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Autism is a lifelong neurodevelopmental disorder characterised by differences in social communication, repetitive and restricted behaviours and sensitivities to sensory input (Diagnostic and Statistical Manual of Mental Disorders 5th ed: DSM-5; APA, 2013). Along with autism symptomology, autism is linked to a greater incidence of insomnia, with the prevalence estimated at 60- 86% in school aged children, compared to 5-30% among their non-autistic peers (Paine & Gradisar, 2011; Papadopoulos et al., 2019; Liu et al., 2006). Consequences of poor sleep include behavioural problems, impaired adaptive behaviour, psychopathology and exacerbated autism symptomology (Paine & Gradisar, 2011; Papadopoulos et al., 2019). Resultingly, effective treatment for insomnia is imperative in order to reduce negative consequences. Cognitive Behavioural Therapy for insomnia (CBTi) is recommended as a primary treatment for insomnia (American Academy of Sleep, 2005) and has demonstrated efficacious outcomes (Quaseem et al., 2016). However, there is scant research on CBTi as a treatment for insomnia among individuals with autism, with the majority of studies focusing on pharmaceutical options (Cortesi et al., 2012). Therefore, the present study aims to establish the efficacy of Cognitive Behaviour Therapy for Insomnia (CBTi) in children aged 7-12 with autism, compared to a waitlist control group of children aged 7-12 with autism. Hypotheses Children who receive CBTi will have significantly greater improvements in sleep parameters including sleep onset latency, wake after sleep onset, sleep duration and sleep efficiency compared to a waitlist controlled autistic group. Additionally, children who receive CBTi will have significantly greater improvements in anxiety, depression and daytime sleepiness compared to the waitlist controlled autistic group.

Following bowel resection due to cancer, up to 80% of patients will experience variable and unpredictable bowel function and symptoms termed as Low Anterior Resection Syndrome (LARS). The exact mechanism of LARS remains unclear and currently there is no standard treatment. Research shows that the gut microbiome, also known as gut bacteria, is changed in patents following bowel cancer and may be linked with LARS and the changes in bowel function and symptoms experienced. This program of research therefore aims to examine the effect of Faecal Microbiota Transplantation in LARS symptoms, the gut microbiome and quality-of-life. Who is it for? You may be eligible for this study if you are aged 19 years or older, have had an ileostomy reversed with a background of low anterior resection or ultra-low anterior resection due to adenocarcinoma of the colon or rectum, and are experiencing symptoms of minor or major LARS. Study details Participants will be randomised (i.e. allocated by chance) to receive one of two different doses of faecal microbiota transplant, or standard care. Faecal microbiota transplant involves administering faecal matter via a syringe using colonoscopy, which requires insertion of a flexible tube into the rectum, and will take an addition of approximately 5 minutes to your routine colonoscopy to complete. Participants allocated to standard care will not receive a faecal microbiota transplant. All participants will answer a number of questionnaires about bowel function and quality of life, and will provide a stool sample for analysis at baseline and week 4 of the study. Participants will also provide a blood sample to assess their immune response and signs of inflammation at baseline and week 4 of study. It is hoped that this research will show that faecal microbiota transplant is an effective treatment for reducing symptoms of LARS and improving quality of life in patients who have undergone a low anterior resection.

This intervention program aims to boost well being and engagement among people aged 65 years and older. The primary intervention uses a behavioural activation approach to support participants to plan and do personally meaningful and enjoyable activities to lead a more rewarding life. This approach has been demonstrated to help people become happier in studies around the world and is also a very effective treatment for depression and has undergone pilot testing (see ACTRN12620000126910). This approach will be compared to a multi-component positive psychology intervention, where participants will be taught a variety of different strategies that use cognitive reframing strategies to build positive emotion and wellbeing. Our goal in this study is to test whether a tailored version of a well-established behavioural activation intervention increases engagement, valued activity, health, and wellbeing in an older adult population, when compared to another wellbeing program that is matched for time, effort, and contact.

A major source of sleep disruption in older adults is obstructive sleep apnoea (OSA), a disorder characterised by frequent pauses in breathing due to partial or complete airway closure during sleep. These events result in sleep disturbance and oxygen deprivation, which previous studies have shown to be associated with an increased risk of dementia. Therefore, there is an imperative to establish definitively whether treatment of sleep apnoea can prevent dementia. This multi-site feasibility randomised-controlled trial aims to determine whether it is feasible to deploy a targeted intervention to treat sleep apnoea in participants with subjective memory complaints and determine the magnitude of effect on memory decline. Participants will be randomised to the intervention or control group for 2 years. Participants in the intervention group will receive treatment for their OSA following an algorithm and incorporating key principles of goal setting and behavioural sleep management. Participants in the control group will have their screening results sent to their referring medical practitioner, with recommendations for further investigation. Further, 90 participants will undergo a 25 min MRI at the study center during their standard visit at baseline and 24 months. For the MRI scan, participants will be selected based on participant choice and willingness to participate, as well as, if they pass the MRI safety questionnaire and consent. The primary outcome is the feasibility of the trial. The stop-go criteria to determine feasibility will depend on meeting the acceptability, hypoxic burden, and tolerability criteria. The secondary outcomes listed are primary being collected for the propose of showing feasibility of collection rather than serious intension of showing efficacy.

TDAY is a pilot open-label randomised control study comparing two different forms of repetitive Transcranial Magnetic Stimulation (rTMS) as a treatment for Major Depressive Disorder (MDD) in adolescents and young adults. Participants with MDD will be randomised to one of two rTMS treatment groups. In both groups a magnetic coil will be applied to L) side of the scalp, in which the coil generates an electrical impulse to the stimulate the underlying brain tissue, No anaesthetic is required. Group 1 will receive what is considered a standard 10Hz treatment protocol while Group 2 will receive a more novel, intensive intermittent thetaburst (iTBS) treatment protocol. Treatments will be administered Monday - Friday for 4 weeks. All participants will be engaged with their treating doctor for the duration of the trial, and will continue their current treatment regimen (i.e., either maintain a stable dose of antidepressant medication, or continue without antidepressant treatment). The primary outcome measures of safety and tolerability will be assessed continually across the study by monitoring adverse events and dropout rates. The secondary outcome measure (change in depression score) will be assessed at the end of week 2 and week 4, with a further assessment at week 8 to ascertain if any improvements have been maintained, and if some participants have a delayed response to treatment. The study hypothesis is that the acceptability and safety/tolerability of the more novel intensive iTBS treatment protocol (Group 2) will similar or greater than that of the standard rTMS treatment protocol (Group 1).

The primary purpose of this trial is to evaluate whether FDG PET is helpful for clinicians treating men with newly diagnosed aggressive prostate cancer (according to tissue histology) and staged with PSMA PET. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have been diagnosed with aggressive prostate cancer (high risk features) and have not had treatment to date, but you may be planning to undergo surgery, radiotherapy or other treatments. Study details: All participants enrolled in this trial will undergo a FDG PET/CT scan. The results of the scan will be made available to your doctors to help them to plan the most suitable treatment course. The accuracy of the PET scans will be determined according to follow-up information available up to 12 months after entering the study. The findings of the scans will be investigated for their ability to predict future cancer outcomes. Patient reported outcomes (PROs) as to how the scans and subsequent treatment affect enrolled participants will also be assessed.

This study aims to determine if increasing nutrient intake of men who are obese can improve sperm function without the need for weight loss. Men who are obese will be allocated to either control (given current South Australian guidelines for health eating) or intervention (prescribed the CSIRO Total Well-being Diet for Men with four Dietician appointments) for a period of 12 weeks. Sperm function will be measured both pre and post intervention.

This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12515000908437. This substudy will evaluate the activity of pamiparib in participants with acute myloid leukaemia or myelodysplastic syndrome with DNA repair pathway mutation (e.g. BRCA1/2), and/or BRCA mutational signature. Who is it for? You may be eligible to join the study if you are aged 18 years and older, with acute myeloid leukaemia or myelodysplastic syndrome. Your cancer will need to harbour DNA repair pathway mutations (e.g. BRCA1/2), and/or BRCA mutational signature. Study details: Participants will receive pamiparib, to be taken orally at a dose of 60 mg twice daily. Pamiparib will be given to participants continuously as long as they and their doctor agree there is a benefit from treatment. Participants will undergo clinical assessments at 4 weekly intervals from first treatment until end of treatment.. Safety and tolerability of treatment will be assessed at 4 weekly intervals. Health related quality of life during treatment will be assessed at 4 weekly intervals and then every 8 weeks after end of treatment until progression. We cannot guarantee that participants will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who have limited treatment options available to them. It is hoped that pamiparib will be well tolerated and will improve outcomes for future patients, however there may be no clear benefit from participation in this study.

Cannabidiol is a phytocannabinoid found naturally in the Cannabis sativa plant. Despite CBD’s long history of use, its medicinal properties have been somewhat anecdotal. There are very few pharmaceutically approved products on market, and these are limited to rare clinical indications (i.e. Epidiolex® for rare childhood epilepsy). Cannabidiol is being developed for a range of medicinal applications. These applications typically require CBD at high purity, which can be extracted and purified from Cannabis sativa, or synthetically manufactured. High purity CBD is a white to pale yellow crystalline solid that is insoluble in water. Consequently, CBD is usually administered in an oil vehicle. The limited aqueous solubility of CBD leads to poor oral bioavailability, which has been reported as between 3-8%. CBD has been selected for clinical development in a formulation containing TPM. It is believed that CBD TPM formulations may have improved bioavailability when compared to CBD alone, which would allow for lower doses administered to patients, or the targeting of therapeutic indications that would ordinarily need CBD doses that are so large as to be prohibitive. The proposed Phase I clinical study will evaluate the PK, safety and tolerability of an oral CBD soft-gel capsule. The PK profile of the capsule will be compared at two separate doses. Results from this study will support further clinical development of the CBD soft-gel product, with a focus on indications that can be treated with low-dose CBD.

We aim to identify complexities in the scale-up, spread and sustainability of convers-ABI-lity, an online conversation skills training program to provide scalable communication training to adults with acquired brain injury (ABI) and familiar communication partners such as family, partners and friends. We therefore seek to identify; 1. Who uses convers-ABI-lity and what are their characteristics? 2. In what geographical locations and healthcare and social contexts is convers-ABI-lity used? 3. Do users complete convers-ABI-lity as intended? Why/not? 4. How usable is the technology for those completing convers-ABI-lity? 5. What barriers, facilitators and workarounds do users experience when completing convers-ABI-lity? 6. How satisfied with convers-ABI-lity are the users? 7. What is the cost of delivering convers-ABI-lity? The direct evaluation of the implementation of convers-ABI-lity by end-users aims to ensure the intervention reaches and meets their needs in a feasible, scalable, sustainable and acceptable manner.