ANZCTR search results

Transcutanous vagus nerve stimulation (taVNS) is an emerging non-invasive neuromodulation therapy which aims to modulate brain activity through electrical stimulation of a small branch of the vagus nerve located in the auricle. Recently, taVNS paired with rehabilitation has been shown to be a feasible and safe approach to improve upper-limb weakness in subacute and chronic stroke when combined with physical rehabilitation. The positive effect of taVNS on upper-limb motor function, likely driven by enhanced neuroplasticity suggests that pairing taVNS with physical rehabilitation might prove beneficial for enhancing other motor impairments after stroke. This research aims to assess the feasibility, safety, and preliminary efficacy of taVNS paired with rehabilitation for enhancing gait and balance after stroke (> 6 months).

This is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human study in which the safety, tolerability, and PK of orally administered AC-201 will be assessed in healthy adult subjects. The study will consist of 3 parts: a SAD phase (Part 1) enrolling a total of 5 cohorts of healthy subjects, and a MAD phase (Part 3) enrolling 3 cohorts of healthy subjects.

After a Senate inquiry into Australian Lyme-like illness in 2016, the Australian Government released a position statement specifying that “there is a group of Australian patients suffering from the symptoms of a chronic debilitating illness, which many associate with a tick bite”. They described this patient group as having Debilitating Symptom Complexes Attributed to Ticks (DSCATT). The precise scale of DSCATT is at present unknown, though it is believed there are large numbers affected, and that their morbidity is profound. After extensive medical investigations, individuals with DSCATT are often left without a clear explanation for their illness, nor do they feel that their symptoms and level of impairment are believed by many healthcare providers. Collectively, this can lead to further distress and perpetuate their disease process and disability. There are no recognised treatments for DSCATT at present, however, there has been much research into treatments for other medically unexplained and contested illnesses. An increasing body of evidence shows that psychological therapies such as Acceptance and Commitment Therapy (ACT) can be effective in reducing symptom-related disability and improving quality of life in such conditions. This project will explore the feasibility of an ACT informed intervention which has been tailored to suit the needs of this patient group. We have elected to complete a feasibility trial given there are no published clinical trials or cases reports which investigate potential treatments for DSCATT at present, including psychology-based approaches. As such, there is uncertainty surrounding the demand for, and acceptability of this type of treatment approach for DSCATT. Therefore, we wish to assess if our therapy is acceptable, practical, and in demand for patients with DSCATT before a larger scale, treatment efficacy trial is conducted. Completion of this feasibility trial may also assist in identifying an appropriate primary outcome measure by exploring the therapy’s potential mechanism of actions and perceived value to participants. The study will utilise quantitative and qualitative data collection methods to address its study aims (feasibility, effects on health-related outcomes, and safety and tolerability) following a mixed-methods, parallel convergent design.

Reading impairment (dyslexia) is the most common specific learning difficulty in Australia. Approximately 10% of Australian children have substantial difficulties in reading and spelling, and these children are at elevated risk of developing mental health problems: both internalising disorders (e.g. anxiety, depression) and externalising disorders (e.g. attention and conduct problems, delinquency). The transition from primary to secondary school is a particularly stressful period for children with dyslexia due to the increased educational demands and expectations placed on children regarding the quantity and quality of reading and writing. We will conduct a randomised controlled trial to evaluate the efficacy of a mental health promotion program (Clever Kids) in improving coping, emotion regulation, perseverance, assertiveness, and self-esteem, as well as both internalising and externalising symptoms for children with dyslexia in their final two years of primary school. We predict that program attendance will be associated with improvements in coping and emotion regulation skills, self-esteem, perseverance, assertiveness, as well as internalising and externalising symptoms. Additionally, we predict that these improvements will be maintained over the three month follow-up period. Acceptability of the program will be assessed using in-depth qualitative interviews with program attendees. The research will be conducted in partnership with the Dyslexia-SPELD Foundation (DSF).

The aim of this study is to explore the effects of an online quality improvement tool developed for service providers and educators in family day care to promote healthier nutrition and physical activity practices. it is hypothesised that using the online tool will improve the quality of the service provider's revised quality improvement plan (QIP) compared to the service provider's previous QIP.

Chronic pelvic pain (CPP) is a condition that significantly impacts the quality of life (QoL) of effected people, with substantial associated costs to both the individual and healthcare system. Hypnotherapy is an effective psychological treatment for mental health and pain. Hypnotherapy modulates neural processes associated with pain intensity and unpleasantness, supporting its use for CPP where pain and distress become entrenched. A parallel-group, investigator-blinded, randomized control trial will aim to establish the efficacy of e-hypnotherapy over relaxation and waitlist controls on pain, QoL, biopsychosocial outcomes, and cost-effectiveness. The e-hypnotherapy program will be reviewed by a group of eligible healthcare providers who will consider potential barriers/facilitators to ‘real world’ implementation. Review of the program by elegible healthcare providers will happen after the trial has been finalised. This review is relevant to the implementation rather than the participants.

This study will investigate the levels of pepsin (an enzyme normally found in the stomach and not in the lungs) in the exhaled breath (EBC) of patients with idiopathic pulmonary fibrosis (IPF) and compare them to levels recorded in healthy, matched adults. This information will help the understanding of whether pepsin (or other stomach contents) may contribute to the development of IPF

Research Aims: 1. To determine the effectiveness of the Triple P Online System (TPOS) and each individual TPOS variant (Triple P Online, Fear-Less Triple P, Triple P for Baby) on child and parent outcomes. 2. To examine the relationship between pre-intervention characteristics (moderators) and program outcomes (child and parent effects, module completion, and program satisfaction). 3. To identify predictors of responders and non-responders to TPOS interventions at each stage of the engagement and completion process (commencing the programs, completion of within-module activities, module completion and program completion). The Triple P Online System has been disseminated in Australia since 2014 and randomized controlled trials have shown that the system is effective in improving parenting practices, enhancing parenting efficacy and reducing child behavioural and emotional problems. Little is known however about its efficacy in a practice-as-usual context and about parents’ interaction with the program and the mediators and moderators that influence program outcomes. This study will take advantage of a roll-out of TPOS within Australia to collect data on effectiveness in a practice-as-usual context. The TPOS system has been funded for dissemination to all eligible Australian parents by the Commonwealth Government’s Parenting and Education Support Program from 2022. Continuous tracking of program outcomes embedded within the Triple P Online System interventions, will provide an ongoing quality management and improvement process. A mix of routinely collected Triple P Online System (TPOS) process data, mapped against parent and child characteristics and parent questionnaire responses pre, during and post program completion will track program effectiveness and allow rapid identification of specific areas for improvement. Tracking of module-by-module parent progress and program use will enable us to identify specific program components that are especially effective and engaging, as well as any that are less engaging and effective for parents.

The digital Covid Risk Calculator (CoRiCal) tool has been developed by a team of Australian GPs and epidemiologists in collaboration with the Immunisation Coalition to facilitate informed choice about COVID-19 vaccination risk and benefits: https://corical.immunisationcoalition.org.au. The study will be a randomised experiment, to investigate the impact COVID vaccine information on participants understand. The aim of this study is to improve the risk communication interface for CoRiCal, to ensure Australians with varying health literacy have access to updated evidence on COVID-19 vaccination benefits and risks in a form they can understand and act on. Key research questions will be: 1.Does the standard CoRiCal website output increase knowledge about COVID-19 vaccination compared to control 2.Do video explanations increase knowledge about COVID-19 vaccination compared to standard CoRiCal output 3.Does the absolute risk format increase knowledge and intention compared to 1 in x format This study is a survey which will be conducted online through the Qualtrics platform. Participants will be recruited from the general Australian public using a market research company, Dynata. Once they have read the PIS and Consent form and given consent, participants will complete a 10-minute survey. Participants will answer demographic questions and then will be randomised to receive one of three interventions or a control. This will take about 5 minutes to complete. Immediately following this, they will be asked our outcome questions, which will also take about 5 minutes to complete. Therefore the complete survey will take about 10 minutes in total. They will receive a debriefing document at the end to explain the aims of the study and that the data is based on current evidence but may not apply to their own situation, with references for reliable and updated information. Participants are told in the PIS that the results of the study will be posted on the research group website (https://sydneyhealthliteracylab.org.au).

Low back pain is a common problem, affecting over 4 million Australians every year. Advice, defined as any advice, education or information given by a healthcare professional to improve a patient’s understanding of pain or appropriate management, is recommended by guidelines internationally as a first line treatment for acute low back pain (pain less than or equal to 6 weeks). The goal of advice for acute low back pain is to reduce worries and concerns and to promote positive future healthcare behaviours. It is currently unknown which type of advice is best at reassuring patients with acute low back pain. The current approach recommended by guidelines involves providing information on the nature of low back pain and its generally favourable prognosis and encouragement to continue with normal activities (e.g. activities of daily living, leisure, and work) and avoid bed rest. Other approaches include pain science education-based advice and ergonomic-based advice. Pain science education-based advice aims to reframe unhelpful beliefs about pain by presenting information about the biologic basis and protective nature of acute low back pain. Ergonomic-based advice describes how postures and lifting techniques can contribute to a person’s acute low back pain and provides advice about how to reduce or prevent pain by maintaining good posture (e.g. when sitting or lifting objects).