ANZCTR search results

Objective: The current trial examined whether the inclusion of a parental anxiety management (PAM) program in addition to family cognitive-behavioral therapy (CBT) was more efficacious than family CBT only in treating childhood anxiety disorders. Method: Two hundred and nine children (aged 6-13 years) with a principal anxiety disorder were randomly allocated to a 5 session PAM program (n = 109) in addition to family CBT or family CBT only. Results: Overall, results revealed that the addition of PAM did not significantly improve principal anxiety diagnostic outcomes for the child or the parent compared to the CBT only group at post-treatment and 6-month follow-up. Results further suggest that children with non-anxious parents were more likely to be diagnosis-free for any anxiety disorder compared to children with anxious parents at post-treatment and 6-mth follow-up. Conclusions: The present findings indicate that the addition of PAM in its current format did not lead to additional gains in diagnostic status when used as an adjunct to family CBT in the treatment of the child’s anxiety disorder. The addition of PAM did not lead to a sufficient decline in parental anxiety disorders over and above the decline observed across time for children receiving CBT. Parental anxiety status impacted on child diagnostic outcome: Children were less likely to be diagnosis-free following treatment if they had a parent who also had an anxiety disorder.

Sleep is commonly disturbed during pregnancy and following childbirth. Even individuals who have been ‘healthy sleepers’ will notice a change in their sleep patterns during pregnancy. Given the high associations between sleep deprivation and depression amongst insomnia patients and depressed patients, it is important to note that sleep deprivation may be one factor that contributes to a greater propensity for women to become depressed in the post-natal period compared to other periods in their life. Post Natal Depression (PND) is common yet rarely acknowledged until after the full onset of symptoms negatively affecting all family members. The aim of the current study is to educate and prepare first time parents about sleep and sleep management with a new baby. First time mothers attending prenatal classes will be approached during the last trimester of their pregnancy and randomised to either a sleep psychoeducational intervention or treatment as usual. The primary aim of this project is to determine the efficacy of a brief pragmatic sleep intervention in improving sleep management and reducing depressive symptoms or prevalence of PND in first time mothers compared with treatment as usual.

Studies indicate that men who have sex with men (MSM) have a high prevalence of anogenital Human papillomavirus (HPV) infection and increased risk for HPV related anogenital lesions including anogenital warts, anal intraepithelial neoplasia ( the abnormal proliferation of cells) and anal cancer. Currently in Australia, HPV vaccine for men is not covered by programs. This study will explore the prevalence of persistent HPV infection, distinguishing this from transient HPV infection and sexual behaviours associated with varying prevalence of HPV infection. We will survey 200 MSM aged 16-20 who just started their sexual life. We will use a questionnaire to collect information of socio-demographic characteristics, lifetime sexual experience, recent sexual experience, the most recent sexual contact, STIs/HIV history and testing history, HPV knowledge and attitude, smoking/alcohol/drug/circumcision. We will also collect oral, penile and anal samples as well as blood samples to test for HPV DNA, mRNA and antibody. The study will include four visits in the 12-month period. In each visit, participants will be asked to fill a questionnaire and provide oral, penile and anal samples as well as blood samples. Each participant will receive $25 at each visit as compensation for their time. All participants will be offered free HPV vaccine at the end of the study.

The aim of this study is to investigate the use of a therapeutic Smartphone application in the delivery of thearpy homework. It is expected that the electronic delivery of homeowrk tasks will facilitate greater patient adherence with these tasks, when compared to pen and paper delivery.

ATL1103 is being developed as a potential treatment for diseases of excessive growth hormone and insulin-like growth hormone (IGF-I) action. This is the first in man study for ATL1103, and is being conducted as a randomized, placebo-controlled, double-blind trial. Thirty six healthy male subjects will participate in the study. In stage A, subjects will receive one dose of either placebo or ATL1103 (at a dose of 25 mg, 75 mg, 250 mg or 400 mg). In stage B, subjects will receive 6 doses of placebo or ATL1103 (at a dose to be determined after review of the safety data from Stage A). All treatments will be administered by subcutaneous injection. The primary objectives of the study is to evaluate the safety and tolerability of single or multiple injections of ATL1103, and to investigate the pharmacokinetic profiles of ATL1103 after subcutaneous administration. The effect of ATL1103 on serum IGF-I levels will also be monitored.

The purpose of this study is to determine cardiac function in pregnant women at the time of the diagnosis of preeclampsia and before any treatment is commenced. The cardiac function at this time will be compared to healthy gestationally matched pregnant women and also to non-pregnant healthy women.

The aim of this study is to determine whether naloxone, an opioid reversal agent, is as effective for the treatment of acute opioid overdose when administered via the intranasal (IN) route compared with the intramuscular route. The term 'opioid' refers to a class of drugs that includes heroin, and the prescription medications oxycontin and morphine. Injection of naloxone into a muscle is currently the standard method of emergency treatment for an opioid overdose on site at the Sydney Medically Supervised Injecting Centre. However, Naloxone can be administered as an intranasal (IN) spray using a 'mucosal atomisation device’. Evidence suggests that IN naloxone may be an effective and practical alternative. The significant benefits of IN administration include removing the risk of needlestick injury (and thus any blood borne virus transmission risk) to treating personnel. This is particularly relevant to ambulance officers and paramedics, as well as other emergency health care workers, such as in the hospital emergency department setting. Additionally, given the ease of administration and reduced issues regarding disposal of used needles, the availability of IN naloxone may potentially be extended. This may include non health care workers who regularly deal with opioid overdose in community settings, and drug users’ peers, who are likely to be present in the event of an overdose. The Sydney Medically Supervised Injecting Centre (MSIC) provides the ideal setting for this study.

This is a randomized controlled trial comparing intensive ongoing dietetic management vs usual hospital care, using an intention to treat protocol. Those patients that volunteered were randomly allocated to either the hospital model of care(HMoC) or Ambulatory model of care (AMoC). The HMoC intervention consists of dietetic management throughout the hospitalisation period with referral to other healthcare providers upon discharge ( such as the local community doctor or community support groups or private dietitian). The AMoC intervention consists of the same dietetic management throughout the hospitalization period but with formal requirement to provide ongoing support from a team of community based dietitians for up to 6 months after discharge. The primary outcome measures will be ; the change in nutritional status, evaluation of the patients dietetic management goals, assessment of the quality of the patients’ diet and patient level of satisfaction with the service provided. The secondary outcome measures collected will be mortality, readmission rates and total bed days occupied during the six month study period,

The strongest risk factors for prostate cancer are age and having a family history of the disease. Men at increased risk for prostate cancer on the basis of family history are confronted with difficult decisions regarding the management of their cancer risk, particularly in view of the ongoing controversary surrounding the balance of uncertain benefits and harms of PSA testing. An online screening decision aid was developed to assist unaffected men with a family history of prostate cancer to make informed decisions about prostate cancer screening. The aim of this study is to compare in a randomised controlled trial the efficacy of general information about prostate cancer screening with that of an online screening decision aid, developed specifically for men with a family history of prostate cancer. The control information is comparable to the decision aid in identifying the general benefits and risks of prostate cancer screening. However, it does not include features commonly used in decision aids e.g., a personal worksheet and provision of details about the pros and cons of each option. The randomised trial will involve 120 unaffected men with a family history of prostate cancer who will complete three questionnaires at three time points: i) Questionnaire 1: before reading the online decision aid or general information (control) materials; ii) Questionnaire 2: immediately after reading the materials; and iii) Questionnaire 3: 12 months after reading the materials, to assess the longer term effect of the information. The sample will be randomised such that there will be approximately 60 participants in each group. The following hypotheses will be tested: Compared to men receiving the control materials, men who receive the decision aid will have:- (i) less decisional conflict and uncertainty about their risk management options (primary outcome variable); (ii) better knowledge of the genetics of prostate cancer and their screening options; (iii) more accurate perceptions of their risk of developing prostate cancer.

This study aims to improve the likelihood that people with a mental illness who are trying to return to work will do so successfully. Unemployment and subsequent poverty and welfare dependence are major problems for people with a severe mental illness. The use of interventions such as supported employment has improved the chance of person with a severe mental illness obtaining and keeping employment, however a significant number, if not the majority of these people still experience under or unemployment. An important, but virtually untreated determinant of continued poor functioning in the community is the level of cognitive deficits found in severe mental illness. This study will employ computer assisted cognitive remediation, an approach that has been demonstrated to improve cognitive function in severe mental illness, to improve cognitive functioning and then test to see if this intervention improves overall employment outcomes. This study will be conducted in a community based setting in cooperation with the Schizophrenia Fellowship of New South Wales, a non-government organisation that is operating 6 supported employment centres through regional and metropolitan areas in New South Wales, thus making this study an important demonstration of effectiveness of psychosocial treatment in community care.