Follow the Dot to Beat your Anxiety - Using EMDR in Virtual Reality at home to diminish trauma and anxiety in youth

Around 30% of trauma-exposed children and adolescents develop post-traumatic
stress disorder (PTSD) symptoms. A frequently used therapy to reduce acute and
long-term effects of trauma exposure is Eye Movement Desensitisation and
Reprocessing (EMDR). While EMDR is effective, children and adolescents often
experience symptom recurrence when exposed to the feared situation outside the
therapeutic context. This maintenance of fear could be due to avoidance
behavior or context-dependent learning. The Mental Video Check (MVC) and Future
Template (FT), which are included as optional additives to the standard
EMDR-protocol, target avoidance and safety behaviors. The MVC and the FT are
diversely used in clinical practice, but these additives are not scientifically
evaluated yet as component of EMDR.
Moreover, as a solution for relapse from context dependent learning, the
start-up company Psylaris will develop a Virtual Reality (VR) application
targeting avoidance and safety behaviors with the MVC and the FT (VR-based
EMDR), making it possible to intensify treatment by transferring this part from
the therapeutic context to the own living environment.

The main aim of the current study is to evaluate the effectiveness of the MVC
and FT additives of regular EMDR treatment a) in the therapeutic context and b)
with the use of VR-based EMDR in the own living environment of children and
adolescents with avoidance behaviour (a core symptom of both anxiety disorders
and PTSD). .
In addition, to understand how VR-based EMDR works and for whom, participant
characteristics will be identified, and mechanisms of emotion regulation will
be examined.
Children who receive the MVC and FT in the therapeutic context are expected to
have less anxiety symptoms and avoidance behaviors than those who only receive
regular EMDR (without these additives). VR-based EMDR will result in
longer-lasting extinction of trauma-related stress and anxiety because of the
possibility to intensify and relocate EMDR treatment to the home environment.
Furthermore, VR-based EMDR stimulates self-care in the family setting and is
expected to reduce symptom recurrence, enhance patient satisfaction and improve
quality of life.

The MVC and FT will be scientifically evaluated in a multicenter Randomized
Clinical Trial (RCT), with three conditions: a) EMDR-treatment as usual
(EMDR-TAU), b) EMDR-TAU + additives c) EMDR-TAU + VR-based EMDR. Questionnaires
are administered repeatedly (baseline, during intervention, post-intervention
and 1, 3, and 12 months after intervention). Experience Sampling Methodology
(ESM) is used before and during intervention to collect in-the-moment data of
emotions and emotion regulation.

MVC and FT: These optional steps are applicable for all situations which are
still avoided or endured with anxiety after standard EMDR treatment. It starts
with assessment of such situation(s). The MVC consists of the patient mentally
walking through the situation as a movie and whenever the patient feels anxiety
or stress, a desensitisation set is given by the therapist until the patient
can walk through the movie without tension. The FT follows the MVC with a
mental image of the desired situation and behaviour, installing the positive
cognition *I can do it*, until the patient believes it fully.
VR-based EMDR: VR-based EMDR consists of the MVC and FT exactly as described in
the EMDR protocol appendix, but then provided through smart software which acts
on the input of the patient. It will be used first with the presence of the
therapist, and afterwards the patient can follow the steps again at home to
relocate and intensify the treatment.

The risk profile is low, considering all children and adolescents in all groups
will receive standard EMDR (TAU), which has been proven effective and is the
current standard in clinical practice. Moreover, all children will be able to
follow the optional MVC and FT. In the EMDR-TAU + additives and + VR-based EMDR
groups, the optional steps are part of their treatment. Children in the
EMDR-TAU group will be given the opportunity to follow these additives after
the post-intervention assessment.

VR-based EMDR is a CE-certified product with class 1 risk. Children in the
VR-based EMDR group will already profit from the possibility to practice with
the FT and the MVC in their own environment. The MVC an FT focus on the future
and both include a mental video (MVC) or image (FT) of a desired, positive
situation of the previously avoided situation. Due to this positive approach,
this part of the treatment is appropriate for practice at home. Secondly, the
use of VR-based EMDR will be practiced first in the therapeutic context.
Thirdly, parents are aware of the use and can help children in case is
necessary. A safe home-environment is therefore part of the inclusion criteria
of the present study.