Eye Movement Desensitisation and Reprocessing therapie (no) more Pressure. Does wearing a pressure vest reduce anxiety and dissociation during EMDR?

1. INTRODUCTION AND RATIONALE

The Netherlands has about 400,000 people with PTSD every year, according to the
National Health Care Institute (PTSD Improvement Report, 2020). Only 10 to 35%
of people with PTSD appear to seek help. Trauma-oriented treatment also appears
to have a high incidence of dropout, on average about 16% (Lewis et al., 2020).
However, this differs greatly between client populations. Veterans, for
example, show a high rate of 68% dropout (Schok, 2013). Therapies that focus on
the here-and-now appear to show less dropout. Other researchers report a 40%
dropout rate in cognitive processing therapies for trauma (Alpert et al.,
2019). Focus on the here-and-now, as well as the fact that only 10 to 35% of
people with PTSD seek help, could indicate people's fear of dealing with their
trauma. This seems consistent with research on trauma-related cognitions. (Van
Emmerik, 2007; Merker et al., 2020). The concept of 'window-of-tolerance',
which is often used in the trauma world, also comes in handy here (Siegel,
1999). This theory assumes that processing requires staying within an optimal
voltage window. People with PTSD may have a fear of getting out of their
window-of-tolerance, even during trauma treatment. Deep pressure, such as is
obtained, among other things, while wearing a pressure vest, is known to have a
calming and concentration-enhancing effect. (e.g. Grandin, 1992; Brazelton,
1990; Gunzenhauser, 1990; Alder, 2020; Minoura et al., 2020) This study wants
to add the calming and concentration-enhancing effect of the pressure vest to
an already proven effective trauma treatment (EMDR) and investigate whether
this reduces participants experienced fear and less dissociation during the
EMDR sessions in which they wear the pressure vest than in the EMDR sessions in
which they do not wear the pressure vest. A second research question is whether
the mean number of minutes needed to reach a subjective units of distress (SUD)
score of 0 during the EMDR treatment is smaller in the sessions with a pressure
vest than in the sessions without a pressure vest.

2. OBJECTIVES

2.1 Primary Objective
Do clients experience less anxiety and less dissociation when wearing a
pressure vest during EMDR sessions than when they do not wear a pressure vest
during EMDR sessions?

2.2 Secondary Objective(s)
Do clients experience a faster SUD drop in the vested sessions compared to the
no vest sessions?

3. SINGLE CASE EXPERIMENTAL DESIGN Quantitative research in the form of a
Single Case Experimental Design (SCED). It concerns an alternating treatment
design (ATD), of the SCEDs most suitable for randomization (N-of-1 RCT).
Ambulatory adult SGGZ clients aged 18 to 65 come to the Change-oriented and
Young Adults departments of GGZ WNB. Clients with at least an IQ of 85 who come
for treatment of more than one trauma (multiple trauma), who are not acutely
psychotic and where no addiction is paramount, will be asked whether they want
to participate in the study. • As soon as clients agree to the examination, a
pre-measurement is taken (for measuring instruments, see appendices F1). This
takes about 40 to 70 minutes. • After this, the treatment starts, which
consists of several sessions of EMDR (standard of care PTSD: 6 to 12 sessions).
Clients will receive treatment until they are 'finished' with their PTSD
treatment. This is also for ethical reasons. • For every two sessions, a
randomization program (ATD) determines which of those two sessions the pressure
vest is not worn (condition A) or whether is worn (condition B). This
randomization is repeated for every two sessions, resulting in the pressure
vest being worn as often as not. This creates many possible sequences of
alternating treatment with the pressure vest. For randomisation, use is made of
the randomisation program developed by KU Leuven (see chapter 6, methods; in
particular paragraph 6.2). The pressure vest is professionally measured and
there is a separate instruction, so that the way of wearing is comparable
between different participants and as intended according to the
manufacturer/supplier and according to CE approval. (Size S = 15/20 pumps; size
M = 20/25 pumps; size L = 25/30 pumps. See also Appendix C of the 'subject
information', form E1.) • During each session, some scores are also taken, such
as the SUD, according to EMDR protocol. But also perceived fear and perceived
dissociation are scored on a scale of 0 to 10 at the end of each session. •
After the full EMDR treatment, but maximum after 12 sessions, a post-test is
performed on the client (see appendices F1 for the measuring instruments). This
measurement also takes 40 to 70 minutes. In total, this concerns a
pre-measurement, in which, in particular, the assessment also takes place and
the target group is determined, as well as the seriousness of complaints. A
post-test for this seriousness of complaints is also performed after the
treatment. ========================================== 6.3 Study procedures
6.3.1 Measurement(s) to be administered each EMDR session At the end of each
session, two scores are requested: - A score on a scale of 0 to 10 for the fear
experienced during the session, where 0 = no fear and 10 = maximum experienced
fear. - A score on a scale of 0 to 10 for the degree of dissociation
experienced during the session. Again, 0=no experienced dissociation and
10=constantly / throughout the session experienced dissociation. (minimum 6
sessions / measurements of 5 minutes) The SUD (Subjective Units of Distress)
score during the EMDR. The SUD score is requested at the start of each session
according to EMDR protocol for the target concerned and also according to EMDR
protocol regularly during the session. This continues until the SUD=0. When the
SUD has dropped to 0 during a session, the time during that session is noted.
This is so that the total time required to determine a SUD decrease or the
number of points SUD decrease within a certain time can be determined. In any
case, at the end of each session, the SUD of a target that has been worked on
is determined in accordance with the EMDR protocol. >>> SUD
determination is therefore no extra burden for participants, because it is part
of the regular EMDR protocol. 6.3.2 Instruments included in the pre- and
post-measurement: • To be able to be included in the study and to determine
that there is PTSD: CAPS-5 (Clinical Interview PTSD) • LEC-5 (Life Events
Checklist for DSM-5) a self-assessment questionnaire for the inventory of major
and/or stressful events. Targets for EMDR can also be determined using this.
These questionnaires are normally administered to every registered client with
trauma complaints, so this is also no extra burden for participants. (10
minutes) • Dissociative reactions can be part of criterion B of PTSD according
to the DSM-5, as can physiological reactions. These are measured with: • DES
(Dissociative Experience Scale) 28 questions to more specifically map the
degree of dissociative complaints. (approx. 10 minutes) • SBC (Scale of Body
Connection) 20 questions about the degree of connection that the participant
experiences with his/her body and to map out any somatic dissociative
complaints. (5-10 minutes) DSM-5 screeners to visualize comorbidity (and to be
able to say something about the complexity of both groups): • SCID-5-SV
(Structured Clinical Interview DSM-5 Syndrome Disorders Questionnaire -
screener) to gain insight into other psychological complaints, which regularly
accompany trauma complaints, such as anxiety, depression, panic, concentration
problems, etcetera. (10-20 minutes) • SCID-5-PV (Structured Clinical Interview
DSM-5 Personality Questionnaire - screener) to map out any degree of
personality problems. (20 minutes) These screeners are normally also regularly
indicated and administered as ROM, certainly in the SGGZ population. Therefore
it is not an additional burden. In doing so, the researcher opts practically
for the above-mentioned questionnaires and screeners, because they can all be
prepared within the ROM system of the GGZ WNB and can therefore easily be
completed digitally by participants. In addition, they are scored
automatically. Licenses are available. Whenever possible, the shortest variant
of questionnaires was chosen in order to burden participants as little as
possible with questionnaires. In that case, participants can choose to fill in
the questionnaires somewhat divided over time (within a time frame of one
week). In total, filling in the questionnaires takes the participants about 40
to 70 minutes per measurement (before and after measurement). During the
post-test, the test subjects will also be asked: *How did you experience the
pressure vest?* This gives subjects the opportunity to briefly tell their own
story. Information obtained from this will be analyzed qualitatively. 6.3.3
Safety of the Squease Pressure Vest During the development of the Squease deep
pressure vest, the manufacturer/supplier had frequent contact with the MMC in
Eindhoven. The Quality & Safety department and the Pulmonary Medicine
department advised them during the development. The pulmonologists indicated
that applying pressure to the upper body for a long time with the pressure vest
cannot cause any damage. The pressure vest puts pressure on the rib cage and
only activates the deep layers of the skin. In case of doubt, the supplier
always advises to consult with a concerned doctor or healthcare professional.
The pressure vest is approved as a 'medical device, type 1'. (See Appendix D4.)
Effect of the pressure vest on breathing The vest falls just to / above the
navel so the abdomen is free for abdominal breathing. The pressure vest makes
you more aware of breathing due to the pressure on the upper body. Because the
air can be distributed differently in the air chambers, the chest can still
expand well when you breathe in the chest. The sizes small, medium and large
also have elastic bands in the back, which do not hinder the rib expansion for
breathing. Because the vest falls above the navel, it is not a problem in case
of pregnancy, at most extra Velcro parts will be needed further in the
pregnancy. 6.3.4 Medical Indications Squea

5. TREATMENT OF SUBJECTS
The participants/clients are all diagnosed with PTSD and suffer from multiple
trauma (several traumatic experiences in their lives). For this they are
treated with EMDR for at least 6 weeks, once a week for an hour.

5.1. Investigational product/treatment
A pressure vest is a kind of body warmer, which can be brought to light
pressure with a hand pump. The vest already has the intended effect when it is
inflated 'firmly but comfortably'. It depends on the size of the pressure vest,
how many times it needs to be pumped. (See Appendix D in Subject Information
-E1- Pressure Vest Instructions for Use.)

5.2. Use of co-intervention
During the EMDR treatment it is not a problem if clients also follow another
treatment. Because the scores are compared between EMDR sessions within the
person, and it is determined at random which sessions the patient does / does
not wear a pressure vest, each participant is his own control. This controls
the possible effect of external factors such as additional treatment.

All participants receive evidence-based trauma treatment. The pressure vest is
added, there are no negative experiences with it from the literature. It is a
registered class I medical device and is authorized for use as such (in 2012).
In addition, participants complete questionnaires before and after the
treatment. The questionnaires can be experienced as burdensome. Today, however,
questionnaires (ROM) are used as standard. Incidentally, EMDR treatment can
also be experienced as burdensome. This is why so many failures are reported in
trauma treatment. (See also rationale.)