Plasma Exchange And Glucocorticoids In ANCA Associated Vasculitis: A Randomised Controlled Trial (PEXIVAS Australia)
Funder
National Health and Medical Research Council
Funding Amount
$635,243.00
Summary
Vasculitis is a life-threatening disease, and the current treatment for this condition is not satisfactory. This clinical trial aims to determine 1) if plasma exchange can lower mortality and the development of severe kidney failure due to this disease, and 2) if the use of lower doses of corticosteroids can lessen the infectious complications of treatment. This trial is part of a major international effort which will involve a total of 500 patients from Australia, UK, Europe, USA and NZ.
Enhancing Efficacy Of Cognitive Behavioural Treatment For Children With Anxiety Disorders: Treating Parent Anxiety.
Funder
National Health and Medical Research Council
Funding Amount
$377,961.00
Summary
Much attention is focused on childhood problems such as attention-deficit, depression and substance abuse. However, the most prevalent psychological problem experienced in childhood is anxiety. There is even some evidence to suggest that anxiety may lead to later problems such as depression or substance abuse. We know that anxiety disorders are a widespread problem in our youth. We also know that anxiety, if left untreated, will persist through the child's life and cause significant disruption t ....Much attention is focused on childhood problems such as attention-deficit, depression and substance abuse. However, the most prevalent psychological problem experienced in childhood is anxiety. There is even some evidence to suggest that anxiety may lead to later problems such as depression or substance abuse. We know that anxiety disorders are a widespread problem in our youth. We also know that anxiety, if left untreated, will persist through the child's life and cause significant disruption to their life. The good news is that there has been an increased interest in these disorders and as a result treatments that work have been developed. However, a recent review of the best psychological treatments for anxiety in children showed that on average studies are reporting remission rates of only 56.5%. Clearly we need to develop more effective treatments for anxious children. One possible approach to improve outcomes for children with anxiety is to provide additional treatment for the parents. We know that anxiety runs in families: anxious children are more likely than non-anxious children to have anxious parents. A number of theories have suggested that parental anxiety plays an important role in the development of anxiety in children: An anxious parent may model anxious behaviour, encourage avoidance of anxious situations and reinforce anxious behaviour in their child. The results of this study will determine whether it is possible to improve the efficacy of treatments for anxiety in children by addressing anxiety in their parents. If the data show no additional benefit of the modified treatment, therapists can be more efficient in their treatment of anxious children by ignoring the parent's own anxiety. However, if as expected the modified treatment proves to be more efficacious, then we will have identified an important strategy to increase the efficacy of intervention for this highly prevalent and debilitating childhood problem.Read moreRead less
A Randomised Control Trial Of A Group-Based Intervention For Substance Abuse In Psychosis.
Funder
National Health and Medical Research Council
Funding Amount
$345,250.00
Summary
The use of alcohol and illicit substances is common amongst people with psychotic illnesses, and is associated with a poor outcome in terms of severity of symptoms, treatment adherence, work-studies, family cohesion, aggression and quality of life. All this adds significantly to the cost of mental health services and society more broadly. The proposed study aims to refine, pilot, and rigorously evaluate a group-based intervention that targets substance use in such individuals at different stages ....The use of alcohol and illicit substances is common amongst people with psychotic illnesses, and is associated with a poor outcome in terms of severity of symptoms, treatment adherence, work-studies, family cohesion, aggression and quality of life. All this adds significantly to the cost of mental health services and society more broadly. The proposed study aims to refine, pilot, and rigorously evaluate a group-based intervention that targets substance use in such individuals at different stages of their illness, and within a number of different treatment settings. The intervention will be informed by an enhanced understanding of the motivations for substance use in people with psychotic illnesses The specific aims are to: Refine, implement and evaluate, using a controlled experimental design, a novel group-based intervention for reducing substance abuse comorbidity in people with psychotic disorders; Determine reasons for substance use by these individuals, to inform the intervention procedures; Pilot the intervention in a series of different treatment settings, including early episode and rehabilitation programs, and non-government organisations dealing with people with psychotic disorders, to ensure generalisability, adaptability, and acceptability; Augment case managers' knowledge and skills in dealing with comorbid drug and alcohol use Enhance detection, motivation to change, ongoing monitoring and relapse prevention of substance misuse in clients with psychotic disorders. It will also be possible, once the treatment intervention is finalised and evaluated, to expand its use to patients with non-psychotic mental illnesses.Read moreRead less
Gabapentin In The Treatment Of Idiopathic Chronic Cough: A Randomised Double-blind Placebo-controlled Trial
Funder
National Health and Medical Research Council
Funding Amount
$331,229.00
Summary
Better treatment approaches are needed to address the significant quality of life impairment associated with chronic cough. We propose to conduct a double-blind, placebo controlled study comparing the efficacy (and safety) of oral gabapentin therapy on cough reflex severity and cough-specific quality of life in people with idiopathic cough. The advantages are a strong design, use of objective assessment techniques, and investigation of a new treatment modality for cough.
Randomised Trial Of Homocysteine Lowering Treatment Of Depression In Later Life (B-VITAge)
Funder
National Health and Medical Research Council
Funding Amount
$775,530.00
Summary
The causes of depression in later life are varied and complex, but available evidence suggests that cardiovascular disease plays an important role. High homocysteine (a robust risk factor for myocardial infarction and strokes) accounts for about 20% of all cases of depression in older age. We have previously shown that treatment with vitamins B12, B6 and folate reduces homocysteine. We propose to run a trial to test if lowering homocysteine decreases the severity and prevalence of depression.
Knee osteoarthritis (OA) affects about 30% of Australians over the age of 65, but also at younger ages. It causes joint pain and stiffness, especially on exercise. The cause is unknown but it results in loss of joint cartilage. There are few treatments available to stop the progression, which can finally result in need for an artificial joint. Most treatments such as paracetamol and non-steroid anti-inflammatory drugs (NSAIDs) reduce pain but have no effect on cartilage. NSAIDs can have serious ....Knee osteoarthritis (OA) affects about 30% of Australians over the age of 65, but also at younger ages. It causes joint pain and stiffness, especially on exercise. The cause is unknown but it results in loss of joint cartilage. There are few treatments available to stop the progression, which can finally result in need for an artificial joint. Most treatments such as paracetamol and non-steroid anti-inflammatory drugs (NSAIDs) reduce pain but have no effect on cartilage. NSAIDs can have serious side effects such as stomach ulcers and increased cardiovascular events (such as heart attacks). Fish oil has possible benefits in OA as it decreases pain and inflammation in rheumatoid arthritis (RA, another type of arthritis with joint inflammation and swelling), less use of NSAID in patients with RA, and in laboratory experiments may reduce cartilage breakdown in OA. It is likely that fish oil will have few side effects and decrease blood cholesterol. Many people with OA are already taking fish oil, however, there is no studies to know if it is effective in OA. The aim of this proposal is to study the effect of fish oil on pain and progression of knee OA, by doing a randomised clinical trial. Participants with knee OA will be given either high dose fish oil or similar oil with low levels of fish oil. The study will run for 2 years and during that time, we will measure pain and blood levels of fatty acids (part of the fish oil) and cholesterol. At the beginning and end of the study, magnetic resonance imaging (MRI) of the knee, a knee xray, and bone density testing will be done. The outcomes of the study will be to determine if fish oil affects pain and function (measured by questionnaires) and progression of OA (measured by cartilage changes on MRI). If fish oil is shown to reduce pain and disability and cartilage loss in OA, it will provide Australians with OA an alternative treatment that is low in side effects with positive effects on cardiovascular disease.Read moreRead less
The AMAZES Study: Asthma And Macrolides: The AZithromycin Efficacy And Safety Study
Funder
National Health and Medical Research Council
Funding Amount
$3,157,566.00
Summary
Asthma is a health priority for Australia where better and new treatment approaches are needed. This project tests the benefit of a common antibiotic for use in asthma. We propose to conduct a large-scale, multicentre, double-blind, placebo controlled study comparing the efficacy (and safety) of the addition of oral low dose azithromycin to maintenance asthma therapy on the incidence of asthma exacerbations and clinical asthma status in participants with asthma.
Randomised Control Trial Of Three Treatments For Adolescent Stutterers
Funder
National Health and Medical Research Council
Funding Amount
$376,320.00
Summary
Effective communication is an essential of everyday life, and stuttering impairs this function. Those who stutter may find effective communication impossible, and severe cases may be rendered almost mute. Clinically significant anxiety figures prominently in the disorder with almost half of those seeking treatment warranting a comorbid diagnosis of social phobia. The adolescent years are generally regarded as a difficult time of life, at which time the potential effects of disfigured speech can ....Effective communication is an essential of everyday life, and stuttering impairs this function. Those who stutter may find effective communication impossible, and severe cases may be rendered almost mute. Clinically significant anxiety figures prominently in the disorder with almost half of those seeking treatment warranting a comorbid diagnosis of social phobia. The adolescent years are generally regarded as a difficult time of life, at which time the potential effects of disfigured speech can be devastating. There has been much research and development of treatments for children and adults who stutter, proven effective treatments are available for those age groups. However, little is known about how to treat adolescents who stutter, and there has been little research and development to find the best treatment-s for this age group. The present proposal is for a randomised, controlled trial of three treatments that have been shown recently to have promise as treatment methods for this age group of patients. The trial will compare (1) a treatment that involves biofeedback muscle activity during speech, (2) a treatment that involves biofeedback of voice box activity during speech, and (3) a variant of a standard treatment that trains the speaker in a new speech pattern. The control group will receive no treatment. The trial extends for a period of 12 months after the subjects are randomly allocated to a treatment group or a control group. The subjects' speech will be assessed in a variety of situations in the clinic and during everyday life. The prime outcome measure will be percentage of syllables stuttered, and secondary measures will be the time required for treatment and how natural the patients sound after treatment. At the conclusion of the trial, the subjects in the control group will be given the treatment that was shown to be most effective.Read moreRead less
VITATOPS - A Randomised Controlled Trial Of Vitamins To Prevent Stroke
Funder
National Health and Medical Research Council
Funding Amount
$391,364.00
Summary
A high level of a normal protein component in the blood (homocysteine) is fast becoming recognised as a new risk factor for premature stroke and heart disease, although it remains uncertain whether treatment with vitamins can prevent these diseases from occurring. VITATOPS is a multi-centre, double-blind, placebo-controlled trial designed to examine the efficacy and safety of multi-vitamin therapy (folate, B6 and B12) in the prevention of stroke and other types of vascular disease. The VITATOPS ....A high level of a normal protein component in the blood (homocysteine) is fast becoming recognised as a new risk factor for premature stroke and heart disease, although it remains uncertain whether treatment with vitamins can prevent these diseases from occurring. VITATOPS is a multi-centre, double-blind, placebo-controlled trial designed to examine the efficacy and safety of multi-vitamin therapy (folate, B6 and B12) in the prevention of stroke and other types of vascular disease. The VITATOPS study arises from a large body of consistent, biologically plausible evidence linking homocysteine in a dose-dependent fashion to stroke and other types of vascular disease. A simple, non-toxic, and inexpensive intervention in the form of multivitamins (folate, B6 and B12) has been shown to be highly effective at reducing homocysteine levels, irrespective of the underlying cause. All patients who are referred to a neurologist or general physician in one of the collaborating centres within six months of a stroke or transient ischaemic attack are eligible for the trial. In total, treatment will continue for a period of between 1 and 5 years. During this time, patients will be closely monitored in order to record the occurrence of any vascular events (particularly strokes and heart attacks). Neither the study investigator nor the patient will know which treatment they are receiving (i.e. it is 'double blind'). The number of vascular events in the treatment groups will be compared at the end of the study in order to determine whether vitamin treatment is beneficial. This application is for five years of support to allow the investigators to move from the pilot phase of VITATOPS in Perth to begin recruitment to the definitive trial in other centres across Australia and New Zealand. This study may have a major impact on patient management. If vitamins prove to be effective, we may recommend vitamin supplementation to all of our stroke patients in the future.Read moreRead less
Fetal Middle Cerebral Artery Doppler To Time Second And Subsequent Fetal Transfusions For Red Cell Alloimmunisation.
Funder
National Health and Medical Research Council
Funding Amount
$449,585.00
Summary
Blood group incompatability between a mother and her unborn baby can result in the production of antibodies that can damage the baby's red blood cells, causing anaemia. Treatment involves a procedure to transfuse blood to the baby while in the mother's uterus, which often needs to be repeated several times during a pregnancy. This randomised trial will assess if an ultrasound examination can be used to time second or subsequent fetal transfusions, and the impact this has on infant health.