ANZCTR search results

Currently, equine-assisted therapy (EAT) programs are offered and promoted by popular media as an intervention for children with autism spectrum disorder (ASD). Results from the qualitative study conducted as part of this PhD research suggests that EAT programs have become more accessible due participants being able to access NDIS funding if they are deemed reasonable and necessary, particularly if provided by allied health professionals. However, the evidence base for benefits achieved through EAT interventions remains limited and requires further exploration. Due to the nature of EAT, research faces difficulty meeting some of the gold standard requirements of RCT studies, including large sample size and double blinding. Therefore, this study will contribute to the field of EAT research through the use of the single subject (N-of-1 design) as a valid means of evaluating data on novel, less established treatments (Barlow & Nock, 2009; Borckardt et al., 2008; Portney & Watkins, 2009). A single subject, multiple cross-over (N-of-1) study design with multiple baseline will be used to test the overall effectiveness of a nature based, equine assisted, intervention and will examine whether effectiveness and/or motivation during sessions can be enhanced by the addition of a horse. A mindfulness-based, cognitive-behavioural therapy intervention (MCBT) will be provided in a farm setting and will be adapted to allow for the inclusion of a horse in some of the scheduled activities. The study will test the following hypotheses for children with ASD: H1) A nature based, equine- assisted intervention decreases participants' idiosyncratic "problem behaviour" as measured by the Parent Daily Report Checklist. H2) Equine- assisted sessions reduce idiosyncratic "problem behaviour" more than nature-based strategies alone. H3) A nature based, equine- assisted intervention improves externalising and overall behaviour as measured by Strengths and Difficulties Questionnaire. H4) Participants show higher observable idiosyncratic signs of happiness in equine- assisted sessions than during nature-based strategies alone. H5) A nature based, equine- assisted intervention improves quality of life as measured by the Pediatric Quality of Life Inventory. Research. To ensure rigor, the planning and reporting of this study will follow guidelines provided by the Consolidated Standards of Reporting Trials (CONSORT) extension for reporting N-of-1 trials (CENT) 2015 Statement (Vohra et al.,2015) the Single-Case Reporting guideline in Behavioural Interventions (SCRIBE) statement (Tate et al., 2016). It is anticipated that the results of this study will provide information about the effectiveness of equine-assisted interventions. The findings will also provide insight into possible mechanisms of change, which can inform the development of future interventions.

People coming into the Transition Care Program (TCP) are invited to participate in a research project. Researchers from the University of Queensland and Metro South Health are conducting a study to understand goals, activity patterns and other health data relevant to older people who enter the TCP following their stay in hospital. We will use Fitbits to collect activity and health data. Fitbits are worn on the wrist and track your movement and sleep throughout the day. You will also be asked to do some additional health assessments when you first start TCP, when you exit TCP, and 6 months after that. These assessments will either be done in person by someone in your rehabilitation team, or over the phone by our research assistant The purpose of this study is to examine how much TCP clients’ move around each day and to see how this is related to their goals, health and quality of life outcomes throughout the program. Future benefits for TCP clients’ may include improved clinical monitoring and patient care, as well as better goal attainment and health outcomes.

This project aims to compare different swim strokes (freestyle, breaststroke and backstroke) for pain response and biomechanical movements in the spine in participants with chronic low back pain. This will be completed with 30 adult participants at Macquarie University Aquatic Centre. Participants experiencing an episode of chronic low back who are comfortable with completing 100m of swimming in freestyle, breaststroke, and backstroke will be eligible to participate. Participants will attend one 1-hour session. Participants will then complete a set of swimming trials for each swim stroke (Freestyle, breaststroke, and backstroke), totaling three 100m swimming trials. They will be instructed to swim at a comfortable pace and, if required, to take short breaks after every 25m. Participants will complete a short warm up prior to each swim (a 50m walk) and will be given a 10-minute rest break in between each swimming trial. The primary outcome is the average and worst pain experienced during each swimming exposure. Secondary outcomes include further measures of pain, heart rate, perceived exertion, accelerometer data and self-rated swim stroke preference.

This project aims to fill a gap in existing services by helping young people living in rural areas who are feeling distressed about climate change. Specifically, the project aims to support the mental health and resilience of young people aged 16-18 in rural NSW who have been affected by natural disasters, such as fire, drought, or flooding. The program will take place outdoors for a full day, on two separate occasions. It will draw on the best-available evidence in the field of eco-therapy for mental health resilience in the era of climate change.

Mallet finger deformity is a common injury to the extensor tendon of the fingers. Currently, there are no published randomised clinical trials comparing operative and non-operative management of this condition. Traditionally, non-operative management has been considered the ‘gold standard’ treatment for uncomplicated mallet finger deformity. However, recent studies have suggested superior patient outcomes regarding compliance amongst patients, patient satisfaction, incidence of skin complications, time out of work and treatment outcomes in the operative management group. Therefore, this randomised clinical trial is required to identify which treatment path is optimal following mallet injury.

The primary aim of this pilot cross-over RCT is to estimate the immediate-effects of the knee brace. Together with a feasibility evaluation of a 6-week intervention with the knee brace (separate trial registration), this pilot study will inform a future full-scale RCT.

This study is evaluating the utility of an intracavernosal injection of botox for penile rehabilitation in men undergoing a nerve sparing radical prostatectomy, a procedure which causes erectile dysfunction in over two-thirds of patients. Who is it for? You may be eligible for this study if you are an adult male aged 40 to 75 years old who has been diagnosed with prostate cancer, and is undergoing unilateral/bilateral nerve sparing radical prostatectomy. Study details Participants will be randomly assigned to receive an intracavernosal injection of either botox or normal saline immediately at the end of their surgical procedure (radical prostatectomy). Participants will also be asked to complete questionnaires regarding their sexual function and quality of life at several timepoints during the 12 months following the prostatectomy. It is hoped that findings from this study will help determine the utility of botox in penile rehabilitation for men with prostate cancer undergoing radical prostatectomy.

This is a study to characterise the effects of a Moderate CYP3A4 and P-glycoprotein Inhibitor on the impact of Bomedemstat (IMG-7289) in healthy volunteers. IMG-7289 may be indicated for use in patients with cancer. A drug-drug interaction trial is needed to better understand how the body interacts with administered drugs throughout the entire duration of drug exposure. Who is it for? You may be eligible for this study if you are aged 18 to 65 years and are in good general health without a clinically significant medical history. People who have been diagnosed with cancer will not be eligible for this study. Study details This trial will take place over 73 days, where participants will be screened for 28 days, receive oral medication over a 13-day period, and will then be followed up. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. It is hoped this research will determine whether Moderate CYP3A4 and P-glycoprotein Inhibitor have an effect on the reaction of volunteers to Bomedemstat (IMG-7289). Healthy participants in the current study will not receive any health benefit (beyond that of an assessment of their medical status) from participating in the study; however, data from this study will support the potential development of bomedemstat.

This study aims to determine the impact of coeliac plexus neurolysis on pain and quality of life in patients with pancreatic cancer. Who is it for? You may be eligible to join this study if you are aged 18 years and older and have confirmed clinical diagnosis of pancreatic cancer and have cancer-related pain. Study details All participants in this study will undergo Endoscopic ultrasound (EUS) - coeliac plexus neurolysis (CPN) procedure performed by an interventional gastroenterologist. EUS-CPN is conducted as a day-only procedure under deep intravenous sedation. Participants will then be followed-up and assessed regularly for 6 months to determine the impact of EUS-CPN on pain and quality of life. Longer follow-up to 12 months post EUS-CPN procedure will be conducted to assess safety and survivorship. It is hoped that this research project will improve the quality of life of patients with pancreatic cancer through reducing pain and assisting with other activities of daily life that maybe affected by the cancer.

The purpose of this study is to explore the therapeutic benefits, tolerability and acceptability of psychedelic therapy using psilocybin and its potential to improve symptoms of treatment resistant depression (TRD), depression in people which has not resolved with a number of courses of standard treatment. Prior research has suggested that this type of treatment may have significant antidepressant effects, but we require further evidence to fully understand the therapeutic value, benefits, and risk of psilocybin in a treatment setting. The design includes an adaptive, dose finding, single phase 2b clinical trial exploring the efficacy and safety of psilocybin assisted psychotherapy (PAP) in the treatment of people diagnosed with treatment resistant major depressive disorder (TRD). If successful, this will lead to the conduct of a subsequent multi-site phase 3 trial to report findings of the therapeutic value, benefits and risks of psilocybin for the treatment of mental health conditions, including the size of effect, the quality of evidence and the relevance to real-world use in Australia.