ANZCTR search results

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.

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.

The primary purpose of this research is to evaluate potential benefits of thickening the soft tissue (gums) that surround dental implants, by placing a soft tissue substitute at the time of implant placement. The application of the soft tissue substitute may minimise the amount of bone loss that occurs following implant placement in the presence of thin soft tissue/gums (known as thin mucosal phenotype). Thin mucosal phenotype is observed when the thickness of the soft tissue (gums) at the planned implant site is 2mm or less. It has been demonstrated that a minimum thickness of the gums is required around dental implants, if this is not present loss of bone may occur around the shoulder/collar of the implant (the part of the implant closest to the surface), This occurs to accommodate an increase in thickness of the gums. This study is evaluating the differences in marginal bone level changes which occur in the first 12 months after the implant is restored (a crown is placed on the implant), in sites which receive a soft tissue substitute at the time of implant placement (group 2), compared to sites which receive implant placement alone (group 1- this is the usual treatment approach). Study participants will be randomised to one of these treatment groups.

The research project is testing a new imaging/treatment device for use during breast conserving surgery, involving the use of a medical device called ORM-P2 System. The purpose of this study is to find out if it is safe to use the ORM-P2 System during breast conserving surgery for patients with breast cancer. Who is it for? You may be eligible for this study if you are a woman aged 18 years or older, you have been diagnosed with invasive or in situ breast cancer and you are eligible to undergo breast conserving surgery as part of your cancer treatment. Study details All participants who choose to enrol in this study will be asked to attend three study visits scheduled over a 4 month period. The first visit will be a screening visit to determine whether you are eligible to enrol in the study. Those participants who are eligible to enrol will continue with their standard cancer care and will be scheduled for a breast conserving surgery. The surgery will be undertaken per standard protocols, with the addition of the ORM-P2 medical device. During the surgery, a clinician will use the device to scan the breast tissue. The device will provide images on the tissue's optical and mechanical properties on a micro-scale. Use of the device is anticipated to add 5 to 10 minutes to the overall surgery time. At 4 weeks after the surgery, participants will be asked to attend a final study visit where a surgical review and adverse event assessment will be undertaken. It is hoped this research will determine whether use of the ORM-P2 System is effective at differentiating tissue types remaining in the surgical cavity.

In postmenopausal women, the follicle stimulating hormone (FSH) is elevated. Elevated FSH has been shown to accelerate aging, as high FSH leads to decreased bone mass, reduced muscle mass and increased fat mass, as well as to increased risks of diabetes, metabolic syndrome, kidney dysfunction, heart disease and Alzheimer’s disease. ALG-801 has been designed to block certain proteins within the transforming growth factor-beta (TGF-ß) family, including activin A and activin B, which stimulate FSH release. By blocking these proteins that control the release of FSH hormone, the effects of elevated FSH on bone loss, muscle atrophy, fat accumulation and insulin resistance may be reduced. This clinical study is designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of ALG-801 in healthy postmenopausal women who meet the eligibility requirements. This study is a multiple ascending (increasing) dose study where approximately 32 participants will be randomized to receive 4 doses of the study drug or placebo over a period of 4 weeks. The primary objective of this study is to establish safe dose levels of ALG-801 in healthy postmenopausal women following multiple dose administration, and secondarily to evaluate the influence of ALG-801 on biomarkers of bone turnover and muscle mass.

The aim of this study is to assess the safety and efficacy of a novel anti-cancer drug called SON-DP in patients with advanced or metastatic solid tumours that have relapsed or are not responding to standard treatment. This novel anti-cancer drug is different from the traditional cancer cell killing drug as it is expected to transform cancer cells into normal tissue cells via a SON-DP induced cancer cell reprogramming and re-differentiation process. Who is it for? You may be eligible to join this study if you are aged 18 years or older, and you have a histologically confirmed locally advanced or metastatic solid tumour that is relapsed or not responding to currently approved therapies. Study details All participants will be treated with SON-DP administered via a 90 minute intravenous infusion twice per week in 28-day cycles, for a maximum of 6 cycles. The first few participants enrolled will start at a low dose, and will be assessed for safety and anti-cancer activity of the drug. If determined to be safe, the next participants enrolled will receive a higher dose level, or alternatively will receive a lower dose level if side effects are experienced. For the duration of treatment and up to 1 month after completing treatment, participants will undergo blood tests and imaging to determine the safety and anti-cancer efficacy of SON-DP. Participants may also be asked to undergo tumour biopsies, although this will be voluntary for participants receiving lower dose levels. It is hoped that this study will show that this novel drug is safe and effective for the treatment of patients with advanced or metastatic solid tumours that have relapsed or are not responding to standard treatment. The information in this phase 1a study will be used to determine the optimal dose of SON-DP for future treatment of similar patients.

Members of the LGBTQIA+ (lesbian, gay, bisexuals, transgender, queer, intersexual, asexual, plus other gender, sexual, or romantic minority identities) are at higher risk of poor mental health. One therapeutic approach that has been shown to improve mental health for this community is Acceptance and Commitment Therapy (ACT). In addition, digital programs that promote mental health have been shown to be effective and acceptable in this community. This project aims to conduct the first randomised control trial (RCT) evaluating a digital mental health promotion program underpinned by ACT with the LGBTQIA+ community. The intervention used in this program is called YOLO (You Only Live Once), which has demonstrated efficacy in improving mental health with university students. Findings from this RCT will inform changes necessary to the YOLO program to co-design a world-first digital ACT program for LGBTQIA+ people. This trial will involve three distinct phases. Phase 1 involves the quantitative evaluation of efficacy based on self-report data on measures of mental health and ACT processes. This will determine the efficacy of the program to improve mental health. Phase 2 involves the qualitative analysis of feedback provided during YOLO modules. Phase 3 involves interviews with participants about their experiences with the YOLO program and desired changes. Both phases 2 and 3 will inform changes to the YOLO program to make it more LGBTQIA+ affirming in future projects. This research is guided by six research questions: Question 1: Will the YOLO program be associated with improved mental health for members of the LGBTQIA+ community compared to a waitlist control? Question 2: What changes will participants recommend to improve the usability of the program and make it LGBTQIA+ affirming? Question 3: Will the YOLO program improve ACT processes for members of the LGBTQIA+ community compared to a waitlist control? Question 4: Will ACT processes mediate the mental health changes that occur during the RCT? Question 5: Does completion rate influence the mental health outcomes experienced during the RCT? Question 6: Do changes in ACT processes mediate the relationship between LGBTQIA+ minority stress and mental health outcomes? In brief, we hypothesise that completing the program will improve the mental health of participants. We anticipate high usability, but a myriad of changes recommended to make the program more affirming. We further predict that ACT processes will improve throughout the trial and that these changes will influence the mental health outcomes gained. As well, we predict that completion amount of the program will influence the mental health outcomes and changes in ACT processes reported, in that those who complete all modules will report higher mental health and ACT process changes. We finally predict that the relationship between LGBTQIA+ minority stress and mental health will be influenced by ACT processes.

This study aims to compare the agreement in echocardiographic findings between and within three defined groups: cardiac sonographers, junior clinicians and senior clinicians, when performing transthoracic echocardiography on critically unwell patients. This information is vital when comparing scans performed by different operators and making clinical decisions based on the differences between the two scans.

Women will be recruited from the Women's and Children's Hospital GDM clinic. At enrolment, participants will be asked to complete the following measures: height and weight, blood pressure, non-fasting blood test, a web-based dietary survey, and a 5-item questionnaire on behaviour change. Women will then be randomised to the control (standard GDM care) or the intervention group (standard care + personalised dietary advice and health coaching). The intervention group will receive guidance on food choices to increase intake of whole fruits, vegetables, and nuts, decrease intake of ultra-processed foods, and modify cooking oils. Dietary advice will be culturally informed. At 36-38 weeks pregnancy, participants will be asked to repeat the measures they completed at baseline. The feasibility of the recruitment criteria and acceptability of the intervention will be evaluated.

State-based Guidelines were issued for Early Childhood Education and Care (ECEC) services recommending greater time outdoors and inclusion of indoor-outdoor programs to facilitate social distancing to reduce spread of COVID-19. The aim of this 3-arm randomised controlled trial was to examine the impact of different dissemination strategies on increasing ECEC service intentions to adopt recommendations from the Guidelines. The intervention was designed to address key determinants of guideline adoption including awareness and knowledge. Participants were randomly assigned to receive either a generic email (control group) or an email that included a link to an e-newsletter or animated video (intervention groups) with further information regarding the Guidelines. It was hypothesised that services receiving the e-newsletter or animated video would have a greater intention to adopt the Guidelines. Following delivery of the intervention in September 2021, services were invited to participate in an online or telephone survey from October-December 2021. This study found potential for the inclusion of interactive strategies to disseminate policy and guideline information within the ECEC setting, in the context of the need for rapid communication. Further research should explore the added benefits of embedding such strategies within a multi-strategy intervention.