ANZCTR search results

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

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31373 results sorted by trial registration date.
  • Investigating Mental and Physical Health Approaches for Supporting Men with Depression and Overweight or Obesity: A Feasibility Trial

    Depression and obesity in men are two of the largest public health concerns in Australia. These conditions also appear to be linked as men with overweight or obesity are ~30% more likely to develop depression than healthy weight men. Furthermore, men with depression are 43% more likely to develop obesity than men without depression. The SHED-IT: Recharge randomised trial (ACTRN12619001209189) tested a self-guided eHealth program combining lifestyle behaviour change advice and mental health support to reduce depression (and weight status) in men. It was the first RCT of an integrated mental and physical health intervention for men with depression. Results indicated significant and clinically meaningful intervention effects on both depressive symptoms and weight loss at post-intervention compared to the control group, which was maintained at 6-month follow up. However, because the program targeted physical and mental health it was unclear which components were most important for driving changes in the men's depressive symptoms. As such, the purpose of this pilot trial is the examine the feasibility and preliminary efficacy of comparing an online program focused only on lifestyle behaviour change to an online program focused only on mental health support for men with depression and overweight or obesity.

  • The Australian Endometriosis Clinicians Collaborative (AECC): adenomyosis substudy

    Like endometriosis, adenomyosis is a benign uterine disorder and is histologically defined by presence of endometrial tissue in the myometrium (muscle layer) of the uterus. The prevalence of adenomyosis is difficult to determine, since histological confirmation is necessary following surgical biopsy or more commonly hysterectomy. For women wanting to retain their uterus, hysterectomy is not an option. Imaging technologies (e.g. transvaginal ultrasound and MRI), are used as a less invasive method of diagnosis and detection, although they have limitations. The Australian Endometriosis Clinicians Collaborative (AECC): adenomyosis substudy is a prospective longitudinal clinical study that will: 1. compare diagnosis and treatment of adenomyosis with regards to impact on pain, bleeding patterns, general health symptoms and quality of life using validated questionnaires 2. determine cost-effectiveness of diagnostic and treatment options 3. establish a national biobank of adenomyosis (and endometriosis) for future research capacity. Outcomes will determine optimised diagnosis and treatment pathways for clinicians that improve quality of life for women with adenomyosis.

  • The CHILL BONES trial: testing Tai Chi and high intensity resistance and impact training (HiRIT) as therapy for older adults with low bone mass.

    Ageing results in gradual loss of bone mass, which increases our risk of fracture. Increased stress responses are also associated with ageing and may contribute to accelerated bone loss. This study will be the first to investigate whether Tai Chi (a gentle, mind-body exercise) is able to reduce stress responses and optimise osteoporosis rehabilitation outcomes (i.e. improve bone mass, falls risk) when practised in combination with high-intensity resistance and impact exercise.

  • Effectiveness of aspirin in children undergoing heart surgery

    A significant number of neonates and infants require systemic-to-pulmonary artery shunt procedures as a part of staged treatment of their congenital cardiac condition. These shunts are at risk of thrombotic occlusion. Shunt patency is critical for survival of these children. The interim mortality of shunt dependent children has been found to be as high as 14%, and about 33% of these are due to thrombosis of the shunt. Some eventually undergo correction of their cardiac anomalies while the remaining undergo further surgeries for a single ventricle palliation (Fontan pathway). The children with single ventricle palliation are dependent on the patency of their subsequent shunts for survival. They are at risk of life-threatening thrombosis throughout their lives. Cross-sectional surveys of post-Fontan patients have reported a prevalence of intracardiac thrombosis of 17% to 33% and incidences of venous thrombosis and stroke ranging from 3% to 19%. The reported mortality from post-Fontan surgery thromboembolism is 25%. Aspirin has been the cornerstone of thromboprophylaxis in such children and its use has been associated with a significantly lower risk of mortality. Unfortunately, not all children respond equally to aspirin with an increase in the dose of aspirin suggested to reduce the incidence of thrombosis in some while the remaining have no response to aspirin. The prevalence of aspirin unresponsiveness in adults is estimated to be 0.4 to 35%, however this information in lacking in the paediatric population. The primary objective of the study is therefore to determine the prevalence of aspirin resistance in children undergoing cardiac surgery in Queensland. Secondary objectives are: 1) to assess if response to aspirin is dose dependent and 2) assess the incidence of thrombosis in children who respond to aspirin.

  • Maawit Maladjin: Targeting child development in Urban Aboriginal children.

    Despite the high burden of developmental vulnerability in Aboriginal infants, there has been no systematic implementation of early child neurodevelopment programs starting in the first four weeks of life (neonatal period) implemented by primary health care providers. The Care for Child Development (CCD) program developed by the WHO and UNICEF provides an evidence-based, theoretically sound model for improving early child development and maternal depression in low and middle-income countries. The CCD program has been implemented in 19 countries and 23 sites, with providers in various sectors implementing the approach after appropriate training. It combines responsive caregiving and the promotion of early learning to provide caregivers with recommendations from the first month of life up to 36 months on play, responsive stimulation, mother-child interaction, and maternal depression. The most recent effectiveness trial of the CCD program in a large, factorial, cluster-randomised trial published in The Lancet Global Health found ‘low intensity’ CCD delivered to infants aged 0-24 months resulted in substantial improvements at 12 and 24 months in cognitive child development compared to the control group. We will undertake a 2-year community-based, randomised effectiveness trial of 514 mother-infant pairs with a team of national and international experts. We aim to address the low level of an Aboriginal child’s development attainment by improving primary health care’s capability to deliver world-leading child development services for Aboriginal babies and children. We will do this by determining whether the CCD intervention delivered through child health checks from the neonatal period will improve mothers’ abilities to play, communicate and respond to their child’s neurodevelopmental needs throughout the first 24 months of life postpartum.

  • Testing a new model of guided health care for young Aboriginal people to achieve better mental health and emotional wellbeing outcomes

    'Aboriginal’ & 'Indigenous’ are used to respectfully refer to Aboriginal and/ or Torres Strait Islander peoples. We are testing a practical solution to improve engagement of Aboriginal young people with primary care for mental health. Currently <25% of Aboriginal adolescents attend a health clinic to receive a Medicare-funded annual health check. We will compare a new model of health care to standard primary health care to test which best supports the mind, body and spirit of Aboriginal youth. It was developed with Noongar young people, parents/ carers, health workers and Elders in Perth and Bunbury. The new model of care supports the wellbeing of young people in two ways. - A new online health check tool to use before visiting a GP. - A new type of health worker to help young people with their wellbeing needs. This is a specially-trained outreach health support worker role. This health worker supports all the decision made by a young person. They might help with making health appointments, or finding activities to help a young person feel good (like job training or taking part in cultural events). They will have $500 per youth to support wellbeing activities. To be a part of this trial, a person must: – Be an Aboriginal person aged 15 – 24 years – Be living in or near Perth – Have high levels of distress (youth must consent to answer short 10 question tool to measure distress level) A trial research assistant will identify and recruit potential participants via connections with the Aboriginal community, peer group leaders, organisations working with young Aboriginal people and ‘snowball’ sampling of young Indigenous people. For recruitment, trial promotion may include, but is not limited to, the following: brochures, radio, newsletters, websites and private study page on social media. A young person must consent to join the trial before being assigned to a group. Two groups are being compared. A youth is put into a group by random chance, like flipping a coin. Briefly, the: • Intervention group receive guided care though an Outreach Service Navigator in Perth for up to 5 months. They complete an online health check tool which is not the current standard tool used by GPs. A GP at Derbarl Yerrigan Health Service will develop a mental health care plan with the youth based on the new health check. • Waitlist control group receive standard care at Derbarl Yerrigan Health Service in Perth for up to 5 months. The control treatment includes the standard Indigenous health check (Medicare 715) and GP care at DYHS. A GP will develop a mental health care plan with the youth. After the 10 month assessment, a control participant can choose to receive Intervention treatment. At 3 timepoints, participants complete assessments (baseline, 5 months & 10 months). Baseline is after consent and before randomisation. Assessments will measure level of distress, quality of life, social factors, use of health services, work/ study and government support.

  • A comparison of the effectiveness of mindfulness training and computerized working memory training in improving working memory performance of healthy adults in the age range between 18 and 55 years

    Participants are asked to fill in 4 online questionnaires of memory, mindfulness, attention, mood and mind-wandering, and complete two online tasks of working memory and reasoning ability prior to training. Participants are asked to complete similar tests after the training is completed. After completing baseline measures, participants are then randomly assigned to either of the training groups (mindfulness training or computerised working memory training). Working memory training group is our intervention group and participants in this group will complete their training from the DREAM website by playing CrushStations game. The game is based on the principles of n-back task, a measure of working memory capacity popularly used in working memory training research. Different types and colors of ocean animals will be displayed on participant's screen, and at a later recall test, participants will be asked to recall and remember types and colors of ocean animals. Group 2 is our active control group where participants will complete mindfulness training via the Mindfulness Coach Explorer app. Participants will practice open monitoring and focused attention types of meditation during their training. Both groups will train for 21 minutes in each sitting, for 4 days a week and for 6 weeks altogether. It is hypothesised that working memory training group will show improved performance at post-test on the measures of working memory and reasoning ability, whereas mindfulness training group will show improved performance on the measures of mood, mind-wandering, and mindfulness trait.

  • RISE SAFELY in rural Australia - Redesigning maternity services for Aboriginal mothers and babies who are accessing care at Waminda South Coast Women’s Health and Wellbeing Aboriginal Corporation in Nowra, New South Wales, using Birthing on Country principles and the RISE implementation Framework, to address preterm birth and health outcomes: A prospective, non-randomised, intervention trial.

    This study aims to establish and evaluate Australia’s ‘Birthing on Country’ rural demonstration site at Waminda South Coast Women’s Health and Wellbeing Aboriginal Corporation in Nowra, New South Wales (Waminda), Yuin Lands. A redesign of the health service will increase continuity and quality of maternity care, and positively impact the health and wellbeing of Aboriginal and Torres Strait Islander (referred to hereafter as Aboriginal in accordance with Waminda’s wishes) women and babies who are accessing care at Waminda. The clinical safety and cost effectiveness of the new service will be systematically evaluated. This project has strong Aboriginal governance, agency and leadership.

  • A randomized controlled trial of Cognitive Processing Therapy for 18-35-year-olds with co-occurring post-traumatic stress and substance use disorders.

    There are disproportionately higher rates of lifetime trauma and Post-traumatic Stress Disorder (PTSD) among people with substance use disorders (SUDs), which can both precede, and occur as a consequence of substance use. Cognitive Processing Therapy (CPT) is a ‘gold-standard’ PTSD treatment, with a strong emphasis on processing and restructuring maladaptive beliefs around a traumatic event without employing exposure-based strategies. However, the effectiveness of CPT for individuals with co-occurring PTSD and SUD has not been extensively studied. The current project will be a randomized controlled parallel-group trial, which will determine the outcomes of CPT for young people with SUD/PTSD in the residential treatment setting for substance use. Participants will be randomised to receive either TAU or CPT alongside their usual residential treatment (CPT+TAU). Client outcomes on measures of substance use and PTSD, depression, anxiety symptoms will be evaluated at baseline, 1-, 3-, 6-, and 12-months follow-up.

  • A study to evaluate the safety of BW-20829 in subjects with elevated lipoprotein(a)

    This study is investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single ascending dose of BW-20829 in subjects with elevated lipoprotein(a) in 5 dose level cohorts (up to 3 optional cohorts with 24 subjects may be added). Approximately 40 men and women aged (more than equal to) 18 to (less than equal to) 65 years who fulfill the inclusion and exclusion criteria will be enrolled at sites in Australia. Eligible subjects will be admitted to the clinical research unit on Day -1, dosed on Day 1, discharged on Day 2 (24 hours post-dose), and return for outpatient visits through Day365. Within each cohort, 8 subjects will be randomized in a 3:1 ratio to receive a single dose of BW-20829 (n=6) or placebo (n=2) on Day 1 in a double-blind fashion.

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