The purpose of the current study is to test the effectiveness of both trainings (IBT and ABT) in a non-clinical and clinical sample, with the future goal of making the training available to all patients with BPS. The central objectives for this…
ID
Source
Brief title
Condition
- Personality disorders and disturbances in behaviour
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measures:
- Effectiveness of the IBT: the threshold on the continuum from an angry to
happy face on day 1 is compared to the threshold measured on day 7
- Effectiveness of the ABT: the mean reaction time for finding the happy face
among angry faces within the premeasurement on day 1 is compared to the mean
reaction time for finding the happy face among angry faces within the
postmeasurement on day 7
Secondary outcome
Secondary outcome measure.
- A shift on the questionnaire assessing quality of life between the
premeasurement on day 1 and the follow-up measurements on day 7, after one
month and after three months.
- A shift on the questionnaire mapping perceived social support between the
premeasurement on day 1 and the follow-up measurements on day 7, after one
month and after three months.
Background summary
Borderline personality disorder (BPS) is characterized by a predominant pattern
of instability and problems with affect regulation, impulse control,
interpersonal relationships, and self-image (Lieb et al., 2004). BPS is a
psychiatric disorder associated with high suicide rates, significant functional
impairment, high prevalence of comorbid disorders, intensive use of treatments,
and high costs to society (Lieb et al., 2004; Oldham, 2006).
Emotional dysregulation is the core of the disorder and all other symptoms
follow from this disorder (Linehan, 1993 in Baer et al., 2012). This emotional
dysregulation is again strongly associated with several maladaptive cognitive
processes that are overly focused on negativity (Lis & Bohus, 2013). One of
these maladaptive cognitive processes is called interpretation bias (IB), which
is the tendency to interpret ambiguous scenarios or interactions as positive or
negative (Holmes et al., 2011). Several studies have concluded that people with
BPS have a negative bias when interpreting neutral or ambiguous faces (see, for
example, Domes et al., 2008; Dyck et al., 2009; Wagner & Linehan, 1999).
Another maladaptive cognitive process is attention bias (AB), which represents
the tendency to focus or assign attention to certain types of emotional stimuli
(Mathews & MacLeod, 2005). For example, in the case of BPS, a person has an
attentional bias for negative emotional stimuli (Baer et al., 2012).
Given the finding that these maladaptive processes are at the core of the
disorder and influence all other symptoms of BPS (Linehan, 1993 in Baer et al.,
2012), it is important to shift these cognitive biases to a more positive
interpretation. The current study builds on a previous study by Van de Pas
(2020), in which participants completed an online training course to shift
interpretive and attentional bias. The study was conducted on a group of
healthy adult participants, where the goal was to obtain a more positive
interpretation of faces and disconnect attention from negative cues. The
results of this study indicated that the online training was effective in
shifting both biases: the participants had a more positive interpretation of
faces and a faster attention rate for happy faces over angry faces. Thus, the
training appeared to be effective with healthy participants. In Van de Pas's
(2020) study, all participants received the training, meaning there was no
control group to test for effectiveness of the training. To replicate and
demonstrate the effectiveness of these findings, this study will conduct an RCT
within a non-clinical sample.
In addition, an RCT will be conducted within a clinical norm group, consisting
of patients with borderline personality disorder who are in treatment at a
mental health institution. Also within this clinical norm group, the
effectiveness of the interpretation bias training (IBT) and attention bias
training (ABT) will be investigated. The training in the clinical group will,
just like the non-clinical group, be randomized controlled. This is to
carefully examine the effectiveness of the training. Without a control group, a
possible effect of the training may be linked by the treatment the patients are
receiving in addition to taking the training. It is important to know that the
effects are purely the result of the training and not a consequence of their
treatment. The training being studied here is an "add-on" training, added to
the treatment-as-usual that patients with borderline personality disorder
normally receive.
Finally, it is clinically relevant to investigate whether the shifting of the
attention and interpretation biases also has an effect on the daily functioning
of the patient. Therefore, a short questionnaire on quality of life (MHQoL), a
questionnaire on social interactions (SSL-12) and a short questionnaire with
some questions on how contact with others is perceived will be administered
before the training, after the training, one month and three months after the
training to give an indication of improvement in quality of life and social
interactions.
Study objective
The purpose of the current study is to test the effectiveness of both trainings
(IBT and ABT) in a non-clinical and clinical sample, with the future goal of
making the training available to all patients with BPS.
The central objectives for this project:
1. To test effectiveness of interpretation-bias training (IBT) and
attention-bias training (ABT) in a non-clinical sample.
2. Effectiveness of interpretation-bias training (IBT) and attention-bias
training (ABT) tests in a clinical sample.
3. To investigate whether the trainings have an impact in daily life and daily
interactions in the clinical sample.
The research questions for the research project are:
1. Is the IBT effective in shifting one's interpretation bias to a more
positive interpretation of facial stimuli?
2. Is the ABT effective in shifting one's attention bias toward happy faces?
3. Do the IBT and ABT have a positive effect on a person's quality of life and
social interactions?
Study design
Randomised Controlled Trial
Intervention
Interpretation Bias Training:
The goal of the training is to shift the interpretation bias toward a more
positive interpretation of faces. Subjects are shown a face for a brief moment,
after which they must indicate whether the face shows a happy or an angry
emotion. They do this by keying in a "c" for a happy face and an "m" for an
angry face.
On day 1 of the study, a pre-measurement is done. This measures where the
boundary lies for a person between an angry and a happy face. On day 2 to day 6
the training starts with a pre-test to measure where the border lies for a test
subject between an angry and a happy face at that moment. Based on that
boundary, feedback is given in the training. The test subject is shown after
each answer he gives whether this answer was correct.
In the experimental group, the feedback is based on a boundary that has moved
two faces toward the happy face. This means that two faces that were perceived
as angry in the pre-test are now referred to as happy in the feedback to the
subject. In the control group, this boundary does not shift. The training will
take place from day 2 to day 6 and will last 10 minutes each time. Per the
training, one person's face will be used each time. In total there are four
different persons whose faces are shown.
The post measurement is the same task as the pre-measurement, whereby the
borderline between a happy and an angry face is measured again. For the pre-
and post-measurement, a different face is used than during the training
sessions. This is to investigate whether the effect can also be generalized to
other stimuli.
Effectiveness of the IBT:
- The pre-measurement (day 1) will be compared with the score on the
post-measurement (day 7). In the pre- and post-measurement other stimuli are
used than those in the training tasks of day 2 to 6. The difference in
threshold between day 1 and day 7 is used as a measurement of effectiveness,
whereby it can be examined whether the training effects can also be generalized
to other stimuli.
Attention bias training:
The goal of this training is to shift the attention bias toward happy faces
rather than angry faces. The subject in the experimental condition is shown
nine faces, where he has to click as quickly as possible on the happy face that
is among eight angry faces. The control group, doing the placebo training, has
to click as quickly as possible on the neutral face which is among eight angry
faces. At the pre- and post-measurement, both groups are asked to click the
happy face among the angry faces. The reaction times of the pre- and
post-measurement will be compared. The training will take place from day 2 to
day 6 and will last 10 minutes each time. These pre- and post-measurements will
be done with different stimuli than those used in the training tasks on days 2
through 6 to investigate whether the results can be generalized to other face
stimuli.
Effectiveness of the ABT:
- Measured by reaction times at the premeasurement and postmeasurement on days
1 and 7 (Attention bias assessment).
Study burden and risks
There is no risk to subjects.
There is slight cognitive load due to the training having to be done on several
days at a computer. The training can be done from home, so there is no
additional burden due to travel time.
There is also a slight burden due to filling out the questionnaires for this
study (10 to 20 minutes per research moment).
Since this research is subject to the WMO, an exemption has been requested for
a trial subject insurance.
Veldwijk 75
Ermelo 3853LC
NL
Veldwijk 75
Ermelo 3853LC
NL
Listed location countries
Age
Inclusion criteria
The patients in the clinical group are in treatment at GGZ Centraal, a mental
health institution. They will be approached through GGZ Centraal. BPD has been
determined in these patients with the SCID-5P. The non-clinical group will be
approached through the SONA-system of Utrecht University. The patients and
healthy individuals will be between 18 and 65 years old.
Exclusion criteria
Exclusion criteria for participants: Participants should not have any problems
with their vision. In the non-clinical group, participants with a score above
cut-off point on the BSL-23 will be excluded. In the clinical group,
participants with acute psychotic symptoms, a neurological disease or being
under influence of addictive substances will be excluded.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL80948.075.22 |