Flashforward EMDR Treatment for Patients With an ICD
- Conditions
- Anxiety and Fear
- Interventions
- Behavioral: Flashforward EMDRBehavioral: Flashback EMDR
- Registration Number
- NCT06174051
- Lead Sponsor
- Erasmus Medical Center
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 33
- subjects have an ICD;
- subjects have clinical anxiety symptoms related to their ICD.
- insufficient knowledge on Dutch or English language;
- severe psychiatric disorders that warrant (other) psychiatric first, such as suicidality or psychotic disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FF EMDR Flashforward EMDR Subjects in this group will receive two EMDR treatment sessions following the flashforward protocol. FB EMDR Flashback EMDR Subjects in this group will receive two EMDR treatment sessions following the flashback protocol.
- Primary Outcome Measures
Name Time Method Cardiac Anxiety Questionnaire (CAQ) Baseline (Before treatment T0), after the first treatment session T1(for wait list after 2 weeks), and after the second treatment session T2 (for wait list after 4 weeks) Self-report questionnaire to asses heart focussed anxiety
- Secondary Outcome Measures
Name Time Method PTSD Check-List (PCL-5) Baseline (Before treatment T0) and after the second treatment session T2 (for wait list after 4 weeks) Self-report questionnaire to examine PTSD symptoms
Patient Health Questionnaire (PHQ-9) Baseline (Before treatment T0) and after the second treatment session T2 (for wait list after 4 weeks) Self-report questionnaire to examine depression symptoms
General Anxiety Questionnaire (GAD-7) Baseline (Before treatment T0) and after the second treatment session T2 (for wait list after 4 weeks) Self-report questionnaire to examine general anxiety symptoms
EuroQol (EQ5D-5L) Baseline (Before treatment T0) and after the second treatment session T2 (for wait list after 4 weeks) Self-report questionnaire to examine quality of life