisfaction as well as pain outcomes will be assessed at 3 months and 9 months after commencement of the program. The primary study hypothesis is that individuals participating in the Our Recovery program will report greater pain self-efficacy, less pain-related disability, greater acceptance of pain and better mood, than those receiving usual care. It is also hypothesized that individuals participating in Our Recovery will take fewer pain medications and be performing more hours at work each week (paid and unpaid) than those receiving usual care.

This randomised control trial aims to evaluate outcomes following a) standard care, and b) a multimodal hand therapy management package to deliver acute post-operative hand therapy education and care, guide patient expectations of key milestones in recovery, and highlight ‘triggers’ to help patients identify when and how to access the hospital hand therapy service. We hypothesise targeted, rather than routine referral to HT may allow better allocation of resources with non-inferior patient outcomes.

Evidence based services available for young people experiencing anxiety and depressive symptoms in Australia have primarily relied on individual psychological therapy and/or pharmacotherapy. Many young people do not fully respond to these treatments, and there are a range of alternative treatment options that require further evaluation. There is evidence that approaches involving mindfulness meditation and yogic exercise may also be effective. However, there has been limited evaluation of interventions that involve an encompassing yogic practice involving mindfulness meditation, breath work, and yogic exercise. We have adapted a specialised program (Sudarshan Kriya Yoga Campus Happiness Program; SKY-CHP) involving yogic breathing and meditation delivered in a group format that encourages social connection and stress management and propose to examine its feasibility as an intervention for youth depression and anxiety symptoms. The adaptation has involved clinicians who work with young people experiencing anxiety and depression, and young people with a lived experience of these difficulties. The aim of the BREATHE study is to examine whether this adapted novel yoga program is safe, feasible, and acceptable among young people experiencing symptoms of anxiety and/or depression. A secondary aim is to evaluate changes in depression, anxiety, psychological distress, quality of life and wellbeing, functioning, and mindfulness. Exploratory aims will examine changes in resting state electroencephalography (EEG) and electrophysiological markers.

The research study aims to explore the potential interaction between application time of the day and short-term myopia (or ‘short-sightedness’) control contact lens wear and different lighting conditions. Participants will wear contact lenses and goggles fitted with one of the three different light filters (neutral density filters, blue filters and red filters) during each visit and their eyes will be measured using non-invasive methods at the beginning and the end of each visit.

A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Intravenous Dose Study to Assess the Safety, Tolerability and Pharmacokinetics. VGL101 or placebo will be administered to healthy volunteers to test if VGL101 is safe and can be explored as a treatment for Adult onset leukoencephalopathy with axonal spheroids and pigmented glia.

This study aims to understand the feasibility and cost of allied health assistants delivering a structured falls prevention education script for patients in the first 48 hours of admission to a rehabilitation hospital. We hypothesise that this project will help patients to reduce their rate of falls and injuries arising from a fall whilst in hospital. Findings from this study will contribute to society new knowledge on the effects of using different health workforce approaches to educating patients about how to reduce their risk of falls whilst in hospital. The findings may also contribute to future workforce redesign. We will seek to measure any changes in patient views and knowledge about falls prevention from before and after the education. The views of the allied health assistant staff delivering and those supervising them will also be sought via focus groups and interviews. We aim to analyse the costs of delivering patient education via allied health assistants versus: (i) an occupational therapist (ii) a physiotherapist and (iii) a registered nurse. Finally, we will track falls rates and any associated injuries during the trial and compare these to the historical data for the rehabilitation hospital.

The primary objective is to evaluate the safety and tolerability of a single dose of PMX205 in individuals with ALS. The secondary objectives are: to determine the plasma pharmacokinetics (PK) of PMX205, evaluate PMX205 levels in the cerebrospinal fluid (CSF) after dosing at a single level, and to evaluate PMX205 pharmacodynamic (PD) activity by measuring cytokine levels following C5a challenge in peripheral immune cells. It is important to determine the extent to which PMX205 crosses the blood-brain barrier and enters brain tissue in individuals with ALS. PMX205 is to be administered as a subcutaneous (SC) injection into the anterior abdomen. Patients who have ALS or are likely to have ALS will be selected by the investigators based on history, examination, imaging and laboratory results. A total of up to 8 participants will be enrolled and assessed for safety (physical exam and clinical laboratory pathology), PMX205 PK and PMX205 PD during the study.

The Frailty Reduction via Implementation of Exercise, Nutritional support and Deprescribing Project (FRIEND) Project is a pilot implementation study that aims to establish integrated processes and pathways within a residential aged care facility to enable early identification and effective reduction of frailty in residents with Mild Cognitive Impairment (MCI) or Dementia. The study involves the evaluation of current practices within a large, regional aged care facility (The Good Shepherd Home Townsville) and the delivery of a multicomponent intervention which aims to reduce frailty in residents living within this facility over a six-month period. Outcomes collected will include not only those relating to improvements in the clinical status within the residents including frailty, nutritional status, quality of life, depression, physical function and cognition, but also facility level outcomes relating to the implementation of the intervention including adoption, acceptability, fidelity, cost, and safety. As part of the study, the research team including the study geriatrician, dietitian, exercise physiologist, and pharmacist will work together with the Clinical Nurse Manager and relevant staff members at TGSH, including the resident’s general practitioner (GP), to design individualised treatment plans for the residents that aim to reduce frailty via the implementation of an exercise, nutritional support and medication review intervention. To sustain these interventions, educational modules for residents and families (face-to-face), as well as pharmacy, nursing, GPs, and other relevant staff (online modules) will also be delivered and integrated into the intervention to educate on the role that exercise, nutrition and deprescribing has on reducing frailty and improving resident’s overall health, as well a build capacity within the facility to continue with this evidence-based care model. Ultimately, the modules and education materials developed and implemented during this study will be refined and disseminated widely to be freely accessible for all aged care facilities nationwide.

The MAP-APS registry has been established to assess the feasability and utility of populating a standardised longitudinal dataset on participants with atypical parkinsonsian syndromes at a single site. The protocol has been devised to acquire enough clinical-biological data to perform deep clinical phenotyping while maintaining brevity and minimising allocation of resources and burden on participants.