ANZCTR search results

This project aims to determine whether a protocol of 30 minutes of exercise prescribed based on enjoyment can elicit similar physiological responses (heart rate, rating of perceived exertion, and blood pressure) compared to aerobic exercise prescribed based on intensity-driven guidelines (moderate intensity, 40-60% Heart rate). A secondary aim will be to determine if 4 weeks of enjoyment-driven aerobic exercise (three 40 minute sessions per week, 30 mins exercise, 5 mins each for pre post assessments) can provide similar benefits (aerobic capacity, physical and mental wellbeing) to a 4 week intensity-driven aerobic exercise program. I will recruit up to 40 adults (aged 18 years or older) to participate in a two phase randomised controlled clinical trial. Participants will complete a graded exercise test pre and post intervention. Measurements of current physical activity (PAQ), autonomous motivation to participate in exercise (BREQ3 questionnaire), symptoms of depression and anxiety (via the DASS-21 questionnaire) and psychological distress (using the K10) will also be measured. Participants will then be randomised in a cross-over design to complete an acute enjoyment-driven and an intensity driven exercise session, with one week washout in-between. All participants will then be randomised into parallel groups and complete 4 weeks (three 30 minute sessions per week) of either intensity-driven (standard prescription) or enjoyment driven (novel prescription) exercise. Affective response (FS), and HR, RPE and BP will be measured each session. Significance: This project proposes a transformative approach to exercise prescription whereby the focus of exercise prescription would shift away from objective intensity measures and instead centre on the individual’s level of enjoyment. If proven successful, this project has the potential to transform how exercise is prescribed and can be translated to the community and the health care system.

Sports betting has become one of the nation’s rapidly increasing forms of gambling addiction with $1.235 billion lost in 2017 - 18 , particularly in young males. This proposal is based on the recent publication from the SA Statewide Gambling Therapy Service, reporting the successful treatment of 6 young men with sports betting addiction using exposure therapy delivered face to face. The phase 1 pilot study aims to recruit 40 participants from all areas of SA using social media and provide cue exposure therapy (CET) for 10 sessions using mobile phone or internet.

Mothers of preterm infants often struggle to produce enough breast milk to meet the daily feed requirements of their infants, especially in the longer-term. This randomized multi-centre double-blind parallel controlled trial will evaluate the efficacy and safety of two commonly used galactagogues, Brewer’s yeast and beta-glucan, compared with placebo in improving maternal breast milk supply following preterm birth. Eligible women will be randomised to receive Brewer's yeast (1680 mg/day), Beta-glucan (250 mg/day) or placebo for 7 days, commencing within 72 hours of birth. The primary outcome will be assessed at day 7 following treatment initiation. All participants will undertake regular study assessments including at baseline (study enrolment), day 7 of treatment, postnatal day 21 and at infant discharge to home or term corrected (whichever comes first). Women will regularly undertake questionnaires evaluating demographics and lifestyle, breast health, milk expression, postnatal health, mental health and wellbeing, and infant feeding practices. Women will also undergo anthropometric assessment, and a breast milk, blood, urine, stool and buccal cell swab sample.

The aim of this study is to assess the feasibility and acceptability of the Living My Life Program for stroke survivors beyond 6 months post-stroke, living in rural and remote areas. The Living My Life Program is a digital health intervention, designed to support the participant to work towards their goals, using technology in a way that works for them, in their world. Case study design, informed by principles of co-design, will be used to trial the Program with stroke survivors living in rural and remote locations. Feasibility will be assessed according to pre-determined minimum success criteria. Acceptability will be explored through a brief survey and semi-structured interviews with stroke survivor participants. Learnings from the study will be used to refine the Living My Life Program for subsequent use.

This study aims to assess improvement in complex post-traumatic stress disorder symptoms in Aboriginal children in Out of Home Care (OOHC) after treatment with neurofeedback. It will also aim to assess improvement in the child’s self-concept, academic, social and personal functioning and the foster carer’s stress levels and confidence in parenting their foster child. Thirty Aboriginal children in OOHC aged 6-17 years will be recruited from a Hunter, NSW based Aboriginal community service. Baseline assessments to establish symptom levels in the domains of interest will be completed prior to offering a novel intervention, neurofeedback. This will consist of 32 treatment sessions over 24 weeks. Assessments to measure any change in symptom level will be conducted post neurofeedback. It is hypothesised that this intervention will be effective and acceptable in this vulnerable population.

This study will be investigating the safety and tolerability of NIDO-361 and the amount of NIDO-361 in the body when taken in single and multiple doses in healthy male participants so as to possibly be a treatment in the future for Spinal and bulbar muscular atrophy (SBMA), also known as Kennedy’s Disease. This is a condition that only affects men and causes muscle weakness, tremor, and cramps among other neuromuscular and hormonal symptoms. Kennedy’s Disease is caused by a genetic mutation affecting the androgen receptor, which controls how hormones like testosterone work in the body. It is hoped that in patients with Kennedy’s Disease, NIDO-361 will correct the way the androgen receptor interprets signals from the testosterone re-establishing its normal function. This study will involve the recruitment of 64 healthy male participants between the ages of 18 and 55 years who weigh at least 45kg and have a body mass index between 18-32 kg/m2. There will be 5 cohorts of 8 participating in the single ascending dose part of the study involving a 3 night in house stay and follow-up visit on Day 8 and 3 cohorts of 8 participating in the multiple ascending dose part of the study involving 7 days of consecutive dosing, a 9 night in house stay and follow-up visit on Day 15.

The aim of this study is to investigate if testing for the DPYD gene in patients is practical and useful, for the purpose of providing personalised dosing of chemotherapy treatment Fluoropyrimidine (FP; 5FU, Capecitabine). Who is it for? You may be eligible to join this study if you are aged 18 years or older; and have or will be receiving Fluoropyrimidine chemotherapy treatment. Study details All patients will be asked to provide a blood sample, and the blood sample will be tested for the DPYD gene. The result will be shared with the patient's doctor, and whether this affects the patient's chemotherapy treatment or not will be decided by the patient's doctor. Additionally, patients and medical professionals will also be invited to do a questionnaire exploring the perceived knowledge and attitudes toward genetic testing for DPYD. It is hoped that this study will reveal if screening for the DPYD gene can be used to inform personalised chemotherapy dosing, and understand factors that affect this process, to be able to provide better care to cancer patients.

This pilot clinical trial aims to evaluate the safety and acceptability of relational peer work for young people (aged 12-25 years) with personality disorder. Peer workers are people who have lived experience of mental illness, and are trained to use that experience to provide support for other young people with mental ill health. Participants will be young people attending headspace, who will be offered up to 10 sessions of relational peer work over a 13-week period. In addition to testing safety and acceptability, this trial will also explore whether peer work is associated with improvements in young people’s sense of belonging, hope, and functioning, while reducing their severity of personality pathology, depressive symptomatology, anxiety, and substance use.

The aim of this study is to assess the pharmacokinetics, safety and tolerability of two CBD formulations and test for bioequivalence to an existing commercial CBD product HYPOTHESIS: CBD oil given as either a soft gel or oil solution will have a bioequivalent absorption to that of a commercial CBD oil (Epidylex). DESIGN: A randomised, cross-over trial with 3 interventions. Product will be allocated on a 1:1:1 ratio.

Extensive research has suggests that high levels of perfectionism are associated with various mental health issues and that many university students possess perfectionistic traits. A previous pilot study showed that the Intentional Imperfection Program (IIP) was feasible and resulted in reductions in different aspects of perfectionism as well as reductions in hostility, rejections sensitivity, depression and anxiety. This study expands the findings of the previous study to assess the efficacy of the IIP in comparison to a healthy lifestyle intervention. Both interventions will consist of one 2.5 hour session. Eligible participants are university students with high levels of perfectionism. Participants will be assessed at baseline and at 1 month and 3 months post-intervention. The primary outcome is psychological distress. Secondary outcomes include perfectionism, rejection sensitivity, interpersonal hostilitiy, social disconnection, self-compassion, distress tolerance, mindfulness and academic performance.