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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.

Feasibility of a mobile health intervention to motivate adolescent fitness and high-intensity exercise adherence (Motivating Adolescent Fitness (MOTAFIT)): protocol for a randomised controlled trial

Por: Koep · J. L. · Sansum · K. M. · Low · J. · Smith · K. J. · Cocks · M. · McManus · A. M.
Introduction

Most adolescents fail to achieve recommended levels of vigorous-intensity physical activity, despite the established benefits for cardiorespiratory fitness and vascular health. Supervised interventions can be effective, but are resource-intensive and lack scalability. Mobile health (mHealth) technologies may provide a cost-effective and accessible approach to support structured, individualised training for adolescents. The Motivating Adolescent Fitness (MOTAFIT) trial will assess the feasibility and acceptability of an mHealth-supported exercise intervention for adolescents to inform the design of a definitive randomised controlled trial (RCT).

Methods and analysis

MOTAFIT is a three-arm feasibility RCT targeting 120 adolescents aged 13–16 years from the Okanagan Valley, British Columbia. Participants will be randomised (1:1:1) to: (1) MOTAFIT, (2) active control or (3) control group. The 12-week intervention targets ≥40 min/week of vigorous-intensity exercise (≥80% HRmax), co-designed with an exercise specialist and supported by mHealth technology. Primary outcomes for feasibility, including recruitment, retention, adherence, fidelity and acceptability, will be assessed as part of a process evaluation. Secondary measures (cardiorespiratory fitness, vascular health and blood pressure) will provide preliminary estimates to guide future sample size calculations.

Ethics and dissemination

The study has received approval from the University of British Columbia Clinical Research Ethics Board (H22-03183) and the University of Victoria Human Research Ethics Board. Parental consent and adolescent assent will be obtained prior to participation. Findings will be disseminated via peer-reviewed publications, conferences and community engagement.

Trial registration number

NCT06409793.

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