ANZCTR search results

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

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31173 results sorted by trial registration date.
  • Can resilience lessons be usefully integrated into the training of technical skills?

    At present, the self-reflective resilience training (Mental Fitness Training) involves a 40-minute training brief and then 15 minutes of guided self-reflection writing activities each week for five weeks. Cadets are required to reflect on their stressor experiences, evaluate their initial approaches to coping with those stressors, and arrive at alternative strategies that could be applied to future demands. However, the research team and RMC leadership believe that the coping and emotion regulatory skills can be integrated into the training of core technical skills. Our objective is to design and test the efficacy of a new integrated self-reflection training involving RMC instructors (instructor Mental Fitness Training). Formally, we proposed three hypotheses for (1) mental health outcomes, (2) performance outcomes, and (3) mediations: H1(a): Indicative of greater expeditiousness of the integrated self-reflection training involving RMC instructors, the intervention group would report lower average mental ill-health symptoms and perceived stress at intermediate time points (T2/T3) compared to the control group, and a more gradual decline in mental ill-health symptoms and perceived stress between T2/T3 to T4 compared to the control H1(b): Indicative of greater efficacy of the integrated self-reflection training involving RMC instructor, the intervention group would report lower average mental ill-health symptoms and perceived stress compared to the control group at T4. H2: Indicative of greater efficacy of the integrated self-reflection training involving RMC instructors, the intervention group would demonstrate higher average performance scores across the four performance measures (foundation warfighting, merit points, command, and leadership and character) than the control group. H3: The effect of training condition on mental ill-health symptoms, perceived stress, and performance will be mediated by (a) perceived instructor support and (b) instructor encouragement of resilience training principles and strategies.

  • Evaluation of a community-based assertive follow-up suicide prevention program for people who have attempted suicide or are at high risk of suicide

    The study aims to evaluate the efficacy of a community-based assertive aftercare follow-up suicide prevention program in reducing repeat suicide attempts for people who have presented to the participating emergency departments following a suicide attempt or with high risk of suicide. A secondary aim of the study is to measure changes in known suicide risk factors (e.g. depressed mood, psychache) for people who participated in the intervention. The assertive follow-up intervention will be delivered by mental health clinicians and peer workers, using both face-to-face interventions and phone follow-up sessions, for a duration of four weeks (with an option of extension to 12 weeks). The intervention is based on the GROW coaching model and will utilise the Suicide Status Form-4 (SSF-4) from the Collaborative Assessment and Management of Suicide (CAMS) model (Jobes, 2016; Jobes, Jacoby, Cimbolic, & Hustead, 1997). Participants will be asked to outline the key issues that are contributing to their suicide risk, and in collaboration with a clinician, will produce a set of goals and objectives for addressing these issues in a set timeframe, and follow a stabilisation plan. Participants will re-rate their suicide risk factors and evaluate their goals and stabilisation plan at each contact with a clinician or peer worker. Quantitative and qualitative measures of progress toward goals, stabilisation plan and suicide risk will be monitored using the SSF-4 at each contact, measuring psychological pain, agitation, stress, hopelessness, self-hate and overall risk. It is hypothesised that; 1. Compared to health consumers who receive treatment as usual (TAU) following their episode of care in an emergency department as a result of a suicide attempt or high risk of suicide, participants of the Aftercare intervention will be significant less likely to re-present to an emergency department for suicide attempt or high risk of suicide. 2. Compared to health consumers who receive TAU following their episode of care in an emergency department for suicide attempt or high risk of suicide, participants of the Aftercare intervention will experience a significant reduction in the number repeat suicide attempts (as measured by re-presentations to an emergency department for a suicide attempt or being deemed to be at high risk of suicide). 3. Compared to health consumers who receive treatment as usual (TAU) following their episode of care in an emergency department as a result of a suicide attempt or high risk of suicide, participants of the Aftercare intervention will be significant less likely to die by any cause in 24 months. 4. Participants of the Aftercare intervention will show significant reductions in suicide risk factors following the intervention.

  • How doctors' language impacts peoples' understanding and decision making about cardiovascular risk

    This experimental study seeks to investigate the effect of different labels for high blood pressure (e.g. hypertension vs high normal blood pressure) on treatment decision-making and psychosocial outcomes (perceived severity; level of concern), compared to a control group where no label is given. It will also explore whether any effect is affected by a) sharing absolute risk information and b) health literacy. Australian adults aged 40-50 with a normal risk of hypertension will be sampled. Only those with an average risk profile will be included in the study, to be presented with a hypothetical diagnosis and asked a number of survey questions investigating health literacy, treatment decision making, risk perception and perceived self-efficacy.

  • Examining the reciprocal effects of stress-related eating on sleeve gastrectomy: a randomised controlled study in people seeking treatment for obesity

  • Detecting new bone metastases in patients on androgen deprivation therapy

    This study's purpose is to assess new bones lesion(s) in prostate cancer participants starting androgen deprivation therapy (ADT). Who is it for? You may be eligible to join this study if you have prostate cancer with a high risk of metastatic disease and your treating doctor recommends starting ADT and targeted radiotherapy. Study Details: Participants in this study will undergo a 68Ga-PSMA PET CT at study entry. Participants will have two additional 68Ga-PSMA PET CT at 6 and 12 months. Participants will be followed up per routine clinical care. Participants have the option of providing optional blood test. It is hoped that this research will provide insight in the incidence and mechanism of bone lesions in advanced prostate cancer.

  • A protocol to standardise intravenous fluid therapy after cardiac surgery

    The purpose of this study is to identify if introducing a protocol to standardise post-cardiac surgery fluid resuscitation can reduce the amount of intravenous fluid administered and potential patient harm. By using a protocol and the calculated mean systemic filling pressure analogue, the amount of intravenous fluid received post-cardiac surgery can be restricted.

  • The Efficacy, Safety and Tolerability of Oral NP202 in Adults who have Paroxysmal Atrial Fibrillation and a Cardiac Device

    NP202 has been shown to reduce rhythm disturbances in heart muscle in the ventricles, and it is compelling to discover if it similarly reduces rhythm disturbances in heart muscle in the atria. As AF is the most common rhythm disturbance in the atria, it is the most suitable target to investigate a benefit. This is a single-centre, randomised, double blind, placebo controlled study to assess the efficacy, safety and tolerability of NP202. Subjects will be screened during routine interrogation of their cardiac device. Eligible subjects will have a high burden of paroxysmal atrial fibrillation. They will be randomised and administered their first dose of investigational product (IP) on Study Day 1. Subjects will take their IP dose once a day for 1 month (30 days). During this treatment period they will return to the site for study visits at Week 2, and Months 1, 2, and 3. Month 3 is the end of the Treatment Period. Subject will return for follow up and the final study visit at Month 4. A Data Monitoring Committee (DMC) will review safety data at agreed recruitment and progression milestones to provide independent oversight of subject safety. Armaron Bio Pty Ltd has provided the study drug at no cost. They have not have provided any funding and the study investigators have full intellectual property and rights over the study data.

  • Breath-Hold in Abdominal & Lung Cancer Radiotherapy - Tumour Reproducibility, Tumour Stability & Patient Experience

    This aim of this study is to compare three breath hold techniques for radiotherapy in patients with liver, kidney, adrenal, pancreatic or lung tumours. Who is it for? You may be eligible to join this study if you are aged 18 years or above and are eligible for radiotherapy treatment to the liver, kidney, adrenal gland, pancreas or lung. Study details Non-lung cancer participants will undergo three breath hold techniques in a random order: exhale breath-hold (EBH); inhale breath-hold (IBH) and deep-inhale breath-hold (DIBH). Participants with lung cancer will undertake the DIBH technique only. The patient breathes through an Active Breathing Coordinator machine, which automatically stops air flow when the correct volume of air is measured. Exhale Breath Hold requires the patient to breathe out and hold their breath. Inhale Breath Hold requires the patient to breathe in and hold their breath. Deep Inhale Breath Hold requires the patient to take a deep breath in and hold their breath. X-Ray images will be taken while the patient holds their breath, to measure the stability and reproducibility of their tumour. Patients will also be asked to complete a questionnaire to assess their experience of the breath-hold technique(s). It is hoped that we can determine the best techniques to enable delivery of high dose radiation to the tumour, while minimising the radiation dose to healthy organs.

  • Improving quality of life and mental health using a music engagement program people for aged-care residents with Alzheimers disease and dementia

    This single group trial aims to evaluate the effectiveness of a music engagement program in improving quality of life and depression in aged-care residents with Alzheimers disease and dementia. We hypothesise that residents' indicators of quality of life (including feelings of social connectedness to others and emotional mood) will improve from pre to post session. We also hypothesise that residents' symptoms of depression will improve from pre- to post-intervention (8 weeks).

  • HI-LO Trial in Lymphoedema – What is the optimal pressure for compression garments prescribed to women with upper limb lymphoedema

    The purpose of this study is to provide some preliminary data on the impact of different levels of compression on lymphoedema. Who is it for? You may be eligible for this study if you are over 18, have completed breast cancer therapy (except hormone treatments) at least 6 months ago and have been diagnosed with secondary arm lymphoedema. Study details Participants in this study will be randomised (by chance) into two groups. All participants will wear a compression garment for 12 hours a day for 6 months and will be a sleeve and gauntlet. You will be measured for these by a certified lymphoedema therapist. One group will wear a high compression garment, and the other will wear a low compression garment. Participants will have the garments checked after one week, two months and 4 months of wear; as well as have some scans, undergo some measurements and complete a questionnaire before and after the 6 month trial. It is hoped this research will provide important preliminary information as to what the optimal level of compression is for people with secondary arm lymphoedema.

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