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Depressed new fathers rarely access traditional support services and their symptoms go largely unacknowledged and untreated. We aim to evaluate the efficacy, in a randomised controlled trial, of a new online treatment for postnatal depression in men ('DadBooster'). DadBooster is a 6-session only treatment program for paternal postnatal depression that was co-designed with fathers. Previous research confirms that symptoms of depression can be reduced through internet interventions, but no research has examined the efficacy of such interventions specifically for the treatment of depression in fathers with a new baby. We aim to test whether the newly developed DadBooster online program is effective in reducing the severity of symptoms of depression and anxiety compared to standard care. We hypothesise a reduction in depression symptom severity of >50%. Fifty depressed fathers will participate, with 25 randomly allocated to receive the DadBooster program immediately and 25 allocated to a waitlist control condition, receiving standard care and being offered DadBooster at the end of the study. The primary outcomes are depression symptom severity and remission from a diagnosed depressive episode at 12-weeks post-enrolment.

It has been shown that one-third of patients are not engaged in discharge conversations with health care professionals; receiving large volumes of one-way information, immediately prior to being discharged home. Once home, patients identify medication-related problems that they would have liked to voice in hospital or learn more about in hospital. The purpose of this study is to develop and pilot test an intervention that enhances patients’ discharge medication literacy and communication. The primary aims of this study are: * To assess the feasibility of study processes and the intervention to inform a future effectiveness trial. * To assess patients’ and healthcare professionals’ perceptions and experiences of intervention acceptability. This is a single site pilot randomised control trial. A group of consumers and healthcare professionals co-designed the intervention which is a poster placed in the patient’s room. The poster has 3 QR codes, which when scanned, take the patient to: 1) an online search engine to find out more information about medications; 2) a website with information patients may need to help manage their medications once home; and 3) an online question builder to encourage patients to ask questions about their medications in hospital.

This is a first-in-human (FIH) study to assess the safety, tolerability and pharmacokinetics of single-dose study of NP-201 acetate injection in healthy volunteers, Approximately 32 participants (8 participants per dose group) will be randomized across 4 sequential treatment dose groups. Participants will be randomized to receive either the NP-201 acetate or the placebo in a ratio of 6:2 (6 participants will receive the IP and 2 participants will receive the placebo). The study consists of screening (Day - 35 to Day -2), Baseline (Day -1), end of study visit (Day 29). Oversight of the study will be provided by a safety monitoring committee (SMC) comprising of the PI, local Medical Monitor (MM), and the Sponsor’s MM.

Over their lifetime, 15% of Australians will experience major depressive disorder or bipolar disorder. Of those who access treatment, 20–50% will not achieve symptom remission with standard therapies. There is now consistent and compelling top-tier efficacy data from controlled research settings that lifestyle interventions targeting diet, exercise, sleep and/or substance use can improve the symptoms of mental disorders. Despite these significant advances and its enormous potential to alleviate the burden on GPs and psychological service providers, lifestyle-based mental health care is not available as part of mainstream mental health care. There are a range of complex reasons for the evidence–translation gap, one critical deficit is that almost no data exist from real world settings that compare effectiveness to standard care for individuals presenting to their GP with clinical depression. The HARMON-E Trial is a nationwide, non-inferiority trial that aims to determine the effectiveness of a group-based lifestyle program for reducing depressive symptoms compared to group-based psychotherapy. Participants include adults who have a diagnosis of either major depressive disorder or bipolar disorder, who are randomised to receive six telehealth group-based sessions with either psychologists for the psychotherapy arm, or a dietitian and exercise physiologist for the lifestyle arm. It is hypothesised that changes in mental health symptom outcomes for participants in the lifestyle program will not be inferior to those in the psychotherapy program.

This Phase 1 study will comprise a single group conducted in up to 8 participants who will receive a single dose of EmtinB in an open-label fashion. In addition to safety, tolerability and pharmacokinetics (PK), a single cerebrospinal fluid (CSF) sample will be collected from each participant via lumbar puncture to assess the ability of EmtinB to cross the blood brain barrier.

Community pharmacies are accessible health services where the public can access the ECP over-the-counter and have their MS-2 Step prescriptions for EMA filled. All women should receive information about and be offered effective contraception as part of their care when seeking ECP and EMA: this is because delayed contraceptive provision is associated with higher odds of repeat unintended pregnancy. The study's primary aim is to compare the subsequent uptake of effective contraception (hormonal or intrauterine) in women seeking EC or MS-2Step medicines, who receive the ALLIANCE community pharmacy-based intervention with those who do not receive the intervention. We will utilise a pragmatic stepped-wedge cluster randomised trial across three Australian states. In the intervention phase, women purchasing EC or medical abortion medicines will be offered contraceptive counselling and referral to contraceptive providers when appropriate. Pharmacists will be supported through: online education, academic detailing (co-designed with consumers and pharmacy stakeholders), assistance identifying referral pathways, peer-support through AusCAPPS online community of practice and remuneration. It is anticipated that this trial will equip community-based pharmacists with the resources, networks, knowledge and skills to expand their scope of practice to include the delivery of high-quality, patient-centred, effectiveness-based contraceptive counselling. This will result in improved access to and more effective use of contraception by Australian women, and reduce their risk of subsequent unintended pregnancy after ECP or EMA.

This is a first-in-human, Phase 1, single-center study that will evaluate single ascending doses (SAD) and multiple ascending doses (MAD) of EmtinB conducted in 2 parts. Part 1 (SAD) of this study will be conducted in approximately 40 healthy participants in up to 5 groups. Each group will consist of up to 8 participants who will be randomized to receive a single dose of EmtinB or placebo. Part 2 (MAD) of this study will be conducted in approximately 32 healthy participants in up to 4 groups and will commence after safety data for the highest dose in the SAD phase has been evaluated. Each group will consist of up to 8 participants who will be randomized to receive 7 daily doses of EmtinB or placebo.

Vaginal prolapse is a common problem with approximately 1 in 10 women in the developed world requiring prolapse surgery in their lifetime . The problem has a myriad of symptoms ranging from mild discomfort to being very problematic and having a huge impact on quality of life. Surgery is generally seen as a last resort for managing vaginal prolapse, especially if a conservative method has been tried (eg: vaginal pessary device). However, the results of surgery alone are not perfect, and some women will develop recurrent prolapse or not be satisfied with the result. The thought of having a vaginal pessary device inserted at the end of the operation is for the pessary device to take tension away from the native tissue and suture lines and hence improve tissue regeneration, healing without scarring, leading to better surgical results and patient satisfaction. This could revolutionize the way we manage our level 1 and level 2 repairs and may result in better surgical outcomes, lower prolapse recurrence and better quality of life for our women in the long term. This study is to determine if having a vaginal pessary device (shaatz pessary) inserted intraoperatively at the end of vaginal prolapse surgery temporarily for 4 weeks will improve surgical results and patient satisfaction.

Orygen Virtual Worlds (OVW) is a project aimed at developing and testing an innovative and engaging prototype for an online, virtual platform to help the delivery of mental health treatments for young people with mental health difficulties. In a time of increasing reliance on digital delivery of mental health care, we propose this major opportunity to build on previous work to develop a standalone, purpose built, online virtual world. OVW aims to increase engagement and provide therapy to an isolated and disadvantaged patient group. A prototype of the OVW platform has been developed using user centred design principles, alongside a group of 10 - 15 young people and 6 clinicians to ensure it is purpose built to fit their needs. The current trial aims to evaluate the feasibility, acceptability and usefulness of the platform for delivering standard treatments (individual, group and peer therapy).

After a new stroke, the presence of physical disability, loss of employment, inability to participate in pre-stroke activities, social isolation, anxiety and depression make returning to the community difficult. Many people living with stroke have ongoing disability and report extreme problems in their quality of life. The purpose of this project is to develop and evaluate the feasibility of providing a co-designed, hospital-initiated follow-up service to support people living with stroke. This service is designed to prioritise support to people who are registered in the Australian Stroke Clinical Registry and report unmet needs and extreme health problems on a patient-reported outcomes survey collected between 90-180 days of discharge from hospital after a new stroke. Following the design and an initial non-randomised piloting of the intervention components (not registered separately) in up to 5 patients at one hospital to enable refinements to the clinical tools and protocol, we seek to complete a multicentre, randomised controlled pilot trial. In up to 6 hospitals and with approximately 100 eligible patients randomised to either usual care or the intervention we will test the feasibility and acceptability of this proposed follow-up service. Our study includes a process evaluation and cost consequences analysis to inform future scaling of the intervention including providing an understanding of the costs to provide the service in terms of the type of patient benefits may be achieved. The outcomes of this study may also be used to inform undertaking a fully powered effectiveness study. We seek to proactively use registry data to provide more tailored support for survivors of stroke who have reported extreme unmet needs and direct them to relevant services.