ANZCTR search results

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

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31290 results sorted by trial registration date.
  • Targeting Depression in the Lesbian, Gay, and Bisexual Population

    The Compassion Focused Therapy (CFT) study aims to develop and evaluate a first-ever mindfulness-based compassion intervention to treat depression in lesbian, gay, and bisexual (LGB) Australians, a high-risk, underserved population. Participants will be 50 LGB adults aged 18-25 with mild-to-moderate depression, who will be randomly assigned to either the eight week compassion-focussed intervention which will be delivered via Skype, or to an active control condition whereby participants will work through a self-help book for depression which has been evaluated in prior research as effective, over an eight week period. Therapists will be Provisionally Registered Psychologists, with training and supervision from Clinical Psychologist, Dr. Chris Pepping. Participants will complete pre-intervention, post-intervention, and 3-month follow-up assessments to evaluate intervention effectiveness. Study outcomes include depression and anxiety symptoms, suicidal behaviours, internalised homophobia, self-compassion, and shame-proneness.

  • The validity and reliability of a portable device for the diagnosis of Obstructive Sleep Apnoea in patients with Atrial Fibrillation: SAFARI

    Mounting evidence highlights the importance of screening for obstructive sleep apnoea in patients with atrial fibrillation. Treating obstructive sleep apnoea in these patients may improve outcomes, such as improving the risk of recurrence of atrial fibrillation after Pulmonary Vein Isolation procedures. We will examine the validity of a portable sleep study device (ApneaLink) for the diagnosis of Obstructive Sleep Apnoea in patients with Atrial Fibrillation.

  • Management of severe asthma using a combination of exhaled and blood markers of inflammation

    Treatment options for severe asthma remain limited and oral corticosteroids (OCS e.g. prednisone) are often needed to control severe asthma when it worsens or flares up. One disadvantage of OCS is their side-effects and therefore any measure that would reduce or eliminate the dose of OCS required would be advantageous. This study is designed to test if asthma management is better if a simple blood test is incorporated into clinical care to provide information to the clinician that prevents unnecessary use of OCS in severe asthma management. One type of airway inflammation (called eosinophilia) has been found to be common in some people who have severe asthma. Clinical studies have shown that these people have a high risk of exacerbation or asthma flare ups even in the presence of high doses of inhaled corticosteroids (ICS). Determining if a person with severe asthma has a high level of eosinophils in their lungs requires the induction of sputum that comes from deep in the airways. This is a lengthy procedure, requires specialist equipment and is not easily carried out in the clinic. Recent research has shown that measuring the number of eosinophils in a blood sample is a substitute for an induced sputum sample and is much simpler. In this study we seek to determine if severe eosinophilic asthma can be managed more effectively using blood eosinophil counts.

  • Efficacy of a health coaching program for improving wellness and pregnancy outcomes in women with gestational Diabetes Mellitus (GDM): a pilot study

    Elevated blood glucose levels developing for the first time in pregnancy (Gestational Diabetes Mellitus; GDM) is a common complication of pregnancy in our local community. In most cases, the diabetes will resolve after the baby is delivered, although it may return years later (type 2 diabetes). However, we have found that in certain women there is a high chance that the blood glucose levels will remain elevated after pregnancy, with adverse effects on the health of the woman in the long-term, and potentially also on the baby during a subsequent pregnancy. There is strong evidence that diabetes in individuals at high risk can be prevented through lifestyle intervention with diet and exercise. Our study will determine whether in high-risk women with GDM, we can prevent elevated blood glucose levels in the first year after their pregnancy by offering them one-on-one advice about a healthy lifestyle by a health coach (a nurse or other allied health professional) during their pregnancy and for the first year after giving birth. The women who participate in this trial will mostly see their health coach during routine antenatal visits so that inconvenience to the patient will be minimized. We will compare high risk women who had a health coach to those who did not i.e. outcomes during pregnancy and in the first year after giving birth. If our trial is successful, we believe our program could easily be incorporated into routine clinical care in our antenatal clinics..

  • Pilot randomised control trial of a problem-solving intervention tailored to quality of life difficulties experienced by patients with diabetic retinopathy

    To our knowledge there have been no studies examining problem-solving therapy (PST) specifically in people with diabetic retinopathy (DR), yet from our first study we established that this group face the greatest risk of depression and reduced quality of life (QoL) as well as showing poorer diabetic control compared to those without DR. PST has been shown to be an essential skill for effective diabetes management and effective in reducing diabetes related emotional distress and depressive symptoms. However there is a need for more research that integrates problem-focused and emotion focused interventions in diabetes management. Addressing diabetes specific distress, stress management and healthy coping, some of the key underlying subjective QoL experiences, may improve glycaemic outcomes. This study also would provide novel research specific to those that have ophthalmological diabetic complications. We propose to adopt a PST designed for primary care that teaches problem solving skills and assists individuals with DR to find practical solutions to vision-related and diabetes-related problems. In doing so we anticipate that participants will adopt a more positive problem solving orientation that will hopefully empower them to subsequently improve their psychological well-being. It has been previously established that developing a problem solving pattern and working through individual solutions assists with perpetuating more positive behavioural habit loops. As a result, this intervention may also have knock on effects in improving diabetes self-management behaviours as this has been shown in previous studies. Hypothesis Individuals with diabetic retinopathy who receive tailored problem solving training will show improved quality of life and psychological well-being compared to individuals undergoing usual care. Aim 1: To develop a tailored, problem solving based program that targets individual quality of life difficulties. Aim 2: To assess, using a randomised control trial, the effectiveness of this program in improving participants’ quality of life and psychological well-being (reducing diabetes related distress and depressive symptoms). Investigation will also be undertaken to assess whether enhancing problem solving skills have a direct influence on a participant’s ability to self-manage their diabetes including improving overall glycaemic control and adopting recommended lifestyle practices.

  • The utility of predicting intrapartum fetal compromise at term using fetal cerebro-umbilical ratio and maternal placental growth factor

    In Australia, hypoxic peripartum death (stillbirth or neonatal death of mature infants after the onset of labour in an otherwise healthy pregnancy) is one of the top three causes of mortality in singleton term pregnancies. In addition, there is significant neonatal morbidity (neonatal encephalopathy, respiratory distress, acidosis, admission to the neonatal intensive care unit) associated with intrapartum hypoxia. Furthermore, these babies frequently require rapid delivery by emergency caesarean section which carries considerably more maternal and neonatal risk than less urgent procedures. We have found that combining the fetal cerebro-umbilical ratio (CUR) (measured by ultrasound) as a functional measure of fetal wellbeing, and maternal serum placental growth factor (PlGF) as a biomarker of placental function, at >37 weeks of gestation defines women at greatest risk of fetal compromise in labour. We therefore propose a pilot randomised controlled trial (RCT) to test whether introduction of this test can reduce intrapartum fetal compromise at term. Our primary outcome measure of fetal compromise will be a composite of emergency caesarean section for fetal compromise or severe adverse neonatal outcomes (cord arterial pH <7.1 and/or Lactate >6 mmol/L or Base Excess >12 or Apgar <5 at 5 minutes) or fetal/neonatal death. A pre-labour test which identifies babies most at risk of compromise in labour will address a critically unmet need in obstetrics as there is currently no good antenatal test for the prediction or risk assessment for intrapartum fetal compromise at term.

  • A randomised controlled trial of a continuous indoor/outdoor play intervention to increase physical activity in childcare

    Changing the scheduling of existing programs in childcare centres may represent an effective strategy which is suitable to ‘scale-up’ for population-wide implementation. Unstructured outdoor free play (as opposed to structured, staff-guided play) has been consistently associated with greater child physical activity. The study hypothesises that when compared to children attending control services, where continuous indoor/outdoor play is scheduled, children attending intervention services will spend an additional 10 minutes in moderate-to-vigorous physical activity per day at childcare. An increase of 10 minutes of moderate-to-vigorous physical activity in preschool-aged children has been found to have clinically important effects on fat mass and peak bone mass.

  • Evaluating the Impact of Androgen Deprivation Therapy on Cognition in an Australian Sample of Prostate Cancer Patients

    The primary purpose of this study is to evaluate the impact of androgen deprivation therapy (ADT) on cognitive function in men with prostate cancer. Who is it for? You may be eligible to enroll in this study if you are aged 18 or over and have been diagnosed with prostate cancer for which you have received no ADT previously. You must either be scheduled to begin ADT in the next month, or have no ADT planned. Study details All participants in this study will complete a screening questionnaire and then if eligible, an assessment session at enrolment and again 9 months later. Each assessment session is expected to last 45-80 minutes and will involve computer-based testing, pen and paper tasks, plus a number of paper questionnaires. It is hoped that this study will improve understanding of the cognitive effects of ADT in men with prostate cancer.

  • Trial of Psychotherapy for Posttraumatic Stress Disorder in Emergency Service Personnel

    Emergency service personnel are exposed to major stressors in the line of their work. They are at elevated risk of developing posttraumatic stress disorder (PTSD), with approximately 10% of police suffering the condition. The nature and pattern of trauma exposure amongst Emergency service personnel is different to those experienced by other populations. They suffer repeated exposure to trauma, may witness individuals who have been badly hurt, directly threatened themselves or be required to seriously wound others. Hence, their response to trauma is often anger and guilt, rather than the fear often described by members of the general population exposed to one off, trauma. There is currently limited evidence of optimal treatment of PTSD in emergency service personnel. In the absence of evidence, there is a critical need for controlled trials of optimal interventions to assist emergency service personnel with PTSD. This study conducts a randomized controlled trial of cognitive behavior therapy for (CBT) in emergency service personnel to determine the optimal means to enhance treatment response.. This study will provide the much-needed evidence to shape policy and practice. Emergency service personnel with PTSD will be randomized to receive either 12 sessions of cognitive behaviour therapy delivered by clinical psychologists Treatment is based on 12 weekly 1-hour sessions. Emergency service personnel will be randomised to either CBT, which involves focusing on reliving trauma memories, as well as teaching strategies to reframe common maladaptive appraisals. Alternately, emergency service personnel will be randomised to a modified version of CBT that will also include depression treatment strategies. Participants will be assessed prior to treatment, immediately following treatment, and again 6 months later. These data will provide much-needed evidence for treating Emergency service personnel and provide police, fire-fighting, and ambulance services direction on how to limit PTSD in their organisations.

  • Efficacy, feasibility and usability of a facial recognition technology integrated mobile app for identifying the presence and severity of pain in institutionalised patients with dementia.

    Pain management amongst patients with cognitive dysfunction is problematic, particularly in those cases where the carer is given the responsibility of determining whether or not pain relief is required. Numerous pain scales have been developed to assist carers assess patients’ pain status; most of which include items derived from widely accepted guidelines of persistent pain . This study aims to develop and assess the feasibility of using face recognition software linked to those pain indicators on a Samsung Note 3 to enhance pain management amongst a population of cognitive impaired residential aged care residents. Surrogate markers of pain control will be used including cognition and behaviour.

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