ANZCTR search results

This trial will test the effectiveness of a brief, video-based online program for reducing depression and anxiety in Australian adults (FitMindKit). Those with elevated psychological distress will be invited to participate and randomised to use either FitMindKit or a comparable general health online program (HealthWatch) for a period of 4 weeks. FitMindKit is an online program that uses brief therapeutic modules to reduce symptoms of common mental disorders (major depression, anxiety disorders, substance use disorders). The intervention consists of 12 modules adapted and abridged to encapsulate CBT-based therapeutic techniques, such as behavioural activation, cognitive reframing, problem solving, and mindfulness. Participants will complete brief pre- and post-program questionnaires, and will receive weekly e-mail reminders to use FitMindKit or HealthWatch. Outcome measures include depression and anxiety symptoms. It is hypothesised that those who receive the FitMindKit program will show significant reductions in depression and anxiety symptoms relative to those in the control condition post-intervention. It is also hypothesised that greater adherence to the intervention (number of modules completed) will be observed in the intervention group relative to the control group, and that greater adherence will be associated with greater reductions in depression and anxiety symptoms post-intervention among those who receive the FitMindKit program.

This dismantling study will examine the effectiveness of the three DBT skills modules - distress tolerance, emotion regulation and interpersonal effectiveness - on distress tolerance skills, emotion regulation skills, and interpersonal skills, in a sample of patients with Borderline Personality Disorder (BPD) in three adult mental health services in Queensland, Australia. It will further analyse the differential and combined effects of these modules on symptoms of BPD. We hypothesise that patients who participate in the skills modules will show specific improvements in the domains that the skills are designed to address.

This multicentre randomised controlled trial will determine how best to apply Positive End-Expiratory Pressure (PEEP) to support the preterm lung during stabilisation (‘resuscitation’) at birth. PEEP is a proven therapy that helps preterm babies breath but what PEEP levels to use is unknown. Currently PEEP levels of 5-6 cmH2O are usually used, but increasing evidence suggests that higher PEEP levels than this are initially needed immediately after birth. We hypothesise that in preterm infants born between 23 and 28 weeks post menstrual age, a high, dynamic PEEP strategy (PEEP 8-10 cmH2O individualised to clinical need) as compared to a standard, static PEEP of 5-6 cmH2O during stabilisation at birth, will 1) increase survival without bronchopulmonary dysplasia, 2) reduce the failure of non-invasive respiratory support in the first 72 hours of life (co-primary outcomes), and 3) reduce rates of common neonatal morbidities (secondary outcomes).

Conceiving before natural fertility declines is impossible or unsuitable for some women, which may lead to missed opportunity due to age-related infertility. Egg freezing can extend a woman's reproductive lifespan, however the decision to freeze is complex and requires consideration of a number of different factors. A decision aid (DA) may assist women to make an informed decision about egg freezing, as it aims to provide unbiased and balanced information about the positive and negative aspects of egg freezing and its alternatives. This study aims to evaluate whether an online DA is acceptable and useful for women considering egg freezing. To be eligible to participate in this study: - You are female and aged between 18-45 years; - Interested in receiving egg freezing information (even if you have already frozen your eggs or made a decision about egg freezing); - Live in Australia, and; - Able to read English well. Participants will be given access to the online DA by the Research team, and asked to read through the website over a two week period. Participants will also be asked to complete two surveys (one before, and one after being provided with access to the DA). Each survey will take about 10-15 minutes to complete.

The disability associated with a minor to moderate injury sustained in a road traffic crash (RTC) can have a significant impact on a range of life domains, one of which is returning to paid employment. This inception cohort study will follow people injured in a road traffic crash (RTC) from within 28 days of injury over 12 months. It is intended that multiple hospital health services will be recruited across Queensland. Participants will also be recruited through print and social media. The specific aims of the study are as follows: • Aim 1: To plot the trajectory of recovery of vocational and functional outcomes following RTC • Aim 2: To explore associations between key sociodemographic, injury, quality of life, physical activity, symptomatic, and psychosocial wellbeing factors with vocational and functional outcomes at 6 and 12 months • Aim 3: To determine the factors that predict vocational and functional outcomes at 6 and 12 months, for people who had been working prior to RTC • Aim 4: To determine the factors that predict functional outcomes at 6 and 12 months, for people who had not been working prior to RTC • Aim 5: To explore the pattern of objectively measured physical activity changes in a subgroup of participants at baseline, 6 and 12 months

The study will investigate the effectiveness of six months of self-paced aquatic exercise for individuals with CFS/ME, compared to usual care (control group). Outcome measures will include physical capacity (resting heart rate, resting blood pressure, oxygen saturation, perceived exertion (RPE), 6 minute walk test, hand grip strength, sit to stand test, sit and reach test, and the Apley's shoulder test); health and symptoms (full blood test with white cell differential, assessment of orthostatic blood pressure, FACIT fatigue and tiredness scale, and a VAS Pain scale); and quality of life (SF-36 Quality of Life; Hospital Anxiety and Depression Scale [HADS], surveys, and open-ended questions in interviews). Participants will be allocated to an exercise or control group, and supervised, self-paced exercise sessions will be held twice a week in a heated pool. The results will be applicable to all age groups who suffer CFS/ME, with or without FM. This is a proof-of-concept study with a view to conducting a larger, longitudinal trial to provide further evidence for clinical practice. It is hypothesized that (1) the aquatic exercise group will improve their exercise tolerance, physiological responses and quality of life, and reduce symptoms of fatigue, pain and anxiety compared to the control group; (2) the number of immune cells (leukocytes) will increase in the exercise group compared to the control group.

The purpose of this research project is to determine the effects and safety of Cera-Q on memory, cognitive function and mood. With Australia's increasingly ageing population, interventions capable of ameliorating age-related neurocognitive change are becoming vital areas of research. In addition to pharmacological interventions, nutritional supplements such as silk fibroin proteins provide an alternative way for maintaining optimal health, including brain health. This study will be the first study in Australia to assess the effectiveness and safety of Cera-Q on cognitive function and mood. Cera-Q is an extract of fibroin protein from silkworm (Bombyx mori) cocoon, and is available commercially in the Republic of Korea and the United States of America. It is a bioactive peptide (protein fragment formed by amino acids) suggested to support brain/cognitive function. Whilst the exact composition of this product may be slightly different to others used in animal and human studies, several studies of the effects of fibroin proteins from silkworm cocoon have shown positive effects on cognitive function. We will be measuring the effects and safety of Cera-Q compared to a placebo using assessments of mental performance and mood, along with the collection of blood samples. Seventy-five participants will be enrolled into this trial, in order to obtain a sample of 60 participants who will complete the trial. Bio and Gene Pty Ltd. are covering all of the costs of this study and providing the products to Swinburne University for the purpose of this research project.

The eustachian tube constitutes a natural conduit between the middle ear (ME) and the nasopharynx and is essential for normal ME function. Eustachian tube dilatory dysfunction (ETDD) causes inadequate ventilation of the ME and is associated with significant morbidity. Several treatments have been proposed to treat ETDD, including breathing manoeuvres, pharmacological agents, mechanical devices and nasal surgery, though these methods have had limited success and can be ineffective at treating the underlying tubal dysfunction. Recently, catheter assisted balloon dilatation of the eustachian tube (BDET) has been undertaken as a means of improving ME ventilation and eustachian tube compliance with safety and success for the treatment of persistent ETDD. The proposed study aims to assess the effectiveness of the Spiggle and Theis Medizentechnik balloon catheter system for the treatment of ETDD in conjunction with medical management (MM) of ETDD compared with MM alone. Participants with a diagnosis of ETTD who consent, will be randomised to BDET + MM or MM alone and followed up at 2,6,12 and 24 weeks. They will undergo repeat examination and tympanometry to examine for resolution of ETDD. The primary outcome measure for the study will be normalisation of tympanometry at 6 weeks post intervention. For patients in the control group that elect to do so, they will be permitted to undergo the intervention intervention. The proposed study is a prospective multicenter, non­-significant risk, randomised control trial that has been designed to demonstrate the superiority of balloon dilatation of the eustachian tube using a eustachian tube balloon catheter plus medical management when compared to medical management alone for the treatment of ETDD.

Cardiovascular disease remains a leading cause of morbidity and mortality in the developed world. Patients who have heart attacks remain the highest risk group, with up to 30% dying or having a further event in 3 years and improved methods of risk stratification are urgently needed. Intra-coronary optical coherence tomography (OCT) is a modality based on near infrared spectrum light with a superior resolution of the high risk components of coronary plaque. We hypothesise that coronary OCT imaging at the time of routine coronary revascularisation when combined with computational methods will be superior to conventional risk scores in predicting future major adverse cardiovascular events. Patients admitted with a Non ST elevation Myocardial Infarction (NSTEMI) and who proceed to inpatient angiography or a ST Elevation Myocardial Infarction (STEMI) and who proceed to non-emergency in-patient angiography or stable/unstable angina may be eligible to participate in the study. The study aims to 1) to determine the predictive value of high risk plaque on OCT for patient oriented clinical events (POCE: recurrent myocardial infarction, coronary revascularisation or death). 2) to determine the predictive value of OCT derived low endothelial shear stress for recurrent POCE. 3) To determine the predictive value of OCT derived high endothelial shear stress for recurrent myocardial infarction and death 4) To develop a multivariate model for predicting residual risk based on multiple imaging parameters and determine its incremental predictive power when added to clinical risk factors and existing risk scores (eg. GRACE-score, Syntax score, Clinical Syntax score).

Triple therapy prevention of Recurrent Intracerebral Disease EveNts Trial or ‘TRIDENT’, is investigating the effectiveness of more intensive blood pressure-lowering treatment to prevent recurrent stroke. As part of the TRIDENT study, we are inviting participants to the TRIDENT Cognitive Sub-study to assess the effectiveness of the TRIDENT blood pressure-lowering study treatment on cognition as assessed by neuropsychological tests. ‘Cognition’ is a term referring to memory and other thinking skills. These processes include speed of thinking, finding words, visual skills and problem-solving. Neuropsychological tests, also referred to as ‘cognitive assessments’ assess these mental processes. Cerebral small vessel disease (CSVD) is a disease process in the brain involving small blood vessels. CSVD is common in people who have had a stroke caused by intracerebral haemorrhage (ICH) (large bleed in the brain). CSVD has been shown to be associated with dementia, memory problems, balance disturbances and other neurological conditions such as Parkinson’s disease. CSVD is also known to be more common in people with high blood pressure or hypertension. There is uncertainty, however, if lowering blood pressure slows the progression of cognitive decline associated with CSVD. The purpose of this study is to investigate the effect of intensive blood pressure-lowering treatment on cognitive decline measured by specific neuropsychological tests.