ANZCTR search results

Exposure and Response Prevention (ERP), delivered individually, is the gold-standard treatment for Obsessive-Compulsive Disorder (OCD). However, there are significant barriers to accessing this form of treatment such as a limited number of specialists skilled in the provision of the treatment and long wait-lists. As such,attention has been given to exploring alternative modes of delivery of ERP. These alternatives include provision of ERP via the Internet and provision of ERP in a group format. A recent meta-analysis (Schwartz et al., 2016) found that ERP provided in a group format has equivalent effect sizes to individually administered ERP. The 12 studies in the meta-analysis were controlled trials comparing group ERP to wait-list and to individual ERP. The results of this meta-analysis lend support for the provision of ERP in group formats in clinical practice. However, most studies to date have been conducted in highly controlled settings (e.g. university clinics) and so little is known about how effective group ERP is in typical clinical settings. The aim of this study is to evaluate the effectiveness of group ERP in a ‘real-world’ clinical setting.

Maternal sleep disturbance is a significant and widespread complaint during the postpartum period. Though some aspects of sleep eventually improve over time, some mothers continue to experience poor sleep with persistent difficulties in initiating and reinitiating sleep. These postnatal sleep complaints have been associated with a range of deleterious outcomes, including fatigue, sleepiness, and symptoms of depression/anxiety. Despite the prevalence and associated negative outcomes of postnatal sleep disturbance, research investigating potential interventions to promote maternal sleep is scarce, representing a significant gap in the current literature. We plan to examine the efficacy of non-pharmacological interventions to improve sleep and wellbeing in sleep-disturbed mothers: (1) Cognitive Behavioural Therapy (CBT) and (2) Light and Dark Therapy (LDT). The CBT arm will involve strategies to target healthy sleep habits and management of daytime symptoms (including fatigue), delivered via emails with therapist assistance. The LDT arm will involve participants wearing light glasses each morning and adhering to recommendations for appropriate light exposure at night. Interventions will be personalised in an orientation call with a researcher in which specific recommendations will be made based on the participants’ individual needs. There will be four conditions: (1) a CBT-only group; (2) a LDT-only group; (3) a combined CBT-LDT group; and (4) a waitlist control that will receive CBT emails following trial completion. The active intervention phase will be six weeks, with four assessment time-points: (1) baseline; (2) mid-point – Week 3; (3) post-intervention – Week 6; and (4) follow-up – Week 10. This aims of this study are to: 1) Investigate the efficacy of CBT, LDT, and the combinations of LDT and CBT in the reduction of maternal sleep complaints as the primary outcome, and maternal fatigue, sleepiness, and mood as secondary outcomes. 2) Explore predictors and mediators of treatment effects. 3) Evaluate whether the combination of CBT and LDT supersede the effects of either intervention delivered alone.

BACKGROUND: The ‘artificial pancreas’ or hybrid closed-loop (HCL) insulin pump has been shown to be effective in improving glucose control in individuals with type 1 diabetes. The HCL system has been further modified from previous prototypes resulting in the advanced-HCL (A-HCL) system. The A-HCL system aims to increase time-in-target glucose range and improve user acceptability. The impact of the modifications implemented in A-HCL systems have yet to be evaluated. AIMS: The study aims to generate preliminary data regarding glucose control using A-HCL systems, and challenged by meal interventions, exercise and sensor miscalibrations. METHODS: The study is a prospective, three-stage study, incorporating ‘in-hotel’, ‘in-hospital’ and ‘free-living’ stages over a 5 week duration. Pump-experienced adults with type 1 diabetes will be recruited. All participants will be assigned the A-HCL system. Interventions in the supervised ‘in-hotel’ and ‘in-hospital’ stage aim to challenge glucose control and A-HCL system performance. Thereafter, participants will return home in the ‘free-living’ stage for 3 weeks using the A-HCL system. OUTCOME MEASURES: Glucose control including CGM time-in-target glucose range, and time in hyperglycaemic and hypoglycaemic ranges. Safety end points including number of episodes of hypoglycaemia and ketoacidosis, and system performance.

Purpose The purpose of this study is to evaluate the safety, tolerability, immunogenicity and anti-tumour activity of BIL06v/Alhydrogel in patients with advanced solid tumours. Who is it for? Adults who have locally advanced or metastatic solid tumours. Study details This is a two-cohort study which means approximately 10-15 participants assigned to 1 dose of BIL06v/Alhydrogel®, and a different cohort of 10-15 participants assigned to a different dose of BIL06v/Alhydrogel®. In total, approximately 20-30 participants will be enrolled in this study at 2-4 sites in Australia. Participants will be assigned to a cohort and dose level by the study doctor. The study treatment will take place in two parts depending on the number of treatments each participant receives (see below). Participants who are continuing to benefit from the study treatment, according to the study doctor, may continue to receive study treatment, as appropriate, for up to approximately 2 years. Part 1 In Part 1, BIL06v/Alhydrogel® is administered every 14 days up to the 12th treatment (22 weeks) as subcutaneous injections (a short needle is used to inject the drug under the skin). Dose Level 1: 1.0mg each dose Dose Level 2: 1.5mg each dose A maximum of 15 participants will be enrolled in each dose level group. Dosing at the next level will occur sequentially, after completion of enrolment of participants in the first dose cohort. Treatment will be monitored by the study doctor/s, and the medically qualified Safety Review Committee (SRC) to ensure safety is maintained. The SRC may choose to change the planned dose schedule based on results from the previous groups. Part 2 Once a participant has received 12 injections of BIL06v/Alhydrogel®, which will occur at the end of Cycle 6, the participant will enter Part 2 of the study. In Part 2, which will start in Cycle 7, study treatments will be given at 28 day intervals. Participants will continue to receive the same dose once every 28 days until the study doctor determines participants are not benefiting from treatment or if participants are not compliant with the study protocol. Participants will be required to attend a Screening Visit to assess their eligibility for the study up to two weeks before being given BIL06v/Alhydrogel®. Participants will need to return to the study site for a Treatment Visit (Day 1) for administration of BIL06v/Alhydrogel® and to have a number of assessments performed to check their general health. During the treatment period, participants will be required to attend the study site for BIL06v/Alhydrogel® administration every 14 days (treatment cycles 1-6) and every 28 days thereafter (cycles 7 and beyond), for ongoing safety, tolerability, immunogenicity and clinical assessments to be conducted. Biosceptre hopes this treatment may extend overall survival for some participants.

Clinical management of asthma involves tailoring medication to minimise the frequency and intensity of symptoms and prevent exacerbation's. However, management is currently based on subjective patient recall of symptoms, rather than objective and personalised measures of current status and predictors of future risk of exacerbation's. A potential solution may be offered by daily home monitoring using Forced Oscillation Technique (FOT), which patients can measure unsupervised at home due to its ease of use compared to peak flow or spirometry. We have shown potential clinical utility of advanced analyses to study the day­-to-­day variability in lung function in asthma in a series of retrospective studies, including the ability to predict future exacerbation's within a month in an individual. This project aims to adapt such analyses to FOT data as the basis of a home telemonitoring system, and initiate a prospective study investigating the potential benefit of long-­term FOT home monitoring in Australian patients with both well­-controlled and uncontrolled asthma. We aim to show that FOT variability (i) predicts occurrence of exacerbation's, (ii) is related to asthma control, and (iii) is sensitive to treatment changes. We will demonstrate this by studying moderate-to-severe asthma patients in a pragmatic, observational study in well­-controlled asthma patients who are being considered for reduction of their inhaled corticosteroid treatment dose. Treatment is initiated by the physician according to Australian guidelines independent of participation in the study, and we will study these relationships regardless of the nature of treatment. We will monitor unsupervised FOT measurements and symptoms over a period of 10-­24 weeks. Data will be uploaded automatically via mobile internet to encrypted servers and regularly checked for quality. We will also monitor exacerbation's and asthma control via weekly telephone interviews and questionnaires. From these results, we eventually hope to develop an automated alert system which can signal to the patient whether or not they are about to deteriorate and to initiate self-treatment, enabling them to gain control of their disease.

Hypermobility Spectrum Disorder is characterized by generalized joint hypermobility and musculoskeletal pain (Pacey 2014) and is now the recommended name for the condition previously referred to as Joint Hypermobility Syndrome (Castori 2017). It is diagnosed using the Beighton Scale, in individuals presenting with 6/9 hypermobile joints in addition to at least one painful joint for at least 3 months following exclusion of other heritable connective tissue disorders such as Ehlers Danlos Syndrome (Malfait 2017). The prevalence of Hypermobility Spectrum Disorder in children is variably reported, ranging from 2% to 64% depending on age, ethnicity and the defining criteria used (Murray 2006). Children with HSD experience a range of chronic symptoms and life impacts including: • Joint laxity which can lead to bony subluxations and dislocations and chronic joint instability. • Pain in joints or surrounding muscles and soft tissue. • Deconditioning of musculature surrounding joints causing ongoing exacerbation of symptoms. • Limited endurance with mobility and physical activities such as walking longer distances or negotiating stairs which impacts function at school and in the community. • Poor school attendance due to chronic pain which impacts negatively on academic learning. • Reduced, or absent participation in physical activity leading to poorer health outcomes such as bony development and cardiovascular fitness. • Any of the above factors can cause personal distress, decreased social interaction and isolation which can lead to mental health issues including anxiety and depression. Recent research has suggested that providing a physiotherapist-led exercise program is significantly effective in reducing pain, improving health-related quality of life, and increasing muscle strength in children with HSD and knee pain (Pacey 2013). However, it was also noted that there is limited research evidence about optimal type of exercise in adults and even less research available regarding children. This study focuses on researching the potential benefits of Physiotherapy-led Pilates as an effective alternative exercise program helpful in the management of children with HSD. The study design will involve a single case experimental design (SCED), with repeated measures during baseline and treatment phases, and a multiple baseline design (MBD) for the introduction of treatment to allow a smaller number of subjects to be studied in greater detail to provide a high level of evidence (Level II). The study hypothesis is that the study will show that: a) Children and young people will show a decrease in pain and an increase in their strength and endurance, which will improve their ability to participate in everyday activities such as school, sport and social activities. b) This improvement will be maintained for a period of at least 3 months following the intervention.

The primary purpose of the current study is to evaluate whether a brief behavioural treatment for insomnia (BBT-i) improves sleep for adolescents (aged 12-17 years). We will also monitor mood and behavioural changes using self- and parent-reports. Around 10% of 13-18 year old Australians meet DSM-5 criteria for insomnia and up to 70% of teenagers are sleep deprived. The current solution to this highly prevalent condition is often hypnotic pharmacotherapy, despite substantial evidence that drugs are only marginally better than placebo and recommendations against long term drug therapy. Behavioural interventions are recommended as the front-line treatment for sleep disordered behaviour for adolescents, yet both prescription and non-prescription medications are widely used, often in the absence of medical advice. BBT-I provides a potentially effective alternative. BBT-I includes psychoeducation around sleep hygiene, stimulus control (i.e., learning healthy associations with sleep cues), and sleep quality (regulating sleep patterns to enhance sleep quality). Literature supports the appropriateness of behavioural sleep strategies for adolescents. The methods to be used in this study have been used extensively in past child and adolescent research involving various formats/sequences of delivery, albeit in ways that differ to the brief format that is to be evaluated here. Importantly, the specific components of the current sleep program have been used for children as young as 6 years. We expect that adolescents will experience improved sleep after the 3-week intervention period. We also anticipate positive changes in mood (e.g., depression, anxiety and stress) and behaviour (e.g., interactions with parents) after the 3-week intervention period. We will evaluate if any changes are maintained 2-months after the 3-week intervention period.

This randomised, within subject cross-over pilot study aims to quantify the acute dose-dependent changes in intact anthocyanins (such as cyanidin-3-rutinoside, cyanidin-3-glucoside, peonidin-3-rutinoside and pelargonin-3-rutinoside) and phenolic acid metabolites (such as vanillic acid, hippuric acid, ferulic acid) in biological specimens (urine, faecal matter) over 24 hours after consumption of 200 g and 500 g anthocyanin-rich Tasmanian sweet cherries (‘Lapins’). It is hypothesised that anthocyanin-rich Tasmanian sweet cherry consumption will increase anthocyanin and phenolic acid metabolite biomarkers in biological samples (urine, faecal matter) in a dose-dependent manner. This is a preliminary and fundamental step which will be useful in future studies, as a measure of compliance to the intervention, and may provide evidence of the mechanisms of action by which cherry anthocyanins are perceived to work.

This project will evaluate the impact of implementing 'Smarter Safer Homes'(SSH), a platform designed by CSIRO specifically to support older Australians living in their own homes, through a parallel group randomised controlled trial. The study will recruit 200 participants, 65 years and older, alone or couples (with the partner being an informal carer), using stratified randomisation across metro, regional, and rural/remote aged care sites from four Aged Care Service Providers. Main objectives are to evaluate potential beneficial impact of implementing the SSH platform on: A: - Quality of care provided by Aged Care Providers; - Quality of life for older persons living independently in their homes; - Activities of daily living; - Depression in elderly living independently in their own homes; - Carer burden (informal carers); B: - Health service utilisation including unscheduled visits to hospital, to GPs and Nurse visits; - Existing and changes in service delivery care models, adoption by Aged Care Service Providers - Costs effectiveness Participants will be recruited by appointed site officers at each site. Intervention Group participants will have the SSH sensor kit installed in their homes (including physical environment sensors and human movement sensor networks), be provided with an iPad and have access to the SSH Platform/App for 12 months. The novelty of the SSH platform is its feature of providing an Objective Activities of Daily Living (O-ADL) component and scoring through non-wearable and non-intrusive sensors in the home environment; and the ability to correlate this measure with self- or care-reported status of health and wellbeing. The SSH portal provides access for multidisciplinary care teams to monitor the resident's O-ADL's. During this trial, Intervention Group participant data will be viewed by Aged Care Provider clinical staff at least once/week to optimise care with efficient utilisation of clinical and care workers. Participants allocated to the Control group will continue to receive their existing care.

Alcohol related harm is a significant issue for Australians. Unfortunately, few people seek help early to reduce their alcohol use, despite the effectiveness of available programs. Many barriers to seeking help for problem alcohol use are overcome through confidential, telephone delivered programs that are available after hours. These programs may provide support options for Australians who would never seek treatment in traditional settings due to stigma, service operating hours, thinking the problem isn’t serious enough for treatment, or thinking that it will get better on its own. People age 18+ years, who would like to reduce how much or how often they drink, are invited to take part in this study comparing two types of telephone delivered programs (1. the Ready-to-Change intervention; 2. minimal standard of care). These support programs are delivered over the telephone at times convenient to participants, from anywhere in Australia: - Participants will receive between 4 and 6 telephone calls from their dedicated support caller - Supporting information will be sent - Our researcher will check in with participants at baseline and then 4 times over a 12-month period - Participants will be paid for their time.