Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001160527
Ethics application status
Approved
Date submitted
31/08/2015
Date registered
30/10/2015
Date last updated
6/11/2019
Date data sharing statement initially provided
30/08/2019
Date results information initially provided
30/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mindful Student Study: An evaluation of the provision of mindfulness training to support university students' wellbeing and resilience to stress
Scientific title
A randomised controlled evaluation of the provision of mindfulness training to support university students’ wellbeing and resilience to stress
Secondary ID [1] 287379 0
None
Universal Trial Number (UTN)
Trial acronym
MSS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological distress
 296064 0
Use of mental health services 296544 0
Academic performance 296545 0
Wellbeing 296546 0
Condition category
Condition code
Mental Health 296328 296328 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 296808 296808 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The delivery of a mindfulness course called “Mindfulness Skills for Students”, a secular, manualised, group-based skills training programme based on the course book Mindfulness: A Practical Guide to Finding Peace in a Frantic World, by Mark Williams and Danny Penman, and adapted for university students. The course is free but students need to buy the course book.
The sessions last for 90 minutes for the first session, and 75 minutes for the remaining sessions. There are eight weekly sessions. The sessions are run by Dr Elizabeth English, a certified Mindfulness trainer with over 30 years’ experience of practising and teaching meditation. The sessions include two mindfulness meditations, the first embedding the meditation that the students have practised at home throughout the week; the second, introducing them to the new meditation that they will practice at home in the coming week. There are also periods of reflection and inquiry, helping the students to understand the nature of mindfulness, to deepen their learning and embed it into their everyday lives. A few simple models are used and developed throughout the course, to give the students some theoretical understanding of the points developed experientially. Each session also includes interactive exercises, so that the students share their experience and get to know each other throughout the course, building a sense of safety and community. Before and after each class, students receive an email from their Mindfulness teacher. This reminds them of the themes covered in the previous class, and lets them know the topics coming up in the next class. These emails also include handy tips, poems and video clips. There is also a course handout available in hard copy at each class, which describes the home practice for the coming week (this handout is also available as a download in the post class email, and the home practice is also described in the course book.) The home practice time varies through the course, starting at eight minutes, and increasing to about 15-25 minutes per week, plus ongoing reflection through the day. More practice is possible for those who want it, and students are encouraged not to miss a day, and therefore to consider doing less on days when they are very busy, rather than missing the practice altogether. The home practice includes meditations from the CD by Mark Williams, as described in the course book above. Other mindfulness practices are recommended by the authors of the course book, such as a mindful walk, mindful eating, habit breakers, and so on.
Seven courses are offered to students each term, two terms a year (Michaelmas, which runs from October to December, and Lent, which runs from January to March). Courses are not offered during the exam period (Easter term, which runs from April to June).
The following process measures will assess how the course is being delivered: (a) Registering attendance to mindfulness courses and asking why sessions were missed; (b) Asking students about their compliance with their mindfulness homework.
Intervention code [1] 292723 0
Prevention
Intervention code [2] 292737 0
Lifestyle
Intervention code [3] 292738 0
Behaviour
Comparator / control treatment
Students will be recruited at the beginning of Michaelmas 2015 (October) and Lent 2016 (January). The comparator will be university mental health provision as usual. Those who are still students will receive the intervention a year later (October 2016 and January 2017 respectively).
Control group
Active

Outcomes
Primary outcome [1] 295983 0
Psychological distress with CORE-OM
Timepoint [1] 295983 0
Post-intervention, exam period (primary outcome measurement), one-year follow-up
Secondary outcome [1] 317092 0
Wellbeing with Warwick-Edinburgh Mental Wellbeing Scale
Timepoint [1] 317092 0
Post-intervention, exam period, one-year follow-up
Secondary outcome [2] 317093 0
Mental health services use during exam period (single question)
Timepoint [2] 317093 0
one-year follow-up
Secondary outcome [3] 317094 0
Perceived impact of students' problems on their academic performance (bespoke questionnaire)
Timepoint [3] 317094 0
Exam period
Secondary outcome [4] 317095 0
Exam grades (data linkage)
Timepoint [4] 317095 0
Exam period
Secondary outcome [5] 317096 0
Use of the University Counselling Service (data linkage)
Timepoint [5] 317096 0
Exam period
Secondary outcome [6] 317097 0
Interference with academic life: special circumstances requests for exams, intermissions and degrading (data linkage)
Timepoint [6] 317097 0
Exam period
Secondary outcome [7] 317098 0
Stress and coping level (ecological momentary assessment)
Timepoint [7] 317098 0
Exam period
Secondary outcome [8] 317099 0
Physical activity and sleep patterns (sensor-assisted data collection)
Timepoint [8] 317099 0
Exam period
Secondary outcome [9] 322279 0
Helping behaviour (donations)
Timepoint [9] 322279 0
Post-intervention, exam period, one-year follow-up

Eligibility
Key inclusion criteria
(a) Undergraduate and graduate University of Cambridge students;
(b) Who consider they can realistically attend at least seven sessions of the course (courses timetables will be available for potential participants to assess availability).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(a) Currently suffering from severe periods of anxiety or depression;
(b) Experiencing severe mental illness such as hypomania or psychotic episodes;
(c) Following recent bereavement or major loss;
(d) Experiencing any other serious mental or physical health issue that would impact on their ability to engage with the course.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be done automatically by the website administering the baseline questionnaires so that assignation will be concealed from researchers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/09/2015
Date of last participant enrolment
Anticipated
15/01/2016
Actual
15/01/2016
Date of last data collection
Anticipated
Actual
24/01/2017
Sample size
Target
550
Accrual to date
Final
616
Recruitment outside Australia
Country [1] 7129 0
United Kingdom
State/province [1] 7129 0
Cambridgeshire

Funding & Sponsors
Funding source category [1] 291941 0
University
Name [1] 291941 0
Vice-Chancellor’s Endowment Fund, University of Cambridge
Country [1] 291941 0
United Kingdom
Funding source category [2] 291942 0
University
Name [2] 291942 0
University Counselling Service, University of Cambridge
Country [2] 291942 0
United Kingdom
Funding source category [3] 291943 0
Other Collaborative groups
Name [3] 291943 0
Collaboration for Leadership in Applied Health Research & Care (CLAHRC) East of England
Country [3] 291943 0
United Kingdom
Primary sponsor type
University
Name
University of Cambridge
Address
16 Mill Lane
Cambridge
CB2 1SB
Country
United Kingdom
Secondary sponsor category [1] 290611 0
Individual
Name [1] 290611 0
Julieta Galante
Address [1] 290611 0
Department of Psychiatry
University of Cambridge
Douglas House
18b Trumpington Road
Cambridge CB2 8AH
Country [1] 290611 0
United Kingdom
Secondary sponsor category [2] 290612 0
University
Name [2] 290612 0
Geraldine Dufour
Address [2] 290612 0
University Counselling Service
2-3 Bene't Place, Lensfield Road
Cambridge CB2 1EL
Country [2] 290612 0
United Kingdom
Secondary sponsor category [3] 292020 0
Individual
Name [3] 292020 0
Peter B Jones
Address [3] 292020 0
Department of Psychiatry
University of Cambridge
Herchel Smith Building for Brain and Mind Sciences
Forvie Site Robinson Way
Cambridge Biomedical Campus
CB2 0SZ
Country [3] 292020 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293440 0
Cambridge Psychology Research Ethics Committee
Ethics committee address [1] 293440 0
University of Cambridge
17 Mill Lane
Cambridge CB2 1RX
Ethics committee country [1] 293440 0
United Kingdom
Date submitted for ethics approval [1] 293440 0
03/07/2015
Approval date [1] 293440 0
25/08/2015
Ethics approval number [1] 293440 0
PRE.2015.060

Summary
Brief summary
Undergraduate and graduate university students show elevated levels of stress. At the University of Cambridge, the University Counselling Service and other support services see an increasing number of students seeking help. A preventative intervention to help students cope with stress is needed.
To address this need the University has funded an implementation and evaluation project. A three-year pilot mindfulness intervention began in late 2014. Eight-week introductory mindfulness courses are being provided to healthy volunteer students in groups that are oversubscribed. An evaluation of this provision will be conducted too see whether it:
1. Improves university students’ mental wellbeing and resilience to stress up to one year later.
2. Reduces their use of mental health treatment and support services
3. Helps them to manage stress during the examination term
4. Improves their engagement with student life, including their academic performance.
Trial website
Trial related presentations / publications
Results:
Galante J, Dufour G, Vainre M, Wagner AP, Stochl J, Benton A, et al. A mindfulness-based intervention to increase resilience to stress in university students (the Mindful Student Study): a pragmatic randomised controlled trial. The Lancet. Public health, ISSN: 2468-2667, 2018 Vol: 3, Issue: 2, Page: e72-e81 (http://www.thelancet.com/journals/lanpub/article/PIIS2468-2667(17)30231-1/fulltext).

Protocol:
Galante J, Dufour G, Benton A, et al 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. BMJ Open 2016;6:e012300. doi: 10.1136/bmjopen-2016-012300 (http://bmjopen.bmj.com/content/6/11/e012300).
Public notes
Attachments [1] 1018 1018 0 0
/AnzctrAttachments/369222-PRE.2015.060 primary outcome statement.pdf (Ethics approval)

Contacts
Principal investigator
Name 59946 0
Prof Peter B Jones
Address 59946 0
Department of Psychiatry
University of Cambridge
Herchel Smith Building for Brain and Mind Sciences
Forvie Site Robinson Way
Cambridge Biomedical Campus
CB2 0SZ
Country 59946 0
United Kingdom
Phone 59946 0
+44 (0) 1223 336961
Fax 59946 0
Email 59946 0
[email protected]
Contact person for public queries
Name 59947 0
Dr Julieta Galante
Address 59947 0
Department of Psychiatry
University of Cambridge
Douglas House
18b Trumpington Road
Cambridge CB2 8AH
Country 59947 0
United Kingdom
Phone 59947 0
+44 (0) 1223 465192
Fax 59947 0
Email 59947 0
[email protected]
Contact person for scientific queries
Name 59948 0
Dr Julieta Galante
Address 59948 0
Department of Psychiatry
University of Cambridge
Douglas House
18b Trumpington Road
Cambridge CB2 8AH
Country 59948 0
United Kingdom
Phone 59948 0
+44 (0) 1223 465192
Fax 59948 0
Email 59948 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We are in the process of preparing a data sharing statement that will be uploaded in due course.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4275Other    Economic Evaluation Analysis Plan (HEAP) 369222-(Uploaded-23-08-2019-20-02-35)-Study-related document.pdf
4276Study protocolGalante J, Dufour G, Benton A, et al 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 BMJ Open 2016;6:e012300. doi: 10.1136/bmjopen-2016-012300 (open access)https://bmjopen.bmj.com/content/6/11/e012300 
4277Statistical analysis planGalante J, Dufour G, Benton A, et al 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 BMJ Open 2016;6:e012300. doi: 10.1136/bmjopen-2016-012300 (open access)https://bmjopen.bmj.com/content/6/11/e012300 
5570Study protocol    Mindful Student Study: The physiology of mindfulne... [More Details] 369222-(Uploaded-04-11-2019-22-22-16)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Lancet Public Health. 2018 Feb;3(2):e72-e81. doi: ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProtocol 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.2016https://dx.doi.org/10.1136/bmjopen-2016-012300
EmbaseA mindfulness-based intervention to increase resilience to stress in university students (the Mindful Student Study): a pragmatic randomised controlled trial.2018https://dx.doi.org/10.1016/S2468-2667%2817%2930231-1
EmbaseEffectiveness of providing university students with a mindfulness-based intervention to increase resilience to stress: 1-year follow-up of a pragmatic randomised controlled trial.2021https://dx.doi.org/10.1136/jech-2020-214390
N.B. These documents automatically identified may not have been verified by the study sponsor.