ANZCTR search results

This study aims to evaluate the effect of a psychological treatment program on anxiety and depression in adults who are carers for persons with dementia-related conditions. Any carer who is experiencing distress and is looking after family members or relatives (including partners and parents) with dementia-related conditions may be eligible for this study. Who is this study for? You can join this study if you are aged 18 to 80 years and are caring for a family member or relative who has a dementia-related condition (e.g., Alzheimer’s). You must also be experiencing at least mild to moderate levels of anxiety and depressive symptoms for which you may or may not be taking medication. Trial details: Participants in this trial will be randomly (by chance) assigned to one of two groups. Participants in one group will undertake a psychological therapy program, titled the ‘Behavioural and Acceptance Based Therapy (BABT)’ program. This involves attending six consecutive weekly meetings of 1.5 hours each with a psychologist, followed by two follow-up sessions at fortnightly intervals. Participants in the other group will receive no psychological treatment for 12 weeks, after which time they will be offered the BABT program. Participants in both groups will be asked to complete questionnaires at 4 time-points throughout the study to assess whether the program is effective in helping them to reduce their distress and improve their overall quality of life.

This study aims to evaluate the effect of a psychological treatment program on anxiety and depression in adult brain tumour patients. Who is it for? You can join this study if you are aged 18 to 80 years and have been diagnosed with a primary low to medium grade brain tumour, for which you have completed all acute medical treatments. You must also be experiencing at least moderate levels of anxiety and depressive symptoms for which you may or may not be taking medication. Trial details: Participants in this trial will be randomly (by chance) assigned to one of two groups. Participants in one group will undertake a psychological therapy program, titled the ‘Behavioural and Acceptance Based Therapy (BABT)’ program. This involves attending six consecutive weekly meetings of 1.5 hours each with a psychologist, followed by two follow-up sessions at fortnightly intervals. Participants in the other group will receive no psychological treatment for 12 weeks, after which time they will be offered the BABT program. Participants in both groups will be asked to complete questionnaires at 4 timepoints throughout the study to assess whether the program is effective in helping them to reduce their distress and improve their overall quality of life.

Infants “at risk” of cerebral palsy (CP) because of premature birth or early brain injury can now be diagnosed early. Early diagnosis allows early intervention to begin at the critical period when the brain is rapidly developing. It has not yet been clearly demonstrated that current early intervention programmes can improve the motor development of infants "at risk" of CP. "Goal Directed Training" (GDT) is one newer intervention which has been shown to be effective in older children. GDT is based on motor learning principles and involves designing therapy around the family's goals and engaging them to work with their child in their real life environments. A recent systematic review and meta analysis of the effect of environmental enrichment (EE) on infants at high risk of CP demonstrated a small favourable effect for enrichment. Using environmental enrichment strategies, specifically for motor development is a focus of this intervention approach. Our pilot study (n=13) of 12 weeks of goal directed, motor enrichment intervention demonstrated a significant advantage on the Peabody Developmental Motor Scale for the experimental group. This study aims to test the effectiveness of GDT and enriched home environments on infants with cerebral palsy. The study is a 2 group RCT (n=30) which compares the effectiveness of GDT and enriched environments with standard care. Participants will be infants 3-6 months of age at enrolment, determined to be at "high risk" of cerebral palsy using the Qualitative Assessment of General Movements (GMs). All infants will receive therapy in this trial until their first birthday. Outcomes of interest include attainment of motor skills, parental emotional well being and quality of the home environment for motor learning.

While many studies have shown that cognitive training in older people is associated with improved cognitive abilities, little is known about the predictors of change, or whether cognitive training is associated with improvements in neurophysiological activity or in ‘real world’ functions such as social relationships. In older individuals ‘at risk’ of cognitive decline, this study therefore aims to determine the neurobiological, clinical and cognitive predictors of ability to benefit from a ‘healthy brain ageing’ cognitive training program. It is expected that those who participate in the treatment will improve in terms of memory functioning.

This study is a multicentre randomized clinical trial aiming to evaluate the potential benefits of employing indwelling small-bore pleural catheters (IPCs) as first-line management of malignant pleural effusion, especially in reducing the need of inpatient hospital care for these patients. The study also evaluates the adverse event rates, health costs and acceptability of this new management option to patients and clinicians. Who is it for? You may be eligible for this study if you are over 18 years of age and have been diagnosed with a Symptomatic Malignant Pleural Effusion Trial Details: Participants in this study will be randomized to one of two treatment arms: either Indwelling Pleural Catheter (IPC) or Talc Pleurodesis. IPC involves a soft, flexible, silicon catheter placed in the pleural space and tunnelled through the subcutaneous tissues, administered under light sedation and local anaesthesia - often in a Day Procedure Unit with you being discharged home after just a few hours. The insertion of the catheter will allow simple, painless drainage of effusions which may end up with you needing to visit hospital less often. They are designed to remain in your chest for the rest of your life, but around 40% of patients are able to have the IPC removed because of spontaneous pleurodesis (a benefit of the IPC treatment in keeping the pleural space dry). Talc pleurodesis is a conventional, inpatient procedure performed at the bedside. It takes an average of 6 days in hospital. A small bore chest drain is inserted, the fluid is completely drained away, and then talc is injected into the pleural space. Pleurodesis has a 60-80% chance of successfully preventing the need for further pleural drainage.

Chest pain is a common reason for presentation to an Emergency Department. Current management usually involves observing patients in an Emergency Department over 8-12 hours doing repeated heart tracings and blood tests. A large trial in Perth and overseas studies have suggested that it is possible to shorten this observation period to 2 hours using a panel of blood tests and looking at particular patient characteristics. The aim of this study is to ensure that changing to this method of management will not cause an increase in adverse patient outcomes

Aggressive behaviour related to acute psychosis is an ever present problem in emergency admissions to psychiatric wards and intensive care units. It can lead to patient harm and prolonged distress, injury to staff and/or other patients and damage to hospital property if the situation is not rapidly controlled. Intramuscular sedation is commonly used to manage these patients when all other attempts including verbal de-escalation and oral sedation have failed. The most commonly used drugs for this purpose have been benzodiazepines and antipsychotics given by the intramuscular route, mainly midazolam and haloperidol. Intramuscular midazolam has proven to be unpredictable and can lead to both over-or under sedation of the acutely disturbed patient. It has a significant adverse effect profile due to over-sedation with respiratory depression and/or loss of airways patency. Conversely it is associated with under sedation when used to sedate patients with benzodiazepine tolerance. For this reason we no longer recommend the use of intramuscular midazolam for rapid sedation of acute behavioural disturbance in the emergency department. Haloperidol is also commonly used in this patient cohort but is associated with a high risk of extrapyramidal side effects and a risk of QT prolongation with associated Torsades de Pointes. Droperidol is less commonly used but is a highly sedative antipsychotic medication that is rarely associated with complications. This study aims to compare the effectiveness of droperidol compared to haloperidol for the sedation of aggressive patients with acute functional psychotic symptoms in a randomised controlled trial. The study is designed to assess both the speed of onset, effectiveness, and adverse effect profile of both agents. AIMS: This study aims to: 1. Compare the effectiveness of intramuscular droperidol to intramuscular haloperidol for sedation of aggressive patients with acute behavioural disturbance based on: a. the time until sedation occurs; b. the requirements for additional sedation. 2. Investigate the safety of intramuscular droperidol compared to haloperidol 3. Determine the practicality and effectiveness of introducing a sedation protocol into the psychiatric intensive care setting for patients with acute behavioural disturbance with related violent and aggressive symptoms; HYPOTHESES: The specific hypotheses of the study are that: 1. The time to sedation with intramuscular droperidol is shorter than intramuscular haloperidol; 2. Initial sedation with droperidol will require less additional sedation attempts compared to haloperidol; 3. Droperidol will result in a smaller proportion of extrapyramidal side-effects compared to haloperidol;

One’s ability to self regulate or control their behaviour is important for human function, and recent studies have suggested that self-control is a depletable resource. When participants perform two consecutive tasks that require self-control, their performance on the second task is worse than when people perform a task that does not require self-control followed by a self-control task. This phenomenon is referred to as resource-depletion. Although previous studies have shown that methylphenidate can improve various aspects of self-control, its effects on resource depletion are unknown. We will give methylphenidate to healthy individuals to investigate its effect on cognitive performance following resource depletion. We will also measure cardioviascular responses, cortisol levels and record electroencephalography (EEG) to study the neural processes associated with resource depletion, and those influenced by methylphenidate.

There is some evidence to suggest that oral corticosteroid medications may increase appetite and lead to weight gain. However it is unknown whether people with asthma experience these effects when prescribed oral corticosteroids when their asthma symptoms worsen. This study is designed to examine whether taking oral corticosteroids for a short time affects appetite, dietary intake, body weight or body composition and bone metabolism.