Investigating a digital device to increase the efficiency of trauma-focused psychotherapy in PTSD patients: a pilot randomized controlled trial of the EMD app.

Posttraumatic stress disorder (PTSD) is a mental health problem with a high
prevalence in the general population; 8% of the population is diagnosed with
this disorder during their lives. Trauma-focused psychotherapies such as
Cognitive Behavioural Therapy (CBT) and Eye Movement Desensitization and
Reprocessing therapy (EMDR) are the first line treatments for PTSD, but 30% of
patients do not benefit sufficiently from these interventions. There is a need
to increase the efficiency and efficacy of treatments for PTSD. Mobile
applications can facilitate application of therapeutic techniques at home in a
way that is easily accessible and low in costs.

The primary objective of the current study is to investigate a potential
increase in efficiency of standard trauma treatment for outpatients with PTSD
by adding a digital device that closely follows the principles of manualized
EMDR treatment, the EMD app (EMD stands for Eye Movement Desensitization).
Secondly, we aim to assess the acceptability and usability of the EMD app from
the perspective of the patients who are treated for their PTSD. Good
feasibility (i.e. adequate system acceptability and usability) and a positive
preliminary effect will justify a larger study investigating the efficiency
gains of the application in the future.

This is a two arm pilot randomized controlled trial with a pre-post design, in
which patients will be randomized to receive EMDR treatment with addition of
the EMD app (five weeks unlimited access to the EMD app) or EMDR treatment
alone (no access to the EMD app). Measurements will take place at baseline and
at each of the five weekly EMDR sessions. A post-measurement takes place in the
sixth week; after five EMDR sessions.

The EMD app is a digital application that can be used on smartphone, laptop and
computer at home as an additive therapeutic intervention to EMDR treatment. The
application closely follows the main steps of the EMDR treatment, which is one
of the most effective interventions for PTSD. It includes focusing on a
repetitive intrusive image together with the associated cognition and emotion,
followed by repeatedly performing a task that taxes working memory, monitoring
of the distress evoked by the image, and introduction of a more positive
cognition in relation to the image.

Because all participating patients receive regular manualized treatment for
their PTSD by a licensed psychologist or psychotherapist, participation in this
study entails a negligible additional risk. If patients do not experience a
drop in distress related to an image during the use of the app, the app has a
built-in feature to advise contacting the therapist. During the development of
the application, the EMD app was tested among employees of Arq Psychotrauma
Expert Group. This pilot study indicated preliminary positive results for the
usability, acceptability and efficacy of the application.