ANZCTR search results

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

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32712 results sorted by trial registration date.
  • A randomised controlled trial of individual imagery based cognitive-behavioural therapy for clinical perfectionism

    This project will primarily examine whether an individual mental imagery based treatment for distressing mental images related to clinical perfectionism is better than receiving a standard cognitive treatment technique or relaxation techniques in a) reducing individuals' levels of clinical perfectionism, b) reducing the impact and distress caused by negative mental imagery and, c) reducing their symptoms of anxiety, depression, and/or eating concerns and It is predicted that the mental imagery individual treatment will lead to greater reductions in clinical perfectionism, greater reductions in imagery distress, frequency, and intensity experienced, and psychological symptoms compared to the standard cognitive disputation technique and relaxation. Additionally this project will examine whether individual mental imagery psychological treatment for clinical perfectionism produces treatment-related change in each individual and whether this is clinically significant.

  • Efficacy of the Positive Parenting Program (Triple P) for parents of young children with type 1 diabetes

    Type 1 diabetes is a serious condition affecting thousands of Australian children. It can lead to severe consequences for children including negative health outcomes, and elevated rates of behavioural and emotional problems, which can persist into adulthood. Parents of children with diabetes experience considerable difficulties, lack confidence, are unsure about what is appropriate for their child, and struggle with incorporating tasks into their day-to-day routines. This study aims to evaluate the efficacy of a brief, group-based parenting intervention for parents of children with type 1 diabetes. It is expected that participating in a group based parenting intervention has the potential to reduce ineffective and coercive parenting practices, and lead to improved child behavioural and emotional adjustment, better family wellbeing, and healthier children.

  • A randomised controlled trial of the effects of fruit intake on cardiovascular disease risk factors in children

    Background Dietary choice habits are known to influence cardiovascular disease (CVD) risk factors, which even in childhood are a predictor of future morbidity. Our objective was determining the impact of a school-based intervention of providing fruit daily in the classroom and its effects on risk factors for CVD, and dietary behavior. Methods The study was a randomized controlled trial involving two public and two private schools, one of each in an intervention and control group. Measurement at both the start and end of eight weeks aimed to identify any changes in physiological measures, child and parental attitudes and food choices. Results The intervention had minimal impact on physiological variables, but was effective in improving the amount of fruit and vegetables consumed and attitudes towards fruit intake. Parent lifestyle and dietary choices were poor at baseline, but significantly improved in parents of children in the intervention group compared to the control group. Conclusion This intervention was effective in improving the amount of fruit consumed and attitudes towards fruit intake over just 2 months. It has also shown the importance of not just the school environment but also suggests the home environment can influence children developing good dietary choice habits and lifestyle.

  • Prothrombinex or Fresh Frozen Plasma for Cardio Pulmonary Bypass Associated Bleeding (POPCAB)

    A multi centre, randomised, active control, trial of 200 patients comparing Prothrombinex VF with Fresh Frozen Plasma (FFP) as first line treatment for non surgical bleeding after cardiopulmonary bypass.

  • A prospective randomised controlled trial investigating three dimensional knee joint kinematics in total knee replacement – a comparison of cruciate retaining, posterior cruciate sacrificing and medially stabilised designs.

    This is an investigator initiated study, aiming to assess the prosthetic performance of total knee replacements (TKR) and to determine whether abnormal movement of the replaced knee has an impact upon function and pain at one year post-operatively. By using a prospective analysis of patients randomized to receive TKR of different designs, this study aims to determine the effect the type of prosthesis has on gait, three-dimensional joint movement plus both clinical and patient reported outcomes. In order to achieve this, joint motion, ground reaction forces and muscle activity will be recorded simultaneously from each subject during four test conditions; level walking, stair ascent, stair descent and chair rise. Limb alignment, pain and functional assessments will also be evaluated, to assist in determining variables associated with improved functional outcomes following TKR.

  • Weight loss using Implementation Intentions and Mental Imagery.

    The current research will investigate the efficacy of a brief, minimal contact, cost effective theory-based intervention using implementation intentions and mental imagery techniques to target diet and physical activity behaviour to promote weight loss. In addition, the present study will evaluate whether mobile phone text messaging will be effective in augmenting the effectiveness of the intervention.

  • Australian Father's Study: A longitudinal study of men about to become fathers and their engagement in pregnancy, birth and the early postnatal period.

    Prospective study of 1000 men who are the acknowledged father of an unborn baby. Men will be recruited via their partner. Following informed consent, men are followed across the antenatal period, birth and their involvement in the study concludes six weeks postpartum. Men complete an antenatal, birth and postnatal questionnaires that addresses demographic, engagement, anxiety and depression, quality of life questionnaires and in addition questionnaires specific to each stage (antenatal focuses on pregnancy issues, birth on birth issues and postnatal on issues anticipated to arise in the first six weeks postpartum).

  • Psychological stress, pain management and the development of a stiff, painful shoulder following rotator cuff or clavicular surgery.

    This study aims to find out whether having a depressed mood or inadequate postoperative pain control are associated with the development of a stiff and painful shoulder following shoulder surgery. Surgery to the muscles and tendons (rotator cuff) of the shoulder and surgery to the end of the collar bone (clavicle) are common procedures. However one complication that occurs is the development of a stiff painful shoulder in the first 3 months of the postoperative phase. A number of factors have been associated with the development of postoperative shoulder stiffness. It has been suggested that depressed mood and postoperative pain are associated with the development of postoperative shoulder stiffness but this area has not been studied. The purpose of this study is to look at the relationship between postoperative pain, depressed mood and the development of postoperative shoulder stiffness and determine whether either depressed mood or postoperative pain are important predictors of and possible management targets to decrease the rate of postoperative shoulder stiffness. The study will involve 100 to 200 participants who will all be patients of A/Professor Simon Bell undergoing rotator cuff or clavicular surgery

  • Efficacy of Metacognitive Therapy for Prolonged Grief Disorder: A Randomised Control Trial.

    Recent research has demonstrated that 16% of the bereaved population experience a complicated form of grief called Prolonged Grief Disorder (PGD), that causes extreme disruption to daily functioning (Prigerson, Vanderwerker, & Maciejewski, 2008). Based on these findings, it is estimated that out of the 140,000 deaths registered in Australia per year (Australian Bureau of Statistics, 2012) each conservatively affecting approximately 5 people, around 112,000 people could develop prolonged grief disorder. Despite the prevalence of this disorder, studies of psychotherapy for individuals suffering from the effects of prolonged grief are scarce. The purpose of this research project is to test the efficacy of Metacognitive Therapy on traumatic grief-related effects for individuals with PGD. Male and female participants (N=50; aged 18 or over) will be randomly assigned to either a waiting list or an intervention condition (Metacognitive Therapy), which promotes new ways of relating to their thoughts and beliefs about the loss. Measures of prolonged grief, anxiety, depression, rumination, metacognition and quality of life will be taken pre and post treatment and at the 3-month follow-up for both groups and at the 6-month follow-up for the intervention group. Multi-level mixed effects linear regression will be used to assess treatment efficacy. It is hypothesised that compared to participants in the wait-list condition, the intervention group will have lower levels of PGD symptoms and better quality of life at completion of the study. A greater awareness of the treatments that support the return to pre-loss levels of functioning for bereaved individuals is required.

  • Measuring the effectiveness of a phonological awareness teaching program for the kindergarten classroom

    The Cracking the Code program is designed to target the phonological awareness (PA) skills and alphabet knowledge of kindergarten students (aged 3 years and 6 months to 5 years and 6 months) within the context of classroom based instruction. This study aims to explore the effectiveness of this program in improving; PA, alphabet knowledge and early reading and spelling, when delivered within a Speech Pathologist guided, teacher implemented, intervention structure. Schools will be randomly assigned to either the treatment or control condition. Control groups will participate in an alternative program, targeting alternative language areas. To evaluate the effectiveness of the Cracking the Code program (CtC) (Fremantle Language Development Centre (FLDC) Outreach Service, 2013) the following hypotheses will be tested; 1. Participation in CtC will lead to a significant improvement compared to the control group in PA skills across the levels of syllable, onset-rime and phoneme as measured by the Cracking the Code PA Assessment (FLDC Outreach Service, 2013). 2. Participation in the CtC program will lead to a significant improvement compared to the control group in alphabet knowledge, including the identification of both name and sound of each letter for both upper and lower case representations as measured by an alphabet knowledge assessment. 3. Participation in the CtC program will lead to a significant improvement compared to the control group in early (a) reading and (b) spelling skills as measured by a non-word reading and spelling assessment.

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