Main outcome is the stronger reduction in PTSD symptoms in the ACT+EMDR condition compared to the Control+EMDR condition.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
trauma-en stressorgerelateerde stoornis (PTSS)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The most important primary research variable is the (differential) decrease in
PTSD symptomatology between the experimental group and the control group from
baseline (T0) to post-EMDR (T2). We use the PCL-5 to measure this. The 20 items
of the PCL-5 can be answered on a 5-point scale from *Not at all* (0) to
*Extremely much* (4). Completing the PCL-5 takes about 5-10 minutes. The
interpretation of the PCL-5 should be made by a clinician.
PCL-5 scores demonstrated similarly strong reliability and validity. Overall,
results indicate that the PCL-5 is a psychometrically sound measure of PTSD
symptoms (Blevins & Weathers & Davis & Witte & Domino, 2015).
Secondary outcome
The secondary research variables are the differences in general well-being;
degree of aggression and quality of life between the experimental group and the
control group. We use the PHQ-9, AGQ and ORS questionnaires to measure this.
The PHQ-9 questionnaire consists of 9 questions about the severity of
depressive complaints based on the DSM IV criteria, with a maximum score of 27
points. The AGQ is a 29-item, four-factor instrument that measures physical
aggression, verbal aggression, anger, and hostility. The ORS is a simple,
four-item session-by-session measure designed to assess areas of life
functioning known to change as a result of therapeutic intervention. These
include: symptom distress, interpersonal well-being, social role, and overall
well-being. The ORS translates these four dimensions of functioning into four
visual analogue scales which are 10cm lines, with instructions to place a mark
on each line with low estimate to the left and high to the right.
Background summary
PTSD is a highly prevalent health issue, with serious consequences in terms of
morbidity and mortality, economic costs, and social problems.
There are good and easily applicable treatment options for treating PTSD and
other trauma-related complaints. Recent Dutch research shows that PTSD can be
treated safely and effectively with EMDR and prolonged imaginary exposure (Berg
et al., 2015). Although EMDR and PE are the first choice in the treatment of
PTSD, there is still room for improvement. After treatment many patients remain
symptomatic (Schnurr et al., 2007). In addition, the dropout percentages are
significant and range between 20 and 35% (Schnurr et al., 2015 & Steenkamp, M.,
Litz, B., Hoge, C.W., & Marmar, C., 2014). Attention bias may play a role in
this and it is therefore interesting to pay attention to this.
During a traumatic experience there are two ways of information processing
(Ehlers & Clark, 2000): Conceptual processing and data-driven processing
(data-driven processing).
Conceptual processing means that the meaning of the traumatic experience is
processed in an organized way and that the information is placed in a context
by making connections with existing concepts, knowledge and views within the
person.
Data-driven processing means that primarily the sensory aspects are processed,
such as sensory, visual and auditory information, without the information
having a clear context and being integrated into the autobiographical memory.
When the information in the representation of the trauma in the memory consists
mainly of sensory information and relatively less conceptual processing has
taken place, the memory, when activated, triggers a sense of re-experience.
When the traumatic experience leads tops views that are very threatening (e.g.
the world is dangerous) this complicates the integration of the trauma
information into the autobiographical memory. The result is that the memory can
be activated quickly and automatically by internal and external stimuli and is
experienced in the here-and-now (also known as flash-backs).
For example, trauma victims more easily remember parts of the trauma that
matches their interpretations of what happened. Corrective information is not
noticed or processed as quickly and this creates a vicious circle.
In accordance with the vicious circle of distortions in the memory and the
interpretation, people with a PTSD will also more quickly perceive
trauma-related stimuli from the environment (perceptual priming), also known as
attention distortion. For example, someone who has ever experienced a dangerous
fire will be more likely to see an upcoming fire truck than someone without
such an experience.
Vermetten (2009) indicates that the prefrontal cortex is an important mechanism
behind both the consolidation and extinction of anxiety. According to
Vermetten, conditioned emotional responses do not extinguish from repeated
exposure to conditioned stimuli without the aversive stimulus.
Woud & Krans (2013) indicate that it is of clinical importance to take these
cognitive distortions in treatment seriously as the subject of treatment.
According to them, these distortions can be changed using cognitive bias
modification techniques.
There are indications that the attention system of anxious individuals has a
distortion of attention in the direction of threat. This is not the case with
non-anxious individuals (Bar-Haim et al., 2007). Research by Badura-Brack et
al. (2015) shows in two randomized control trials that an attention control
training (ACT) provides significantly better symptom reduction than attention
bias modification (ABM) in PTSD patients. In addition, they found that an ACT
and not ABM significantly reduces attention distortion. They conclude that with
a reduction in attention bias a significant decrease in trauma-related problems
occurs.
Taking these results into account, it is interesting to see what the effects of
EMDR are on PTSD symptomatology after this ACT training. These studies do not
answer that. We hope to be able to answer that with this research. Therefore we
think it is important to investigate whether an ACT compared to a placebo
intervention, prior to the EMDR treatment, leads to a better outcome.
Study objective
Main outcome is the stronger reduction in PTSD symptoms in the ACT+EMDR
condition compared to the Control+EMDR condition.
Study design
A double-blind randomized placebo-controlled trial will be conducted.
This is a double-blind randomized controlled trial with an experimental and
control group.
The research will be chronologically in time as follows:
1) A standard intake procedure will take place by administering the PCL-5;
LEC-5; PHQ-9; AGQ and ORS (T0) and the PTSD will be diagnosed by the
Clinician-Administered PTSD scale for DSM-5.
2) The person concerned and diagnosed with PTSD is asked if he wants to
participate in the investigation.
3) If so, randomization takes place. If not, the person will receive a
treatment as usual.
4) The person concerned will then undergo an ACT or ACT-sham training of 12
sessions (2 sessions 5 minutes per day, so 6 days in total).
5) Then we have through the PCL-5 again a measuring moment (T1).
6) Afterwards, each test subject will undergo 6 sessions EMDR.
7) Finally, after these 6 sessions, we have another measuring moment (T2) by
taking the PCL-5; PHQ-9; AGQ and ORS.
Intervention
ACT training involves a simple computerized performance task, that is
non-invasive, requires little cognitive effort, and does not affect the
personal integrity of participants.
Performing reaction time tasks on the computer (ACT training), whereby simple
responses must be given. During the task, distractor stimuli are shown with an
emotional charge. The stimuli are not extreme, but consist of faces with a
neutral or angry expression. The tasks are performed as training in 12 sessions
of 5 minutes each 2 times per day, so 6 days in total.
Attention Control Training, or De-salience Training, task:
Each session of the training task consisted of a block of 120 trials of a
dot-probe task. Trials began with a white fixation cross, onscreen for 200,
300, or 400 ms (with equal probabilities). On every trial a neutral and an
angry face were then presented as cues, one above and one below a fixation
cross, for 400 ms. The facial stimuli were selected from a subset of 11 faces
from the BESST (Thoma et al., 2013). Following the cue period, a probe stimulus
appeared at one of the locations (above or below fixation) at random. Probes
were left- or right-arrows (<< or >>), requiring a left- versus right-hand
button press response. On the other location, a distractor stimulus with
similar visual features was presented (\\ or //), to the aim of making it more
difficult to recognize the probe without actually shifting attention to its
location. The location of the probe stimulus was random and had no relationship
to the locations of the angry and neutral faces presented as cue: This was
intended to train the participants to learn that the cues were irrelevant.
In the Neutral control condition, only neutral faces were presented, removing
the primary negative emotional component of stimuli.
Description ACT training see heading E4.
Study burden and risks
With regard to risks associated with participation, it is highly unlikely that
participants will suffer any negative consequences of the ACT training or
placebo-training. ACT training involves a simple computerized performance task,
that is non-invasive, requires little cognitive effort, and does not affect the
personal integrity of participants.
The burden consists of filling in standard questionnaires about mental health
and PTSD (PCL-5; LEC-5; PHQ-9; AGQ and ORS). Secondly, from performing reaction
time tasks on the computer (ACT training), where simple responses must be
given. During the task, distractor stimuli are shown with an emotional charge.
The stimuli are not extreme, but consist of faces with a neutral or angry
expression. As mentioned earlier, this training has been used successfully in
patient populations without serious side effects. The questionnaires are not
intrusive and are comparable to questionnaires that are also completed in the
context of the treatment. In total, completing the questionnaires takes around
10 minutes.
The study tests an experimental intervention from which patients could
hypothetically benefit, if results provide sufficient evidence to incorporate
the intervention in practice. The training is hypothesized to improve patients'
ability to self-regulate their cognition and emotion and to improve how well
they profit from therapy. The training would be very cost-effective. The
potential benefits of the study are thus significant, against only minimal
costs/risks.
Heidelberglaan 8
Utrecht. 3584 CS
NL
Heidelberglaan 8
Utrecht. 3584 CS
NL
Listed location countries
Age
Inclusion criteria
Participants are admitted if PTSD has been determined in the intake with the
help of the PCL-5 and LEC-5 and CAPS.
Exclusion criteria
The exclusion criteria are:
1) psychotic or bipolar disorder
2) nonfluent Dutch
3) patient does not have a computer
4) no internet access at home
5) inability to use a computer keyboard
6) current psychotherapy
7) use of psychotropic medication that started within the past year.
Participants will be removed from the study if their medication has to be
changed during the trial. They will be admitted if they have been taking a
stable dose of medication for at least 1 year.
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 | NL65710.041.20 |
Other | NTR NL7936 |