title: Protocol for the Mindful Student Study: a randomised controlled trial of the provision of a mindfulness intervention to support university students' well-being and resilience to stress.
abstract: Levels of stress in UK university students are high, with an increase in the proportion of students seeking help in recent years. Academic pressure is reported as a major trigger. Mindfulness training has been shown to reduce stress and is popular among students, but its effectiveness in this context needs to be ascertained. In this pragmatic randomised controlled trial, we hypothesise that the provision of a preventative mindfulness intervention in universities could reduce students' psychological distress during the examination period (primary outcome), improve their resilience to stress up to at least 1 year later, reduce their use of mental health support services and improve academic performance.
  
  
  
  At least 550 University of Cambridge students free from active crises or severe mental illness will be randomised to joining an 8-week mindfulness course or to mental health provision as usual (one-to-one allocation rate). Psychological distress will be measured using the Clinical Outcomes in Routine Evaluation Outcome Measure at baseline, postintervention, examination term and 1-year follow-up. Other outcomes are use of mental health services, inability to sit examinations or special circumstance requests, examination grades, well-being, altruism and coping measured with ecological momentary assessment. Outcome assessment and intention-to-treat primary analysis using linear mixed models adjusted for baseline scores will be blind to intervention allocation. We will also conduct per-protocol, subgroup and secondary outcome analyses. An Independent Data Monitoring and Ethics Committee will be set up. We will systematically monitor for, and react to, possible adverse events. An advisory reference group will comprise student representatives, members of the University Counselling Service and other student welfare staff.
  
  
  
  Approval has been obtained from Cambridge Psychology Research Ethics Committee (PRE.2015.060). Results will be published in peer-reviewed journals. A lay summary will be disseminated to a wider audience including other universities.
  
  
  
  ACTRN12615001160527; pre-results.
authors.affiliation: Department of Psychiatry, University of Cambridge, Cambridge, UK.|NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) East of England, Cambridge, UK.
authors.forename: Julieta
authors.identifier: 0000-0002-4108-5341
authors.initials: J
authors.lastname: Galante
authors.affiliation: University Counselling Service, University of Cambridge, Cambridge, UK.
authors.forename: Geraldine
authors.initials: G
authors.lastname: Dufour
authors.affiliation: Academic Division, University of Cambridge, Cambridge, UK.
authors.forename: Alice
authors.initials: A
authors.lastname: Benton
authors.affiliation: NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) East of England, Cambridge, UK.
authors.forename: Emma
authors.initials: E
authors.lastname: Howarth
authors.affiliation: NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) East of England, Cambridge, UK.
authors.forename: Maris
authors.initials: M
authors.lastname: Vainre
authors.affiliation: Dundee Centre for Health and Related Research, School of Nursing and Health Sciences, University of Dundee, Dundee, UK.
authors.forename: Timothy J
authors.initials: TJ
authors.lastname: Croudace
authors.affiliation: NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) East of England, Cambridge, UK.|Norwich Medical School, University of East Anglia, Norwich, UK.
authors.forename: Adam P
authors.identifier: 0000-0002-9101-3477
authors.initials: AP
authors.lastname: Wagner
authors.affiliation: Department of Psychiatry, University of Cambridge, Cambridge, UK.|NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) East of England, Cambridge, UK.
authors.forename: Jan
authors.initials: J
authors.lastname: Stochl
authors.affiliation: Department of Psychiatry, University of Cambridge, Cambridge, UK.|NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) East of England, Cambridge, UK.
authors.forename: Peter B
authors.initials: PB
authors.lastname: Jones
mesh_terms: D003376:Counseling; D006801:Humans; D008603:Mental Health / Q000592:standards; D008605:Mental Health Services / Q000706:statistics & numerical data; D064866:Mindfulness / Q000379:methods*; D012107:Research Design; D055500:Resilience, Psychological; D057566:Self Report; D013315:Stress, Psychological / Q000628:therapy*; D013334:Students / Q000523:psychology*; D016896:Treatment Outcome; D006113:United Kingdom; D014495:Universities
keywords: mindfulness; stress; students