Think different. A study into the feasibility and the effectiveness of an online Cognitive Bias Modification training on an app for adolescents with an obsessive compulsive disorder (OCD)

The present study is a continuation of our recently conducted pilot study into
the effectiveness of CBM-I training for children and adolescents with a
obsessive compulsive disorder (OCD), METC number: NL 35351.018.11 and on the
still ongoing study into the effect of CBM-I training as pre-therapy on the
effectiveness of Cognitive Behaviour Therapy (CBT) METC nummer: NL
44055.018.13. .

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 accidents, disasters or sickness. Examples of compulsions are
washing hands too often and too long, checking rituals that take hours,
repeatedly asking for reassurance about 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. So there is a need for improving the therapy.

According to cognitive models (Salkovskis et al.) (fast) negative
interpretations play a crucial role in Obsessive Compulsive Disorder (OCD).
Recently, methods have been developed to change these fast, initial
interpretations with the aid of a computer training (Mathews & Mackintosh,
2000); Cognitive Bias Modification- Interpretation training (CBM-I). Promising
effects of this training have been found in adults both with anxiety symptoms
(see eg Salemink et al., 2009) and with OCD (Clerkin & Teachman, 2011). In a
pilotstudy we examined this training in adolescents with OCD and found evidence
for a positive effect of CBM-I at different clinical outcomes (CY-BOCS
obsessions severity score, and score on scale for internalizing problems)
(Salemink, Wolters, & de Haan, 2015. The preliminary results of the ongoing
study

This indicates an added value of the CBM-I training above the 'treatment as
usual' (CBT). The evaluation of the training, however, shows that, although the
training is perceived as useful, a major drawback is that the training at the
moment can only be done on a computer or PC. This possibly affects the
frequency and duration, of the training and will thus have a negative influence
on the effectiveness. It is expected that the application of CBM-I on a mobile
phone through an app better fits into the lifestyle of adolescents and
consequently will be better used.

This study concerns research into the applicability and effectiveness of CBM-I
training through an app on the mobile phone. The research is done in
adolescents (12-18 years) treated at the Bascule clinic for OCD. The training
will take place during the regular treatment (CBT possibly with medication).
When the CBM-I training through an app appeals to the adolescents and leads to
a better treatment effect, this implies a positive contribution to the
treatment.

The study has a Multiple Baseline Single Case Experimental Design, with two
baseline periods to investigate the effect and the appreciation
(apllicability) of the CBM-I training (12 sessions in two weeks). There are two
phases: baseline phase and training phase. The Baseline phase consists of two
'conditions': 10 days and 14 days baseline. Patients will be randomly allocated
to one of the two baseline conditions. Measurements are carried out at the
start of the baseline, at the beginning of the training phase (= end of the
baseline phase) and at the end of the training phase. During the baseline and
the training phase there is a daily severity measurement, through a Visual
Analogue Scale. .
Training takes place during the usual treatment with CBT and possibly
medication.

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 on the patient is as follows:
Pre test: 1 hour
- A semi-structured interview into the severity of OC symptoms (CYBOCS), with
patient by the assessor
- An interview to determine the dimensions of OCD (DOCS).
- Establishement of the patient's individualized VASschaal taken

Mid- test: 15 minutes
- CY-BOCS

Post test: 30 min
- CY-BOCS
- a questionnaire to evaluate the evaluation

3,5 or 4 weeks (depending on the duration of the Baseline-phase) daily
measurement: VASschaal: 2 minutes a day (total 48 or 56 minutes)

Training
- 12 sessions CBM-I of from about 15 minutes in 2 weeks: 180 minutes

In total, the load is 5-6 hours in three and half to four weeks.
Risks

The measurements and the intervention have no risks.