ANZCTR search results

Atherosclerosis is a disease that is thought to be primarily inflammatory in origin. It is well established that patients with inflammatory diseases, including inflammatory bowel disease (IBD), are at higher risk of experiencing poor cardiovascular outcomes. Recent studies have shown having active disease seems to be the key driver for these outcomes in IBD patients. We aim to look at whether commencing treatment for IBD in patients who are at high risk of developing these poor cardiovascular outcomes reduces their risk.

This open-label trial will investigate feasibility and efficacy of psilocybin-assisted psychotherapy for treatment-resistant depression. Individuals will be thoroughly screened to ensure they meet all eligibility criteria before entering the trial. All participants will receive the trial treatment. The treatment consists of two psilocybin dosing sessions (second dose optional), preceded by 3 preparatory psychotherapy sessions and followed by 3 integrative psychotherapy sessions. Participants will be under the care of a specialist team of two psychotherapists throughout the intervention. Participants will undergo multiple assessment sessions throughout the trial and there will be a long-term follow up assessment 20 weeks after the second dose. Where possible, assessments will be conducted via online surveys. Some assessments need to take place at the study site; these will be at baseline, 1 day, 3 weeks, and 20 weeks after dose 2. Assessments include questionnaires, cognitive and social processing tasks, fMRI scans, blood samples, and semi-structured interviews. It is predicted that this treatment will be effective in reducing symptoms of depression in those with treatment resistant depression.

La Trobe University’s Centre for Ergonomics & Human Factors developed an evidence-based risk management ‘toolkit’ intended for routine workplace use to manage risk of work-related musculoskeletal disorders (MSDs) more effectively. It is called APHIRM (a Participative Hazard Identification & Risk Management) toolkit. This toolkit has been further developed to manage work-related mental health disorders (MHDs), as well as MSDs. The primary aim of this study is to evaluate both the implementation processes and impact of this toolkit when used by workers in the Manufacturing sector as part of their workplace procedures to control MSD & MHD hazard and risk levels. Implementation by workplace personnel will be supported by researchers, who will use workplace feedback to amend some toolkit components if needed to maximise its practicability and ease of use. The research team is recruiting six medium/large organisations in the Manufacturing industry sector. Organisations will be randomly assigned to either the intervention group or the control group. The intervention group will receive free toolkit training and full support to implement the toolkit. The control group will have an opportunity to implement the toolkit at the end of the study. Workers in both the intervention and control organisations will complete an online survey to determine their pain/discomfort, and levels of stress. They will also provide responses to questions related to their workplace which will identify the top 10 hazards. These surveys will be undertaken at baseline and 12 months post intervention.

This study is a pilot to inform a larger RCT that will use Artificial Intelligence (AI) and adaptive trial methods to discover the most effective treatments to provide to Australian university students, 25% of whom experience severe psychological distress and, consequently, drop out of study or go on to develop more severe psychiatric disorders in their peak years. Both the pilot study and the planned RCT (to be registered after this pilot study) will compare app-delivered self-care intervention for psychological distress in tertiary students based on mindfulness, physical activity and sleep hygiene, with an active control condition consisting of Ecological Momentary Assessment (daily mood monitoring). The current pilot study aims to test the feasibility of the study infrastructure, including study app, intervention content, and the algorithm.

The primary objective is to evaluate, through a randomised controlled trial, the clinical efficacy of an Internet-delivered pain self-management program, the Youth Pain Course, for adolescents with chronic pain. Clinical efficacy will be assessed through clinically meaningful (>30%) improvements in primary (physical functioning) and secondary (pain effects, emotional functioning, role functioning) outcomes at post-treatment. We hypothesise that: (a) The Youth Pain Course will result in improvements in physical functioning at the completion of treatment; (b) The Youth Pain Course will result in improvements in pain effects (intensity, frequency, affect and cognitions), emotional functioning (anxiety and depressions symptoms), and role functioning (quality of life, school presenteeism and absenteeism) at the completion of treatment; and (c) Improvements on primary and secondary outcomes will be maintained at 3- and 12-months post-treatment. The secondary objectives of this project are to explore predictors and moderators of treatment response to guide program improvements and research directions. These objectives are exploratory, and no specific hypotheses can be made; however, the results of these analyses will guide the further development, evaluation and eventual deployment of the treatment.

Eosinophilic oesophagitis is a chronic allergic, inflammatory disorder that leads to oesophageal dysfunction. The underlying eosinophilic inflammation seen on biopsy manifests itself clinically with symptoms such as dysphagia (difficulty swallowing), food impaction and heartburn. The mainstays of therapy include both pharmacological and dietary modifications. Elimination diets involve patients empirically eliminating all common allergens with gradual re-introduction and reassessment to then identify the offending food antigen(s). Although studies have demonstrated the efficacy of elimination diets in EoE, the high level of dietary restriction, duration of intensive follow-up and requirement for multiple endoscopies limits patient participation. Consequently, finding a process to identify the offending food allergens for a targeted elimination diet would be beneficial. The purpose of this study is to test the effectiveness of using food-specific IgG4 (FS-IgG4) to direct a targeted elimination diet in patients with eosinophilic oesophagitis. The effectiveness will be determined by clinical assessment with a symptom survey, as well as histological improvement (via endoscopy and biopsy).

A hip fracture can have a serious impact on an older person’s everyday life. Recovery is complex and extends well beyond discharge from hospital with the transition home presenting significant challenges for older people and their carers. Planning for discharge home enables health professionals and older people to work together to identify any needs and organise support after discharge. This study aims to examine the feasibility and effectiveness of using telerehabilitation via a smartphone, tablet or computer to deliver a pre-discharge home safety intervention in a sample of 40 older adults recovering in hospital after hip fracture. Feasibility will be considered in relation to demand, acceptability, practicality and limited efficacy with a view to applying telerehabilitation home safety assessments to older people recovering in hospital after hip fracture who are planning to return to community living.

The overall aim of the FDCC study is to evaluate: 1) impact, of FDCC (an integrated Child and Family Health (CFH) hub with navigation support) on attendance at CFH services and completion of CFH checks, support of child growth and development, breastfeeding and maternal wellbeing, and meeting family psychosocial needs. 2) process of implementing FDCC and: (implementation evaluation – future Phase 2 of study not applicable to current ANZCTR). 3) cost-effectiveness of FDCC. (economic evaluation – future Phase 2 of study not applicable to current ANZCTR). FDCC is a non-randomised study of newly arrived migrants and refugee women from culturally and linguistically diverse backgrounds who are:newly arrived migrant (< 10 years in Australia) or self-identified refugee (< 10 years in Australia); expectant mothers > 20 weeks gestation or or mother who has recently given birth at the abovementioned hospitals and has not been discharged from postnatal ward; attending antenatal clinics or postnatal wards in SESLHD (St George Hospital), NSLHD (Royal North Shore/Hornsby Hospital) and SWSLHD (Liverpool Hospital). Potential participants will be identified by the midwifery and, where available, the cross-cultural worker service. The study compares markers of attendance and completion of CFH checks, child health and development measured by Ages and Stages Questionnaire, Body Mass Index, and Emergency Department Presentations, rates of breastfeeding, and mother’s social and health needs (depression, quality of life and other psychosocial stressors) between those attending FDCC (an integrated CFH hub with navigation support) and those attending usual care not through FDCC.

Anxiety-related mental health disorders, particularly social anxiety disorder, are common comorbid conditions among adults who stutter. Our research has discovered that social anxiety disorder and other DSM-V disorders involving anxiety prevent effective speech treatment for adults who stutter. We have developed and trialled an innovative internet cognitive behaviour therapy (CBT) program specifically designed to target the social anxiety experienced by people who stutter. This internet CBT program has been shown to reduce the social anxiety experienced by adults who stutter and even eliminate social anxiety disorder diagnoses. The proposed study aims to investigate whether access to an internet cognitive behaviour therapy (CBT) program immediately after a period of speech treatment designed to reduce stuttering behaviours, improves psychological and/or speech outcomes. The research design is a randomised clinical trial of speech restructuring treatment or speech restructuring treatment plus internet CBT treatment for adults who stutter. The outcomes of this research will generate new knowledge about the benefits of concurrently controlling the speech problems and the anxiety related mental health disorders of adults who stutter.

The Breathe Easy Study is an observational study which has been conducted at Joondalup Health Campus (JHC) (and Perth Children’s Hospital (PCH)) since 2015. The objective of the study is to develop a suite of diagnostic tests for paediatric and adult respiratory diseases by evaluating patient-reported symptoms and sound-signatures emitted during a cough event. As part of approved study procedures, participants recruited to the study are required to cough at least five times towards the microphone of a standard smartphone (iPhone 6). Phones are wiped down between participants and research nurses are provided with personal protective equipment (PPE). However, with changing infection control procedures many patients are increasingly required to wear protective apparel such as surgical masks when presenting to healthcare facilities. We would like to know whether masks impede the sound collected by the phone’s microphone. Participants will be required to provide at five coughs, with and without impedance, and we will compare the diagnosis obtained in both instances.