Walk and Talk: A Randomized Controlled Trial of High Intensive 3MDR Treatment versus Care as Usual for Posttraumatic Stress Disorder.

Posttraumatic stress disorder (PTSD) is a mental disorder with a major health
and economic burden on patients, their relatives and society. National and
international guidelines recommend trauma-focused psychotherapies (TF-PT) as
first-line treatments. TF-PT have proven to be efficacious and cost-effective,
but two thirds of selected PTSD populations do not benefit sufficiently. We
hypothesize that innovative exposure-based psychotherapy that employs
personalisation and interactive movement as novel ingredients (called
multi-modular motion-assisted memory desensitization and reconsolidation
(3MDR)) will augment recovery processes and speed of recovery, will promote
compliance and will therefore be superior in cost-effectiveness compared to
usual care.

The primary objective is to assess the efficacy and cost-effectiveness of 3MDR
against conventional TF-PT in the treatment of work-related PTSD. In addition,
we will examine whether 3MDR treatment compared to care as usual (CAU) results
in a significant difference in depressive symptoms, anxiety symptoms,
avoidance, and impairment in daily functioning due to PTSD symptoms. For both
groups neuropsychological functioning will be examined and possible predictors
for treatment outcome will be explored.

This study is set up as a single blind parallel group randomized controlled
trial in which patients will be randomized to receive 3MDR treatment (10 weekly
sessions) or CAU (16 weekly sessions of TF-PT). Measurements for both groups
will take place at baseline, at eight weeks , directly after treatment, and
with a 12 week interval twice for follow-up. The control condition will undergo
a short additional assessment at 11 weeks, the experimental condition at 17
weeks.

This study entails two treatment conditions: the experimental 3MDR intervention
and conventional TF-PT. The 3MDR intervention is a new type of high intensive
exposure treatment, which combines elements of virtual reality exposure therapy
(VRET), eye movement desensitisation and reprocessing (EMDR), physical activity
and music. During a 3MDR session patients are continuously walking on the
treadmill. The protocollized sessions start with music that facilitates
reminders of the traumatic period, followed by walking on a vitual path towards
prior selected pictures that are highly affect laden. After narrating each
picture and labeling current emotions and physical sensations a second
neurocognitive task is presented in the form of a oscilating ball with numbers
that need to be read. This task is taxing working memory, and is aimed as
distractor from the highly affective memories recalled just before. After seven
pictures the session finishes by walking back on the path to current time
accompanied by contemporary music that facilitates reorientation into the
present. The CAU condition can consist of one of four selected evidence-based
psychotherapies: trauma-focused cognitive behavioural therapy (TF-CBT), EMDR,
narrative exposure therapy (NET) or brief eclectic psychotherapy for PTSD
(BEPP).

Subjects in the 3MDR group will receive a different treatment than care as
usual. Possible risks from the 3MDR condition are physical harm due to falling
on the treatmill. For this the necessary safety precautions have been taken by
the use of a safety harnass and emergency protocol. Patients might experience
initial emotional discomfort and stress due to exposure to their trauma.
However, these risks are comparable to regular trauma treatments. Therefore,
these risk are considered acceptable and maintainable. A previous proof of
concept and pilot study have shown positive effects for 3MDR in therapy
resistant war veterans reported no drop-out or counterproductive effects. In
addition, six assessments are planned which will take 20 minutes to three
hours each. We consider this an acceptable burden, since these assessments are
spread over a period of approximately nine months. None of the procedures are
invasive.