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Examining the efficacy and acceptability of an internet-delivered pain management program for endometriosis
The Endometriosis Pain Course is an internet-delivered psychological treatment that addresses the impacts of endometriosis-associated symptoms and difficulties, such as chronic pain, on women's daily functioning and wellbeing. The course is based on cognitive behaviour therapy principles and consists of 5 lessons released over an 8-week period. Each lesson covers a different topic and introduces 1-2 core CBT skills designed to promote self-management, psychological wellbeing and quality of life. In addition to the core lessons, the program includes extra resources such as redirecting attention from pain and do-it-yourself guides to promote skills practise. Alongside the internet-delivered materials, participants have the option of accessing telephone support from a Clinical Psychologist who is available during the 8 weeks to discuss concepts, answer questions and promote and encourage skills practise. This intervention will be a modified version of the Pain Course, which was developed and validated through 4 randomised controlled trials by the eCentreClinic at Macquarie University and is now widely available through the MindSpot Clinic. The aim of this study is to investigate the efficacy of a psychologically-based pain management program when specifically adapted for women with endometriosis. We hypothesise that, compared to a delayed treatment waitlist group, participants in the Endometriosis Pain Course will report greater symptom improvements (in terms of mood, anxiety and level of pain-related disability). By recruiting a large group of participants, we are also aiming to understand what particular groups of people (or what participant characteristics) may benefit most from the Endometriosis Pain Course.
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Assessing the Efficacy and Durability of Faricimab in Patients Currently Treated for Neovascular Age-Related Macular Degeneration.
This study is being conducted to investigate the efficacy and durability of faricimab (trade name: Vabysmo), given as an intravitreal injection into the eye. Faricimab is believed to improve visual function in patients currently treated for neovascular age-related macular degeneration (nAMD) with longer lasting effects. An open labelled, single-arm, multi-centered study will be conducted. Faricimab (trade name: Vabysmo) is a recently approved therapeutic agent, which acts by preventing the growth of abnormal blood vessels in the back of the eye. Faricimab is given as an injection into the eye, similar to current standard of care therapies for nAMD. Eligible patients will be switched to receive faricimab treatment given by intravitreal injection into the eye over 24 months. Following four monthly loading doses, the interval between treatments and study visits will be extended or reduced depending on if there is disease activity present. At each visit, a variety of ocular imaging procedures and assessments will be conducted to monitor the ocular health of the eye and assess visual function.
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Immunogenicity and safety of the Japanese encephalitis vaccine given intradermally in children and adults
Australia is on the cusp of a potential outbreak of Japanese encephalitis (JE) viral infections as we move into spring and summer and having back-to-back La Niña seasons. There are effective JE vaccines which are licensed for children over 9 months old and given by subcutaneous (SC) injection. Intradermal (ID) vaccine administration only uses 1/5 of the subcutaneous dose and is therefore “dose sparing” enabling more people to be vaccinated from each vaccine vial. ID JE vaccination has found to be safe and immunogenic in adults, however has not yet been tested in children and adolescents. One recent study suggests that as much as 3% of the Australian population may be at risk of JE virus (JEV) exposure. In a naïve population, the risk of severe disease is likely to be equally distributed between age-groups. Of the 6 JEV deaths recorded in 2022, one was an infant. The aim of this project is to study immunogenicity and safety of JE viral vaccine (Imojev®) given ID using traditional needle and syringe in children and adults and to compare safety and immunogenicity with Imojev® given via the current recommended SC route. The results will be useful to inform vaccination programs if there is a significant JEV outbreak and especially if we have insufficient supplies of JE vaccines in Australia to vaccinate our most at risk populations, including children.
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Exploring the efficacy of remote stepped care treatment for obsessive-compulsive disorder: A feasibility study.
The purpose of this project is to assess the acceptability and feasibility of a remote stepped care treatment for individuals with obsessive-compulsive disorder. After assessment all participants will commence clinician-guided cognitive-behavioural bibliotherapy (BCBT) for 8 weeks. Participants who do not meet the predefined response criteria (YBOCS reduction of greater than or equal to 25% and a CGI-I score of less than or equal to 3) will then complete 8 sessions of internet-videoconferencing cognitive-behavioural therapy (VCBT) with a psychologist.
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A novel knot-free proximal skin closure technique for transverse caesarean section skin incisions
This pilot study will investigate the use of a new knot-free skin closure technique for caesarean section skin wounds. By using this new method to close the skin wound, the researchers aim to reduce the risk of post-operative wound infections and improve patient comfort, whilst also providing surgeons with an easy and reproducible skin closure technique. Currently, a surgical knot named an ‘Aberdeen knot’ is placed beneath the skin at the end of a running stitch during the skin closure at caesarean section. Unfortunately, patients have reported discomfort from the bulky nature of this knot and the bulky knot also increases the risk of wound infection and wound breakdown. Participants will have the proposed skin closure technique performed at the time of their caesarean section and will then be monitored post-operatively by the midwifery and medical staff at Frankston Hospital. Participants will also be required to submit serial photographs and short questionnaires as means of follow-up. This will allow for appropriate monitoring for any wound complications, such as wound infection or wound breakdown. The researchers hope to prove that this knot-free skin closure technique is safe for use in closing the skin wound during caesarean section. Should this small initial study prove to be safe and of good design, a larger randomised trial will be commenced.
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A Biomarker-Driven Approach to Identify Pathogenic Mechanisms and Novel Therapeutic Targets in Chronic Wounds (Pyoderma Gangrenosum) using Tildrakizumab
This study aims to look at measures of disease activity in ulcers (Pyoderma Gangrenosum) and the potential of response to a new therapy, Tildrakizumab, an injection which is administered under the skin every 4 weeks, for a total of 12 weeks. We intend to perform an exploratory analysis for potential biomarkers of disease activity in Pyoderma Gangrenosum (PG). Our proposal would include an open-label study with 12 weeks of treatment with Tildrakizumab in line with the published dosing frequency for Hidradenitis Suppurativa (200mg Week 0,4 and 8). Outcome measures are obtained from a recent systematic review of outcome measures used in clinical trials of PG.
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The Baby Gut Health Study
The early life microbiome plays a crucial role in immune system development and is associated with various health outcomes later in life. A healthy gut microbiome established in early life can reduce the risk of microbiome-related diseases and promote long-term health benefits. Weaning, the transition to solid foods during early life, particularly complex carbohydrates, is considered a “window of opportunity” for shaping the gut microbiome with its optimal configuration. Introducing prebiotic complementary foods can be an effective strategy for establishing a healthy microbiome during this time. However, the infant gut microbiota at the early weaning stage has limited capability to ferment complex carbohydrates and prebiotic substrates. It remains unclear how and when important carbohydrate fermenting microbes and butyrate producers colonize the infant's gut. To develop an effective and practical strategy for shaping healthy infant gut microbiota, a deeper understanding of the developmental trajectory of gut microbiota and its fermentation ability along with the introduction of solid foods is required.
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PERsonalised Selection Of medication for Newly diagnosed Adult epiLepsy - the PERSONAL Trial
To establish the (1) effectiveness, (2) cost-effectiveness and (3) acceptability of our machine learning (ML) model compared to usual care in selecting the first anti-seizure medication (ASM). Hypothesis: (1) seizure-free rate at 1 year of treatment with the first ASM will be higher in the machine learning group. (2) quality of life, depression and anxiety will improve more in the ML group, and ML model will be more cost-effective. (3) ML model will be acceptable to patients and clinicians. This is a multicentre randomised controlled trial (RCT) across all six states of Australia. Adults will be randomised 1:1 to ML Group (ASM recommended by the ML model) or the UC Group (ASM selected by the neurologist) and followed for 12 months. A sample size of 234 (including 10% dropout) participants will allow for measure of a minimum absolute difference of 20% in 1-year seizure-free rate on the first ASM between the study group (55% ML vs. 35% UC).
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Implementation evaluation of a blended digital mental health intervention for adults with depression or anxiety
Anxiety and depression affect > 3 million Australians, at a cost of over $12.8 billion/year. Without proactive treatment, these disorders can result in chronic disability, illness, low workforce participation, impaired relationships, self-harm, and suicide. Digital mental health interventions (e.g., online cognitive behavioural therapy [CBT]) are effective, and cost-effective treatments for depression and anxiety, achieving similar outcomes to face-to-face therapy and pharmacotherapy. Most importantly, they improve the accessibility, quality, and standardisation of mental health care. Despite this evidence, they have poor uptake and limited use in routine care settings (e.g., private practice). Evidence indicates that blended digital and in-person treatments are preferred by practitioners over digital-only treatments, and reduce treatment length, sessions, and costs compared to face-to-face only treatment. Based on this evidence, along with knowledge about barriers and facilitators of implementation gained via extensive consultation with health professionals and end-users with lived experience of depression and anxiety, we have developed a new blended model of mental health care that integrates leading evidence-based digital interventions with in-person (and/or telehealth) therapy for depression and anxiety. This blended model of care comprises a smartphone application that clients use throughout the course of therapy to enhance therapy skills and provide support between therapy sessions. Psychologists can monitor their clients’ symptoms via a purpose-built Health Professional Portal and tailor their treatment based on their clients’ progress. The aim of this study is to evaluate the acceptability, feasibility and preliminary effectiveness of this new blended model of care in the context of psychological therapy for adults with depression or anxiety. Implementation barriers and facilitators, as well as outcomes at the client, psychologist, and practice level will be evaluated. The findings from this study are expected to generate new knowledge that will help to improve the uptake, use and sustained implementation of digital interventions for depression and anxiety in routine psychological therapy. In doing so, we hope to increase the quality of care provided to patients, and ultimately improve patient outcomes.
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Mental Durability in NSW Police Officers
Research has shown that first responders, including police officers are more vulnerable to experiencing stress-related conditions due to the nature of their work. Studies have also shown that hyperarousal is a common symptom associated with work-related stress, and mental health problems such as posttraumatic stress disorder (PTSD), anxiety and mood disorders. Specifically targeting the management of hyperarousal in therapy programs may be useful to helping police officers experiencing hyperarousal symptoms. The primary aim of this study is to investigate the feasibility and effects of a newly developed de-arousal therapy program in managing hyperarousal symptoms in NSW police officers. We expect that the therapy program will help officers to reduce their hyperarousal symptoms as well as concurrent stress, anxiety and/or low mood symptoms and improve their general well-being. This is a pilot feasibility study. Therefore, feedback from officers who take part in this study will offer insights into which types of de-arousal strategies are more helpful in managing symptoms and improving well-being. The data from this study will also contribute to enhancing work towards organisational change in the police force.