ANZCTR search results

A recent review has indicated that apps have the potential to improve suicidal thinking. However, poor engagement—defined as suboptimal levels of sustained use of an intervention by its intended users—has been recognised a major challenge to the dissemination of digital mental-health interventions (DMHIs) in real world-settings. In order to develop engagement strategies that are sensitive to the needs of intended users, we have engaged young people with lived experience (via survey, interview, and workshops) to co-design the content modifications to LifeBuoy - a smartphone app to help young people manage suicidal thoughts - as well as digital engagement strategies for the current study. This project aims to (i) assess the efficacy of the LifeBuoy app in reducing suicide ideation across time, and (ii) examine the efficacy of a digital engagement strategy on app engagement across time. The research questions that this study seeks to address are as follows: Co-Primary Research Questions 1) Is the LifeBuoy app efficacious in reducing suicide ideation across time, relative to a placebo attention control condition? 2) Is the proposed digital engagement strategy efficacious in promoting greater engagement with the LifeBuoy app across time, relative to a LifeBuoy-only control condition? Secondary Research Questions 1) Is the LifeBuoy app efficacious in reducing incidents of suicide attempt and non-suicidal self injury across time, relative to a placebo attentional control condition? 2) Is the LifeBuoy app efficacious in reducing symptoms of depression and anxiety across time, relative to a placebo attention control condition? 3) Is the effect of the LifeBuoy intervention for suicidal ideation is greater among those in the engagement strategy condition, relative to the effect seen for the LifeBuoy-only condition at post-intervention?

This project aims to determine the best surgical method of suspending the vagina after hysterectomy for pelvic organ prolapse. This will be measured by checking for symptomatic and objective recurrence of prolapse at multiple time points after the surgery. Participants will include all those with symptomatic POP requesting hysterectomy as part of the surgical management for their symptoms. Patients will be recruited from public and private clinics and surgeries will be performed by gynaecologists or accredited trainees. Participants will be randomised in equal probablity to a vaginal or laparoscopic approach for hysterectomy and the subsequent suspension of the vaginal vault (apex). There is a strict surgical protocol for surgeons to adhere to and patient will undergo subjective and objective assessment prior to surgery and then at several timepoints post surgery. We expect to identify that both methods of vaginal suspension are equivalent based on the primary outcome

The global impact of COVID-19 has been profound, and the public health threat it represents is the most serious seen in recent pandemic history. Thus, concerns about COVID-19 are pervasive and have several serious adverse impacts on the mental health of health workers and the general community. There is an urgent demand for programs that can address the stress experienced by people during the COVID-19 pandemic. This situation does not require therapy because these personnel do not necessarily suffer from a mental disorder. Instead, there are huge numbers of people who are facing unprecedented levels of stress and require strategies to manage this stress. A suitable and evidence-based program that helps to cope with stress in times of crisis is the Coping with COVID (CWC). As a low-intensity intervention for adults affected by the pandemic, this program teaches people well-documented strategies to manage stress. This project aims to conduct a rapid trial of a brief psychological intervention, termed CWC to reduce distress associated with concerns about COVID-19. There is an urgent need for publicly available strategies to reduce COVID-19 related distress. This project does not aim to treat a mental disorder but rather alleviate distress and improve coping in people with distress about COVID-19. The most common mental health programs implemented in the pandemic are videoconferencing-delivered programs and app programs. This trial compares the efficacy of these two types of programs by comparing CWC and a proven mental health app program. We hypothesise that CWC will result in greater reductions in anxiety, depression, and worry relative to the app to manage distress. Adults who screen positive for psychological distress will be randomized to PM+ or a control condition. PM+ will comprise 6 x 60-minute sessions delivered by a clinical psychologist via teleconferencing to groups of 4 people at a time. The control arm will direct people to a portal with stress coping strategies. All participants will be assessed at baseline, post-intervention, and 3 and 6 months follow-up.

The present research is evaluating the efficacy of an app-based prevention and early intervention program (SEED) targeting eating disorder symptoms in adults. Developed by the WIRED project, the SEED app is a 10-week eHealth intervention which integrates cognitive behavioural techniques, psychoeducation, media literacy, and acceptance and mindfulness relaxation with the aim to modify participants’ attitudes and behaviours relative to their body image and eating/exercise habits. The randomized controlled trial will compare three conditions: (1) waitlist control group, (2) self-guided use of our intervention app (WIRED), and (3) tailored use of our intervention app (i.e., matching content based on participant’s symptom profile at baseline and also during the intervention phase). We hypothesize that, compared to a waitlist control condition, the two WIRED intervention groups will demonstrate improvements in eating disorder symptoms and related secondary outcomes and indicate cost-effectiveness of the intervention, with pronounced improvements in the tailored WIRED group relative to the self-guided WIRED group.

Cutaneous Actinic Keratosis (AK) and Intraepidermal Carcinoma (IEC) lesions are precursors of skin cancer. This study aims to assess the effectiveness of 5FU (EfudixTM) skin cream alone, compared to a combined 5FU-calcipotriol skin cream, for treating these skin cancer precursors. Who is it for? You may be eligible for this study if you are aged between 18 to 85 years, and you have skin cancer precursors of AK and IEC lesions. People who have been diagnosed with skin cancer will not be eligible for this study. Study details All participants who choose to enrol in this study will be asked to apply the single skin cream on one side of the face, and the combined skin cream on the other side of the face. Each cream will be applied twice daily. The single cream will be used for 2-4 weeks, as tolerated; while the combined cream will be used for 4-6 days. The allocation of the side of the face (left/right) to the cream treatment will be random. After 3 months, 1 year, and 2 years, we will ask for your preference of either the single or double cream, and assess changes in the skin cancer precursor lesions. It is hoped this research will determine the effectiveness of a combined skin cream in treating skin cancer precursors, which may reduce the risk of developing skin cancer.

Phase 2 of the study will assess glucose sensing accuracy of the investigational Pacific Diabetes Technology (PDT) combined continuous glucose monitor (CGM) and insulin delivery device, and compare post meal glycaemia with the EOPatch pump automated insulin delivery (AID) system with a commercially available closed loop system (Tandem Control-IQ system). We hypothesize that the PDT sensor is able to measure interstitial glucose accurately without being affected by the preservatives in insulin. We hypothesize that the EOPatch pump is as effective at reducing post-prandial blood glucose excursions in persons with Type 1 diabetes compared with a commercially available closed loop system (Tandem Control-IQ system).

COVID-19 was declared a global pandemic in March 2020. Australia promptly adopted a range of strategies that successfully controlled the spread of COVID-19, but they involved severe limitations of social interactions of all kinds, including whether people could work and buy food. Our study aims to determine how the COVID-19 pandemic affected the daily activities and quality of life of Australians, and who was affected most. Our goal is to understand more broadly the impact of pandemics on all Australians. This may help communities, governments and other organisations in planning for future pandemics. Sampling, recruitment, survey administration and data collection will be conducted by Survey Engine (surveyengine.com) via an online panel of respondents.

Acute severe behavioural disturbance (ASBD) is an emergency situation where a patient experiences severe agitation or aggression. One of the common strategies used to manage those presenting to the emergency department (ED) with ASBD is the provision of medications. Medications assist in allowing the young person to gain control over their behaviour. In most instances, oral medications are used. For a small proportion of young people with ASBD, their emotional dysregulation is so extreme that they are unable or unwilling to accept oral medication and, therefore, IM medication is required to de-escalate their behaviour. In individuals less than 18 years of age, there is no evidence available to guide doctors about which medications are the most effective, despite them being commonly used to manage ASBD. It is also not known how well these medications are tolerated by young people. Therefore, the primary aim of this study is to determine whether, in children and adolescents with ASBD, IM olanzapine is more effective than IM droperidol at achieving successful sedation (i.e.: a state of calm) at 1 hour after randomisation. These medications were chosen as they are the two of the most commonly used medications in Australia. This study will be a randomised, open label, multi-centre effectiveness trial which will enrol young people aged 9 to 17 and 364 days presenting to participating EDs with ASBD. We hope to determine which medication is most effective and to assess the side effects of these medications. We hypothesise that 15% more children will achieve successful sedation 1 hour after randomisation to olanzapine compared to those children who were randomised to droperidol.

When hospitalised, patients with infective pulmonology often require some form of breathing support: oxygen administered using different delivery modes (nasal prongs, high flow nasal cannula, The currently limited data suggests that each of these strategies increase the spread of exhaled droplets, with the distance and direction-dependent upon the specific strategy, resulting in an increased viral transmission risk if this patient is still infective. Therefore, it is necessary to determine droplet spread from human patients with each of the respiratory support strategies administered to patients with a viral infection, so that protective measures can be adapted accordingly to protect staff and other patients in the hospital. We hypothesise that the administration of respiratory support will increase the number of detected respiratory aerosol particles detected around the study subject.

Acute severe behavioural disturbance (ASBD) is an emergency situation where a patient experiences severe agitation or aggression. One of the common strategies used to manage those presenting to the emergency department (ED) with ASBD is the provision of medications. Medications assist in allowing the young person to gain control over their behaviour. In most instances, oral medications are used. In individuals less than 18 years of age, there is no evidence available to guide doctors about which medications are the most efficacious, despite them being commonly used to manage ASBD. It is also not known how well these medications are tolerated by young people. Therefore, the primary aim of this study is to determine whether, in children and adolescents with ASBD, oral olanzapine is more effective than oral diazepam at achieving successful sedation (i.e.: a state of calm) at 1 hour after randomisation. These medications were chosen as they are the two most commonly used medication in Australia. This study will be a randomised, open label, multi-centre effectiveness trial which will enrol young people aged 9 to 17 and 364 days presenting to participating EDs with ASBD. We hope to determine which medication is most effective and to assess the side effects of these medications. We hypothesise that 15% more children will achieve successful sedation 1 hour after randomisation to olanzapine compared to those children who were randomised to diazepam.