ANZCTR search results

The overarching goal of this research is to develop and evaluate a digital exposure-focused intervention (the Courage Quest intervention) for children aged 8 to 12 years with one or more anxiety disorders. We are aiming to answer the following research question: Does the Courage Quest intervention reduce anxiety symptoms and result in greater remission of anxiety and related disorders for children aged 8 to 12 years compared to children participating in an active control intervention? The “Courage Quest” intervention will be developed as a parent guided intervention with therapist support. We aim to evaluate this through a randomised controlled trial comparing the efficacy of the "Courage Quest” intervention to an active control condition. The control condition will use the Raising Healthy Minds intervention before being given access to the “Courage Quest” intervention. Hypotheses of this study are that both groups will show reduction in anxiety symptoms and disorders at post-treatment and delayed follow-up. Further, we hypothesise that children in the intervention group completing the Courage Quest intervention will show significantly greater reduction in children’s anxiety symptoms and disorders (parent and child reported) than children in the control condition at post-treatment. Lastly, due to the control group’s access to the “Courage Quest” intervention, we hypothesise that children in the control group’s reduction in children’s anxiety symptoms and disorders at delayed follow-up will be similar to that of children in the intervention group.

While grief is a normal reaction to loss, 30% of cancer carers are reported to experience prolonged grief disorder. Patients with prolonged grief require grief-focused intervention in addition to the depression-focused treatment. Psilocybin-assisted psychotherapy is an experimental intervention that could reduce grief-related distress and suffering. PARTING is a single-arm (open-label) study of a psilocybin-assisted psychotherapy trial. This study aims to determine whether this new treatment is acceptable to and safe for participants and to establish an initial impression of its effectiveness in treating people with prolonged grief. It will include approximately 15 participants. Bereaved carers of people with cancer who meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for prolonged grief disorder will be invited to take part in PARTING. Potential participants will undergo rigorous screening before enrolment to meet general medicine and psychiatric eligibility criteria. The intervention will include three psychotherapy sessions in preparation for one psilocybin dosing session and then four post-experience psychotherapy integration sessions. All participants’ sessions will involve a trial psychologist and assistant therapist being present. Baseline and follow-up survey and clinical assessments will measure prolonged grief symptoms i.e. the outcome for the future full-scale trial. Following participants’ final intervention session, participants will complete a semi-structured evaluation interview about their experience. Responses will be transcribed and qualitatively analysed using thematic analysis. The 15 evaluation interviews with participants will provide information about intervention acceptability and a qualitative initial impression of efficacy and will be used to refine the intervention. As a secondary analysis of potential efficacy we will also explore changes in grief scores. We postulate that the treatment will be well tolerated and accepted and grief symptoms will be substantially reduced.

Obsessive-compulsive disorder (OCD) is a chronic, debilitating mental health condition that is difficult to treat with conventional methods such as, pharmacotherapy and cognitive behavioural therapy. Electroencephalographic (EEG) studies have shown several differences in the brain oscillatory activity in patients with OCD when compared to healthy individuals. Some of the key EEG abnormalities in OCD such as increased slow wave activity and decreased alpha activity have been linked to poor functional connectivity in the fronto-striato-thalamic (FST) circuit, leading to impaired integration of information between brain regions. Therefore, modulation of these oscillatory anomalies might alleviate the undesirable symptoms of OCD. Furthermore, task-related EEG studies have reported several event-related potential (ERP) differences, which are suggested to be potential biomarkers for OCD. Transcranial alternating current stimulation (tACS) is a novel, non-invasive brain stimulation method that delivers a weak electrical current to the brain and is able to modulate brain oscillatory activity. The main advantage of this technique is the ability to individualise treatment by delivering the current at a specifically targeted frequency related to the intrinsic oscillatory activity of each patient. A secondary benefit of tACS is the ability to self-administer treatments at home, which is pivotal when treating OCD, as disease-related fears usually result in participants avoiding frequent hospital visits. Furthermore, our recent pilot study that investigated the use of individualised alpha tACS in OCD reported significantly greater improvement in OCD severity with active therapy compared to sham/placebo. Therefore, we propose to conduct a randomised, controlled study with a large sample to explore the use of individualised, alpha-tACS when compared to sham stimulation in individuals with OCD. The primary hypothesis of this study is that individualised, alpha-tACS will cause a significantly greater improvement in clinical severity of OCD than sham stimulation in individuals with OCD. Baseline and post-treatment resting and task-related EEG will be collected from a selected group of participants to further investigate the pathophysiological basis of OCD, and explore ERPs as potential biomarkers for OCD. The primary aim of this study is to establish whether individualised, home-based alpha-tACS is significantly superior to sham stimulation in improving clinical symptoms of OCD.

This is a pilot RCT to test the hypothesis that sevoflurane use for maintenance of general anaesthesia will result in reduced inducibility of ventricular tachyarrhythmias when compared to maintenance with propofol. The study is conducted in adult patients (>18 years) who are scheduled for elective or semi- elective ventricular tachycardia ablation under general anaesthesia at 2 hospitals in Sydney. Patients will receive both types of anaesthesia for maintenance during 2 subsequent periods of time (in random order, and with a wash-out period in between). During each period, a standardised VT induction protocol will be performed. The primary outcome of the study is VT inducibility. Secondary outcomes include modes of induction required, quality of recovery on post-procedure day 1, and long-term ablation success rate.

Tourette Syndrome (TS) is characterised by sudden, rapid and recurrent motor and vocal tics that cause significant disruptions in social and occupational functioning. Habit Reversal Training (HRT) is a behavioural treatment for tics that has received substantial empirical support for tic reduction in individuals with diagnosed Tourette Syndrome (Dutta & Cavanna, 2013). HRT focuses on increasing an individual’s awareness of tics, followed by training in performing a physically competing response (Woods, 2001). Recent research on related habit disorders, however, has indicated that treatments targeting experiential avoidance, referred to as “psychological inflexibility”, might be useful adjuncts to HRT (Franklin, Best, Wilson, Loew & Compton, 2011). Acceptance and Commitment Therapy (ACT) targets experiential avoidance by aiming to modify an individual’s attempts to control unwanted private experiences and therefore focuses on promoting acceptance of unpleasant thoughts, feelings and urges. For this reason, ACT may serve as a useful addition to HRT protocols, particularly in addressing tic-related urges and the associated unpleasant thoughts and feelings that may not be remediated by HRT. The current pilot study aims to investigate the effectiveness of a combined HRT/ACT protocol in the treatment of tics in adults. It is hypothesised that this treatment will not only reduce tic symptoms but result in positive improvements in quality of life (QoL), work/social adjustment, mood, stress and anxiety. Participants will receive ten weekly sessions of therapy in accordance with a combined HRT/ACT protocol. Two booster sessions will be provided at 1 and 2 months following completion of the eight-week treatment program. Assessments will be completed before and immediately after the eight-week course of treatment, and again at 3, 6, 9 and 12-months post-treatment to assess for any maintained improvements.

The purpose of this study is to assess the retinal function and axial length of a prototype contact lens with a line edge pattern compared to a commercially available single vision contact lens.

The gut and tumour microbiome are known to metabolize drugs through various mechanisms resulting in degradation or modification of the drug's chemical structure which can lead to decreased drug bioavailability and effectiveness. Conversely, certain gut microbiome-derived molecules can enhance the absorption and efficacy of drugs. Ibrutinib is an example of an orally administered cancer drug (typically used to treat breast cancer) with variable pharmacokinetics which contributes to both lack of efficacy and increased toxicity. This study aims to assess how the gut microbiome can influence the pharmacokinetics of Ibrutinib in healthy adult volunteers. Who is it for? You may be eligible for this study if you are a male or female adult aged 18 to 65 years and are in good general health without a clinically significant medical history. People who have been diagnosed with cancer will not be eligible for this study. Study details Participants who choose to enrol in this study will firstly undergo a series of physical assessments, including blood tests, to ensure that they are suitable to be included in the study. Participants who are found to be suitable will be asked to stay at the research unit for up to 3 days. Participants will be asked to provide a stool sample prior to being given a single oral dose of Ibrutinib. After receiving the Ibrutinib, participants will then be asked to provide a series of blood samples over the next 2 days, and will also be asked to provide a second stool sample for analysis. At the end of the third day, participants will be allowed to return home but will be asked to contact the study team if they experience any side effects. It is hoped this research will determine any impact that different biological features such as the gut microbiome have on the ability to absorb Ibrutinib (chemotherapy) treatment. These results may then inform the usefulness of Ibrutinib as a treatment for patients with breast cancer.

The gut and tumour microbiome are known to metabolize drugs through various mechanisms resulting in degradation or modification of the drug's chemical structure which can lead to decreased drug bioavailability and effectiveness. Conversely, certain gut microbiome-derived molecules can enhance the absorption and efficacy of drugs. Palbociclib is an example of an orally administered cancer drug (typically used to treat breast cancer) with variable pharmacokinetics which contributes to both lack of efficacy and increased toxicity. This study aims to assess how the gut microbiome can influence the pharmacokinetics of palbociclib in healthy adult volunteers. Who is it for? You may be eligible for this study if you are a female adult aged 18 to 65 years and are in good general health without a clinically significant medical history. People who have been diagnosed with cancer will not be eligible for this study. Study details Participants who choose to enrol in this study will firstly undergo a series of physical assessments, including blood tests, to ensure that they are suitable to be included in the study. Participants who are found to be suitable will be asked to stay at the research unit for up to 3 days. Participants will be asked to provide a stool sample prior to being given a single oral dose of palbociclib. After receiving the palbociclib, participants will then be asked to provide a series of blood samples over the next 2 days, and will also be asked to provide a second stool sample for analysis. At the end of the third day, participants will be allowed to return home but will be asked to contact the study team if they experience any side effects. It is hoped this research will determine any impact that different biological features such as the gut microbiome have on the ability to absorb palbociclib (chemotherapy) treatment. These results may then inform the usefulness of palbociclib as a treatment for patients with breast cancer.

This research study aims to investigate and establish the feasibility, clinical accuracy of remotely-performed, robot-assisted abdominal ultrasound examination performed by general sonographers.

This pilot study is assessing the acceptability, appropriateness, and feasibility of a group therapy program for people with stage III melanoma at Melanoma Institute Australia. Who is it for? You may be eligible for this trial if you are aged over 18 years and have a diagnosis of stage III melanoma. Study details: Group therapy has been helpful to people diagnosed with cancer as it can reduce feelings of isolation that are often experienced following a diagnosis of cancer by increasing social connection to people with similar experiences, while also providing people with tools and strategies to help address difficult emotions or thoughts. Thus, Melanoma Institute Australia have created a new group therapy program for people diagnosed with stage III melanoma, and the aim of this study to ensure it is acceptable and appropriate to participants. There will be a total of 8 sessions that occur every two weeks (fortnightly) either in-person at Melanoma Institute Australia or online via a videoconferencing platform (Zoom). Sessions will be two hours in length and will be focused on discussing skills and strategies that may be helpful in coping with difficult situations/emotions associated with a diagnosis of stage III melanoma. Groups will consist of approximately 8 people recently diagnosed with stage III melanoma. Information from this study will be used to design a larger study to test how helpful it is with the aim or implementing MELGROUP therapy into routine clinical practice in the future.