NL7623.

Study name	Public title: DEcrease STress through RESilience training for Students Scientific title: DEcrease STress through RESilience training for Students
Methods	Study design: hybrid design: longitudinal observational cohort with nested RCT Study grouping: parallel group (IG vs CG); sequential multiple assignment Unit of randomisation: individuals Power (power sample size calculation, level of power achieved): not specified in trial registration Imputation of missing data: not specified
Participants	Country: The Netherlands Setting: not specified Age: not specified Sample size (randomised): 706 targeted Sex: not specified Comorbidity (mean (SD) of respective measures in indicated, if available) at baseline: not specified Population description: students at the Erasmus University Medical Centre Rotterdam, aged 16 years and older, who provide informed consent and have a score of 14 or higher on the PSS‐10 Method of recruitment: not specified Inclusion criteria: eligible for longitudinal cohort study: 1) all medical students, research master students, PhD students, nanobiology and clinical technology students at the Erasmus University Medical Centre (Erasmus MC) Rotterdam; 2) aged 16 years or older; 3) who give informed consent; within observational cohort, students fulfilling the following criteria are included in the nested RCT: 1) participation in the cohort study; 2) score of 14 or higher on the PSS‐10 Exclusion criteria: A student who meets any of the following criteria will be excluded from participation in the RCT, but can participate in the cohort study: 1) not insured for health care (for care provided in The Netherlands); 2) diagnosis of, or previously treated for, psychosis or mania; 3) response to at least 1 question on the Four‐Dimensional Symptom Questionnaire (4DSQ) items 33 or 46 is “often” or “very often or constantly" Attrition (withdrawals and exclusions): not specified Reasons for missing data: not specified
Interventions	Intervention: multiple behavioural interventions (n randomised not specified) delivery: interventions offered either in e‐health format or in blended format or both; blended interventions: group intervention with weekly meetings with e‐health practice at home providers: e‐health format: self‐guided; not specified for blended interventions and group intervention duration of treatment period and timing: 8 weeks (duration of MBSR course) description: IG receives 1 of 9 active interventions, of which 4 are in e‐health format and 5 in blended format): The interventions are: mindfulness‐based stress reduction (e‐health and blended) yoga (blended) running (blended) aikido (e‐health and blended) music (e‐health) stress management training (e‐health and blended) evaluated in parallel and sequentially as dynamic intervention regimens all active interventions encompass at least 3 components: relaxation, focused attention, and (self‐)awareness Participants in intervention arm are able to select and rank order 4 (out of the 8) preferred interventions and are randomised to 1 of these 4 with equal probability Non‐response to the intervention is followed by sequential randomised assignment to another intervention in the next period, with an increased chance of randomisation to higher‐ranked preferred interventions, which is repeated once more, for a total maximum of 3 sequential interventions. Participants in the intervention arm of the RCT will follow a maximum of 3 intervention periods of 8 weeks each compliance: not specified integrity of delivery: not specified economic information: not specified theoretical basis: multimodal (see active interventions) Control: active control (n randomised not specified) delivery: study web‐portal; email with information providers : probably self‐guided duration of treatment period and timing: not specified description: psycho‐education about chronic stress and the prevention of burnout, which consists of explanation of chronic stress, how burnout develops, the role of self‐care, and stress management compliance: not specified integrity of delivery: not specified economic information: not specified theoretical basis: not specified
Outcomes	Outcomes collected and reported: Primary outcome perceived stress ‐ PSS‐10 Secondary outcomes mental well‐being ‐ Short WWEMWS symptoms of burnout ‐ OBI ‐ Student version overall quality of life and well‐being ‐ Visual Analogue Scales (VAS) stress‐related symptoms (headaches, migraines, gastrointestinal complaints, neck pain, back pain, palpitations) ‐ VAS trouble sleeping ‐ VAS symptoms from a sports injury ‐ VAS healthcare utilization and medication alcohol consumption smoking drug use physical activity mental and physical stress‐related symptoms ‐ Four‐Dimensional Symptom Questionnaire resilience ‐ BRS current weighted average grade accumulated European Credit points BMI adherence preference for training programmes Outcomes reported not specified Time points measured and reported: 1) pre‐intervention; 2) post‐intervention (before and after each 8‐week intervention period); 3) 1‐year follow‐up; 4) 2‐year follow‐up;time points reported not specified Adverse events: not specified
Starting date	Study start/end date: February 2019 ‐ September 2023
Contact information	Principal investigator: Prof. Myriam Hunink Address: Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands Email: m.hunink@erasmusmc.nl Telephone: +31107043489
Notes	Contact with authors: no correspondence required Funding source: Erasmus MC, Studie Voorschot Middelen Declaration of interest: not specified in trial registration Ethical approval needed/obtained for study: not specified in trial registration Comments by study authors: website, destress.info Miscellaneous outcomes by the review authors:trialregister.nl/trial/7623 (trial register number assigned 22 March 2019); according to trial registration, the recruitment status is 'recruiting'