ANZCTR search results

ATLAS is a 12-week research study sponsored by the University of Sydney, evaluating the efficacy of an oral supplement combination for reducing knee pain compared to a placebo in people with symptomatic knee OA.

Cleft palate is a birth defect that affects the roof of the mouth and requires surgery in the first year of life to close the abnormal opening between the nose and mouth. After surgery, moderate to severe pain is managed using opioid painkillers. However, opioids can cause breathing problems and can be especially risky for children who have had cleft palate surgery. Monitoring a patient's oxygen and carbon dioxide levels can help clinicians understand a patient's respiratory status and detect changes in their breathing and ventilation. This is important in patients who are vulnerable to breathing problems, such as patients recovering after cleft palate surgery. Carbon dioxide monitoring is not currently a routine feature of monitoring for palatoplasty patients. A proposed pilot study aims to monitor both oxygen and carbon dioxide saturations in infants on opioid infusions after palatoplasty to better understand their ventilatory recovery after cleft palate surgery.

The primary aim of this study is to determine whether a patient-led communication intervention can improve recall of health information following a healthcare interaction. This study follows a mixed-methods design whereby quantitative and qualitative data will be collected and analysed. A prospective, single centre, two arm RCT will determine the proportion of information recalled at two time points. A qualitative evaluation will be conducted parallel to the RCT, exploring patient perspectives on usability, relevance and value of the intervention through semi-structured interviews. These interviews will only be conducted among participants who have been randomised to the intervention arm of the RCT.

Poor financial health and wellbeing are known to affect psychological wellbeing in adults. There is good evidence that financial stress can result in a low mood. Behavioral Activation is known to treat depression in adult patients. Potentially, Behavioral Activation (BA) may have a role to play in treating depression in people experiencing financial distress. We are not aware of any studies that have tested the feasibility and acceptability of BA conjunctively delivered with financial support service care for financially stressed adults with depression. This study will examine the feasibility and acceptability of implementing a BA tele-trial delivered collaboratively with the Financial Wellbeing & Capability Programs – Outback SA (FWCP) financial support service offered by Centacare Catholic Country SA, a not-for-profit organization in South Australia. Methods A sample of 60 FWCP clients aged 18 years or above with symptoms of depression as indicated by the PHQ-9 scores of 5-14 (mild to moderate depression) and eight Financial Capability Workers will be recruited from across six sites in regional, rural, and remote South Australia. Study participants will be randomized to receive Behavioral Activation plus FWCP financial support service care or FWCP financial support service care alone. The Behavioral Activation component will involve 6 sessions of 30-minute duration which will be delivered twice weekly over six weeks. Specific BA techniques that will be applied include the identification of depressed behaviors; analysis of the triggers and consequences of depressed behaviors; monitoring of activities; development of alternative goal-orientated behaviors; scheduling of activities; and the development of alternative behavioral responses to rumination. The Financial Capability Workers will complete a 10-week online training program in BA comprising five modules: (a) the evidence base of BA (b) introduction to BA (c) assessment and mood monitoring (d) functional analysis, and (e) activity scheduling before they can deliver the psychotherapy to their clients. Changes in depression symptoms will be assessed at three-time points: (a) at baseline, at 6 weeks, and 3-month follow-ups. Quality of life will be assessed at two-time points: (a) at baseline and (b) immediately at postintervention after six weeks. Descriptive statistics and thematic analysis will be used to assess feasibility and acceptability. Discussion The findings from the study will inform the design of a full-scale randomized controlled trial to test the effectiveness preparing FCW to deliver BA to people in financial distress who are depressed.

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.