Effectiveness of a two-day EMDR treatment programme for parents of MPS III patients: a randomized controlled pilot trial

Parents of mucopolysaccharidosis type II (MPS III of Sanfilippo syndrome)
patients frequently face potentially traumatic events (e.g., receiving the
initial diagnosis and experiencing the progression of the disease) followed by
short- and long term stress responses. Exposure to such traumatic events can
lead to a wide variety of psychological problems, such as posttraumatic stress,
depression and anxiety. In addition, parents often suffer from anxious thoughts
about the future (such as the progressive course of the disease and death of
their child). Recent research by our group on parenting a MPS III patient
demonstrates high levels of anxiety and depression. The majority of the parents
reported posttraumatic stress symptoms related to their child*s illness and 22%
meet the criteria for Post-Traumatic Stress Disorder (PTSD), compared to 3.8%
in the general population. It is known that stress symptoms in parents have a
great impact on the well-being of the child, even on very young children and
children with a cognitive disability. Therefore, treatment of the post
traumatic stress symptoms of parents is important for both the well-being of
the parent and the child. However, parents of children with a progressive
life-threatening disease, such as MPS III, often do not get the specialized
psychological care they need. Possibly because (1) psychologists in their own
environment are mostly not all experts in this field of medical traumatic
stress related to the progressive disease of their child, and (2) they are
overburdened and therefore long-term therapies or weekly hospital visits are
not sufficient. To overcome above barriers and offer sufficient help to parents
and the patients, a short and more intensive psychological treatment provided
by a pediatric expertise center is needed.

One of the most successful treatments for post-traumatic stress is 'Eye
Movement Desensitization and Reprocessing' (EMDR). EMDR is traditionally
provided in multiple weekly sessions divided over several months. We suspect
however that this approach will lead to high drop-out rates in the already
overburdened parents. Earlier studies showed that a short, intensive EMDR
treatment in combination with physical exercise is effective in reducing PTSD
symptoms in a short amount of time in other study populations (e.g., patients
with severe PTSD). No research has been carried out yet to assess the
effectiveness of a more intensive EMDR treatment programme for parental
posttraumatic stress in the clinical practice of paediatric psychology. Within
this research project, we want to assess the effectiveness of a short,
intensive EMDR treatment programme (two days of EMDR sessions) on the
post-traumatic stress symptoms and psychological comorbidity (psychopathology
in general and parenting distress) in parents of MPS III parents. We believe
that offering a two-day EMDR treatment programme will result in a clinically
significant decrease in post-traumatic stress symptoms and psychological
comorbidity in parents.

The primary objective is to assess the effectiveness of a two-day EMDR
treatment programme compared to a wait-list condition for parents of MPS III
patients, in reducing posttraumatic stress symptoms.

The secondary objective is to assess the effectiveness of a two-day EMDR
treatment programme compared to a wait-list condition for parents of MPS III
patients, in reducing psychological comorbidity (psychopathology in general,
parental stress, and everyday problems in parenting).

The current study will use a *randomized controlled trial pilot design* with
two arms: the intervention condition and the wait-list condition (6 weeks)to
assess the effectiveness of the two-day EMDR treatment programme (see Figure
1). Both mothers and fathers will be invited by letter to participate in the
study. If parents are interested in participating in the study, they will be
asked to fill in online questionnaires at home (T0, pre-treatment) as baseline
measurement and to screen for the inclusion criteria. Eligible parents (see
section 4.2) will be randomly allocated to the intervention condition or the
wait-list condition. For parents in the intervention condition an intake
session (1 hour) consisting of a semi-structured interview will be scheduled 2
weeks after randomization. The two-day EMDR treatment programme will start
within one week after the intake session and has a total duration of 6 hours (4
x 1.5 hour EMDR sessions). There will be one week between the first and second
treatment day (or a maximum of two weeks if one week is not realisable for the
parent). Parents in the intervention as well as the wait-list condition will be
asked to fill in online questionnaires at 6 weeks after the baseline
measurement (T1, two weeks post treatment or post waitlist). In the
intervention condition a follow up assessment will be scheduled at three months
post treatment (T2, follow up). Parents in the wait-list condition can start
with the treatment programme after the waitlist period of 6 weeks (also
followed by measurements two weeks post treatment and three months post
treatment). We have chosen to offer the treatment to parents in the wait-list
condition directly after six weeks since EMDR is a treatment with negligible
risks and we suspect that a waiting period of 6 weeks will keep parents
motivated for the study. Moreover, it will minimize the period in which parents
can exchange information with each other and thereby influence the outcomes.
Both the intake session and EMDR therapy will be carried out at the
Psychosocial Department of the Emma Children*s Hospital/Amsterdam UMC in a
suitable consultation room.

The therapists that provide the EMDR therapy are licensed master*s degree
(clinical) psychologists and advanced EMDR practitioners, working at the
Amsterdam UMC or de Bascule.

Intake session:
A standardized case conceptualization will be developed by the therapist and
parent consisting of a hierarchy of disturbing and stressful memories of
traumatic experiences or flash forwards (fears of the future that are
experienced in the present) regarding the disease of their child. If an acute
psychiatric condition appears to be present and a two-day EMDR treatment
programme seems not indicated, the therapist will refer the parent (if
preferred) to more appropriate psychosocial/psychiatric support. Besides the
EMDR therapist, a researcher (that is also a psychologist) or psychological
intern will be present to take notes.

EMDR treatment:
EMDR treatment (4 x 1.5 hour divided over 2 days, see Table 1) will be offered
by following the standard eight-phase protocol (that is also used as standard
care) presented by De Jongh and Ten Broeke. There will be one week between the
first and second treatment day (a maximum of two weeks if one week is not
realisable for parents). During an EMDR session, the patient focuses on
emotionally disturbing memories (image, thoughts, emotions and sensations) in
brief sequential doses while simultaneously focusing on an external distracting
stimulus (e.g., lateral eye movements). This process facilitates accessing the
traumatic memory network so information processing is enhanced and new
associations can be made between the traumatic memory and more adaptive
memories and information. As result, the traumatic memory representation will
be less intense and emotionally disturbing. Besides the EMDR therapist, a
researcher (that is also a psychologist) or psychological intern will be
present to take notes.

Important to note is that parents will be told at the last treatment day that
they can call at any time if they need more psychological support before the
end of the study.

Evaluation:
The researcher (not the therapist) will have a short telephonic interview with
parents about how they experienced the treatment program, if they would
recommend it to other parents, if they have suggestions for improvement, if the
program was sufficient for them to relieve stress related complaints or if they
need more psychological support. At last the researcher will explore if
potential traumatic events related to the disease of their child occurred since
the last treatment day.

Parents will spent approximately 7 hours in the Amsterdam UMC during
participation in the study. Participation in the study is associated with
negligible risks for parents. EMDR is proven to be a safe, well tolerated
treatment, even for very vulnerable patients. EMDR will be offered by qualified
therapists and is part of standard care in the Emma Children*s Hospital. As
with any form of psychotherapy, there may be a temporary increase in distress.
Subsequent to the treatment session, the processing of information may continue
and dreams, memories or feelings may emerge. The experience is however that
EMDR is very effective in decreasing stress levels immediately and after the
session. Earlier studies have shown that both an intensive eight-day EMDR
treatment programme and five-day EMDR treatment programme were well tolerated
without exacerbation of symptoms, even in patients with severe PTSD and
comorbidity. In our study we focus on unresolved traumatic memories and flash
forwards related to the diagnosis and illness of their child, and we do not
suspect a highly vulnerable research population with severe psychopathology.
Important to note is that parents will be called by the researcher within three
months after the two-day EMDR treatment to ask if they need more psychosocial
support. Moreover, parents will be told at the last treatment day that they can
call at any time if they need more psychological support before the end of the
study. Parents may benefit from the intervention as EMDR is recognized as an
effective first line treatment for reducing posttraumatic stress symptoms and a
wide variety of psychological comorbidity. If the two-day EMDR treatment turns
out to be effective for parents, future parents of severely ill children may
benefit from the treatment and family centred care in the Emma Children*s
Hospital could be permanently improved. Moreover, it is known that stress
symptoms in parents have a great impact on the well-being of the child, even on
very young children or children with a cognitive disability. Therefore
treatment is highly relevant for both the psychosocial wellbeing of the parent
and the child.

Parents have to fill in online questionnaires at their home that last
approximately 35 minutes at a time (three or four time points depending on the
allocated arm). The burden of these measurements are considered minimal.