Flashforward EMDR Treatment for Patients With an ICD

Anxiety and Fear Clinical Trial

— eFFective  

Official title:

The Effectiveness of Flashforward EMDR Treatment for Patients With an ICD

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06174051
• Other study ID #: 85546
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: July 2025

Study information

• Verified date: December 2023
• Source: Erasmus Medical Center
• Contact: Leonieke Kranenburg, PhD
• Phone: +31654276606
• Email: l.kranenburg[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 33
• Est. completion date: July 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety and Fear

Intervention

Behavioral:
• Flashforward EMDR
The Flashforward procedure in EMDR-treatment aims to reduce fear evoked by images of imagined future adverse events.
• Flashback EMDR
The Flashback procedure in EMDR-treatment aims to successfuly process the memories of traumatic events that happened in the past.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Life Events Checklist (LEC-5)	Self-report questionnaire to obtain information on previous traumatic life events	Baseline (Before treatment T0)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)