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Melchior et al. Trials (2019) 20:277
https://doi.org/10.1186/s13063-019-3381-9
STUDY PROTOCOL Open Access
Metacognitive therapy versus exposure
and response prevention for obsessive-
compulsive disorder: study protocol for
a randomized controlled trial
1* 2 3 1
Kim Melchior , Ingmar Franken , Mathijs Deen and Colin van der Heiden
Abstract
Background: The recommended psychological treatment of choice for obsessive-compulsive disorder (OCD) is
exposure with response prevention (ERP). However, recovery rates are relatively modest, so better treatments are
needed. This superiority study aims to explore the relative efficacy of metacognitive therapy (MCT), a new form
of cognitive therapy based on the metacognitive model of OCD.
Design and method: In a randomized controlled trial, we will compare MCT with ERP. One hundred patients
diagnosed with OCD will be recruited in an outpatient mental health center in Rotterdam (the Netherlands). The
primary outcome measure is OCD severity, measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).
Data are assessed at baseline, after treatment, and at 6 and 30months follow-up.
Discussion: By comparing MCT with ERP we hope to provide an indication whether MCT is efficacious in the
treatment of OCD and, if so, whether it has the potential to be more efficacious than the current “gold standard”
psychological treatment for OCD, ERP.
Trial registration: Dutch Trial Register, NTR4855. Registered on 21 October 2014.
Keywords: Obsessive-compulsive disorder, Metacognitive therapy, Exposure and response prevention, Randomized
controlled trial
Background modalities in reducing symptoms of OCD [3]. The
Phenomenology and treatment first-choice psychological treatment for OCD is exposure
Obsessive-compulsive disorder (OCD) is a severe mental and response prevention (ERP) [31, 34, 37], a specific
condition which is characterized by intrusive thoughts type of cognitive behavioral therapy (CBT) based on
(obsessions) and repetitive behaviors (compulsions) learning theory, which suggests that classical condition-
intended to neutralize anxiety induced by these thoughts ing is responsible for the development of obsessions,
[1]. OCD has been ranked among the 10 most debilitat- whereas operant conditioning processes maintain anxiety
ing disorders by the World Health Organization (WHO) and compulsive behaviors [27]. In ERP treatment, patients
and tends to be chronic without adequate treatment are exposed to anxiety-provoking stimuli (situations, ob-
[48]. Both studies into pharmacological treatment, pri- jects, thoughts) combined with the strict prevention of
marily with selective serotonin reuptake inhibitors performing ritual behaviors [26]. Since its introduction in
(SSRIs), and studies into specific forms of psychological 1966, the prognosis for OCD improved substantially.
treatment supported the effectiveness of these treatment However, OCD remains a difficult disorder to treat.
Although numerous studies have found statistically signifi-
* Correspondence: k.melchior@psyq.nl cant change and large improvements in OCD symptoms
1 after ERP, the outcomes are sub-optimal for the majority
Outpatient Treatment Centre PsyQ & Erasmus University Rotterdam, Max
Euwelaan 70, 3062 MA Rotterdam, the Netherlands of patients. More specifically: although about 60% of
Full list of author information is available at the end of the article
©The Author(s). 2019 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.
Melchior et al. Trials (2019) 20:277 Page 2 of 11
treatment completers achieve recovery, only approxi- thought object fusion (TOF). TAF [32] refers to the belief
mately 25% of patients are asymptomatic following treat- that obsessional thoughts can lead to the commission of an
ment [11, 14], which means that the majority of patients action (e.g. “thinking about killing someone will make me
treated with ERP continue to experience distressing OCD do it”). TEF [42] refers to the belief that obsessional
symptoms. Furthermore, the overall effectiveness of ERP thoughts can make events happen (e.g. “thinking about a
for OCD is attenuated by some limitations of the car accident means I will be involved in such an accident”)
approach. As approximately 30% of patients with OCD or mean an event has already occurred (e.g. “If I think I ran
refuse ERP or drop out from treatment prematurely, it is into someone with my car, I probably did it”). Finally, TOF
assumed that overall recovery rates are lower [30]. More- [43] refers to the belief that thoughts or negative feelings
over, these figures suggest that ERP might be hard to can be passed into objects (e.g. “my feeling of evil could be
tolerate and is burdensome, which is supported by the passed into objects and from these objects to other
finding that an important reason for not attempting ERP people”). Once the fusion beliefs are activated, they give
are the requirements of treatment (e.g. exposure to significance to obsessional thoughts and lead to appraisal
anxiety provoking stimuli [46]). So, although it can be of, and worrying about, the thoughts and consequently to
concluded that ERP is efficacious, there is clearly room for feelings of anxiety and perceived threat. This anxiety primes
improvement in the psychological treatment of OCD. It is a second domain of metacognitive beliefs: beliefs about the
assumed that this improvement could result from a better necessity of performing rituals in response to obsessive
understanding in the mechanisms involved in the main- thoughts in order to reduce the perceived threat (e.g.
tenance of the disorder. “Counting to seven will restrain me from acting on my
thoughts”). Consequently, patients with OCD engage in
The metacognitive model of OCD both overt and covert ritual behaviors and, thereby, use
A recently developed theoretical account explaining the specific internal rules (instead of external observation) and
maintenance of OCD symptoms is the metacognitive so-called “stop signals” to determine how the ritual must be
model by Adrian Wells [42, 43]. In this model of OCD, two conducted and when it can be terminated. Such stop sig-
belief domains are assumed to be fundamental in the main- nals are often metacognitive experiences, such as a feeling
tenance of the disorder. First, it is proposed that obsessions of satisfaction (e.g. “I must wash my hands until ‘it feels
are misinterpreted because of metacognitive beliefs about right’”). They also use other neutralizing coping strategies
the dangerousness, significance, and consequences of intru- such as monitoring for further intrusive experiences, which
sive thoughts and feelings, the so-called fusion beliefs. is seen as a counterproductive strategy as it increases the
Three classes of fusion beliefs are highlighted: thought awareness and frequency of intrusive thoughts. The meta-
action fusion (TAF); thought event fusion (TEF); and cognitive model of OCD is illustrated in Fig. 1.
Fig. 1 Metacognitive model for OCD [42]
Melchior et al. Trials (2019) 20:277 Page 3 of 11
Metacognitive treatment for OCD al. [39] found statistically significant reductions on all out-
Based on the metacognitive model, treatment should come variables. Moreover, in terms of clinically significant
focus exclusively on modifying patients’ beliefs about the results, 74% of the treatment completers (n=19) were
importance and power of intrusive thoughts and the classified as recovered after treatment and 47% as asymp-
necessity of performing rituals, instead of challenging tomatic. At follow-up, this increased to 80% and 67% re-
the actual content of the obsessions and compulsions spectively. Finally, Simons et al. [35] found positive
[12]. Although metacognitive therapy (MCT) uses com- outcomes of MCT in comparison to ERP in the treatment
parable techniques as cognitive therapy (CT) for this of pediatric OCD in a case series design. Together, these
purpose, such as verbal reattribution and behavioral findings suggest that MCT might be an efficacious treat-
experiments, the two approaches are fundamentally dif- ment for OCD and deserves controlled evaluation. The
ferent [13]. For example, patients with OCD can describe present trial has been initiated to compare the relative
appraisals in the domain of inflated responsibility, perfec- efficacy of MCT with ERP, in an outpatient clinical sample
tionism, and intolerance of uncertainty. The metacognitive of patients with OCD. Our main hypothesis is that
model proposes that such appraisals result from the acti- MCT is more efficacious than ERP in the treatment
vation of metacognitive beliefs about obsessions; con- of OCD in terms of both statistically and clinically
sequently, it is not necessary to modify these lower order significant improvements, both directly after treatment
beliefs as is done in CT (e.g. by using the pie chart tech- (primary outcome) and at follow-up.
nique to compare the patient’s original estimated proba-
bility with a more realistic estimate of probability) [5, 17]. Design and methods
Targeting such lower order beliefs and automatic thoughts Design
is seen as counterproductive as it just promotes further We will conduct a randomized controlled trial (RCT)
conceptual processing, such as worrying and rumination with a pretest–post-test (primary outcome) 6-month–
[15]. Instead, it is thought that modification of the meta- 30-month follow-up-design. Patients will be recruited
cognitive beliefs about the meaning and power of obses- from consecutive referrals to the Anxiety Disorders
sions removes the need for further conceptual processing. department of PsyQ, an outpatient community mental
Therefore, interventions are explicitly aimed at the meta- health center in the Netherlands. After screening for
cognitive processes which perpetuate the continued eligibility and informed consent, we will randomize the
maladaptive processing instead of attempting to modify patients into two groups: MCTand ERP. The number of
the content of perseverative thinking (i.e. appraisals) [13]. excluded patients and refusers and their reasons are
So far, there is preliminary evidence supporting the registered. Participating patients will be assessed by
efficacy of MCT for OCD. The clinical significance of self-report measures and semi-structured clinical inter-
treatment effects in the following mentioned studies is views administered by a research assistant who is blind
calculated using the standard criteria developed by Fisher to group allocation at entry (pre-treatment), after the last
and Wells [11, 14], based on the method of Jacobson and treatment session (post-treatment – primary outcome),
Truax [21]. Based on these criteria, patients are classified six months (first follow-up) after treatment completion
as recovered if they achieved a reduction of minimal 10 and 30months (second follow-up) after treatment has
points on the Yale-Brown Obsessive Compulsive Scale ended. The latter assessment is included to answer a
(Y-BOCS[19]; a semi-structured interview for OCS) and a secondary research questions on the durability of both
post-treatment score <14. When achieving a post-treat- the ERP and MCT effect on the long term. Due to a
ment score <7, patients are classified as asymptomatic. lack of studies with follow-up periods of >1 year [9, 47],
Using single case methodology, Fisher and Wells [12] the information on longer-term effects are unknown. In
found clinically significant improvements for four OCD case of drop-out, measurements and interviews are also
patients with different clinical presentations who were administered directly after treatment had ended whenever
treated individually with MCT. Two of the four parti- this is possible. The study has received ethical approval
cipants were asymptomatic at both post-treatment and from the Medical Ethical Committee of the Leiden
three-monthfollow-up assessments. Furthermore, Rees University Medical Centre (LUMC) (protocol number
and Van Koesveld [33] found that seven out of eight NL50201.058.14) and is registered in the Dutch Trial
participants in an open trial of group MCT for OCD Register (protocol number NTR4855). All data will be
reached criteria for a recovery status on the Y-BOCS at stored anonymously; there is a data safety and monitoring
three-monthfollow-up (87.5%). In an additional study, Fitt board for the study. Figure 2 shows a flowchart of the
and Rees [16] found similar clinically significant reduc- study from patient enrollment up to data analysis and
tions among three patients treated with MCT using video- reporting. This study follows the “guidance of standard
conference. In an open trial of individual metacognitive protocol items: recommendations of interventional study’s
therapy among 25 patients with OCD, Van der Heiden et (SPIRIT).” The SPIRIT figure template is displayed in
Melchior et al. Trials (2019) 20:277 Page 4 of 11
Entry at PsyQ
Participants are excluded if
they:
Intake phase. Semi structured interview 1) meet DSM-IV criteria for
using the SCID-I major depressive disorder or
substance use disorders
(other than smoking) that
needs immediately treatment
Assessed for eligibility 2) meet DSM-IV criteria for
Inclusion criteria are: psychotic or bipolar disorder.
1) Primary diagnosis of OCD have mental impairment or
2) Seeking treatment for OCD organic brain disorder.
3) Age 18-65. 3) have started medication or
have a change in medication
type or dose in the 6 weeks
before treatment, or during
Potential participants receive information treatment.
about the design and procedures of the
study, both verbally and written.
Informed consent Refusers are offered treatment
as usual, which is exposure
and response prevention at
the Anxiety Disorders
Department of PsyQ.
Pretreatment assessment
Randomization
Allocated to metacognitive Allocated to exposure and
therapy (n=50) response prevention (n=50)
Posttreatment assessment Posttreatment assessment
(primary outcome) (primary outcome)
Follow-up assessment 1 Follow-up assessment 1
(6 months after treatment (6 months after treatment
completion) completion)
Follow-up assessment 2 Follow-up assessment 2
(30 months after treatment (30 months after treatment
completion) completion)
Data analysis and reporting
Fig. 2 Flowchart of the study
Fig. 3. In addition, the SPIRIT checklist can be found in between-group effect (Cohen’s d=0.5 [6]) from baseline
Additional file 1. to post-treatment. We chose for this medium between-
group effect because expecting a larger difference between
Sample size the two treatment groups does seem unrealistic since
There are no studies available directly comparing ERP numerous studies have found statistically significant
with MCT. We chose to design our study with enough change and large improvements in OCD symptoms after
statistical power to enable us to detect a medium ERP. On the other hand, designing our study to enable us
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