ANZCTR search results

Osteoarthritis (OA) is the most common joint disease and frequently involves the hand. Painful hand OA is associated with a significant burden of disease and reduced health-related quality of life. The effect of hand OA on quality of life is comparable to rheumatoid arthritis, but effects considerably more people (prevalence ~40% versus ~1% in older adults). With an ageing population, the burden and health-care costs related to hand OA will increase. Since no treatment affects disease progression, there is an urgent and unmet need for effective treatment to slow structural disease and reduce symptoms. Only treatments that impact on the underlying biological processes causing hand OA will be able to achieve this. Hand OA is a heterogeneous condition. A common phenotype is joint swelling (synovitis). Synovitis is present in approximately 50% of people with symptomatic hand OA. Joints in hands with synovitis are 3.5 times more likely to experience joint destruction and radiographic progression than those without synovitis. Drugs used to treat synovitis may offer a novel therapeutic approach for reducing disease burden from hand OA. Recent efforts to examine anti-synovitis therapies in hand OA have been hampered by their application to the general population, rather than the synovitis phenotype. Moreover, previous attempts to examine anti-synovitis therapies examined costly and poorly accepted drugs. Methotrexate (MTX) is a well-established, low-cost drug with a well-described safety profile commonly prescribed as first-line therapy for the treatment of inflammatory arthritis. Recently, MTX has been shown to improve both synovitis and symptoms in a RCT and open label trial of knee OA. We propose that MTX might be a potential disease modifying OA drug for patients with symptomatic hand OA and synovitis to reduce disease progression and pain.

Inflammatory Bowel Disease is an auto-inflammatory disease characterised by chronic inflammation of the gastrointestinal tract and a chronic, relapsing and remitting course. Individuals with IBD are significantly more likely to suffer from depressive and other emotional health symptoms than age matched individuals in general population as well as people suffering from other chronic illnesses. Research has shown that individuals with IBD have triple the rate of mental disorders than that of general population. In particular, youth with IBD had higher rates of depressive disorders than youth with other chronic conditions, lower parent- and youth-reported QOL, and lower youth-reported social functioning compared to healthy youth.Research to date identifies that psychological interventions involving IBD cohorts are effective in reducing psychological distress (e.g., anxiety and/or depression), with cognitive behaviour therapy having the most evidential support. More recently, mindfulness based interventions have been found to reduce anxiety and depression and enhance quality of life]. The aim of this study is to conduct a randomised controlled trial (RCT) exploring the potential benefit of a group, IBD-focused, mindfulness-based cognitive therapy (MBCT) for youth living with IBD and comorbid depression. This randomised trial will also explore the potential benefit of the mindfulness intervention on immune markers associated with IBD and functional neuroimaging changes in response to the mindfulness intervention to provide insight in the mechanisms of action of this intervention. HYPOTHESES 1. MBCT (intervention group) will improve depression scores (pre-post); 2. Intervention will increase quality of life, mindfulness, medication adherence, perceived health care empowerment, coping and perceived illness perceptions and it will reduce anxiety symptoms (pre-post); 3. Intervention will change the structural and functional connectivity in default mode and executive control networks; 4. Intervention will be associated with decreased inflammatory burden, and improved microbiome. 5. MBCT intervention will be feasible and acceptable as indicated by sessions attendance, completion of home practices, recruitment and attrition rates, and participants’ MBCT group experiences assessed through focus groups and post MBCT evaluation questionnaire. OBJECTIVES Using 64 volunteer individuals (aged 16-29) with IBD and depression, the aim of this study is to conduct an RCT exploring the benefits of IBD-focused MBCT on depressive symptoms in youth living with IBD and comorbid depression. Secondary aims of this study are to explore the potential benefits of the MBCT on: • QoL, post-traumatic growth, medication adherence, health care empowerment, coping patterns, illness perceptions, and anxiety; • Biological markers of IBD, • Brain neuroconnectivity • Specific aim related to the pilot nature of the study is to determine the feasibility of the program

The importance of identifying and targeting early symptoms of poor mental health in adolescence cannot be underestimated. Adolescence offers a critical window for developing emotional resilience and healthy coping strategies, which could improve the trajectory of mental health across the lifespan. Yet mental health disorders form a substantial proportion of overall disease burden in young people in all societies (Patel, Flisher, Hetrick, & McGorry, 2007). Internalising disorders, such as anxiety and depression, are consistently reported as the most common mental health problems amongst Australian children aged between 7 and 14 years and are often less likely to be detected compared to externalising disorders (Australian Institute of Health, 2012; Klein, Jacobs, & Reinecke, 2007; Letcher, Sanson, Smart, & Toumbourou, 2012; Seligman, Ernst, Gillham, Reivich, & Linkins, 2009). Poor mental health often begins in early adolescence (12 years of age), and a shift toward early intervention has seen some promise in preventing the trajectory of later diagnosable conditions as well as enabling adolescents to full their potential (Klein, et al., 2007; McGorry, Bates, & Birchwood, 2013). Perfectionism has recently gained attention as is a transdiagnositic entity. This means it underlies many other series pathologies such as depression, social anxiety, generalized anxiety disorder, eating disorders and even personality disorders (Dimaggio et al., 2015; Holland, Bodell, & Keel, 2013). Perfectionism refers to a tendency to strive for flawlessness and set exceedingly high standards for performance, accompanied by tendencies for overly critical evaluations (Stoeber, Eklund, & Tenenbaum, 2014). Its transdiagnostic nature positions perfectionism to be an ideal target for early intervention in addition to low mood and social worry to prevent the longitudinal development of future mental health disorders. Self-compassion is a construct gaining prominence over recent years and may directly target the key features of perfectionism, low mood and social worry (Neff, 2011; Neff & Germer, 2013; Neff, 2010). Self-compassion refers to an adaptive way of relating to one’s self when considering personal inadequacies or difficult life circumstances. Self-compassion has also been shown to be an effective intervention target for adolescents suffering from negative world views (Neff, 2010). When working with a non-clinical high school population, it is important to ensure content is relevant and engaging and appropriate for this population. Thus the combined framework of CBT and Self-Compassion has been used to develop a psycho-educational workshop series, Compassionate Brain. In addition, high schools may be an appropriate target for early intervention programs given their access to a large group and capacity for the provision of ongoing support. The current study seeks to evaluate the effectiveness of the Compassionate Brain program in an adolescent population.

Higher protein intakes during both energy balance and energy restriction may have favourable effects on conservation of lean tissue, stimulation of whole body protein turnover (WBPT) and energy expenditure and suppression of the motivation to eat. This may prove beneficial for prevention of further weight gain and inducing weight loss. Obese individuals have been shown to have metabolic dysregulation of carbohydrates and fats, however much less is known about their regulation of protein metabolism. This could affect their ability to lose body fat and maintain lean mass. Further research is required to understand the effects of increasing protein intake during energy balance and energy restriction, as well as the influence of body composition on WBPT, metabolism and appetite. The main aims of this study are to compare WBPT, appetite and substrate oxidation between individuals of varying body compositions during their habitual diets and their adaptations in response to increased protein intake during energy balance and energy restriction. Specifically, the aim is to determine whether increasing protein during energy balance can stimulate protein turnover and energy expenditure and suppress the motivation to eat and whether high protein during energy restriction can inhibit commonly experienced reductions in protein turnover, energy expenditure and increases in motivation to eat. Secondary aims where to assess the reproducibility of appetite and the Leeds food preference questionnaire to assess liking and wanting across a whole day and to assess the reproducibility and effects or urine collection duration on the assessment of whole body protein turnover with the end products method. The study will consist of 4 x 2 week phases; habitual diet 1 (HD1), habitual diet 2 (HD2), High protein energy balance (HPEbal) (increase in protein intake of 0.5 g/kg/d through provision a whey protein supplement) and high protein energy restriction (HPER) (matching of protein intake to that during HPEbal and continuing to consume the whey supplement, while reducing energy intake by 33%). At the end of each study phase measurements will be undertaken to assess body weight and body composition, WBPT and Nitrogen balance, resting and postprandial energy expenditure and substrate oxidation and motivation to eat (appetite and liking and wanting).

The study aims to evaluate an evidence based approach to the design of a new treatment service for users of methamphetamine. Traditionally, services were designed for heroin or alcohol using clients who have different treatment needs and problems to methamphetamine users. Holyoake will implement an intensive case management model including medical, peer and family support for methamphetamine users at one site (Northam) but will offer its standard service at other regional sites (Narrogin and Merredin). We will compare outcomes for the new and standard programs (target to recruit 120 people in total) in terms of changes in substance use, mental health, wellbeing and social indicators (i.e. employment and housing status). Participants will be followed up by telephone at 4 weeks and 6 months and by record linkage at 12 months. We hypothesize that those receiving the intensive intervention will show greater improvement in key measures that the standard care group. We also plan telephone interviews with a close family member (e.g. partner, parent) to evaluate improved wellbeing for that person.

A double-blind, randomised, placebo-controlled interventional study to evaluate the effect of orally-dosed herbal extract, Slimaluma capsules on appetite control and body composition in overweight men and women aged between 20 and 50 years.

This study will investigate if reduced antipsychotic dosage combined with evidence-based intensive recovery treatment (EBIRT) leads to improved functioning for young people recovering from first episode psychosis (FEP). The study will be a RCT comparing an antipsychotic medication dose reduction strategy (DRS) combined with EBIRT (DRS+) against a group who will receive antipsychotic maintenance treatment (AMTx) plus EBIRT (AMTx+).

This research project will be a pilot study to test the concept of gamification on cardiovascular disease (CVD) management by evaluating the effectiveness of a new and innovative smart phone app, "My Heart Mate", on engagement in important cardiovascular disease (CVD) risk factor behaviours and outcomes at 6 months follow-up. The game has been developed to promote uptake and acceptability in collaboration with cardiac patients (front-end users) and effective strategies in key risk factors by leading experts in cardiology and behaviour change. Our study will determine whether the novel MyHeartMate app can improve multiple CVD risk factors in coronary heart disease patients and evaluate patients’ views of usability and tolerability of the app and Facebook group.

Energy restriction to induce weight loss presents a physiologically challenging process as the effects of energy restriction often include a downregulation of metabolic processes and increases in the motivation to eat. Manipulation of the macronutrient content of the diet particularly in regards to protein, has been proposed as a potential beneficial strategy to maintain metabolic processes and appetite. Changes in protein intake irrespective of changes in energy intake may effect metabolism and appetite and therefore this study aimed to determine whether maintaining habitual protein intake, rather than reducing protein intake during energy restriction would be adequate to minimise the commonly seen energy restriction induced adaptive changes in REE and appetite. The key aims of this study where to compare the short term effects of protein maintenance versus protein reduction during energy restriction, on changes in body weight, body composition, resting energy expenditure, appetite and food liking and wanting. During energy balance participants consumed their own habitual weight maintenance diet, and during energy restriction, participants were given guidelines on how to make changes to their own diet to meet specific energy and macronutrient goals based on providing 67% of each individual’s habitual diet and tailed to either protein maintenance or protein reduction.

With increasing life expectancy of individuals with cystic fibrosis (CF), the musculoskeletal sequelae of this chronic disease results in an increased burden of management and demand on healthcare services. Bone mineral density deficits, with fragility fractures (osteoporosis) and, more recently, reduced muscle mass (sarcopenia), are recognised as a long term health concerns. Importantly, muscle mass has been shown as an independent predictor of bone accrual in individuals with CF. Whole body vibration training (WBVT) has been shown to have a therapeutic impact on bone and muscle response in adults, and some paediatric cohorts, with CF. These data appear to support WBVT as an emerging therapeutic alternative for preventing/reversing sarcopenia and possibly osteoporosis. Efficient and novel models of service delivery are required to provide equitable, safe, and effective healthcare across extensive geographical regions of the state of Queensland. Telehealth provides a viable means of accessing specialist health services not available to consumers in their local areas. Queensland Health has recently provided infrastructure to support telehealth within regional facilities and homes, especially for chronic disease management. Our project aims to demonstrate the utility of telehealth-supported home treatments with WBVT via a model of service delivery which reduces travel time, costs, and negative impacts on quality of life(QOL), while providing an efficacious clinical intervention. A state-wide study of 32 pre-pubertal outpatients with CF, over 6 years of age, will be recruited to the study conducted over a 12-week period. Stratified randomisation will allocate the 32 subjects to either a control group or WBVT group. The control cohort (n=16) will continue their normal physiotherapy airway clearance regime. The WBVT cohort (n=16) will participate in the WBVT arm. Participants in the WBVT cohort will be reviewed either face-to-face or via telehealth at weeks 2,4,8 of their program. WBVT participants will perform a standardised WBVT program (20 minutes in duration), 5 times a week, in combination with their normal physiotherapy airway clearance regime. Outcome measures will be taken at weeks 0 and 12 of the program, and include primary outcome measures of lean body mass (LBM) via dual-energy X-ray absorptiometry (DXA), converted as an index (LBM/Ht2). Secondary outcome measures include Cystic Fibrosis Quality of Life Questionnaire-Revised (CFQ-R), Spirometry and Lung Clearance Index (LCI), muscle and bone parameters via DXA and peripheral Quantitative Computed Tomography (pQCT), vertical jump height, transversus abdominus real-time ultrasound, urinary continence and thoracic kyphosis measure.