ANZCTR search results

This preliminary project examines the efficacy of an education program for people with PTSD. We expect that people in either immediate or delayed treatment groups will report similar benefit following the active component of their program.

Stroke and depression are two of the highest ranked diseases in the Burden of Disease rankings of the World Health Organisation. Depression is a common sequela of stroke, with recent estimates between 30-60% of all stroke patients. Depression after stroke is often under diagnosed despite the fact that effective treatment exists. Good predictors of depression that could be used to identify ‘at risk’ patients early as part of the clinical care pathway for stroke currently do not exist. This study aims to investigate the association between poststroke depression and 1) novel imaging markers of brain structure and function as identified by specialized MRI, and 2)functional outcomes including cognition, mood, sensorimotor function, and participation in daily activities. START-PrePARE is an observational cohort study that is part of the START program of study. In addition it will be linked as a sub-study of the START-EXTEND study (NTA 0901), which is a randomised, multicentre, double blinded, placebo controlled phase 3 trial within a larger cohort study of ischaemic stroke patients. START-PrePARE will comprise 100 patients. Participants consented onto the START-PrePARE study will be seen at their hospital at baseline, Day 3-7, 3 months and 12 months for collection of bloods and a series of research tests investigating mood, thinking ability (cognition), diet and lifestyle. The patients will also travel to a central site in Melbourne (the Melbourne Brain Centre), at 3 month and 12 month time points. Here advanced MR imaging, plus more advanced clinical measures of mood, cognition, sensori-motor function and participation will be performed. Investigators and patients will remain blinded to START-EXTEND treatment designation. At Baseline a blood sample will be taken, two brief neurological assessments will be conducted and a medical history will be obtained. 3-7 days following stroke, participants will have another blood test, one brief neurological assessment and three questionnaires conducted asking about their diet and lifestyle and their mood and cognition. At the 3 month and 12 month visits participants will have specialised brain MRI scans which will approximately take 40 minutes plus set up time. They will also be given 10 short assessment tasks and three questionnaires to measure functional outcomes including cognition, mood, and movement as well as participation in household, leisure and social activities and quality of life. These assessments will be administered by a qualified therapist, and will take approximately 120 minutes. The blood test and neurological assessments will be conducted at hospital and the 10 short tasks will be conducted at the Melbourne Brain Centre or at the participant's place of residence if more convenient. All information collected will be recorded without any identifying information and kept private and confidential. An independent Data Safety Monitoring Committee has been set up to monitor safety for START-PrePARE patients for the duration of the trial.

To investigate whether interval execise training reduces cardiovascular risk factors (including improving cardiorespiratory fitness) and how this compares with traditional continuous exercise training.

The purpose of this study is to assess if mesenchymal stem cells are a safe and effective therapeutic treatment option for people suffering from chronic disabling tendinopathy, who have no other effective treatment options

Obesity is a global epidemic. It is associated with a high burden of chronic diseases such as type 2 diabetes mellitus (T2DM), cardiovascular disease (CVD) and some cancers. Obesity and CVD progression have been associated with altered levels of biologically active proteins secreted by adipocytes, including the hormones adiponectin and leptin. This study aims to assess the effect of a high dose marine lipid supplement [dose: 4000mg per day for 8 weeks] on plasma adiponectin and leptin levels in overweight and obese individuals.

The primary purpose of this study is to test a simple and non-invasive method for estimating intravascular volume status. Estimation of intravascular volume status (hydration status) is of crucial importance in treating patients in various specialties including intensive care. The current methods available are mostly invasive. The non-invasive methods currently in vogue are resource intensive. Hence, there is a need for a simple, consistent and reliable measure for assessment of intravascular volume status. With this view, this study proposes the use of Central Retinal Venous blood flow velocity as an index of intravascular volume status.

Communication and swallowing difficulties are a common sequelae for people who have suffered a stroke. These difficulties can affect interpersonal relationships, self image and community reintegration. This project is designed to evaluate the effect of a treatment program on the speech, swallowing and quality of life of stroke survivors when delivered by a therapy assistant in a home based setting. The intensive treatment program will include education, behavioural intervention and oral motor rehabilitation, with functional speech or swallowing practice. It is anticipated that patients who have intensive treatment will achieve improved outcomes in swallowing status and speech intelligibility as well as self-confidence and independence. Stroke survivor details will be collected and analysed with frequency of treatment and home practice to determine any barriers to treatment delivery and ability to practice on their own.

This study will determine if rehabilitation programs for people with ankle pain and stiffness following immobilisation for ankle fracture produce clinically worthwhile effects and are cost-effective.

The objective of this trial is to examine whether 14 week administration of lyprinol(registered trademark) improves a range of cognitive, mood, behavioural and psychophysiological measures in children aged 6-14 years with symptoms of inattention and hyperactivity relative to placebo. Children will be enrolled into the study if they have elevated inattention or hyperactivity whether or not they have been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) and whether or not they are currently medicated for their ADHD. As there is no evidence that Omega 3 intake interferes with current ADHD medications, providing children or adolescents who are currently taking ADHD medication with Lyprinol should be safe and well tolerated (Whitehouse et al, 1997). Their inclusion in the trial will be based on their level of hyperactivity and impulsiveness. If participants are included in the trial and are currently taking stimulant or other medications then this indicates that their current medication is not efficacious, as they are still presenting with high levels of inattention and hyperactivity. We will not include participants who have started stimulant medication for ADHD within the past two weeks as the medication may not have had sufficient time to reach maximum effectiveness. As this is a randomized trial there will be equal probability of the control (placebo) and active (Lyprinol) groups to have the same numbers of participants who are currently on medication. All participants will receive a 14 week supply of Lyprinol(registered trademark) once they finish the study. This is to ensure participants who are allocated to the placebo group also have the opportunity to take the Lyprinol for the same duration as the study.

This project aims to compare the outcomes of two different formats of Cognitive Behavioural Therapy for insomnia (CBT-i) programmes implemented by our team in real life clinic populations. Key components of these education-based programmes include: - teaching about sleep mechanisms and factors contributing to the development and maintenance of insomnia - challenging current beliefs about sleep - structured behavior modification - strategies to cope with anxiety and mood disturbances CBT-i can be used in different formats, with individual sessions, group sessions or both. This study will compare two formats of CBT-i presented in a standardised slide presentation: - The CBT-i4 Programme which involves 4 group sessions - The CBT-i2-2 Programme which involves 2 group sessions with 2 subsequent individual follow-up sessions focussing on the participant’s implementation of the behavioural strategies learnt during the group session and allowing individual guidance and support. These two programmes will be conducted at the Woolcock Institute of Medical Research with individuals who have at least a one month history of insomnia symptoms (DSM-IV criteria). Voluntary participants will be recruited by sleep psychologists and sleep physicians at the Woolcock Insomnia Clinic after completing an assessment for sleep disorders. To quantify improvements in subjective sleep quality assessments, participants will be asked to complete questionnaires and sleep diaries between the assessment visit and the first CBT-i session, at the end of the programme (4th group session or 2nd individual session) and 6 months after the last session. The current study will also include data from a CBT-i4 Programme previously run at Royal Prince Alfred Hospital’s Sleep Unit through a project that has been approved by the SSWAHS Ethics Review Committee (RPAH ZONE). Results from the current study are likely to provide empiric evidence on ways to optimize cognitive-behaviour therapy for insomnia in real world clinical settings.