ANZCTR search results

Almost half of all Australians experience a mental health disorder in their lifetime. Comorbidity is the norm and is associated with poorer functioning and lower quality of life. The COVID-19 pandemic has increased psychological distress and reduced access to gold standard mental health treatment like cognitive behavioural therapy (CBT). A paradigm shift is needed to increase the evidence-base and availability of mental health interventions. A “transdiagnostic” treatment approach where an intervention targets shared processes underlying comorbidity (e.g., sleep, emotion regulation) rather than disorder-specific symptoms is an innovative way to improve comorbid mental health. Individuals with better sleep and emotion regulation have less intense and persistent negative emotions in response to environmental stressors (e.g., pandemics, bushfires, floods), thus protecting against poor mental health. Yoga, a combination of mindfulness meditation, breathwork, and physical postures, is a compelling novel transdiagnostic solution. Yoga is efficacious for prevalent and comorbid mental health disorders among Australians: anxiety, major depressive, posttraumatic stress, and alcohol use disorders. Yet no study has assessed yoga efficacy for comorbid mental health. Yoga is popular and has several advantages over first-line CBT like lower associated stigma and wait times and increased cost-effectiveness. Yoga is proposed to exert positive effects via improved sleep and emotion regulation. This innovative research aims to establish yoga efficacy for comorbid mental health and to assess if sleep and/or emotion regulation are moderators and/or mediators of mental health outcome. It will use a non-inferiority randomised controlled trial design with CBT as the active control and both subjective (questionnaires, ecological momentary assessment) and objective (actigraphy, heart rate variability) measures of sleep and emotion regulation. This research will bring about a paradigm shift in mental health care and advance precision medicine.

This research has direct translational value for people with MS, critical given the impact of depression on people with MS. Outcomes are aimed at supporting clinicians to improve detection and management of depression in people with MS through neurology services. It will provide recommendations and supports to improve detection and treatment and will enable submission of funding proposals to facilitate the next translational phase (years 4-5) through iterative feasibility and acceptability implementation across neurology settings, ensuring suitability for rollout. Results will: 1) fill a knowledge gap about barriers and required supports to improve assessment and treatment in Australian neurology practices, 2) provide Australian validation data to screen for depression in routine clinical practice; 3) characterise the depressive symptom profile in MS to identify whether it differs in presentation from depression in people without MS requiring specific patient and clinician education; 4) utilise this research, literature review and advisory committee expertise to develop recommendations and supports that improve detection, treatment and monitoring of depression in people with MS. It will result in high-quality peer review journal outputs and conference presentation outputs reporting each sub- study, as well as a report detailing overall program results that will be submitted to relevant MS healthcare, consumer, advocacy and research organisations. This research has potential to positively impact people with MS who experience depression, and their families, as well as to provide economic gains by reducing direct and indirect costs of the impact of depression on MS.

The aim of this study is to investigate the use of pseudoephedrine in patients experiencing retrograde ejaculation following retroperitoneal lymph node dissection for the treatment of testicular cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, have a confirmed diagnosis of a testicular germ cell tumour, have received retroperitoneal lymph node dissection at least 6 months ago, and have confirmed retrograde ejaculation following the procedure. Study details All participants will complete a one-off series of questionnaires assessing quality of life, and will then receive pseudoephedrine (60mg every 6 hours the day prior to semen collection, followed by an additional 60mg of pseudoephedrine at 0600hrs and 30-60 minutes prior to semen collection) as an oral tablet over a period of 1 day. After 1 day of treatment, participants will undergo semen and post-ejaculatory urine analysis to explore the efficacy of the treatment and any side effects experienced. It is hoped that this study may demonstrate that a short course of pseudoephedrine is effective and safe for the treatment of retrograde ejaculation following retroperitoneal lymph node dissection for the treatment of testicular cancer.

As we age, the quality and strength of muscles and bone diminishes. Furthermore, changes in posture and musculoskeletal dysfunction, such as rotator cuff pathologies, can accelerate this deconditioning. Resistance training is recommended in older adults to try to slow the rate of decline and maintain strength and function, however the minimum National Physical Activity Guidelines are only being met by approximately 1 in 4 Australian older adults, with no indication that the resistance guidelines are being met. This project aims to investigate the most effective upper limb resistance exercise equipment to use for maximal range of motion and muscle activation of the targeted muscle(s) in older adults. Participants will be asked to attend a single testing session, where they will perform six upper limb exercises without resistance and then using elastic banding (Theraband), milk bottles and resistance machines. Total range of motion and muscle activity will be measured for each exercise, using each piece of resistance equipment, on the major muscles in the arms and chest. The order of exercise completion and the item of equipment used will be randomized between each participant. The results of this study will provide further insight for exercise professionals to prescribe home-based upper limb resistance exercises in older adults, taking into consideration the type of resistance equipment, that will allow for the greatest activation of the targeted muscle(s).

There is limited research on the medium-term recovery and outcomes of patients three months following major upper abdominal surgery. The aim of this study was to explore the functional outcomes and lived experiences in adults three months after major upper abdominal surgery at Royal Perth Hospital in Perth, Western Australia. Data collected from the participants prior to their surgery was compared with data collected from them three months after the procedure.. The measures included clinical frailty and functional independence. At three months post-surgery, information regarding abdominal pain, post-surgical fatigue, and cognition were also gathered in order to explore the association between these variables and the participants level of functional recovery three months following the surgery. Qualitative interviews were also conducted at this time to explore the participants lived experiences and those of their primary carer.

This trial is exploring if an online shared care plan and telehealth improve the frequency and quality of primary and preventive care for people with a lived experience of severe mental illness. It aims to improve the health of people living with mental illness by facilitating their engagement with primary care. It also aims identify more effective and time efficient shared care processes, which are essential given the multiple competing demands on primary care and mental health clinicians. The online shared care plan outlines the preventive care tasks that GPs and SLHD Mental Health Care Coordinators will share. This includes, for example, physical health checks, metabolic blood tests, lifestyle assessment and advice, preventive screening, medication management and referrals to allied health. This pragmatic trial will invite clients of the Sydney Local Health District Community Mental Health Teams and their usual GPs to participate. Participants will be followed for 12 months.

Neuropathic pain (or nerve pain) is a type of pain that can affect people who have had a traumatic incident or surgery that causes damage to nerves. It occurs in bursts and is often severe and chronic. Pain relief can be difficult to achieve in people with this type of pain. Lidocaine is a local anaesthetic drug that can be given by intravenous drip in a hospital setting, to provide a period of relief from neuropathic pain. Pain is a unique experience for the individual person, blending a combination of body and mind factors. The response to intravenous lidocaine varies greatly from almost complete pain relief for months through to no relief or even feeling worse pain after the drip. We don’t know enough about the optimal dose or which people will get the best pain relief from intravenous lidocaine. The Tess Cramond Pain and Research Centre (TCPRC) is a specialised centre for people with chronic pain. Researchers at the TCPRC will compare two different doses of intravenous lidocaine and a placebo dose (saline without lidocaine) for people with neuropathic pain, to see which gives the best pain relief while minimising the risk of side effects over one week. This study also aims to provide more understanding about each individual person, with participants completing a series of questionnaires about their how their pains feel, expectations from the treatment, their thoughts, feelings and physical activity relative to their goals. Sensory assessments will also be measured, involving standardised hot, cold and pressure stimuli at the skin to determine how the person’s nerve sensitivity contributes to their neuropathic pain. The results of this important study will help to guide anaesthetist’s and specialists pain doctor’s decisions about the best dose of intravenous lidocaine to provide, and which patient characteristics of people with neuropathic pain are most likely to get the most effective and sustained pain relief. This will have potential to improve the quality and the efficiency of care provided at the Tess Cramond Pain and Research Centre and potentially at other treatment centres. The results of this study will also provide the foundation for a much larger study across many hospitals, to conclusively determine the dose of intravenous lidocaine and patient characteristics that achieve the best pain relief, to inform the standard for treating post-traumatic neuropathic pain in Australia and overseas.

The aim of this study is to determine how common retrograde ejaculation is in patients following retroperitoneal lymph node dissection for the treatment of testicular cancer and the impacts that this might have on quality of life. Who is it for? You may be eligible for this study if you are aged 18 years or older, have a confirmed diagnosis of a testicular germ cell tumour, have received retroperitoneal lymph node dissection at least 6 months ago. Study details All participants will be invited to complete a once-off series of questionnaires assessing quality of life, which is expected to take around 20 minutes to complete. Additionally, participants will be invited to partake in an optional semi-structured interview, which will last up to 45 minutes and will occur at a later time. It is hoped that this study will contribute important data to help understand the impact of retrograde ejaculation following retroperitoneal lymph node dissection has on survivors of testicular cancer.

This study will to investigate whether using Cyclophosphamide/Anti-Thymocyte Globulin (ATG) will be as safe as Carmustine, Etoposide, Cytarabine and Melphalan (BEAM) with ATG. We also want to know if it is as effective in suppressing your MS. This study will also investigate how a new immune system develops (by studying your blood), including the microbiome (by studying stool and saliva samples), after using these different types of chemotherapy. The AHSCT procedure involves two stages: collecting and then giving back the patients stem cells. In the first stage, the patients blood stem cells are collected by initially giving high dose of intravenous chemotherapy called cyclophosphamide followed by subcutaneous injections of granulocyte stimulating factor to stimulate the stem cells to 'grow in number'. Once the required number of stem cells are detected through blood tests, the patient undergoes undergo daily leukapheresis until minimum number of stem cells are collected. Once this is done, the patient returns after a period of time, the patient is re-hospitalised for the transplantation procedure. Chemotherapy will be given to knock out the current immune system consisting of one of two regimens; Cyclophosphamide/Anti-Thymocyte Globulin (ATG) or Carmustine, Etoposide, Cytarabine and Melphalan with ATG and then reinfusing their own stem cells to ‘grow’ a new immune system. Patients would be enrolled in sequential cohorts to fully assess safety, tolerability and efficacy of both BEAM and cyclophosphamide conditioning with rabbit ATG as outlined below. Patients would be assigned to a cohort (in a block of 15:15 fashion) unless there is a clear medical reason determined by the transplant physician that they should be treated with a particular regimen (eg: history of allergic reaction to one of the drugs). We hypothesize that HSCT will continue to be safe and beneficial (as measured by resolution of disease characteristics) to patients with severe treatment-resistant neuroinflammatory disease whilst using a variation in conditioning regimen. There are three groups being enrolled. Patients enrolled to have a AHSCT will be compared to patients having standard MS treatment and those undergoing a AHSCT for a hematological cancer

While the role of dietary fibre for the maintenance of gut health is well recognised, typical dietary consumption in Australian adults remains below recommendations. Further, there are many types of dietary fibre, each with different health benefits. In particular, fermentable fibres such as beta glucan and fructans that can impact gut microbe activity, are less likely to be consumed than standard stool bulking agent fibres such as cellulose. This study uses bread as the test product, a common source of dietary fibre for Australians, to pose the question of whether the simple replacement of white fibre bread with a highly fermentable fibre (barleyMAX) bread is achievable and effective in increasing the fibre intake and gut health of Australian parents/caregivers, a group whose busy lifestyle often can result in less favourable dietary patterns, and who can be tested as ideal role models for increasing dietary fibre consumption for the whole family unit.