ANZCTR search results

The aim of this study is to develop a mixed reality-based exposure and response prevention intervention (MERP) that targets contamination fears and to assess its feasibility and acceptability in a clinical OCD sample. A secondary aim of this study is to explore whether MERP increases the acceptability of in vivo exposure and response prevention (ERP). We hypothesise that participants will find MERP acceptable, immersive, and able to elicit contamination fears (i.e., feasible). We also hypothesise that acceptability of MERP is positively associated with the acceptability of in vivo ERP. This study is a single-arm pilot study (Phase I Clinical Trial).

Diet has been identified as a risk factor in ulcerative colitis. Understanding the habitual diet of people with ulcerative colitis is therefore important. Protein supplementation has become increasingly popular to optimise dietary protein intakes across the general population however data on protein supplement use in ulcerative colitis has not been examined. It is hypothesised that people with ulcerative colitis are consuming protein supplements for perceived health benefits.

Children diagnosed with autism can experience difficulties expressing and communicating their emotions, which can be linked to later mental health difficulties. There is evidence that a parent emotion coaching program, called Tuning in to Toddlers, can improve a parent's ability to respond to their child's emotions and impact child behaviours; however, it is unknown whether this program would be suitable for children diagnosed with autism. The purpose of this feasibility pilot is to understand whether it is feasible to deliver this program to families of very young autistic children and family's perspectives and acceptability of this program.

The study will be conducted in one cohort of participants. The study will consist of multiple periods: a screening period (Day -28 to Day -2), radiprodil period (Day -1 to Day 5 pre-rabaprazole dose), a rabeprazole run-in period (Day 5 rabeprazole dose to Day 9 pre-radiprodil dose), a combined rabeprazole and radiprodil period (Day 9 radiprodil dose to Day 13). Participants will be discharged on Day 13 (end of study).

The overall aim of this study is to evaluate the clinical and economic impact and implementation of a service model (intervention) delivered by community pharmacists in New South Wales (NSW) and 15 pharmacies in the Australian Capital Territory (ACT), managing four skin conditions for individuals presenting with a suspected diagnosis – Impetigo, Atopic Dermatitis, Mild Plaque Psoriasis and Herpes Zoster. The specific objectives of this study are to: - Assess implementation uptake of the intervention including the reach, fidelity and adoption of the intervention in community pharmacies, participant characteristics, and variation in uptake by geographic region. - Assess the clinical outcomes and patient experience for patients managed by community pharmacists. - Assess the safety of the intervention and identify any risks that need to be addressed for future implementation. - Qualitatively assess the acceptability and feasibility of the intervention to pharmacists, other care providers and participants using the service. - Identify contextual enablers and constraints to access, adoption, fidelity, delivery, impact, sustainability, and generalisability of the intervention. - Conduct a health economic evaluation to determine the economic benefits. The study will use a cohort study design to assess the clinical and economic impact and implementation of the intervention in NSW and ACT. Pharmacies will be onboarded from June 2024 to December 2024, with the possibility to include further pharmacies in a case-by-case basis. This is due to administrative processes associated with MedAdvisor program installation, and the numbers of pharmacies that can be onboarded will be batched over this time. The study will be completed on 31 August 2025. The intervention is multicomponent including Pharmacist training and support, and a Pharmacist-patient consultation, using an IT program, applying clinical guidelines. Pharmacies and pharmacists must meet the criteria of an ‘approved pharmacy’ and an ‘approved pharmacist’ outlined in the NSW Health Authority, or a licence in ACT, to participate. Pharmacists and pharmacies will be provided follow up support as part of a translational/implementation strategy. Practice change facilitators will visit/contact these pharmacies during the study to provide ongoing support, answer any queries, ensure quality data is being collected, and collect implementation data. Pharmacies will be divided into low, medium and high contact, and this will depend on the number and nature of consultations delivered throughout the trial period. The primary outcome will be symptom resolution/relief (completely resolved, improvement, no improvement or worsening) (based on self-report at 7-day or a 14 day follow up (depending on the skin condition)). This will be a composite measure based on patient self-reported data.

This study aims to see how group-based self-instructional training, neurological music therapy, and a combination of both will affect executive functioning in people with moderate to severe traumatic brain injury.

This study is testing a new multifactorial online platform called PRO-Health which provides individualised educational material on prostate cancer, its treatment side effects, and individualised nutrition and exercise services delivered to you anytime, anywhere in Australia. Who is it for? You may be eligible for this study if you are an adult with a confirmed diagnosis of prostate cancer and have been receiving androgen deprivation therapy (ADT) for at least 3 months. You should also not be currently meeting the dietary and exercise guidelines for cancer survivors or under the care of a nutrition or exercise health professional. Study details Participants will be randomly assigned to either receive usual care from their treating practitioner, or receive individualised consultations from a dietitian (4 sessions) and exercise physiologist (4 sessions) over a period of 12 weeks. These will involve dietary and exercise prescriptions that are tailored to participants based on their medical history, and reflect guidelines for prostate cancer patients. The usual care group will also receive access to PRO-Health and a consultation from a dietitian or exercise physiologist after the 12 week period. Participants will be asked to complete a body composition scan (equipment couriered), physical function test over Zoom that is facilitated by a research team member, and asked to completed questionnaires over a 12-week period from baseline. It is hoped that findings from this study will help develop this PRO-Health platform to help prostate cancer patients manage side effects from androgen deprivation therapy.

This study aims to evaluate the effect on risk-appropriate cancer screening of multi-cancer polygenic risk scores and tailored advice on risk-appropriate cancer screening in general practice. Who is it for? People aged 40-59 years old who are able to read and write in English and currently do not have any alarm symptoms or diagnosis of cancer. All participants must be under the care of a General Practitioner who is participating in the trial. Study Details Participants will be randomly allocated into the intervention or control group. The intervention group will receive an individualised cancer risk report and tailored advice for risk-appropriate screening for melanoma, colorectal, and breast or prostate cancer during a consultation with a researcher . The control group will receive the ‘Cut your Cancer Risk’ brochure and information about lifestyle factors that can impact cancer risk during a consultation with a researcher. This study will contribute to what we know about how individualised risk information can impact peoples' cancer screening behaviours.

Depression is associated with moderate impairment in cognition, and this impairment is associated with functional impairment and even suicide. Second generation antidepressants and psychotherapies are first line treatment for depression. However, impairment in cognition among individuals with depression persists even after receiving conventional treatment, resulting in an urge to investigate alternative treatment modalities such as yoga. Yoga is known to improve cognition, neurobiological and psychological outcomes in various populations, however these studies are limited by study design, sample size, and heterogenous nature of population, and further randomized controlled trials are warranted. Hence, the present study is designed to assess the effect of yoga on cognition (i.e., neuropsychological tests), neurobiological (i.e., markers of stress, neuroplasticity, neurodegeneration and cortical inhibition) and psychological outcomes (i.e., psychological questionnaires) in individuals with depression. In this uneven two-arm randomized control trial, participants of both genders, aged 18 to 45 years and having moderate to severe depression as measured by ‘Quick Inventory of Depressive Symptomology Self-Report’, will be randomly allocated into 12 weeks yoga intervention (n = 34) or waitlist control (n = 17) groups. Participants in the intervention group will perform yoga, 3 days a week for 12 weeks, while participants in the waitlist group will be provided with yoga training after the 12 weeks follow-up. Outcome assessments will be done at baseline (t1), at the end of the 12 (t2) and 24 (t3) weeks. The primary outcome will be between group differences on global cognition from t1 to t2. Secondary and tertiary outcomes will assess between and within (yoga group only) differences in a number of cognitive functions, neurobiological markers and psychological outcomes associated with mental health and/or depression severity, across all time points.

Traumatic experiences and consequent development of trauma disorder (PTSD, complex-PTSD) frequently occurs in people diagnosed with borderline personality disorder (BPD). The only evidence-based treatment for BPD is psychotherapy, however this does not directly address the impact of trauma disorder which reduces the likelihood of achieving remission and recovery. The recent decision of the TGA to approve the prescription of 3,4-methylenedioxy-methamphetamine (MDMA) as an adjunct to psychotherapy represents a break-through that could dramatically improving treatment outcomes for BPD and post-traumatic stress disorder (PTSD or Complex-PTSD) when they co-occur. Spectrum is a specialist public mental health service that provides treatment for people experiencing severe, complex, and high-risk clinical presentations of BPD and trauma throughout Victoria. In this pilot study, we will conduct a controlled before and after pilot study to assess the feasibility and acceptability of offering MDMA-assisted psychotherapy in our specialist public mental health service. Given that the efficacy and safety of MDMA for the treatment of PTSD has already been established, our study will assess efficacy, safety, and cost-effectiveness as secondary outcomes. MDMA will be administered within an evidence-based psychotherapy program. The pilot study will entail recruiting participants diagnosed with PTSD (or C-PTSD) and co-occurring BPD. There are two arms in the study. In the first, six to eight participants will receive psychotherapy + MDMA while in the second arm, six to eight matched participants will receive psychotherapy only. A wide range of assessment and evaluation measures will be used, utilising quantitative and qualitative approaches to examine clinician assessed and participant self-reported outcomes.