ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32712 results sorted by trial registration date.
  • A randomised control trial assessing the effects of an adaptive attention training intervention in children with Intellectual Disabilities.

    The ability to concentrate and stay focused on a task, to switch attention between tasks, to inhibit impulsive responding, and to mentally hold and use information are critical skills for learning and academic outcomes. The development of these skills, collectively known as Executive Functions (EF), begins early in life and become progressively more robust from the preschool years onwards. Recent studies highlight that EF’s serve as predictors of literacy and numeracy scores in preschool through high school, facilitate social inclusion and peer relationships, and play an important role in maintaining mental health across the lifespan. Fundamental to EF skills is the construct of “attention”, a set of cognitive processes that gate learning more generally. Disruption to these essential processes can lead to increased levels of distractibility, impulsivity, forgetfulness and poor focus. In the case of children who are especially vulnerable to learning impairments because of an underlying intellectual disability (e.g. autism, Down Syndrome), attention difficulties will likely exacerbate an already compromised cognitive system by significantly impacting on a developing child’s ability to interact with the world and community around them. This will in turn reduce their capacity to engage in educational programs, and increase their already heightened risk of long-term behavioural and emotional problems. The high prevalence of Australian children and adolescents with intellectual disabilities, estimated at 650,000 (approximately 3% of the population) warrants an extensive and inclusive program of research that will investigate how core attention skills can be captured and strengthened in young children in order to maximise learning capacity from as early as possible in development. We propose to address this unmet need by delivering a novel attention training program that is targeted at primary school children with Intellectual disabilities. Our proposed project therefore hypothesises that the attention training program will improve inattentive behaviours in the classroom and home. As well as hypothesising that the attention training program will increase performance on other non-trained cognitive skills (working memory, math and literacy). Finally we hypothesise that the attention training program will result in sustained improvements in inattentive behaviours and performance on cognitive tasks 3 months after completion of the intervention.

  • Improving sexual health in men with prostate cancer through exercise and psychosexual therapies

    The study is evaluating whether exercise aids in the management of sexual dysfunction and explores if an integrated treatment model incorporating pharmacological, exercise and psychosexual therapies maximises improvement in sexual health in men with prostate cancer. Who is it for? You may be eligible to join if you are a male aged 18 years and over; have had prior and/or current treatment for prostate cancer including prostatectomy, radiotherapy or androgen deprivation therapy; and concerned about sexual health (as assessed by International Index of Erectile Functioning overall satisfaction score and/or Expanded Prostate Cancer Index Composite sexual bother score). Trial details. Participants in this study will be randomly (by chance) divided into one of three groups. Participants in one group (i.e. Exercise intervention group) will attend a 6 month physical exercise intervention program that involves resistance (i.e. lifting weights) and aerobic exercise (e.g. walking, jogging, cycling) undertaken 3 times per week in an exercise clinic. Exercise sessions will take approximately 60 minutes and will be conducted in small groups under the supervision of an accredited exercise physiologist. Participants in the second group (i.e. Exercise and psychosexual intervention group) will also undergo the exercise intervention described above as well as attend a single, 60 minute, one-on-one psycho-educational session with their exercise physiologist and receive a self-management kit that addresses psychological and sexual well-being. Participants in the third group (i.e. Usual care – delayed intervention group) will maintain usual care for 6 months before receiving the intervention – half will receive the intervention provided to the Exercise Group, and half will receive the intervention provided to the Exercise and Psychosexual Intervention Group.

  • Treating Comorbid Insomnia with Obstructive sleep Apnoea (COMISA) Study: A new treatment strategy for patients with combined insomnia and sleep apnoea.

    1. To conduct a randomized controlled trial of Cognitive Behaviour Therapy for insomnia (CBTi) in patients with co-morbid Obstructive sleep Apnoea (OSA) and insomnia to establish whether CBTi therapy improves Continuous Positive Airway Pressure (CPAP) adherence and sleep-related patient outcomes. 2. To explore whether insomnia and OSA are causally inter-related.

  • Investigating breathing training for lung cancer radiotherapy

    Purpose: This study is investigating whether the breathing training system can improve breathing regularity and reduce medical imaging errors in lung cancer patients undergoing radiotherapy. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with lung cancer, for which you are scheduled to undergo radiation treatment. Study details: Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will use the audiovisual (AV) biofeedback breathing training system during radiotherapy treatment if deemed helpful. AV biofeedback is an interactive, personalised and non-invasive breathing training system designed to assist the patient to breathe regularly. AV biofeedback is comprised of the real-time position management (RPM) system and a visual display (e.g. monitor, tablet computer), none of which are of any risk to the patient. The system is designed to be easily implemented into any treatment or imaging facilities. The patient views the tablet screen which displays their breathing pattern to them based on the real-time respiratory motion captured by the RPM system. Participants in the other group will receive treatment as usual, i.e. radiotherapy without breathing training. Participants will be monitored during treatment in order to determine whether AV biofeedback makes breathing more regular for imaging and treatment procedures during radiotherapy. Hypothesis: We hypothsise that AV biofeedback will significantly improve breathing regularity and reduce medical imaging errors for lung cancer patients undergoing imaging and treatment procedures during radiotherapy. Successful completion of this trial and positive testing of the primary hypothesis will give clinicians a simple tool to improve breathing regularity and reduce imaging and treatment errors for cancer radiotherapy patients.

  • Assessing the psychological and physiological efficacy of an exercise intervention in aged individuals: Is there a role for core-stability training?

    Age-related loss of skeletal muscle leads to reduced engagement in physical activity, impaired performance of activities of daily living and reduced quality of life. This may be associated with increased rates of depression and anxiety. We aim to explore a role for exercise in improving the multiple factors comprising quality of life in aged individuals.

  • Improving postural stability in people with Parkinson's disease: A randomised controlled trial

    [The primary purpose of this study is to examine whether an exercise program targeted at improving the strength and endurance of the trunk muscles has the potential to improve standing and walking balance in individuals with Parkinson’s disease. It is hypothesized that exercise will improve aspects of standing and walking stability in people with PD, particularly the smoothness of head and trunk motion.]

  • Online treatment for depression in people with osteoarthritis: a randomised controlled trial

    The aims of the current study are to evaluate the efficacy of a validated internet-based cognitive behavioural therapy (iCBT) program (CRUfAD's Sadness Program) for depression when delivered to individuals who meet criteria for a major depressive episode comorbid with osteoarthritis (OA). This study will recruit 100 people with depression and OA and randomly allocate them to 1 of 2 conditions: OA treatment as usual (TAU) + iCBT for depression or OA TAU + delayed iCBT for depression (TAU waitlist control). The primary outcomes will be to determine the impact of online CBT for MDD on depression symptoms and remission rates, as well as on OA-specific outcomes. We will also measure adherence to the course material and satisfaction with the intervention generally.

  • The Fluid Translation of Research into Practice Study (Fluid-TRIPS): An International Cross-Sectional Survey of Fluid Resuscitation Practice in Intensive Care Unit Patients

    The objective of this project is to describe international trends in the prescription of intravenous fluids for fluid resuscitation in intensive care and to determine the major drivers of choice.

  • Novel brain biomarkers of performance impairment in sleep apnea

    Obstructive sleep apnea (OSA) is a common cause of daytime sleepiness, impaired cognition, and has a 3 -13 times increased risk of motor vehicle crashes and double the rate of work accidents. This neurobehavioural dysfunction has a critical impact on health and society. One of the major challenges in dealing with this problem is the difficulty in clinically assessing neurobehavioural dysfunction such as impairment in driving ability. Many patients underestimate their impairment and there is wide inter-individual variability in how patients are affected by sleepiness and its consequences. For example, patients with sleep studies showing severe OSA may report few symptoms while others with apparent mild disease exhibit severe sleepiness. Unravelling this problem of inter-individual variability demands better assessment tools as conventional metrics such as sleep studies are uninformative. What is urgently needed are biomarkers, measured at a single or very limited time points that better reflect the individual risk of vigilance failure such as impaired driving. In this study, simulated driving and other performance tasks will be administered during a load of prolonged wakefulness extending throughout the night to unmask variation in neurobehavoural function in OSA. Performance under these conditions will be related to practically deployable biomarkers (or combination of biomarkers) measured at baseline. We have compelling preliminary data on brain bioenergetics (magnetic resonance imaging), quantitative electroencephalogram (qEEG) and cortical activation (event related potentials) as candidate biomarkers for neurobehavioural impairment in OSA. Such biomarkers would also be potentially valuable as tests to monitor treatment effectiveness or a phenotyping tools in molecular and genetic discovery in OSA.

  • Cancer Coping Online: evaluating the efficacy a self-guided internet intervention for reducing cancer-related distress.

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