ANZCTR search results

Major depressive disorder ranks second amongst the most important causes of disability in Australia. Anxiety disorders also rank in the top ten causes of disability. One problem is that the benefits of antidepressant medication, the most widely used remedy for both these disorders, are small and the harms are significant. There is a swing towards the use of psychological treatments, of which cognitive behaviour therapy (CBT) is the best researched. However CBT has many out of pocket costs (average >$60 per visit), quality is not assured, and therapy is not widely available outside major city centres. Internet delivered automated cognitive behaviour therapy (iCBT) on the other hand, produces the same benefit and freedom from harms as face to face CBT, but has advantages of low cost, high fidelity and wide distribution at levels comparable to medication. In iCBT studies, however, adherence varies markedly according to the amount of encouragement or clinical guidance provided. In our research, adherence varied from 33% for a group who received no support, to 68% for those who received automated reminders, to 81% for the group who received telephone reminders from a technician. A later comparison of technician reminders with coaching by a clinician showed no difference in adherence or efficacy. The two levels of support were therefore comparable but the costs to the health system were not. The primary purpose of this trial is to examine the efficacy and adherence of iCBT for anxiety and depression (6 lessons + homework + automated reminders) across five varying levels of support plus usual care, compared with usual care alone. Eligible participants will be randomly allocated to one of six groups with varying levels of support: 1) Self-help only; 2) Technician contact upon request; 3) Scheduled technician contact after each lesson; 4) Clinician contact upon request; 5) Scheduled clinician contact after each lesson; or 6) Treatment as usual (TAU) control group. The main hypotheses to be tested are: 1. iCBT at all 5 levels of support will significantly reduce symptoms of anxiety, depression, distress and disability compared to a TAU control group. 2. The efficacy will be related to the frequency of support. 3. The adherence rate will be related to frequency of support. 4. The most cost effective (staff cost per unit of health gain) will be technician support on request. It is hoped that the findings of this trial will provide further information regarding (1) the adherence rates and treatment effects that are associated with various levels of clinician or technician support, (2) the cost effectiveness that is characteristic of each level of intervention, (3) whether certain levels of intervention are not sufficiently effective to be attractive to a health service, and (4) whether there are levels of intervention that are not sufficiently more cost effective than a lower cost intervention to be attractive to a health service.

The aim of this study is to determine whether an SMS-text message follow-up intervention for deliberate self-harm (DSH) is more effective in reducing DSH re-presentation to hospital, than treatment-as-usual hospital follow-up. Method This study will be conducted at Blacktown, Westmead and Nepean Hospitals as a Randomised Controlled Trial (RCT). Individuals will be eligible for study inclusion if they present with DSH to a hospital Emergency Department during the recruitment period, have access to a mobile phone for personal use and are aged 16 years and over. Eligible study participants will be randomly assigned to either hospital follow-up treatment as usual (TAU) or TAU plus SMS-text message follow-up. The study will have a two year recruitment phase with participants in the intervention condition receiving a supportive SMS text message at 1, 2, 3, 4, 5, 6, 8, 10 and 12 months after their index admission/randomisation. The outcomes of interest are i) the number of DSH re-presentations in each group, ii) median time to first re-presentation in each group and, iii) deaths within each group, within 12 months following recruitment. Benefits Repetition of self-harm within 12 months of an index episode occurs at a median rate of 15% (interquartile range 12-25%). This has a strong association with subsequent completed suicide and significant ongoing resource implications for the health care system. We have demonstrated in our previous ’Postcards from the EDge’ study (Carter et al, 2005, 2007, 2013, Milner and Carter, 2015) that, in individuals with a prior admission for deliberate self-poisoning (DSP), a simple postcard follow-up significantly reduces hospital re-presentation rates and associated costs. SMS text messaging has been demonstrated to be an effective method of communication with vulnerable people. Determining whether electronic communication is more effective than current practice in preventing DSH re-presentation is of the utmost importance, since DSH accounts for 5% of all general hospital admissions in Australia and mobile phone ownership is becoming almost universal, particularly among young people who are more at risk of self-harm. Should text messaging prove more effective, it allows for a vastly more flexible, direct and deliverable medical follow-up system than has ever existed under traditional models of care for DSH patients.

Increasingly recognised within the clinical disciplines of Medicine and Public Heath over the past four decades, dysfunctional sleep continues to impose incremental costs to the community due to declining quality of life and vocational productivity. The adverse effects of sleepiness and sleeplessness are confounded by the associated burden of co-existing non-communicable diseases (NCDs) such as chronic pain, obesity, diabetes, obstructive sleep apnoea and obstructive coronary artery disease. The primary aim of the Eastern Australian Sleep and Health Livingness Study is to describe and quantify the multi-faceted interrelationship between the diverse manifestation of impaired sleep and individual variations in physical activity, daytime cognitive function, emotional well-being and other lifestyle characteristics following adjunctive treatments for sleep rhythm maintenance. ‘Adjunctive’ treatments include a broad range of environmental modification, physical activity, sedatives, exogenous hormonal replacements, dietary supplements and/or emerging trend of adjunctive Complementary Medicine modalities in addition to conventional medical treatments. The study is a prospective observational cohort study of adults in Eastern Australian rural and urban centres who report of impaired sleep with or without chronic bodily symptom(s). Interviewer-assisted survey and stratified sampling over a five-year period will stratified participants into case-control study for their exposure to important risk factors of impaired sleep and/or chronic bodily symptoms, pattern of health care utilisation, pattern and quality of sleep, persistence and/or development of bodily symptoms such as pain(s), tiredness and fatigability in addition to task-specific cognitive impairment and emotional well-being. The matched case-control study design of comparison of participants living in rural and urban centres offers an efficient method of testing the study hypotheses within a relatively shorter period of follow up time. It also allows testing of multiple study outcomes, different case-control scenario such as patterns of health care utilisation, calculation of time-dependent or exposure-dependent risk and minimise selection bias as compared to a large-scale population study which is most costly to implement. The currently available estimated prevalence of impaired sleep, chronic bodily symptom(s) and ‘adjunctive’ treatment is significant to reduce potential bias of risk factor exposure. Given the etiological importance of regular physical activity and adverse lifestyle factors, the study will confirm supportive sleep rhythm(s) is/are represented by a consistent pattern(s) of ‘livingness’ which is readily identifiable and reproducible. The implication of the study proposes the reorientation of our Public Health policy in practical lifestyle modification which are necessary in improving productivity and preventing the long-term complications of sleep-related disorders.

Globally children's intake of unhealthy foods and beverages is excessive, contributing to weight gain and risk of obesity. Parents’ attitudes and beliefs influencing food provision provide a promising new avenue for obesity prevention through reducing children’s intake of unhealthy foods and beverages. There is a need to understand the relative importance of different parental attitudes and beliefs in influencing their provision, starting with the home setting. The aim of this study is to understand the relationships between, and relative importance of, parents’ attitudes and beliefs and children’s intake of unhealthy foods and beverages. This aim will be achieved by an online cross-sectional survey of parents of 3-7 year olds to measure parental attitudes and beliefs influencing their provision of unhealthy foods. The data will be examined using Structural Equation Modelling analyses to determine the predictive ability of attitudes and beliefs on parents’ provision of unhealthy foods to 3-7 year old children. Findings from this study can then be used to develop evidence-based interventions to support parents’ to limit provision of unhealthy foods and beverages, hence improve energy balance and prevent obesity from an early age.

An active break intervention targeting improving academic and physical activity related outcomes will be implemented in selected Victorian Government primary schools. Our findings will determine the feasibility and potential efficacy of active breaks for improving academic and physical activity related outcomes.

Constipation is a common problem in people with end stage kidney failure. Treatment of this condition with a high fibre diet and adequate fluid is not possible in this group of people because they need to follow a specialized diet and restrict their fluid intake. The aim of this study is to determine if a non drug treatment in the form of 40g of almonds daily for 4 weeks will help improve the symptoms of constipation. Other outcomes such as improvements to the level of inflammation, dietary intake, memory, gut bacteria and quality of life will also be investigated.

This study aims to assess the effect of nicotinamide (vitamin B3) on nonmelanoma skin cancer incidence in renal, hepatic, heart and lung transplant recipients. Who is it for? You may be eligible to join this study if you are aged 18 years or more and have had a transplant more than 12 months ago. You should be experiencing current immune suppression and have a past history of at least two confirmed nonmelanoma skin cancers within the past 5 years. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will take two 500mg nicotinamide (vitamin B3) tablets daily for 12 months, whilst those in the other group will take two placebo (inactive) tablets daily instead. Participants will not know which group they are in until the end of the trial. Participants will be regularly assessed over the treatment period to determine the efficacy of nicotinamide in preventing nonmelanoma skin cancers and the safety of this treatment in transplant recipients.

This pilot study will be the first to report on the response of myopic (short-sighted) children living in Australia to low dose atropine treatment. It will also examine outdoor/physical activity levels to inform guidelines that balance minimizing the long term effects of myopia (short-sightedness) versus the risks of increased UV exposure. The aim of this study is to test whether a very dilute (0.01%) solution of muscle relaxing mediation (Atropine) given as a single daily eye drop, can slow the progress of myopia. The treatment part of the study will run for 2 years.

This study will evaluate the use of PET/CT and PET/MRI imaging for head and neck cancer patients receiving definitive radiation or chemoradiation treatment. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and are receiving definitive radiotherapy or chemoradiation for head and neck cancer at the Royal Brisbane and Women’s Hospital. Study details All participants in this study will undergo an additional imaging session at the Herston Imaging Research Facility (HIRF). During the additional imaging session participants will undergo a 18-FDG PET/CT and 18-FDG PET/MRI. You will be asked to fast for up to 6 hours prior to the scan session. A qualified Nuclear Medicine Technologist will insert a tube into a vein in your arm and give you an injection of a radioactive substance called FDG. If you are having the PET/MRI first then the scan will start immediately during the period known as the uptake time. You will be positioned in a way that closely matches your radiation therapy treatment position. The scan involves lying flat with knees and neck supported. The scan time for the FDG PET/MRI is approximately 1 hour. After the examination is completed, you will be asked to empty your bladder and move to the PET/CT scanner where the scan will commence. The exam will take approximately 30 minutes. After the examination is completed, you will be able to eat and drink normally. If you are having the PET/CT scan first then you will rest for 1 hour during the uptake time, before emptying your bladder and proceeding to have your PET/CT scan which will last approximately 30 minutes. You will then be moved to the PET/MRI scanner and the scan will commence, lasting approximately 1 hour. After completing both scans you will be able to eat and drink normally. Gross tumour volumes derived from each of the scans will be compared, as will the radiation dose. It is hoped that the new scans will improve our ability to localise cancer more accurately than our current methods, for planning radiation treatment.

This study will compare the accuracy of an investigative imaging technique (known as 68Ga-CPCR4-2 (68Ga-Pentixafor) PET/CT imaging) with conventional staging (contrast enhanced Pelvic MRI and CT chest, abdomen and pelvis) at initial diagnosis of rectal cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have biopsy proven, newly diagnosed rectal adenocarcinoma (of any subtype). Study details All participants in this study will undergo a 68Ga-CPCR4-2 (68Ga-Pentixafor) PET scan together with a contemporaneous, non contrast, low dose CT for anatomical correlation, in one session, at the Herston Imaging Research facility (HIRF). A qualified Nuclear Medicine Technologist will insert a tube into a vein in your arm and give you an injection of a radioactive substance called 68Ga-Pentixafor. You will then be required to wait for 1 hour, called the uptake time, before emptying your bladder and proceeding to have your scan. The scan involves lying flat with knees supported and arms resting above your head. You will be scanned from head to mid-thigh. The scan time for the 68Ga-Pentixafor PET/CT will be approximately 45 minutes. We will monitor all participants for adverse events for 30 days after the PET scan or until the time of treatment initiation whichever comes first. We will also measure the level of tracer uptake by the cancer . If results of this study are promising, we hope to further explore the impact of the PET tracer on management decisions, diagnostic accuracy, as well as the prognostic impact of the uptake of this tracer.