ANZCTR search results

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

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32856 results sorted by trial registration date.
  • IBDmindfulness-mindfulness for youth with Inflammatory Bowel Disease (IBD) and depression trial

    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

  • Compassionate Brain: Evaluation of a psychoeducational workshop program for middle school students

    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.

  • The effects of dietary protein supplementation and energy restriction on whole body protein turnover, substrate oxidation and appetite in lean to obese healthy adults

    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).

  • An Evaluation of Holyoake's Methamphetamine Programs In Reducing Drug-Related Harms

  • 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.

    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.

  • Does Antipsychotic Dose Reduction in combination with Evidence-Based Intensive Recovery Treatment (EBIRT) Lead to Better Functional Recovery in First Episode Psychosis: A Randomised Controlled Trial

    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+).

  • "Apps for health following a heart event: MyHeartMate”

    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.

  • The effects of reducing of maintaining protein intake during energy restriction on body composition, metabolism and appetite in lean to obese healthy adults.

    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.

  • Telehealth compared to face to face delivered whole body vibration training in children with Cystic Fibrosis (CF).

    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.

  • In-home light therapy for fatigue following traumatic brain injury: A pilot randomized controlled trial

    Fatigue is the most common and persistent complaint following a traumatic brain injury (Sinclair, 2012). It has been reported in patients who have experienced TBI across the spectrum of injury severity (Mathias & Alvaro, 2012) and is present in both the early and later stages of recovery (Baumann, Werth, Stocker, Ludwig, & Bassetti, 2007; Cantor, Bushnik, & Cicerone, 2012; Kempf, Werth, & Kaiser, 2010). Despite this, there are currently no effective treatments for post­traumatic brain injury fatigue (PTBIF). However, findings from a recent pilot trial suggest that light therapy may reduce PTBIF, as well as daytime sleepiness (Sinclair et al., 2014). The study found reductions in fatigue and daytime sleepiness following blue light treatment, in addition to a nonsignificant trend towards reduced depression, which suggest that light therapy may be an effective treatment for fatigue and sleepiness following TBI. However this therapy required the person with TBI to sit in front of a light box for 45 minutes in the morning. As such it places considerable demand on the user. As a consequence for many individuals it does not represent a long­term solution to the problem. This project aims to develop, implement and evaluate the efficacy of an in-­home light therapy treatment for individuals experiencing post-­traumatic brain injury fatigue (PTBIF). The study will be a pilot randomized controlled trial evaluating the impact of in­-home lighting on subjective fatigue, as well as daytime sleepiness, sleep quality, psychomotor vigilance, mood, activity levels and quality of life. The study will employ a cross­over design and thus all participants will be exposed to both lighting conditions (the active light condition, consisting of bright predominantly short wavelength light) and a second lighting condition that constitutes a placebo condition. Primary and secondary outcome variables will be measured at four weekly intervals: baseline, mid­way and end of each intervention and one month­ follow up, resulting in a protocol of approximately 5.5 months, with six assessment points. Multiple measures will be taken at each of the assessment points. The study will recruit participants from the Epworth hospital who have sustained a mild, moderate or severe TBI and who are self-­reporting significant fatigue. A sample size of 34 is proposed. Participants order of exposure to the light conditions will be randomised. The placebo condition will constitute a sham condition, and all participants will be blinded to the treatment conditions. The study will also entail a health economics analysis to assess the cost ­effectiveness of the intervention, as well as an examination of factors associated with response to the intervention.

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