ANZCTR search results

This study is examining two biopsy regimens for surveillance follow-up in patients where Barrett’s oesophagus with dysplasia or cancer has been eradicated. Who is it for? You may be eligible for this study if you have undergone successful endoscopic Barrett's oesophagus and/or oesophageal adenocarcinoma eradication and are currently having follow-up surveillance endoscopies. Study details All participants will undergo surveillance endoscope and biopsy as per their current standard treatment. The study personnel will record the time taken to take samples and perform economic analysis. Please note there is no additional testing or input required by participants in this study beyond participating in their routine care. It is hoped this research will demonstrate that a reduced test biopsy regimen is more cost- and time-efficient than the standard biopsy regimen without reducing the surveillance quality.

BNC210 is being developed for the treatment of anxiety, and trauma- and stressor-related, disorders including post-traumatic stress disorder (PTSD). This three-way crossover single dose study will compare the pharmacokinetic profiles of oral suspension and tablet formulations of BNC210.

Working memory (WM) training using emotional stimuli has been designed to improve the mental control of emotional information. The aim of this project is to test whether individuals with elevated social anxiety would benefit from WM training with emotional stimuli. It is anticipated that individuals with elevated social anxiety who engage in a WM training task with emotional stimuli, relative to those who engage in a control training task, will exhibit: (a) reduced theory-based social-evaluative processes (anticipatory processing, self-focused attention, post-event processing), b) reduced attentional bias towards negative social stimuli, and (c) improved cognitive and affective empathy.

ADHD is an impairing neurobiological disorder affecting over 300,000 young people in Australia. Up to 70% of children with ADHD experience sleep problems which contribute to substantially worse functioning. A number of studies have now demonstrated that sleep problems are amenable to intervention in young children with ADHD, with large improvements in sleep and child and family wellbeing. This study will extend this program to adolescents with ADHD, given that sleep problems continue to be prevalent in adolescents and are associated with poorer wellbeing. There are currently no evidence-based sleep interventions for adolescents with ADHD. This study aims to conduct a pilot randomised controlled trial (RCT) to determine the feasibility, and acceptability of the adapted Sleeping Sound intervention, in adolescents aged 13-17 years with ADHD. We hypothesise that the Sleeping Sound adolescent intervention will be a feasible and acceptable treatment for sleep problems in adolescents with ADHD. We will also explore the effect of the intervention on the following outcomes at 3 and 5 months post-randomisation: 1. Adolescent sleep problems and sleep hygiene 2. ADHD symptom severity 3. Adolescent wellbeing (i.e., mental health and quality of life) 4. Parent mental health

Background: Over 35% of Australians who drink in excess of NHMRC guideline levels (AIHW, 2008). Individuals who drink at harmful levels can experience a range of negative physical, psychological and social consequences (NHMRC, 2009; LaBrie et al. 2009) but are generally unlikely to seek professional help to reduce their alcohol consumption (Reavley et al, 2010). Smartphone health-related apps may mitigate many identified barriers to help-seeking, such as concerns about privacy and stigma, treatment cost and time commitment and a preference for self-reliance (Ballon et al., 2004; Saunders et al., 2006). Additionally, other advantages include their low cost, convenience and accessibility. However, while numerous apps purport to reduce alcohol consumption, most show poor evidence-based content quality (Penzenstadler et al. 2016). Only nine apps have been subject to assessment and only four of these have demonstrated promising outcomes, albeit most with major methodological limitations (Gajecki et al., 2017; Gonzalez & Dulin, 2015; Gustafson et al., 2014; You et al., 2017). This intervention: To address this intervention gap, a team of clinicians and researchers at the Centre of Drug, Alcohol and Addiction Research (CEDAAR) at Deakin University developed a unique evidence-based smartphone app. Through an iterative process involving clinical expert input, consumer feedback, user-testing and piloting, we have developed an app that uses an effective behaviour change technique–Implementation Intentions (Gollwitzer & Sheeran, 2006)–in addition to goals, monitoring, feedback. Implementation Intentions have the ability to bridge the intention-behaviour gap, and are associated with strong and consistent behaviour change outcomes, including for risky drinking (e.g. Armitage, 2009). Implementation Intentions work by pairing a key obstacle (‘If my friends pressure me to drink’) with a concrete alternative behaviour (‘Then I will say I have a big day tomorrow and decline’). Through memory cues and scripted responses, Implementation Intentions replace automatic unhelpful habits with helpful alternative responses that become increasingly automatic. General procedure: This Randomised Controlled Trial (RCT) aims to investigate whether personalised Implementation Intentions delivered through an app are efficacious for reducing alcohol consumption and related harms among risky drinkers. It will also examine a number of potential mediators and moderators. Participants will be randomised to one of two groups: Intervention or Waitlist. Outcomes: The RCT will assess whether alcohol consumption and related harm are reduced post intervention in the Intervention group compared with the Waitlist group and whether these reductions are maintained at 4-weeks follow-up. In addition, the study will assess whether a range of secondary outcomes are impacted by the intervention and whether certain baseline and change variables predict outcome.

Bipolar Disorder (BD) is an affective psychotic disorder characterised by extreme changes in mood, thoughts and behaviour. BDI disorder epitomises the classic manic depressive description of BD with characteristic periods of mania and depression. The severity of symptoms impacts on social and occupational functioning. In the early stages of illness, despite potential symptomatic recovery, functional recovery is less common. Social and occupational functioning are surprisingly poor, despite evidence that this group displays exemplary functional performance prior to illness onset. Furthermore, if functional recovery is not achieved early, positive outcomes are rarely attained later. Psychological interventions appear more effective in early stages of BD than later illness stages. Our group developed a novel psychological intervention for young people with early stage BD, in collaboration with end users, and tailored to the specific needs of the intended population. The intervention (known as RECOVER), specifically targets symptoms and psychological functioning, with pilot data indicating it as being effective in reducing depressive symptoms (the major burden of BD) and resulting in better functional outcomes than treatment as usual (TAU) at an early psychosis service. This study will provide definitive support for the utility of RECOVER. The aims of the project are to: (i) Refine RECOVER for translation beyond the specialist service in which it was developed; (ii) Evaluate the effectiveness of RECOVER for improving symptom, global functioning and quality of life outcomes, in early-stage BD; and (iii) Investigate mechanisms that may underpin changes in functioning Participants will include 122 young people aged between 15-25 years, admitted to Orygen Youth Health (OYH, Melbourne Health) or the Recovery and Prevention of Psychosis Service (RAPPS, Monash Health) for treatment of early stage bipolar disorder. The participants will be randomised into one of two groups: RECOVER+TAU, or TAU. Participants in the RECOVER+TAU group will receive weekly to fortnightly sessions of RECOVER for up to 6months, with the primary endpoint at this time. All participants will complete follow-up assessments for 18months. The primary outcome is global functioning, with greater results expected in the RECOVER group. A range of symptomatic, quality of life, and functioning measures will be included as secondary outcomes. Treatment related variables will be explored, with measures of medication adherence, maladaptive schemas, comorbidity, premorbid functioning, participant expectations and therapeutic alliances included.

Poor diabetes-treatment adherence is a major contributor to health complications, avoidable hospitalizations and long-term disease in people living with diabetes. Behavioural intervention is not currently part of standard care to improve adherence to conventional medical and lifestyle regimens for patients with complex diabetes. This research aims to demonstrate how personalised behavioural intervention aimed at increasing diabetes self-care and active coping, can lead to improvements in diabetes control and psychological wellbeing. The main purposes of this study are to implement and evaluate the effects of a multicomponent behavioural intervention on diabetes treatment adherence and glycaemic control in patients with complex diabetes and suboptimal control, and identify behavioural and contextual factors associated with the response to intervention. The study aims to demonstrate that: A. Personalised behavioural intervention will improve glycaemic control in complex patients with sub-optimally controlled diabetes, who are already attending a tertiary diabetes clinic. B. Improvements in glycaemic control are modulated via increased adherence to treatment. C. Behavioural intervention reduces diabetes distress and improves quality of life in this complex group of patients. We aim to recruit 60 participants with either type 1 or type 2 diabetes on insulin, attending dedicated outpatient clinics at Fiona Stanley and Fremantle Hospitals for their diabetes management. All participants will receive behavioural intervention either immediately or following a monitoring period of 3months. Current clinical care will continue unchanged. Clinical outcomes including measures of glycaemic control, psychological distress/wellbeing and quality of life will be evaluated every 3months for up to 1 year following study entry to obtain longer term assessment of study outcomes. During the behavioural intervention component of this study, daily self-monitoring of diabetes self-care behaviour will be obtained via a standardized study diary and questionnaire measures including frequency of diabetes self-care activities, psychological distress/wellbeing, coping and quality of life will be collected at specified intervals for assessment of treatment efficacy. We also plan to undertake a health economic analysis to determine costs and benefits of providing behavioural intervention as part of standard diabetes care. The results of this study will provide a foundation for future work to extend this behavioural intervention model to optimize care in the wider population living with diabetes.

This research aims to examine the effectiveness of a six-week cognitive remediation intervention for adults in residential treatment for Alcohol and Other Drug (AOD) use. We aim to primarily investigate whether cognitive remediation will be effective in improving executive functioning and treatment retention rates, compared to treatment-as-usual. In addition, we will examine the effect of cognitive remediation on a number of secondary outcomes, including long-term AOD use, goal attainment, quality of life, health service utilisation and measures of cognition. This will be evaluated by conducting a number of self-report and performance-based measures before and after six weeks of cognitive remediation or treatment-as-usual, and for follow up (2-months, 4-months, 6-months and 8-months). Participants will undergo cognitive remediation in addition to receiving treatment as usual. The cognitive remediation will be administered in a group setting, in one-hour sessions, twice a week for six weeks. The intervention will take a strategy-based approach, with a strong emphasis on the training of executive functioning, and will include traditional instructional pedagogical approaches, modelling, exercises to demonstrate concepts, and role-plays. The intervention will be administered by trained staff at the residential AOD services. The proposed study will be conducted as a prospective stepped wedge cluster randomised trial, where randomisation will occur at the cluster level. The design involves random and sequential crossover of clusters from treatment as usual to Cognitive Remediation until all clusters have implemented the CRiDAS program. It is hypothesised that cognitive remediation will be associated with improved executive functioning and improved treatment retention.

The aims of the project is to examine: 1) the effect of a weight management smartphone application (app) for people living with chronic illnesses on participants’ body weight (primary outcome), Body Mass Index (BMI), activity level, mood and quality of life (secondary outcomes). 2) participants’ appraisal and perceived benefits of the app, and frequency of app use. Project aims: To examine: 1) the effect of a weight management smartphone application (app) for people living with chronic illnesses on participants’ body weight (primary outcome), Body Mass Index (BMI), activity level, mood and quality of life (secondary outcomes). 2) participants’ appraisal and perceived benefits of the app, and frequency of app use. Why is this study needed? Being overweight or obese are major risk factors for many chronic diseases, such as diabetes and cardiovascular diseases, and are dramatically on the rise in urban and rural settings. There are weight loss apps available, but few randomised controlled trials (RCTs) have been conducted to evaluate the effectiveness of these apps. Few apps adopted an evidence-based and theory-based approach in its development. Method: A pilot RCT of an interactive ‘Weight Management Wellness App’. 76 patients who have a diagnosis of chronic illness with BMI greater than or equal to 25 kg/m2 will be randomly allocated to intervention or control groups. The app is developed based on cognitive behavioural therapy (CBT) principles. It contains video, text information, podcast, weight tracker, mood tracker, daily activity tracker, daily questionnaires and resources locator. Outcomes measured at baseline, 6-week, 3-months and 6-months, include: body weight, BMI, activity level, mood and quality of life. Benefits and translation: This study generates reliable evidence using a rigorous RCT design to evaluate an app which contains unique feature – adopting principles of CBT in weight management. This study addresses current gap in information quality and lack of theory underpinning current weight management apps in app stores. The app could reach out to people living with chronic illness with weight management issues, and help reduce the weight- associated comorbidities, thus leading to an enhanced quality of life and minimise the long-term burden of chronic diseases on healthcare system.

This project will deliver innovative resilience training for older Australians (50+ years). Fifty years of age reflects a point of major work and life transition (National Seniors Australia) and we seek to assist adjustment at this critical life-stage. According to Beyond Blue and government reports, incidences of depression and stress are reported by 10-15% of the population over 50 years of age (Commonwealth Department of Health), with physical and psychological illness ranked the 2nd most common reason for people leaving the workforce prematurely (ABS, 2017). Our project is designed to mitigate these effects by improving psychological resilience among older Australians to keep them in the workforce longer, and to improve psychological outcomes and enhance community engagement among older unemployed Australians. Unlike conventional resilience training that takes a ‘one size fits all’ approach, we have developed a personalised self-reflection strategy to building resilience. This strategy enables participants to identify and build on their individual strengths, and to harness these in the face of challenges. Leveraging our success in fostering resilience in the Australian military, we will tailor our unique approach for older Australians and test its efficacy with two key groups; working and unemployed and retired older adults. This will be the first resilience training tailored to older adults with the objective of preventing mental illness and developing the skills and insights needed to cope with the inevitable adjustments and challenges of ageing. In collaboration with a major national employer and local councils, we will deliver a new tool to support older Australians to lead active and fulfilling lives, while reducing the risk of mental illness that affects Australians over 50.