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Feasibility of an adjunctive INtervention for Debilitating symptom complexes attributed to ticks (FIND): study protocol for a randomised, waitlist-controlled feasibility trial

Por: Kanaan · R. A. A. · Macdonell · R. · Long · M. · Richardson · R. J. · Rogers · C. · Mcmanus · M. · Braat · S. · Zaloumis · S. · Mihalopoulos · C. · Chatterton · M. L. · Gibney · K. B. · Oliver · G. · Wilson · S. J. · Chalder · T.
Background

Debilitating Symptom Complexes Attributed to Ticks (DSCATT) is a new term for an unexplained Australian syndrome—people who suffer from a chronic, multifaceted and debilitating illness, characteristically attributed to tick bites, but in a country without endemic Lyme disease. Despite the profound morbidity of DSCATT, no single causative agent has been identified and there are no recognised treatments for the illness at present. An increasing body of evidence shows psychological therapies such as Acceptance and Commitment Therapy (ACT) can be effective in reducing symptom-related disability and improving quality of life for other unexplained syndromes. Here we present a study protocol to assess the feasibility of an ACT-informed intervention for patients suffering from DSCATT, to be used adjunctively to their pre-existing healthcare. The study aims to assess the acceptability, practicality and demand for the treatment. Additionally, we will examine the effects of therapy on participants’ health and well-being, its safety, potential mediators of response to therapy and its preliminary cost-effectiveness.

Methods

We will assess the feasibility of a 32-week, randomised, waitlist-controlled, parallel convergent mixed-methods pilot trial for DSCATT. Participants will be randomised in a 1:1 ratio to receive either 16 sessions of ACT-informed therapy adjunctive to their pre-existing healthcare, delivered one-to-one with a trial therapist within a 20-week period or be assigned to the waitlist control group where they will continue their treatments as usual. We will collect quantitative and qualitative data to address study aims, with retention rate being the primary feasibility outcome.

Ethics and dissemination

The study has ethical approval from Austin Health Human Research Ethics Committee (HREC). The outcomes will be published in peer-reviewed journals. Data from participants who have given extended consent will be available for other HREC-approved studies.

Trial registration number

ACTRN12623000372684, prospectively registered 13 April 2023, URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385579&isReview=true; the last participant is expected to complete in November 2026.

Breathing control training as a treatment for functional seizures (BREATHS trial): a multicentre, assessor-blinded, randomised controlled efficacy and acceptability trial study protocol

Por: Kanaan · R. · Duncan · R. · Mihalopoulos · C. · Braat · S. · OBrien · T. J. · Velakoulis · D. · Kwan · P. · Mulder · R. T. · Cook · M. · Mullen · S. · Mayne · D. · Oliver · G. · Eleftheriadis · D. · Ameen · O. · Chatterton · M. L. · DSouza · W. · Nicolo · J.-P. · Perucca · P. · Winton-Brow
Introduction

Functional seizures (FS) are events that resemble epileptic seizures, but are not attributed to brain pathology and are instead thought to be due to psychological factors. A small, multisite, open-label, single-arm, pilot trial of a breathing intervention known as breathing control training (BCT) found it to be safe and effective in reducing seizure frequency in FS. We propose a protocol for a study to confirm these results.

Methods and analysis

A 24-week, multicentre, individually-randomised, assessor-blinded, two-arm, parallel-group efficacy and acceptability trial of BCT versus control (Befriending) in 220 participants ≥16 years of age with FS. Eligible participants will be randomly allocated to receive two sessions of either BCT or Befriending over a 4-week period. Sessions will be delivered by a respiratory physiotherapist at a clinical care site or via telehealth. They will complete assessments prior to commencing treatment and at 4, 12 and 24 weeks after their initial session of BCT/Befriending. The trial will be conducted alongside treatment as usual. An economic evaluation including cost-utility and cost-effectiveness analyses will be carried out from health sector and societal perspectives.

Ethics and dissemination

The study has been approved by The Austin Health Human Research Ethics Committee (HREC/84335/Austin-2022) and the New Zealand Central Health and Disability Ethics Committee (2022 FULL 12324). Findings will be reported to trial participants and consumers; presented at local, national and international conferences; and disseminated by a peer-reviewed scientific journal.

Evaluation of a text-mining application for the rapid analysis of free-text wildlife necropsy reports

by Stefan Saverimuttu, Kate McInnes, Kristin Warren, Lian Yeap, Stuart Hunter, Brett Gartrell, An Pas, James Chatterton, Bethany Jackson

The ability to efficiently derive insights from wildlife necropsy data is essential for advancing conservation and One Health objectives, yet close reading remains the mainstay of knowledge retrieval from ubiquitous free-text clinical data. This time-consuming process poses a barrier to the efficient utilisation of such valuable resources. This study evaluates part of a bespoke text-mining application, DEE (Describe, Explore, Examine), designed for extracting insights from free-text necropsy reports housed in Aotearoa New Zealand’s Wildbase Pathology Register. A pilot test involving nine veterinary professionals assessed DEE’s ability to quantify the occurrence of four clinicopathologic findings (external oiling, trauma, diphtheritic stomatitis, and starvation) across two species datasets by comparison to manual review. Performance metrics—recall, precision, and F1-score—were calculated and analysed alongside tester-driven misclassification patterns. Findings reveal that while DEE (and the principals underlying its function) offers time-efficient data retrieval, its performance is influenced by search term selection and the breadth of vocabulary which may describe a clinicopathologic finding. Those findings characterized by limited terminological variance, such as external oiling, yielded the highest performance scores and the most consistency across application testers. Mean F1-scores across all tested findings and application testers was 0.63–0.93. Results highlight the utility and limitations of term-based text-mining approaches and suggests that enhancements to automatically capture this terminological variance may be necessary for broader implementation. This pilot study highlights the potential of relatively simple, rule-based text-mining approaches to derive insights natural language wildlife data in the support of One Health goals.

N-acetyl cysteine for the treatment of alcohol use disorder: study protocol for a multi-site, double-blind randomised controlled trial (NAC-AUD study)

Por: Morley · K. · Arunogiri · S. · Connor · J. P. · Clark · P. J. · Chatterton · M. L. · Baillie · A. · Slade · T. · Berk · M. · Lubman · D. · Haber · P. S.
Introduction

Current treatments for alcohol use disorders (AUD) have limited efficacy. A previous 28-day pilot trial of N-acetyl cysteine (NAC) vs placebo found NAC to be feasible and safe, with evidence of improvement on some measures of alcohol consumption. Thus, the primary aim of the NAC-AUD study is to examine the therapeutic and cost-effectiveness of NAC vs placebo in improving treatment outcomes for AUD. We will also examine the (i) effect of NAC vs placebo on mood, markers of liver injury, cognition and hangover symptoms; and (ii) predictors of any response.

Methods and analysis

This double-blind trial will randomise participants with AUD to a 12-week regimen of either NAC (2400 mg/day) or placebo. All participants will receive medical management. The primary drinking outcome will be the number of heavy drinking days (HDDs) per week, validated by phosphatidylethanol (PEth). Secondary alcohol-related outcomes will include standard drinks per drinking day (SDDD) per week and absence of any HDDs. Other secondary outcomes will include markers of liver injury, depression, anxiety, craving, hangover symptoms, cognition and blood oxidative stress markers. We will also examine the cost-efficacy of NAC vs placebo.

Ethics and dissemination

Ethics approval for the study has been granted by The Sydney Local Health District Ethics Review Committee (X21-0342& HREC2021/ETH11614). There are no restrictions on publication from the sponsor or other parties.

Trial registration number

NCT05408247.

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