ANZCTR search results

People with anorexia nervosa often restrict food even when it causes serious harm, but current treatments help fewer than half of those affected. This project aims to understand why the drive to avoid eating becomes so strong. Instead of assuming people with anorexia nervosa simply don’t find food rewarding, the study explores whether avoiding calories may itself feel rewarding. To investigate this, researchers will use a device that delivers tiny amounts of real food during brain scans, allowing them to study how the brain responds during actual eating rather than just looking at pictures. The study will also examine hormones and gut bacteria, which may influence appetite, stress, and decision-making around food. People with lived experience have helped shape the study to ensure it is safe and acceptable. Ultimately, the goal is to uncover the biological mechanisms that sustain self-starvation and identify different subgroups who may benefit from tailored treatments.

Tinnitus can severely affect a person’s quality of life, and although there are ways to manage it, clinicians are not sure how well treatments work and which treatment an individual would respond to best. This is because tinnitus and how it affects individuals are sometimes very subjective and difficult to describe reliably. Our research group has previously demonstrated that a non-invasive brain imaging technique called functional near-infrared spectroscopy (fNIRS) can detect tinnitus-related changes in brain activity. This research project now aims to perform fNIRS measurements on people with tinnitus before and after starting a new treatment. This would allow us to assess how changes in our measurements compare with changes in individuals’ subjective ratings of their tinnitus. The treatment is a digital therapeutic for tinnitus management, accessed via a smartphone app called Oto. Oto aims to assist people to adjust to their tinnitus and therefore reduce tinnitus associated distress.

This randomised controlled trial aims to determine the efficacy of a coach-supported online cognitive training program for preventing PTSD and depression in early career Defence personnel. The study involves an active, experiential preventative intervention that develops practical evidence-based skills through exercises and videos, with opportunities to apply and test acquired strategies across six weekly modules. The study includes a standard practice condition in which participants can access standard support services as needed. Participants will complete questionnaires at baseline, post-intervention, and at one-year follow-up to measure PTSD and depression symptom severity and track rates of probable PTSD and depression.

This study will use a single-case experimental design (SCED) to investigate the feasibility and preliminary effectiveness of ENVIRO, a co-designed environmental cognitive rehabilitation intervention for adults with traumatic brain injury (TBI). A multiple-baseline A-B design across behaviours will be used, with up to three tiers, staggering the introduction of the intervention across three target behaviours of each participant. Prior to baseline, participants will undergo a brief cognitive assessment and clinical interview. Participants will then collaboratively establish up to three rehabilitation goals with a clinician. Goals will be operationalised using Goal Attainment Scaling (GAS) and associated target behaviours will be identified. Baseline will involve repeated measurement of each target behaviour, with baseline durations staggered across behaviours (two, three, or four weeks). The intervention phase will involve the sequential introduction of the ENVIRO intervention framework to each target behaviour over six weeks. An up to eight-week maintenance phase will follow, including a one-hour booster session. It is hypothesised that using the ENVIRO intervention will assist participants to make progress towards their goals, and will be a feasible and acceptable approach for people with TBI and their close others.

This is a Phase II, prospective, randomised, double blind, placebo controlled, parallel group study. Approximately 40–60 participants will be randomised 1:1 to receive either: • E2Spine (autologous SVF) suspended in Plasma Lyte, or • Plasma Lyte placebo. All participants undergo adipose tissue harvest and SVF processing to maintain blinding. Treatment consists of combined image guided intradiscal and ipsilateral facet joint injections at the symptomatic lumbar level(s). Participants are followed for 12 months, with an optional descriptive extension to 24 months. The study hypothesis, in plain language: We believe that a single treatment using a person’s own fat-derived cells, injected into the affected areas of the lower spine, may reduce long-term low back pain and improve daily function more than placebo treatment, while remaining safe and well tolerated.

This multi-site randomised controlled trial will test whether adding an online stoma-specific core-strengthening exercise program, Convatec Me+Recovery®, to standard stoma support garment use helps prevent parastomal hernia or delays the time to parastomal hernia after stoma formation. The study will recruit 450 adults with a new stoma across Australian hospitals/services. Participants will be randomly allocated 1:1 to either stoma support garment alone or stoma support garment plus the Convatec Me+Recovery® program. Participants will complete monthly online surveys and attend routine Stomal Therapy Nurse reviews for up to 24 months. The main outcome is time to diagnosis of parastomal hernia.

Depression is one of the leading causes of disability worldwide. Intermittent theta burst stimulation (iTBS) is a safe and effective neuromodulation therapy for depression, but its effects can vary between individuals. This study aims to investigate whether combining iTBS with transcranial alternating current stimulation (tACS) using a personalised, phase-synchronised approach improves brain responses compared with fixed-frequency and sham stimulation. The main hypothesis is that individualising stimulation frequencies based on brain activity will enhance the effects on brain function, compared with fixed-frequency and sham conditions. The findings will help inform the development of more effective, personalised brain stimulation treatments for depression in future research.

The aim of this study is to evaluate the impact and feasibility of using domiciliary humidified nasal high flow therapy as an adjunct to standard care in reducing exacerbation burden and healthcare utilisation in patients with chronic lung disease, using respiratory rate as an early physiological marker of clinical deterioration. This study is a randomised, 2-period, open-label crossover trial evaluating domiciliary humidified nasal high flow (NHF) therapy in adults with chronic lung disease (CLD) who experience recurrent exacerbations.

This trial evaluates the feasibility and preliminary effectiveness of delivering iCBT for insomnia prior to Reboot Online. It will assess whether targeting sleep first leads to greater improvements in pain, psychological wellbeing, and functioning compared with Reboot alone. We hypothesis that iCBT insomnia + Reboot Online will be a feasible model of care for participants reporting chronic pain and sleep disturbance and will result in significant reductions in pain interference and pain disability.

GRWD5769 is a first-in-class, orally bioavailable small molecule inhibitor of ERAP1, developed for immune-oncology applications, particularly for solid malignancies. Thid study aims to compare the bioavailability of a new tablet formulation versus the existing capsule formulation and to assess the effect of food on drug absorption in healthy adults. The rationale for developing a tablet is to reduce pill burden and improve participant convenience. This is a Phase 1, open-label, randomized, cross-over study in healthy adults (18–65 years) consisting of 2 and up to 3 parts: Part A1: Compares 800 mg tablet (2 x 400 mg) vs. 800 mg capsule (4 x 200 mg) in fasted state. Optional Part A2: If needed, compares 400 mg tablet vs. 400 mg capsule. Part B: Assesses food effect on the selected formulation/dose (fed vs. fasted).