ANZCTR search results

Participants will be randomly allocated to either treatment or control conditions. All participants will be asked to complete a number of pre-treatment questionnaires. These questionnaires will measure stress, burnout, resilience, mood, and related factors. Those participants allocated to the treatment condition will then be provided with access to the online intervention. The intervention will consist of 6 online modules (each of approximately 30-45 minutes duration) that focus on stress management techniques, emotion monitoring and regulation techniques, and selfcare. Participants will have access to one module per week over a six week period. At the start of each module they will also be asked to answer a small number of questions relating to their mood and engagement with skills learnt in the previous module. Participants allocated to the control condition will not be given access to the intervention at commencement of the study. At the end of the six week intervention period, and again three months following the intervention, both control and intervention participants will be asked to complete a small number of questionnaires measuring the same constructs as at pre-intervention, with the addition of a small number of questions relating to satisfaction and experience with the program.

Anxiety and depression are common in the perinatal period (i.e. during pregnancy and the first year after childbirth). Postnatal depression and anxiety disorders affect around 15% of women, with up to 45% of cases beginning in pregnancy (e.g., Austin et al., 2010). Early evidence shows that iCBT is effective for reducing postnatal depression, anxiety, general distress and parental distress (Danaher et al., 2013; Pugh, Hadjistavropoulos, & Dirkse, in press). Tailored iCBT programs are needed to provide women in the perinatal period with practical coping skills to manage depression and anxiety symptoms, as well as deal with the unique difficulties they may face which can impact on depression and anxiety (e.g. complications during pregnancy and/or delivery, body image, difficulty breastfeeding, an unsettled baby, and unrealistic expectations about motherhood). The primary purpose of this pilot trial is to evaluate and gather feasibility of a newly developed internet-delivered cognitive behaviour therapy (iCBT) program, the Perinatal MUMentum Program. Postpartum Pilot will be conducted as a feasibility exercise to get feedback and evaluation on the efficacy and acceptability of an iCBT program tailored to maternal anxiety and depression experienced during the postpartum period, prior to commencing a larger randomised trial. The main hypothesis to be tested for Postpartum Pilot is as follows: 1. Internet cognitive behavioural therapy delivered during the postpartum period will significantly reduce symptoms of anxiety, depression, distress and disability. It is hoped that the findings of this trial will provide further information regarding the efficacy and acceptability of the Perinatal MUMentum Program- in reducing maternal anxiety and depression experienced during the perinatal period- before embarking on a larger RCT.

This study aims to evaluate the efficacy of fractional microablative carbon dioxide (CO2) laser for the treatment of vaginal atrophy in in post-menopausal women with breast cancer on aromatase inhibitors. Who is it for? You may be eligible to join this study if you are a post-menopausal female aged 18-75 years who has completed curative intent surgery and/or chemotherapy and/or radiotherapy for hormone-positive early-stage breast cancer. You will also need to be currently taking an aromatase-inhibitor for a minimum of 6 months and have reported symptoms of genitourinary syndrome of menopause (GSM) such as vaginal dryness or painful intercourse. Study details All participants in this study will receive three treatment sessions scheduled four weeks apart of fractional microablative CO2 intra-vaginal laser (MonaLisa Touch 'Trademark') MonaLisa Touch 'Trademark' is an adjustable probe inserted into the vagina that emits laser energy onto the surface of the vaginal wall to stimulate healthy tissue production and improve blood circulation. This process aims to restore the tissue to its form before you went through menopause and needed to take aromatase inhibitors. The procedure is performed by a gynaecologist (women’s health specialist) and takes approximately 10 mins. No medication or anaesthetic is required beforehand. To assess if fractional micro ablative CO2 laser is an effective in improving vaginal atrophy in women with breast cancer on aromatase inhibitors, a small tissue sampling (vaginal biopsy) under local anaesthetic and vaginal surface scraping (vaginal cytology) will be taken before and at 12-weeks after after completion of treatment for comparison. In addition, participants will be asked to complete questionnaires to assess severity of GSM symptoms and sexual functioning before and at 12-weeks after completion of treatment. Whilst fractional CO2 laser has demonstrated improvement in GSM symptoms in a general population of women, no current literature exists describing the impact of this intervention in a population of post-menopausal women with hormone-positive breast cancer on aromatase inhibitors. In this population, there are no effective long-term strategies to manage GSM.

Current evidence suggests exercise plays an important role in the management of blood glucose levels for individuals with T2DM. The frequency of consecutive exercise session over a two-week period on glucose regulation is not well understood and limited. Previous research have investigated either combined exercise or a single mode of exercise on glucose tolerance, However the comparison of 12 consecutive session of exercise remains limited, especially in a clinical population of type 2 diabetes. We seek to determine how effective treadmill exercise is in managing glucose tolerance since walking/running is freely accessible without the need to sign up to a gym. It is now understood that type 2 diabetes is associated with a chronic state of inflammation. Recent evidence have shown that exercise is beneficial in improving inflammation along with reducing insulin resistance. We aim to identify the influence of exercise on the level of inflammation and glucose tolerance following a two-week training period. Findings of this study may help inform future exercise prescription to improving health status in this population.

To investigate whether using Virtual Reality distraction (using a computer simulation of an environment) can reduce the pain and distress children aged 4 – 11 year olds experience during needle based procedures. In addition, will determine whether Virtual Reality has an impact on the amount of anxiety parents feel about what their children are experiencing, procedural time and number of needle attempts.

The primary purpose of this study is to analyse the differences in language used by clinicians and melanoma patients of different socioeconomic statuses (SES) and between male and female patients. Who is it for? You may be eligible to take part in this trial if you are aged 18 or over and have been diagnosed with melanoma for which you are scheduled to attend your first consultation at one of the study sites. All participants enrolled in this study will have a single consultation with their clinician (surgeon/oncologist/nurse, etc.) audio recorded. This audio recording will then be analysed for different types of language used, including phrasing of questions, the control of 'turn taking' and expression of degrees of probability. Researchers will then look for patterns between patients of low and high SES, and between males and females. It is hoped that the findings from this study will provide information on the communication used by clinicians with melanoma patients, and how this communication differs between people with different SES statuses, and between men and women.

Advance Care Planning (ACP) is a process of reflection, discussion and communication that enables a person to plan for their future medical treatment and other care, for a time when they are not competent to make, or communicate, decisions for themselves. ACP could significantly improve the quality of care provided to patients with advanced illnesses. ACP allows patients to have a voice, to receive patient-centred care, in the setting of their choice, and avoid unwanted hospitalisations and inappropriate treatments. The importance of ACP in patient care has been widely recognised. The Australian Government National Health and Hospitals Reform Commission (2009) recommended the implementation of a national program of ACP in Australia. ACP has been widely endorsed by a large number of professional groups, specialist colleges, peak bodies and patient advocate groups. The NSW Health’s policy on ACP is outlined in the 2013 document ‘Advance Planning for Quality Care at End of Life: Action Plan 2013-18’. Among others, it shows that NSW Health’s priority is to: (i) incorporate ACP into routine care; (ii) educate health professionals in both conducting and responding to ACP; and (iii) improve collaboration between NSW clinical services and community and primary care health professionals. The policy also noted deficiencies that currently exist in NSW Health clinical services in identifying and recognising patients who might be at risk of dying in the near future. The intervention is informed by the Diffusion of Innovation Theory. This theory states that for innovation to be taken up, five conditions need to be met - relative advantage, compatibility, complexity (how difficult the innovation appears), trialability and observability (whether positive outcomes of the innovation can be observed). This means that didactic education sessions alone are unlikely to be sufficient to lead to significant increase in ACP undertaken by health professionals. This intervention will allow clinical services to ‘see’ a few, ‘do’ a few, and ‘teach’ a few, thereby embedding ACP firmly into routine care of patients. GPs of participating patients will be exposed to ACP documents and information material; the chance of them engaging with the educational material is significantly increased because they relate to their own patients. This research aims to trial and evaluate on patients attending NSW hospital clinics with advanced illnesses identified as potentially having supportive and palliative care needs, a model of ACP that seeks to: (i) increase the uptake of ACP by patients; and (ii) encourage NSW Health clinical services and GPs and other health professionals providing care for the patients to incorporate ACP into routine care. This study seeks to determine if this model of ACP will reduce acute health resources utilisation; improve the quality of care for patients and caregivers/family; and result in improved understanding and uptake of ACP by health professionals.

Our research team has recently been awarded an Australian Mental Health Award by Beyondblue and the Movember Foundation that will fund a program of research aimed at developing and evaluating a range of new e-health interventions for men. The study aims to evaluate a comprehensive online training program for managers in male-dominated industries to determine its effectiveness in modifying manager's behaviour, improving mental health literacy, reducing stigma and enhancing managers’ confidence in discussing mental health matters with their staff. Managers have a key role in the well-being of their staff. They often become involved when a staff member is having difficulties and should always have a role once someone is away on sickness absence. However, managers often report feeling unsure what to do when a staff member is ill, particularly if they are suffering from a mental illness. These problems are amplified in male-dominated industries, where there is culture that makes discussing emotions difficult or impossible. Together with our collaborators, we have recently developed two new types of face-to-face manager training for male-dominate industries; one focused on how depression may present in a male dominated workforce and helps managers develop the skills and confidence to have conversations about emotions with their staff, while the other focuses more on primary prevention via teaching managers how they can modify work-based mental health risk factors, such a job demands, job control and perceived support and promote the positive aspects of work. We propose that a combination of these two approaches would provide a comprehensive manager mental health training that would simultaneously address mental health literacy, stigma reduction and promote primary, secondary and tertiary prevention approaches to mental health in the workplace. This comprehensive online training program for managers will be delivered via a mobile responsive website and has 3 topics each with a set of 10-minute modules to work through. Completion of the program can occur in one go or spread out over a few days or a few weeks. This freedom and flexibility has been incorporated in the design so learning pace is matched to individual styles. Evaluation will be conducted through a randomised controlled trial within industry partner organisations. Waitlist control participants will be offered the training 6 months from the commencement of the study once follow up data is collected from the intervention group.

to determine whether in normal healthy volunteers without recent antibiotic exposure, one month of daily erythromycin treatment will induce lower rates of macrolide resistance in commensal oropharyngeal flora than one month of daily azithromycin

The trial will consider the clinical effectiveness of electrical stimulation therapy compared to or in combination with compression therapy. People with a lower leg ulcers will be recruited into the study. Participates will be randomised to either (1) continue their current compression therapy (control). (2) to use electronic stimulation therapy (intervention) or (3) use both compression therapy and electric stimulation. Participants in the study group involving electrical stimulation therapy will use a portable stimulation device that can be self administered in the home setting 4 times a day daily for 20 minutes per session. The number of wounds that heal and the percentage of wound size change will be monitored for 14 weeks in total. Fortnightly for the first follow up visit and then monthly. The clinical effectiveness of the treatments will be considered as will cost effectiveness.