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Mindfulness-based cognitive therapy v. treatment as usual in adults with

ADHD: a multicentre, single-blind, randomised controlled trial

Article in Psychological Medicine · February 2018

DOI: 10.1017/S0033291718000429

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 Psychological Medicine Mindfulness-based cognitive therapy v.
[Link]/psm
treatment as usual in adults with ADHD:
a multicentre, single-blind, randomised
controlled trial
Original Article
Cite this article: Janssen L, Kan CC, Lotte Janssen1, Cornelis C. Kan1, Pieter J. Carpentier2, Bram Sizoo3,
Carpentier PJ, Sizoo B, Hepark S, Schellekens Sevket Hepark1, Melanie P.J. Schellekens1, A. Rogier T. Donders4,
MPJ, Donders ART, Buitelaar JK, Speckens
AEM. Mindfulness-based cognitive therapy v. Jan K. Buitelaar5,6 and Anne E.M. Speckens1
treatment as usual in adults with ADHD: a
multicentre, single-blind, randomised 1
Department of Psychiatry, Radboud University Medical Centre, Nijmegen, The Netherlands; 2Reinier van Arkel,
controlled trial. Psychological Medicine https://
‘s-Hertogenbosch, The Netherlands; 3Dimence, Deventer, The Netherlands; 4Department for Health Evidence,
[Link]/10.1017/S0033291718000429
Radboud University Medical Centre, Nijmegen, The Netherlands; 5Department of Cognitive Neuroscience, Donders
Received: 23 May 2017 Institute for Brain, Cognition, and Behaviour, Radboud University Medical Centre, Nijmegen, The Netherlands and
6
Revised: 29 January 2018 Karakter Child and Adolescent Psychiatry, Nijmegen, The Netherlands
Accepted: 1 February 2018

Key words:
Abstract
ADHD symptoms; adult ADHD; mental health; Background. There is a high need for evidence-based psychosocial treatments for adult atten-
mindfulness; mindfulness-based cognitive tion-deficit hyperactivity disorder (ADHD) to offer alongside treatment as usual (TAU).
therapy; psychosocial treatment; randomised
controlled trial
Mindfulness-based cognitive therapy (MBCT) is a promising psychosocial treatment. This
trial investigated the efficacy of MBCT + TAU v. TAU in reducing core symptoms in adults
Author for correspondence: with ADHD.
Lotte Janssen, Methods. A multicentre, single-blind, randomised controlled trial ([Link]:
E-mail: [Link]@[Link]
NCT02463396). Participants were randomly assigned to MBCT + TAU (n = 60), an 8-weekly
group therapy including meditation exercises, psychoeducation and group discussions, or
TAU only (n = 60), which reflected usual treatment in the Netherlands and included pharma-
cotherapy and/or psychoeducation. Primary outcome was ADHD symptoms rated by blinded
clinicians. Secondary outcomes included self-reported ADHD symptoms, executive function-
ing, mindfulness skills, self-compassion, positive mental health and general functioning.
Outcomes were assessed at baseline, post-treatment, 3- and 6-month follow-up. Post-treat-
ment effects at group and individual level, and follow-up effects were examined.
Results. In MBCT + TAU patients, a significant reduction of clinician-rated ADHD symptoms
was found at post-treatment [M difference = −3.44 (−5.75, −1.11), p = 0.004, d = 0.41]. This
effect was maintained until 6-month follow-up. More MBCT + TAU (27%) than TAU partici-
pants (4%) showed a ⩽30% reduction of ADHD symptoms ( p = 0.001). MBCT + TAU patients
compared with TAU patients also reported significant improvements in ADHD symptoms,
mindfulness skills, self-compassion and positive mental health at post-treatment, which were
maintained until 6-month follow-up. Although patients in MBCT + TAU compared with
TAU reported no improvement in executive functioning at post-treatment, they did report
improvement at 6-month follow-up.
Conclusions. MBCT might be a valuable treatment option alongside TAU for adult ADHD
aimed at alleviating symptoms.

Attention-deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder that can

persist into adulthood and has an estimated prevalence of 2.5% at adult age (Simon et al.
2009). In several European countries and the United States, pharmacotherapy with stimulant
medication is suggested as first-line treatment for adult ADHD (NICE, 2009; Kooij et al. 2010;
UMHS, 2013). In the Netherlands, stimulant medication is often combined with psychoedu-
cation and skills training after or parallel to pharmacotherapy (NVvP, 2015). Despite the
demonstrated efficacy of stimulants in the short term (Faraone & Glatt, 2010; Moriyama
et al. 2013), there is a call for evidence-based psychosocial treatments to offer in addition
or as an alternative to pharmacotherapy (Matheson et al. 2013). Several patients experience
adverse effects that can result in discontinuation (Gajria et al. 2014), some patients are reluc-
tant to take medication (Matheson et al. 2013), or respond insufficiently to stimulants and
experience residual symptoms (Wigal, 2009) and long-term beneficial effects have not been
© Cambridge University Press 2018 convincingly established (Moriyama et al. 2013). Consequently, the NICE guidelines (NICE,
2009) and the European consensus statement (Kooij et al. 2010) emphasise that pharmaco-
therapy should be part of a multimodal treatment approach.
A growing amount of evidence is showing that psychosocial treatments, like cognitive–behav-
ioural therapy (CBT), can have an additional effect to pharmacotherapy in alleviating residual

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 2 Lotte Janssen et al.

symptoms in adults with ADHD (Young et al. 2016), although a diagnosis assessed with the semi-structured Diagnostic Interview
recent study did not find a difference between a group psychother- for ADHD in adults (DIVA) (Kooij, 2010). This interview was
apy programme, including cognitive–behavioural elements and only conducted in those patients that had not received an
clinical management (Philipsen et al. 2015). Upcoming psycho- ADHD diagnosis based on the DIVA before. For the other patients,
social treatments for ADHD are mindfulness-based interventions the previously determined diagnosis was maintained. Exclusion
(MBIs). Mindfulness is defined as intentionally paying attention criteria were: (a) not capable of filling out questionnaires in
to present moment experiences in a non-judgemental way Dutch; (b) current depressive disorder with psychotic symptoms
(Kabat-Zinn, 1990). Neuroscientific studies showed that in healthy or suicidality; (c) current manic episode; (d) borderline or anti-
subjects, MBIs can result in improved attention regulation, social personality disorder assessed with the Clinical Interview
enhanced brain activity and altered attention-related brain areas for DSM-IV Axis II Disorders (SCID-II) (First & Gibbon, 2004);
such as greater cortical thickness and enhanced white-matter integ- (e) substance dependence; (f) autism spectrum disorder; (g) tic
rity in the anterior cingulated cortex (Fox et al. 2014; Tang et al. disorder with vocal tics; (h) learning difficulties or other cognitive
2015). Bachmann et al. (2016) suggested that mindfulness medita- impairments; and (i) former participation in MBCT or other MBI
tion can strengthen functioning in brain regions that underlie or workshop (>2 h). Criteria b, c and e were assessed with a psychi-
neuropsychological deficits in ADHD, positioning MBI as a prom- atric structured diagnostic interview (MINI-Plus) (Van Vliet & De
ising treatment for ADHD. Currently, the evidence for MBIs for Beurs, 2007).
ADHD is growing and a first meta-analysis including three studies
in adults demonstrated preliminary evidence for the efficacy of
Procedure
MBIs in reducing core symptoms, especially inattentiveness, with
moderate-to-large effect sizes (Cairncross & Miller, 2016). Participants were recruited between September 2014 and
However, these findings should be interpreted with caution, December 2015 by referral via three specialised outpatient clinics
as the included studies either lacked randomisation (Edel et al. for adults with ADHD: the Department of Psychiatry of the
2017), were underpowered (Schoenberg et al. 2014; Mitchell Radboud university medical centre in Nijmegen, Reinier van
et al. 2017), used different MBIs (Schoenberg et al. 2014; Edel Arkel Group in ‘s-Hertogenbosch, Dimence in Deventer and by
et al. 2017; Mitchell et al. 2017) and/or lacked a follow-up period self-selection through media advertisements (website, social
(Schoenberg et al. 2014; Edel et al. 2017; Mitchell et al. 2017). media) and presentations at regional thematic meetings of the
Mindfulness-based cognitive therapy (MBCT) combines mindful- Dutch association of adults with ADHD ‘Impuls & Woortblind’.
ness practice with elements of CBT (Segal et al. 2012). We previ- Currently and previously treated patients were informed about
ously reported moderate-to-large efficacy of a 12-weekly adapted the study by their attending clinician in various stages of their
version of MBCT in reducing ADHD symptoms and improving treatment process. Eligibility was assessed in a research interview
executive functioning in comparison to a waitlist control group conducted by the researcher or a research assistant. Each partici-
(Hepark et al. 2015). These results were in line with a recent rando- pant provided written informed consent after receiving detailed
mised controlled trial (RCT) in college students with ADHD that information about the trial.
found a reduction of ADHD symptoms after an adapted 6 weeks
version of MBCT. However, both studies had methodological lim- Randomisation and blinding
itations, such as a small sample size (Gu et al. 2018), the lack of a Random assignment to MBCT or TAU was performed by a web-
follow-up period, no outcome data for drop-outs and single-centre site specifically developed for this study by an independent statis-
enrolment (Hepark et al. 2015). Therefore, the current RCT took tician. Randomisation was stratified by centre, after which block
account of these limitations. The main aim of our RCT was to exam- randomisation with varying predefined block sizes was used com-
ine the efficacy of MBCT added to treatment as usual (TAU) com- bined with minimisation for use of medication for ADHD (yes/
pared with TAU alone in reducing core symptoms as rated by a no); previous participation in a psychoeducation training (yes/
clinician in adults with ADHD. Secondary outcomes included self- no); gender and ADHD subtype (combined/inattentive/hyper-
reported ADHD symptoms, executive functioning, mindfulness active–impulsive/not otherwise specified). The researcher was
skills, self-compassion, positive mental health and general blind for the block sizes and filled-out the online form.
functioning. Blinded assessments by a psychiatrist or specialist nurse took
place at baseline (T0), post-treatment (T1), 3 (T2) and 6 (T3)
months follow-up. Randomisation took place after enrolment,
Method but participants were not informed about the assigned condition
Trial design until after completion of T0. To ensure the blinding of the inter-
viewers, participants were instructed not to share information
A multicentre, single-blind, parallel-group, randomised controlled about allocation with the interviewer.
superiority trial was conducted comparing MBCT + TAU with
TAU alone (allocation ratio 1 : 1). The study protocol has been pub-
lished previously (Janssen et al. 2015) and has been approved by the Intervention
local medical ethics committee CMO Arnhem-Nijmegen for all Mindfulness-based cognitive therapy
participating centres (2014/206). The methodology is described The programme was primarily based on MBCT (Segal et al.
briefly below, for more detail see our protocol (Janssen et al. 2015). 2012), consisting of 8-weekly sessions of 2.5 h and a 6 h silent
day between the sixth and seventh sessions. The programme
included meditation exercises (bodyscan, sitting meditation,
Participants
mindful movement) combined with psychoeducation, CBT tech-
Patients were eligible when they were 18 years or older and met niques and group discussions. In addition to the group sessions,
DSM-IV (APA, 2000) criteria for ADHD as their primary participants were instructed to practice 6 days a week at home

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 Psychological Medicine 3

for approximately 30 min a day with guided exercises. Some mod- Rating Inventory of Executive Function-Adult Version
ifications were made based on our pilot study (Janssen et al. 2017) (BRIEF-A) (Roth & Gioia, 2005); the Five Facet Mindfulness
and the Mindful Awareness Practices for ADHD programme Questionnaire-Short Form (FFMQ-SF) (Bohlmeijer et al. 2011);
(MAPs) (Zylowska et al. 2008; Mitchell et al. 2015) to make the the Self-Compassion Scale-Short Form (SCS-SF) (Raes et al.
intervention more suitable for adults with ADHD, like the more 2011); the Mental Health Continuum-Short Form (MHC-SF)
gradual increase of the duration of meditation exercises, replace- (Lamers et al. 2011) assessing positive mental health; and the
ment of psychoeducation about depression by psychoeducation Outcome Questionnaire (OQ 45.2) (Lambert et al. 1996) measur-
about ADHD, more emphasis on mindfulness awareness in ing general functioning. Further details about these outcome mea-
daily life and inclusion of one session on mindful listening and sures can be found in our study protocol (Janssen et al. 2015).
speaking. See our study protocol for more details (Janssen et al.
2015). MBCT was taught in 10 groups with approximately nine
Statistical analyses
individuals per group (consisting of both study and non-study
participants with ADHD to strive for a group size of 8–12 All analyses were performed at a significance threshold of 5%
patients) by four mindfulness teachers, who all met the advanced (two-tailed) and two-sided 95% CIs were used.
criteria of the internationally agreed good practice guidelines
of the UK Network for Mindfulness-Based Teachers ([Link] Sample size calculation
[Link]/pdf/[Link]). Once The power calculation was based on an estimated minimum clin-
every 3 weeks, the teachers participated in peer supervision. ically relevant difference of four points (S.D. = 7.5) on the DSM-IV
Teacher competence and adherence to the protocol were assessed symptom score of the CAARS-INV, based on our previous RCT
by the Mindfulness-Based Interventions-Teaching Assessment (Hepark et al. 2015). Using an α of 0.5, a power of 80% and an
Criteria (MBI: TAC) (Crane et al. 2012). Two videotaped sessions analysis of covariance (ANCOVA) controlling for baseline levels
per teacher were randomly selected to be rated independently by with an assumed correlation of 0.5 between T0 and T1, 45 parti-
two assessors with experience in teaching mindfulness. The asses- cipants per treatment group were required. Taking account of an
sors discussed possible differences in their evaluations to arrive at anticipated drop-out rate of 25%, a total number of 120 partici-
an agreed evaluation. The competence levels of the teachers were pants was necessary, 60 per treatment group.
advanced (taught nine participants), competent (taught 21 parti-
cipants), advanced beginner (taught 22 participants) and beginner Treatment effects at T1
(taught six participants). All analyses were performed on both the intention-to-treat (ITT)
sample, consisting of all participants who completed the question-
Treatment as usual naire at T0 and T1, and additionally the per protocol (PP) sample
TAU was designed to reflect the usual treatments of adults with (MBCT + TAU: participants who attended ⩾4 MBCT sessions;
ADHD in various mental health centres across the Netherlands. TAU: participants who did not attend an MBI). In the primary
All participants were open to start, continue and stop a treatment analyses, scores at T1 were compared between groups, using an
if desired and the research team did not influence participants’ ANCOVA while controlling for baseline levels, centre and mini-
decisions. We monitored TAU with additional online questions misation variables (use of ADHD medication, previous participa-
about pharmacological and psychosocial treatments during the tion in a psychoeducation training, gender and ADHD subtype).
last 3 months. Participants in the TAU group were offered Cohens’ d effect size was calculated by dividing the adjusted group
MBCT after completing the T3 assessments. difference at T1 by the pooled standard deviation at T0. The reli-
able change index (RCI; Jacobson & Truax, 1991) was calculated
for the primary outcome between T0 and T1, using Cronbach’s α
Outcome measures
for calculating the standard error of the difference, to determine
Primary outcome which participants changed reliably. The number of improved
The investigator-rated screening version of the Conners’ Adult (RCI <−1.96) and deteriorated (RCI >1.96) participants between
ADHD Rating Scale (CAARS-INV: SV) (Adler et al. 2007) was groups was tested with χ2 tests. Additionally, the number of par-
used by blinded clinicians (n = 12) to assess ADHD symptoms ticipants per group that showed a symptom reduction of ⩾30% on
at each time point. Ratings can be organised in a DSM-IV symp- the primary outcome was calculated to determine which partici-
tom score (which served as the primary outcome) and in the sub- pants showed a clinical significant change (Zylowska et al. 2008;
scales: inattention and hyperactivity/impulsivity. To reduce Hepark et al. 2015; Mitchell et al. 2017). The symptomatic remis-
inter-rater variance, two training workshops were provided by sion rate per group was calculated. Remission was defined by a
two expert raters, and as far as possible, the same assessor con- mean total score ⩽1 on the 18 DSM-IV symptom scores of the
ducted all interviews with a particular participant. A random CAARS-INV (Ramos-Quiroga & Casas, 2011). Sensitivity ana-
sample of audiotaped CAARS-INV interviews (n = 25) was lyses were performed by imputing missing data according to
rated by blinded raters (n = 5) from another centre. The intraclass Last Observation Carried Forward (LOCF) and Multiple
correlation coefficient was 0.73 [95% confidence interval (CI) Imputation (MI) techniques.
0.48–0.87].
Follow-up effects
Secondary outcomes The consolidation of treatment effects over the follow-up period
The following self-report questionnaires were administered online for primary and secondary outcomes was evaluated with multi-
as secondary outcomes at each time point: Conners’ Adult ADHD level modelling with time point as repeated measurement in the
Rating Scale-Self-Report: Screening Version (CAARS-S:SV) ITT and PP samples, controlling for baseline levels, centre and
(Adler et al. 2007) assessing the DSM-IV AHDH symptom minimisation variables (use of ADHD medication, previous par-
score, Inattention and Hyperactivity/Impulsivity; the Behaviour ticipation in a psychoeducation training, gender and ADHD

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 4 Lotte Janssen et al.

subtype). An unstructured covariance matrix was used. When no (Table 1). From T0 to T1, TAU did not differ between groups,
group × time interaction was found, the interaction term was apart from the fact that more participants in the MBCT + TAU
dropped from the analysis for the respecting outcome variable. group than in the TAU group kept their medication stable,
Cohens’ d effect size was calculated by dividing the adjusted χ2(1) = 5.83, p = 0.016 (online Supplementary Table S1). A minor-
group difference between the pooled means (T1, T2, T3) by the ity of participants received psychosocial treatment for ADHD.
pooled standard deviation at T0. Within the MBCT + TAU group, participants who dropped-
out of MBCT (n = 9; 15%) were less likely to use ADHD medica-
Moderation analysis tion at T0 than MBCT completers, χ2(1) = 6.30, p = 0.023. There
Moderation analyses, while controlling for baseline ADHD symp- were no differences in characteristics between those with missing
toms, were performed by adding potential predictors and its data at T1 on all outcomes (n = 7) and those included in at least
interaction with group to the models for testing treatment effects one of the ITT analyses at T1 (n = 113).
at T1 and follow-up effects. The following predictors were used:
gender, age, ADHD subtype, use of ADHD medication, comorbid Treatment effects at T1
depressive disorder and comorbid anxiety disorder.
Primary outcome
ITT analyses revealed that participants in the MBCT + TAU
Results group demonstrated significantly less clinician-rated ADHD
symptoms than those in the TAU group, with an effect size
Sample characteristics and TAU
of d = 0.41 (Table 2). Analysis based on the PP sample (p = 0.007,
Of the 120 participants who met the eligibility criteria, the major- d = 0.39) and sensitivity analyses based on LOCF (p = 0.005, d =
ity was referred by the participating specialised outpatient clinics 0.37) and MI (p = 0.046, d = 0.29) resulted in similar findings.
(n = 67; 56%). The remaining participants were referred by their Based on the RCI, the number of participants who had improved
general practitioner or another health care professional (n = 18; was higher in the MBCT + TAU group (n = 16; 31%) than in the
15%); or were self-referrals (n = 35; 29%). The participants were TAU group (n = 3; 5%), χ2(1) = 11.73, p = 0.001, see online
randomly assigned to MBCT + TAU (n = 60) or TAU (n = 60) Supplementary Fig. S1. There was no difference between the
(Fig. 1). At baseline, there were no significant differences in two groups in the number of participants deteriorating (MBCT +
demographic and clinical characteristics between both groups TAU: n = 6; 12%; TAU: n = 3; 5%), χ2(1) = 1.28, p = 0.311. More

Fig. 1. CONSORT flow diagram. Note. ITT, intention-to-treat; PP, per protocol.

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 Psychological Medicine 5

Table 1. Baseline sociodemographic and clinical characteristics

MBCT + TAU (n = 60) TAU (n = 60)

a
Demographic characteristics n (%) n (%) p

Female gender 32 (53) 32 (53) 1.000

b
Age; M (S.D) 39.7 (11.1) 39.0 (10.1) 0.699
Married/living togethera 31 (52) 36 (60) 0.473
a
Employment status 0.674
Employed 36 (60) 31 (52)
Unemployed 7 (12) 9 (15)
(Partially) disabled 7 (12) 11 (18)
Other (student/housewife-man/retired) 8 (13) 9 (15)
Educational levela,c 0.573
Low 8 (14) 5 (8)
Middle 25 (43) 30 (50)
High 25 (43) 25 (42)

Clinical characteristicsa n (%) n (%) p

Subtype of ADHD, DSM-IV 0.298

Inattentive type 23 (38) 29 (48)
Hyperactive/impulsive type 5 (8) 1 (2)
Combined type 30 (50) 27 (45)
Not otherwise specified typed 2 (3) 3 (5)
Comorbidity Axis I, DSM-IV
Current depression 9 (15) 9 (15) 1.000
Recurrent depression, in remission 14 (23) 19 (32) 0.307
Dysthymia 1 (2) 2 (3) 1.000
Bipolar disorder 1 (2) 1 (2) 1.000
Anxiety disorder 8 (13) 14 (23) 0.157
Somatoform disorder 4 (70) 6 (10) 0.509
Eating disorder 1 (2) 1 (2) 1.000
No comorbidity 28 (47) 22 (37) 0.267
Years since ADHD diagnosis; M (S.D.)b 1.8 (2.8) 2.8 (5.7) 0.235
Use of ADHD medication 36 (60) 29 (48) 0.200
Previous and current psychoeducation/skills training 36 (60) 35 (58) 0.853
Previous and current psychosocial treatment ADHD 35 (58) 31 (52) 0.463

Outcome measuresb,e M (S.D.) M (S.D.) p

ADHD symptoms (CAARS-INV) 30.8 (9.0) 32.8 (7.8) 0.196

ADHD symptoms (CAARS-S) 28.7 (7.0) 29.0 (6.0) 0.828
Executive functioning (BRIEF-A) 147.6 (18.3) 146.2 (18.8) 0.681
Mindfulness skills (FFMQ-SF) 72.0 (9.2) 74.0 (9.6) 0.255
Self-compassion (SCS-SF) 44.8 (12.7) 44.8 (12.7) 0.970
Positive mental health (MHC-SF) 3.7 (0.9) 3.6 (0.9) 0.511
General functioning (OQ 45.2) 61.4 (15.4) 63.7 (21.8) 0.510

BRIEF-A, Behaviour Rating Inventory of Executive Function-Adult; CAARS-INV, Conners’ Adult ADHD Rating Scale-Investigator; CAARS-S, Conners’ Adult ADHD-Self-report; FFMQ-SF, Five Facet
Mindfulness Questionnaire-Short Form; MHC-SF, Mental Health Continuum-Short Form; OQ 45.2, Outcome Questionnaire 45.2; SCS-SF, Self Compassion Scale-Short Form.
χ test.
a 2
b
Independent samples t test.
c
Educational level was classified as low (no education, elementary school, lower secondary education), middle (intermediate vocational education, upper secondary education) and high
(higher vocational education, university).
d
Reasons were: difficulty with recalling the presence of ADHD symptoms in childhood and no collateral history available (n = 1), ADHD symptoms in adulthood were aggravated by physical
injury (n = 1), not displaying sufficient symptoms in childhood and symptoms emerging after meningitis in adulthood (n = 1), not displaying sufficient symptoms in childhood and no collateral
history available (n = 2).
e
Two participants in the MBCT + TAU group did not complete the baseline questionnaires. Data are based on n = 58.

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 6 Lotte Janssen et al.

Table 2. Intention-to-treat analyses on primary and secondary outcomes at post-treatment

Analysis
MBCT + TAU (n = 52) TAU (n = 55) Group difference Effect size
a
M (S.D.) M (S.D.) M [95% CI] F df p d

Primary outcome
ADHD symptoms (CAARS-INV), n = 107
Baseline 31.0 (9.1) 32.6 (7.9)
Post-treatment 27.4 (10.2) 31.5 (8.6) −3.4 [−5.8 to −1.1] 8.6 96 0.004 0.41
Secondary outcomes
Inattention (CAARS-INV)
Baseline 17.3 (5.3) 18.0 (4.2)
Post-treatment 14.8 (5.6) 17.0 (4.4) −2.1 [−3.5 to −0.7] 8.6 96 0.004 0.45
Hyperactive/impulsive (CAARS-INV)
Baseline 13.8 (6.1) 14.6 (5.5)
Post-treatment 12.7 (6.6) 14.5 (5.6) −1.4 [−2.7 to −0.1] 4.4 96 0.039 0.24
ADHD symptoms (CAARS-S), n = 106
Baseline 28.8 (6.9) 29.3 (6.1)
Post-treatment 25.5 (6.8) 28.1 (6.3) −2.4 [−4.2 to −0.6] 7.1 95 0.009 0.37
Inattention (CAARS-S)
Baseline 15.6 (3.6) 15.5 (3.3)
Post-treatment 13.8 (3.9) 14.9 (3.8) −1.2 [−2.3 to −0.1] 4.4 95 0.038 0.33
Hyperactive/impulsive (CAARS-S)
Baseline 13.2 (5.0) 13.7 (4.6)
Post-treatment 11.6 (4.1) 13.2 (4.0) −1.3 [−2.3 to −0.3] 6.2 95 0.014 0.26
Executive functioning (BRIEF-A), n = 105
Baseline 146.2 (17.8) 147.2 (18.4)
Post-treatment 140.9 (22.5) 145.9 (19.3) −3.8 [−8.8 to 1.3] 2.2 94 0.140 0.20
Mindfulness skills (FFMQ-SF), n = 104
Baseline 72.6 (8.7) 74.1 (9.6)
Post-treatment 76.0 (10.9) 73.5 (9.8) 3.4 [0.1 to 6.7] 4.2 93 0.043 0.36
Self-compassion (SCS-SF) n = 104
Baseline 45.7 (12.8) 44.0 (12.7)
Post-treatment 50.2 (13.0) 43.5 (13.7) 5.3 [1.5 to 9.1] 7.8 93 0.006 0.42
Positive mental health (MHC-SF), n = 105
Baseline 3.7 (0.9) 3.6 (0.9)
Post-treatment 3.9 (0.9) 3.5 (0.9) 0.3 [0.04 to 0.5] 5.4 94 0.023 0.32
General functioning (OQ 45.2), n = 106
Baseline 61.7 (15.6) 63.4 (21.4)
Post-treatment 59.1 (18.2) 61.4 (21.0) −1.0 [−6.0 to 4.0] 0.2 95 0.693 0.05
BRIEF-A, Behaviour Rating Inventory of Executive Function-Adult; CAARS-INV, Conners’ Adult ADHD Rating Scale-Investigator; CAARS-S, Conners’ Adult ADHD-Self-report; FFMQ-SF, Five Facet
Mindfulness Questionnaire-Short Form; MHC-SF, Mental Health Continuum-Short Form; OQ 45.2, Outcome Questionnaire 45.2; SCS-SF, Self Compassion Scale-Short Form.
a
Differences between MBCT + TAU and TAU at T1 based on the adjusted means, controlling for baseline levels, centre, use of ADHD medication, previous psychoeducation, gender and ADHD
subtype.

participants in MBCT + TAU (n = 14; 27%) than in TAU (n = 2; Secondary outcomes

4%) showed a symptom reduction of ⩾30%, χ2(1) = 11.40, p = ITT analyses revealed that participants in the MBCT + TAU group
0.001. Symptomatic remission was achieved by more participants demonstrated a significant larger reduction of self-reported ADHD
in MBCT + TAU (n = 11; 21%) than in TAU (n = 4; 7%), χ2(1) = symptoms and improvements of mindfulness skills, self-compassion
4.27, p = 0.039. and positive mental health compared with those receiving TAU only,

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 Psychological Medicine 7

with effect sizes varying from d = 0.32 to 0.42 (Table 2). No effects became significant for executive functioning with improvement
were found on executive functioning and general functioning. The of executive functioning in MBCT + TAU compared with TAU.
PP analyses showed similar results, except for the effect on mindful- PP analyses resulted in a similar finding for the primary
ness skills (p = 0.051, d = 0.35). No effects were found for mindful- outcome, F(1, 94) = 11.9, p = 0.001, d = 0.40 and for the secondary
ness skills in the LOCF analyses and for mental health in the MI outcomes, except for the effect on executive functioning. A sig-
analyses. The MI analyses did, however, show a small effect on nificant group × time interaction, F(2, 95) = 3.5, p = 0.034, showed
total executive functioning (p = 0.040, d = 0.27). that executive functioning further improved over time in MBCT +
TAU compared with TAU resulting in an effect size of d = 0.49 at
6-month follow-up.
Follow-up effects
ITT analyses revealed that the significant difference between
Moderation of treatment outcome
MBCT + TAU and TAU in clinician-rated ADHD symptoms
remained stable over the course of the 6-month follow-up period Clinician-rated ADHD symptoms at T1 were not predicted by gen-
(Fig. 2 and Table 3). The same pattern was found for mindfulness der, F(1,102) = 0.1, p = 0.783; age, F(1,102) = 1.8, p = 0.189; ADHD
skills, self-compassion and positive mental health. A significant subtype, F(3,98) = 0.2, p = 0.878; use of ADHD medication,
group × time interaction was found for self-reported ADHD F(1,102) = 0.08, p = 0.782; comorbid depressive disorder,
symptoms, showing that self-reported ADHD symptoms further F(1,102) = 2.2, p = 0.145 and comorbid anxiety disorder, F(1,102)
decreased over time in MBCT + TAU compared with TAU result- = 0.2, p = 0.632. Similar results were found for clinician-rated
ing in an effect size of d = 0.79 at 6-month follow-up. Over the ADHD symptoms over the course of the 6-month follow-up period
course of the follow-up period, the difference between groups and in the PP sample.

Fig. 2. Unadjusted means for participants in MBCT + TAU and TAU at baseline, post-treatment, 3- and 6-month follow-up of ADHD Symptoms. Note. (a) clinician-
rated ADHD symptoms, (b) clinician-rated symptoms of inattention, (c) clinician-rated symptoms of hyperactivity/impulsivity, (d) self-reported ADHD symptoms, (e)
self-reported symptoms of inattention, (f) self-reported symptoms of hyperactivity/impulsivity.

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 8 Lotte Janssen et al.

Table 3. Follow-up results of primary and secondary outcomes in the intention-to-treat sample

Analysis
MBCT + TAU (n = 52) TAU (n = 56) Group difference Effect size
a
M (S.D) M (S.D) M [95% CI] F df p d

Primary outcome
ADHD symptoms (CAARS-INV) −3.6 [−5.6 to −1.7] 13.4 97 <0.001 0.43
Baseline 31.0 (9.1) 32.4 (7.9)
Post-treatment 27.4 (10.2) 31.5 (8.6)
3-month follow-up 25.2 (9.7) 28.9 (7.4)
6-month follow-up 25.4 (9.5) 29.2 (6.8)
Secondary outcome
Inattention (CAARS-INV) −1.7 [−2.8 to −0.5] 7.8 97 0.006 0.35
Baseline 17.3 (5.3) 17.8 (4.2)
Post-treatment 14.8 (5.6) 17.0 (4.4)
3-month follow-up 13.8 (5.4) 15.3 (3.8)
6-month follow-up 14.4 (5.2) 15.8 (3.5)
Hyperactive/impulsive (CAARS-INV) −1.9 [−3.0 to −0.9] 12.7 97 0.001 0.34
Baseline 13.8 (6.1) 14.6 (5.6)
Post-treatment 12.7 (6.6) 14.5 (5.6)
3-month follow-up 11.3 (5.8) 13.5 (5.1)
6-month follow-up 11.1 (5.6) 13.4 (4.9)
b
ADHD symptoms (CAARS-S) , n = 107 6.3 98 0.003
Baseline 28.8 (6.9) 29.3 (6.1)
Post-treatment 25.5 (6.8) 28.1 (6.3) −2.4 [−4.2 to −0.6] 2.7 97 0.008 0.37
3-month follow-up 23.4 (8.0) 28.2 (6.1) −4.6 [−6.8 to −2.5] 4.3 99 <0.001 0.71
6-month follow-up 23.7 (8.0) 28.4 (5.8) −5.2 [−7.3 to −3.0] 4.7 98 <0.001 0.79
b
Inattention (CAARS-S) 3.5 99 0.035
Baseline 15.6 (3.6) 15.6 (3.3)
Post-treatment 13.8 (3.9) 14.9 (3.8) −1.2 [−2.3 to −0.1] 2.2 96 0.033 0.34
3-month follow-up 13.0 (4.6) 15.2 (3.9) −2.3 [−3.6 to −0.9] 3.3 98 0.001 0.65
6-month follow-up 12.9 (4.4) 15.1 (3.6) −2.5 [−3.8 to −1.1] 3.6 95 <0.001 0.70
a
M (S.D.) M (S.D.) M [95% CI] F df p d

b
Hyperactive/impulsive (CAARS-S) 4.7 98 0.012
Baseline 13.2 (5.0) 13.7 (4.5)
Post-treatment 11.6 (4.6) 13.2 (4.0) −1.2 [−2.2 to −0.3] 2.5 97 0.015 0.26
3-month follow-up 10.3 (4.6) 13.0 (3.9) −2.4 [−3.6 to −1.3] 4.1 96 <0.001 0.50
6-month follow-up 10.8 (4.9) 13.3 (3.8) −2.7 [−3.8 to −1.6] 4.8 99 <0.001 0.56
Executive functioning (BRIEF-A) n = 106 −5.3 [−10.1 to −0.5] 4.8 96 0.032 0.29
Baseline 146.2 (17.8) 147.6 (18.5)
Post-treatment 141.0 (22.3) 145.9 (19.3)
3-month follow-up 136.6 (25.7) 147.3 (17.6)
6-month follow-up 137.4 (23.7) 146.7 (18.3)
Mindfulness skills (FFMQ-SF), n = 105 4.0 [1.1 to 7.0] 7.7 93 0.007 0.43
Baseline 72.6 (8.7) 74.3 (9.6)
Post-treatment 76.1 (10.7) 73.5 (9.8)
(Continued )

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 Psychological Medicine 9

Table 3. (Continued.)

M (S.D.) M (S.D.) M [95% CI]a F df p d

3-month follow-up 78.0 (10.3) 72.5 (9.2)

6-month follow-up 76.7 (11.0) 74.9 (9.0)
Self-compassion (SCS-SF), n = 105 5.9 [2.8 to 9.1] 13.7 94 <0.001 0.47
Baseline 45.7 (12.8) 43.9 (12.6)
Post-treatment 50.4 (12.9) 43.5 (13.7)
3-month follow-up 52.0 (13.3) 43.4 (12.1)
6-month follow-up 53.8 (13.8) 47.0 (14.4)
Positive mental health (MHC-SF), n = 106 0.2 [0.02 to 0.4] 4.6 94 0.034 0.23
Baseline 3.7 (0.9) 3.6 (0.9)
Post-treatment 3.9 (0.9) 3.5 (0.9)
3-month follow-up 3.9 (1.1) 3.8 (0.9)
6-month follow-up 3.9 (0.9) 3.7 (0.9)
General functioning (OQ 45.2), n = 107 −2.4 [−6.7 to 2.0] 1.2 93 0.284 0.12
Baseline 61.7 (15.6) 64.1 (21.7)
Post-treatment 59.1 (18.2) 61.4 (21.0)
3-month follow-up 54.7 (20.6) 60.7 (20.8)
6-month follow-up 54.7 (19.1) 61.5 (21.0)
BRIEF-A, Behaviour Rating Inventory of Executive Function-Adult; CAARS-INV, Conners’ Adult ADHD Rating Scale-Investigator; CAARS-S, Conners’ Adult ADHD-Self-report; FFMQ-SF, Five Facet
Mindfulness Questionnaire-Short Form; MHC-SF, Mental Health Continuum-Short Form; OQ 45.2, Outcome Questionnaire 45.2; SCS-SF, Self Compassion Scale-Short Form.
a
Differences between the pooled scores in MBCT + TAU and TAU based on the adjusted means, controlling for baseline levels, centre, use of ADHD medication, previous psychoeducation,
gender and ADHD subtype.
b
A group × time interaction was found. Therefore, we reported the F-statistic for the interaction effect and the group differences per time point with the corresponding test-statistics (t, df, p)
instead of the main effect of group.

Discussion instead of the 12-week programme (Hepark et al. 2015). The

found effect at follow-up in participants who completed the
Principal findings
MBCT might suggest that it takes more time and practice before
This first well-powered, multicentre, single-blind RCT with MBCT results in improvements of executive functioning; how-
follow-up assessments on MBCT for adult ADHD showed that ever, this hypothesis needs further investigation, for example, by
MBCT + TAU is effective in reducing core ADHD symptoms combining observational clinician-rated and self-reported mea-
rated by a blinded clinician. The PP and sensitivity analyses sures with neurocognitive tasks.
underscore the robustness of this finding. The effect on core
ADHD symptoms was maintained beyond completion of
MBCT until 6-month follow-up.
Limitations and strengths
Additionally, MBCT + TAU resulted in a significant reduction
of self-reported ADHD symptoms and improvements of mindful- Unfortunately, no data were collected on the number and charac-
ness skills, self-compassion and positive mental health at post- teristics of people who were excluded from participation or who
treatment. While most differences between groups remained declined to be enrolled, which would have provided additional
stable over the 6-month follow-up period, self-reported ADHD information about the generalizability of our findings. However,
symptoms further decreased in MBCT + TAU compared with since the recruitment for the study was very successful and only
TAU. Although no effects were found on executive functioning lasted 16 months, there seemed to be a substantial interest in
at post-treatment, over the follow-up period executive functioning MBIs among participants with ADHD. This is in line with the
was significantly better in the MBCT + TAU group than in the findings of a qualitative study (Matheson et al. 2013) under adults
TAU group. with ADHD that there is an unmet need for additional psycho-
These results were largely in accordance with the findings of social interventions alongside medication to improve functioning,
the two previous RCTs on MBIs for adults with ADHD since for many access to non-pharmacological treatment is lack-
(Hepark et al. 2015; Mitchell et al. 2017), which also found sig- ing. The ecological validity of this study was also enhanced by
nificant reductions of clinician-rated and self-reported core symp- the multicentre design with specialised outpatient clinics for
toms in comparison to a non-active control group. In contrast adult ADHD located in an academic hospital and in two centres
with these two studies, which also reported an immediate post- for mental health care across the Netherlands, the relatively broad
treatment improvement of executive functioning, we only found eligibility criteria including patients with most of the Axis I and II
this over the course of the 6-month follow-up. This could be comorbidities according to the DSM-IV and the participation of
explained by the application of a more rigorous methodological patients in varying stages of their treatment process. In this way
design and the use of the regular 8-week MBCT programme we stayed close to the daily clinical practice.

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 10 Lotte Janssen et al.

A second limitation was that, although we did our best to this RCT indicate that psychosocial interventions, like MBCT,
ensure the blinding of the clinicians, we did not assess the success might be valuable additional treatments alongside TAU for adults
of blinding as recommended by Boutron et al. (2005). This infor- with ADHD.
mation would have increased the confidence in the validity of our
Supplementary material. The supplementary material for this article can
main results. An aspect to reflect on is the range of competence
be found at [Link]
levels of the teachers. This may be considered as a limitation;
however, a current study did not find robust effects of teacher Acknowledgements. The authors thank all participants for their time and
competence on possible mediators and outcomes in MBCT for effort, the mindfulness teachers for teaching the MBCT groups, Irene
recurrent depression (Huijbers et al. 2017). Furthermore, the Geujen for coordinating the data collection at Dimence, Geert Schattenberg
found range may be representative of mindfulness teachers in for data management, Merel Fokkema for rating the teachers and Caroline
daily clinical practice. Another factor to reflect on is the study Truijens for her assistance in a MBCT group. The authors also thank the inter-
design with TAU as comparison group. This pragmatic choice viewers of the CAARS, the employees of the specialised outpatient clinics for
ADHD and the secretaries of the Reinier van Arkel, Dimence and
enabled us to determine whether MBCT adds incremental benefit
Radboudumc for their contribution to this research project. This work was
to the usual treatments in ADHD (Dimidjian & Segal, 2015),
supported by ZonMW, the Netherlands Organisation for Health Research
which is an advantage over the comparison with an active control and Development (A.S., Grant number 837001501).
group. It has, however, also limitations, such as the diminished
internal validity due to possible differences in TAU between the Declaration of Interest. The research team declares it had no part in devel-
two conditions. We did, nonetheless, not find any differences in oping the original MBCT programme. AS, LJ and SH made small modifications
TAU between the two conditions during the intervention period, to this programme as described in our pilot study (Janssen et al. 2017). The
except for stability of medication. Therefore, an effect of a change team does not gain income from the sale of books on MBCT, nor does it
in medication could not be completely eliminated. gain income from giving lectures or workshops about it. AS is the founder
and clinical director of the Radboudumc Centre for Mindfulness. LJ and MS
are affiliated with this centre. JB has been in the past 4 years a consultant to/
Research and clinical implications member of advisory board of/and/or speaker for Janssen Cilag BV, Eli Lilly,
Lundbeck, Shire, Medice and Servier. He is not an employee of any of these
Interestingly, the participants who dropped-out of the MBCT companies and not a stock shareholder of any of these companies. He has no
were less likely to use ADHD medication during the intervention other financial or material support, including expert testimony, patents and
than completers. This suggests that MBCT might be more feasible royalties. CK has also been a member of the advisory board and consultancy
for patients on ADHD medication. This is in accordance with a team of Eli Lilly BV and was a speaker at the Adult-ADHD Academy of Eli
recent study that demonstrated that psychological interventions Lilly. The other authors declare that they had no competing interests.
result in better outcomes when combined with methylphenidate
About the authors. LJ, CK, PC, BS, SH, RD, JB and AS contributed to the
instead of a placebo (Philipsen et al. 2015). Although we did design of the study. AS was the principal investigator of the study. LJ, CK, PC,
not find that baseline use of ADHD medication predicted the BS and SH were involved in recruiting participants. LJ took care of the logistics
treatment outcome, future research should further explore the of the project and data collection. LJ and MS analysed and interpreted the data
possible interaction between pharmacological and psychosocial under supervision of RD. LJ drafted the paper, which was critically modified
interventions in ADHD and the optimal combination of the and supplemented by all other authors. All authors read and approved the
two. For example, future RCTs could examine to what extent final version of the manuscript.
MBCT is suitable as a stand-alone treatment or as an additional
Ethical standards. The authors assert that all procedures contributing to
intervention to pharmacotherapy to diminish residual symptoms.
this work comply with the ethical standards of the relevant national and insti-
A 2 × 2 design, where the effects of MBCT and TAU with and tutional committees on human experimentation and with the Helsinki
without pharmacotherapy are compared, might be suitable to Declaration of 1975, as revised in 2008.
answer this issue.
In addition, it would be relevant to compare MBCT with an
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