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Protected by copyright.
Original research

Effectiveness of providing university students with a

mindfulness-based intervention to increase resilience
to stress: 1-year follow-up of a pragmatic randomised
controlled trial
Julieta Galante ,1,2 Jan Stochl,1,2,3 Géraldine Dufour,4,5 Maris Vainre,6,7
Adam Peter Wagner,2,8 Peter Brian Jones1,2

►►Supplemental material is ABSTRACT is needed,6 it is clear that the number of university

published online only. To view Background There is concern that increasing demand students accessing counselling services has increased
please visit the journal online for student mental health services reflects deteriorating faster than the growth in student numbers.7
(http://dx.doi.org/10.1136/
jech-2020-214390).
student well-being. We designed a pragmatic, parallel, Mindfulness, a non-stigmatising means of train-
single-blinded randomised controlled trial hypothesising ing the attention for the purpose of mental health
For numbered affiliations see that providing mindfulness courses to university students promotion, has become popular in universities.8 In
end of article. would promote their resilience to stress up to a year later. this context, mindfulness practice is often defined as
Here we present 1-year follow-up outcomes. learning to pay attention to what is happening in the
Correspondence to Methods University of Cambridge students without present moment in the mind, body and external
Julieta Galante, Department severe mental illness or crisis were randomised (1:1,
of Psychiatry, University of environment with an attitude of curiosity and
remote software-generated random numbers), to join an kindness.9 There is evidence for its effectiveness in
Cambridge, Cambridge, ​UK;
m
​ jg231@​cam.​ac.​uk
8-week mindfulness course adapted for university preventing psychological distress,10 and improving
students (Mindfulness Skills for Students (MSS)), or to
symptoms of common mental disorders.11
mental health support as usual (SAU).
In 2016, we completed the Mindful Student
Received 25 April 2020
Results We randomised 616 students; 53% completed
Study, a randomised controlled trial (RCT) to con-
Revised 15 July 2020 the 1-year follow-up questionnaire. Self-reported
psychological distress and mental well-being improved in firm the effectiveness of a preventative mindfulness-
Accepted 30 August 2020
Published Online First the MSS arm for up to 1 year compared to SAU (p<0.001). based programme tailored to university students
10 September 2020 Effects were smaller than during the examination period. called Mindfulness Skills for Students (MSS).12 In
No significant differences between arms were detected in a recent publication, we confirmed our primary
the use of University Counselling Service and other hypothesis that MSS would reduce students’ psy-
support resources, but there was a trend for MSS chological distress during the examination period
participants having milder needs. There were no (3–6 months after randomisation) compared with
differences in students’ workload management; MSS access to mental health support as usual (SAU).13
participants made more donations. Home practice had A reduction in distress under exam conditions was
positive dose–response effects; few participants deemed an indicator of resilience to stress. These
meditated. No adverse effects related to self-harm, results are consistent with other evidence, although
suicidality or harm to others were detected. data on longer-term effects and on use of mental
Conclusion Loss to follow-up is a limitation, but health services are sparse.10
evidence suggests beneficial effects on students’ average Participants in the Mindful Student Study were
psychological distress that last for at least a year. Effects followed up for a year post randomisation.
are on average larger at stressful times, consistent with Outcomes pertaining to this time point and partici-
the hypothesis that this type of mindfulness training pants’ trajectories are presented herein. Consistent
increases resilience to stress. with the idea of resilience and prior evidence, our
Trial registration number ACTRN12615001160527. main hypothesis for this analysis was that MSS
would have a long-term effect on psychological dis-
tress still outperforming SAU for reducing psycho-
INTRODUCTION logical distress after 1 year, but that this effect would
Official statistics show that the prevalence of mental be smaller than that during the examination period
health disorders among children and young people in because students would no longer be under the
England, emotional disorders in particular, has been examination universal stressor.
increasing over time, reaching almost one in five aged
© Author(s) (or their
17–19 years in 2017.1 In England, now over 50% of METHODS
employer(s)) 2021. Re-use young people enrol in higher education institutions,2 The Cambridge Psychology Research Ethics
permitted under CC BY. which have a golden yet under-used opportunity for Committee approved the trial on 25 August 2015
Published by BMJ prevention of mental illness in young people.3 4 This (PRE.2015.060). This research conforms to the
To cite: Galante J, Stochl J, seems particularly relevant as there are concerns that principles embodied in the Declaration of
Dufour G, et al. J Epidemiol the pressure that young people experience when they Helsinki. The protocol12 was submitted to the
Community Health transition to university can contribute to mental Australian New Zealand Clinical Trials Registry on
2021;75:151–160. health issues for some of them.5 While more research 31 August 2015, before the study began, and

Galante J, et al. J Epidemiol Community Health 2021;75:151–160. doi:10.1136/jech-2020-214390 151

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Original research
accepted on 30 October 2015 (trial registration: and its colleges, and from health services including the National
ACTRN12615001160527). Health Service, external to the University. Participants rando-
mised to SAU were guaranteed a space in the following year’s
mindfulness courses and were requested to inform the team if
Randomisation and blinding
they decided to learn mindfulness elsewhere during the follow-up
We conducted a pragmatic RCTwith two parallel arms and a one-
period.
to-one allocation ratio testing the superiority of mindfulness
training provision compared with no provision. All the students
at the University of Cambridge were invited to join the study.
Measures
Those who responded positively were randomised via remote
Self-reported data were collected using online questionnaires
survey software (Qualtrics, concealed from researchers) using
accessed by participants via a unique link. The examination
computer-generated random numbers (simple randomisation)
period as defined by the Student Registry spanned
to being offered the MSS course plus SAU, or to SAU alone.
16 May 2016–10 June 2016, the most stressful weeks of the
Participants were aware of group allocation.
academic year for most students (not all have exams, approxi-
We set up an independent data monitoring and ethics commit-
mately 14% did not in our sample), approximately 6 months after
tee (IDMEC), and co-produced the trial with stakeholders.
randomisation for Cohort 1, and 3 months after randomisation
Further details including sample size calculations can be found
for Cohort 2. Online supplemental table 1 lists all trial outcome
in previous publications.12 13
measures and data collection time points.

Eligibility
Eligibility criteria were assessed by participants themselves, and Self-reported mental health
based on those used routinely by the University of Cambridge Psychological distress was measured with the Clinical Outcomes
Counselling Service (UCS) for the MSS courses. Inclusion criteria in Routine Evaluation Outcome Measure (CORE-OM), a 34-
were as follows: (a) current undergraduate or postgraduate stu- item scale that has been widely used with UK university
dents at the University of Cambridge; (b) who believed they could students.15 Higher scores mean more distress. The total mean
attend at least seven sessions of the course. Exclusion criteria score (range 0–4) is obtained by dividing the total score by the
were as follows: (a) currently suffering from severe periods of number of completed items (as long as no more than three items
anxiety or depression; (b) experiencing severe mental illness such have been missed).16 This measure also contains four subscales:
as hypomania or psychotic episodes; (c) recent bereavement or subjective well-being (4 items), problems/symptoms (12 items),
major loss; and (d) experiencing any other serious mental or life functioning (12 items) and risk/harm (6 items). We have
physical health problem that would affect their ability to engage primarily used the full-scale total mean score, but also explored
with the course. the sub-scale mean scores to see whether the effect of mindfulness
Two cohorts of students were recruited (October 2015 and would focus on specific dimensions of distress.
January 2016; no main outcome differences were found between Mental well-being was assessed with the 14-item Warwick-
cohorts).13 MSS courses were free to students. A total of £11 was Edinburgh Mental Wellbeing Scale (WEMWBS).17 The total
available to each participant as a token of appreciation for ques- score is calculated by adding the response values of all items
tionnaire completion. (range 14–70, higher scores indicate greater well-being).

Intervention Use of mental health support resources

The MSS intervention consisted of a secular, face-to-face, group- Following confidentiality protocols, the UCS provided the
based skills training programme based on the course book research team with information about which participants used
‘Mindfulness: A Practical Guide to Finding Peace in a Frantic their services, what type of services they used and how frequently
World’,14 and adapted for university students. This course aimed they were used. The UCS offers a variety of support services for
to optimise well-being and resilience for all students, and was not students depending on their needs and ranging from workshops
specifically developed for those with distress in a clinical range. or therapy groups, to attending a consultation with a counsellor,
Seven MSS courses ran in parallel during university terms, with CBT therapist, mental health advisor or sexual assault & harass-
up to 30 students in each course, all delivered by an experienced ment advisor. We assessed usage of the services from the moment
and certified mindfulness teacher. The eight, weekly sessions each participant was randomised up to a year after that, and usage
lasted 75–90 min. Sessions included mindfulness meditation during the examination period specifically. We also assessed UCS
exercises, periods of reflection and inquiry, and interactive exer- services according to the intensity of support. For this, blind to
cises. Students were encouraged to also practise at home and any data and before analysis, GD (accredited senior psychothera-
were given reading materials. The recommended home practice pist and head of service) and three accredited senior counsellors
time started at 8 min, then increasing to 15–25 min/day. It categorised services according to the intensity of the support they
included guided formal meditations (from here on: ‘formal prac- provide into low, medium or high, reflecting the severity of the
tice’) and other practices such as a mindful walking and mindful mental health problems that they are intended to address (online
eating (from here on: ‘informal practice’). Students were con- supplemental table 2). Then, these categories were uniformly
tacted by email when they missed a session to check whether the applied to the type of service variable in the data set provided
absence related to a negative experience with mindfulness. by the UCS.
Students were also given the opportunity to talk with the teacher To assess the use of the wider range of mental health support
in confidence outside course times. Further details can be found resources, participants were asked ‘Have you turned to any of the
in previous publications.12 13 following resources to discuss your mental health during the
SAU consisted of access to comprehensive centralised support past year?’, and a list of available resources was presented to
at the UCS in addition to support available from the university them. They could choose multiple items and there was an

152 Galante J, et al. J Epidemiol Community Health 2021;75:151–160. doi:10.1136/jech-2020-214390

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Original research
‘other resources’ option with a text box to specify any unlisted To assess dose–response effects of mindfulness practice on
resources. We analysed the usage of resources overall and by type. psychological distress (the trial’s main outcome), the basic
growth model mentioned earlier was extended with time-
varying covariates representing mindfulness practice and distress
Other outcomes compared between arms
reported at each time point. One model was created to assess
Mindfulness aims to cultivate a general attitude of care and
formal mindfulness meditation, and another to assess informal
kindness, prompting claims, and some evidence, that it may also
mindfulness practice. These models also controlled for cohort,
increase altruistic behaviour.18 We therefore incorporated an
gender and age. Mindfulness practice data required pre-
opportunistic measure of altruism, based on offering high street
processing to include within the models (see online supplemental
shopping vouchers to participants upon questionnaire comple-
materials for detail).
tion (equivalent to £3 at post-intervention and 1-year follow-up,
and £5 during the examination period) with a choice to donate
them to a named charity. RESULTS
We have also measured perceived university course workload. One-year follow-up questionnaire data were collected between
This was assessed by asking participants to indicate agreement on 26 September 2016 and 11 October 2016 for Cohort 1, and
a five-point Likert scale with the statement ‘The workload on my between 10 Jamuary 2017 and 23 Jamuary 2017 for Cohort 2.
course was manageable during the past year’. Of the 616 randomised participants (MSS=309, SAU=307), 326
We report the number of adverse scores recorded at the 1-year (53%) completed the 1-year follow-up questionnaire
follow-up (identified by CORE-OM risk subscales above stan- (MSS=161, 52%, SAU=165, 54%, online supplemental figure
dard thresholds). Such ratings were defined as adverse events not 1). No reasons were given for non-completion. There were no
necessarily caused by the intervention (as opposed to adverse significant baseline differences between completers and non-
effects, which would be). For further detail, see the trial completers, except that completers were less likely to be
protocol.12 final year students. This may be explained by the fact that those
who were in their final year at the beginning of the study may no
longer have had the university email account used to contact
Mindfulness practice effects them 1 year later (nor was a non-university address shared
In order to assess mindfulness practice dose–response effects, we when requested ahead of their departure). Leaving university
monitored participants’ practice throughout the follow-up. might have also reduced investment in the study.
Within the MSS arm, formal and informal practice were self-
reported via two questions asked at each time point except for
Self-reported mental health
baseline (eg, ‘During the mindfulness course did you practice
Table 1 shows CORE-OM total mean scores and subscale mean
mindfulness informally at home (eg, mindful living, mindful
scores, overall and by arm measured at 1-year follow-up. Average
walks, mindful pauses, mindful attitudes)?’, ‘Have you been
distress levels were lower at this time point than at any previous
practising mindfulness formally (meditation practice) since you
ones.13 To evaluate the long-term effect of mindfulness training,
finished your mindfulness course?’). Attendance at mindfulness
we have parameterised the growth model (online supplemental
courses was registered. Also, at each time point, SAU participants
figure 2) such that the slope estimate can be interpreted as the
were asked whether they had practised meditation elsewhere (eg,
difference in CORE-OM total mean scores between arm trajec-
‘About how many hours have you spent meditating in total since
tories at the 1-year follow-up adjusted for our a priori set of
May, when we last sent you a questionnaire?’) and the type of
baseline covariates. This slope takes the value of −0.22
meditation practised.
(SE=0.05, p<0.001) suggesting that the MSS course reduces
psychological distress for at least 1 year compared to SAU. This
reduction is slightly smaller than that during the examination
Statistical methods
period (−0.25 points).13
All analyses were conducted according to intention-to-treat at an
Figure 1 shows the estimated trajectory by arm including
alpha level of p=0.05 (two-sided). Logistic regression was
CORE-OM subscales. The trajectory of the MSS group CORE-
employed to assess baseline predictors of outcome completeness
OM total mean score is an inverted U-shaped curve: the differ-
using R version 3.4.4.19
ences with the SAU group are larger at mid-follow-up time
The expected average trajectory for each arm over time on
points. Subscales show very similar patterns to the total mean
psychological distress and well-being was estimated using latent
score.
growth curve modelling,20 21 controlling for cohort, gender and
Table 1 shows WEMWBS total scores overall and by arm
age (variables controlled for in the primary outcome analysis as
measured at 1-year follow-up. Average well-being levels were
pre-specified in the protocol).12 13 Multiple imputation was not
higher at this time point than at any previous ones.13 The latent
employed.
growth model, built in the same way as that for CORE-OM,
For comparing differences between arms in the proportion of
shows that the difference in total WEMWBS scores between
users of UCS and other support resources, we used χ2 tests.
SAU and MSS was 2.73 (SE=1.03, p=0.008). This suggests that
Differences in the number of UCS contacts per user, or number
the MSS course improves well-being for at least 1 year compared
of support resources, were compared using quasi-Poisson
to SAU, although the difference with SAU lies slightly below the
regression.
‘minimum detectable change’ for this instrument (defined as 3
We used a hierarchical multinomial logit model in MPlus to
points23). Figure 2 shows the modelled trajectory by arm.
compare differences between arms in terms of intensity of service
use provision.22 This accounts for the hierarchical nature of the
data structure, as any one student can use any particular service one Use of mental health support resources
or more times, and services belong to different levels of intensity. Table 2 shows UCS service usage overall and by arm. Overall,
We expressed results as ORs. We also used χ2, quasi-Poisson regres- 20% of all the study participants (122 of 616) used (ie, attended)
sion and ORs to compare altruism and workload by arm. at least one of the services offered by the UCS during the full
Galante J, et al. J Epidemiol Community Health 2021;75:151–160. doi:10.1136/jech-2021-214390 153
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Original research

Table 1 One-year follow-up psychological distress (CORE-OM and its subscales) and well-being (WEMWBS) outcomes
All MSS SAU
CORE-OM total mean score N 338 169 169
Mean 0.86 0.80 0.93
SD 0.52 0.49 0.55
Median 0.74 0.68 0.82
Min–Max 0–2.76 0–2.76 0–2.68
CORE-OM well-being subscale mean score N 338 169 169
Mean 1.04 0.98 1.10
SD 0.74 0.73 0.75
Median 1 0.75 1
Min–Max 0–3.50 0–3.50 0–3.50
CORE-OM symptoms subscale mean score N 337 168 169
Mean 1.13 1.06 1.20
SD 0.71 0.68 0.75
Median 1 0.92 1.08
Min–Max 0–3.58 0–3.33 0–3.58
CORE-OM functioning sub-scale mean score N 335 168 167
Mean 0.92 0.85 0.99
SD 0.57 0.55 0.59
Median 0.83 0.75 0.92
Min–Max 0–3.17 0–3.17 0–2.83
CORE-OM risk subscale mean score N 339 179 169
Mean 0.08 0.06 0.10
SD 0.21 0.17 0.25
Median 0 0 0
Min–Max 0–1.17 0–1.17 0–1.17
WEMWBS total score N 335 168 167
Mean 49.92 51.06 48.77
SD 9.31 9.58 8.92
Median 51 52 50
Min–Max 17–70 17–70 25–70
CORE-OM, Clinical Outcomes in Routine Evaluation Outcome Measure; MSS, Mindfulness Skills for Students; Min–Max, minimum and maximum values; SAU, support as usual; WEMWBS,
Warwick-Edinburgh Mental Wellbeing Scale.

follow-up year, 5% during the examination period. Many UCS question). Those who chose the category ‘other resources’ had
users had more than one contact with the UCS (median of three the chance to explain further. Of the 16 people who chose this
contacts among those who used the UCS). Sixteen participants category, 13 (MSS=9, SAU=4) mentioned friends, family or
booked UCS services but did not attend. No significant differ- loved ones. There are no significant differences between the
ences between arms were detected in the proportion of UCS users arms in whether participants used any resources or not
(χ2=0.56, df=1, p=0.46) or in the number of contacts per user (χ2=0.36, df=1, p=0.55), the number of resources used (quasi-
(quasi-Poisson regression coefficient= −0.17, p=0.46). Poisson regression coefficient=0.03, p=0.87) or in the usage by
Restricting observations to the main examination period yielded type of resource (all p values >0.3).
similar results (data not reported).
Regarding differences in the type of support provided by arm
(online supplemental table 3), MSS participants had 13% the odds Other outcomes comparing arms
of SAU participants of using high-intensity UCS support compared Table 2 shows the number of participants donating the vouchers
with low-intensity support (OR 0.13, 95% CI 0.02 to 0.72, offered to recompense them for completion of the 1-year follow-
p=0.02), and 22% the odds compared with mid-intensity support up questionnaires, and the cumulative count of donations
(OR 0.22, 95% CI 0.05 to 1.00, p=0.05). There were no statisti- throughout the follow-up period. Significantly more MSS parti-
cally significant differences between the use of low- and middle- cipants donated at the 1-year follow-up time point, compared to
intensity support (OR 1.71, 95% CI 0.70 to 4.20, p=0.24). SAU participants (OR=1.91, 95% CI 1.21 to 3.04, χ2=7.88,
Table 2 shows the self-reported use of mental health resources df=1, p=0.005). Over the course of the year, 101 participants
overall and by arm. Overall, 51% of the students who completed donated once, 106 donated twice and 122 donated thrice. MSS
this question reported using at least one of these resources, with participants donated more times than SAU participants (quasi-
many students using more than one resource (median of two Poisson regression coefficient=0.37, p<0.0001).
resources among those who used them). In both arms, the most Table 2 shows participants’ degree of agreement with the state-
frequently used resource was seeing their college supervisor, ment that their course workload during the past year had been
director of studies or tutor (27% of those who responded to the manageable. There were no significant differences between trial

154 Galante J, et al. J Epidemiol Community Health 2021;75:151–160. doi:10.1136/jech-2020-214390

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Original research

Figure 1 Multiple group growth model trajectories for psychological distress outcome (CORE-OM total mean and its subscales: well-being, symptoms,
functioning and risk). CORE-OM, Clinical Outcomes in Routine Evaluation Outcome Measure; MSS, Mindfulness Skills for Students; SAU, support as
usual.

Figure 2 Multiple group growth model trajectories for well-being outcome (WEMWBS). WEMWBS, Warwick-Edinburgh Mental Wellbeing Scale; MSS,
Mindfulness Skills for Students; SAU, support as usual.

arms in whether participants viewed their academic workload as events in the period between the examination period time point
manageable (χ2 =4.65, df=4, p=0.33). and the 1-year follow-up time point were generated by the mon-
Table 2 presents the number of adverse events counted at the itoring of the CORE-OM risk subscales,12 and none of them was
1-year follow-up, and the cumulative count of adverse events considered by the IDMEC as an adverse effect deriving from
throughout the follow-up period. There were fewer adverse mindfulness practice. Overall, four people experienced more
events in the MSS arm than in the SAU arm. All of the adverse than one adverse event in the year, and they were all SAU.

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Original research

Table 2 One-year follow-up and cumulative results for various outcome measures
All MSS SAU
Use of UCS services Participants who used the UCS during the full follow-up period 122 20% 57 18% 65 21%
(nMSS=309, nSAU=307) Total number of contacts 517 238 279
Number of contacts per user among users (median range) 3 19 3 17 3 19
Participants who used the UCS during the exam period 32 5% 13 4% 19 6%
Severity of UCS contacts Total number of low severity contacts 49 9% 29 12% 20 7%
(nMSS=309, nSAU=307) Total number of medium severity contacts 449 87% 206 87% 243 87%
Total number of high severity contacts 19 4% 3 1% 16 6%
Mental health resources used (self-report) None 162 49% 78 47% 84 51%
(nMSS=166, nSAU=165) Supervisor/director of studies/tutor 91 27% 44 27% 47 28%
UCS counsellor/mental health advisor 66 20% 31 19% 35 21%
College nurse/counsellor 60 18% 34 20% 26 16%
GP 57 17% 26 16% 31 19%
External professional counsellor/psychotherapist/psychologist 40 12% 22 13% 18 11%
Psychiatrist 19 6% 10 6% 9 5%
Other 16 5% 12 7% 4 2%
Chaplain 15 5% 8 5% 7 4%
Complementary medicine 14 4% 5 3% 9 5%
Helpline, nightline, Samaritans 7 2% 4 2% 3 2%
Emergency services 3 1% 1 1% 2 1%
Used any resource 169 51% 88 53% 81 49%
Number of resources per user among users (median range) 2 8 2 8 2 7
Workload perceived as manageable Definitely agree 51 15% 30 18% 21 13%
(nMSS=165, nSAU=166) Mostly agree 136 41% 66 40% 70 42%
Neither agree nor disagree 51 15% 20 12% 31 19%
Mostly disagree 68 21% 37 22% 31 19%
Definitely disagree 25 8% 12 7% 13 8%
Adverse events Participants with adverse events between exam period and 1-year 11 2% 4 1% 7 2%
follow-up time points
(nMSS=179, nSAU=169) One-year cumulative count of adverse events 60 28 32
Altruism Participants donating at 1-year follow-up 191 57% 109 65% 82 49%
(nMSS=168, nSAU=167) One-year cumulative count of donations 679 403 276
Showing n(%) unless otherwise stated.
GP, general practitioner; MSS, Mindfulness Skills for Students; SAU, support as usual; UCS, University Counselling Service.

Mindfulness practice effects sizes (post-intervention estimate=−0.08, examination period

Figure 3 shows the frequency of formal mindfulness meditation estimate=−0.09, 1-year follow-up estimate=−0.09, all
and informal mindfulness exercises respectively at each time p values <0.001, model in online supplemental figure 4).
point for the MSS participants who answered these questions. Having practised formal or informal mindfulness exercises
Most participants (33%) meditated at home between 1 and 3 improved well-being at all time points (formal practice: post-
hours/week during the MSS course, but meditation dropped intervention estimate=0.17, p<0.001; examination period esti-
sharply later with 38% not having meditated at all between mate=0.12, p=0.001; 1-year follow-up estimate=0.09,
course completion and the examination period, and 46% not p=0.004. Informal practice: post-intervention estimate=1.80,
having done so after the examination period. However, doing p<0.001; examination period estimate=1.82, p<0.001, 1-year
informal mindfulness exercises was more stable, with most parti- follow-up estimate=1.26, p=0.01).
cipants reporting doing them ‘sometimes’ (35%, 33% and 33% at
post intervention, exam period and 1-year follow-up, respec- DISCUSSION
tively). After 1 year, at least 33 (11%) SAU participants had After 1 year, average distress and well-being levels improved in
practised more than 10 hours of any type of meditation (all of both trial arms. Multiple factors could account for this: regres-
them either mindfulness or vipassana24) or done an 8-week mind- sion to the mean, increasing familiarity with the university envir-
fulness course. onment, recent return from summer holidays or even graduation.
Having practised formal mindfulness meditation significantly Our evidence supports an average beneficial effect of the MSS
reduced psychological distress at all time points at post- course on students’ psychological distress and mental well-being
intervention (post-intervention estimate=−0.01, p<0.001; that lasts at least a year. The effect seems to be larger at stressful
examination period estimate=−0.005, p=0.03; 1-year follow- times: the CORE-OM difference between the MSS and the SAU
up estimate=−0.005, p=0.003; model in online supplemental participants corresponded to a moderate effect size during the
figure 3). Having practised informal mindfulness exercises sig- examination period according to Cohen’s rules of thumb,13 25
nificantly reduced distress at all time points and with larger effect while after a year this difference was slightly smaller (−0.25 vs

156 Galante J, et al. J Epidemiol Community Health 2021;75:151–160. doi:10.1136/jech-2020-214390

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Original research

Figure 3 Frequency of formal (A) and informal (B) mindfulness practice at home at each time point.

−0.22 CORE-OM points). This pattern is consistent with the swifter. In any case, we only provide evidence on a voluntary
hypothesis that mindfulness training increases resilience to stress. student course. Appropriateness, acceptability and effectiveness
It also may explain why mindfulness-based programmes are of incorporating mindfulness training into students’ compulsory
being used in clinical settings, or as indicative preventative inter- curricula are still unclear.27 28 Mindfulness courses may not be
ventions for those with subclinical symptoms. Still, universal suitable or engaging for some groups of people. We favour the
interventions not explicitly addressing mental health may appeal implementation of the MSS to be offered along with other pre-
to those who would otherwise not seek help, as they are less ventative interventions as part of a wider student well-being
stigmatising.13 Small-to-moderate effect sizes are typical of this strategy.
type of interventions,26 which aim to impact by producing small The MSS course may not impact the subjective experience of
changes in broad sections of the population. The MSS group managing academic workload29 or the frequency of use of mental
format makes such large-scale implementation easier and impact health support services. However, it may impact the type of

Galante J, et al. J Epidemiol Community Health 2021;75:151–160. doi:10.1136/jech-2021-214390 157

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Original research
mental health support needed in a desirable direction: SAU par- not inform the quality of the practice (i.e., what/how participants
ticipants needed more intensive types of UCS support that indi- practise). Quality could be a critical factor in determining prac-
cated more severe circumstances, while MSS participants needed tice effects,33 particularly given the generally low level of support
types of UCS support that indicated milder severity. MSS parti- offered to participants once mindfulness courses have concluded.
cipants may have experienced less severe problems, and/or they Recent systematic reviews indicate an effect of mindfulness
were more pro-active at asking help. This finding was not evident training on prosocial behaviours, although this may only be true
in the self-reported use of mental health resources—although the in studies where the meditation teacher was a co-author and the
latter was only available from approximately half of participants control group was passive.18 40 When a meditation course aiming
and questions lacked sensitivity in determining support intensity. to cultivate empathy was compared with an active control
Economic implications of these results for the UCS are being (stretching), the intervention failed to show clear evidence of
explored in an economic evaluation currently being conducted. increased altruism despite increased prosocial reflection.41
Participants randomised to the MSS arm have consistently These support the idea that SAU participants in our trial donated
donated more than those allocated to SAU. This may partly be less because of not receiving an intervention.
a specific effect of mindfulness training, but it is possible that Our active monitoring system has found no evidence of
MSS participants felt more predisposed to donate than SAU adverse effects related to self-harm, harm to others or suicidality
participants because they were offered the MSS course, while among MSS participants. However, there are suggestions that
those in the SAU arm were offered nothing. Therefore, the subtler adverse effects may go underreported unless asked
extra donations may have worked more as a ‘payment for about specifically42—further research is needed.
a service’, so more related to a sense of justice than altruism.
Despite MSS course teacher’s advice, very few students con-
Strengths and limitations
tinued practising formal mindfulness meditation after the course,
This RCT is the largest, to our knowledge, assessing mindfulness
although they reported continuing practising mindfulness infor-
training for university students. Its careful design and analysis were
mally in their everyday life. Formal practice requires dedicated
prespecified in a publicly registered protocol, which minimises
time, while informal practice (eg, washing dishes mindfully) does
reporting biases. However, it lacked an active control intervention
not; this may explain our results. Our dose–response analyses
beyond the standard support on offer to students. Therefore, it is
suggest that mindfulness practice matters: the more participants
not possible from our data to find out to what extent results are
practised, formally or informally, the more benefit they got. This
influenced by participants’ expectations, peer and teacher support,
makes informal practice especially relevant: adherence is good
and other factors unspecific to mindfulness training. However,
and it still has desirable effects.
there are reasons to think that at least part of the effect seen in
this trial is specific to mindfulness.11 Outcomes were self-reported
Comparison with existing evidence
and participants were not blind to trial arm, meaning that
Our study confirms previous evidence, derived from smaller and/
responses may have been indeed influenced by their expectations.
or lower-quality trials conducted in different settings and coun-
Loss to follow-up was considerable, and despite our efforts to
tries, that mindfulness courses reduce distress among university
collect data, reasons for loss to follow-up are unknown to us.
students.10 Very few studies have looked at longer-term effects
Requesting personal, as well as institutional, email addresses at
among students. One trial followed 288 students up for 6 years
the start of the study might have helped to mitigate this.
and found increased well-being compared with a no-intervention
UCS data had no loss to follow-up and were collected from the
control although only a third of the sample were responsive by
UCS directly rather than self-reported, making these results
then.30
highly reliable. However, this was planned as a secondary out-
Similarly to our findings, Bondolfi et al found that following
come, and the service intensity subgroup analyses are subject to
course completion, frequency of informal mindfulness practice
multiple testing bias.
remained unchanged over 14 months, whereas the use of formal
In contrast to most studies, we measured formal and informal
meditation decreased over time.31 A recent systematic review
practice. Our analyses of the impact of practice on mental health
found that participants do on average 64% of the formal practice
discard reverse-causality and take into account contamination in
amount requested during the course, with high variability.32 We
the control group. However, they did not compare randomly
are unable to calculate such a figure with our data regarding
allocated groups, so they may be subject to residual confounding
adherence to formal practice during the course, but our results
(eg, those with more time to spare may meditate more and also
are roughly aligned with it.
feel less distressed). In addition, we treated nominal variables as
We have found beneficial effects to be correlated with mindful-
continuous which may contribute bias.
ness practice. Agreeing with our findings, a recent systematic review
found a small but significant association between formal mindful-
ness practice during the course and post-intervention outcomes.32
Analyses of associations between formal practice after the course What is already known on this subject
and follow-up outcomes are scarce and inconsistent.33–35
► A recent systematic review of trials suggests that, measured
Very few studies have assessed the frequency and effects of
shortly after their completion, mindfulness‐based programmes
informal mindfulness practice,33 in part because of the difficulties
improve university students’ distress and well-being in
in measuring it.36 A recent dose–response analysis found that
comparison with passive controls.10 More research is needed to
informal practice was associated with improved positive emo-
assess longer-term effects and mental health service use. Poor
tions with no association with negative emotions.37 Other studies
trial methodology undermines confidence in review results,
have not found associations.38 39 Our finding that those who
highlighting the need for higher-quality trials. How long the
practice more get more benefit only apply to contexts where
effects of a universal intervention to increase resilience to stress
beginner mindfulness practitioners practise in their everyday
last, and whether support services are affected, are key questions
lives, and do not inform about dose–response effects in intensive
for policymakers to plan ahead.
practice contexts such as meditation retreats. Similarly, they do

158 Galante J, et al. J Epidemiol Community Health 2021;75:151–160. doi:10.1136/jech-2020-214390

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Original research
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160 Galante J, et al. J Epidemiol Community Health 2021;75:151–160. doi:10.1136/jech-2020-214390