ANZCTR search results

The project aims to explore the efficacy, acceptability and feasibility of an internet-delivered mindfulness-enhanced cognitive behavioural therapy (MEiCBT) program for depression and anxiety. Up to 30 people with elevated depression and/or anxiety will be assigned to the active treatment group. The treatment group will commence the Mindfulness-Based Program for Depression and Anxiety immediately. The efficacy of the program will be determined by comparing the depression and/or anxiety symptom levels before and after treatment, and at 3 month follow-up.

The present study aims to increase our understanding of post discharge follow up processes in trauma patients with predominantly minor injury. The aim of the study is to determine whether a post discharge follow up clinic results in earlier return to work and baseline health status in patients sustaining minor injury.

ETOH-AF trial: While the association between binge drinking and atrial tachyarrhythmias is well-established, even moderate alcohol consumption has recently been identified as a significant risk factor for atrial fibrillation and/or flutter (AF) in a dose-dependent manner. To date, there have been no randomised-controlled trials looking at the impact of alcohol abstinence on AF outcomes. Moreover, we are keen to look at the overall effects of alcohol abstinence on other cardiovascular outcomes (inc. blood pressure, cardiac structure and function, sleep apnoea) and non-cardiovascular outcomes (inc. quality of life, mood). We hypothesise that alcohol abstinence will reduce AF recurrences, AF burden, AF symptoms and AF hospitalisations, as well as resulting in reductions in LV size, LA size, sleep apnoea parameters and blood pressure, and improvements in LA & LV function, mood and quality of life. We intend to recruit at least 140 patients and randomise them to either an alcohol Abstinence or Control arm, and follow them up for 12 months (with a 1 month run-in phase prior). Alcohol consumption in both arms will be monitored using weekly alcohol diaries, urine ETG (pending funding) and blood tests (inc. MCV, GGT). Monitoring for AF recurrences will occur by either: (i) Insertion of an implantable loop recorder OR (ii) Wearing a 7-day Holter monitor every 3 months +/- ECG transmission using the AliveECG smartphone app (if available) +/- ECG during symptoms of AF (iii) Interrogation of permanent pacemakers/defibrillators every 3 months in those with pre-existing dual chamber devices. Baseline and follow-up data collected includes: 12-lead ECG - 0 and 12 months. Blood pressure and weight - 0,3,6,9,12 months. Sleep study - 0 and 12 months. Basic bloods (lipids, glucose, FBE, UEC, LFT, BNP) - 0,6,12 months. Transthoracic echocardiogram (inc. LV size & EF, LA size, LA strain) - 0 and 12 months. AF symptom severity questionnaire (AFSS) & Medical questionnaire - 0,3,6,9,12 months. Mood & quality of life questionnaires - 0 & 12 months. Cardiac MRI substudy (pending funding) - 0 and 6-12 months. We will also be looking at a subgroup of patients who have had a previous pulmonary vein isolation (ABSTAIN-PVI substudy) to determine whether alcohol abstinence is beneficial in this sub-population. The trial protocol is unchanged (inc. outcomes) for these patients.

This pilot study will explore the effect of a type of non-invasive brain stimulation on the ability of older adult stroke survivors to participate in inpatient rehabilitation therapy. Clinicians in the stroke unit at Bentley Health Service (BHS) have identified that after a stroke, many people complain of feeling fatigued and being unable to concentrate during their therapy sessions. This is a problem since rehabilitation is typically offered only in the initial months post stroke, and therefore it is essential that patients are able to take best advantage of the available therapy during their inpatient stay. Fatigue is common post stroke, and is a complex impairment which may be partly due to reduced excitability of parts of the brain. Research has suggested that a type of non-invasive brain stimulation called ‘transcranial direct current stimulation’ (tDCS), in combination with therapy, can increase brain activity which may facilitate recovery after a stroke. All stroke admissions to BHS would be screened for eligibility, and consenting individuals will be randomly allocated to receive tDCS or sham tDCS for 10 days (20 minutes immediately prior to 10 therapy sessions), then cross over to the other group for a matched duration and number of sessions. Only the person applying tDCS will be aware of group allocation. The primary measures will be whether the first therapy session of the day is completed as intended. The duration of this session will be recorded, along with reason(s) for failure to complete the session. This outcome has been chosen as it is unambiguous, addresses the identified clinical problem and is an important surrogate of rehabilitation outcomes. Secondary measures will be patient reported fatigue using the Fatigue Assessment Scale, alertness/vigilance measured using the Go/NoGo test and alertness (numerical rating scale) reported by staff at set times during the day. It is hypothesized that patients receiving tDCS will be more likely, at the end of the series of ten tDCS sessions, to remain alert and engaged for the planned duration of the therapy session immediately following tDCS, perform better on a test of alertness, report feeling less fatigued and be observed by staff to be more alert during the day, than those receiving an equal number of sham tDCS sessions.

Crohn's disease (CD) is a chronic inflammatory condition of the bowel that carries a 70% lifetime risk of requiring surgical resection due to stricture formation or bowel perforation. CD often requires prolonged courses of immunosuppressive medications in order to induce remission, and these medications in themselves carry their own sets of risks. Exclusive Enteral Nutrition (EEN) has proven successful in inducing remission in pediatric CD patients. EEN is a polymeric supplement feed that is meant to provide all of the daily requirements of macro and micro nutrients. It is intended that patients consume this polymeric supplement feed for at least 80% of their daily nutritional requirement. Uncontrolled studies and small controlled trials suggest that there are benefits of EEN in adult CD patients as well but to date there has been no large controlled trial to formally test this hypothesis. The proposed study will seek to test in a randomized controlled trial the hypothesis that EEN can improve outcomes in patients with severe CD affecting the terminal ileum, which is a part of the bowel that is most commonly affected by CD. The study will have two phases. Phase 1, will see participants randomized into two groups, either EEN or standard of care calorie matched diet for 6 weeks prior to their planned operation. The primary outcome compared between the two groups at the end of phase 1 is both clinical disease remission and reduction of bowel wall swelling of the terminal ileum as measured by Magnetic Resonance (MR) enterography, an imaging modality commonly used in CD. Other secondary outcomes which will be assessed at the end of Phase 1 include quality of life, nutritional status, microbiome comparison, mean intestinal permeability, tolerability of diet, health economics and predicative markers for response. Following their surgical resection, participants will be re-randomized for phase 2 of the trial. Phase 2 of the trial will seek to test the hypothesis that partial enteral nutrition for 6 months as compared to standard of care calorie matched diet results in improved outcomes following surgical resection of the terminal ileum. The primary outcome at the end of phase 2 will be assessment of recurrence via colonoscopy after 6 months of the prescribed diet. Other secondary outcomes which will be assessed at the end of Phase 2 include quality of life, nutritional status, microbiome comparison, tolerability of diet and health economics.

The project aims to evaluate the acceptability and clinical efficacy of an online Pain Program Management program, 'Reboot' online. And to examine the moderators and mediators of change during the Reboot program. Up to 100 people with chronic pain will be randomly assigned to either the active treatment group or a Treatment as Usual (TAU) control group. The treatment group will commence the Reboot program immediately, whereas the TAU group will commence once the treatment group has completed and a 3 month follow-up period has been completed. The efficacy of the Reboot program will be determined by comparing the pain severity, disability and interference levels of the two groups at the time the treatment group completes treatment. Mediation analyses will be used to explore the role of variables that may influence positive change.

Approximately 68% of adults worldwide own mobile phones, with an estimated 1.08 billion of these being smartphones. Studies have shown that more people own a smartphone than a computer. Mobile health allows for the provision of evidence-based therapeutic techniques to a greater proportion of the population. Anxiety disorders are the most common mental disorders and the current study aims to evaluate the efficacy of a smartphone application ("app") designed to reduce worry by giving users greater control over it. Participants will be randomly assigned to use one of two apps. Measures of worry, depression, anxiety, negative metacognitive beliefs and repetitive negative thinking will be taken pre-, post- and follow-up intervals, with weekly measures of anxiety and negative metacognitive beliefs during the intervention.

Men who have sex with men tested positive for pharyngeal gonorrhoea at Melbourne Sexual Health Centre (MSHC) who volunteer will be randomised to rinse and gargle the study mouthwash every day within the next 12 weeks. The primary outcome is the proportion of MSM with diagnosed with pharyngeal gonorrhoea within 12 weeks.

This study will investigate the impact of early nutrition counselling delivered electronically on health-related quality of life and nutritional status in patients diagnosed with stomach or oesophageal or lung cancer compared with both early nutrition counselling delivered via the telephone and standard nutrition care. You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with upper gastrointestinal (GI) cancer or lung cancer and are being treated at Monash Health and your consultant is agreeable. Participants in this study are randomly allocated (by chance) to one of three groups. Participants in one group will receive early nutrition counselling delivered electronically via a mobile device (ipad). Participants in another group will receive early nutrition counselling delivered via telephone. Participants in the third group will receive standard nutrition care as deemed necessary by their health professional. Participants with early nutrition intervention will receive contact from the dietitian for the first 18 weeks of the study. Health-related quality of life and nutritional status will be assessed by questionnaires throughout the study up to 26 weeks.

Skin-to-skin contact (SSC) has advantages for newborn babies. It increases weight gain, reduces mortality, severe infection, and length of hospital stay. There are, however, conflicting results from studies, which measured physiological parameters (heart rate, breathing frequency and oxygen saturation) of preterm babies. This uncertainty is a barrier to implementation of SSC especially in very immature preterm babies. Both too much and too little oxygen supply to the brain contributes to morbidity and mortality in very preterm babies. Regional brain oxygenation (rcO2) can now be measured by a technology called near-infrared spectroscopy (NIRS). There is a lack of knowledge about brain oxygenation during SSC. If stability in rcO2 during SSC could be demonstrated this would provide reassurance that SSC is “safe” and could be used in immature babies. The primary objective of this study is to measure rcO2 during SCC compared with measurements when the baby is being cared for in their incubator or cot. We aim to include 40 very preterm babies with a gestational age at birth less than 33 weeks. We hypothesise that rcO2 remains stable during SSC (noninferiority trial). The brain oxygen levels will not be visible to the medical and nursing staff. The primary outcome will be changes (mean of the differences) in rcO2 between SSC (intervention) and incubator care (baseline) (1 hour period for each observation). Secondary outcome will be changes (mean of the differences) in physiological parameters e.g. peripheral oxygen saturation (SpO2), fractional tissue oxygen extraction (FTOE) equal to (SpO2 – rcO2)/SpO2) heart rate (HR), and respiratory rate (RR), axillary body temperature and sleep status (quiet sleep vs. active sleep) between SSC (intervention) and incubator care (baseline), the number of hypoxemic (SpO2 less than 80%) and bradycardic episodes (bradycardia: fall in instantaneous HR by one third of the infants’ baseline HR lasting for at least 5 seconds between SSC (intervention) and incubator care (baseline), changes (mean of the differences) in rcO2, SpO2, fractional tissue oxygen extraction (FTOE) equal to (SpO2 – rcO2)/SpO2, HR, RR, number of hypoxemic and bradycardic episodes, axillary body temperature, and sleep status (quiet sleep vs. active sleep) between post intervention incubator care and pre-intervention incubator care (baseline) (1 hour period for each observation). Further sub group analysis will be changes (mean of the differences) in rcO2 obtained during washout period with those obtained during the main observation period for all three periods (baseline, intervention, postintervention) and changes in rcO2 (mean of the differences) obtained during feeding periods with the rest of the observation period for all three periods (baseline, intervention, post-intervention).