Cognitive bias modification for patients with cluster-C personality problems (CBM-I ST) a pre-therapy

Rationale: The proposed study investigates whether a Cognitive Bias
Modification Imagery (CBM-I) intervention will change cognitive biases of
patients with cluster-C personality disorders or personality disorder NOS in a
more positive way. It is hypothesized that they will end up with having a more
positive perspective on who they are, on others and the world around them.
Objective: Positive change in cognitive bias and secondary a positive change in
symptomatology.
Study design: Multiple baseline design.
Study population: 24 patients with Cluster C personality or personality
disorder NOS.
Intervention: After a variable baseline period subjects will receive CBM-I via
a computer on a daily bases during 2 weeks.
Main study parameters/endpoints: The main parameter within this research is the
score on the daily measurements; the VAS-MCB and the PANAS. It is to be
expected that patients with personality disorder benefit by following the
computer task training. The scores are expected to be significantly lower on
the VAS-MCB and the PANAS - after the intervention - in comparison to the
control condition (baseline condition).
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Benefits of this study will be, if successful,
that an extra therapeutic tool can be added to Schema therapy for cluster C
patients. It could have the potential to become a first step in ST to treat
this patient group after which one can decide to proceed or not with a longer
term ST after this first step intervention. The risks of this study are
assessed as low. It can be tiring to fill out the questionnaires and other
assessment instruments and perhaps boring to do the computer task, but no other
negative reactions are to be expected.

Primary Objective:
* Is CBM-I successful in changing the cognitive bias in patients with cluster-C
personality disorders or personality disorder NOS?

Secondary Objective(s):
* Will patients following CBM-I show a significant reduction in symptoms and
personality problems?
* Can mental flexibility predict successfulness in changing cognitive bias in
patients who have underwent the CBM-I?

Multiple baseline case series design (also called stepped wedge or staggered
baseline design) using an A-B design with follow up.
Control condition = (randomized) variable waiting time in baseline condition

Start

-Written informed consent
-Administration of sociodemographic measures, MINI and SCID-II
-Verification of eligibility

Measure 1: SQ, SMI-2, SCL-90, ADP-4, IIP, NVM, BRIEF-A

Max. 2 days

Baseline Phase (baseline is variable):
Daily ratings: PANAS and VAS at home each day for a minimum of 2 weeks and a
maximum period of 8 weeks

Measure 2: SQ, SMI-2, SCL-90, ADP-4, IIP

Face-to-face treatment individual orientation session:
*Participants were instructed and trained in generating mental imagery with a
particular emphasis on using a field perspective and not engaging in verbal
processing, before completing a first session of CBM-I with the researcher.
*First session of CBM-I with the researcher

Max. 2 days

Intervention Phase: 2 weeks
*Complete a session of CBM-I independently each day at home for 14 days
*Daily ratings: PANAS and VAS each day at home for 14 days


Measure 3: SQ, SMI-2, SCL-90, ADP-4, IIP

Max. 2 days

Individual interview about experience patients of completing the CBM-I

4 weeks

Follow up phase: SQ, SMI-2, SCL-90, ADP-4, IIP, Feedback interview question
guidev1.3f 2011.05.11 (Blackwell & Holmes, 2010)

CBM-I-computer task
During the 2 weeks of CBM-I training patients will receive 64 positive
paragraphs each day (total amount of 896 positive paragraphs). The positive
training paragraphs are targeted at the 5 primary schema*s and the primary
schema domain which are; 1. Abandonment/ instability (AB), 2. Mistrust/ Abuse
(MA), 3. Emotional deprivation (ED), 4. Defectiveness / shame (DS), 5. Social
isolation / alienation (SI) and Disconnection and rejection (DR). Each
paragraph is designed to have a positive outcome at the end. For example
(Abandonment/ instability): *Your boyfriend comes home and looks worried. He
says that he has to go away for a couple of weeks for work. He then says that
he only will go if you will go with him.* To focus participants on generating
imagery (Holmes et al., 2006), after each training they rated the vividness of
their imagery (*How vividly could you imagine the situation than was
described?*) on a 5-point scale (1 not at all and 5 very). Each session starts
with a neutral practice item of which the vividness is not rated and not
recorded.
The positive paragraphs are organized into eight blocks of eight paragraphs.
Short self-paced breaks are allowed between the blocks, during which task
instruction reminders are displayed. The order of
presentation of the paragraphs is randomized for all participants..
Half of these 896 positive paragraphs will be read in a female voice and the
other half will be read in a male voice. Paragraphs will last 10-15 seconds and
are digitally recorded. They will be stereophonically presented via headphones,
which will be borrowed to the participants for the purpose of this study. The
CBM-I will be presented via an Internet programme called SOTO which is
developed by the Faculty of Psychology and Neuroscience of the Maastricht
University.

Benefits of this study will be, if successful, that an extra therapeutic tool
can be added to Schema therapy for cluster C patients. It could have the
potential to become a first step in ST to treat this patient group after which
one can decide to proceed or not with a longer term ST after this first step
intervention. The risks of this study are assessed as low. It can be tiring to
fill out the questionnaires and other assessment instruments and perhaps boring
to do the computer task, but no other negative reactions are to be expected.