ANZCTR search results

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

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32107 results sorted by trial registration date.
  • low dose naltrexone in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and long coronavirus disease (long COVID) symptoms

    There is no laboratory-based diagnostic test and universally accepted treatment for ME/CFS and Long COVID, instead diagnosis follows fulfilment of a diagnostic criteria. The study aims to determine if treatment with Low Dose Naltrexone (LDN) improves ion channels function, fatigue, cognitive, neurological symptoms, and health-related quality-of-life (HRQoL) in adults with ME/CFS and Long COVID. If this is the case, Low Dose Naltrexone (LDN) may offer a safe and cost-effective treatment for ME/CFS and Long COVID. The investigational production Low Dose Naltrexone (LDN) will be manufactured, packaged, labelled, coded, stored, supplied, and handled in accordance with the requirements of sections 5.13 and 5.14 of the Therapeutic Goods Administration’s Integrated Addendum. Specifically, Low Dose Naltrexone (LDN) will be manufactured in accordance with good manufacturing practices (GMP) and will be coded or labelled by the compounding pharmacy. While Low Dose Naltrexone (LDN) and placebo will be blinded, a coding system will be implemented to enable rapid identification of the product for safety reasons. Specifically, Low Dose Naltrexone (LDN) capsules are to be stored at room temperature in their original container for up to six months. Low Dose Naltrexone (LDN) will be labelled with a specific expiration date by the compounding pharmacy.

  • Opening up

    Obsessive compulsive disorder (OCD), Body dysmorphic disorder (BDD), and anorexia nervosa (AN) are some of the most debilitating and chronic mental health conditions, sharing overlapping psychopathological determinants in terms of behavioural and cognitive impairments, neurobiological and neurocircuitry mechanisms, and poor response to conventional treatments. This trial aims to investigate the efficacy, safety and tolerability of psilocybin assisted psychotherapy (PAP) for treatment resistant OCD, BDD, and AN. 12 patients from each condition will be recruited in a basket design (multiple conditions) open label trial of 2 dosing sessions with non-directive support, including preparatory and integration therapy, and a 3-month follow up period. It is hypothesised that PAP will lead to statistically significant and clinically significant (35%) improvements in primary symptoms for each condition. Explorative outcomes will be investigated as potential mediators of changes in symptom severity, and lived experience insights will be gained. The outcomes of the trial will enhance scientific understanding and provide rationale for subsequent randomised controlled trials investigating PAP for obsessive-compulsive and body image disorders.

  • TransformUs Wellbeing: Feasibility of a multicomponent school-based systems intervention within Victorian primary schools.

    This research will develop, test, and disseminate a multicomponent childhood obesity intervention for primary schools in South-West Victoria. The innovative TransformUs Wellbeing intervention builds on the successfully scaled-up primary school physical activity behaviour intervention in Victoria (TransformUs) and multi-component WHO STOPS community-based childhood obesity intervention. We hypothesise that by embedding capacity in systems thinking and mapping within primary school settings, and extending on the risk behaviours (e.g. diet quality, physical activity, sedentary behaviour, and sleep sufficiency and mental wellbeing) will lead to greater impacts and sustained changes in key behavioural drivers of childhood obesity. Our aim is test the effectiveness of TransformUs Wellbeing on health-related quality of life through a 9-month cluster-RCT among 8 intervention and 8 control primary schools in South-West Victoria in 2024.

  • The impact of workplace mental health training on knowledge, stigma and mental health management skills for university staff

    With rising mental health strains in the tertiary education sector, it is imperative to promote a supportive, mentally healthy workplace for employees. The current study adapts a skills-based mental health training program, previously successful in training workplace managers to support the mental health of employees, with the aim of upskilling university staff to support their own and their colleagues' mental health. The aim of this study is to ascertain the effectiveness of this training in improving university staff's mental health knowledge, stigmatising attitudes to mental health and mental health management skills.

  • The impact of mental health training on the confidence of university staff in supporting student mental health: a quasi-experimental trial

    Mental health problems among university students are extremely common, and university staff frequently report being approached by students for mental health support. Many university staff members feel they do not have the skills or confidence to respond appropriately. The current study adapted a skills-based training program, previously successful in training workplace managers to support the mental health of employees, with the aim of upskilling university staff regarding student mental health. The aim of this study is to ascertain the effectiveness of this training in improving university staff's confidence supporting student mental health, mental health knowledge, stigmatising attitudes to mental health and behavioural responsiveness to students experiencing mental ill-health.

  • A quasi-experimental study of manager mental health training in the university sector

    Research suggests that managers play an important role in workplace mental health. Indeed, positive managerial behaviours are a key predictor of employee wellbeing. The current study adapts previously successful manager mental health training programs to upskill managers in the university sector. The primary aim of this research is to evaluate whether this evidence-based training program will improve the confidence of managers in the university sector to support mental health and wellbeing in the workplace. Additional secondary aims include ascertaining the effectiveness of the training in improving managers' knowledge, attitudes and responsive behaviours with regard to employee mental health.

  • The effect of a virtual three-dimensional eye model on patient satisfaction and understanding: a randomised control trial

    A single-centre, open-label, randomised controlled trial to investigate whether the use of a virtual three-dimensional interactive eye model (One Right Eye model) during a standard outpatient public ophthalmology clinic affects overall patient satisfaction with their appointment, understanding of their ophthalmic condition, and rating of their doctor’s explanation.

  • Creatine and Exercise as a Novel Treatment Strategy for Depression in Adults Aged 18-39 Years

    Creatine plays a crucial role in rapidly providing energy to the brain during times of increased demand such as sleep deprivation and mental health conditions (i.e.: depression). Such energy provision is crucial considering the brain is a highly metabolically active organ and requires a constant energy supply. However, current research has only investigated the potential anti-depressant effects of creatine supplementation with traditional pharmacological interventions that are known to induce multiple health side effects and are associated with low success. Considering exercise is a well-established, efficacious treatment option for reducing depressive symptoms for individuals with depression, this proposal will test the hypothesis that the synergistic effects of creatine supplementation and exercise can reuce symptoms of depression and anxiety, while concomitantly improving motivation in adults aged between 18-39 years with mild-to-moderate depression over a six-week period.

  • The MOVEMENT study: Exercise and quality of life in people with mental illness

    This study seeks to assess the influences on recovery-oriented quality of life (ReQoL) in adults (i.e., over 18 years) who are receiving treatment for a severe mental illness (SMI). The aim of this study is to evaluate the effectiveness of an AEP service implemented within routine mental health care settings. Participants will be asked to complete questionnaire and physiological assessments at three time-points separated by three months (baseline, 3-months, 6-months). Participants will also be given the option of participating in an exercise service delivered by an Accredited Exercise Physiologist (AEP), involving at least one group-based exercise session each week.

  • Introducing a Vascular Access Specialist Model in the Emergency Department (VAS-ED)

    The primary aim of this randomised controlled trial (RCT) is to compare the clinical and cost eff ectiveness of new Vascular Access Specialist model with the Generalist inserter model (inserted by a doctor or nurse in emergency department). You may be eligible to participate in this trial if you are an emergency department patient more than theage of 18 and are requiring a peripheral venous catheter inserted as part of your therapy. All participants enrolled in this trial will be randomly allocated (by chance) to receive one of two options (inserted by either a Vascular Access Specialist or a doctor/nurse in emergency department). Participants and families will be asked to rate the satisfaction of the insertion, and the peripheral intravenous catheter will be observed closely to examine side effects. It is hoped that the findings of this trial will provide information on which insertion model is the most effective in preventing first insertion failure.

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