DEcrease STress through RESilience training for Students (DESTRESS) Study: Protocol for a randomized controlled trial nested in a longitudinal observational cohort study

• Published in: Contemporary clinical trials 2022-11, Vol.122, p.106928-106928, Article 106928
• Main Authors: Dijk, S.W., Steijlen, O.F.M., Kranenburg, L.W., Rouwet, E.V., Luik, A.I., Bierbooms, A.E., Kouwenhoven-Pasmooij, T.A., Rizopoulos, D., Swanson, S.A., Hoogendijk, W.J.G., Hunink, M.G.M.
• Format: Article
• Language: English
• Subjects: Clinical trial protocol; Cohort Studies; Health occupations students; Humans; Medical education; Mental Health; Mindfulness; Mindfulness - methods; Observational Studies as Topic; Occupational stress; Psychological resilience; Randomized Controlled Trials as Topic; Students - psychology; Universities
• ISSN: 1551-7144; 1559-2030
• DOI: 10.1016/j.cct.2022.106928

Chronic stress and burnout are highly prevalent among academically trained healthcare professionals, negatively affecting their well-being and capacity to engage in their work. Resilience to stress develops early in one's career path, hence offering resilience training to university students in these professions is one approach to fostering well-being and mental health. The aim of this study is to assess whether offering mindfulness-based resilience training to university students in healthcare professions reduces their perceived chronic stress. The study has a hybrid design combining a longitudinal observational cohort with a nested randomized controlled trial (RCT) with sequential multiple assignment and multistage adaptive interventions while taking participants' preferences into account. All students in healthcare related programmes at the Erasmus University Rotterdam are invited to participate. Within the observational cohort, students with a score of 14 or higher on the Perceived Stress Scale (PSS) are invited to take part in the RCT (n = 706). Eligible participants are randomized to control or active intervention in a ratio of 1:6. Those randomized to the control group and non-randomized participants in the cohort receive passive web-based psychoeducation about chronic stress and burnout through referral to specific websites. Participants randomized to the intervention group receive one of 8 active mindfulness-based interventions. They select a rank order of 4 preferred interventions and are randomized across these with equal probability. Non-response to the intervention is followed by sequential randomized assignment to another intervention, for a total maximum of 3 sequential interventions. All participants receive questionnaires at baseline, before and after each 8-week intervention period, and at 1- and 2-year follow-up. The primary outcome is perceived chronic stress measured with the PSS. Secondary outcomes include mental well-being, burnout, quality of life, healthcare utilization, drug use, bodyweight, mental and physical stress-related symptoms, resilience, and study progress. Approval from the Medical Ethics Review Committee was obtained under protocol number MEC-2018-1645. The trial is registered in the Netherlands National Trial Register by registration number NL7623, 22/03/2019, https://www.trialregister.nl/. •Pragmatic designs can approximate real-world practice.•Sequential randomization allows for adjusted preferences over time.•Neste