ANZCTR search results

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

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32712 results sorted by trial registration date.
  • Improving Mental Health and Social Participation Outcomes in Older Adults with Depression and Anxiety

    The aim of this study is to evaluate the efficacy and cost-efficacy of a psychosocial intervention to treat emotional symptoms and increase social participation in anxious and/or depressed older adults, relative to current “best practice” transdiagnostic CBT. We predict that the enhanced program will lead to significantly greater reductions than the standard program on our primary outcome, diagnostic severity of anxiety and depression.

  • Australian Registry of Severe Drug Reactions

    The development of a national clinical and DNA registry, AUS-SCAR, of SCAR patients with severe T cell-mediated drug hypersensitivities will allow investigators to (i) perform surveillance for new and emerging drug causality, (ii) develop clinical prediction rules, (iii) understand best-practice treatment approaches, (iv) discover genomic predictors that prevent SCAR onset and (v) improve long-term outcomes and medication safety.

  • The Role of Intense Pulsed Light in Contact Lens Discomfort

    The aim of this study is to determine whether contact lens discomfort can be reduced following the use of intense pulsed light to manage Meibomian gland dysfunction. We, the investigators, hypothesise that contact lens discomfort can be reduced by managing Meibomian gland dysfunction with intense pulsed light. This study will occur over 5 visits and participants will be monitored for comfort, Meibomian gland structure and function, inflammation and corneal nerve morphology.

  • Testing an Early Intervention Programme for Very Young Children with Emerging Disruptive Behaviour

    This project is a pilot study aiming to examine the initial feasibility, acceptability and preliminary efficacy of a seven-week early intervention programme among a sample of very young children with emerging disruptive behaviours and their families. The empirically-supported PCIT protocol will be adapted to meet the needs of 12-24-month old children. In particular, the intervention under investigation involves an initial parent-only session, which focuses on teaching parents how to positively engage with their child. Parent(s) and children will then attend six-weekly 60-minute sessions, in which parents receive in-vivo coaching from a clinician using skills taught in the initial session, using a wireless headset from behind a one-way mirror. Parents will then be asked to complete daily 5-minute skills practice activities involving playtime with their child at home. It is hypothesized that families will show improvement in the primary outcomes at post-treatment and 6-month follow-up. Primary outcome measures include improvements in child disruptive behaviours, precursor markers of callous-unemotional (CU) behaviours (e.g., lack of empathy/ guilt, uncaring attitudes/behaviours), and parental stress and wellbeing.

  • Efficacy of a heel off-loading boot in reducing heel pressure injuries in intensive care patients: a single-blinded randomised controlled trial.

    This is a multisite single-blinded randomised controlled trial of 418 patients across three intensive care units in three acute hospitals to evaluate the clinical effectiveness of a heel off-loading boot (Prevalon TM) in reducing heel pressure injuries and preventing foot contractures in intensive care patients. Patients in ICU who meet the eligibility criteria will be allocated to one of two arms, either the intervention (PrevalonTM heel protector boot - https://sageproducts.com/prevalon-heel-protectors/) or the control (standard care - use of pillow/s for heel elevation). The trial design follows the Consolidated Standards of reporting Trials (CONSORT) protocol RCTs. Our hypothesis is patients who receive the intervention have a lower incidence of heel PIs and plantar flexion contractures compared to those patients who have standard care. The planned duration of this study is 18 months.

  • Superior laryngeal nerve block for laryngeal sensory neuropathy

    We hypothesis that chronic cough and vocal cord dysfunction are both manifestations of sensory neuropathy of the larynx. The Superior laryngeal nerve supplies the sensory supply of the larynx above the level of the vocal cords. We hypothesize that injection of the superior laryngeal nerve with a steroid and a local anaesthetic will treat the underlying neuropathy and result in reduced patient symptoms. In this study we aim to assess superior laryngeal nerve block in patients with chronic cough and/or VCD in a randomised double blind controlled study. Potential participants will be screened and treated for common causes of chronic cough. Participants with persistent symptoms will be offered enrollment within the trial and after enrollment will be randomized to receive a local anaesthetic with steroid nerve block or placebo (normal saline). Participant symptoms will be monitored with verified patient symptom questionnaires.

  • Peer Tree: A smartphone application for young people (aged 16-25) with psychosis and other mental health conditions

    The aim of the research project is to deliver and test an innovative digital smartphone intervention, Peer Tree, which is designed to reduce loneliness in young people with psychosis and other mental health conditions. The intervention is administered daily for 6 weeks. Young people aged 16-25 years who report high levels of loneliness and have a diagnosis of a psychotic disorder or a different disorder that has psychotic features will be recruited. In accordance with a randomised control trial study design, after participants complete the baseline assessment, they will be randomised to either the treatment as usual or intervention group. Those in the waitlist group will complete treatment as usual but will be provided with the same content once they have completed the research project. This will be provided in the form of +Connect, the predecessor of Peer Tree that doesn’t not contain the forums. Our research is expected to contribute to the development of personalised, modular mental health interventions that are cost-effective and efficient. There are currently no personalised, modular interventions available to address loneliness in young people.

  • Exercise-therapy and education for knee osteoarthritis: comparison of telerehabilitation with face-to-face delivery

    This research project aims to determine the feasibility of completing a randomised controlled trial (RCT), to establish if tele-rehabilitation (exercise and education) is as effective as face-to-face delivery in people with knee osteoarthritis (OA). Osteoarthritis affects approximately 2.2 million Australians. People with OA are 2-3 times more likely to be out of work, report poor health, and have high psychological distress and severe pain. Knee OA is the most common presentation of OA and a National Health Priority. This study aims to determine the feasibility of completing a non-inferiority randomised controlled trial (RCT), to establish if telerehabilitation (exercise and education) is as effective as face-to-face delivery in people with knee osteoarthritis (OA).

  • Enhancing Treatment for Depressed Youth: A Randomised Trial of Adjunct Memory Specificity Training

    Current effects of treatment for depression in youth are modest. There is clear scope to enhance intervention in this critical period of early-onset depression. One way to do this is to target known cognitive vulnerabilities. This study will examine the effect of computerised memory specificity training (c-MeST) in addition to usual care, and test whether it enhances treatment effects and reduces risk of depression at follow-up. Youth aged 15-25 presenting to participating mental health service providers will be randomised to usual care + c-MeST or usual care. c-MeST involves completing a series of online modules providing personal memories with feedback to encourage more specific and detailed account of experiences. It is hypothesised that: • The c-MeST + usual care group will report significantly higher rates of remission of clinical and subclinical depression and lower severity of depressive symptoms at 1, 3, and 6 six-month follow-up, relative to a usual care group. • Improvements in memory specificity at 2 weeks will predict improvements in remission rates and severity of depressive symptoms at 1, 3 months and at 6 month follow-up. • The c-MeST + usual care group will report significant improvements on secondary outcomes of suicidal ideation, rumination, executive functioning, and problem-solving ability at 1, 3 months and six-month follow-up, relative to a usual care group.

  • Sleepwear fibre and sleep quality in menopausal women

    This study compares the sleep outcomes (sleep quality) between two different sleepwear type (closely matched for fabric thickness and weight) in peri- and post-menopausal women. It is hypothesised that sleepwearA provides beneficial measured sleep outcomes (sleep quality and quantity, and sleep encephalograph power density) over sleepwearB.

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