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E-IMR: E-health added to face-to-face delivery of Illness Management & Recovery programme for people with severe mental illness, an exploratory clustered randomized controlled trial

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Background E-mental health holds promise for people with severe mental illness, but has a limited evidence base. This study explored the effect of e-health added to face-to-face delivery of the Illness Management and Recovery Programme (e-IMR). Method In this multi-centre exploratory cluster randomized controlled trial, seven clusters (n = 60; 41 in intervention group and 19 in control group) were randomly assigned to e-IMR + IMR or IMR only. Outcomes of illness management, self-management, recovery, symptoms, quality of life, and general health were measured at baseline (T0), halfway (T1), and at twelve months (T2). The data were analysed using mixed model for repeated measurements in four models: in 1) we included fixed main effects for time trend and group, in 2) we controlled for confounding effects, in 3) we controlled for interaction effects, and in 4) we performed sub-group analyses within the intervention group. Results Notwithstanding low activity on e-IMR, significant effects were present in model 1 analyses for self-management (p = .01) and recovery (p = .02) at T1, and for general health perception (p = .02) at T2, all in favour of the intervention group. In model 2, the confounding covariate gender explained the effects at T1 and T2, except for self-management. In model 3, the interacting covariate non-completer explained the effects for self-management (p = .03) at T1. In model 4, the sub-group analyses of e-IMR-users versus non-users showed no differences in effect. Conclusion Because of confounding and interaction modifications, effectiveness of e-IMR cannot be concluded. Low use of e-health precludes definite conclusions on its potential efficacy. Low use of e-IMR calls for a thorough process evaluation of the intervention. Trial registration The Dutch Trial Register (NTR4772) Electronic supplementary material The online version of this article (10.1186/s12913-018-3767-5) contains supplementary material, which is available to authorized users.
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R E S E A R C H A R T I C L E Open Access
E-IMR: e-health added to face-to-face
delivery of Illness Management & Recovery
programme for people with severe mental
illness, an exploratory clustered
randomized controlled trial
Titus A. A. Beentjes
1,2,3*
, Peter J. J. Goossens
3,4
, Hester Vermeulen
1
, Steven Teerenstra
5
,
Maria W. G. Nijhuis-van der Sanden
1
and Betsie G. I. van Gaal
1,6
Abstract
Background: E-mental health holds promise for people with severe mental illness, but has a limited evidence base.
This study explored the effect of e-health added to face-to-face delivery of the Illness Management and Recovery
Programme (e-IMR).
Method: In this multi-centre exploratory cluster randomized controlled trial, seven clusters (n= 60; 41 in intervention
group and 19 in control group) were randomly assigned to e-IMR + IMR or IMR only. Outcomes of illness management,
self-management, recovery, symptoms, quality of life, and general health were measured at baseline (T
0
), halfway (T
1
),
and at twelve months (T
2
). The data were analysed using mixed model for repeated measurements in four models: in 1)
we included fixed main effects for time trend and group, in 2) we controlled for confounding effects, in 3) we controlled
for interaction effects, and in 4) we performed sub-group analyses within the intervention group.
Results: Notwithstanding low activity on e-IMR, significant effects were present in model 1 analyses for self-management
(p= .01) and recovery (p= .02) at T
1
, and for general health perception (p = .02) at T
2
, all in favour of the intervention
group. In model 2, the confounding covariate gender explained the effects at T
1
and T
2
, except for self-management. In
model 3, the interacting covariate non-completer explained the effects for self-management (p=.03)atT
1
.Inmodel4,
the sub-group analyses of e-IMR-users versus non-users showed no differences in effect.
Conclusion: Because of confounding and interaction modifications, effectiveness of e-IMR cannot be concluded. Low
use of e-health precludes definite conclusions on its potential efficacy. Low use of e-IMR calls for a thorough process
evaluation of the intervention.
Trial registration: The Dutch Trial Register (NTR4772)
Keywords: Severe mental illness, E-mental health, Illness management and recovery
* Correspondence: titus.beentjes@radboudumc.nl
1
Titus Beentjes, IQ Healthcare, Radboud University Medical Center, Radboud
Institute for Health Sciences, PO Box 9101, 6500, HB, Nijmegen, the
Netherlands
2
Center for Nursing Research, Saxion University of Applied Science,
Deventer/Enschede, the Netherlands
Full list of author information is available at the end of the article
© The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Beentjes et al. BMC Health Services Research (2018) 18:962
https://doi.org/10.1186/s12913-018-3767-5
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
Background
In spite of the growing interest in e-mental health, evi-
dence for the effectiveness of e-health for people with a
severe or serious mental illness (SMI) is limited [1,2].
Naslund et al. [2] found that e-health interventions for
people with SMI have high feasibility and acceptability.
Van der Krieke et al. [3] found that people with psych-
otic disorders were able and willing to engage in
e-health, and found larger effects for medication man-
agement [3]. However, one should be cautious about
drawing conclusions regarding the effectiveness [2,3].
E-health is used in a wide range of interventions for
people with SMI on (1) illness self-management and re-
lapse prevention, (2) promoting adherence to medica-
tions and/or treatment, (3) psycho-education, supporting
recovery, and promoting health and wellness, and (4)
symptom monitoring [2]. E-health interventions make
use of personal digital assistance, medication tracking
devices, home monitoring systems, smartphone applica-
tions, SMS, and web-based interventions [2].
Also in general mental health, e-health approaches show
great potential and offer the possibility of expanding ac-
cess to care while being economically and socially efficient
[4]. But e-health interventions in mental health have high
attrition rates [5]. The addition of face-to-face contact to
e-health is supposed to increase the therapeutic relation
and prevent attrition [6]..In the case of people with SMI,
e-health components could be added to an
evidence-based face-to-face recovery-oriented interven-
tion. Such an intervention is the Illness Management &
Recovery programme (IMR) [7]. The IMR is a standard-
ized curriculum-based approach designed to provide
people with SMI the information and skills necessary for
managing their illnesses effectively and working towards
achieving personal recovery goals. In addition to the
standard face-to-face delivery of the IMR, an e-health
intervention (e-IMR) was designed which follows the
IMR-curriculum, and was further developed with the
end-users of the intervention [8]. The aim of this study
was to explore the effect of the e-IMR for people with
SMI who were referred to the Illness Management & Re-
covery programme.
Methods
The e-IMR was tested in an exploratory multi-centre
cluster randomized controlled trial. According to the
Medical Research Council guidance [9], an exploratory
trial evaluated an intervention before testing it in a con-
firmative trial. In this study, a cluster was a subdivision
of a mental health institute. The cluster randomization
prevented contamination between the intervention and
control group participants. Data were collected at base-
line, halfway and endpoint. The inclusion period was
between January and October 2015. Data collecting
lasted until October 2016.
Eligible clusters delivered the IMR-programme as a
whole package with an experienced trainer-couple
meaning that at least one trainer completed the
IMR-total-training organized by the Dutch IMR-network
and executed at least the first five modules of the
IMR-programme before starting the IMR-programme in
the trial.
Trial monitoring
An employee of the Radboudumc Technology Center
Clinical Studiesmonitored the process of trial adminis-
tration. The administration of Trial Master Files, both
paper as well as computerized files, was independently
checked for completeness and accuracy.
Randomization
A statistician generated a randomization schedule using
Statistical Analysis System®, version 9.4. The allocation
to the intervention or control group was communicated
after the participating institutional board provided their
consent to participation. Because of the nature of the
intervention, blinding was not possible.
Sample size
Because of the exploratory character of this study, a
power calculation was considered unnecessary.
Participants
Eligible participants met the following criteria: above 18
years of age; capable of giving informed consent; and
meeting the Dutch SMI criteria according to Delespaul
[10] (being diagnosed with a psychiatric disorder that
causes, and is due to, serious impairments in social and/
or occupational functioning which lasts longer than at
least a couple of years and necessitates coordinated
multidisciplinary care. Persons who were overwhelmed
by disability, including dependence, denial, confusion,
anger or despair, were excluded from participating.
Care as usual
All participants, in both the intervention and control
group, received care consisting of extensive inpatient
and/or outpatient psychiatric treatment including case
management. They also received the IMR-programme,
which was provided in weekly, 2-h, face-to-face group
sessions according to the Dutch version of the IMR 3.0
programme [11] using the hard-copy version of 11
modules.
Intervention
On top of this care as usual, participants in the intervention
group had the opportunity to use the e-IMR intervention
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[8]. The e-IMR intervention started with a welcome page
explaining the use of e-IMR and leading participants to the
11 modules. The e-IMR intervention included the same
fill-in forms as in the hard-copy version of the
IMR-programme. E-IMR added illustrative videos showing
peer testimonials to encourage participants to talk more
freely about themselves and to take steps in their recovery
process. E-IMR also added problem-solving forms at the
end of each module, registration of successful coping strat-
egies, and a symptom-monitoring page.
The e-IMR was introduced to the trainers and partici-
pants of the intervention group by the first researcher in
the second group session. Individuals who did not pro-
vide informed consent were allowed to join the e-IMR
without participating in the research. The trainer-cou-
ples were supported in learning how to support partici-
pants in the use of e-IMR; how to install e-IMR on a
computer in the session room and how to use e-IMR
during the sessions.
In e-IMR, the registration forms of successful coping
strategies and the symptom-monitoring page were intro-
duced after the second module practical facts about men-
tal illnesses. Weekly emails with a link to the e-IMR
platform led the participants to the symptom-monitoring
page. After closing each module, one of the trainers gave
feedback to the participants via the platform and guided
the participants to the next module.
Data collection
Data were collected in face-to-face interviews by the re-
searcher or a researcher assistant at three time points: at
baseline, a week before starting the IMR-programme
(T
0
); halfway, after completing the 5th module (T
1
); and
endpoint, at least a week after finishing the IMR-
programme (T
2
). The data were recorded on paper and
later transferred into a LimeSurvey® [12] database. The
original recorded data as well as the transferred were
double-checked for accuracy and completeness.
Outcome measures
At baseline, independent demographic and clinical char-
acteristics were recorded. At all three time points, six
dependent outcome domains were gathered.
At T
0
the following participant characteristics were
collected: age, gender, physical comorbidities, treatment
history, cultural background, social economic status,
education level, computer/Internet availability and use.
At T
0
, the participants case manager provided their
diagnostic classification according to the Diagnostic and
Statistical Manual of Mental Disorders, 4th edition.
The participants ability to manage their illness was
measured with the consumer version of the Illness
Management & Recovery Scales (IMRS), consisting of
15 items [13]. The response anchors, on a five-point
Likert scale (15) vary depending on the item. The
IMRS total-up score ranged between 15 and 75. The
IMRSCronbachs alpha is .55.83 [1417].
The participantsself-management ability, which refers
to the individuals knowledge, skill and confidence for
managing his/her own health and healthcare, was mea-
sured with the Patients Activation Measure (PAM-13)
[18], consisting of 13 items. The response anchors on a
five-point scale, vary from not applicable (0), strongly
disagree(1) to strongly agree(4). The term doctorin
the items five and six was explained as their mental
health clinician, which includes a nurse and/or case
manager. Raw scores were transformed into standard-
ized activation scores ranging between 0 and 100. The
PAM-13s Cronbachs alpha is .84.88 [1922].
The Mental Health Recovery Measure (MHRM)
assessed the participantsprogress in their recovery
process. The MHRM consists of 30 items with response
anchors, on a five-point scale, varying from strongly dis-
agree(0) to strongly agree(4), and neutral(2) in be-
tween [23]. The MHRM total-up scores ranged between
0 and 120. The MHRMs Cronbachs alpha is .93 [24].
The participants estimated the level of burden of
symptoms they experienced using the Brief Symptom
Inventory(BSI), consisting of 53 items [25]. The re-
sponse anchors, on a five-point scale, vary from not at
all(0) to extremely(4). The mean BSI scores ranged
between 0 and 4. A negative time trend for the BSI
means a reduced level of burden. The BSIs Cronbachs
alpha is .96 [26].
The participantssubjective satisfaction with life was
measured with the Manchester Short Assessment of
quality of life (MANSA), consisting of 12 items [27].
The response anchors on a seven-point scale vary from
couldnt be worse(1) to couldnt be better(7). The
mean MANSA score ranged between 1 and 7. The
MANSAs Cronbachs alpha is .81 [28].
The participantsgeneral health status was measured
with the Rand 36-item Health Survey (Rand-36), con-
sisting of eight subscales: physical functioning (Rand-
PF), social functioning (Rand-SF), role limitations due to
a physical (Rand-RLPP) and an emotional problem
(Rand-RLEP), mental health (Rand-MH), vitality
(Rand-V), pain (Rand-P), and general health perception
(Rand-GHP) [29]. The response anchors vary between
yes/no to Likert scales with three, five, and six options.
Raw scores of all the concepts were transformed into
scores ranging between 0 and 100. The Cronbachs alpha
of Rand-36s eight concepts are .71 and .92 [30].
The extent of participantsactivity on the e-IMR plat-
form was determined by counting the number of com-
pleted modules and number of log-ins. An e-IMR user is
identified by having completed at least module one or
having logged in at least five times. Users were regarded
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as having had the opportunity to benefit from the
e-IMR.
As in other studies on IMR [31], participants who
attended the face-to-face IMR programme sessions less
than 50% were considered to be non-completers. In our
study, this resembles stopping the IMR programme be-
fore T
1
.
Statistical methods
The Statistical Package for the Social Sciences®.23 [32]
was used to carry out the analyses. Mixed model multi-
level regression analyses were used to examine the main
effects on the outcome measures, taking into account
clustering of participants and repeated measures. This
method automatically uses the missing at randomas-
sumption to handle missing data. Random effects on
cluster, trainer-couple, and individual participants nested
within the cluster were included in the model. Model 1
included fixed main effects for time trend and group.
The analyses were executed according to the
intention-to-treat principle to prevent bias caused by the
loss of participants [33] and to reflect the normal prac-
tice [34] of high attrition rates in treatments of people
with SMI [7] and e-health [5].
Post hoc analyses of effect differences were performed
to control for covariates. We considered the covariate
gender to be a potential confounder because of its
known differences in exposure and reactions to stress
and health [35]. The covariate was included in model 2,
controlling for confounding time trend effects.
In model 3, covariates were included that were ex-
pected to interact with the effect differences.
Fig. 1 Participants flow diagram through the study
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Non-completion of the face-to-face IMR-programme
sessions was expected to interact with the effects be-
cause being a non-completer is correlated to lower func-
tioning; for instance, lower social functioning [36] and
higher emergency room visits and hospitalization [37].
In addition, we searched for correlations in T
0
scores be-
tween the groups of completers and non-completers.
Because of the known low adherence-rate to
Web-based interventions [5], additional subgroup ana-
lyses were performed within the intervention group to
investigate whether actual use compared to non-use of
the e-IMR leads to outcome differences. Thus in model
4, two groups of e-IMR users and non-users were in-
cluded according to the aforementioned adherence
measurement.
Results
Participant flow
Nine institutions with potentially 15 clusters were
screened for eligibility. Two clusters were not eligible
because they did not deliver the IMR-programme as a
whole. Two clusters did not start an IMR-programme
Table 1 Demographic and clinical characteristics at baseline per group
Variables Intervention group Control group
n (% within group) n (% within group)
Mean (SD) Mean (SD)
Participants 41 19
Age 46.9 (11.6) 40.7 (10.6)
Gender
**
Female 30 (73.2) 6 (31.6)
Male 11 (26.8) 13 (68.4)
Diagnoses
Psychotic disorders 14 (34.1) 6 (31.6)
Mood/anxiety disorders 15 (36.6) 10 (52.6)
Other disorders 12 (29.3) 3 (15.8)
Global Assessment of Functioning 50.86 (8.2) 49.8 (10)
Having a somatic comorbidity 23 (56.1) 7 (36.8)
Having a psychiatric comorbidity 27 (65.9) 11 (57.9)
Treatment history
Years ago since first treatment 17.15 (12.3) 16.17 (9.9)
Number of admissions 4.15 (3.9) 3.94 (3.3)
Never admitted 7 (17) 2 (10.5)
Cultural Background
Dutch 37 (90.2) 19 (100)
Turkish, Maroc, Surinam, or English 4 (9.8) 0 (0)
In/outpatients
*
Independent living 30 (73.2) 8 (42.1)
Supported housing 11 (26.8) 11 (57.9)
Netto income
Minimal income 31 (75.6) 16 (84.2)
> Minimal income 10 (24.4) 3 (15.8)
Highest graduated education
Middle school 26 (63.4) 12 (63.2)
High school 15 (36.6) 7 (36.8)
Computer availability / usage
I dont have a computer/laptop 8 (19.5) 3 (15.8)
I never use a computer/laptop 6 (14.6) 2 (10.5)
Abbreviations:nnumber; SD Standard Deviation;
*
&
**
: significant between group differences
*
p< .05;
**
p< .01 (2-tailed)
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group. Four clusters declined because of organizational
problems. Seven clusters were included: four were allo-
cated to the intervention group and three to the control
group. In three intervention clusters, a second
trainer-couple started a second IMR group. So in total,
ten IMR-programme groups (seven in the intervention
and three in the control group) trained 60 participants:
41 in the intervention and 19 in the control group (see
Fig. 1).
Table 1shows baseline characteristics and distribution
over the two groups. The characteristics genderand in-
patients/outpatientswere unequally distributed over the
groups, p= .002 and p= .02 respectively.
All ten IMR-programme groups completed the trial. In
the intervention group, 12 out of 41 participants were
lost in the follow-up measures in the study. We lost five
at T
1
and another seven at T
2
. In the control group, four
out of 19 participants were lost in the follow-up at T
1
and T
2
. We have missing data at T
1
for one participant
in the control group. Participants either refused to be
interviewed because of being too burdened by the inter-
views, or they did not respond to attempts to get in
touch with them. Out of the 60 participants, 51 (36 and
15) participants were interviewed at T
1
, and 45 at T
2
(29
and 16) (See Fig. 1).
Out of the total of 60 participants, eighteen (30%)
were identified as a non-completer: participants who
attended the face-to-face IMR programme sessions less
than 50%. Eight participants (20%) in the intervention
group and ten participants (58%) in the control group
were non-completers, which differed significantly (p
= .01). Of these non-completers, 14 participants entered
the intention-to-treat analyses, eight in the intervention
group and six in the control group at T
1
, and seven in
both groups at T
2
.
Out of the 41 participants in the intervention group,
23 (56.1%) logged in on the e-IMR platform, twelve of
whom completed the first online module and eight of
whom visited the symptom-monitoring page (See Fig. 2).
In total, 14 (34.1%) participants were identified as e-IMR
users.
Outcomes and estimation
The mean scores and standard deviations of the out-
comes in both groups are presented in the Additional
file 1. Since the random effect of cluster was zero in
nearly all the analyses, this factor was excluded from the
analyses models. The relevant results of the mixed
model analyses are shown in Table 2. In model 1, the
participants in the intervention group scored signifi-
cantly higher compared to the control group for the
measures PAM-13 (p= .01), MHRM (p= .02), and
Rand-RLEP (p= .03) at T
1
, which faded at T
2
.AtT
2
, the
effect on the Rand-GHP was significant (p = .02) in
favour of the intervention group.
Post hoc analyses
In model 2, the analyses accounting for the covariate
gender showed that the significant effects above could
be explained by confounding except for the remaining
effect for PAM-13 (p = .01) at T
1
.AtT
0
, male partici-
pants scored significantly higher on nearly all the mea-
sures except for the PAM-13. The same exception
occurred in the time trends, but contrarily in favour of
female participants.
In model 3, the analyses showed that the interaction of
the covariate non-completer was significant for the mea-
sures: PAM-13, (p = .03) and Rand-V (p = .03) at T
1
,
which faded at T
2
. As an illustration of the interaction,
the graphic in Fig. 3shows the scores for the PAM-13,
Fig. 2 Number of participants active on the e-IMR platform within the intervention group
Beentjes et al. BMC Health Services Research (2018) 18:962 Page 6 of 10
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Table 2 Mixed Model analyses, effect differences for outcome domains
Model 1 Model 2 Model 3 Model 4
Main group effects Confounder analyses of covariate gender Interaction analyses of covariate non-completer Sub-group analyses
within intervention
group
Outcome domains Parameter T
1
*Group T
2
*Group T
0
*Male T
1
*Male T
2
*Male T
1
*Group T
2
*Group T
0
*
completer
T
1
*Group T
1
*Group*
completer
T
2
*Group T
2
*Group*
completer
T
1
*e-IMR-
users
T
2
*e-IMR-
users
Illness management:
IMRS
effect 2.55 3.06 4.89 2.31 3.26 2.26 2.42 1.57 1.12 .62 2.38 .74 1.89 1.71
p .13 .07 .00
**
.19 .08 .19 .17 .38 .70 .86 .41 .84 .32 .44
Self-management: PAM-
13
effect 7.95 3.90 4.40 .75 1.76 8.71 5.04 1.52 17.72 15.13 6.80 4.81 .73 3.03
p .01
*
.22 .19 .82 .62 .01
*
.14 .67 .00
*
.03
*
.21 .48 .81 .40
Recovery: MHRM effect 7.23 5.06 12.69 7.02 3.55 5.35 4.42 6.89 13.36 10.90 8.09 3.85 3.27 .84
p .02
*
.11 .00
**
.03
*
.28 .10 .19 .13 .01
*
.10 .14 .57 .32 .82
Symptoms: BSI effect .07 .13 .60 .28 .31 .02 .07 .13 .08 .12 .06 .24 .18 .22
p .58 .30 .00
**
.03
*
.02
*
.90 .62 .47 .72 .66 .77 .39 .19 .17
Quality of Life: MANSA effect .15 .11 .37 .22 .36 .10 .00 .10 .49 .58 .04 .24 .10 .12
p .35 .52 .07 .18 .04
*
.57 .99 .65 .08 .09 .90 .50 .57 .55
General Health
Status:
Rand-
PF
effect 6.61 5.21 19.87 3.57 6.59 8.73 3.63 3.92 13.2 13.01 6.1 3.17 .48 6.78
p .16 .27 .00
**
.45 .18 .07 .46 .58 .11 .20 .46 .76 .93 .26
Rand-
SF
effect .02 .93 15.91 1.24 14.26 1.67 2.24 1355 2.04 7.55 3.39 5.04 .35 9.07
p 1.00 .88 .02
*
.13 .04
*
.80 .74 .04
*
.85 .58 .76 .71 .96 .24
Rand-
RLPP
effect 9.47 7.88 29.85 3.43 13.61 9.98 4.68 11.85 29.73 32.31 11.28 6.33 6.56 4.99
p .39 .48 .01
*
.76 .26 .39 .69 .36 .12 .17 .55 .79 .59 .73
Rand-
RLEP
effect 25.58 9.47 29.18 9.99 17.38 21.33 11.43 8.18 28.77 5.24 21.27 44.85 18.90 23.40
p .03
*
.43 .01
**
.46 .22 .09 .37 .47 .16 .84 .31 .08
*
.15 .13
Rand-
MH
effect 2.40 1.09 15.11 6.73 5.80 3.85 2.17 8.07 .50 5.33 4.94 5.65 2.24 .83
p .57 .80 .00
**
.13 .21 .39 .64 .13 .95 .56 .50 .54 .61 .87
Rand-V effect .26 .91 15.11 3.18 7.04 .55 .35 8.76 14.76 22.9 8.6 8.36 7.62 9.42
p .96 .85 .00
**
.53 .19 .92 .95 .11 .07 .03
*
.30 .42 .11 .09
Rand-P effect 1.63 3.46 21.37 2.74 1.11 6.01 3.74 10.34 4.51 2.84 6.01 .68 2.14 1.73
p .82 .63 .00
**
.72 .21 .42 .62 .19 .72 .85 .63 .97 .80 .28
Rand-
GHP
effect 7.84 1.10 15.21 2.91 13.97 7.13 5.31 1.65 9.28 3.13 9.44 3.43 3.01 5.26
p .07 .02
*
.00
**
.50 .00
**
.10 .23 .76 .22 .73 .21 .71 .53 .35
BSI Brief Symptom Inventory, e-IMR e-health application to Illness Management & Recovery programme, IMRS Illness Management & Recovery Scales, MANSA Manchester Short Assessment of Quality of Life, MHRM
Mental Health Recovery Measure, pp-value, PAM Patient Activation Measure, Rand-GHP Rand General Health Perception, Rand-MH Rand Mental Health, Rand-P Rand Pain, Rand-PF Rand Physical Functioning, Rand-SF
Rand Social Functioning, Rand-RLEP Rand Role Limitation due to Emotional Problems, Rand-RLPP Rand Role Limitation due to Physical Problems, Rand-V Rand Vitality;
*
p-value < .05;
**
p-value < .01
Beentjes et al. BMC Health Services Research (2018) 18:962 Page 7 of 10
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
which resembles the scores of the Rand-V. We did not
find significant correlations in PAM-13 scores at T
0
be-
tween the completers and non-completers (p= .77).
In model 4, the subgroup analyses within the interven-
tion group between the groups of e-IMR users and
non-users showed no significant effect differences at T
1
and T
2
.
Harm
No serious adverse events were reported during the trial.
Discussion
This study shows significant differences in main effects
for the parameters self-management (PAM-13), recovery
(MHRM), and role limitation due to emotional problems
(Rand-RLEP) in favour of the intervention group at T
1
,
which faded at T
2
.AtT
2
, a significant effect for general
health perception (Rand-GHP) occurred, also in favour
of the intervention group.
Post hoc analyses showed that the confounder gender
explained the effects for recovery and role limitation due
to emotional problems at T
1,
and for general health per-
ception at T
2
. The confounding effects of gender were
based on three types of differences: first, the baseline
distribution showed significantly more females in the
intervention group; second, at T
0
males scored signifi-
cantly higher on most of the measures; and third, time
trends were in favour of female participants. In general,
women do differ from men in a number of ways; for in-
stance, exposure and reactions to stress [35], needs and
care [38,39], and coping styles [40]. With regard to cop-
ing styles, women could benefit more from a
problem-solving-focused intervention and men from an
emotion-focused one [41]. IMR, with its emphasis on
learning how to manage an illness in a context of pursu-
ing recovery goals [42], has a greater focus on problem-
solving- than on emotional strategies. Therefore, women
could have benefitted more from the IMR-programme
than men.
Post-hoc analyses showed that the confounder gender
did not explain the effects for the parameter
self-management. Also in studies with people with dia-
betes II [43] and other chronic illnesses [44], no rela-
tions were found between gender and self-management,
measured by the PAM-13.
The interaction covariate non-completer significantly
modified the effect for the parameter self-management
(PAM) and vitality (Rand-V) such that a large interven-
tion effect was seen in the non-completers and a small
effect in the completers. Apparently, stopping the
IMR-programme was based on differences in their im-
provements. In this study, improvements in conditions
of people who dropped out of the IRM-programme were
unequally distributed over the groups, which modified
the effects. The unlikeliness of the effects is confirmed
by the subgroup analyses within the intervention group
which showed no significant effect differences between
the groups of e-IMR users and non-users.
A last issue to discuss is the low use of the e-IMR plat-
form by the participants in the intervention group which
resulted in a minor contrast in the treatments provided
to the participants in the intervention and control group
and further calls into question the validity of ascribing
the effects observed to the e-IMR. The modest use of
the e-IMR matches with 6% of consumers using e-health
in general mental health in the year of this study [45].
Fig. 3 The course of PAM-13 scores in analysis with covariate non-completer
Beentjes et al. BMC Health Services Research (2018) 18:962 Page 8 of 10
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
A number of limitations should be noted. Unfortunately,
the planned sample size was not achieved and a lower
number of participants entered the control group. This
might have caused the unequal distribution of some co-
variates. Due to the small sample, we could not control
for more than one covariate in the mixed models without
risking overfitting. Notwithstanding the small sample, a
number of non-completers did not withdraw from the
study. The overall non-completer rate of 30% is similar to
other IMR studies [7]. Therefore, the intention-to-treat
analyses resemble normal practice.
Conclusion
Finally, this study precludes definite conclusions on the
potential efficacy of e-health for people with SMI. This
leaves us with many questions about the barriers and facil-
itators of the e-IMR intervention and its implementation.
Against the backdrop of the great promise of e-mental
health [46], the modest use of the e-IMR platform might
be an interesting outcome which needs to be further in-
vestigated. Before deciding how to continue studying the
effectiveness of e-IMR, we will investigate barriers and fa-
cilitators of the e-IMR and its implementation.
Additional files
Additional file 1: Mean scores and standard deviation of the outcome
domains per group at baseline (T
0
), halfway (T
1
) and post treatment (T
2
)
(DOCX 29 kb)
Abbreviations
BSI: Brief Symptom Inventory; e-IMR: e-health application to Illness Management
& Recovery programme; IMR: Illness Management & Recovery programme;
IMRS: Illness Management & Recovery Scales; MANSA: Manchester Short
Assessment of Quality of Life; MHRM: Mental Health Recovery Measure; PAM-
13: Patient Activation Measure; Rand-GHP: Rand General Health Perception;
Rand-MH: Rand Mental Health; Rand-P: Rand Pain; Rand-PF: Rand Physical
Functioning; Rand-RLEP: Rand Role Limitation due to Emotional Problems;
Rand-RLPP: Rand Role Limitation due to Physical Problems; Rand-SF: Rand
Social Functioning; Rand-V: Rand Vitality; SMI: Severe (or Serious) Mental Illness;
T
0
: Time point 0, baseline;; T
1
: Time point 1, halfway, after completing the 5th
module; T
2
: Time point 2, endpoint, at least a week after finishing the IMR-
programme
Acknowledgements
Not applicable.
Funding
This study was funded by the ZonMW (the Netherlands Organisation for
Health Care Research and Development) programme Tussen Weten en
Doen(Grant 520001001). The funder had no influence on study design, the
collection, analysis and interpretation of the data, the writing of the report,
and the decision to submit the article for publication.
Availability of data and materials
Data and materials will be made available after a request to the
corresponding author.
Authorscontributions
TB., PG, ST, MN and BvG contributed to the conception and design of the
study. TB contributed to the data collection. All authors contributed to the
analysis and interpretation, and provided drafting of the article. All authors
contributed to the critical revision of the article for important intellectual
content and final approval of the article.
Ethics approval and consent to participate
Individuals who were referred to the IMR-programme were informed about
the trial by their case manager. The researcher contacted those who
expressed an interest individually and explained the trial and research activ-
ities. If they were still interested and eligible, the written consent to partici-
pate was signed. No incentives were provided. The ethical approval for
conducting the e-IMR trial was provided by the Committee on Research In-
volving Human Subjects, Arnhem-Nijmegen (NL49693.091.14).
Consent for publication
Not applicable.
Competing interests
The authors declare that they have no competing interests.
PublishersNote
Springer Nature remains neutral with regard to jurisdictional claims in
published maps and institutional affiliations.
Author details
1
Titus Beentjes, IQ Healthcare, Radboud University Medical Center, Radboud
Institute for Health Sciences, PO Box 9101, 6500, HB, Nijmegen, the
Netherlands.
2
Center for Nursing Research, Saxion University of Applied
Science, Deventer/Enschede, the Netherlands.
3
Dimence Group Mental
Health Care Centre, Deventer, the Netherlands.
4
Department of Public
Health, Faculty of Medicine and Health Sciences, University Centre for
Nursing and Midwifery, Ghent University, Ghent, Belgium.
5
Department for
Health Evidence, Radboud University Medical Center, Radboud Institute for
Health Sciences, Group Biostatistics, Nijmegen, the Netherlands.
6
Faculty of
Health and Social Studies, HAN University of Applied Sciences, Nijmegen, the
Netherlands.
Received: 7 June 2018 Accepted: 23 November 2018
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... Tables 1 and 2 outline the characteristics of the included studies (n=23) and patients (n=2554). The papers incorporated into the review were predominantly from research groups in Germany (8/23, 35%) [43,44,[46][47][48]53,57,58], followed by the United Kingdom (5/23, 22%) [39,40,51,54,59], the Netherlands (4/23, 17%) [49,50,55,61], and Australia (3/23, 13%) [42,45,56]; 1 study was conducted in the United States [60], and 2 were structured as transnational collaborative research [41,52]. We identified articles published between 2012 and 2021. ...
... Among the bPT studies, the majority (12/23, 52%) utilized randomized controlled trial designs [43][44][45][46][47][48][49]51,52,57,59,61]; 2/23 studies (9%) were nonrandomized controlled trials [42,55], and 1 used a quasi-experimental 4-group design [39]. The remaining studies comprised 6/23 (26%) observational pilots [50,53,54,56,58,60], 1 observational study [40], and 1 qualitative evaluation [41]. ...
... Among the bPT trials with control groups (15/23; 65%) [39,40,[42][43][44][45][46][47][48][49]51,52,57,59,61], 11 utilized treatment as usual (TAU) groups [40,[45][46][47][48][49]51,52,57,59,61], 3 used an active control group [39,43,44], and 1 study had a waiting list control group [42]. The bPT interventions covered a range of SMI study populations, involving a total of 2554 patients with SMI. ...
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Background Blended psychotherapy (bPT) combines face-to-face psychotherapy with digital interventions to enhance the effectiveness of mental health treatment. The feasibility and effectiveness of bPT have been demonstrated for various mental health issues, although primarily for patients with higher levels of functioning. Objective This scoping review aims to investigate the feasibility, adherence, and effectiveness of bPT for the treatment of patients with severe mental illnesses (SMIs). Methods Following the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidelines, we conducted searches in PubMed, MEDLINE, Embase, PsycINFO, and PsycArticles for studies published until March 23, 2023. Results Out of 587 screened papers, we incorporated 25 studies encompassing 23 bPT interventions, involving a total of 2554 patients with SMI. The intervention formats and research designs exhibited significant variation. Our findings offer preliminary evidence supporting the feasibility of bPT for SMI, although there is limited research on adherence. Nevertheless, the summarized studies indicated promising attrition rates, spanning from 0% to 37%, implying a potential beneficial impact of bPT on adherence to SMI treatment. The quantity of evidence on the effects of bPT for SMI was limited and challenging to generalize. Among the 15 controlled trials, 4 concluded that bPT interventions were effective compared with controls. However, it is noteworthy that 2 of these studies used the same study population, and the control groups exhibited significant variations. Conclusions Overall, our review suggests that while bPT appears promising as a treatment method, further research is necessary to establish its effectiveness for SMI. We discuss considerations for clinical implementation, directions, and future research.
... adapting, continuation and techniques) with relatively low participant rates (e.g. Beentjes et al., 2018;Christensen et al., 2014). ...
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Introduction: Self-management is one of the cornerstones in the treatment of bipolar disorder (BD). Complementing interventions by apps are seen as a good opportunity to support self-management. However, there is insufficient knowledge about understanding the use of health-related applications by consumers with BD for self-management purposes. Aim: The study aims to gain insight from patients diagnosed with BD about reasons to use, continue, or discontinue health-related apps. Method: This study employed a mixed-method design in which 41 participants diagnosed with BD participated in a quantitative survey, and 11 participants also participated in an in-depth interview. Results: The survey showed that 44% (n=18) of the participants use health-related apps, and 26.8% (n = 11) use those apps consistently. Interviews revealed that adjustability, usability, trustworthiness, and the guarantee of privacy were the main reasons determining whether participants used or terminated the use of a health-related app. Implications for practice: Although we found that a substantial number of patients diagnosed with BD use one or more apps to support self-management, their use is often discontinued due to content that needs more robust to address their needs. Besides appropriate content, tailoring and persuasive technologies will likely promote the continued use of an app for self-management purposes. Cooperation between those diagnosed with bipolar disorder and health professionals (like mental health nurses) in developing and designing applications that are aimed to support self-management in BD is necessary for successful implementation and adaptation.
... For comparison, none of the studies of related resources identified by a recent scoping review (Williams et al., 2019) reported uptake. The SMART website is one of the very few digital resources intended for use together by the consumer-worker dyads (Beentjes et al., 2018;Deegan, 2010;Wright-Berryman et al., 2013). To gauge its potential to be adopted alongside routine care, the current study invited dyads to explore its use as they wished. ...
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Background Digital technologies enable the dissemination of multimedia resources to support adults with serious mental illness in their self-management and personal recovery. However, delivery needs to accommodate engagement and accessibility challenges. Aims We examined how a digital resource, designed for mental health workers and consumers to use together in session, would be used in routine practice. Methods Thirty consumers and their workers participated. The web-based resource, Self-Management And Recovery Technology (SMART), was available to use within and between sessions, for a 6-month period. Workers initiated in-session use where relevant. Feasibility was explored via uptake and usage data; and acceptability and impact via questionnaires. A pre-post design assessed recovery outcomes for consumers and relationship outcomes for consumers and workers. Results In participating mental health practitioner-consumer dyads, consumers gave strong acceptability ratings, and reported improved working relationships. However, the resource was typically used in one-third or fewer appointments, with consumers expressing a desire for greater in-session use. Improvements in self-rated personal recovery were not observed, possibly contributed to by low usage. Conclusions In-session use was found helpful by consumers but may be constrained by other demands in mental health care delivery: collaborative use may require dedicated staff time or more formal implementation.
... However, adoption by users and professionals is not always easily achieved; professionals can be skeptical about the potential benefits and experience little support in using eHealth applications [66]. Implementing a web-based recovery treatment program for patients with severe mental illness revealed that they were not easily engaged [67]. However, these challenges should not prevent a push forward for health care technology changes [68]. ...
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Background: Patients with Bipolar Disorder (BD) report a lower quality of life and lower levels of well-being than the general population. Despite the growing availability of psychotherapeutic and self-management interventions, there are still important unmet needs. These unmet needs are closely linked to positive psychology domains. Although a growing number of studies evaluated the impact of positive psychology interventions (PPIs) on patients with severe mental illness in general, only few addressed the application of positive psychology in BD. Objective: The current study aimed to gain insight into the opinion of patients with BD and health care professionals about (online) PPIs for BD and to develop and pilot-test an app containing PPIs specifically designed for patients with BD. Methods: The study was conducted in accordance with the Center for eHealth and Disease Management (CeHRes) roadmap principles and incorporated co-creation and designing for implementation. Data was collected using focus group discussions (FGs), questionnaires, rapid prototyping (RPT), and online feedback on a prototype from the participants. Three FGs were held with eight BD patients and five professionals. The collected data was used to develop a smartphone app containing short PPIs. The content was based on PPIs for which a solid base of evidence is available. Finally, a Pilot Test (PT) was used to test the app. Results: FGs revealed that positive psychology interventions as part of the current BD treatment could potentially meet the following needs: offering hope, increasing self-esteem, expressing feelings, acceptance, and preventing social isolation. Some patients expressed concern that PPIs may provoke a (hypo)manic episode by increasing positive affect. The pilot test of the app showed that the PPIs are moderate to highly valued by the participants. There were no adverse effects such as an increase of (hypo)manic symptoms. Conclusions: With the systematic utilisation of user involvement (patients and professionals) in all steps of the development process, we were able to create an app that can potentially fulfil some of the current unmet needs in the treatment of BS. We reached consensus among consumers and professionals about the potential benefits of positive psychology interventions to address unmet needs of BD patients. The use of PPI in BD is intriguing and could be usefully explored in further research. We emphasise that more evaluation studies (quantitative and qualitative) should be carried out that are focused on the effect of PPIs in the treatment of BD. In addition, to establish the working mechanisms in BD, explorative qualitative designed studies are also required to reveal if PPIs indeed can cover unmet needs in BD. Clinicaltrial:
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Mental health services are in the process of much systemic, organisational, and philosophical change as we transition from a culture focused on biomedical understandings of mental health and illness to that which is centred around personal recovery. Personal recovery, according to William Anthony (1993) is a deeply personal unique process whereby one lives the best life possible even with the limitations imposed onto the person through mental illness. Since this definition was released into mental health discourse in 1993, personal recovery has exploded across much of the western world, including in the Republic of Ireland where a recovery orientated service is fast becoming a dream that has reached reality. As a result, this study aims to add to the evidence base by co-designing a recovery measurement tool specifically for Irish mental health services based on the Health Service Executive forthcoming framework: ‘A National Framework for Mental Health Engagement and Recovery’. To support its development, a systematised critical literature review was conducted utilising the updated 2020 PRISMA guidelines, which identified ten for inclusion, describing nine recovery measurement tools. Three of these studies measure recovery from an organisational perspective. A process of co-design was described based on the evidenced based conceptual model of ‘Health Services Change Framework’ (Health Service Executive 2018a), in order to co-produce a recovery orientation measurement tool. Finally, limitations were documented along with two specific areas for future research. All of which will support future scholars in enhancing the work commenced during this study.
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El concepto de recuperación, su conceptualización y consideración para las prácticas en el campo de la salud mental, pese a su significativo desarrollo a nivel mundial, están pendientes en América Latina. Como consecuencia, se registran demoras para implementar cambios estructurales en la atención especializada y las personas usuarias del sistema de salud mental se ven privadas de prácticas basadas en la evidencia que podrían alentar sus procesos de recuperación. Una historia de violencia estatal y crisis económicas cíclicas atentaron contra la continuidad de invalorables prácticas comunitarias que, particularmente en Argentina, fueron borradas por mucho tiempo a partir del golpe de estado de 1976. Este artículo describe el proceso de adaptación cultural para Argentina del programa Illness Management and Recovery llevado a cabo por un equipo conformado por personas usuarias de servicios de salud mental, ex usuarios y profesionales. Esta adaptación se plantea como un puente entre el legado de prácticas comunitarias latinoamericanas en salud mental y las nuevas prácticas basadas en la evidencia que surgen con la incorporación de la voz y la experiencia de las personas usuarias al campo de la salud mental. Finalmente, se incluyen reflexiones sobre la experiencia de adaptación y recomendaciones para la futura implementación local del programa renombrado como “Programa Activo para la Recuperación”.
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El concepto de recuperación, su conceptualización y consideración para las prácticas en el campo de la salud mental, pese a su significativo desarrollo a nivel mundial, están pendientes en América Latina. Como consecuencia, se registran demoras para implementar cambios estructurales en la atención especializada y las personas usuarias del sistema de salud mental se ven privadas de prácticas basadas en la evidencia que podrían alentar sus procesos de recuperación. Una historia de violencia estatal y crisis económicas cíclicas atentaron contra la continuidad de invalorables prácticas comunitarias que, particularmente en Argentina, fueron borradas por mucho tiempo a partir del golpe de estado de 1976. Este artículo describe el proceso de adaptación cultural para Argentina del programa Illness Management and Recovery llevado a cabo por un equipo conformado por personas usuarias de servicios de salud mental, ex usuarios y profesionales. Esta adaptación se plantea como un puente entre el legado de prácticas comunitarias latinoamericanas en salud mental y las nuevas prácticas basadas en la evidencia que surgen con la incorporación de la voz y la experiencia de las personas usuarias al campo de la salud mental. Finalmente, se incluyen reflexiones sobre la experiencia de adaptación y recomendaciones para la futura implementación local del programa renombrado como “Programa Activo para la Recuperación”.
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Purpose Complementary interventions for persons with severe mental illness (SMI) focus on both personal recovery and illness self-management. This paper aimed to identify the patient-reported outcome measures (PROMs) associated with the most relevant and meaningful change in persons with SMI who attended the Illness Management and Recovery Programme (IMR). Methods The effect of the IMR was measured with PROMs concerning recovery, illness self-management, burden of symptoms and quality of life (QoL). From the QoL measures, an anchor was chosen based on the most statistically significant correlations with the PROMs. Then, we estimated the minimal important difference (MID) for all PROMs using an anchor-based method supported by distribution-based methods. The PROM with the highest outcome for effect score divided by MID (the effect/MID index) was considered to be a measure of the most relevant and meaningful change. Results All PROMs showed significant pre–post-effects. The QoL measure ‘General Health Perception (Rand-GHP)’ was identified as the anchor. Based on the anchor method, the Mental Health Recovery Measure (MHRM) showed the highest effect/MID index, which was supported by the distribution-based methods. Because of the modifying gender covariate, we stratified the MID calculations. In most MIDs, the MHRM showed the highest effect/MID indexes. Conclusion Taking into account the low sample size and the gender covariate, we conclude that the MHRM was capable of showing the most relevant and meaningful change as a result of the IMR in persons with SMI.
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This study examined gender differences in perceived unmet treatment needs among persons with and without co-occurring substance use disorders and serious mental health conditions. Data were drawn from the 2008-2013 National Survey on Drug Use and Health (unweighted N=37,187) to test the hypothesis that the relationships between diagnosis and perceived unmet treatment needs differ as a function of gender. Compared to individuals with a substance use disorder or severe mental illness, those with co-occurring disorders were more likely to report perceived unmet needs for substance abuse and mental health treatment. Gender significantly moderated the relationship between diagnosis and unmet needs, suggesting that men with co-occurring disorders might be more adversely affected. Findings highlight the need for better understanding of gender-diagnosis differences with respect to unmet needs for substance abuse and mental health care.
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The Patient Activation Measure-13 (PAM-13) has been found useful for assessing patient knowledge, skills and confidence in management of chronic conditions, but the empirical evidence from mental health is sparse. The psychometric properties of PAM in out-patients waiting for treatment in community mental health centers (CMHC) have therefore been examined. A total of 290 adults from two CMHC completed PAM. An exploratory factor analysis was conducted with 273 patients. Data at baseline and after 4 weeks were used to analyze test-retest reliability (n=60) and to analyze the sensitivity to change (n=51). The exploratory factor analysis revealed a fit for a two-factor model (Cronbach's α was 0.86 and 0.67), and was assessed for a one-factor model (α=0.87). The test-retest intraclass correlation coefficient was 0.76. Sensitivity to change was good with a statistically significant activation improvement (p<0.001) on patients receiving a peer co-led-educational intervention (Cohen's d was 0.85). PAM has appropriate and acceptable psychometric properties in mental health settings. Assessing activation before treatment might be useful for scheduling the delivery of mental health services as well as evaluating educational interventions aimed at improving patient engagement in mental health. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
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Women have a life-expectancy advantage over men, but a marked disadvantage with regards to morbidity. This is known as the female–male health-survival paradox in disciplines such as medicine, medical sociology, and epidemiology. Individual differences in physical and mental health are further notably explained by the degree of stress individuals endure, with women being more affected by stressors than men. Here, we briefly examine the literature on women’s disadvantage in health and stress. Beyond biological considerations, we follow with socio-cognitive explanations of gender differences in health and stress. We show that gender roles and traits (masculinity in particular) explain part of the gender differences in stress, notably cognitive appraisal and coping. Stress in turn degrades health. Implications are discussed. In conclusion, traditional socialization is advantageous for men in terms of health.
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Background: The Illness Management and Recovery scales (IMRS) can measure the progress of clients' illness self-management and recovery. Previous studies have examined the psychometric properties of the IMRS. Aims: This study examined the reliability and validity of the Dutch version of the IMRS. Method: Clients (n = 111) and clinicians (n = 40) completed the client and clinician versions of the IMRS, respectively. The scales were administered again 2 weeks later to assess stability over time. Validity was assessed with the Utrecht Coping List (UCL), Dutch Empowerment Scale (DES), and Brief Symptom Inventory (BSI). Results: The client and clinician versions of the IMRS had moderate internal reliability, with α = 0.69 and 0.71, respectively. The scales showed strong test-retest reliability, r = 0.79, for the client version and r = 0.86 for the clinician version. Correlations between client and clinician versions ranged from r = 0.37 to 0.69 for the total and subscales. We also found relationships in expected directions between the client IMRS and UCL, DES and BSI, which supports validity of the Dutch version of the IMRS. Conclusions: The Dutch version of the IMRS demonstrated good reliability and validity. The IMRS could be useful for Dutch-speaking programs interested in evaluating client progress on illness self-management and recovery.