Introduction Recent studies have revealed a high prevalence of depression, anxiety and stress symptoms among university students, highlighting an urgent need for preventative measures at low cost to better support often overwhelmed support services.
Objective Here we propose a protocol for assessing the feasibility of a randomised controlled trial (RCT) for an online transdiagnostic psychoeducational intervention called ‘A Bite of ACT’ compared with a waitlist control.
Methods and analysis This is an RCT with crossover design involving baseline assessments and two follow-up periods. The primary outcome measure will be the Acceptance Checklist for Clinical Effectiveness Pilot Trials (ACCEPT) for measuring the feasibility of the trial design and methods. Secondary outcomes include measures of well-being, social connectedness, quality of life (EuroQol Five Dimensions), depression, anxiety and stress (Depression Anxiety Stress Scales-21), as well as the process measures: psychological flexibility (Acceptance and Action Questionnaire-Second Version and the Mindful Attention Awareness Scale) and heart rate variability. Analysis will involve calculating descriptive statistics, examining trial feasibility outcomes through ACCEPT, and determining effect size measures to determine the sample size needed in a future trial (if indicated). Qualitative interviews and preliminary health economics analysis will provide additional insights into the feasibility of the intervention and trial methods.
Ethics and dissemination This study has been approved by the Department of Psychology Research Ethics Committee in the College of Human and Health Sciences at Swansea University. Dissemination will involve publication in international peer-reviewed journals, presentation of findings at relevant local, national and international conferences, and promotion of study outcomes using social media and other channels for disseminating findings to the wider community.
Trial registration number NCT03810131; Pre-results.
- acceptance and commitment therapy
- mental distress
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Contributors DJE and AHK conceived the idea for the study. DJE and AHK agreed on a set of outcomes and process measures, as well as the overall RCT design. DJE wrote the first draft of the protocol and created the intervention. DJE and AHK then revised the subsequent drafts of the protocol. MSc students (ER, YW and VB) supported the intervention design and protocol write-up. JT and PB provided further expert advice on clinical trial randomisation and methodology. PB, a clinical psychologist, provided feedback in relation to the intervention. All authors helped to revise the manuscript for intellectual content and agreed on the final version prior to submission for peer review.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Ethics approval Full ethical approval has been obtained through the Department of Psychology Research Ethics Committee in the College of Human and Health Sciences at Swansea University (reference: 107), which included the information sheets (AHK will receive these), consent and debrief forms.
Provenance and peer review Not commissioned; externally peer reviewed.
Patient consent for publication Not required.
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