ANZCTR search results

This study is to investigate the effectiveness of Imagery Rescripting (IR) in treatment eating disorders. It is common for people with eating disorders to report that memories of early negative experiences related to their body or eating (e.g., being teased about weight), or even unrelated to their body or eating (e.g., being rejected by a friend), are still relevant to how they feel emotionally about their body and eating today. With the use of IR, we go back in our imagination to experience the past event from a new perspective. We hypothesized that eating disorders treatment is more effective in decreasing disordered eating behaviours and improving body image among people with an eating disorder than with IR is used as a treatment adjunct.

The aim of this project is to examine the role of a ‘global’ coagulation assay called Rotational Thromboelastometry (ROTEM) in the guidance of prophylactic blood product in patients with liver cirrhosis undergoing invasive procedures. Currently available laboratory tests (such as platelet count, International Normalised Ratio (INR) and activated partial thromboplastin time (aPTT)) are suboptimal for the assessment of bleeding risk in patients with chronic liver disease. These tests may overestimate the risk of bleeding, and their use may result in unnecessary transfusion of blood and coagulation products, exposing the patients to risk of serious adverse events and potentially overuse of scarce blood products. During the past few years, ‘global’ coagulation tests such as ROTEM have been developed to provide an overall measurement of the clotting system. These point of care tests provide quick results and have been used to assess coagulation and better guide blood product transfusion in a number of surgical and trauma multi-transfusion settings. However, the value of these global tests in predicting bleeding outcomes and guiding blood component transfusion in liver disease has not been well studied. We plan a multi-centre randomised-controlled trial (RCT) examining ROTEM-based decisions to guide FFP and platelet use in patients with cirrhosis undergoing invasive procedures. We hypothesise that using ROTEM to guide blood product delivery in this setting, will lead to reduced usage of blood products whilst maintaining optimal clinical outcomes.

This is a pragmatic trial designed to test the effectiveness of osteopathic healthcare compared to a standardised education and activity care plan in chronic non-specific low back pain. It is a pragmatic design as it is testing two active interventions that people commonly seek for management of musculoskeletal pain, and the interventions are applied with real-world authenticity. The study aims to see if these interventions improve the pain and health status of participants, and whether the osteopathic healthcare intervention is any more effective than the standardised exercise and activity care plan. The core elements of the osteopathic healthcare intervention has been established through research, and includes assessment of musculoskeletal function, manual therapy, education, therapeutic exercise and health promotion advice. The exercise and activity care plan intervention is based on evidence based guidelines for chronic low back pain. After screening for the inclusion and exclusion criteria, participants will complete the first outcome measurements, and then be randomised into groups and receive four weekly consultations. The second outcome measurement will be completed immediately after the final consultation, the third 2 weeks after the interventions and a fourth 6 weeks after the end of interventions in order to test short and medium terms outcomes. Statistical approach is by Intention To Treat, and analysis will be undertaken using a multivariate approach and calculating effect sizes.

The primary aim of this study is to determine whether the addition of IRT to CBT-I improves sleep disturbances in ex-service personnel with PTSD, insomnia, and nightmares compared to CBT-I alone. This study also aims to explore if risk of obstructive sleep apnoea (OSA) negatively moderates treatment outcomes in ex-service personnel receiving either CBT-I or CBT-I+IRT. Participants will be a minimum of 60 ex-serving personnel with PTSD, insomnia, and nightmares. Eligible participants will be randomised to either CBT-I or CBT-I+IRT treatment groups. Participants will attend 8 x weekly 60 minute CBT-I group sessions or 8 x weekly 120 minute CBT-I+IRT group sessions. Participants will complete a series of outcome measures at three time points (baseline, post-intervention, and at three months post-intervention). It is expected that the addition of IRT to CBT-I treatment will result in greater reduction in sleep disturbances than treatment with CBT-I alone.

Research Question: Does Visualisation Affect Pain and Function in Achilles tendonopathy (AT)? Pain is clearly a complex process and involves integration of multiple streams of sensory information. An area of recent research interest has been the integration of what a person sees to augment or moderate the pain experience. Visually-induced analgesia is a term used to describe the reduction of pain intensity by directly viewing one’s own body-part when painful stimulation is applied. In chronic low back pain for example, patients’ visualisation of their lumbar spine reduced pain with movement. We hope to explore this phenomenon to see if, and to what extent, it exists in AT, and to simultaneously investigate the effect of vision on tendon function – something which no study of visually induced analgesia has done before. The aim of this study is therefore to examine the effect of visualisation on pain and function in people with AT. To achieve this, we will assess pain and leg stiffness with hopping in people with AT while they view a video image of their leg and compare these results with a no vision condition. This study will help inform whether non-nociceptive information sources are important in influencing pain in a clinical condition while performing a functionally relevant task, reveal if any changes in pain are associated with functional performance changes and may inform management strategies for the management of AT.

The purpose of this study is to assess whether the drug PAX-1 can delay cancer progression in patients with recurrence glioblastoma. Who is it for? You may be eligible for this study if you are aged 18 to 70, diagnosed with recurrent glioblastoma. Study details Participants who are resistant to SOC therapy will receive PAX-1 monotherapy alone until disease progression/recurrence or patient withdrawal (due to intolerance or withdrawal of consent).Patients will receive a maximum daily daily 15 mg oral dose of PAX-1 Every 8 weeks the patient will have a scan of their tumour to determine whether the therapy is working. It is hoped that information gained in this study will aid in the understanding of treatment of glioblastoma and help in the development of new approaches to its treatment and the care of future patients who share your condition.

A compassion-based digital health program (called CompassionateUs) to increase psychological wellbeing, for adults in the general community, will be evaluated. CompassionateUs is one of the digital health programs offered through the My Digital Health platform. People who consent to take part in the study will be randomly allocation to one of three conditions upon completion of the pre-program survey. The three conditions vary based on when program modules are released (i.e., all modules are open from first login; modules are released on a time schedule; modules released sequentially, following completion of the current module). The CompassionateUs program consists of 10 brief modules (i.e., 5 compassion-knowledge building and 5 compassion-skill building), delivered over 8 weeks. Each module will take 10-20 minutes to read and to consolidate learning, participants will be asked to complete various practise activities (10 minutes per day on average). Participants will also receive automated emails (e.g., when a module is released, once they have completed a module, when scheduled program assessments are due). It is expected that people who undertake the CompassionateUs program will show improvements in their psychological wellbeing (e.g., self-compassion levels) at post-intervention and follow-up assessment time points.

A multi-centre randomised design will be utilised to compare control centre normal practice conditions with intervention centres receiving physical literacy educator professional development and curriculum support. Approximately 60 educators and 300 children (age 4 to 5 years) will be recruited from 16 Early Learning Centres in Queensland and NSW. Centres will be randomly allocated (stratified cluster randomization) to either intervention, or control over a 24-week period. The reach, effectiveness, adoption, implementation, of the intervention will be examined. Change in aspects of children’s physical literacy will also be assessed. Assessments will be conducted at baseline and 6 months (end of intervention),It is hypothesised that educators receiving the intervention will improve the provision of physical literacy activities to children and that children receiving the intervention will have greater improvements in physical literacy.

Improvements in the management of critically ill patients have resulted in improved survival. However, these survivors are at an increased risk of cognitive, psychiatric and physical disability. This constellation of symptoms is known as Post-ICU Syndrome (PICS). One particular component of PICS is the development of chronic pain. Clinically and epidemiologically, chronic pain has been defined as pain that persists for 3 months or more Currently, the incidence of chronic pain in survivors of intensive care in Australia is unknown. The current literature from overseas estimates the incidence of chronic pain to be between 40-60% of ICU survivors. To date, there are no studies that have identified modifiable risk factors that therapeutic interventions can target to prevent the development of chronic pain. In addition, there is no literature about long-term opioid use in survivors of ICU. Hence, noting that there is a high incidence of chronic pain in ICU survivors, we aim to confirm this and hypothesise that risk factors associated with analgesic management, sedative management and immobility are implicated in the development of chronic pain. We plan to do this by conducting a large cohort study that accurately measures chronic pain using internationally recommended definitions. In addition, we will evaluate the impact of chronic pain (i.e. requirement of opioids, quality of life, interference, neuropathic components, psychiatric comorbidities, employment) using validated scales. We will also identify modifiable risk factors to develop targeted therapeutic interventions that aim to reduce the incidence of chronic pain, which will inform larger therapeutic clinical trials.

The purpose of this study is to determine the efficacy of vitamin D3 with or without HMB on the physical function, skeletal muscle mass, strength, bone turnover and bone microarchitecture in community-dwelling men and women aged 65 years with osteosarcopenia. This is a single-centre randomised, double-blind, placebo-controlled study design with approximately 88 osteosarcopenic patients randomised to daily oral treatments: vitamin D3 (1,000 IU/d) plus HMB or placebo in tablet form. The study will consist of a 24-week treatment period followed by a 12-week follow-up period. Assessments will be performed at the time of randomisation and at Weeks 12, 24 and 36.