ANZCTR search results

The primary purpose of the study is to determine whether frequent milk removal and phone support across the first three weeks after birth improves both breastfeeding outcomes and maternal fetal health outcomes for women at high risk of low milk production. The study is a randomised control trial (RCT) with 180 participants. Women who are antenatally identified as being at high risk for lactation difficulties will be eligible for the trial. They may have one or a combination of the following health factors, overweight or obesity defined by pre-pregnancy BMI, pre-existing diabetes mellitus, gestational diabetes mellitus (GDM), polycystic ovarian syndrome (PCOS), intrauterine growth restriction (IUGR), pregnancy induced hypertension, preeclampsia and previous history of low unexplained breastmilk supply, The intervention arm (n=90) will receive individual education about frequent feeding and removal of milk from the breast after birth, provision of an electric hospital grade pump in late pregnancy for ease of access post birth and postpartum phone support from an IBCLC every days 3- 4 days for 3 weeks. In contrast, the control arm (n=90) will only receive individual education about frequent feeding and removal of milk from the breast after birth. The primary outcome of the trial is 24 hour milk production at 2 and 6 weeks postpartum. Other data to be compared between the two groups over the 12 months are: - Exclusivity and duration of breastmilk feeding - Incidence and duration of acute infant infections - Anthropometric data on the infants - Maternal physical and emotional health The study will also investigate changes in breastmilk composition associated with low breastmilk production at 1, 2 and 6 weeks. The study hypothesis is that women who are provided with regular telephone support to regularly remove milk through breastfeeding +/- pumping during the first 3 postnatal weeks, and are loaned an electric hospital grade breast pump, will have a higher milk production volume at 2 weeks and 6 weeks postpartum than those who do not receive regular telephone support and an electric hospital grade breast pump.

Toe pressures will be measured at the patients initial visit at Blacktown High Risk Foot Service and will then be asked if they are able to cease smoking for 12 hours prior to their next appointment, and toe pressures measured again. Factors such as smoking history, cigarettes per day, years smoking, and other medical history will be taken. At the end of the study period, this will allow us to assess the direct affect of acute smoking on toe pressures.

Linguistic markers generated from within individuals’ text data may present a new way to identify individuals who are experiencing depression and anxiety. The MyMood&Me study aims to explore the potential of text data for producing reliable linguistic markers of depression, anxiety, and suicidal ideation among adults with mental illness. Our aim is to learn how whether the way individuals construct their sentences (i.e., how they write, rather than what they write) can indicate feelings of depression, anxiety, and thoughts of suicide. To investigate this, adults with depression will be invited to participate in a 9-week randomised crossover pilot trial in which they complete fortnightly symptom scales for depression and anxiety (PHQ-9, GAD-7), while being allocated to a random sequence of writing tasks. The writing tasks are varied in their emotional anchoring, and participants are instructed to write freely for approximately ten minutes. Upon completion of the study, individuals’ linguistic features will be extracted from the text data using the LIWC tool. Bivariate and multivariate analyses will be performed to investigate the correlations between the linguistic features and symptoms between subjects. Multivariate analyses will be used to explore the relationship between symptoms and linguistic expression within subjects throughout the study period. Descriptive analyses will examine the impact of writing tasks on participant burden. Together, these results will provide initial evidence to support the use of text tasks for generating linguistic markers of depression, anxiety, and suicidal thoughts, and determine the type of text task (e.g., SMS, social media posts, expressive writing) most useful and engaging for participants to undertake. If the brief writing tasks are deemed acceptable and engaging, this may present a new way to monitor participants’ response to therapy, including tracking recovery and relapse.

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.