ANZCTR search results

This clinical trial aims to investigate the effectiveness of a Cognitive Behavioural Therapy (CBT) program delivered via a smartphone application (called ClearlyMe) for improving mental health outcomes in Australian adolescents (aged 12 to 17 years) with mild to moderate depressive symptoms. This trial will examine the effectiveness of a new CBT smartphone application (ClearlyMe) for reducing depressive symptoms in adolescents when compared to guided use and an active-attention matched control condition. The primary research questions that this trial seeks to address are: 1. What is the effectiveness of ClearlyMe (both self-directed and guided use) for reducing depressive symptoms? Secondary research questions include: 2. What is the effectiveness of ClearlyMe for reducing anxiety symptoms, psychological distress, rumination, and improving emotional wellbeing, quality of life, emotion regulation, and CBT skill acquisition? 3. Does guided support lead to greater engagement with and completion of the ClearlyMe app when compared to self-directed use? 4. Do factors such as gender, age, baseline mental health history or symptom severity, perceived need for care, or openness to digital mental health moderate the improvements in depressive symptoms found among users of ClearlyMe? 5. Do factors such as rumination, emotion regulation, CBT skill acquisition, digital therapeutic alliance and program engagement/completion mediate the improvements in depressive symptoms found among users of ClearlyMe?

There is a need for better treatments for spasticity in cerebral palsy (CP). Spasticity is a common target for many established treatments for CP such as Botulinum toxin A injection, oral baclofen, intrathecal baclofen pump implantation, and selective dorsal rhizotomy surgery. For over 40 years there have been attempts to use spinal cord stimulation (SCS) to treat spasticity, yet its role as a treatment in cerebral palsy has been limited. Recent advances in technology have enabled closed-loop control of SCS devices meaning that targeted electrical stimulation of the spinal cord can now be used in a real world setting with a device that is not adversely affected by sudden movements in posture, such as from muscle spasms. This technological advance combined with evidence relating to the importance of early intervention in cerebral palsy have led to the initiation of this trial. The Liberty Trial investigates the use of closed loop spinal cord stimulation in the treatment of lower limb spasticity for children living with spasticity. Children between 6 and 16 years with CP and spasticity predominately affecting at least one lower limb and who are candidates for SCS will be enrolled. The total study duration is 36 months. The study enrolment period is expected to be 12 months, and participants implanted with the investigational device will be followed for 24 months from implant. Treatment safety will be investigated, and efficacy will be determined by evaluation of the outcome measures at determined time-points using defined performance criteria. Additionally; the patient demographics, diagnosis and prior anti-spasticity treatments will be documented. The intervention in this trial consists of the implantation of an electronic medical device, a spinal cord stimulator, known as the EvokeTM Closed Loop Stimulator and leads, to reduce lower limb spasticity in children living with cerebral palsy. Intensive physiotherapy will accompany the intervention to try to improve lower limb function and mobility. This will be performed face to face by a physiotherapist experienced in post-spasticity intervention rehabilitation (i.e. botulinum toxin and selective dorsal rhizotomy). The principles of Goal Directed Therapy will be followed to compare the ability of the participants to achieve meaningful functional goals before and after the intervention.

Loss of appetite, known as anorexia, is a distressing symptom for people with cancer resulting in considerable involuntary weight loss, reduced physical activity, poor prognosis and death. To date, there are limited treatment options and no registered therapy for the treatment of cancer anorexia. Patients with small cell lung cancer have high prevalence of weight loss. The aim of this study is to determine whether it is feasible and desirable to conduct a study of anamorelin for the treatment of anorexia symptoms in patients with small cell lung cancer. – Who is it for? You may be eligible for this study if you are aged 18 years or older, have been diagnosed with small cell lung cancer (local or advanced) and have planned systemic therapy OR have first recurrence of disease after at least 6 months of documented disease-free following successful treatment, and you are at risk of developing anorexia based on a dietary score. Study details Participants who choose to enrol in this study will be randomly allocated (by chance, similar to flipping a coin) to receive 12 weeks of either anamorelin or placebo as an oral tablet. Participants will be assessed [~4 weekly] by the study team for the duration of treatment to monitor safety, feasibility and acceptability of study procedures and medication, and suitability of outcome measures for a full trial. Participants will be asked to undergo some laboratory tests and scans and to complete a study diary and a number of questionnaires at 1, 4, 8 and 12 weeks post-treatment commencement. These will involve answering questions regarding general well-being and quality of life, pain, nausea, side effects, capability in daily functions and dietary intake. Participants will also be asked to monitor their physical activity using a pedometer or mobile app. At the end of the 12 week study, all participants will be invited to continue taking their allocated medication for another 12 weeks, with additional questionnaires and assessments to be undertaken at 18 and 24 weeks after starting the medication. This extension stage is completely optional and up to the participant. It is hoped that this study will help clinicians to evaluate the safety, feasibility and desirability of anamorelin as a treatment for cancer-related anorexia and for a phase III trial.

Temporary ileostomies are formed in patients for multiple reasons. Some reasons include permitting bowel rest and promoting healing in patients with inflammatory bowel diseases as well as in patients who have received bowel resections and anastomoses for malignancies. These temporary ileostomies are often reversed at a later point. The site of the ileostomy closure is at risk of incisional hernia formation. These herniae can cause significant impairment in quality of life and often require re-operation for repairs. The high rate of re-operations can incur significant cost to the health system as well as expose patients to the risks of an operation. This project trials the use of a biodegradable mesh at the site of ileostomy closures in an attempt to reduce the rate of incisional herniae thereby, reducing the chances of operative complications as well as reducing a burden off the healthcare system. This project aims to trial the use of the mesh in a randomized study design (Prospective Randomized Open Blinded End-point study) to see if there is a change in the incidence of incisional herniae. Patients will be recruited at the time of the clinic appointment when they are being consented for the reversal of ileostomy procedure. At the time of the operation, the mesh would be implemented depending on whether the patient is in the interventional group. the patient would be followed up in the clinic and receive imaging to assess for whether incisional herniae have formed.

The primary aim of this study is to estimate the effectiveness of audit and feedback for reducing prescribing of benzodiazepines and/or opioids by Australian GPs and OMPs compared with no intervention control. A secondary aim is to evaluate the effect of two factors: tailored peer comparator (no vs. yes) and printed educational materials (no vs. yes).

Electro-convulsive therapy (ECT) is an effective treatment for major depression. ECT is often more successful and achieves a more rapid result than the use of medications or psychotherapy. ECT works by generating an epileptic seizure so the patient must be given a short general anaesthetic so that they are not aware during the procedure. Anaesthetic drugs have a tendency to suppress the ECT seizure, so it is common practice to use as a low an anaesthetic dose as practical, but the low dose of the anaesthetic drug can lead to an increased risk of awareness under anaesthesia. Despite this increased risk, many institutions take no extra precautions or monitoring for awareness. Others, such as our institution, use an isolated limb technique, where the patient's foot is isolated from the paralysing anaesthetic drugs with a blood pressure cuff so if the patient is still awake they can still communicate by moving their foot and more anaesthetic drug can be given to get the patient back asleep prior to treatment. Brain monitoring to detect awareness is often used in other types of anaesthetics and has been used in small trials for ECT but there are no studies comparing brain monitoring and the isolated limb technique to compare their relative accuracy. Which method is the best for detecting awareness? Our study will compare the exposure of brain monitoring to our isolated limb technique, and have an independent observer record the value on the brain monitor, that way we can see if one technique is a better detector of awareness than the other.

The finding of a PI-RADS 4 or 5 lesion on mpMRI carries a high index of suspicion, and probability, of the lesion being clinically significant PCa. However, the sensitivity and specificity is not sufficient to make a definitive diagnosis of PCa without biopsy. Early literature shows that PSMA PET-MRI is superior to mpMRI alone at detecting clinically significant prostate cancer. A positive PSMA PET-MRI lesion is therefore even more likely to correlate with histopathological confirmation of clinically significant PCa. Given that size of the lesion can impact on the successful confirmatory sampling, and detection on PSMA PET, a minimum size of 10mm would make it highly unlikely that the lesion would be missed on biopsy or PET scan. This work has the potential to identify a select group of men who could potentially proceed to definitive surgical treatment without the need for prostate biopsy. Study Details All participants in this study will undergo a mpMRI which is a standard of care investigation, and an 18F-PSMA PET-CT as the research investigation after which a transperineal prostate biopsy of identified lesions will take place as is standard of care, All participants will be recruited via clinics of and by Urologists with scans and biopsies performed at the SAH. Within 2 weeks post biopsy; participants will follow-up with their urologist for discussion of results. For the subset of patients proceeding to radical prostatectomy, histopathological concordance with identified lesions on each of the imaging modalities will be analysed. The proportion of men with change in Gleason grade group following radical prostatectomy will also be recorded.

This trial aims to investigate the relative impact of two online professional development activities for physiotherapists on clinical practice and their patients outcomes. Physiotherapist learners will be randomised to participate in either online clinical mentoring or online pre-recorded lectures. The primary outcome evaluated will be the effect on the physiotherapist learners patients with spinal pain as measured by the 'patient specific functional scale'. Secondary outcomes will be the effect on other patient health outcomes as well as the physiotherapist learners confidence, self-reflection and satisfaction. The clinical mentoring group participants will also complete semi-structured interviews which will be thematically analysed using a phenomenological approach.

Males are at higher risk of death by suicide than females in Australia, and among men, blue-collar males are at higher risk compared to the rest of the male working population. In response to this issue, MATES in Construction developed a workplace suicide prevention program for the construction sector in 2007 that has been widely implemented in Australia. In the current project, this program is being adapted and trialled in the manufacturing sector. The aims of the MATES program are to improve suicide prevention literacy, and help-seeking intentions, and helping behaviours. The program will be evaluated using a cluster randomised-controlled trial design with wait list controls across up to 20 manufacturing worksites in New South Wales. We hypothesise that after 6 months of the MATES in Manufacturing program, there will be significantly greater improvements in help-seeking intentions (primary outcome) compared to wait-list controls. The project is led by Deakin University in collaboration with the University of Melbourne, and in partnership with MATES in Construction.

Chronic pain after a musculoskeletal injury is a chronic pain syndrome characterised by a persistent chronic pain that persists following injury to the musculoskeletal system. Currently, the commonly recommended pain medications carry risks relating to side effects (in particular opioids). This trial aims to study the oral formulation, ZTL-106, in patients with chronic pain as a result of a previous musculoskeletal injury of the knee or hip. The study is a double-blind, placebo controlled, phase 2a study to determine the effect of ZTL-106 on pain, quality of life, emotional state and function, in people with chronic pain that follows a prior knee or hip musculoskeletal injury. Eligible participants will be randomised to receive ether ZTL-106 or Placebo. The investigational treatments will be administered as an oral oil twice daily, once in the morning and once in the evening for each participant for up to 6 weeks. Throughout the study participants will complete a range of patient reported outcome measures (PROMs) that assess their pain interference and severity, as well as the effect of their pain on their quality of life, the frequency of pain flares, and their emotional wellbeing. In addition, blood samples will be taken at several time points throughout the study.