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BDD is one of the most debilitating chronic mental health conditions, with impacts across multiple domains of functioning. Approximately 2% of the Australian population live with this serious disorder. Reappropriated pharmacological and psychological treatments (developed for mental health disorders with some similar symptoms, i.e. social anxiety disorder (SAD)) have efficacy for some people with BDD; however, most patients remain symptomatic and impaired, and many fail to respond at all. Thus, there is an urgent and immediate need for new BDD-targeted treatments given this significant clinical gap. There are only a few researchers worldwide attempting to improve the knowledge gaps in our understanding of BDD in a bid to develop novel interventions. Our CI team represents one of these groups. We have pilot data using a single dose of intranasal oxytocin (OXT) that restored activity in the ‘social brain’ (i.e. amygdala) in a double-blind placebo-controlled trial of BDD patients (d=0.78). This study seeks funding to extend and expand this world-leading work. Patients with BDD have a chronic illness course that has a major negative impact on social engagement, leading to social isolation and a quality of life that is worse than that associated with many chronic physical illnesses, let alone other psychiatric disorders (e.g. SAD). People with BDD are socially anxious, fear negative evaluations, hide their perceived appearance “flaws” from others, disconnect from family and friends, become depressed and are often suicidal. Despite these prominent social impacts, no treatments for BDD address social affiliation directly. We postulate (supported by our pilot data) that treatments which directly address social aspects of BDD, that is intranasal OXT, will have the potential to achieve symptom reduction/remission as well as substantially improve social functioning (i.e. reduced isolation and a better quality of life). Thus, we are proposing to conduct an innovative phase II randomised-controlled trial (RCT) to investigate whether daily intranasal OXT compared to placebo is an effective intervention for the treatment of BDD symptoms as well as related social impairments.

This is a study of EMD-RX5, an experimental new treatment for stress. EMD-RX5 is a cannabidiol (CBD) capsule which is hoped to be absorbed more effectively than other approved CBD products. Some research indicates that CBD affects receptors (a group of cells that control the movement of chemicals and molecules) in the brain, that may alter a key hormone (serotonin) relating to mood, happiness and feelings of well-being. In this study, we are investigating whether EMD-RX5 capsules are safe and how the body breaks down and absorbs the new drug in comparison to approved CBD (Epidyolex).

Reducing sedentary behaviour (SB) is recommended for adults with type 2 diabetes (T2D) and is not a replacement for exercising. Breaking sitting time by light activity is suggested as a management tool in T2D that can provide a medium for further behaviour change towards more active lifestyle. Smartphones are widely being used by people. Smartphones have functionalities such as computational power, internet connectivity and ability to install apps that altogether provide opportunities to conduct real-time, adaptive and interactive health behaviour change interventions. Therefore, we will be able to test what behavioural components (e.g., motivational messages) are most effective in improving behaviour, at what contexts (e.g., location) and how the behaviour changes over time. The overall aim of this research is to evaluate a mobile app-based intervention to help people with T2D Sit Less and Move More. Sedentary participants will be randomized to Sit Less intervention, Move More intervention, or waitlist control condition five times a day. Intervention participants will receive appropriate messages via the app, and their changing activity states will be evaluated within 1 hour from sending a notification message. Moreover, overall time spent sedentary or active during course of the intervention will be measured.

Stroke is a major cause of disability. Loss of movement is a major part of this. Studies show that high doses of rehabilitation therapy can reduce disability, but many patients do not receive this, e.g., due to obstacles such as difficulty accessing care. Our collaborator (Dr. Steven C. Cramer at the University of California at Cal. Rehab) has previously found that telerehabilitation is an effective way to deliver care and improve outcomes. These prior studies were performed after hospital discharge when patients were already back at home. The current study aims to extend this work by introducing telerehabilitation to the bedside of patients admitted to an inpatient rehabilitation facility (Osborne Park Hospital). In this study, we will measure issues and effects of telerehabilitation that is started during the rehab admission. We hypothesize that telerehabilitation started early after stroke is feasible and that participants will experience an improvement in their function.

A novel medical device, the Atmo gas-sensing capsule, has emerged as a technique capable of reliably assessing regional gastrointestinal transit time. In order to standardise assessments made using the Atmo gas-sensing capsule, the meal that is eaten as part of the investigation needs to be consistent across assessments. An alternative nutrient bar has been developed for this purpose to approximate the nutrition profile and form of a predicate nutrient bar. This study aims to compare how the two nutrient bars impact regional gastrointestinal transit time, to determine whether the newly developed, alternative nutrient bar is suitable for future evaluations of transit time using the Atmo gas-sensing capsule.

Persistent cancer-related fatigue affects many cancer survivors and can have impacts on their physical, psychological and emotional wellbeing. Cognitive Behaviour Therapy (CBT) is a recommended treatment for persistent cancer fatigue in survivors. CBT focuses on changing unhelpful ways of thinking and modifying learned patterns of unhelpful behaviour, but traditional CBT programs are often provided over a long period of time (more than 6 months). This study aims to determine if a stepped-care model of behavioural care that involves patient self-management of fatigue symptoms followed by a shorter course of CBT is feasible and acceptable to cancer patients. Who is it for? You may be eligible for this study if you are an adult aged 18 or older, you have been diagnosed and finished treatment for any cancer type within 3 months, and you report moderate to severe fatigue based on a series of screening questions (asked prior to enrolment). Additional eligibility criteria may apply to patients with melanoma and/or blood cancers, we recommend you contact the Public queries person listed below to see if you are eligible for this study. Study details All participants who choose to enrol in this study will be given a self-management cognitive behaviour therapy (CBT) work booklet that contains activities and educational materials (Step 1). Participants will be asked to work through the booklet at their own pace over a 5 week period, and will have access to telephone and email support after the first week. Participants who do not have any change in their fatigue levels after completing this 5-week program will then be offered Step 2, which involves an additional 4 x 50 minute face-to-face/Telehealth individual or group CBT sessions with a Clinical Psychologist. It is hoped this research will determine whether it is possible and acceptable to cancer patients to deliver behavioural therapy in a stepped-care manner rather than a standard 12-week program. If this stepped-care model is acceptable to patients, it may be delivered as part of a larger trial that could help future cancer patients with their fatigue as well.

The CANCAN trial aims to provide the evidence needed to better inform healthcare professionals in the use of medicinal cannabis in people with cancer. The purpose of this study is to investigate whether medicinal cannabis – a combination of cannabidiol (CBD) and tetrahydrocannabinol (THC) – is effective and safe for the management of chemotherapy symptoms and side effects in people receiving treatment for cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, and are scheduled to undergo either at least 3 cycles of chemotherapy for treatment of a solid tumour, or autologous stem cell transplantation for treatment of a haemotological cancer. Study details Participants will be randomised (i.e. allocated by chance) to receive either the medicinal cannabis treatment or a placebo. Participants in the medicinal cannabis group will receive 400mg per day of CBD and a starting dose of 2.5mg per day of THC in the form of an oral capsule for the duration of each treatment cycle, while participants in the placebo group will receive a daily glucose capsule. All participants will be monitored for symptoms of gut distress, have blood tests and their body weight taken, and answer a number of questionnaires, to determine if the medicinal cannabis treatment has an effect on chemotherapy symptoms and side effects for up to 6 months after the completion of treatment. Participants will also be monitored over this period for whether they have used supportive care or been hospitalised, for whether they have completed or ceased treatment and why, for their response to chemotherapy, and for any adverse events. It is hoped that this study may show that medicinal cannabis will minimise the intensity of chemotherapy symptoms, and thus have beneficial effects on the outcomes of chemotherapy. Specifically, we anticipate that CBD will minimise gut injury, therefore minimising local symptoms including diarrhea, malabsorption and pain, while THC will promote food intake, improve sleep quality and decrease anxiety. We expect this to have benefits on quality of life, and the ability of participants to receive their intended dose of chemotherapy without interruptions.

Cardiac involvement remains one of the biggest killers in Fabry disease. Yet our ability predict cardiac involvement before irreversible damage occurs remains limited. The chief reason for this is the differences in Fabry disease presentation that remains unexplained by biomarker or predictable natural history. Current tools, such as biomarkers (e.g., enzyme activity level, plasma Gb3, etc.) and genetic testing give a good measure of 'general' Fabry progression or diagnosis; but these are non-specific to phenotype or individual organ involvement. Further insight into which patients are at risk of developing heart complications would direct clinicians to consider commencement of Fabry-specific therapy in potentially high-risk patients. Markers and mechanistic insights that explain individual susceptibility to cardiac fibrosis and hypertrophy in the context of Fabry disease may also have broader implications to understanding heart failure and cardiomyopathy more broadly.

This study is a prospective, randomized, longitudinal study of the clinical and biomechanical outcomes of osteoarthritis patients treated by two different alignment philosophies for total knee replacement. All patients will be treated with the same knee system, implanted using nagivated assisted technology. We hypothosize that Inverse Kinematic alignment (iKA) will result in better Oxford Knee score (OKS) and satisfaction visual analogue scale (VAS) score compared to mechanical alignment (MA).

This study builds upon our world-first clinical trial of nicotinamide in glaucoma (ACTRN12617000809336) demonstrating the potential protective role of vitamin B3 (nicotinamide) supplements in people with glaucoma. Glaucoma causes progressive loss of nerve tissue in the eye, and irreversible vision loss. This study investigates the effect of taking nicotinamide supplements over 2 years on the eye’s structure and function compared to placebo. The primary aim of this study is to determine whether nicotinamide supplements in participants with glaucoma leads to reduced rate of progression in visual function measured using visual fields over 2 years. Participants diagnosed and treated for glaucoma will be invited to undertake the study. They will be randomly assigned to take nicotinamide or placebo daily for 24 months. Clinical tests including visual fields and imaging of the eye are performed at baseline, and every 4 months post-intervention.