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S T U D Y P R O T O C O L Open Access
Mentalization-based treatment for
psychotic disorder: protocol of a
randomized controlled trial
Jonas Weijers
1,2,6*
, Coriene ten Kate
1
, Elisabeth Eurelings-Bontekoe
3
, Wolfgang Viechtbauer
2
, Rutger Rampaart
1
,
Anthony Bateman
4,5
and Jean-Paul Selten
1,2
Abstract
Background: Many patients with a non-affective psychotic disorder suffer from impairments in social functioning and
social cognition. To target these impairments, mentalization-based treatment for psychotic disorder, a psychodynamic
treatment rooted in attachment theory, has been developed. It is expected to improve social cognition, and thereby to
improve social functioning. The treatment is further expected to increase quality of life and the awareness of having a
mental disorder, and to reduce substance abuse, social stress reactivity, positive symptoms, negative, anxious and
depressive symptoms.
Methods/design: The study is a rater-blinded randomized controlled trial. Patients are offered 18 months of therapy
and are randomly allocated to mentalization-based treatment for psychotic disorders or treatment as usual. Patients
are recruited from outpatient departments of the Rivierduinen mental health institute, the Netherlands, and are aged
18 to 55 years and have been diagnosed with a non-affective psychotic disorder. Social functioning, the primary
outcome variable, is measured with the social functioning scale. The administration of all tests and questionnaires
takes approximately 22 hours. Mentalization-based treatment for psychotic disorders adds a total of 60 hours of
group therapy and 15 hours of individual therapy to treatment as usual. No known health risks are involved in the
study, though it is known that group dynamics can have adverse effects on a psychiatric disorder.
Discussion: If Mentalization-based treatment for psychotic disorders proves to be effective, it could be a useful
addition to treatment.
Trial registration: Dutch Trial Register. NTR4747. Trial registration date 08-19-2014.
Keywords: Mentalization, Treatment, Schizophrenia, Psychosis, Social functioning, Social cognition, Psychotherapy
Background and rationale
Non-affective psychotic disorders (NAPD) like schizo-
phrenia are accountable for a substantial part of the total
burden of disease, constituting the fifth and sixth leading
cause of disability in the world, for men and women re-
spectively [1]. A major contributor to this high level of
disability is thought to be the decline in social functioning
associated with NAPD. Patients with NAPD experience
difficulty communicating [2], and tend to have poor social
problem-solving skills [3]. These social deficits are pre-
dictive of poor vocational outcome [4] and poor quality
of life [5]. It is surprising, therefore, that few treatments
have been developed to effectively target them.
Social cognition –defined as “the ability to construct
representations of the relation between oneself and
others, and to use those representations flexibly to guide
social behavior”[6] has been identified as one of the
strongest predictors of social functioning in patients
with NAPD [7]. Examples of social cognitive impairments
in NAPD include difficulties recognizing emotions [8],
* Correspondence: j.weijers@ggzleiden.nl
1
Rivierduinen Institute for Mental Health Care, Leiden, The Netherlands
2
Department of Psychiatry and Neuropsychology, South Limburg Mental
Health Research and Teaching Network, EURON, Maastricht University,
Maastricht, The Netherlands
Full list of author information is available at the end of the article
© 2016 The Author(s). 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.
Weijers et al. BMC Psychiatry (2016) 16:191
DOI 10.1186/s12888-016-0902-x
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
empathizing [9] taking another person’s perspective [10]
and understanding social hints [11]. In recent years just a
few treatments, mostly rooted in cognitive/behavioral
theory [12–14], have been developed that target social
cognition. Results, are preliminary, but do suggest that
impaired social cognitive deficits are targetable by psy-
chosocial interventions [13–15].
Mentalization-based treatment for psychotic disorder
(MBT-P) is based on a manualized psychodynamic
treatment for Borderline Personality Disorder (BPD)
[16]. Recent prospective studies suggest that psycho-
dynamic therapy may improve global functioning in
NAPD [17, 18], although randomized controlled trials
should be conducted to substantiate this claim. Also,
metacognitive psychotherapy [19] –which is closely
related to MBT [20] –holds promise as a treatment
for patients with schizophrenia [21]. MBT-P was devel-
oped to specifically improve social functioning by tar-
geting the social cognitive process called ‘mentalizing’.
Fonagy and colleagues [22] describe mentalizing as
“the process by which we implicitly and explicitly
interprettheactionsofourselvesandothersasmean-
ingful on the basis of intentional mental states”.MBT
adheres to a few important principles: (i) The therapist
focuses on the current mental state of the patient to
practice making representations of internal states; (ii)
the therapist focuses on the present as opposed to the
past; (iii) the therapist avoids talking about mental
states that are not linked to subjectively felt reality; (iv)
the therapist avoids talking about complex mental states;
(v) the therapist focuses on recovering mentalizing, not
creating insight [23].
This approach was found to reduce symptoms and
interpersonal distress, and improve social functioning
in patients with BPD [24]. Although BPD and NAPD
may seem qualitatively different disorders, early views
assumed borderline psychopathology occupied an area
between neurosis and psychosis (e.g. Kernberg [25])
and could involve transient psychotic episodes. Since
then, evidence has substantiated psychosis proneness
in BPD. Psychotic symptoms, including hallucinatory
experiences and delusions, occur regularly in patients
with BPD, often persist over time, and are for a large
part already present in early childhood [26]. In a re-
cent study that included patients with either BPD or
Schizophrenia, 17 % of participants met the criteria
for both disorders [27]. Additionally, some NAPD and
BPD patients share a tendency to excessively attribute
incorrect intentions to others, or to “hypermentalize”
[28–30]. Furthermore, disturbances in self-awareness
and self-representation have been suggested to play an
important role in both disorders [31]. Lastly, childhood
trauma has been established as an important factor in the
origins of both disorders [32]. Thus, as has been
suggested earlier [20, 33], MBT may be a similarly suit-
able treatment for NAPD.
Research aims and hypotheses
Primary research aim
The primary aim of this study is to establish whether
mentalization-based treatment for psychotic disorder
(MBT-P) improves self-reported social functioning in
patients with NAPD. We hypothesize that patients who
receive MBT-P will show greater improvements in
social functioning compared to patients who have had
treatment as usual (TAU) only. We also expect that any
difference observed will still be present at a 6 month
follow-up.
Secondary research aims
In addition to the self-reported level of social functioning,
we will also examine global functioning as rated by
researchers. Other outcome measures were chosen with
previous research regarding MBT in mind. According
to Fonagy and Bateman [34], MBT’smechanismof
change is improving patients’mentalizing capacities.
We therefore aim to establish whether MBT-P indeed
increases mentalizing capacity, measuring several di-
mensions of social cognition, and whether this increase
mediates a potential treatment effect. Furthermore, in
earlier studies, Bateman and Fonagy [24] reported a
reduction of anxious and depressive symptoms and of
substance abuse. We expect similar results regarding
NAPD patients. Given the strong relation between
social functioning and quality of life, we assume that
patients receiving MBT-P will report a higher quality of
life. Additionally, based on previous research [35], we
predict that improvement of social cognitive capacity
will also lead to an increased awareness of having a
mental disorder. Furthermore, as Bateman and Fonagy
describe [34] that MBT was designed to improve
emotion regulation in situations of attachment related
(i.e., social) stress. Based on this, we assert that patients
will have less aversive emotional reactions to situations
of social stress as a result of MBT-P. If MBT-P can
reduce patients’emotional reactivity to social stress,
they may also become less prone to develop positive
psychotic symptoms, as social stress reactivity may be
an affective pathway to psychosis [36]. Lastly, because
social functioning and mentalizing ability have been
found to be strongly related to negative symptoms, we
will examine whether MBT-P reduces negative symp-
toms [37–39].
Covariates
Certain potential effect modifiers will be taken into
account. First, adverse childhood experiences such as
neglect or physical, psychological, and sexual abuse have
Weijers et al. BMC Psychiatry (2016) 16:191 Page 2 of 10
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been associated with social dysfunction later in life [40].
Second, personality organization (PO) has been shown
to impact psychotherapy treatment response [41] and
the level of social cognition [42]. Five levels of persona-
lity organization (PO) are identified, each characterized
by different levels of anxiety tolerance and different cap-
acities for impulse inhibition or ‘control’: Neurotic PO
(good anxiety tolerance, over-control); Borderline PO
(moderate to poor anxiety tolerance, differing levels of
control); Narcissistic Borderline PO (good anxiety tole-
rance, undercontrol); Latent Psychotic PO (moderate
anxiety tolerance, weak control); and Manifest Psychotic
PO (poor anxiety tolerance, weak control). Third, the
awareness of bodily sensations has been regarded as the
first level of emotional awareness [43], which is an es-
sential part of social cognition [44]. Psychopathology
usually is accompanied by (vague) physical complaints,
called “somatization”. A failure to report physical com-
plaints while suffering (severe) psychopathology may be
indicative of an absence of bodily awareness and there-
fore an impaired social cognitive capacity. Fourth, medi-
cation use can affect social functioning in patients with
NAPD, therefore the type of medication is registered
and adherence to medication is measured. Fifth, MBT
attendance is taken into account, because it is expected
that those who attend more sessions will profit more.
Sixth, baseline measurements of the outcome variables
will be accounted for. Seventh, the duration of illness,
because of its negative impact on functioning; and eighth,
adherence to the MBT model by therapists, because it is
likely to influence treatment outcome.
Methods/design
Trial design/setting
This study is a rater-blinded, randomized controlled trial.
Patients referred to outpatient sites of the Rivierduinen
mental health institute are randomly assigned to Treat-
ment as Usual (TAU) plus MBT-P or TAU only. The
Rivierduinen mental health institute provides in- and
outpatient treatment to thousands of patients with psychi-
atric disorders in the Dutch province of South-Holland
(e.g., Leiden, Gouda). The investigator and patients are
aware of treatment allocation, but all measurements are
performed by researchers blind to treatment allocation.
Social functioning at baseline (t0) and after treatment (t2)
will be compared for both treatment conditions. The pa-
tients are blind to this primary aim.
Participants
Participants in the study are patients with NAPD (DSM-
IV criteria [34]): schizophrenia, schizophreniform, or schi-
zoaffective disorder (295.x), delusional disorder (297.1),
brief psychotic disorder (298.8), or psychotic disorder not
otherwise specified (298.9). At least 80 participants will be
included from the Rivierduinen mental health institute.
Inclusion criteria are:
–At least 6 months of prior treatment.
–No more than 10 years of treatment for NAPD.
–Between 18 and 55 years of age.
Exclusion criteria are:
–Intellectual disability and/or illiteracy.
–A lack of mastery of the Dutch language.
–Substance abuse to such an extent that it necessitates
inpatient detoxification. After detoxification the
patient is still eligible for participation in the study.
Patients cannot participate in a session while under
the influence of drugs.
Sample size calculation
The estimated effect size of the current study is based
on two previous studies. A study examining the effect of
MBT on BPD [35] showed moderate to large reductions
of problems relating to interpersonal distress (d = 0.95;
95 %; CI: 0.59–1.30) and social functioning (d = 0.72;
95 % CI 0.37–1.06). A study concerning Social Cognition
and Interaction Training (SCIT) –a treatment for patients
with schizophrenia that shares many elements with
MBT –showed large effects on social engagement (d =
1.77) and interpersonal communication (d= 1.57) on the
Social Functioning Scale [36]. Based on these results, we
expect to find a moderate to large effect of MBT-P on
social cognition (i.e., a Cohen’s d of at least 0.7).
To calculate the required sample size, G*Power [37]
was used. To obtain a significant difference with power
equal to .80 with an independent samples t-test (for a
true effect size of .7 and alpha = .05), 68 participants
are needed. However, because repeated measurements
(baseline and post-treatment) increase the power –de-
pending on the test-retest reliability of the outcome
measure –a smaller sample size is required. A formula
has been devised [38] to account for the increased power
when using multiple measurements: n
repeated measures
=
(1-ρ
2
)*n
t-test
;whereρis the test-retest reliability of
the scale used. Previous research has shown that the
test-retest reliability of the social functioning scale
after two and a half years is ρ= .40 [39]. Thus we
need: (1-0.4
2
)*68 ≈58 participants to have 80 % power
to find a significant difference.
It is difficult to predict the amount of drop-out in the
study. In an unpublished pilot study, conducted at the
Rivierduinen mental health institute, the drop-out rate
of MBT-P within a period of 1 year was 10 %. Since the
current RCT combines treatment and measurements, we
estimate that the drop-out rate will be higher. Therefore,
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to be sure, we will recruit at least 40 (TAU) + 40 (TAU
plus MBT-P) = 80 individuals. Even if 25 % of those ini-
tial patients (i.e., 20) drop out, there will be 60 patients
left to detect an effect. Because patients in the MBT-P
condition receive therapy in groups of up to eight per-
sons, five groups will be formed in order to recruit 40
patients in the MBT-P condition.
Procedure
Psychiatrists, psychologists, or psychiatric nurses will
check their caseload for patients who meet the require-
ments for participation and ascertain whether they are
interested in participating. If this is the case, the re-
searcher will provide an information letter. The patient
will be given 7 days to read the letter and to decide
whether he/she wants to participate. At a second ap-
pointment, the researcher will check whether the patient
has understood the information in the letter. Subse-
quently, both parties sign an informed consent form in
twofold. Randomization is performed by an independent
external agency.
Measurements and instruments
There are four moments of assessment over the course
of 2 years. The baseline assessment takes place before
MBT-P is started. Furthermore, there will be an assess-
ment after 9 months (halfway MBT-P), after 18 months
(directly after MBT-P has ended), and after 24 months
(6 months after MBT-P has ended). See Table 1 for the
specific instruments that are used at each assessment.
Diagnosis
All patients are diagnosed according to DSM-IV criteria
[45] by a psychiatrist. Prior to participation, this diagnosis
will also be verified using the Comprehensive Assessment
of Symptoms and History (CASH). The CASH is a semi-
structured interview that documents signs, symptoms,
and history of psychotic, manic and depressive syndromes
as well as substance abuse. The instrument has been ex-
tensively tested concerning interrater reliability, test-retest
reliability and validity [46].
Social functioning
Social functioning is measured using the Social Func-
tioning Scale (SFS), a self-report questionnaire. The
SFS has been found to be reliable, valid, sensitive, and
responsive to change [47]. The scale contains seven
dimensions of global social functioning that are espe-
cially pertinent to patients suffering from psychotic disor-
ders. The dimensions are: social withdrawal, interpersonal
communication, independence (competence), independ-
ence (performance), recreational activities, social activities,
and employment.
Secondly, using the modified GAF scale [48], global
functioning will be assessed. The modified GAF scale is
a clinician or researcher-rated instrument, which makes
it a good addition to the self-reported SFS. It has more
detailed criteria and a more structured scoring system
than the original GAF, which is underscored by a high
interrater reliability.
Social cognitive capacity
It has been pointed out that there is to date no agree-
ment on the assessment of social cognition, but there is
a broad consensus that it is a multifaceted construct
[49]. In the current study, social cognition is therefore
assessed with two instruments that measure different as-
pects of social cognition: the Thematic Apperception
Test (TAT) and the hinting task (HT). The TAT [50],
scored with the Social Cognition and Object Relations
System (SCORS) [51], is used to assess four dimensions
of social cognition: complexity of representations of
people and understanding of social causality, which
comprise cognitive aspects of social cognition, and the
affect-tone of relationships and the capacity for emo-
tional investment, comprising affective aspects of social
cognition. Each dimension is scored on a 5-point scale,
with higher scores representing higher social cognitive
functioning in that dimension. Six pictures of the TAT
are used. TAT responses are recorded and transcribed
verbatim. TAT responses, when analyzed with the SCORS,
have been found to be a valid and reliable way to measure
social cognition and object relations [52, 53]. According
to Luyten and colleagues [54], the TAT is one of the
few tests that takes almost all aspects of mentalization
into account, including affective and cognitive aspects.
The HT [37] is used to measure the ability to infer
intentions from others, or ‘Theory of Mind’(ToM).
Table 1 Overview of the different instruments at each
measurement moment
Intake T0: Baseline
measurement
(0 months)
T1: Halfway
Measurement
(9 months)
T3: End of
Treatment
(18 months)
T4:
Follow-up
(24 months)
CASH X
SFS X X X
TAT X X X
ESM X X X X
HT X X X
MANSA X X X
MAQ X X X X
DSFM X
PANSS X X X
GDQ X
CECA X
GAF X X X
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Patients read extracts that describe an interaction between
two characters in which one character says something
with an implicit message. If the patient infers the implicit
message correctly, two points are scored. If a hint is
needed, a score of 1 is given. When the answer is incor-
rect or the participant does not know, 0 points are scored.
The test comprise ten short passages. The Hinting Task
has very recently been reviewed [55] regarding test-retest
reliability, utility as a repeated measure, relation to func-
tional outcome, and internal consistency and was one of
two tests shown with strong psychometric properties
across all evaluation criteria.
Social stress reactivity
Emotional reactivity to stress in social situations is
measured with an electronic diary using the ‘Experience
Sampling Method’(ESM) [56]. ESM is a repeated self-
assessment technique with great ecological validity. Par-
ticipants carry around an ESM device, which facilitates
the monitoring of daily life experiences and behavior. Ten
times daily on five consecutive days, it generates an aud-
ible signal (beep) at unpredictable moments of the day
which participants answer by using the touch screen of
the device. Participants are asked whether they are alone
or in company of others. Then, both the level of social
stress and negative/positive affect are assessed. Social
stress is measured with items such as: “I would rather be
alone”and “I like the present company”(reverse coded).
Negative affect is the averaged score of the mood items
“anxious”,“lonely”,“insecure”,“irritated”,“down”,“guilty”,
and “gloomy”. Positive affect will be measured with the
items “happy”,“satisfied”,“cheerful”,“relaxed”,and“en-
thusiastic”. All items are scored on a 7-point Likert Scale.
Quality of life
Using the Manchester Short Assessment of quality of life
(MANSA) [57], changes in overall quality of life are
measured. The MANSA is a 16-item, 7-point Likert-
scale self-rating instrument.
Psychotic symptom severity
Interviewers use the Positive and Negative Syndrome
Scale (PANSS) [58] to assess positive (subscale P), nega-
tive (subscale N), anxious (item G2), and depressive
symptoms (item G4). The PANSS is a 30-item, 7-point
Likert-scale rating instrument developed for the assess-
ment of phenomena associated with schizophrenia. A
Dutch version is used [59].
Additionally, the ESM diary is used to measure mo-
mentary psychotic experiences. Seven ESM items are
used: ‘I feel suspicious’,‘I am afraid of losing control’,‘I
feel that others don’t like me’,‘I feel that others want to
hurt me’,‘My thoughts are influenced by other people’,‘I
feel unreal’, and ‘I hear voices’.
Awareness of having a mental disorder
The PANSS (item G12) is used to assess awareness of
having a mental disorder.
Substance abuse
Patients are asked to report substance use on the ESM
device at each beep using categorical questions. Patients
will report whether they have used any substance since
the last beep, including: (1) caffeine, (2) nicotine, (3)
medication, (4) alcohol, (5) cannabis, (6) other drugs, or
(7) none.
Personality organization/somatization of
psychopathology
Assessment of personality organization and the tendency
to somatize severe psychopathology is conducted using
theory driven profiles of the Dutch short Form of the
MMPI (DSFM) [60], an 83-item self-assessment question-
naire. The DSFM measures personality traits on 5 scales:
Extraversion, Psychopathology, Shyness, Somatization,
and Negativism. Using the theory driven profile ap-
proach to the DSFM [61–65], five levels of Personality
Organization (PO) are distinguished: Neurotic PO, Bor-
derline PO, Narcissistic Borderline PO, Latent Psychotic
PO and Manifest Psychotic PO. To measure bodily
awareness, the DSFM “Somatization”subscale (20 items)
will be used. This subscale measures the amount and
degree of experienced bodily symptoms, and hence, the
ability to subjectively report, and be aware of bodily
sensations. As described [65] affect regulation through
somatization will be expressed as the relative position of
scores on the subscale somatization to that on the
severe psychopathology subscale.
Childhood trauma
The Childhood Experience of Care and Abuse (CECA)
[66] is a semi-structured interview that aims to assess
details and the time-sequence of traumatic childhood
experiences. It assesses lack of care (neglect, antipathy),
physical abuse, sexual abuse, and psychological abuse.
Adherence to drug treatment
Each patient’s medical record is consulted to ascertain
the pharmacotherapy prescribed at t0, t1, t2, and t3. Ad-
herence to the prescribed medication is measured with
the Medication Adherence Questionnaire (MAQ) [67].
Adherence to the MBT-model
Adherence to the MBT model by therapists is rated by
an experienced MBT therapist according to the MBT
adherence and competence scale [68], using footage of
therapy sessions. Therapists are judged on 17 items that
characterize proper MBT treatment.
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Duration of illness
Assessed using the CASH, refers to the period since first
psychosis.
General demographics
The general demographic questionnaire (GDQ) is a
standard instrument used in all ESM studies conducted
at Maastricht University. It documents treatment history,
socio-economic status, educational level, and urbanicity
of the place of residence.
Treatment
TAU
All patients in the current study receive a multifaceted
treatment based on the ‘Functional Assertive Community
Treatment’(FACT) model. FACT teams consist of
psychiatric nurses, welfare workers, psychologists,
and at least one psychiatrist. The intervention con-
sists of pharmacotherapy, case-management, psycho-
education, and in some cases cognitive behavioral
therapy (CBT). CBT interventions for psychosis usually
take around 20 sessions and are based on the work of
van der Gaag [69, 70]. Whether or not patients have re-
ceived CBT, and how many sessions, will be registered
and taken into account.
Furthermore, all patients will receive supportive-
structuring therapy. Sessions focus on problems patients
may encounter in their social network, work, daily
activities, or medication adherence. Patients meet with
a mental health professional for an average of 30 min
every 2 weeks, with a minimum of 1 meeting of
30 min per month, over 18 months. The total number
of individual sessions is estimated to be around 30
(15 h of individual therapy). Adherence to treatment
sessions is monitored by registering patients’presence
in the sessions.
MBT-P
Patients in the TAU plus MBT-P condition receive the
same treatment mentioned above in combination with
individual and group MBT-P. The key elements of
MBT, shortly described below, provided the basis for
MBT-P [16].
Therapeutic stance
MBT is characterized by the ‘not knowing stance’in
which the therapist admits to not knowing what the
patient experiences. By actively asking questions the
therapist cultivates an attitude of sincere interest in the
patient. This gives the patient the experience of being
‘kept in mind’by someone, but also stimulates curiosity
in the patient towards his own mental states.
Interventions
When applying interventions, it should always be kept
in mind that arousal tends to diminish the capacity to
mentalize. Four stages of intervention can be used in a
step-wise manner, depending on the level of arousal.
At the first level, interventions are aimed at down-
regulating arousal in the patient. These include empathic
validation of the patient’s feelings and complimenting
good mentalizing. At the second stage the therapist asks
for clarification of a situation or elaboration on the
patient’s feelings and thoughts. Often the therapist
stops or rewinds the patient’s narrative to investigate
an aspect of the dialogue. This stage is about making
implicit mentalizing explicit. Often details are investigated
that seem to affect the patient, or should affect the pa-
tient, but do not. This then leads to the next stage, called
‘mentalized affectivity’, which is the activity of reflecting
on emotions, while simultaneously experiencing them. It
is considered to be a crucial aspect of emotion regulation.
The explicit mentalizing of a primary affective experience
gives the patient the opportunity to express (or inhibit)
emotions in a non-automatic manner. At the last stage,
the relationship between therapist and patient or between
patients is mentalized. In this stage, both patient and
therapist reflect on and share their affective experience to
become aware how their relationship is affecting them.
Care should be taken applying this stage of intervention,
as it requires a robust level of mentalizing.
Duration and dose
Compared to original MBT, the length of MBT-P, has
remained unchanged: 18 months. However, the fre-
quency and length of sessions has been reduced. In our
experience, based on a pilot MBT-P intervention, NAPD
is associated with more severe mentalizing deficits than
BPD, as has also been suggested elsewhere [71]. Given,
the danger of overwhelming NAPD patients with menta-
lizing interventions, group therapy is limited to weekly
1-hour sessions, while individual therapy takes place in
biweekly half-hour sessions. We feel this approach is
justified by the low drop-out rate of 10 % in the pilot
intervention.
Psycho-education
MBT-P starts with two sessions of psycho-education, in
which patients are told about the key aspects of MBT,
including the meaning of mentalizing and its sensitivity
to arousal.
Individual therapy
Individual therapy provides an opportunity for intensive
practice in mentalizing. The focus is on establishing a
secure relationship that acts as a safe base from which
failures in mentalizing can be explored. Treatment goals
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on the basis of five problem areas are developed and
routinely reviewed with the patient, including: commit-
ment to treatment, psychiatric symptoms, social inter-
action/relationships, destructive behavior, and community
functioning.
Group therapy
Since patients with NAPD tend to experience a great deal
of stress in social situations, group therapy provides an op-
portunity to practice mentalizing in a stress-evoking setting.
Group therapy can also generate a sense of belonging and
attachment that help foster mentalizing. The group size is
amaximumofeightpatientsandtherewillbeoneMBT-P
therapist and one co-therapist present at each session.
Therapists
Group therapists are experienced and registered MBT
therapists. Individual therapists are mental health profes-
sionals (psychologists, psychiatric nurses or psychia-
trists) who receive training to become MBT-P therapists.
Supervision is provided in weekly sessions of up to 1h,
during which therapists reflect on their interventions
and whether they are faithful to the MBT model.
Statistical analysis
Main effect
The main purpose of the statistical analysis is to com-
pare the overall effect of treatment condition on social
functioning. For this, an ANCOVA will be used with
treatment condition as between-subjects variable, post-
treatment social functioning as dependent variable, and
baseline social functioning as a covariate. Other poten-
tial covariates include childhood trauma, level of PO,
somatization of psychopathology, medication use, at-
tendance of MBT-P sessions, duration of illness and
adherencetotheMBT-modelbytherapists.Similar
analyses will be conducted for the secondary outcome
measures (social cognition, quality of life, awareness of
having a mental disorder, anxious, depressive, negative
and positive symptoms and substance abuse).
Since drop-out will undoubtedly result in missing data,
the possibility of attrition-bias is a cause of concern [72].
For example, it is conceivable that those who fare the
worst in therapy tend to drop out, thus creating a biased
sample. Following the advice of Altman [73], the analyses
will therefore be conducted on the basis of ‘intention to
treat’(ITT), meaning that they will include all patients
who sign up, regardless of actual participation in the entire
program. Missing data will be handled by means of mul-
tiple imputation (MI) [74]. In the current case missingness
is most likely to be caused by participants dropping out of
their respective treatment programs. Since certain vari-
ables have been found to influence drop-out rates in
patients with NAPD, we cannot assume that the data are
missing at random. A review [75] identified a lack of
insight, poor social functioning, positive symptoms, young
age, male gender, a history of drug abuse, and unemploy-
ment as key predictors of treatment program drop out.
Thus in the current study, these variables will be used to
predict missingness. Additionally, treatment condition will
be used as a predictor as well, because the time investment
differs between conditions. For each analysis, a total of 5
imputed datasets will be created using a fully conditional
Markov chain Monte Carlo (MCMC) approach, which will
be combined using standard procedures [76].
Mediation
We also aim to examine whether changes in various so-
cial cognitive dimensions mediate the potential increase
in social functioning. In order to test this mediational
model, we will carry out a multi-mediator analysis [77].
This allows for a parallel testing of the indirect effects
of several social cognitive dimensions, namely: theory
of mind, complexity of representations, affect-tone of
relationships, capacity for emotional investment and
understanding of social causality (Fig. 1).
Multilevel analysis
Social stress reactivity is measured by ESM. This method
generates data with a multilevel structure because there
are multiple measurements per day for 5 days at a time
for each patient. Since observations within patients tend
to be more similar than observations from different
patients, they are not independent. This necessitates a
different (i.e., multilevel) analysis than the one used for
the other outcome measures. Similar to Myin-Germeys
and colleagues [78], differences in social stress reactivity
between groups will be analyzed using mixed-effects
regression models with treatment condition, the amount
of stress during social situations, and their interaction
term as independent variables, and positive and negative
affect as dependent variables. The model will include
random intercepts and random slopes for the stress
predictor at the patient level, which allows for diffe-
rences in overall levels of positive and negative affect
across patients and for differences in the strength of the
relationship between stress and these outcomes.
Discussion
There is evidence that MBT improves, among others,
social functioning and interpersonal distress in patients
with BPD (e.g. [24, 79]) and that these effects remain at
follow-up [80]. Given the similarities in both origins and
symptoms of BPD and NAPD, it has previously been
suggested that MBT could be a useful treatment for
NAPD [20, 33]. This randomized controlled trial, will be
the first to examine the effectiveness of MBT as an
adjunct therapy for patients with NAPD. Furthermore,
Weijers et al. BMC Psychiatry (2016) 16:191 Page 7 of 10
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
we aim to determine a possible mechanism of change
by examining social cognitive capacity as a possible
mediator. By measuring social cognitive capacity with
two instruments, covering a total of five dimensions,
we mean to do justice to its complexity.
Abbreviations
(Z)MLK, Abbreviation for the Dutch term ‘(zeer) moeilijk lerende kinderen’
meaning: children with (severe) learning disabilities; BPD, borderline
personality disorder; CASH, comprehensive assesment of symptoms and
history; CBT, cognitive behavioral therapy; CECA, childhood experiences
of care and abuse; DSFM, Dutch short form of the Minnesota Multiphasic
personality inventory; ESM, experience sampling method; GAF, global
assessment of functioning; GDQ, general demographic questionnaire; HT,
hinting task; ITT, Intention to treat; MANSA, Manchester short assessment
of quality of life; MAQ, medication adherence questionnaire; MBT,
mentalization-based treatment (for borderline personality disorder); MBT-P,
mentalization based treatment for psychotic disorders; MCMC, markov chain
monte carlo; MI, multiple imputation; MMRM, mixed model for repeated
measures; MREC/METC, medical research ethics committee (MREC); in Dutch:
medisch ethische toetsing commissie (METC); NAPD, nonaffective psychotic
disorder; PANSS, positive and negative syndrome scale; PO, personality
organization; SCORS, social cognition and object relations system; SFS, social
functioning scale; TAT, thematic apperception test; TAU, treatment as usual
Acknowledgement
Rivierduinen Institute for Mental Health Care, is funding the costs for this
trial for at least 4 years. The costs include participation fees for up to 80
participants, treatment given, organizational costs and the salaries of
principal investigator Jean-Paul Selten and local investigator Jonas Weijers.
This funding source has no role in the design of this study and will not have
any role during its execution, analyses, interpretation of the data, or decision
to submit results. The protocol was not peer-reviewed by this funding body.
Availability of data and materials
Non applicable.
Authors’contributions
CtK drafted the first version of the manuscript. JW completed the manuscript
with advice from CtK, LEB, WV, RR, AB, and JPS and is the lead author. JW is
also responsible for the collection of data. JPS is principal investigator and
responsible for the coordination of the study. All authors provided comments,
read and approved the final manuscript.
Competing interests
The authors declare that they have no competing interests.
Consent for publication
Consent to publish results and store data and materials for a maximum of
15 years will be obtained from all participants. Consent to share raw data
with outside parties will not be obtained. Reporting of data once obtained
will adhere to the CONSORT guidelines [81].
Ethics approval and consent to participate
The Medical Research and Ethics Committee (MREC) of Maastricht University
in The Netherlands has approved this study, registered under NL47236 068/
METC 13-03-066. Consent to participate will be obtained from all participants.
If no consent is given, the participant will be considered a drop-out.
Administrative information
Protocol identifier: Version 4, date: 02-06-2016
Sponsor: Maastricht University, the Netherlands. Correspondence: D. Op ‘t
Eijnde, P.O. Box 616 (VIJV1), 6200 MD Maastricht T +31 43 388 38 69
Funder: Rivierduinen Institute for Mental Health Care, the Netherlands,
Sandifortdreef 19, 2333 ZZ Leiden.
Trial registration database: Dutch Trial Register
Trial registration: NTR4747
Registration date: 08-19-2014
Author details
1
Rivierduinen Institute for Mental Health Care, Leiden, The Netherlands.
2
Department of Psychiatry and Neuropsychology, South Limburg Mental
Health Research and Teaching Network, EURON, Maastricht University,
Maastricht, The Netherlands.
3
Department of Clinical Psychology, Health and
Neuropsychology, Leiden University, Leiden, The Netherlands.
4
MBT Team,
Anna Freud Centre, London, UK.
5
Psychoanalysis unit, University College
London, London, UK.
6
Rivierduinen, GGZ Leiden, Sandifortdreef 19, room
A426, 2333 ZZ Leiden, The Netherlands.
Received: 27 August 2015 Accepted: 2 June 2016
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