ANZCTR search results

The primary purpose of the study is to assess the safety and tolerability of a single oral dose of EP102 200 mg or 400 mg self-administered at home by adult participants experiencing moderate-to-severe migraine headache.

The present study aimed to evaluate the impact of the Body Blocks program on early learning educators’ knowledge, attitudes, and teaching practices by conducting a randomised controlled trial, with participants randomised to either an intervention group or waitlist control. We anticipated that participants randomised to the intervention group would report higher educator knowledge and attitudes about body image compared to educators in the waitlist control group, as well as greater confidence and capabilities in promoting positive body image. In addition, we explored the moderating role of demographic variables (i.e., age, years in the profession, socio-economic-status), as well as educators’ own body and functionality appreciation and fat attitudes on our main outcome of interest (i.e., knowledge and awareness).

Temperament-Based Therapy with Support (TBT-S) is an innovative, adjunctive eating disorder treatment that incorporates the neurobiology of eating disorders. Patients and their support person(s) attend a 5 day intensive multi-family therapy program that involves psychoeducation, group activities and meals. This study will investigate both the feasibility and acceptability of the TBT-S program in Victorian mental health services from the experience of the patient, their support person and the clinicians involved in the program. It is hypothesised that TBT-S will be an acceptable and feasible treatment option for patients and their supports.

Binge eating disorder (BED) is the most common eating disorder and is associated with obesity and psychiatric comorbidities. Psilocin taken in combination with talk therapy might be a useful treatment for BED by reducing overall anxiety, anxiety around food, perseveration, and repetitive and intrusive thinking, as well as improving mindfulness and self-compassion. This open-label study will evaluate the safety and efficacy of a novel intravenous (IV, i.e. into the vein) formulation of the psychedelic psilocin (TRP-8803) in 12 people with BED. IV administration of TRP-8803 permits a more rapid start to the psychedelic state compared to psilocin taken orally as a tablet, and allows the administering therapist to control and optimise the dose and if required, rapidly reduce the depth of the psychedelic experience by stopping the infusion (i.e., in case of an adverse effect). Eligible participants will complete two doses of TRP-8803, administered in conjunction with psychotherapy over a treatment period of 6 weeks, and followed up until 12 weeks post second dose. Safety will be assessed. Other indicators of clinical severity will also be explored from baseline through to 12 weeks post second dose.

The aim of this study is to test if third-line treatments for depression (MDD), should be prescribed earlier in the illness course, after a first-line treatment fails. This study is testing the idea (hypothesis) that medications that are usually only used third-line ( called Early Intensified Pharmacological Treatment - EIPT in this study) are more effective than the medications that currently get used second-line (Treatment As Usual - TAU). This study has a six-week duration and participants are randomised into either the EIPT or TAU group. Participants must have a regular treating doctor (GP or psychiatrist) who is willing to be contacted by the study team, and who will prescribe and manage the medication for all TAU participants, The study doctors will prescribe and dispense medication for EIPT participants in MDD. There are optional "opt-in' biodata, blood and stool samples that participants may choose to give; these are to help researchers identify predictors for treatment-resistance and treatment response.

In 2021 it is estimated that 744,800 people in Australia, are living with bipolar disorder and account for a significant proportion of the $11.6 billion spent on mental health related services in Australia in 2020-21 .When diagnosed with one of these disorders, patients are prescribed psychotropic medication such as antidepressants, mood stabilisers or antipsychotics. It is unknown whether this first-line treatment will be successful. After this first-line treatment fails, usually a second-line treatment is initiated, and when this is not successful either a third-line treatment is initiated. Third-line treatments are quite successful, especially when compared to second-line treatments. The research question is whether the third-line treatments (early intensified treatments) would be more efficacious than the current second-line treatments (treatment as usual) for schizophrenia, bipolar and major depressive disorders. If this is indeed the case, this could lead to the prevention of unnecessary trials of ineffective treatments and adaptations of worldwide guidelines as well as a reduction of healthcare and societal costs.

The aim of this study is to test if third-line treatments for Schizophrenia (SZ) should be prescribed earlier in the illness course, after a first-line treatment fails. This study is testing the idea (hypothesis) that medications that are usually only used third-line ( called Early Intensified Pharmacological Treatment - EIPT in this study) are more effective than the medications that currently get used second-line (Treatment As Usual - TAU). This study has a six-week duration and participants are randomised into either the EIPT or TAU group. Participants must have a regular treating doctor (GP or psychiatrist) who is willing to be contacted by the study team, and who will prescribe and manage the medication for all TAU participants, There are optional "opt-in' biodata, blood and stool samples that participants may choose to give; these are to help researchers identify predictors for treatment-resistance and treatment response.

This study aims to explore how a slow, controlled breathing technique (developed in a previous study ACTRN12625000101482) affects the body’s stress response during a high-pressure simulated clinical scenario. Participants who previously completed the breathwork program will be compared to those who did not, to see if the breathing practice helps regulate heart rate, breathing, and other physiological responses under stress. We hypothesise that those who practiced the breathwork regularly will show improved autonomic regulation—specifically more stable heart rate variability (HRV), lower heart rate, and more efficient breathing—during a stressful simulation, compared to those who did not receive the intervention.

The social determinants of health are the everyday things in life that all families need to thrive including childcare and schooling; government benefits and vouchers; housing; food; money to pay bills; and transport. Research from Australia has shown that many parent/carers of children with a neurodisability want help with these everyday things in life and have trouble finding the right supports and services for their family. Adverse social determinants of health are experienced by families as unmet social needs. Studies from the United States of America with parent/carers of children have tested different programs to help families with unmet social needs. These studies have found that providing families with a resource pack containing information about local supports and services can help them address problems they are having with their unmet social needs. These studies have also found that providing families with a resource pack and connecting parent/carers with a person called a “Community Linker” can help. The Community Linker provides 1:1 support to help families access supports and services for their unmet social needs. Together with parents/carers of children with a neurodisability and their health care professionals, we have designed a resource pack and Community Linker program that aims to be suitable for the unique needs of families of children with a neurodisability. We have tested these two programs (resource pack; resource pack plus Community Linker) in a pilot research study of parent/carers of children with cerebral palsy. Our pilot has found that parent/carers find this program helpful, acceptable, and easy to engage with. In this current study we will test the long-term effectiveness of the Community linker with a resource pack against the resource pack only in a wider population. We will also see how cost effective the program is and how we can implement it in other settings. We predict that parents/carers who receive the Community Linker program will report greater improvements, compared to parents/carers who receive the resource pack.

This study examines how artificial sweeteners affect fuel utilisation at rest and during exercise. Participants will consume water, artificially sweetened sports drinks, or full-sugar sports drinks across three sessions in a randomised, double-blind crossover trial. Metabolic responses, including fat and carbohydrate oxidation, will be measured using indirect calorimetry and blood sampling. The findings will help determine whether artificial sweeteners impact energy metabolism similarly to sugar.