Flashforward EMDR Treatment for Patients With an ICD (eFFective)

Erasmus University

Status: Not yet enrolling

Conditions: Anxiety and Fear

Treatments: Behavioral: Flashback EMDR; Behavioral: Flashforward EMDR

Study type: Interventional

Funder types: Other

Identifiers

NCT06174051

85546

Details and patient eligibility

About

The goal of this randomized controlled trial is to test whether flashforward (FF) EMDR alone is effective in reducing anxiety symptoms in patients with an implantable cardioverter defibrillator (ICD). Participants will fill out several questionnaires to asses their level of anxiety, depression symptoms and quality of life before, during and after treatment.

Full description

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. Therefore, the main objective in this study is to test whether flashforward (FF) EMDR alone is effective in reducing anxiety symptoms in ICD patients. This will be tested with a pilot randomized controlled trial with a three-arm repeated measures design. Subjects will either receive FF EMDR, FB EMDR or no EMDR during the study. To measure their heart focussed anxiety, subjects will fill out the Cardiac Anxiety Questionnaire (CAQ) before, during and after treatment or waiting period.

Enrollment: 33 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• subjects have an ICD;
• subjects have clinical anxiety symptoms related to their ICD.

Exclusion criteria

• insufficient knowledge on Dutch or English language;
• severe psychiatric disorders that warrant (other) psychiatric first, such as suicidality or psychotic disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 3 patient groups

FF EMDR

Experimental group

Description:

Subjects in this group will receive two EMDR treatment sessions following the flashforward protocol.

Treatment:

Behavioral: Flashforward EMDR

FB EMDR

Active Comparator group

Description:

Subjects in this group will receive two EMDR treatment sessions following the flashback protocol.

Treatment:

Behavioral: Flashback EMDR

Control group

No Intervention group

Description:

Subjects in this group will not receive any treatment until the wait list period (4 weeks) is over