ANZCTR search results

Many people who get help from mental health or drug and alcohol services have PTSD or have been through trauma. Eye Movement Desensitisation and Reprocessing (EMDR) is a type of talking therapy that helps with trauma. It often takes fewer sessions than other therapies. This study will look at how helpful and easy to use EMDR is for people in Brisbane public mental health and drug and alcohol services. 50 participants will be screened and 30 will choose to take part in EMDR therapy. We will monitor their trauma symptoms, how many sessions they attend, their service duration, if they stay in the study, and if they go to hospital or the emergency department. We hope the study shows that EMDR is helpful, easy for people to take part in, improves symptoms, reduces hospital visits, and improves daily life.

The Building Lifestyle skills and Optimising emOtional Mastery (BLOOM) program is a digital intervention delivered in ECEC settings to support educators and parents to integrate social and emotional learning, active play and healthy eating into daily routines. BLOOM aims to improve preschoolers’ mental and physical wellbeing. The program includes professional development, a digital portal, and a culturally informed parent app, making it both scalable and accessible for widespread impact. This randomised controlled trial will evaluate the impact on children's self-regulation and other wellbeing outcomes. We hypothesise that children in the intervention group will have high self-regulation scores at follow-up, compared to control.

This is a prospective study to assess the diagnostic significance of an NKa result. Women will be recruited from clinics at Genea in NSW, ACT, QLD, VIC, SA and WA. They will have the NKa blood test and will agree that both their fertility specialist and themselves will be blinded to the result for their first embryo transfer following the test.

This international prospective, multicentre global cohort study will include consecutive patients undergoing surgery within an overall six-week window between 31st ‘August and 11th October 2026. This study will generate granular data on the global variability in post operative complications for a range of common operations. This will offer insights to the global burden of disease, access to emergency and elective care, imaging and ‘rescue’ from complications. This data will aid in the creation of guidelines to improve care across the world and informing trial design to target areas of preventable morbidity and mortality.

People with Multiple Sclerosis (MS) commonly experience muscle weakness, spasticity, and impaired walking ability. This study investigates whether direct current (DC) electrical stimulation, delivered via the Neubie device to lower-limb muscles, can produce immediate improvements in walking, balance, and functional movement in people with MS. Using a within-subject repeated-baseline design, 20 adults with MS will undergo functional assessments without the device (baseline), during active DC stimulation, and again 30 minutes after the device is removed. This will allow us to determine whether any improvements reflect an immediate assistive (neuroprosthetic) effect or persist after the device is turned off (a therapeutic effect). Participants will also rate their comfort and perception of the device. Results will inform whether DC stimulation is a viable rehabilitation tool for improving movement in MS.

This study will evaluate the feasibility of a personalised omega-3 supplementation intervention in people with multiple sclerosis (MS) using a fully decentralised, home-based trial design. Participants will receive an individualised omega-3 dose based on their baseline Omega-3 Index (O3I), with the aim of achieving an O3I of at least 8% over 16 weeks. The study addresses limitations of previous MS omega-3 trials that used fixed supplement doses despite individual variation in omega-3 requirements. All study procedures, including blood sample collection, supplement delivery, surveys, and telemedicine consultations, will be conducted remotely to improve accessibility and reduce participant burden. The primary objectives are to determine the feasibility and acceptability of this personalised, home-based approach and to estimate the proportion of participants who achieve the target O3I.

Pacemakers for a slow or unreliable heartbeat (sinus node dysfunction) usually have the top wire placed in the right atrial appendage, but this may not be the most natural place for the heart's electrical signal to start. This study compares that standard position with pacing at Bachmann's bundle, the heart's natural electrical bridge between the two upper chambers, in adults who already need a dual-chamber pacemaker. We will measure how quickly the electrical signal travels between the upper chambers (the main measure), and also look at heart pressures and blood flow measured during the implant, left atrial function on ultrasound, the amount of atrial fibrillation recorded by the pacemaker, symptoms and quality of life, over 12 months. We expect Bachmann's bundle pacing to shorten the delay between the chambers, improve heart pressures and flow, and reduce atrial fibrillation compared with the standard position. Because the pacing site is chosen as part of normal clinical care and the study adds only measurements, this is an observational pilot designed to gather the preliminary data needed to plan a larger randomised trial.

MTAI-1025 as a novel agent for the treatment of ulcerative colitis (UC), a debilitating chronic disease caused by inflammation in the colon and rectum. The primary purpose of this study is to test a new oral medication called MTAI-1025 to see if the medication is safe when given as a single dose or when given over 2 weeks of dosing. This study also assesses blood samples to understand how much of the medication is in the blood stream and the impact of food on how much medication is absorbed into the body. The hypothesis is that the new medication will be safe to take.

CRONOS-1 is a prospective, single-arm, single-centre feasibility study evaluating the use of the HybridTherm® cryo-assisted radiofrequency ablation (cryoRFA) system to ablate histologically confirmed malignant pulmonary nodules via a flexible bronchoscopic approach. Five participants with nodules less than or equal to 25 mm, already planned for surgical resection as standard of care, will undergo transbronchial cryoRFA immediately prior to their planned surgery under the same general anaesthetic. The resected specimen is then assessed by histopathology to evaluate ablation effects. The study aims to establish whether the device can be safely and successfully deployed bronchoscopically, and to characterise the immediate histopathological ablation zone in human lung tissue. There are no additional hospital visits; all study activities occur within the index surgical admission. The study is conducted at Macquarie University Hospital, NSW, Australia, and is funded by Erbe Elektromedizin GmbH with Macquarie University as sponsor.

The purpose of this study is to determine whether it is feasible and acceptable to deliver the CALM-Kids program online and to explore its potential to improve anxiety symptoms and healthy lifestyle behaviours in children. The findings will help inform the design of a larger clinical trial. This study is a pilot randomised controlled trial comparing the CALM-Kids lifestyle program with a befriending program delivered via telehealth. Families will be randomly allocated to one of the two programs. Both programs include one individual online session followed by seven weekly small-group online sessions involving the child and a carer, delivered by trained facilitators via Zoom for Education. The CALM-Kids program is a family-based lifestyle intervention designed to support children experiencing anxiety. It focuses on everyday lifestyle habits, including physical activity, healthy eating, sleep, and screen time, using practical activities, goal setting, and parent/carer support to help families make sustainable behaviour changes. The befriending program is a structured group program that provides the same amount of facilitator contact and group interaction but does not include therapeutic or lifestyle advice. Instead, it focuses on social activities and conversation.