ANZCTR search results

Symptoms of psychological distress, also described as acute stress, anxiety or nervous tension are particularly common in patients suffering chronic pain. EMD-RX5 is a cannabidiol (CBD) capsule. Some research indicates that CBD affects receptors (a group of cells that control the movement of chemicals and molecules) in the brain, that may alter a key hormone (serotonin) relating to mood, happiness and feelings of well-being. The purpose of this study is to determine whether EMD-RX5 improves symptoms of psychological distress in patients experiencing chronic pain.

Background Depression is a highly prevalent mental illness that affects over 109 million men worldwide and one in eight Australian men every year. Characterised by persistent feelings of sadness and hopelessness, untreated depression is devastating for individuals, families, and communities. Due to COVID-19, the Australian prevalence of depression increased by 10% in 2020 alone. In Australia, men with depression are often referred to psychotherapy (also known as counselling). However, while effective for treating depression, psychotherapy often fails to engage men who most often report that the process ‘doesn’t feel right’. Given the dominant form of masculinity in Australia encourages men to suppress emotions, it is unsurprising many find it hard to be vulnerable with a relative stranger, in a formal and unfamiliar environment, for a substantive period of time. Recently, the Australian National Men’s Health Strategy highlighted the need to tailor existing mental health services to be more engaging for men. In contrast to traditional psychotherapy, which almost exclusively takes place indoors, ‘walk and talk’ therapy in natural settings has potential to engage men for several reasons. First, walking outdoors may represent a less confronting context (e.g., less direct eye contact, shared ownership of physical space). Second, the biophilia hypothesis suggests humans have a ‘biological attraction to natural environments’, and gain health benefits by simply being in nature. Finally, physical activity has a known anti-depressant effect, that can enhance the benefits of psychotherapy. Despite these benefits, no studies have examined the value of walk-and-talk therapy for supporting men. Study aims Primary aim: To test the feasibility of outdoor, walking-based psychotherapy for men with depression compared to usual care (seated indoor therapy). Secondary aim 1: To investigate the preliminary efficacy of outdoor, walking-based psychotherapy for improving the mental health of men with depression compared to usual care. Secondary aim 2: To investigate differences in perceptions of therapy and the therapeutic alliance between men who participant in outdoor, walking-based psychotherapy compared to usual care.

In Australia between 2015 and 2019, there were 2731 unintentional deaths due to prescription opioids1. Many consumers are unaware of how to use opioids safely and that opioids can cause addiction and harm. Many consumers are not receiving adequate instructions about opioids from doctors. When instructions are poor, consumers are less likely to receive the benefits of opioid medications and more likely to become opioid dependent. Hospital settings such as the emergency department (“ED”) and the surgical outpatient department (“OPD”) are key risk areas for initiating treatment with opioids for acute pain after injury or surgery. Approximately 16% of patients who received their first opioid medication from a WA hospital between 2014 and 2015 were still taking opioids one year later. The OPIOIDS Trial will be run as a multi-site intervention trial to assess the efficacy of personalised, mobile-accessible patient instructions for opioid medications at discharge from the ED and surgical OPD with patients and doctors.

High sensitivity troponin assays have led to increased numbers of patients presented to the emergency department (ED) for suspected acute coronary syndrome (ACS) now having detectable troponin levels. For those with low level troponin elevated, there is limited evidence to guide care. It is suggested that individuals in this zone, have a higher risk of poor outcomes and the risk versus benefit of invasive coronary angiography (ICA) is less clear as the likelihood of an evolving heart attack is lower. Computed tomography coronary angiography (CTCA), being a less invasive alternate approach, may provide useful information to inform subsequent care to these lower risk patients. This randomised clinical trial aims to investigate CTCA vs. ICA in suspected ACS with low level troponin elevations in the ED. Outcomes will be assessed at 30 day, 6 months and 12 months.

The primary purpose of this study is to assess the safety and psychedelic effect of two orally administered DMT and harmala alkaloid formulations provided in separate sessions to healthy volunteers with prior use of these substances. This data will inform the decision to chose one of the formulations for use in a future phase 2 study involving participants with dual diagnosis and major depressive disorder. The potential dose escalation element will focus on determining the psychedelic properties and safety at a range of doses.

Objective: To investigate the feasibility of Sports Stars-JIA, a physiotherapy sports group for children with Juvenile Idiopathic Arthritis (JIA). Methodology: Feasibility study Intervention: Sports Stars is an 8-week (8hr) practitioner-led, peer-group sports intervention which targets physical, social, cognitive and psychological components of Physical Literacy needed for participation in life-long physical activity. Children will be introduced to the four most popular Australian team-sports (soccer, netball, t-ball during active sessions. They will also receive 3x2hr psychoeducation sessions with their family to support ongoing participation in sport. Hypothesis: It is expected that for children with JIA, Sports Stars’ assessments and interventions will be: i. Acceptable (suitable and attractive) ii. In demand (recruitment of appropriate numbers is possible) iii. Practical and able to be implemented (successfully delivered) iv. Likely to be effective (show promise in this population)

Multiple Myeloma is a plasma cell malignancy that remains incurable. In multiple myeloma, patients with non-measurable disease, poor kidney function, extramedullary relapse or central nervous system myeloma have not been studied well in clinical trials. We plan to establish a trial to look at these groups (called strata) who previously had limited prospect of enrolment in clinical trials for multiple myeloma. Therefore, this trial aims to assess the effectiveness of the combination treatment (Selinexor, pomalidomide and dexamethasone) in treating multiple myeloma in the specific group of participants described above. Who is it for? You may be eligible for this study if you have been diagnosed with multiple myeloma and have had 1-2 prior lines of treatment. Study details: After undergoing the consent and screening assessments for the Master trial protocol (MM26/Novel Combinations for Orphan Myeloma: The NORM platform master protocol), you may be consented and assigned to this trial (Domain 1 protocol). All participants on this trial will receive Selinexor, pomalidomide and dexamethasone as oral tablets on a 28-day cycle until the participant experiences either unacceptable toxicity or disease progression. Participants will be monitored for adverse effects for the duration of the treatment, as well as the start of every cycle for assessment of their response to treatment through blood, urine and/or bone marrow samples. They will also be assessed for quality of life, through the completion of a questionnaire. It is hoped that this research will determine whether the combination of selinexor, pomalidomide and dexamethasone will be successful in treating patients with Orphan Multiple Myeloma who have had 1 to 2 prior lines of treatment. If this combination treatment is found to be effective, it may be used to improve the health outcomes for future multiple myeloma patients.

Infliximab is the mainstay of treatment in perianal fistulising Crohn’s disease. It has previously only been administered via infusions for perianal fistulising Crohn’s disease. Subcutaneously delivered infliximab has recently been approved by the Therapeutic Goods Administration for perianal fistulising Crohn’s disease. Real-world data has demonstrated that switching from intravenous to subcutaneous infliximab in patients with disease of their bowel is safe and effective. However, there is currently a lack of data regarding the efficacy or treatment persistence in patients switched from intravenous to subcutaneous infliximab in perianal fistulising Crohn’s disease. Our study involves switching patients from intravenous to subcutaneous infliximab and evaluating how many patients continue to take this medication at 12 months. Secondarily, we will look at how effective this drug is at treating perianal fistulising Crohn’s disease with a variety of measures

The effect of screen use on children’s health and development is now considered a public health issue. National Child Health Polls consistently report excessive screen use as Australian parents’ top-ranked child health concern, and over half of Australian parents are concerned about their own children’s screen use. Parents report that children’s screen use contributes to family conflict, oppositional child behaviour, lack of physical activity, and sleep problems, and data show that high screen use is associated with poorer physical, psychological and developmental health outcomes for children, including in early childhood—relationships which appear to be at least partially mediated by parenting behaviour (e.g., reduced parent-child interaction). Parents report that difficulties with implementing screen use limits, difficult child behaviour when limits are imposed, and parenting practices which encourage screen use are barriers to healthy screen use. Indeed, our own data suggest that difficult child behaviour is a key predictor of low parental self-efficacy for managing children’s screen use which, in turn, predicts greater screen use. This project will evaluate a brief online parenting support intervention designed to help parents develop the skills and confidence to implement healthy screen use practices with children from the earliest years. It will generate essential data to inform study design and applications for funding for a larger scale, fully powered RCT to establish intervention efficacy.

Multiple myeloma is a plasma cell malignancy that remains incurable. In multiple myeloma, patients with non-measurable disease, poor kidney function, extramedullary relapse, or Central nervous system myeloma are frequently excluded from clinical trials. Considering this, none of the available treatments have been adequately studied in these populations, and these patients represent a group with an unmet clinical need. We plan to establish a platform trial to look at these orphan groups (strata) of patients who have previously had no prospect of enrolment in clinical trials and in groups of patients who have not been explored before. Therefore, this clinical trial aims to assess the effectiveness of different treatment regimens for patients with first or second relapse of Multiple Myeloma. Who is it for? You may be eligible for this study if you are aged 18 or older, you have been diagnosed with Multiple myeloma and have had 1-2 prior lines of treatment. Study details Participants who choose to participate in this trial will undergo screening assessments to see if they meet one of the four following disease criterions described as stratums: •Stratum A: Poor kidney function, defined by a laboratory value of creatinine clearance (CrCl) less than 30mls per minute. •Stratum B: Non-measurable disease (defined by specific levels for blood and urine tests collected at screening) •Stratum C: presence of a plasma cell tumour that develops outside the bone marrow (extramedullary plasmacytoma) •Stratum D: Central Nervous System (CNS) myeloma Once the participant has met one of the four disease criteria described above, they will be assigned to the corresponding platform clinical trial (called appendixes) based of the four stratums described above. Once it is determined which platform trial they should be assigned to, the participant will be screened and consented again for the platform trial and go on to receive treatment if they meet the eligibility for the specific platform trial. This will continue until the participant experiences either unacceptable toxicity, or disease progression. Participants will be monitored for adverse effects for the duration of treatment, as well as the start of every cycle for assessment of their response to treatment through blood and urine samples and/or bone marrow biopsies, and assessment of quality of life through completion of a questionnaire. It is hoped this research will determine whether the combination of different treatments in treating a specific population of participants with relapsed or refractory myeloma is successful. If this combination treatment is found to be effective, it may be used to improve the health outcomes of future patients with refractory and relapsed multiple myeloma.