ANZCTR search results

The purpose of this study is to determine the practicality of a new blood test called droplet digital PCR (ddPCR) to detect circulating tumour DNA in early stage lung cancer patients. Who is it for? You may be eligible for this study if you are an adult who has suspected or proven non-small cell lung cancer. Study details Participants will provide blood samples and a sample of lung tumour at time of surgery. Participants will be reviewed one month post-surgery and then every 6 months for 3 years, with a clinical review, CT scan and blood test completed at each follow up. Participants will be reviewed at 4 and 5 years with a clinical review and CT scan. It is hoped this research will enable doctors in the future to use this new blood test to better predict outcomes of cancer surgery in order to determine the best post-operative treatment required for each individual participant.

The purpose of this study is to compare the visual performance (defined by visual acuity measurements and subjective ratings) in presbyopes between two different contact lens designs. To achieve this, participants will each wear both lens types for a minimum of 1 month. Outcome measures will comprise visual acuity and subjective ratings. Our hypotheses are there will be no differences between lens type for either visual acuity or subjective ratings.

Traumatic brain injury (TBI) has been recognised as a major public health issue by the World Health Organisation. Children are particularly susceptible. Children with TBI are at risk of life-long residual cognitive and behavioural deficits. Therefore, development of treatments that promote recovery and improve outcomes is of critical importance. Our initial outcome study showed that 62% of children who sustain moderate to severe TBI experienced sleep disturbance. This is an important finding as sleep is vital for brain development, cognitive, and emotional health. At present, however, sleep disturbances remain largely undiagnosed and untreated after childhood TBI. Development and implementation of effective treatments for sleep disturbances is important, as improved sleep will promote recovery, brain development, cognitive and emotional health, and the wellbeing of children and families. Aims: This study aims to (i) determine the feasibility of CBT for insomnia (CBT-I) following child traumatic brain injury and (ii) determine the efficacy of CBT-I on sleep and secondary functional gains in fatigue, pain, behaviour/mood, and cognition. Participants: Seven children (age 11-16 years) who meet the following criteria will be recruited: (i) receiving outpatient treatment for TBI at the Brain Injury Rehabilitation Program, Sydney Children's Hospital Randwick; (ii) subclinical to clinical symptoms of insomnia (i.e., T-score >55) on the Sleep Disturbance Scale for Children or evidence of reduced sleep quality on actigraphy. In addition, a structured clinical interview will be conducted to evaluate children's sleep against the International Classification of Sleep Disorders (ICSD), 2nd Edition; and (iii) participant and family fluent in English. Baseline assessment: Participants will be randomised to 7- or 14-day baseline assessment of sleep (i.e., wear an actigraphy watch and complete a daily sleep diary) and questionnaires about sleep, fatigue, pain, behaviour/mood, and cognition. Intervention: All participants will then complete 4 x 75min weekly sessions of individual manualised CBT-I treatment during which time they will continue to wear an actigraphy watch and complete the daily sleep diary for the duration of the 4 weeks. Therapists delivering the intervention will rate participants' treatment engagement using a questionnaire after each treatment session. Post-intervention assessment: Following treatment, all participants will complete 7-day assessment of sleep (actigraphy and sleep diary) and questionnaires. They will also be asked to rate whether they found the intervention to be satisfactory and acceptable by completing an additional questionnaire on completion on treatment.

Choice has been found to facilitate placebo effects in acute conditions where standard placebo treatment without choice has failed to elicit a placebo effect. However, it is unknown whether choice can enhance the placebo effect for longer-term treatments where placebo effects are readily established without choice. This study tested whether either a single or daily choice between two treatments enhanced the placebo effect for sleep difficulty relative to no choice and no treatment over a one-week period.

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.