ANZCTR search results

Behavioural activation (BA) is a treatment that aims to activate clients in ways that increase rewarding experiences in their lives, thereby reducing symptoms and behaviours characteristic of depression. BA has the advantage of being more time efficient and less complex than most other treatments for depression. This study is a clinical trial of an innovative behavioural activation treatment for depression (BATD-R) modified for use among people in treatment for substance use disorder (Activate). The aim of the study is to determine the efficacy of Activate (delivered individually) among opioid replacement therapy (ORT) and residential rehabilitation clients. The primary hypotheses are 1) Participants who receive Activate will demonstrate greater reductions in depression symptoms compared to those who receive treatment as usual (TAU), 2) Participants who receive Activate will demonstrate greater reductions in drug use and drug dependence compared to those who receive TAU. The project will also assess the feasibility of implementing BATD-R with ORT and residential rehabilitation clients. This will be measured by treatment retention, client compliance, client satisfaction, and therapist competence. Treatment efficacy will be determined by analysing changes in three outcome measures over the study period: 1. Depression symptoms 2) Substance use 3) Mental health comorbidity

Traditional risk markers of CVD include blood lipids, inflammatory markers, and endothelial function. However, shorter telomeres have recently been associated with increased levels of C-reactive protein, being overweight and obese, and increased odds for developing CHD, when measured in peripheral blood mononuclear cells. Anti-inflammatory dietary habits have been associated with increased telomere length. Specifically, a low fat, high antioxidant diet, with an emphasis on high fruit, vegetable, wholegrain and legume intake, increased telomerase activity; and a small four week intervention of consumption of a Mediterranean diet was found to decrease the percentage of cells with telomere shortening. The Mediterranean diet is high in polyphenols, phytochemicals, and monounsaturated fatty acids that confers antioxidative properties to reduce oxidative stress and inflammation to protect the heart. Recent studies have observed that specific aspects of the diet such as nuts and/or olive oil is protective towards cardiovascular health, and may thus be extracted and incorporated into the diets of other populations. Thus, the association between shorter telomeres and CVD risk factors, and anti-inflammatory diets with telomere biology, suggest that components of diets with anti-inflammatory properties may reduce CVD risk by preventing the loss of telomere length and increasing telomerase activity. To date, no study has compared the effects of fish oil supplementation or a Mediterranean influenced Antioxidant (MAx) diet on telomere length and telomerase activity in the Australian population. Furthermore, while the tolerance and acceptability of fish oil has been studied, acceptability of Mediterranean dietary aspects in an Australian population has not been investigated in a randomised controlled trial. Therefore, investigation into this area is essential to assessing the feasibility of introducing these foods to the population due to the cardiovascular benefits that they accrue. This pilot study aims to identify (1) the adherence to fish oil and a MAx diet in older Australians and thus feasibility of such dietary interventions, and (2) areas for improvement in study design to aid the development of a larger six month study with 210 participants, which will investigate the effects of these dietary interventions on telomere length and telomerase activity.

The purpose of this study is to determine the chronic effects of a generic gym based exercise mode (cycle) in comparison to modified touch football on markers and signalling processes associated with the development of type II diabetes (T2DM) and cardiovascular disease (CVD). Additionally, the current study will assess changes involving, body composition, skeletal muscle glucose uptake, anti- and pro-inflammatory processes, and risk markers associated with T2DM and CVD.

Jumper’s knee (patellar tendinopathy) is often reported in jumping athletes like volleyball players, especially during the volleyball season. It is hard to relieve this pain in-season. In this study we will investigate the effects of two physiotherapy /rehabilitation exercise programs (isometric and isotonic exercises). It is hypothesized that both exercise programs will decrease the level of tendon pain in in-season jumping athletes with patellar tendinopathy.

More than one third of hip fracture patients are likely to be malnourished; these patients routinely fail to meet energy and protein intake requirements after surgery. Malnutrition results in poor nutritional, patient and healthcare outcomes. International trials targeting strategies to adequately address these issues are inconsistent and data relevant to the Australian context is lacking. Baseline data on patients admitted for surgical intervention of an acute hip fracture has suggested a number of barriers to nutritional assessment, diagnosis and delivery in this population. This study will aim to define barriers to nutrition care; the treating team will then collaboratively develop and implement changes to usual clinical practice to overcome these. Before and after measurements will be used to evaluate the success of these changes to routine clinical care. A positive outcome may lead to significant improvements in nutritional, patient and healthcare outcomes.

Insomnia constitutes a significant societal burden, and is thought to affect a significant portion of the adult population, with research citing between 5-20% of the population is affected by these symptoms. In particular, issues with falling asleep seem to be the most frequent complaint. Current treatments available for insomnia include medications such as benzodiazepines and antidepressants. However, long-term use of these has significant limitations, such as addiction, daytime carry-over effects, and a re-bound insomnia effect when medication use is suspended. Additional and/or alternative treatments include Cognitive Behaviour Therapy (CBT) or relaxation, where patients are taught to remedy symptoms through learning more adaptable coping skills. Although both treatment options are efficient, they can often be hard to access due to lack of access to scarce resources, time, motivation and the overall cost. When sleep architecture is clinically assessed, people typically undergo a sleep study. Patients are assessed using a number of physiological measures that indicate the time it takes them to get to sleep, how well they are able to maintain sleep, and whether they wake up during the night. Normally, as a person falls asleep, there are noticeable changes in these physiological measures, compared to when they are awake. In particular, when a person is drowsy and about to fall to sleep, slow eye blinks (slow eye closure) feature and these are thought to indicate the start of sleep. The current study is aiming to examine the use of volitional initiation of slow eye closure to see if attempts to manipulate the speed and time at which they occur might accelerate the start of sleep, coupled with self-distraction techniques, when compared to receiving information only about self-distraction alone. This intervention will be tested in insomnia patients over a period of approximately two weeks. First, participants will need to wear a sleep-activity monitoring watch for one week. This acti-watch will assess sleep and activity levels for a period of 7 days. After the one-week period of monitoring activity-sleep is complete, the participant will need to stay in the sleep laboratory at the Austin Hospital for one night. During the stay in the sleep laboratory, participants in the ‘treatment group’ will be instructed in a method of slow eye closure, using an electronic metronome to appropriately time eye closure, and will have a session with a trained sleep specialist about the use of self-distraction strategies. To test the effectiveness of this intervention, a control group will also be used. The control condition will involve taking part in a ‘self-distraction information only’ session. After the participant has learned either the combined self-distraction and eye closure technique or self-distraction-only technique in the laboratory, they will wear the watch for another week while practicing these strategies at home. After the week of wearing the sleep-monitoring watch, the researcher will collect the watch and also have the participant fill in few questionnaires, as well as a feedback sheet about their experience of the research. This feedback will assist in future, larger-scale version of this study and help to identify how the study may be improved.

This study is evaluating the effect of using T cell immunotherapy following standard chemotherapy for the treatment of nasopharyngeal cancer (NPC). Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with metastatic nasopharyngeal cancer and your clinician is planning to treat you with standard chemotherapy. Trial details All participants in this study will receive standard chemotherapy with gemcitabine and cisplatin according to their clinician’s standard clinical care. Following this, they will undergo the experimental immunotherapy. This involves infusing Epstein-Barr Virus (EBV) specific T-cells intravenously (i.e. directly into the vein) up to 6 times, at fortnightly intervals. Participants will be regularly assessed for up to 38 weeks in order to evaluate their response to treatment, and the safety and tolerability of treatment.

This randomised control trial (RCT) investigates whether targeting specific psychological drinking profiles in alcohol dependent patients is clinically more effective than generic psychological treatment.

This study aims to test the efficacy of the Reframe-IT program in reducing suicidal ideation, hopelessness and depression in school students. The study also aims to determine if the program leads to increased confidence and perceived skill, and / or changes in practice among school wellbeing staff who are implementing the program. The program is a personalised and interactive website which delivers 8 modules of cognitive behavioural therapy over approximately 8 weeks. The program is delivered via a series of videos depicting an adult 'host' and 4 young people who post a weekly video diary reflecting on their experiences. There are weekly activities, a message board and adjunctive therapist involvement. The program differs from existing Internet-based programs in that it: has been purpose-designed for young people; is interactive rather than text-based; and is designed to be a tool for student wellbeing staff to use specifically with suicidal students. The program has been subject to a pilot study (ACTRN12611000866909) which used a before-and-after design. Findings have shown an overall reduction in suicidal ideation, depressive symptoms and hopelessness among participants over the course of the program. We will now test its efficacy in a randomised controlled trial with 170 students from up to 28 Melbourne high schools. Participants will be assessed at baseline, post-intervention (10 weeks) and 12-week follow-up. Hypotheses are that, when compared to treatment as usual, the program will lead to: 1. Reduced suicidal ideation 2. Reduced depressive symptoms 3. Reduced hopelessness 4. Reduced symptoms of anxiety 5. Increased problem solving skills

The aim of the study is to see if the two sterile water injection technique is as effective as the standard four injection technique in relieving lower back pain during labour and birth. If the difference in pain relief between the two techniques, thirty minutes after injection(s) is no greater or less than 1 centimeter on the VAS, the trial will have proven it's hypothesis