Eye Movement Desensitization and Reprocessing (EMDR) in children with a medically related trauma: a randomized controlled trial

(Please see METC protocol Par. 1, which includes also references)

Children admitted to the hospital often undergo invasive and painful medical
procedures, possibly resulting in problems with working through these traumatic
events or even a posttraumatic stress disorder (PTSD). About 1 in every 10
children develops a PTSD and circa 3 in every 10 children develop a
partial/subclinical PTSD. This is associated with increased medical
consumption, reduced medical adherence, unfavorable medical outcomes and mental
health problems at long-term. According to research about 1 in 10 children
develop a PTSD due to hospital admission or medical procedures. PTSD is
characterized by disturbing recurring flashbacks, avoidance or numbing of
memories of the event, hyperarousal (high levels of anxiety), and significant
interference with their daily lives. A distinction is made between:
Trauma type I: when there is a single, sudden, unforeseen event (e.g. traffic
accident);
Trauma type II: when there is an extreme event, of which the child knows it can
re-occur. For example, repeated surgery or diagnostic procedure (e.g. heart
catheterization) in a chronically ill child.

Until now, little research has been done into the treatment of PTSD in
children. Currently, cognitive behavioral therapy (CBT) is the most
evidence-based intervention for PTSD, in which the focus is on reducing and
resolving anxiety. A drawback of this treatment is that reliving and replaying
feared thoughts and memories are psychologically very intensive. An innovative
and promising new method of treating PTSD is Eye Movement Desensitization and
Reprocessing (EMDR). EMDR is a standardized treatment method for trauma,
consisting of a structured eight-phase approach to address the past, present,
and future aspects of a traumatic or distressing memory. The difference between
EMDR and CBT is that with EMDR the child does not have to relive the traumatic
event, which may be very burdensome and extensive (this is done in CBT).
Rather, in EMDR a child is asked to select a memory of the trauma that is
currently emotionally painful.

The efficacy of EMDR intervention on PTSD has been shown in adults, and is
advised in the multidisciplinary directive of the Trimbos institute. However,
EMDR is not routinely offered to children. A previous meta-analysis
demonstrated that EMDR can have positive results in children with PTSD
symptoms, also compared to the classic cognitive behavioral therapy. However,
the cause of PTSD symptoms in these children varied: firework disaster, sexual
abuse, hurricane and different events.
Remarkably, no previous study investigated PTSD symptoms due to
medically-related trauma. Our hypothesis is that EMDR is an effective treatment
for children with medically-related trauma.

Our hypotheses are: 1) EMDR will lead to significant improvement of
psychosocial functioning, quality of life and somatic complaints in children
with elevated PTSD symptoms (subclinical/partial PTSD). 2) Children with
unfavourable predictors (low socioeconomic status, less adequate coping) will
benefit more from EMDR as compared to children with favourable predictors.

The objective of the study is to

I. study the effectiveness of a standardized EMDR protocol for children with
elevated PTSD symptoms (so-called subclinical/partial PTSD) with medically
related trauma, and

II. To identify factors predicting treatment success of EMDR in children with
medically related trauma.

(please see also MECT protocl Par. 3 and Figure 1)

The study is a randomized controlled trial (RCT) stratified by Trauma type
(I/II) and age, patients with PTSD symptoms are allocated to: a) a EMDR or b)
care-as-usual CAU. All patients will receive adequate medical care (CAU). In
case of a clinical PTSD, patients will not be randomized but referred directly
for psychosocial care.
At baseline (T0), self-reported and parent-reported PTSS symptoms are
assessed in children aged 4-16 year (n= 78). At the first follow-up (T1), two
weeks after the end of the EMDR intervention or CAU, self-reported and
parent-reported PTSS symptoms are assessed in children aged 4-16 year. At the
second follow-up (T2), 6 months after the end of the EMDR intervention or CAU,
the same assessment will be carried out,

EMDR is a standardized treatment method for trauma, consisting of a structured
nine-phase approach to address the past, present, and future aspects of a
traumatic or distressing memory (a detailed description is given below).
The difference between EMDR and traditional cognitive behavioural therapy (CBT)
is that with EMDR the child does not have to relive the traumatic event, which
may be very burdensome and extensive (this is done in CBT). Rather, in EMDR a
child is asked to select a memory of the trauma that is currently emotionally
painful. This memory will be discussed (why it is painful, what emotions it
evokes) Then, the desensitization is initiated. Painful thoughts are
neutralized by making simultaneously controlled rhythmic eye movements. The
exact working mechanisms behind EMDR are not precisely known; the rationale is
that the working memory in the brain cannot handle competing tasks and thus the
traumatic memory is neutralized. Finally, pleasant and positive thoughts are
installed.

Intervention (EMDR):
The EMDR treatment will focus on reducing PTSD symptoms and will consist of six
weekly sessions of 1 hour. The EMDR session consists of nine phases. Phases 3
to 8 regular are repeated in accordance with a standardized age-appropriate
protocol.

Phase 1: includes assessing the patients medical, psychological and trauma
history, as is done in any psychotherapeutic treatment
Phase 2: the preparatory stage, is intended to build the therapeutic
relationship. Parents and child receive psychoeducation about how EMDR is done.
The psychologist facilitates that realistic expectations are established and
the child/parents are taught about PTSD symptoms.
Phase 3: Assessment phase of traumatic event. The psychologist explores the
sensory, cognitive and affective components of the traumatic memory. The child
is describing the visual image that is most lively and repulsive. Then it is
explored which negative image of the child is evoked by that image (such as
"I'm a failure ') and the child learns to formulate desired positive image in
the opposite direction formulation (such as: "I can succeed).
Phase 4: the desensitization starts. The child is asked to take the image in
mind as well as the tension in feels in parts of the body, and at the same time
the child has to simultaneously follow the hand of the therapist, thus making
horizontal eye movements. After each set of eye movements, a chain of free
associations can arise. It is important that children notice what they
think / hear / smell / feel. This reprocessing continues until the image does
not evoke tension any more.
Phase 5: Installation phase. The positive cognition, that was obtained in phase
3, is reinforced.
Phase 6: the child examines if it feels unpleasant feelings in the body ('body
scan*)
Phase 7: the psychologists checks if there is avoidance behavior. If so, the
child is taught the cognition that it can cope with this situation in future
((future template).
Phase 8: the phase of closing, followed by phase 9: the re-evaluation phase, in
which potential additional goals and progress are discussed and evaluated

The EMDR will be performed by licensed, and experienced health-psychologists
(GZ-psychologen) of the ErasmusMC-Sophia, who followed specific, EMDR training
(training by the Vereniging EMDR Nederland).
To ensure protocol adherence, these EMDR psychologists will receive regular
supervisions (1 supervision hour per 3 EDMR sessions) by a licensed
psychologist-supervisor.

Care-as-usual: after randomization, half of the patients will receive the EMDR
treatment, the other half receives their regular medical care, if applicable,
called care-as-usual (thus no additional psychosocial intervention).

Most questionnaires will need to be filled in online, taking approximately 1.5
hour per assessment for patients and approximately 1 hour per assessment for
parents. Only the CBSK/CBSA will be filled in on paper when the patient comes
to the hospital (or it will be sent home).
At T1 also a diagnostic psychiatric interview will be executed by a research
psychologist at the hospital (1 hour), to identify whether patients scoring
above the clinical cut-off, suffer from a clinical, psychopathological PTSD
disorder. In case of a clinical PTSD disorder (or if patients/parents at any
time-point express a need for acute psychosocial care), adequate referral for
psychosocial care will be arranged; it would be unethical to randomize these
patients.
The same research psychologist will conduct a shortend version of the same
diagnostic psychiatric interview at T2 and T3 (30 minutes each) if necessary.
That is only when the child meets another symptom criteria (that he/she did not
meet at T1) or when the PTSD-total score falls within a higher normative
category (e.g. from above average at T1 to high at T2).
For patients in the EMDR group, 6 outpatient sessions will take place in the
ErasmusMC-Sophia. These will be combined as much as possible with regular
checkup visits.
Considering research findings that ca. 35% of children with medical related
trauma suffer from partial PTSD, we think it most likely that these patients
will benefit from the EMDR intervention.
For each assessment and EMDR visit, parents/patients will receive 20 Euros for
travel costs.
All parents/children who refuse to participate in the whole screeningmeasure,
will be asked if they are willing to fill in only the SVLK once.

The risks associated with participation can be considered negligible and the
burden minimal. Compared to traditional CGT, EMDR is less painful and stressful
for patients, because exposure to traumatic memories is very short during EMDR
sessions.
There is a slight, potential, but not serious risk that children/adolescents
during the EMDR process temporarily may be more tense, irritable and have more
trouble falling asleep. From extensive clinical practice, it is a well-known
fact that these phenomena usually quickly disappear within a few days. Patients
and parents/guardians will be advised to keep a diary about these phenomena and
to discuss them with their EMDR-psychotherapist during their next appointment.
All patients can also stay in contact with their psychotherapist by e-mail or
telephone. Furthermore, patients will be taught to imagine a safe place so they
can calm down and reassure themselves in the case of too much arousal. In this
way, the EMDR procedure encompasses a lot of different *safety strategies*,
which patients and/or parents can use to help themselves. It is a comfortable
procedure with a fast reduction of anxiety, which leads to feelings of hope and
relief and is known to be experienced as supporting rather than distressing

In the unlikely event a worsening of PTSD symptoms occurs, resulting in
psychiatric problems, direct referral to our clinic Child and Adolescent
Psychiatry/Psychology takes place. We do not expect this to happen; moreover,
experienced GZ-psychologists therapists will perform the EMDR under
supervision.