ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31382 results sorted by trial registration date.
  • Rewriting Grief and Loss: A Pilot Writing-For-Wellbeing Study with participants who have experienced bereavement and non-death losses

    Existing therapeutic writing studies are largely based on Expressive Writing, a short-term intervention based on a single writing-task instruction. They have demonstrated the emotional and physical health benefits in various populations; however, the feasibility and potential effectiveness of a longitudinal therapeutic writing program utilising creative writing undertaken in a therapeutic setting to improve emotional wellbeing and adaptation to grief is unknown. The premise underlying this longitudinal study was that more and longer-lasting health benefits might be achieved than the short-term Expressive Writing intervention in the context of grieving if the writing intervention was extended, if writing prompts were more varied and if the intervention was undertaken in a therapeutic setting. This quantitative and qualitative Writing-for-wellbeing pilot study assessed the feasibility, acceptability, and potential efficacy of a longitudinal writing intervention in helping participants to work through their grief to facilitate adaptation, meaning-making, and emotional wellbeing. The study was designed to test a 6-session writing intervention with two groups of 10 adult participants each. The first comprised bereaved participants. The participants in the second group had experienced living losses, which included life-threatening illness, divorce, infertility, severe long-term menopause, caring for an elderly parent with dementia, loss of family connection, and caring for a disabled child. Groups were small to facilitate a safe environment and an intimate space for sharing. To assess potential efficacy, participants completed a series of measures at pre-test (immediately before session 1) and post-test (at the conclusion of session 6). Participants completed measures of prolonged grief, adaptive coping, anxiety and depression, meaning reconstruction, and a satisfaction questionnaire.

  • The Momentum Program: Online Cognitive Behavioural Therapy (CBT) for Child Anxiety and Sleep Comorbidity

    Anxiety disorders are highly prevalent among children, are often highly comorbid with problematic sleep. These issues are often chronic if left untreated, and lead to numerous problematic consequences. Digital mental health programs increase access to evidence-based interventions and have been shown to be highly effective for numerous mental health problems in youth. However, the online programs developed for child mental health issues to date do not account for comorbidity, and instead focus on only one disorder (e.g., anxiety OR sleep). Children are therefore routinely provided with a digital mental health program targeting their primary presenting problem (i.e., the problem that is causing them the most distress or is most interfering with their functioning). Typically, this means anxiety is routinely treated, but sleep is not. This randomised controlled trial will target children with primary anxiety, who also suffer with a comorbid sleep issue, by comparing an online program targeting BOTH of anxiety and sleep problems, with one that will target ONLY anxiety. We expect that compared to the programs targeting ONLY anxiety, programs directly targeting comorbidity of anxiety and sleep will lead to better and longer-lasting mental health outcomes not only for anxiety problems, but also for comorbid sleep problems.

  • The Momentum Program: Online Cognitive Behavioural Therapy (CBT) for Adolescent Depression and Sleep Comorbidity

    Depressive disorders are highly prevalent among adolescents, are often highly comorbid with problematic sleep. In fact, problematic sleep is one of nine possible criterions of a major depressive disorder diagnosis. These issues are often chronic if left untreated, and lead to numerous problematic consequences. Digital mental health programs increase access to evidence-based interventions and have been shown to be highly effective for numerous mental health problems in youth. However, the online programs developed for child and adolescent mental health issues to date do not account for comorbidity, and instead focus on only one disorder (e.g., depression OR sleep). Youth are therefore routinely provided with a digital mental health program targeting their primary presenting problem only (i.e., the problem that is causing them the most distress or is most interfering with their functioning). Typically, this means depression is routinely treated, but sleep is not. This RCT will target adolescents with primary depression, who also suffer with a comorbid sleep issue, by comparing an online program targeting BOTH depression and sleep, with one that will target only the primary presenting problem of depression. We expect that compared to the program targeting ONLY depression, the program directly targeting BOTH depression and sleep will lead to better and longer-lasting mental health outcomes not only for the depression, but also for the comorbid sleep problem.

  • The Momentum Program: Online Cognitive Behavioural Therapy (CBT) for Adolescent Anxiety and Depression Comorbidity

    Anxiety and depressive disorders are highly prevalent among children and adolescents, are highly comorbid with each other, are chronic if left untreated, and lead to numerous problematic consequences. Digital mental health programs increase access to evidence-based interventions and have been shown to be highly effective for numerous mental health problems in youth. However, the online programs developed for child and adolescent mental health issues to date do not account for comorbidity, and instead focus on only one disorder (e.g., anxiety OR depression). Youth are therefore routinely provided with a digital mental health program targeting their primary presenting problem (i.e., the problem that is causing them the most distress or is most interfering with their functioning). This randomised controlled trial will target adolescents with both anxiety and depression, comparing an online program targeting BOTH anxiety and depression, with one that will target only the PRIMARY presenting problem (i.e., either anxiety OR depression). We expect that compared to the program targeting ONLY the primary presenting problem, the program directly targeting BOTH anxiety and depression will lead to better and longer-lasting mental health outcomes not only for the primary presenting problem, but also for the comorbid problem.

  • A double-blind randomised, placebo-controlled clinical trial to test the treatment of amyotrophic lateral sclerosis with ambroxol.

    Ambroxol is a simple cough medicine that is predicted to slow ALS disease progression. This study aims to investigate if ambroxol in high doses is effective in treating ALS. This study will be carried out across 5 research sites in Australia (2 NSW, 1 VIC, 1 SA and 1 TAS), where newly diagnosed ALS patients will be asked to participate. Participation will be over a 32-week period, where they will come in for a 4-week screening, 24-week treatment, and 4-week end of study safety follow-up period. The participants will receive either the placebo or drug solution that they will take three times a day, up dosing each week till they reach the maximum dose or highest dose they can tolerate. Throughout the study their disease progression will be assessed using tests, questionnaires, and blood biomarkers.

  • RELEASE: Redressing long-term antidepressant use in general practice

    This pragmatic effectiveness-implementation hybrid type-1 cluster randomised controlled trial in general practice will determine effectiveness and cost-effectiveness of two multi-strategy interventions, RELEASE and RELEASE+, in supporting safe cessation of long-term antidepressants when there is no clinical indication for continued use. Implementation strategies will be evaluated and assessed for scale up to improve primary health care and outcomes for patients. All prescribing decisions are made as usual by patient and GP together.

  • An early phase clinical trial to measure the safe dose of a new alpha-radiopharmaceutical for the treatment of advanced prostate cancer

    The aim of this study is to determine the maximum safe and effective dose of a novel therapeutic ADVC001 complexed with the radio-isotope alpha-212 ([212Pb]Pb-ADVC001) for the treatment of metastatic prostate cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, have a diagnosis of metastatic adenocarcinoma of the prostate, and have received at least one cycle of androgen receptor therapy and exposure to a taxane-based chemotherapy. Study details All participants will receive treatment with four cycles of [212Pb]Pb-ADVC001. The intervention will be administered intravenously on day 1 during each 6-week cycle. Participants will be monitored for any adverse events for up to 36 weeks after commencing therapy, and will undergo imaging and blood tests for the duration of treatment to determine their response to therapy. Participants will also have blood samples collected to determine how the study drug is metabolised by the body. It is hoped that this study may help to determine the maximum dose at which [212Pb]Pb-ADVC001 is both safe and effective for the treatment of metastatic prostate cancer. This may help to direct how this novel treatment is used for individuals with metastatic prostate cancer in future.

  • The effect of pump speed and a vessel dilating medication on the exercise capacity of patients with left ventricular assist devices (artificial heart pumps)

    The goal of our study is to assess the effects of increasing left ventricular assist device speed (an artificial heart pump) and intravenous GTN (a medications that dilates the vessels) on exercise capacity. We will also assess the effect of these interventions on the pressures inside the heart and the amount of blood pumped by the LVAD (cardiac output), using an intracardiac catheter and cardiac ultrasound (echocardiography). Blood tests will also be taken during the study for additional information. Patients will perform the exercise protocol on a stationary bike while lying down. Our main hypothesis is that both pump speed increase and intravenous GTN will lead to lower cardiac pressures and vessel dilatation, maximising cardiac output and exercise capacity.

  • The effect of multifocal contact lens (MFCL) and combined therapy of MFCL and atropine on the eye-related functions among adult myopes.

  • The effect of 0.05% atropine eye drops on the eye-related functions among adult myopes.

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