Flashforward EMDR Treatment for Patients With an ICD (eFFective)

The Effectiveness of Flashforward EMDR Treatment for Patients With an ICD

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety and Fear
• Intervention / Treatment: Behavioral: Flashforward EMDR; Behavioral: Flashback EMDR

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.

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leonieke Kranenburg, PhD; Phone Number: +31654276606; Email: l.kranenburg@erasmusmc.nl
• Study Contact Backup: Name: Jan Busschbach, PhD; Phone Number: +31681423366; Email: j.vanbusschbach@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FF EMDR; Subjects in this group will receive two EMDR treatment sessions following the flashforward protocol.	Behavioral: Flashforward EMDR; The Flashforward procedure in EMDR-treatment aims to reduce fear evoked by images of imagined future adverse events.
Active Comparator: FB EMDR; Subjects in this group will receive two EMDR treatment sessions following the flashback protocol.	Behavioral: Flashback EMDR; The Flashback procedure in EMDR-treatment aims to successfuly process the memories of traumatic events that happened in the past.
No Intervention: Control group; Subjects in this group will not receive any treatment until the wait list period (4 weeks) is over

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac Anxiety Questionnaire (CAQ)	Self-report questionnaire to asses heart focussed anxiety	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD Check-List (PCL-5)	Self-report questionnaire to examine PTSD symptoms	Baseline (Before treatment T0) and after the second treatment session T2 (for wait list after 4 weeks)
General Anxiety Questionnaire (GAD-7)	Self-report questionnaire to examine general anxiety symptoms	Baseline (Before treatment T0) and after the second treatment session T2 (for wait list after 4 weeks)
Patient Health Questionnaire (PHQ-9)	Self-report questionnaire to examine depression symptoms	Baseline (Before treatment T0) and after the second treatment session T2 (for wait list after 4 weeks)
EuroQol (EQ5D-5L)	Self-report questionnaire to examine quality of life	Baseline (Before treatment T0) and after the second treatment session T2 (for wait list after 4 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Life Events Checklist (LEC-5)	Self-report questionnaire to obtain information on previous traumatic life events	Baseline (Before treatment T0)

Collaborators and Investigators

• Sponsor: Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: December 8, 2023
• First Submitted That Met QC Criteria: December 15, 2023
• First Posted (Actual): December 18, 2023

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Anxiety; ICD; EMDR; Flashforward
• Other Study ID Numbers: 85546

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be available, anonymized, to other researchers, upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No