The Effectiveness of Flashforward EMDR Treatment for patients with an ICD

Patients with an implantable cardioverter defibrillator (ICD) are at risk of
ventricular arrhythmias (VA). The ICD is a device that can treat VA by
antitachycardia pacing or ICD shocks. Since ICD shocks are painful and
unpredictable, patients with an ICD can suffer from anxiety symptoms. Eye
movement desensitization and reprocessing treatment (EMDR) is an effective
treatment to enhance the process of traumatic events. In addition, this
treatment has also shown to be able to reduce anxiety symptoms. EMDR treatment
according to standard protocol starts with flashback (FB) procedure and may be
followed by the flashforward (FF) procedure. The FB procedure focusses on
events that happened in the past, while the FF procedure aims to reduce fear
evoked by images of imagined future adverse events. So far, it is not clear
whether the FB procedure is always necessary for the EMDR treatment to be
effective. Moving straight towards application of the FF procedure (without
first applying the FB procedure), may save treatment time and costs.

The main objective is to study whether flashforward (FF) EMDR alone is
effective in reducing anxiety symptoms in ICD patients.

This study applies a randomized controlled study design. After having signed
informed consent, patients are randomly allocated to one of three groups. They
fill-out the baseline (T0) questionnaires (LEC-5, PCL-5, CAQ, GAD-7, PHQ-9,
EQ5D-5L) before the treatment. The FF EMDR group starts directly with two
sessions of FF EMDR treatment, without FB procedure. The EMDR FB group starts
with FB EMDR during the first two sessions. Within one to four weeks after the
intake, the participant will have the first EMDR session. The EMDR sessions
will take 90 minutes at maximum and the exact session duration will be timed.
The second EMDR session will be scheduled a week after the first one. Just
before the second EMDR session, the participant will fill out the CAQ (T1).
After the second EMDR session, the patient receives another set with 5
questionnaires (T2; PCL-5, CAQ, GAD-7, PHQ-9, EQ5D-5L) which they will in after
the second EMDR session. Three months after the T2 questionnaires, the patient
receives the set with 5 questionnaires (T3; PCL-5, CAQ, GAD-7, PHQ-9, EQ5D-5L)
again to measure the effects over a longer period of time. The control group
will be on a waiting list for the EMDR treatment hand in the T0 questionnaires
2 weeks after their intake. One week later they will fill out the CAQ (T1) and
one week after that, they will fill out the T2 questionnaires. After that, they
will receive EMDR treatment (which will not be monitored for the purpose of
this study).

The two treated groups will both receive two EMDR treatment sessions. During
the EMDR sessions with patients of the FB group, the focus will be on events
from the past that are perceived as traumatic (flashback or FB), according the
standard EMDR protocol. During the EMDR sessions of the patients in the FF
group, the focus will be on images of (feared) future events (so-called
disaster fantasies), according to the flashforward procedure of the EMDR
protocol.
If the patient requires more than two treatment sessions, the treatment will be
continued with the same psychologist (outside the study context).

We expect that both the FB procedure and the FF procedure will benefit
participants by in reducing their anxiety symptoms. Worsening of symptoms or
adverse events as a result of the intervention are not expected. The duration
of the waiting-list control period is relatively short and falls within the
range of the average waiting time before start of treatment, so this will not
impede an extra burden to patients allocated to the waiting list -control arm.
Study burden consists of filling out questionnaires at three time points.