Think yourself better: A study into the effectiveness of an online pre-treatment Cognitive Bias Modification training for children with an obsessive compulsive disorder

The current study is a continuation of our recently conducted pilotstudy into
the effectiveness of CBM-I training for children and adolescents with an
obsessive compulsive disorder (OCD), METC number: NL 35351.018.11



A patient with an obsessive compulsive disorder (OCD) suffers from obsessions,
compulsions or both. Obsessions are intrusive and distressing thoughts that,
unwanted, come back repeatedly and cause fear. Examples are: the thought of an
accident that will happen, the thought that the patient or his/her relatives
become very sick, or the thought that he or she will cause a disaster.
Compulsions are repetitive behaviors to prevent or reduce anxiety or distress,
often caused by obsessions, even though the patient knows that the compulsions
will not prevent aaccidents, disasters or sickness. Examples of compulsions are
washing hands too often and too long, checking rituals that take hours,
repeatedly asking for reassurance on trivial subjects and counting during all
sorts of behaviors. The compulsions are either excessive or not connected in a
realistic way with what they are designed to prevent. OCD in children and
adolescents is relatively rare, it affects 1-2% of youth. It is associated with
significant impairments in functioning, for example bad or non functioning at
school, disturbed family relations, social dysfunction and depressive symptoms
(Abramowitz, Whiteside, & Deacon, 2005). Untreated symptoms typically persist.
In most adults the disorder started before they turned twenty years of age.
Cognitive behavioral therapy (CBT) is the treatment of choice (Geller et al.,
2012). With CBT an average of 40-65% decrease in symptoms can be achieved
(e.g., de Haan, Hoogduin, Buitelaar, & Keijsers, 1998; O*Kearney, Anstey, Von
Sanden, & Hunt, 2010; Turner, 2006). Recently, our research group conducted a
randomized controlled trial into the effect of CBT in children with OCD. After
16 sessions of CBT an average decrease of 53% in symptoms was achieved (Wolters
et al., in preparation). This implies that half of the symptoms are still
present after CBT. There were large individual differences in treatment effect.
In some children the symptoms were nearly or completely gone, while other
children had still substantial symptoms.
In case of too little improvement with CBT there are a few options for
further treatment: medication, inpatient treatment or proceeding with CBT.
Although the addition of medication to CBT could lead to a better treatment
effect, it is unknown for which children this is the case (March et al., 2004).
Unnecessary prescribing of medication is not without risk: undesirable side
effects, relaps when medication is discontinuated, little knowledge into
longterm effects. Inpatient treatment is expensive and has far reaching
influences on the patients life, while there are no research data about the
efficacy. The third possibility is proceeding with CBT. The treatment protocol
consists mostly of 12-20 sessions (de Haan & Wolters, 2009; O*Kearney et al.,
2010). It is unknown whether with that number of sessions the maximum effect
can be reached. Continuing CBT can lead to an increase of the effect (Wolters
et al, in preparation). However, longer duration of therapy also leads to
higher health costs and longer waiting lists.
In conclusion, there are not enough possibilities to increase the effect of
treatment without increasing the costs and possible side-effects.
Recently a new treatment has been developed for anxiety and OCD: Cognitive Bias
Modification-Interpretation (CBM-I), a computer training, with minimal
therapeutic time needed. In research a positive effect of this training is
found on anxiety symptoms (Lothmann, Holmes, Chan, & Lau, 2011; Vassilopoulos,
Banerjee, & Prantzalou, 2009; Vassilopoulos, Moberly, & Zisimatou, 2012;
Vassilopoulos, Blackwell, Moberly, & Karahaliou, 2012). The first study into
adults with OCD showed a reduction in OCD-related dysfunctional cognitions and
a reduction the tendency to execute compulsions (Clerkin & Teachman, 2011). The
pilot study, recently conducted by our department, into the effectiveness of
CBM-I training by adolescents with an obsessive compulsive disorder, showed,
despite the small sample size, a trend for a positive effect on clinical
measures and on an implicit interpretation bias measure (for more information
about the pilot study: paragraph 5.3 of the research protocol). The present
application concerns a study into the effectiveness of a short-term CBM-I
training as pre-treatment for CBT in children with OCD. The purpose is to
influence the information processing beforehand which could make CBT faster and
more efficient, thereby lowering the need for medication and inpatient
treatment.

The present study aims to improve treatment of children and adolescents with
OCD by adding a short online CBM-I training to CBT. We use a stepped care model
in which CBM-I training is provided as a first step of treatment, followed by
CBT. The CBM-I training is compared to a waiting list condition in which no
treatment occurs. This waiting list condition is not longer than the usual time
a patient has to wait before treatment starts.
If CBM-I turns out to be effective, children could be helped better and
quicker. CBM-I training has important advantages over other treatments: the
CBM-I training is short-term, applicable in waitlist time for CBT which
provides an earlier start with treatment, and CBM-I is motivating for the
patient, inexpensive and easy to implement.
The researchproject consists of two parts.
1. The effect of CBM-I training. Our research question for the first part is:
Does CBM-I training lead to a change in dysfunctional interpretations and to a
decrease of OCD symptoms?
2. The effect of CBM-I training on further therapy. It is expected that CBM-I
has a positive influence on further treatment. Research into the effect of CBT
versus waiting list control shows an average effect size of CBT of -10.71
points on the Children Yale-Brown Obsessive Compulsive Scale (CY-BOCS; see
below) (O-Kearney et al., 2010). We expect to be able to increase this effect
size by adding the CBM-I training to CBT. The research question of the second
part of this research is: Does the addition of CBM-I training as pre-treatment
for CBT lead to a larger effect of CBT? If this is the case, this means a
better quality of life for the children and their families, shorter waiting
lists for treatment and saving of costs.

This study is a multi-centered, randomized controlled trial with two conditions
in which the effect of the CBM-I training (4 weeks) is compared to a waiting
list (4 weeks) that provides no treatment. The waiting list for treatment is no
longer than usual. Before and after the period of training measurements will be
done by a researcher. After those 4 weeks both groups start CBT according to
protocol, 16 weekly sessions. The effect of this treatment (severity of OCS)
will be measured every 4 sessions by the researcher. At the end of CBT another
measurement will take place.

The Cognitive Bias Modificiation-Interpretation (CBM-I) training (Mathews &
Mackintosh, 2000) is used. In this training dysfunctional interpretations are
changed by teaching new associations between ambiguous situations and
functional interpretations. This happens through repeatedly presenting a series
of different short stories (called scenarios) in which such ambiguous
situations are described and a functional interpretation is given. To actively
involve the patient, he or she has to fill in a word. Only one word is possible
in the sentence. An example of a scenario is:

You have to set the table for dinner. You feel the urge to wash your hands
thorough before you touch the cutlery and dinner-service. You think this is not
necess_ry.

The training is provided on a computer. The patient carries out the training at
home, without help of a therapist. The training consists of 12 practice
sessions of 15 minutes each. The sessions are divided over four weeks, with
three practice sessions a week.

The burden for the patients in the experimental condition consists of filling
in the questionnaires (one about 90 minutes, twice about 60 minutes) and
attending 12 training sessions at home of 15 minutes each, divided over four
weeks.
The burden for the patients in the waiting list condition consists of filling
in the questionnaires (one about 90 minutes, twice about 60 minutes). There are
no risk associated with participation. All patients will receive the usual
(evidence based) treatment for OCD. In the CBM-I training no negative or
harmful associations will be trained. The waiting list control condition is no
longer than usual.